(22 days)
Not Found
Missing
No
The summary describes a physical vascular graft and its performance testing, with no mention of software, algorithms, or AI/ML terms.
Yes
The device is described as a bypass graft intended for reconstruction of blood vessels, which directly addresses a physiological issue and restores function.
No
Explanation: The device is described as a bypass graft for reconstruction of blood vessels, which is a therapeutic function, not a diagnostic one. It is used to replace or bypass damaged vessels, which is a treatment, not a means of identifying a medical condition.
No
The device description clearly states it is an expanded polytetrafluoroethylene (ePTFE) vascular graft, which is a physical, implantable medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "bypass or reconstruction of peripheral arterial blood vessels." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "vascular graft," which is an implantable medical device used to replace or bypass blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is a therapeutic implant used to treat a condition within the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
74 DSY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
IMPRA Carboflo® Vascular Graft, Venaflo® Vascular Graft
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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 Street
Tempe, Arizona 85281 |
| Telephone: | (602) 894-9515 |
| Fax: | (602) 966-7062 |
| Contact Person: | Kristi M. Kistner
Manager, 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
000030
Image /page/0/Picture/13 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, with a white fill. The image has a slightly distressed or textured appearance, as if it were printed on a rough surface. The letters are evenly spaced and aligned horizontally.
1
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.
2
Distaflo Bypass Grafts are substantially equivalent to the currently marketed IMPRA
Carboflo Vascular Graft and the Venaflo Vascular Graft.
3
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
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 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)