(78 days)
IMPRA High Porosity Grafts are indicated for use as vascular prosthesis for bypass or reconstruction of peripheral arterial blood vessels.
The IMPRA High Porosity Graft is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a high porosity construction.
This is a 510(k) premarket notification for a medical device (IMPRA High Porosity Graft), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI device is not applicable and cannot be extracted from the provided text.
The document discusses the substantial equivalence of the new device to predicate devices based on performance data. The "performance data" section (Section G) is the most relevant to your request, but it does not contain the specific information you're asking for in the context of an AI/ML study.
Here's what can be extracted from the provided text about the device's performance and testing, but it fundamentally differs from AI/ML device evaluations:
1. A table of acceptance criteria and the reported device performance:
The document states:
"Device testing was performed on the IMPRA High Porosity Graft and compared to the results of testing performed on the IMPRA ePTFE Vascular Graft. 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using methods recommended in ANSI/AAMI VP20-1994: Cardiovascular Implants - Vascular Prostheses and the 1993 FDA Draft Guidance.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 IMPRA High Porosity Graft is suitable for use as vascular prostheses for bypass or reconstruction of arterial blood vessels and the anticipated conditions of use imposed on the device. The results demonstrated that the IMPRA High Porosity Graft has been adequately designed to perform in a manner substantially equivalent to that of the predicate devices."
Analysis for your table format:
| Acceptance Criteria Category (Derived) | Reported Device Performance (Derived) |
|---|---|
| Compliance with ANSI/AAMI VP20-1994 and 1993 FDA Draft Guidance | Testing conducted using these recommended methods. |
| Suitability for use as vascular prostheses for bypass or reconstruction of arterial blood vessels | Indicated as suitable for this use. |
| Adequate design for anticipated conditions of use | Demonstrated "adequately designed" for this purpose. |
| Substantial equivalence to predicate Impra ePTFE Vascular Graft and Atrium Hybrid PTFE Vascular Graft | Results "demonstrated that the IMPRA High Porosity Graft has been adequately designed to perform in a manner substantially equivalent to that of the predicate devices." |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not specified. The document only mentions "device testing was performed."
- Data provenance: Not specified. Standardized test methods (ANSI/AAMI VP20-1994, 1993 FDA Draft Guidance) imply laboratory/bench testing, not patient data in the typical sense of AI/ML studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This is not applicable as it's not an AI/ML device. The "ground truth" for this type of medical device is established by physical and mechanical engineering standards, biocompatibility testing, and functional performance in a laboratory setting, not expert medical opinion on interpretative data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. The "adjudication" in this context refers to compliance with established testing protocols and material science, not a consensus among human reviewers.
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:
- Not applicable. This is not an AI/ML diagnostic or assistive device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical vascular graft, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device would be defined by engineering specifications, material science properties (e.g., porosity, tensile strength, burst pressure according to the referenced standards), and successful material performance under simulated physiological conditions as determined by the ANSI/AAMI and FDA guidance documents. It is not expert consensus, pathology, or outcomes data in the AI/ML sense.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires training data.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device that requires training data or ground truth for algorithmic training.
In summary, the provided document describes a traditional medical device (vascular graft) evaluated for substantial equivalence based on physical and mechanical testing against recognized standards and predicate devices. It does not fit the paradigm of an AI/ML device assessment.
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NOV 1 9 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
Image /page/0/Picture/3 description: The image shows the word "IMPRA" in a bold, sans-serif font. The letters are black and appear to be slightly distressed, giving them a textured look. The word is presented in a slightly slanted or italicized style, adding a sense of dynamism to the design. The background is plain white, which makes the black letters stand out prominently.
CONFIDENTIAL
510(k) Premarket Notification IMPRA High Porosity Grafts
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: | August 27, 1998 |
Device Name B.
| Trade Name: | IMPRA High Porosity Grafts |
|---|---|
| Common/Usual Name: | Vascular Graft Prosthesis |
| Classification Names: | Vascular graft prostheses of greater than or equal to 6 mmdiameter |
IMPRA, Inc., A Subsidiary of C. R. Bard, Inc, C:\MyFiles\REGULATO\HP510K6.kmk.WPD21
000027
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C. Predicate Device Name
Trade Name(s):
IMPRA ePTFE Vascular Graft Atrium Hybrid PTFE Vascular Graft
D. Device Description
The IMPRA High Porosity Graft is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a high porosity construction.
E. Intended Use
The IMPRA High Porosity Graft in Straight and IMPRA Flex configurations is indicated for use as a vascular prosthesis for bypass or reconstruction of arterial blood vessels. IMPRA Flex configurations have an external spiral bead support on the graft and can be used where resistance to compression or kinking is desired.
F. Technological Characteristics Summary
The IMPRA High Porosity Graft is an IMPRA ePTFE Vascular Graft with a high porosity construction.
G. Performance Data
Device testing was performed on the IMPRA High Porosity Graft and compared to the results of testing performed on the IMPRA ePTFE Vascular Graft. 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 IMPRA High Porosity Graft is suitable for use as vascular prostheses for bypass or reconstruction of arterial blood vessels and the anticipated conditions of use imposed on the device. The results demonstrated that the IMPRA High Porosity Graft has been adequately designed to perform in a manner substantially equivalent to that of the predicate devices.
IMPRA High Porosity Grafts are substantially equivalent to the currently marketed IMPRA ePTFE Vascular Graft and the Atrium Hybrid PTFE Vascular Graft.
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NOV 1 9 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kristi M. Kistner Manager, Regulatory Affairs IMPRA, Inc. 1625 West 3rd Street Tempe, AZ 85281
Re : K983064 IMPRA High Porosity Graft Regulatory Class: II (Two) Product Code: 74 DSY Dated: August 27, 1998 September 2, 1998 Received:
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 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 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 regulation may result in requlatory 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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Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
NOV 1 9 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kristi M. Kistner Manager, Regulatory Affairs IMPRA, Inc. 1625 West 3rd Street Tempe, AZ 85281
Re: K983064 IMPRA High Porosity Graft Requlatory Class: II (Two) Product Code: 74 DSY Dated: August 27, 1998 Received: September 2, 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 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 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 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 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" (21 CFR 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/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): K983064
Device Name:_IMPRA High Porosity Grafts
Indications For Use: IMPRA High Porosity Grafts are indicated for use as vascular prosthesis 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)
Rette & Reumerele
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
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.”