MEDLINE SURGICAL SPONGE SCANNER

K061316 · Medline Industries, Inc. · LWH · Nov 2, 2006 · General Hospital

Device Facts

• Record ID: K061316
• Device Name: MEDLINE SURGICAL SPONGE SCANNER
• Applicant: Medline Industries, Inc.
• Product Code: LWH · General Hospital
• Decision Date: Nov 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2740
• Device Class: Class 1

Intended Use

The Medline Surgical Sponge Scanning System is intended to be used to augment current sponge counting practice by providing a means to electronically detect potentially retained springes,

Device Story

System functions as an electronic adjunct to manual sponge counting in surgical settings. Device utilizes scanning technology to detect surgical sponges potentially retained within a patient. Operates by scanning sponges to verify presence or absence, thereby augmenting standard manual counting protocols performed by surgical staff. Output provides electronic confirmation to assist clinicians in ensuring all sponges are accounted for post-procedure. Intended to reduce risk of retained surgical items; enhances accuracy of sponge reconciliation during surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electronic scanning system designed for surgical sponge detection. Operates as an adjunct to manual counting. Class I device under 21 CFR 880.2740 (Surgical sponge scale).

Indications for Use

Indicated for use as an adjunct to manual sponge counting procedures to assist in the detection of retained surgical sponges in patients undergoing surgical procedures.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medline Industries, Inc. % Ms. Lara N. Simmons Corporate Director, Regulatory Affairs One Medline Place

Mundelein, Illinois 60060-4486

NOV - 2 2006

Re: K061316

Trade/Device Name: Medline Surgical Sponge Scanning System Regulation Number: 21 CFR 880.2740 Regulation Name: Surgical sponge scale Regulatory Class: I Product Code: LWH Dated: August 30, 2006 Received: August 31, 2006

Dear Ms. Simmons:

We have reviewed your Scction 510(k) premarket notification of intent to market the device referenced aboye and have determined the device is substantially cquivalent (for the indications for use stated in the enclosure) to legally marketed prodicate 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 -- Ms. Lara N. Simmons

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), 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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Intended Use

Page Page 2 of

510(k) Number (if known): K061316

Device Name: Medline Surgical Sponge Scanning System

Indications for Use:

The Medline Surgical Sponge Scanning System is intended to be used to augment current sponge counting practice by providing a means to electronically detect potentially retained springes,

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Pelo Htz

(Division Sign-Off) Division of General, Restorative, and Neurological Devices Page __ of

**510(k) Number** K06136