(44 days)
The Venaflo Graft with Carbon is indicated for use as a subcutaneous arteriovenous conduit for blood access only.
The Venaflo Graft with Carbon is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a cuffed venous end and a carbon-lined lumenal surface.
The provided text describes a 510(k) Premarket Notification for the VENAFLO™ Vascular Grafts, specifically the Venaflo Graft with Carbon. This is a medical device submission seeking substantial equivalence to existing predicate devices. Consequently, the document does not contain information typically found in a study demonstrating how a device meets acceptance criteria through performance metrics. Instead, it focuses on demonstrating that the new device has "technological characteristics" and "performance data" that are "substantially equivalent" to predicate devices.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert ground truthing, and MRMC studies are not present in this type of regulatory submission. The goal of a 510(k) is to prove equivalence, not necessarily to perform a de novo clinical trial with new acceptance criteria.
However, I can extract the information that is available from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document indicates that testing was performed to demonstrate substantial equivalence to predicate devices, rather than against specific, quantitative acceptance criteria for superior performance.
| Acceptance Criterion Type (Inferred) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate 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." |
| Suitability for Intended Use | "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." |
| Compliance with Industry Standards | Testing 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using methods recommended in ANSI/AAMI VP20-1994: Cardiovascular Implants - Vascular Prostheses and the 1993 FDA Draft Guidance: Guidance for the Preparation of Research and Marketing Applications for Vascular Graft Prostheses. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of a clinical study with a specific sample size. The performance data refers to "device testing" performed on the cuffed portion of the Venaflo Graft with Carbon and compared to predicate devices. The nature of this testing (e.g., in vitro, animal, or limited human experience) is not detailed, nor is the number of units tested.
- Sample Size: Not specified.
- Data Provenance: Not specified, but implied to be laboratory/bench testing and potentially pre-clinical (animal) evaluation based on the industry standards cited. There is no mention of human clinical trial data or retrospective/prospective study design in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable. The document describes laboratory/bench testing against established standards and comparison to predicate devices, not an expert panel adjudicating clinical outcomes or images to establish ground truth for a diagnostic device.
4. Adjudication Method for the Test Set:
Not applicable. There is no mention of an adjudication method as would be used in a clinical study involving human assessment.
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 typically associated with diagnostic imaging devices assessing human reader performance, which is not relevant to a vascular graft.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. This is a physical medical device (vascular graft), not an algorithm or software requiring performance evaluation in a standalone mode.
7. The Type of Ground Truth Used:
The "ground truth" in this context refers to the established performance characteristics and safety profiles of the predicate devices and compliance with recognized industry standards. This is not a "ground truth" derived from expert consensus, pathology, or outcomes data in the usual sense of a diagnostic or therapeutic clinical trial. It's about demonstrating physical and functional equivalence.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device. There is no "training set" as would be used for machine learning algorithms.
9. How the Ground Truth for the Training Set was Established:
Not applicable (see point 8).
{0}------------------------------------------------
K981079
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
Image /page/0/Picture/3 description: The image shows the word "IMPRA" in a bold, sans-serif font. Below the word "IMPRA" is the word "CONFIDENTIAL" in a smaller, serif font. The word "CONFIDENTIAL" is also in bold.
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 StreetTempe, Arizona 85281 |
| Telephone: | (602) 894-9515 |
| Fax: | (602) 966-7062 |
| Contact Person: | Kristi M. KistnerManager, Regulatory Affairs |
| Date of Preparation: | March 20, 1998 |
B. Device Name
| Trade Name: | Venaflo™ Vascular Graft (Venaflo ePTFE Vascular Graftand Venaflo Graft with Carbon) |
|---|---|
| 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, F:\510(k)\VenaCarb\VENACARBgt6.wpd22
Image /page/0/Picture/11 description: The image shows the word "BARD" in a stylized, blocky font. The letters are outlined in black, giving them a bold and distinct appearance. The overall design is simple yet eye-catching, with a focus on the shape and form of the letters.
{1}------------------------------------------------
C. Predicate Device Name
Trade Name(s):
Venaflo Vascular Graft Venaflo ePTFE Vascular Graft IMPRA Carboflo® Vascular Graft
D. 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.
Intended Use E.
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 Graff 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 the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing to the right, with flowing lines suggesting movement or connection. The profiles are stacked on top of each other, creating a sense of unity and collaboration.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1998 MAY
Ms. Kristi Kistner Impra, Inc. A Subsidiary of C. R. Bard, Inc. 1625 West 3rd Street P.O. Box 1740 Tempe, AZ 85280-1740
K981079 Re: Venaflo™ Vascular Graft Requlatory Class: II (two) 74 DSY Product Code: 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 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 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. Callehan
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)
Leese Kemper le
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K971079
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.”