(50 days)
The Distaflo Bypass Graft is intended for bypass or reconstruction of peripheral arterial blood vessels.
The Distaflo Bypass Graft is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a cuffed distal end. The Distaflo Bypass Graft can be manufactured with or without Flex beading and with or without a carbon lining.
The provided text is a 510(k) Premarket Notification for the DISTAFLO™ Bypass Graft. It details the device, its intended use, and claims substantial equivalence to predicate devices based on performance data. However, it does not contain the specific information required to complete the table and answer all the questions about acceptance criteria and a study proving those criteria.
The document states: "Device testing was performed on the cuffed portion of the Distaflo Bypass Graft and compared to the results of testing performed on the IMPRA Carboflo Vascular Graft and the Venaflo Graft with Carbon." It further mentions the testing was conducted using methods recommended in "ANSVAAMI VP20-1994: Cardiovascular Implants - Vascular Prostheses and the 1993 FDA Draft Guidance: Guidance for the Preparation of Research and Marketing Applications for Vascular Graft Prostheses." It concludes that "The results of all testing indicated that the Distaflo Bypass Graft is suitable for bypass or reconstruction of peripheral arterial blood vessels and the anticipated conditions of use imposed on the device. The results demonstrated that the Distaflo Bypass Graft has been adequately designed to perform in a manner substantially equivalent to that of the predicate devices."
This is a high-level summary of performance data, but it does not provide specific acceptance criteria values, reported performance metrics, sample sizes, ground truth establishment methods, or details on expert involvement as requested. The document emphasizes substantial equivalence, meaning the device performs similarly to existing, legally marketed devices, rather than meeting specific, novel performance thresholds explicitly stated in this summary.
Therefore, I cannot fill out the table or answer most of the questions with the provided input.
Here's an attempt to answer what can be inferred or directly quoted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from regulatory guidance) | Reported Device Performance |
|---|---|
| Suitable for bypass or reconstruction of peripheral arterial blood vessels | "suitable for bypass or reconstruction of peripheral arterial blood vessels and the anticipated conditions of use" |
| Performs in a manner substantially equivalent to predicate devices (IMPRA Carboflo Vascular Graft and Venaflo Graft with Carbon) | "adequately designed to perform in a manner substantially equivalent to that of the predicate devices." |
| Compliance with ANST/AAMI VP20-1994 Cardiovascular Implants - Vascular Prostheses standards | Testing conducted using methods from this standard. |
| Compliance with 1993 FDA Draft Guidance: Guidance for the Preparation of Research and Marketing Applications for Vascular Graft Prostheses | Testing conducted using methods from this guidance. |
2. Sample sizes used for the test set and the data provenance
The document does not explicitly state the sample sizes used for the device testing or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Device testing was performed on the cuffed portion of the Distaflo Bypass Graft and compared to the results of testing performed on the IMPRA Carboflo Vascular Graft and the Venaflo Graft with Carbon."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The testing appears to be based on engineering and material performance standards rather than clinical expert consensus for a ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable as the device is a vascular graft, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a vascular graft, not an algorithm. The "standalone" performance here refers to the device's physical and mechanical performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device appears to be defined by regulatory standards (ANSVAAMI VP20-1994, 1993 FDA Draft Guidance) and the performance characteristics of its predicate devices, rather than clinical outcomes or expert consensus in the diagnostic sense. The suitability is based on physical and mechanical testing.
8. The sample size for the training set
This is not applicable as this is a physical medical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
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IMPRA
A Subsidiary of C. R. Bard, Inc. 1625 West 3rd Street P. O. Box 1740 Tempe, AZ 85280-1740 TEL: 800-321-4254 602-894-9515 FAX: 602-966-7062
Image /page/0/Picture/4 description: The image shows the word "IMPRA" in a bold, sans-serif font. The letters are all capitalized and appear to be slightly slanted to the right. The image is in black and white, and the letters are solid black. The font is thick and blocky, giving the word a strong and impactful appearance.
CONFIDENTIAL
510(k) Premarket Notification DISTAFLOTM Bypass Graft
510(k) SUMMARY
Submitter Information A.
| Submitter's Name: | IMPRA, Inc.A Subsidiary of C. R. Bard, Inc. |
|---|---|
| Address: | 1625 West Third StreetTempe, Arizona 85281 |
| Telephone: | (602) 894-9515 |
| Fax: | (602) 966-7062 |
| Contact Person: | Kristi M. KistnerManager, Regulatory Affairs |
| Date of Preparation: | October 22, 1998 |
B. Device Name
| Trade Name: | Dista flo ™ Bypass Graft |
|---|---|
| Common/Usual Name: | Vascular Graft Prosthesis |
| Classification Names: | Vascular graft prostheses of less than 6 mm diameter |
IMPRA, Inc., A Subsidiary of C. R. Bard, Inc, C:\MyFiles\REGULATO\510K\DistafloLT6.wpd25
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C. Predicate Device Name
Trade Name(s):
IMPRA Carboflo® Vascular Graft Venaflo® Vascular Graft (Venaflo ePTFE Vascular Graft and Venaflo Graft with Carbon)
D. Device Description
The Distaflo Bypass Graft is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a cuffed distal end. The Distaflo Bypass Graft can be manufactured with or without Flex beading and with or without a carbon lining.
E. Intended Use
The Distaflo Bypass Graft is intended for bypass or reconstruction of peripheral arterial blood vessels.
ﺘﺸ Technological Characteristics Summary
The Distaflo Bypass Graft is manufactured using the same materials and processes as the predicate devices. The shape of the distal cuff is modeled after the Miller Vein Cuff.
(;. Performance Data
Device testing was performed on the cuffed portion of the Distaflo Bypass Graft and compared to the results of testing performed on the IMPRA Carboflo Vascular Graft and the Venaflo Graft with Carbon. The testing was conducted using methods recommended in ANSVAAMI VP20-1994: Cardiovascular Implants - Vascular Prostheses and the 1993 FDA Draft Guidance: Guidance for the Preparation of Research and Marketing Applications for Vascular Graft Prostheses. The results of all testing indicated that the Distaflo Bypass Graft is suitable for bypass or reconstruction of peripheral arterial blood vessels and the anticipated conditions of use imposed on the device. The results demonstrated that the Distaflo Bypass Graft has been adequately designed to perform in a manner substantially equivalent to that of the predicate devices.
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Distaflo Bypass Grafts are substantially equivalent to the currently marketed IMPRA Carboflo Vascular Graft and the Venaflo Vascular Graft.
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine and health. The caduceus is depicted as a staff with two snakes coiled around it, and a pair of wings at the top.
DEC 1 6 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kristi M. Kistner Manager, Requlatory Affairs IMPRA, Inc. 1625 West 3rd Street P.O. Box 1740 Tempe, AZ 85281-1740
Re : K983769 IMPRA Distaflo™ Bypass Graft Regulatory Class: III (Three) Product Code: 74 DYF Dated: October 22, 1998 Received: October 26, 1998
Dear Ms. Kistner:
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 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 reqistration, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 - Ms. Kristi M. Kistner
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 requlation (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" (21 CFR 807.97). Other qeneral 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/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): K983769 and K983861
Device Name:_Impra Distaflo™ Bypass Graft
Indications For Use: Distaflo™ Bypass Grafts are intended for bypass or reconstruction of peripheral arterial blood vessels.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K983769/K983861
Prescription Use
(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.”