(78 days)
IMPRA ePTFE Vascular Graft
Atrium Hybrid PTFE Vascular Graft
No
The summary describes a physical vascular graft made of ePTFE and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
A therapeutic device is one that performs a treatment or cures a disease. This device is an implantable graft designed to replace blood vessels, which is a reconstructive and supportive function, not a therapeutic one in the sense of actively treating or curing a disease.
No
Explanation: The device is described as a vascular prosthesis for bypass or reconstruction, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is an expanded polytetrafluoroethylene (ePTFE) vascular graft, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as vascular prosthesis for bypass or reconstruction of peripheral arterial blood vessels." This describes a device that is implanted into the body to replace or repair blood vessels.
- Device Description: The device is described as an "expanded polytetrafluoroethylene (ePTFE) vascular graft." This is a physical implant.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with bodily specimens for diagnostic purposes.
Therefore, the IMPRA High Porosity Graft is a surgical implant, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
74 DSY
Device Description
The IMPRA High Porosity Graft is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a high porosity construction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arterial blood vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
IMPRA ePTFE Vascular Graft
Reference Device(s)
Atrium Hybrid PTFE Vascular Graft
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
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 Street
Tempe, Arizona 85281 |
| Telephone: | (602) 894-9515 |
| Fax: | (602) 966-7062 |
| Contact Person: | Kristi M. Kistner
Manager, 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 mm |
| diameter |
IMPRA, Inc., A Subsidiary of C. R. Bard, Inc, C:\MyFiles\REGULATO\HP510K6.kmk.WPD21
000027
1
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.
2
Image /page/2/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 an eagle with its wings spread.
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.
4
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)