TRAATEK COTTONOID PATTIES

K020736 · Traatek, Inc. · HBA · Jun 3, 2002 · Neurology

Device Facts

• Record ID: K020736
• Device Name: TRAATEK COTTONOID PATTIES
• Applicant: Traatek, Inc.
• Product Code: HBA · Neurology
• Decision Date: Jun 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To be used in surgery to protect nervous tissue, absorb fluids, or stop bleeding.

Device Story

Traatek Cottonoid Patties are surgical sponges used during procedures to protect nervous tissue, absorb fluids, or control bleeding. Used by surgeons in an operating room setting. Device provides physical protection and fluid management during neurosurgical or other surgical interventions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cottonoid material; surgical sponge form factor; non-active device.

Indications for Use

Indicated for use in surgical procedures to protect nervous tissue, absorb fluids, or provide hemostasis. No specific patient population or contraindications specified.

Regulatory Classification

Identification

A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.

Submission Summary (Full Text)

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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 [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 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,

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_________________________________________________________________________________________________________________________________________________________________