UNI-GRAFT K DV PATCH

K992776 · Atrium Medical Corp. · DXZ · Nov 16, 1999 · Cardiovascular

Device Facts

• Record ID: K992776
• Device Name: UNI-GRAFT K DV PATCH
• Applicant: Atrium Medical Corp.
• Product Code: DXZ · Cardiovascular
• Decision Date: Nov 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A vascular patch used for reconstructive interventions in the region of the carotid artery, profunda, femoral, arteria iliaca.

Device Story

Uni-Graft KDV Patch is a vascular patch designed for reconstructive surgical interventions. It is used by surgeons in clinical settings to repair or reconstruct specific arterial regions, including the carotid artery, profunda, femoral, and arteria iliaca. The device serves as a graft material to restore vascular integrity. It is intended for prescription use.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Vascular patch for reconstructive surgery. Specific materials and technical specifications are not detailed in the provided documentation.

Indications for Use

Indicated for patients requiring vascular reconstructive interventions in the carotid artery, profunda, femoral, or arteria iliaca regions.

Regulatory Classification

Identification

An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV I 6 1999

Mr. Joseph P. De Paolo Director of Regulatory Affairs Atrium Medical Corporation 5 Wentworth Drive Hudson, NH 03051

Re : K992776 K992770
Trade Name: B.Braun Surgical GMBH Uni-Graft® KDV Patch Requlatory Class: II Product Code: DXZ Dated: August 13, 1999 Received: August 18, 1999

Dear Mr. De Paolo:

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 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 Title 21, Parts 800 to 895. A substantially Requlations, equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 obliqation 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.

{1}------------------------------------------------

## Page 2 - Mr. Joseph P. De Paolo

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

a é écripe le le le le le le le le le le le le le le le le le le le le la le la le la le la le la le la le la contra le la contra le la contra le la contra le la contra le la in chic. 1000 Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular Respiratory and Neurological Devices Office of Device Evaluation Center for Device and Radioloqical Health

Enclosure

{2}------------------------------------------------

Page 1 of 1 510(k) Number (if known): K 992776 Device Name: Uni-Graft® K DV Patch Indications for Use:

> A vascular patch used for reconstructive interventions in the region of the carotid artery, profunda, femoral, arteria iliaca.

& prescription

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Loree K. Sampeur

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

1690:27760 510(k) Number _

Atrium Medical Corporation

CONFIDENTIAL