Medical Devices Advisory Committee




НазваниеMedical Devices Advisory Committee
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FOOD AND DRUG ADMINISTRATION

Medical Devices Advisory Committee


Clinical Chemistry and Clinical


Toxicology Devices Panel


February 26, 1999


Gaithersburg Marriott

9751 Washingtonian Boulevard

Gaithersburg, Maryland


Proceedings By:


CASET Associates, Ltd.

10201 Lee Highway #160

Fairfax, Virginia 22030

(703) 352-0091

PARTICIPANTS:


Committee Members:

Henry Nipper, Ph.D., Chairperson


Voting Members:

Robert Rej, Ph.D.

Beverly Harrington Falls, M.D.

Sherwood Lewis, Ph.D.

Martin Kroll, M.D.

Barbara Manno, Ph.D.

Nader Rifai, Ph.D.


Temporary Voting Members:

Steven Clement, M.D.

James Cooper, M.D.

Arlan Rosenbloom, M.D.

Janine E. Janosky, Ph.D.


Consumer Representative:

Davida Kruger


Industry Representative:

Robert Habig, Ph.D.


Patient Representative:

James Reed


Executive Secretary:

Sharon K. Lappalainen



TABLE OF CONTENTS

Page

Open Public Session 9

Sponsor Presentation

Introduction 18

Terry Gregg, President & CEO, MiniMed, Inc.

System Overview 21

John Mastrototaro, Ph.D.

Clinical Experience at USC 38

Jorge Mestman, M.D.

Multi-Center Study, Overview & Data Analysis 43

Todd Gross, Ph.D.

Clinical Use 60

Alan Marcus, M.D.

FDA Presentation

Overview & Introduction 71

Steven I. Gutman, M.D.

Statistical Review 75

John Dawson

Remarks on Calibration 85

Gregory Campbell, Ph.D.

Open Committee Discussion 97

Open Public Session 262

Vote & Recommendation 265


P R O C E E D I N G S [8:35 a.m.]

Agenda Item: Opening Remarks -- Introduction

MS. LAPPALAINEN: Good morning and welcome. I would like to welcome the chairperson, panel, the members of the audience and the sponsor.

This is the Clinical Chemistry and Clinical Toxicology Devices Panel for February 26, 1999. I am Sharon Lappalainen. I am the executive secretary for this panel.

We are here today to provide advice and recommendations to the Agency regarding a premarket approval application or PMA for the Continuous Glucose Monitoring System presented by MiniMed, Incorporated.

The CGMS is intended to continuously record interstitial glucose levels in persons with diabetes mellitus. This information is intended to supplement, not replace, blood glucose information obtained using standard home glucose monitoring devices. The information collected by the CGMS may be downloaded and displayed on a computer and reviewed by health care professionals.

This information may allow identification of patterns of glucose level excursions above or below the desired range, facilitating therapy adjustments, which may minimize these excursions.

The Clinical Chemistry and Clinical Toxicology Devices Panel last met on December 10th, 1997. At that meeting, the panel deliberated upon a premarket approval application for the Sol Est Test presented by Biex(?), Incorporated. Since that time, this device has been granted approval to the market

For today's panel, I would also like to welcome James Reed, who will serve as our patient representative. Mr. Reed has the distinction of being CDRH's first patient representative to serve on the Medical Devices Advisory Committee and Mr. Reed will be representing individuals who have diabetes.

Welcome.

For the purposes of today's panel, the following individuals have received an appointment to temporary voting status. Pursuant to the authority granted under the Medical Devices Advisory Committee charter, dated October 27th, 1990, as amended April 20th, 1995, I appoint the following people as voting members of the Clinical Chemistry and Clinical Toxicology Devices Panel for the duration of this panel meeting on February 26, 1999: Dr. Steven Clement, Dr. James Cooper, Dr. Arlan Rosenbloom, Dr. Janine Janosky and Dr. James Everett.

