CHASE CARDIOVASCULAR PATCH

K012248 · Chase Medical, Inc. · DXZ · Aug 10, 2001 · Cardiovascular

Device Facts

• Record ID: K012248
• Device Name: CHASE CARDIOVASCULAR PATCH
• Applicant: Chase Medical, Inc.
• Product Code: DXZ · Cardiovascular
• Decision Date: Aug 10, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CHASE Cardiovascular Patch is indicated for use in cardiovascular patching.

Device Story

Chase Cardiovascular Patch is a surgical implant used for cardiovascular patching. Device serves as a patch material for cardiovascular tissue repair. Used by surgeons in an operating room setting. Provides structural support or closure for cardiovascular defects or incisions. Benefits patient by facilitating tissue repair and maintaining cardiovascular integrity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cardiovascular patch material for surgical repair. Specific materials and ASTM standards not disclosed in provided text.

Indications for Use

Indicated for use in cardiovascular patching 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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 0 2001

Mr. Dave Hernon Vice President Regulatory Affairs Chase Medical, Inc. 1704 Enterprise Street Athens, TX 75751

Re: K012248

Trade Name: Chase Cardiovascular Patch Regulation Number: 21 CFR 870.3470 Regulatory Class: Class II (two) Product Code: DXZ Dated: July 13, 2001 Received: July 17, 2001

Dear Mr. Hernon:

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 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 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

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## Page 2 - Mr. Dave Hernon

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.

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 [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 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,

~James E. Dillard III 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): K012248

## Device Name: CHASE Cardiovascular Patch

Indications for Use:

The CHASE Cardiovascular Patch is indicated for use in cardiovascular patching.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012248

(Optional Format 3-10-98)