(61 days)
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No
The provided 510(k) summary does not contain any explicit mentions of AI, ML, deep learning, or related terms, nor does it describe functionalities typically associated with these technologies in medical imaging (like automated detection, segmentation, or analysis beyond simple counting and visibility). The description focuses on aiding in recording and visibility, which can be achieved with standard image processing techniques.
No
Explanation: The device is intended to aid clinical practices in recording the number of surgical sponges and for visibility for assessment of sponge images, which is an assistive function rather than providing a direct therapeutic effect.
No
The device aids in recording the number of surgical sponges and for visibility for assessment of sponge images, which is an operational aid rather than a tool for diagnosing disease or conditions.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to definitively determine if the device is software-only.
Based on the provided information, it is highly unlikely that the Gauss Pixel App is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "aid current clinical practices in recording the number of surgical sponges and for visibility for assessment of sponge images." This describes a tool used in a surgical setting to manage physical objects (sponges) and their visual representation. IVDs, on the other hand, are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
- Lack of IVD-related information: The provided text is completely devoid of any mention of:
- Analyzing biological specimens.
- Providing diagnostic information based on biological samples.
- Any of the typical components or processes associated with IVD testing (reagents, assays, laboratory procedures, etc.).
The description points towards a device used for managing physical items and their visual representation within a clinical workflow, not for analyzing biological samples.
Therefore, based solely on the provided text, the Gauss Pixel App does not appear to be an IVD.
N/A
Intended Use / 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.
Product codes
LWH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
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 (800) 638-2041 or (301) 796-7100 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