For the record, these individuals are special government employees and are either a consultant to this panel or a consultant or voting member of another panel under the Medical Devices Advisory Committee. They have undergone the customary conflict of interest review and they have reviewed the material to be considered at this meeting.

This is signed "D. Bruce Burlington, M.D., Director of the Center for Devices and Radiological Health."

I would also like to read the conflict of interest statement for today's meeting. The conflict of interest statement for the Clinical Chemistry and Clinical Toxicology Devices Panel meeting, February 26, 1999. The following announcement addresses conflict of interest issues associated with this meeting and is made part of the record to preclude even the appearance of an impropriety.

To determine if any conflict existed, the Agency reviewed the submitted agenda and all financial interests reported by the committee participants. The conflict of interest statutes prohibit special government employees from participating in matters that could affect their or their employers' financial interests.

However, the Agency has determined that participation of certain members and consultants, the need for whose services outweighs the potential conflict of interest involved is in the best interest of the government. We would like to note for the record that the Agency took into consideration certain matters regarding Drs. Martin Kroll, Nader Rifai and Steven Clement. Dr. Kroll reported a past interest and Dr. Rifai reported past and current interests in firms at issue on matters not related to the issues before the panel.

DR. Clement reports that a firm at issue provided supplies for a government-funded project. Since these matters are not related to the specific issues of this meeting, the Agency has determined that these panelists may participate in today's deliberations. In the event that the discussions involve any other products or firms not already on the agenda for which the FDA participant has a financial interest, the participants should excuse him or herself from such involvement and the exclusion will be noted to the record.

With respect to all other participants, we ask in the interest of fairness that all persons making statements or presentations disclose any current or previous financial involvement with any firm whose products they may wish to comment upon.

Before I turn the meeting over to Dr. Nipper, I would like to briefly bring Dr. Gutman forward.

DR. GUTMAN: Good morning. I have two for the price of one. I have an introduction and greeting and a thank you and goodbye. The introduction and greeting is to Dr. Jeanne Cooper -- I will ask her to stand -- who is the new branch chief for the Clinical Chemistry and Toxicology Branch.

Dr. Cooper is a veterinary medical officer we have stolen from the Center for Vet Med. She had a sojourn in DCLD earlier, so had some experience with our wild ways and we are delighted to have her lead this group.

The thank you and goodbye is to Dr. Robert Rej, who is completing his term on our panel and who has been very active both in panel meetings and has been very active behind the scene in a number of exciting homework assignments that we have provided him that he has studiously responded to, which -- actually not a real goodbye because we are not going to truly release him. We are going to hold him on as a consultant and he is likely to be back either helping us through homework or actual panel meetings in the future. But we do appreciate the great job he has done.

[Applause.]

MS. LAPPALAINEN: Now, I would like to make two notations to the record. It appears that Dr. Rifai is snowed in at Logan Airport. I think New England got a nor'easter last night.

The other thing is that Dr. Beverly Harrington Falls, I believe, is delayed. We will go ahead and continue with the panel meeting.

Now, I would like to turn the panel over to Dr. Nipper, who will have the committee introduce themselves.

DR. NIPPER: Thank you very much, Ms. Lappalainen. I guess the best way to do this is to start with somebody I know well. We will start with Dr. Bob Habig and we will proceed around the room in order, introducing ourselves and stating our affiliations and, briefly, anything else you want to say.

DR. HABIG: Thank you, Dr. Nipper.

I am Robert Habig. I am director of Corporate Regulatory Affairs at Becton Dickinson and Company. I notice the bio sheets were written when I joined this panel and was at Bayer Corporation, but that is in the past.

I am the non-voting industry representative to the panel.

MS. KRUGER: I am Davida Kruger. I am a certified nurse practitioner at Henry Ford Health Systems in Detroit and I am the consumer representative on this panel.

MR. REED: Jim Reed, the patient member of the panel. I am a Type 1 insulin dependent diabetic and have been for many years. I am a systems engineer, member of the board for Diabetics Educating and Empowering Diabetics, DEED, also involved with ADA and JDS.

