(22 days)
The Distaflo Bypass Graft is intended for bypass or reconstruction of peripheral arterial blood vessels.
Distaflo™ Bypass Grafts are 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.
Here's a breakdown of the acceptance criteria and study findings for the IMPRA Distaflo™ Bypass Graft, based on the provided document:
Acceptance Criteria and Device Performance
The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that the testing aimed to demonstrate "substantial equivalence" to predicate devices. The "Performance Data" section indicates:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Predicate Device Performance / Standard(s) Used | Distaflo Bypass Graft Performance | Outcome |
|---|---|---|---|
| Mechanical/Physical Properties of Cuffed Portion | IMPRA Carboflo Vascular Graft & Venaflo Graft with Carbon (using methods from ANSI/AAMI VP20-1994 and 1993 FDA Draft Guidance for Vascular Graft Prostheses) | Suitable for bypass/reconstruction of peripheral arterial blood vessels under anticipated conditions of use. | Met - Substantially Equivalent |
| Biocompatibility/Material Equivalence | Use of same materials as predicate devices (IMPRA Carboflo Vascular Graft, Venaflo Graft with Carbon, and Venaflo ePTFE Vascular Graft and Venaflo Graft with Carbon). | Same materials as predicate devices. | Met - Substantially Equivalent |
| Manufacturing Process Equivalence | Use of same processes as predicate devices. | Same processes as predicate devices. | Met - Substantially Equivalent |
| Design Equivalence (Distal Cuff) | Modeled after the Miller Vein Cuff. | Modeled after the Miller Vein Cuff. | Met - Substantially Equivalent |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample size for the "test set" (i.e., the number of Distaflo Bypass Grafts or their components tested). It mentions "Device testing was performed on the cuffed portion of the Distaflo Bypass Graft."
- Data Provenance: The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective. Given the nature of medical device testing for regulatory approval in the US (FDA 510(k)), it is generally assumed that the testing was conducted in a controlled lab environment by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable and not provided in the document. The "ground truth" for this type of device (vascular graft) is established through engineering and biocompatibility testing against predefined standards and performance characteristics, rather than expert consensus on diagnostic images or clinical outcomes in humans at this stage of approval.
4. Adjudication Method for the Test Set:
Not applicable. As described above, the evaluation relies on direct physical and mechanical testing against recognized standards and comparison to predicate devices, not on expert adjudication of observations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, and an AI algorithm might assist them. The Distaflo Bypass Graft is a physical implantable device, and its evaluation does not involve human readers interpreting AI output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The device is not an algorithm. Its "performance" is inherently standalone, as it's a physical product assessed directly through testing, not an AI model.
7. The Type of Ground Truth Used:
The "ground truth" for the Distaflo Bypass Graft's performance is based on:
- Engineering and Material Standards: Compliance with methods recommended in ANSI/AAMI 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.
- Predicate Device Performance: Direct comparison of test results to the established performance of legally marketed predicate devices (IMPRA Carboflo Vascular Graft and Venaflo Graft with Carbon).
- Design and Manufacturing Equivalence: Verification that the device uses the same materials, processes, and a design concept (Miller Vein Cuff) found in established devices.
8. The Sample Size for the Training Set:
Not applicable. The Distaflo Bypass Graft is a manufactured medical device, not an AI model requiring a training set of data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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NOV 24 1998
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
IMRA
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 29, 1998 |
B. Device Name
| Trade Name: | Distaflo ™ Bypass Graft |
|---|---|
| Common/Usual Name: | Vascular Graft Prosthesis |
| Classification Names: | Vascular graft prostheses of 6 mm and greater diameter |
IMPRA, Inc., A Subsidiary of C. R. Bard, Inc, C:\MyFiles\REGULATO\510K\DistafloGT6.wpd25
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ز 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.
F. 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 ANSI/AAMI 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 seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
NOV 2 4 1998
Ms. Kristi M. Kistner Manager, Regulatory Affairs IMPRA, Inc. 1625 West 3rd Street P.O. Box 1740 Tempe, AZ 85281-1740
K983861 Re: IMPRA Distaflo™ Bypass Graft Regulatory Class: II (Two) Product Code: 74 DSY Dated: October 29, 1998 Received: November 2, 1998
Dear Ms. Kistner:
We have reviewed your Section 510(k) notification of intent to market nte device referenced above and we have determined the device is ene dovers ally 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 provible fore, market the device, subject to the general controls may 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 Regulations, 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 regulation (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.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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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. Calla 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)
Bite R. Beaspele
(Division Sign-Off) Division of Cardiovascular Respiratory, and Neurological Devices
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.”