K Number
K061316
Device Name
MEDLINE SURGICAL SPONGE SCANNER
Date Cleared
2006-11-02

(175 days)

Product Code
Regulation Number
880.2740
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
Not Found
More Information

Not Found

Not Found

No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found".

No
The device is intended to detect potentially retained sponges, which is a diagnostic or preventative measure, not a treatment for an existing condition.

No
The device is described as augmenting current sponge counting practice to detect potentially retained sponges, which is a method of preventing an issue, not diagnosing a medical condition.

Unknown

The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. The "Intended Use" mentions a "Surgical Sponge Scanning System," which strongly suggests the involvement of hardware for scanning, but without a device description, this cannot be definitively confirmed.

Based on the provided information, the Medline Surgical Sponge Scanning System is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to "electronically detect potentially retained sponges" during surgery. This is a process that happens in vivo (within the living body or in the surgical field), not in vitro (outside the body, typically on biological samples).
  • Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Providing diagnostic information about a patient's health condition.
    • Using reagents or assays.

The system appears to be a device used within the surgical setting to aid in counting and detecting surgical sponges, which is a procedural or safety function, not a diagnostic one.

N/A

Intended Use / 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,

Product codes

LWH

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 880.2740 Surgical sponge scale.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

0

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.

1

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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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

2

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)

  • 5 -

Pelo Htz

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

510(k) Number K06136