DR. KROLL: I am Martin Kroll. I am a clinical pathologist and associate director at Johns Hopkins Hospital, of clinical chemistry.

DR. COOPER: I am James Cooper. I am a geriatrician. I am on the faculty of the Uniform Services University. I am on attending staff of the National Naval Medical Center and I am senior geriatrics advisor for the Medicare Program.

DR. LEWIS: I am Sherwood Lewis, director of toxicology at the Office of the Chief Medical Examiner, the State of Connecticut. I am a voting member of the panel.

DR. REJ: I am Bob Rej. I am associate professor of biomedical sciences at the State University of New York at Albany and director of chemistry and hematology for the New York State Department of Health. I am a voting member of this panel and, as Steve just said, soon to be a has been.

DR. NIPPER: Better to be a has been than a never was and I don't think you are going to be a has been.

I am Henry Nipper. I am a member of the faculty, pathology faculty, at Creighton University in Omaha and I am currently the dean of admissions of the medical school there, which takes me out of the lab actively, much to my regret, but I have been chair of the panel for a little while and I am honored to be here today.

MS. LAPPALAINEN: I am Sharon Lappalainen. I am the executive secretary of the Clinical Chemistry and Clinical Toxicology Devices Panel. In my spare time, I am a scientific reviewer for the Food and Drug Administration, the Division of Clinical Laboratory Devices.

DR. ROSENBLOOM: Arlan Rosenbloom, professor emeritus of pediatrics, the University of Florida in Gainesville and associate director of Children's Medical Services for about a fourth of Florida.

DR. MANNO: I am Barbara Manno. I am professor, Department of Psychiatry at the Louisiana State University Medical Center in Shreveport and I am also co-director of the Clinical Toxicology Laboratory at the University Hospital there.

DR. CLEMENT: Steve Clement, here locally, associate professor here at Georgetown University in Washington, D.C. I am the director of the Georgetown Diabetes Center, spend most of my time working primarily with diabetic patients, as part of an integrated team approach and spend most of my time trying to think up ways to improve the lives of diabetic patients.

DR. EVERETT: I am James Everett, family practice physician in Atlanta, Georgia. Currently, I have been working with teaching residents family practice, but now I am moving on to an administrative position within the university, setting up a rather extensive diabetic education program throughout the State of Georgia.

DR. GUTMAN: I am Steve Gutman. I am the director of the Division of Clinical Laboratory Devices.

DR. JANOSKY: Janine Janosky from the University of Pittsburgh School of Medicine. I am a biostatistician, a voting member of the Dental Products Panel and a consultant to this panel.

DR. NIPPER: Thank you very much.

We are here, as Ms. Lappalainen said, to consider the premarket approval application for a Continuous Glucose Monitoring System for the continuous recording of interstitial glucose levels in persons with diabetes mellitus.

Agenda Item: Open Public Session

At this time, we are going to move to an open public session. Public attendees, who have contacted the executive secretary prior to the meeting will address the panel and present the information relevant to the agenda. Speakers are asked to state whether or not they have any financial involvement with manufacturers of any products being discussed or with their competitors.

At this time, I would like to call on Beth Silvers, a registered dietician with some other letters behind her name she can explain. She is president of Metrolina(?) -- I hope I have pronounced that correctly -- and a member of the Association of Diabetes Educators.

Ms. Silvers.

MS. SILVERS: Thank you, sir. I appreciate that.

I also welcome this opportunity to come before the panel and I just wanted to thank you for that. All the other initials after my name, first and primarily, I am a registered dietician. I am also a certified diabetes educator. That is what the CDE is. And the LDN is in the State of North Carolina, you have to be licensed to practice nutrition. So, the LDN shows that I am licensed in the State of North Carolina.

I am also a Type 1 diabetic. I have been insulin dependent for 36 years. I have been on pump therapy for five years and I am a certified pump trainer with both companies. There are two continuous insulin infusion pumps available in the United States and I am certified to train in either one. I have worn both pumps. The only affiliation that I have financially with either is when they pay me to do a pump training. They have not sponsored me today nor have they paid any of my travel arrangements to be here today.

