SPONGE COUNT

K945144 · Michael Fischer Assoc. · LWH · Jan 12, 1995 · General Hospital

Device Facts

• Record ID: K945144
• Device Name: SPONGE COUNT
• Applicant: Michael Fischer Assoc.
• Product Code: LWH · General Hospital
• Decision Date: Jan 12, 1995
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2740
• Device Class: Class 1

Device Story

Sponge Count™ Surgical Sponge Display System; used in surgical settings to assist staff in tracking surgical sponges during procedures; provides visual display/organization of sponges; aids in manual counting processes to reduce risk of retained foreign objects; operated by surgical staff; output used for real-time inventory management during surgery.

Clinical Evidence

No clinical data provided; device is a Class I exempt surgical sponge scale.

Technological Characteristics

Surgical sponge display system; mechanical/organizational device; no electronic or software components described.

Regulatory Classification

Identification

A surgical sponge scale is a nonelectrically powered device used to weigh surgical sponges that have been used to absorb blood during surgery so that, by comparison with the known dry weight of the sponges, an estimate may be made of the blood lost by the patient during surgery.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

MAR 21 2006

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Michael Fischer Associates

c/o Mr. Michael Fischer

President

1248 Pine Street

Winnetka, Illinois 60093

Re: K945144

Trade/Device Name: Sponge Count™ Surgical Sponge Display System

Regulation Number: 21 CFR 880.2740

Regulation Name: Surgical sponge scale

Regulatory Class: I Exempt

Product Code: LWH

Dated: October 14, 1994

Received: October 20, 1994

Dear Mr. Fischer:

This letter corrects our substantially equivalent letter of January 12, 1995.

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 (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 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. Michael Fischer

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 continue 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Mark N. Melkerson

Mark N. Melkerson

Acting Director

Division of General, Restorative

and Neurological Devices

Office of Device Evaluation

Center for Devices and

Radiological Health