PIXEL APP

K121274 · Gauss Surgical, Inc., · LWH · Jun 27, 2012 · General Hospital

Device Facts

• Record ID: K121274
• Device Name: PIXEL APP
• Applicant: Gauss Surgical, Inc.,
• Product Code: LWH · General Hospital
• Decision Date: Jun 27, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2740
• Device Class: Class 1
• Attributes: Software as a Medical Device

Intended Use

The Gauss Pixel App is intended to be used to aid current clinical practices in recording the number of surgical sponges and for visibility for assessment of sponge images.

Device Story

Gauss Pixel App functions as a software tool to assist clinicians in surgical environments. Device inputs include images of surgical sponges. Software processes these images to facilitate visual assessment and aids in the manual or automated recording of sponge counts. Output is provided to healthcare providers to support sponge management during surgical procedures. Intended to improve accuracy of sponge counting and visibility, potentially reducing risk of retained surgical items.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based application for image assessment and data recording. Operates as a digital aid for surgical sponge management. No specific hardware materials or energy sources defined beyond standard computing platform requirements.

Indications for Use

Indicated for use as an aid in clinical practice for recording surgical sponge counts and visualizing sponge images.

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)

{0}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 2 7 2012

Gauss Surgical, Incorporated % Ms. Peggy McLaughlin Consulting Vice President, Clinical & Regulatory Affairs 22700 Alcalde Road Cupertino, California 95014

Re: K121274

Trade/Device Name: Gauss Pixel App Regulation Number: 21 CFR 880.2740 Regulation Name: Surgical sponge scale Regulatory Class: Class I Product Code: LWH Dated: June 06, 2012 Received: June 11, 2012

Dear Ms. McLaughlin:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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.

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

{1}------------------------------------------------

Page 2 - Ms. Peggy Mclaughlin

CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkers Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Attachment 2 - Indication for Use Form

Indications for Use Form

510(k) Number:

Device Name: Gauss Pixel App

## Indications for Use:

The Gauss Pixel App is intended to be used to aid current clinical practices in recording the number of surgical sponges and for visibility for assessment of sponge images.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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)

Page _ of _ ]

Neil K. Ogden for mixm
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K121274

Attachments, Gauss Surgical, Inc. Special 510(k) Submission

25 April 2012