(44 days)
Not Found
Not Found
No
The summary describes a physical vascular graft and its material properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
Explanation: The device is indicated for use as a "subcutaneous arteriovenous conduit for blood access," which is a medical intervention designed to maintain or restore normal physiological function for patients requiring dialysis, thus qualifying it as a therapeutic device.
No
The device is described as a "subcutaneous arteriovenous conduit for blood access," indicating it is a therapeutic or assistive device for blood flow, not a diagnostic tool for identifying a condition or disease.
No
The device description clearly states it is a physical vascular graft made of ePTFE with a carbon-lined lumenal surface, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a subcutaneous arteriovenous conduit for blood access only." This describes a device that is implanted in the body to facilitate blood access, not a device used to examine specimens in vitro (outside the body).
- Device Description: The description details a vascular graft made of ePTFE with a carbon-lined lumen. This is a physical implant, not a reagent, instrument, or system intended for the examination of specimens.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or calibrators
- Performing tests in a laboratory setting
The device is clearly intended for direct interaction with the patient's circulatory system for therapeutic or access purposes, which is the domain of medical devices, not IVDs.
N/A
Intended Use / Indications for Use
The Venaflo Graft with Carbon is indicated for use as a subcutaneous arteriovenous conduit for blood access only.
Product codes (comma separated list FDA assigned to the subject device)
74 DYF
Device Description
The Venaflo Graft with Carbon is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a cuffed venous end and a carbon-lined lumenal surface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 Venaflo Graft with Carbon and compared to the results of testing performed on the Venaflo 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 Venaflo Graft with Carbon is suitable for use as a subcutaneous arteriovenous conduit for blood access and the anticipated conditions of use imposed on the device. The results demonstrated that the Venaflo Graft with Carbon 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.
Not Found
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
7 1998 MAY
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
1981076
Image /page/0/Picture/4 description: The image shows the word "IMPRA" in bold, black letters. The letters are slightly slanted to the right, giving the word a dynamic appearance. The font is sans-serif, and the letters are closely spaced together. The background is plain white.
CONFIDENTIAL
510(k) Premarket Notification VENAFLOTM Vascular 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: | March 20, 1998 |
B. Device Name
| Trade Name: | Venaflo™ Vascular Graft (Venaflo ePTFE Vascular Graft
and Venaflo Graft with Carbon) |
|-----------------------|-----------------------------------------------------------------------------------------|
| Common/Usual Name: | Vascular Graft Prosthesis |
| Classification Names: | Vascular graft prostheses of less than 6 mm diameter |
March 20, 1998 (12:30PM) IMPRA, Inc., A Subsidiary of C. R. Bard, Inc., C:\MyFiles\VENACARBLT6.wpd23
000029
1
Predicate Device Name C.
Trade Name(s):
Venaflo Vascular Graft Venaflo ePTFE Vascular Graft IMPRA Carboflo® Vascular Graft
Device Description D.
The Venaflo Graft with Carbon is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a cuffed venous end and a carbon-lined lumenal surface.
E. Intended Use
The Venaflo Graft with Carbon is indicated for use as a subcutaneous arteriovenous conduit for blood access only.
F. Technological Characteristics Summary
The Venaflo Graft with Carbon is an IMPRA Carboflo Vascular Graft with a cuffed venous end having the same shape and dimensions as the cuff on the Venaflo ePTFE Vascular Graft.
G. Performance Data
Device testing was performed on the cuffed portion of the Venaflo Graft with Carbon and compared to the results of testing performed on the Venaflo 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 Venaflo Graft with Carbon is suitable for use as a subcutaneous arteriovenous conduit for blood access and the anticipated conditions of use imposed on the device. The results demonstrated that the Venaflo Graft with Carbon has been adequately designed to perform in a manner substantially equivalent to that of the predicate devices.
Venaflo Grafts with Carbon are substantially equivalent to the currently marketed Venaflo ePTFE Vascular Graft and the IMPRA Carboflo Vascular Graft.
2
Image /page/2/Picture/1 description: The image shows a logo with a circular border. Inside the circle, there are three curved lines that resemble stylized waves or swooshes. The lines are thick and black, and they appear to be stacked on top of each other. The overall design is simple and abstract.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 7 1998
Ms. Kristi Kistner Impra, Inc. A Subsidiary of C. R. Bard, Inc. 1625 West 3rd Street P.O. Box 1740 Tempe, AZ 85280-1740
Re: K981076 Venaflo™ Vascular Graft Regulatory Class: III (three) Product Code: 74 DYF Dated: March 20, 1998 Received: March 24, 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 to legally marketed predicate 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 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.
3
Page 2 - Ms. Kristi 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) 594–4646. 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/dsma/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
4
Page 1 of 1
510(k) Number (if known): K971076 and K 971079
Device Name:_ Venaflo Grafts with Carbon_
Indications For Use: The Venaflo Grafts with Carbon are indicated for subcutaneous arteriovenous conduit for blood access only.
(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: k 981076
Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)