I did want to voice my firm approval of this product and let you know that I do think that it would be very beneficial primarily at this point for our insulin dependent pump wearers, but also I think in the foreseeable future we could use this device to help us to regulate blood glucose variations over time in even the insulin dependent diabetics that are not wearing pumps.

We would be able to monitor their blood sugars and see when their levels are peaking, to see when their insulins need to be peaking, if we need to adjust the dietary regime of the client or be able to adjust their exercise patterns to match where their blood sugar exclusions were coming.

I foresee this device as being a very viable product for my client. The Metrolina Association of Diabetes Educators in North Carolina, we educate and train a large number of diabetics. I tried to get a head count on how many we had contact with and the girls in the group said I don't know, you know. We said more than a thousand, but we could very easily use this device if it is approved for the market to help our clients to be able to monitor and to see where their excursions were coming.

So, I look forward to this device coming to the market and to be able to be trained to be able to use that in the clients.

I also as a health care professional have to look at the flip side to every question and look and see where there may be problems. I foresee that this device, if it is anything similar to the insertion sets that are being used with our pump therapy now, I don't foresee that that is going to be a major problem because we have seen the infection rates to be extremely low with pump devices, with the insertion devices.

So, I am foreseeing -- I haven't actually had my hands on one of these devices or know the details of that. I am sure MiniMed could answer those questions, but I don't foresee that there should be any safety or efficacy of that side of it. So, I feel very comfortable that this would be a good device.

Again, I think that I welcome this opportunity and would be welcome to any questions that the panel may have for me as an individual.

DR. NIPPER: Thank you.

There is a little time for a question if the panel has one. Yes, Mr. Reed.

MR. REED: Jim Reed. You mentioned that you see this device as primarily beneficial to Type 1, particularly pumpers. Why not Type 2 and why pumpers in particular versus multiple injection or whatever?

MS. SILVERS: I think as a beginning device, because the pumpers are already trained in this insertion device type device that it would be good to use in them first. I think eventually it would be usable for the Type 2 client, as well as other Type 1s, again, looking to see where those fluctuations in the blood sugar are occurring, to see if the Type 2 diabetic, who is taking the dose of NPH in the morning, if that peak time is really six to eight hours after injection, to look and see if we could better match up that individual's balance of blood sugars to peaking insulin.

So, eventually, I think that it could be used for any type of client, possibly even those not on insulin injections, but I just feel that the Type 1 pump wearers already have the knowledge that would be necessary for the insertion of this type device. So, I think that would be a good starting place. I would not want to exclude the other Type 1s or the Type 2s either.

DR. NIPPER: Thank you.

Are there any other questions from the panel for Ms. Silvers?

[There was no response.]

Thank you for your contribution.

Our next presenter on the list is Dr. Kenneth Emancipator, director of clinical chemistry at Beth Israel. I assume that is in New York. Dr. Emancipator is speaking on behalf of the American Society of Clinical Pathologists.

DR. EMANCIPATOR: I am Kenneth Emancipator. I am a pathologist and director of clinical chemistry at Beth Israel in New York City. I am speaking here today on behalf of the American Society of Clinical Pathologists, where I serve as chairman of the Commission on Continuing Education Council on Clinical Chemistry.

I have no known conflicts of interest on this issue, although I do have to say that I can't tell you the various mutual funds I own. I have no idea what their holdings are.

The American Society of Clinical Pathologists, also known as ASCP, appreciates this opportunity to address your panel today on the premarket approval application of a continuous glucose monitoring system. ASCP is a non-profit medical specialty society organized for educational and scientific purposes.

Its 75,000 members include board certified pathologists and other physicians, clinical scientists and certified technologists and technicians. These professionals recognize the society as the principal source of continuing education in pathology and as the leading organization for the certification of pathology, laboratory personnel.

