(42 days)
The Chase Cardiovascular Patch Kit is indicated for cardiac and vascular patch grafting.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Chase Cardiovascular Patch Kit). It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device... [because] 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..." This indicates that the clearance is based on substantial equivalence to a predicate device, rather than a detailed study proving the device meets specific performance acceptance criteria as would be described in a clinical or performance study report.
Therefore, I cannot provide the requested information from this document.
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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 (301) 594-4648. 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"(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 (800) 638-2041 or (301) 443-6597, 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)
§ 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).