CHASE CARDIOVASCULAR PATCH KIT

K020132 · Chase Medical, Inc. · DXZ · Feb 26, 2002 · Cardiovascular

Device Facts

• Record ID: K020132
• Device Name: CHASE CARDIOVASCULAR PATCH KIT
• Applicant: Chase Medical, Inc.
• Product Code: DXZ · Cardiovascular
• Decision Date: Feb 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Chase Cardiovascular Patch Kit is indicated for cardiac and vascular patch grafting.

Device Story

Chase Cardiovascular Patch Kit is a procedural kit containing components for cardiac and vascular patch grafting. Used by surgeons in clinical or surgical settings to facilitate repair or reconstruction of cardiovascular tissues. The kit consolidates necessary components for the procedure, ensuring they are legally marketed or substantially equivalent. The device functions as a surgical tool to provide structural support or closure during cardiovascular surgery. Benefits include streamlined surgical preparation and standardized component availability for the clinician.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Procedural kit containing cardiovascular patch components. Materials and specifications are dependent on the individual components included in the kit, which must comply with existing regulatory requirements for intracardiac patches (21 CFR 870.3470).

Indications for Use

Indicated for cardiac and vascular patch grafting in patients requiring surgical repair or reconstruction of cardiovascular structures.

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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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 stylized eagle with three curved lines representing its body and wings. The eagle is enclosed in a circle with the text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 2 6 2002

Mr. Dave Hernon Vice President Regulatory Affairs Chase Medical, Inc. 1710 Firman Drive, Suite 100 Richardson, Texas 75801

Re: K020132

Trade Name: Chase Cardiovascular Patch Kit Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac Patch Regulatory Class: Class II (two) Product Code: DXZ Dated: January 11, 2002 Received: January 15, 2002

Dear Mr. Hernon:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your because in ad 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 commores 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 and Cosmouth Free (110). "Teller, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the use us voluporitie in the mess (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you true] 20, 1970, and enation in bulk (i.e., unfinished) and further process (e.g., sterilize) parenase your it ree see of of (k) before including these components in your kit/tray. The general you mast backing a now of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

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## Page 2 - Mr. Dave Hernon

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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 (21 CFR Part 807); 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 the labeling regulation (21 CFR Part 801 and additionally 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"(21 CFR 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,

N. Donlin Tiller

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

Enclosure

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510(k) Number (if known): ____K020132

Device Name: Chase Cardiovascular Patch Kit

Indications For Use:

The Chase Cardiovascular Patch Kit is indicated for cardiac and vascular patch grafting.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K020132

(Optional Format 3-10-98)

**Prescription Use**
(Per 21 CFR 801.109)