ASCP's Certifying Board registers more than 150,000 laboratory professionals annually. It is our understanding that the continuing glucose monitoring device under review today is a sensor that is placed beneath the skin of the abdomen to measure interstitial fluids. The data from the device is not a real time display of information, but is rather transmitted to a computer for measurement and evaluation.

The device is used to assess trends in glucose concentration in order for patients to better plan their glucose finger sticks. The device is intended to be used in concert with blood glucose monitoring.

ASCP is not here today to speak in favor nor in opposition to this particular device. However, we do have concerns that any device that uses interstitial fluids to measure a patient's glucose level must display the same level of precision and accuracy as any other blood glucose monitoring device.

The accurate analytical performance of any device is essential for patient care. In order to foster the best technicological development of a device, it should be used exclusively for its intended purpose. Considering the proposed use of this device and its combined performance with blood glucose monitoring, it is not necessary to demand its equivalence to a laboratory blood glucose.

Again, thank you for your consideration of our comments on Continuous Blood Glucose Monitoring System and I would be pleased to answer any questions you may have.

DR. NIPPER: Thank you, Dr. Emancipator.

Are there any questions from the panel for Dr. Emancipator?

Dr. Habig.

DR. HABIG: I noticed that your society says that the device needs to have the same precision as a blood glucose monitoring. Because of its intended use, since it is not a diagnostic or a screening or a device for a specific diagnosis, what is the background of your sort of requirement that it have the same precision?

DR. EMANCIPATOR: Okay. I think our main concern is that we are trying to force technology here. In other words, an imprecise device may be better than no measurement at all and we are making the distinction between laboratory glucose, which has excellent precision, and the typical reflectance meters used for home monitoring.

But, again, we are looking to force technological development to get a sufficient level of accuracy because I think if you approve a poor device, there isn't as much incentive to force manufacturers to go on and do better.

DR. HABIG: I guess maybe a follow-up question. If the device measures interstitial fluid with the same precision as a blood glucose meter measures blood glucose, does that -- what I want to distinguish is you don't expect the interstitial fluid itself to give you exactly the same information as blood. You want the device to be able to measure the interstitial fluid with the same precision a blood meter measures blood.

DR. EMANCIPATOR: Okay. Right. Well, I think when you look at the clinical interpretation, we are looking for analytical performance, but I think it is also incumbent upon the manufacturer. It doesn't have to give the same numerical result, but I think part of this whole process is there should be a well-defined relationship between glucose and interstitial fluid and blood.

If I could expound on that, if we know that interstitial fluid always runs, let's say, 10 milligrams per deciliter, you know, lower than blood, that is fine, as long as that is a constant. But, again, if the relationship between blood and interstitial fluid fluctuates, then you kind of have to add that to the imprecision of the method.

DR. NIPPER: Dr. Rej.

DR. REJ: Bob Rej.

I am a little bit confused here because on page 1 of your prepared statement, you really do state that it must display the same level of precision and accuracy and then at the end say that it need not be equivalent. I am just curious what -- there seems to be a bit of a dichotomy here.

DR. EMANCIPATOR: No, no, no. Okay. We are talking about, again -- I thought I said -- I guess I wasn't clear -- the dichotomy is that there is a laboratory blood glucose monitor, as you would measure in a clinical laboratory on an instrument, has a very high degree of precision, much higher than a portable glucose meter for home use.

I think what we are saying is that the standard that we are applying here is that this interstitial device should have analytical performance at least as good as a home use device.

DR. REJ: Okay. Fine.

DR. EMANCIPATOR: Okay? Because we do recognize there are two levels of analytical performance here.

DR. NIPPER: That clears up my question, too.

Any other questions from the panel for Dr. Emancipator?

If not, we thank you very much for your presentation.

DR. EMANCIPATOR: Thank you.

DR. NIPPER: At this point, the agenda calls for a presentation by the sponsor, MiniMed. We have an hour and 15 minutes allotted for that purpose and the first person on the list is Mr. Terry Gregg, who is president and CEO of the company, who is going to give us the introduction.

Mr. Gregg, welcome.

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