(5 days)
The Uni-Graft K DV is indicated for use in repair or replacement of damaged and diseased vessels of the abdomen in cases of aneurysmal or occlusive disease.
This device is a vascular graft intended for use as a replacement conduit for abdominal, thoracic, and larger peripheral arterial reconstruction. It is a polyester terephthalate knitted fiber graft coated with modified cross linked gelatin to establish zero porosity or leakage through the wall.
Here's an analysis of the provided text regarding the Uni-graft® K DV Vascular Graft, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Preamble/Background: Replacement conduit for abdominal, thoracic, and larger peripheral arterial reconstruction due to aneurysmal or occlusive disease. | The device is a "replacement conduit for abdominal, thoracic, and larger peripheral arterial reconstruction." Its purpose is to address "aneurysmal disease or potential rupture, and occlusive disease or blockage of the natural vessel." |
| Material/Composition: Polyester terephthalate knitted fiber graft coated with modified cross-linked gelatin to establish zero porosity or leakage. | "It is a polyester terephthalate knitted fiber graft coated with modified cross linked gelatin to establish zero porosity or leakage through the wall." |
| Functional Benefit (coated graft): Does not require preclotting. Minimizes blood loss. Minimizes operative time. Minimizes substitute blood product exposure. Minimizes anesthesia. | "The benefits of a gelatin coated product as a vascular replacement are significant in that it does not require preclotting, minimizes blood loss, operative time, substitute blood product exposure, and anesthesia." |
| Safety (Risk Profile): No increase in risk over an uncoated polyester prosthesis. No increase in complications specifically associated with the Uni-graft prosthesis (bleeding, negative collagen antibody testing). | "Patients undergoing implantation of the Uni-graft® K DV experience no increase in any risk over that of an uncoated polyester prosthesis based upon study results or implantation history of this product in the world marketplace." "This clinical study showed no bleeding, negative collagen antibody testing or complications specifically associated with the Uni-graft® prosthesis at the 6 month study period." |
| Structural Integrity/Stability: Equivalent strength to existing devices. Long-term structural stability. | "All pertinent structural and biological testing such as burst strength, compliance, etc., parameters detailed in the Vascular graft prostheses guidance and tripartite documents have been completed. The results show equivalent strength and long term structural stability of this product compared to existing devices." |
| Effectiveness (Patency Rate): High cumulative patency rate. | "The cumulative patency rate was 98.8%." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The clinical study mentioned involved 100 patients.
- Data Provenance: The study was conducted in Japan from 1990 - 1993. This is prospective data, as it describes a clinical trial designed to collect new information.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided text does not explicitly state the number of experts used to establish ground truth in the Japanese clinical study. It also does not specify their qualifications. The results (e.g., patency rate, absence of complications) would have been assessed by the medical professionals involved in the study (surgeons, other clinicians), but the process for establishing a definitive "ground truth" (e.g., adjudicated outcomes) is not detailed.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the clinical study's outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, nor would it be applicable in this context. This device is a physical vascular graft, not an AI diagnostic tool that human readers would interpret. The studies described are assessing the performance of the device itself in vivo.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone "algorithm only" performance study was not done. This device is a medical implant, not a software algorithm.
7. The Type of Ground Truth Used
For the clinical study on 100 patients, the ground truth was based on clinical outcomes data. This includes:
- Observation of complications (bleeding, immunological reactions, etc.)
- Results of collagen antibody testing
- Measurement of cumulative patency rate
These are objective clinical assessments and measurements rather than expert consensus on images or pathology samples.
8. The Sample Size for the Training Set
The document mentions "Over 200,000 implants worldwide" of the Uni-graft® product with an "exemplary record of success." This vast number of implants represents a significant body of real-world experience and historical data that would have informed the development and validation of the device, essentially acting as a broad "training set" of observational data prior to the specific 100-patient clinical study. However, it's not a formally defined "training set" in the context of an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
For the "over 200,000 implants worldwide," the ground truth was established through implantation history and patient outcomes observed in the world marketplace. This would involve:
- Retrospective review of patient records.
