GELSOFT PLUS ERS

K034010 · Vascutek, Ltd. · DSY · Feb 19, 2004 · Cardiovascular

Device Facts

• Record ID: K034010
• Device Name: GELSOFT PLUS ERS
• Applicant: Vascutek, Ltd.
• Product Code: DSY · Cardiovascular
• Decision Date: Feb 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

EXTRA-ANATOMICAL VASCULAR REPAIR PRIMARILY FOR AXILLO-FEMORAL/BIFEMORAL BYPASS AND FEMORO-POPLITEAL RECONSTRUCTION

Device Story

Gelsoft Plus ERS is a vascular graft used for surgical bypass and reconstruction procedures. It serves as a conduit for blood flow in patients requiring extra-anatomical vascular repair. The device is implanted by a vascular surgeon in an operating room setting. It functions as a mechanical replacement or bypass for diseased or damaged blood vessels, facilitating blood circulation to distal extremities or bypass sites. The graft is designed to maintain patency and support vascular repair, potentially improving patient outcomes by restoring adequate blood flow.

Clinical Evidence

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

Technological Characteristics

Vascular prosthesis (21 CFR 870.3460). Device is a synthetic graft designed for surgical implantation. Specific material composition and ASTM standards not detailed in the provided text.

Indications for Use

Indicated for patients requiring extra-anatomical vascular repair, specifically axillo-femoral/bifemoral bypass and femoro-popliteal reconstruction.

Regulatory Classification

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.

Special Controls

*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.”

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 2004

Vascutek Ltd. c/o Ms. Karen Kelso Regulatory Affairs Manager Newmains Avenue Inchinnan Renfrewshire, PA4 9RR Scotland

Re: K034010 Trade Name: Gelsoft Plus ERS Regulation Number: 21 CFR 870.3460 Regulation Name: Vascular Prostheses Regulatory Class: Class II (two) Product Code: DSY Dated: December 17, 2003 Received: December 24, 2003

Dear Ms. Kelso:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

Page 2 - Ms. Karen Kelso

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594- 4646. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bram D. Zuckerman, M. D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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

## Indications for Use

510(k) Number (if known): K034010

VASCUTEK GELSOFT PLUS ERS VASCULAR GRAFT Device Name: _________________________________________________________________________________________________________________________________________________________________

EXTRA-ANATOMICAL VASCULAR REPAIR PRIMARILY Indications For Use: FOR AXILLO-FEMORAL/BIFEMORAL BYPASS AND FEMORO-POPLITEAL RECONSTRUCTION

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Q. M. Q.

(Division Sign-Off)
Division of Cardiovascular Devices

034010 510(k) Number

Page 1 of 1 ..