(89 days)
To be used in surgery to protect nervous tissue, absorb fluids, or stop bleeding.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the "Traatek Cottonoid Patties." This document describes the regulatory approval of a medical device, specifically traditional cottonoid patties, based on its "substantial equivalence" to legally marketed predicate devices.
Critical Note: The information provided is for a traditional, physical medical device (cottonoid patties) and does not contain any details about an AI/ML-based device or a study proving its performance against specific acceptance criteria in the manner requested by the prompt. The prompt's questions are tailored for AI/ML device evaluations (e.g., sample sizes for training/test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance).
Therefore, I cannot provide the requested information from the given text. The FDA letter is a regulatory approval for a conventional medical product, not an AI/ML diagnostic or therapeutic system.
To answer your prompt, I would need a regulatory document or scientific publication detailing the development and validation of an AI/ML device, including performance metrics, study design, and ground truth methodologies.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 0 3 2002
Traatek, Inc. c/o Mr. Terry Johnston 917 Duriston Road Redwood City, CA 94062
Re: K020736
Trade Name: Traatek Cottonoid Patties Regulation Number: 21 CFR 882.4700 Regulation Name: Cottonoid Pattie Regulatory Class: Class II Product Code: HBA Dated: March 1, 2002 Received: March 6, 2002
Dear Mr. Johnston:
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.
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.
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Page 2 - Mr. Terry Johnston
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) 594-4659. 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,
Neil Rp Ogden
Celia M. Witten, M.D., Ph.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 5
INDICATIONS FOR USE
510(K) Number K020736
Device Name
Traatek Cottonoid Patties
Indications for Use
To be used in surgery to protect nervous tissue, absorb fluids, or stop bleeding.
પ્ર Prescription Use
or
Over the Counter _____________________________________________________________________________________________________________________________________________________________
NRO for cms?
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 882.4700 Neurosurgical paddie.
(a) A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.
(b)
Classification. Class II (performance standards).