(56 days)
The CHASE Cardiovascular Patch With Radiopaque Markings is indicated for cardiac and vascular patch grafting.
Not Found
The provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. This document is an FDA 510(k) clearance letter for a medical device called "Cardiovascular Patch With Radiopaque Markings," indicating it has been deemed substantially equivalent to a legally marketed predicate device. It does not include the details of a study with acceptance criteria and performance metrics.
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Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a serif font. The text is centered in the image and is the only element present.
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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
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.(b)
Classification. Class II (performance standards).