CHARE CARIOVASCULAR PATCH

K021129 · Chase Medical, Inc. · DXZ · Jun 3, 2002 · Cardiovascular

Device Facts

• Record ID: K021129
• Device Name: CHARE CARIOVASCULAR PATCH
• Applicant: Chase Medical, Inc.
• Product Code: DXZ · Cardiovascular
• Decision Date: Jun 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CHASE Cardiovascular Patch With Radiopaque Markings is indicated for cardiac and vascular patch grafting.

Device Story

Cardiovascular patch used for cardiac and vascular repair/reconstruction; incorporates radiopaque markings to facilitate visualization under imaging. Device implanted by surgeons during cardiovascular procedures. Radiopaque markers allow post-operative monitoring of patch position and integrity via standard radiographic imaging. Benefits include structural support for tissue repair and improved visibility for clinical follow-up.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design characteristics.

Technological Characteristics

Intracardiac patch material; includes radiopaque markers for radiographic visualization. Class II device (21 CFR 870.3470).

Indications for Use

Indicated for patients requiring cardiac or vascular patch grafting procedures.

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)

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Public Health Service

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 0 3 2002

Mr. Dave Hernon Vice President Regulatory Affairs Chase Medical, Inc. 1710 Firman Drive. Suite 100 Richardson, TX 75081

Re: K021129

Trade Name: Cardiovascular Patch With Radiopaque Markings Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac Patch Regulatory Class: Class II (two) Product Code: DXZ Dated: April 4, 2002 Received: April 8, 2002

Dear Mr. Hernon:

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.

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Page 2 - Mr. Dave Hernon

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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Den G. Tiller

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## CHASE MEDICAL, INC.

## CARDIOVASCULAR PATCH WITH RADIOPAQUE MARKINGS

## Intended Use:

The CHASE Cardiovascular Patch With Radiopaque Markings is indicated for cardiac and vascular patch grafting.

Prescription Use
(Per 21 CFR 801.109)

Division of Cardiovascular & Respiratory Devices
510(k) Number K021129