- Post-market surveillance data.
- Compilation of reports from various human and animal studies (as stated: "Various human and animal reports are included in this submission for review").
This "ground truth" is therefore derived from a very large, diverse, and likely retrospective observational dataset of real-world clinical experience.
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99/8/3
Section 2 - Summary & Certification
| Date: | September 5, 1996 |
|---|---|
| Submitter's Name: | Ted Karwoski, VP R&D/OperationsAtrium Medical Corporation |
| Address: | 5 Wentworth DriveHudson, NH 03051 |
| Telephone No.: | (603)880-1433 |
| Trade Name: | Uni-graft® K DVVascular Graft 6mm and larger |
Safety and Effectiveness Summary
This device is a vascular graft intended for use as a replacement conduit for abdominal, thoracic, and larger peripheral arterial reconstruction. Reconstruction is required because of - 1) aneurysmal disease or potential rupture, and 2) occlusive disease or blockage of the natural vessel.
It is substantially equivalent to the Meadox Hemashield and Vascutek Gelseal and Gelsoft. It is a polyester terephthalate knitted fiber graft coated with modified cross linked gelatin to establish zero porosity or leakage through the wall. Minimizing blood loss is extremely important in large diameter conduits such as the aorta.
Implantation of all vascular grafts have potential adverse patient effects or complications. These involve surgical risk from the operation, graft occlusion (which include thrombosis, technical errors in surgery or anatomic positioning) coagulopathy, infection, thromboembolic episodes (downstream clotting), aneurysm, hyperplasia, leaking or weeping of blood or serous fluid (seroma). In addition, coated grafts can cause immunological (allergic) reactions, delayed healing. Any, and all of these complications can lead to amputation which is the undesirable event the synthetic vascular graft was intended to ameliorate.
Patients undergoing implantation of the Uni-graft® K DV experience no increase in any risk over that of an uncoated polyester prosthesis based upon study results or implantation history of this product in the world marketplace.
The benefits of a gelatin coated product as a vascular replacement are significant in that it does not require preclotting, minimizes blood loss, operative time, substitute blood product exposure, and anesthesia.
All pertinent structural and biological testing such as burst strength, compliance, etc., parameters detailed in the Vascular graft prostheses guidance and tripartite documents have been completed. The results show equivalent strength and long term structural stability of this product compared to existing devices.
Over 200,000 implants worldwide of the Uni-graft@ product have occurred with an exemplary record of success. Various human and animal reports are included in this submission for review. A definitive clinical trial comparing the Uni-graft@ to historical coated graft controls was conducted in Japan on 100 patients from 1990 - 1993. This clinical study showed no bleeding, negative collagen antibody testing or complications specifically associated with the Uni-graft® prosthesis at the 6 month study period. The cumulative patency rate was 98.8%. This study as well as the other information provided demonstrates this product to be safe and effective with performance as well as or better than the predicate devices.
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Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three stripes representing its wings and tail feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it.
1 1999 JUN
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joseph P. DePaolo Director of Regulatory Affairs Atrium Medical Corporation 5 Wentworth Drive Hudson, NH 03051
Re : K991813 Uni-Graft® K DV Gelatin Coated Vascular Graft Regulatory Class: II (Two) Product Code: DSY Dated: April 20, 1999 Received: May 18, 1999
Dear Mr. DePaolo,
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Joseph P. DePaolo
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_1_of_1_
510(k) Number (if known):_ K991813
Device Name:__Uni-Graft K DV Vascular Graft
Indications For Use:
The Uni-Graft K DV is indicated for use in repair or replacement of damaged and diseased vessels of the abdomen in cases of aneurysmal or occlusive disease.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mr. R
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number _
Prescription Use_V (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 870.3450 Vascular graft prosthesis.
(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”