(53 days)
Not Found
No
The description focuses on image capture, categorization, and automated counting based on user input, without mentioning any AI/ML techniques for image analysis or interpretation.
No
The device is a software program that assists surgical personnel in managing surgical sponges by counting and categorizing images of sponges. It is not intended to diagnose, treat, or prevent any disease or condition.
No
The device is described as a software program to aid in counting and managing surgical sponges, providing visibility for assessment of sponge images. It assists surgical personnel in recording the number of surgical sponges and is explicitly stated as "not intended to replace existing sponge counting practices." It does not provide any diagnosis of a medical condition or disease.
Yes
The device is described as a "software program used on an iPad tablet" and its function is entirely based on image capture, categorization, counting, and visual record keeping. While it utilizes an iPad, the device itself is the software application, not the hardware. The description focuses solely on the software's capabilities and performance.
Based on the provided information, the Gauss Pixel App is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Gauss Pixel App's Function: The Gauss Pixel App's intended use is to aid in the counting and visual assessment of surgical sponges. It captures images of sponges, categorizes them, and provides a count. This process does not involve analyzing biological samples from a patient.
- Predicate Device: The predicate device listed, K912824; Bag-It™ Sponge Counter Bags, is also a device used for managing surgical sponges, not for in vitro diagnostic testing.
The Gauss Pixel App is a software tool designed to assist surgical personnel in managing physical objects (sponges) within the operating room environment. It does not perform any diagnostic testing on patient samples.
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.
The Gauss Pixel App is indicated for use to aid current practices in recording the number of surgical sponges and for visibility for assessment of sponge images.
Product codes
LWH
Device Description
The Gauss Pixel App is a software program used on an iPad tablet to capture images of sponges to assist surgical personnel in the management of surgical sponges after surgical The App allows surgical personnel to categorize sponges by sponge type and use. provides an automated ongoing count of total sponge images and sponge images by tag. It also provides a visual record of images for further evaluation. This program is not intended to replace existing sponge counting practices and sponges should be retained per the user's standard sponge management practice until the case is complete and sponge counting has been finalized.
Mentions image processing
Yes
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
Operating Theatre
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
Results of performance testing confirmed that the application provided instructions for use, recorded images as indicated by the user, accurately tagged images as indicated by the user, accurately provided automated counting both in total and by type and allowed visual review and management (re-tagging, deletion) of all images as appropriate. Results of performance testing through the software verification and validation process demonstrate that the Gauss Pixel App functions as intended and is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Bag-It™ Sponge Counter Bags (Tyco/Covidien) (K912824)
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
Attachment 2
16 Mar 2012 revised section for K120473
5.0 510(k) Summary
Submitters Name and Address Gauss Surgical, Inc. 22700 Alcalde Road Cupertino CA 95014
Contact Person
Peggy McLaughlin Consulting Vice President, Clinical & Regulatory Affairs Gauss Surgical, Inc. 22700 Alcalde Road Cupertino CA 95014 Fax: 650 941-8222 Telephone: 650 504-8501 Email: MPMcLaughlin@sbcglobal.net
Date Prepared 16 Mar 2012
Name of Medical Device
Device Classification Name: Counter, Surgical Sponge Device Classification Number: 21 CFR 880.2740 Device Class: Class 1 Proprietary Name: Gauss Pixel App
Predicate Device
Bag-It™ Sponge Counter Bags (Tyco/Covidien) (K912824)
Device Description
The Gauss Pixel App is a software program used on an iPad tablet to capture images of sponges to assist surgical personnel in the management of surgical sponges after surgical The App allows surgical personnel to categorize sponges by sponge type and use. provides an automated ongoing count of total sponge images and sponge images by tag. It also provides a visual record of images for further evaluation. This program is not intended to replace existing sponge counting practices and sponges should be retained per the user's standard sponge management practice until the case is complete and sponge counting has been finalized.
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.
The App is intended to be used in the Operating Theatre to assist users with sponge management practices by providing another method to visually capture and display images of used sponges using software running on an iPad mobile platform. Running the
Gauss Surgical, Inc. Traditional 510(k) Submission
K 120473 16 Mar 2012
•
APR - 9 2012
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. Attachment 2
16 Mar 2012 revised section for K120473
software, the user captures images of each sponge prior to storing per their standard sponge management practices. The user may categorize the sponge by type. The user may review each image to re-assign sponge type, confirm image quality or delete the image if appropriate. The software counts the images and displays an ongoing count of total sponges and sponges by sponge type as categorized by the user. The software allows users to re-review each sponge image and a display panel of all used sponges to assist in sponge management and review. The sponge image is captured in a fully expanded state, providing a full view of each sponge prior to storage per current clinical practices.
The indications for use for the predicate and proposed device differ in that the proposed device is intended to 'aid current practices' which means it is intended to be used in conjunction with current practices. The software automates the counting procedure and this counting has been verified through verification and validation testing. This difference does not affect the safety or efficacy of the device as it is labeled as an adjunctive product.
Technology
Both the Pixel App and the predicate device utilize visual assessment of sponges to count the number of surgical sponges used in a surgical procedure. The predicate device uses a plastic bag with partitions to separate each sponge for counting and review purposes while the Pixel App uses software running on an iPad mobile platform for counting and review purposes. The Pixel App and the predicate device are intended to be used together so that either method of visual assessment may be used during the surgical procedure and a final sponge count may be made by the user. This software technology has been verified to provide an accurate count of all images and by image type as categorized by the user and does not introduce new questions of safety as the user is advised to retain all sponges using standard sponge management practices and can rereview sponges physically at the end of the procedure if needed.
| Technologic method for: | Predicate | Gauss Pixel App |
|---|---|---|
| Sponge management | Sponges are collected and | |
| stored in partitions within the | ||
| plastic bag. | Sponges are collected and | |
| stored in partitions within the | ||
| plastic bag or other sponge | ||
| management method selected | ||
| by user. | ||
| Sponge counting | User manually counts | |
| sponges as seen in partitions | ||
| and calculates a total. | User captures image of each | |
| sponge prior to storing per | ||
| current sponge management | ||
| practices and software counts | ||
| each image, providing an | ||
| ongoing total on the iPad | ||
| mobile platform. | ||
| Sponge typing | Not available unless user opts | |
| to use separate containers for | ||
| each sponge type. | User assigns sponge type for | |
| each image captured. |
Tachmologio Co
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Attachment 2 -
16 Mar 2012 revised section for K120473
| Technologic method for: | Predicate | Gauss Pixel App |
|---|---|---|
| Sponge counting by type | Not available unless user opts | |
| to use separate containers for | ||
| each sponge type and totals | ||
| each type separately. | Software counts each image | |
| by assigned type, providing an | ||
| ongoing total. | ||
| Visual assessment of each | ||
| sponge | User can view and assess | |
| each sponge in a wadded up | ||
| state in partitions. | User can view and assess | |
| each sponge in an | ||
| open/unfolded state by re- | ||
| reviewing any selected image. | ||
| Visual assessment of all | ||
| sponges used in a clinical | ||
| procedure | User can view and assess the | |
| entire 'sheet' of sponges (or | ||
| series of sheets) as stored in | ||
| the individual partitions. | User can view and assess all | |
| sponges in an open/unfolded | ||
| state in a grid-like display of | ||
| all sponges captured during a | ||
| procedure. |
Performance
Results of performance testing confirmed that the application provided instructions for use, recorded images as indicated by the user, accurately tagged images as indicated by the user, accurately provided automated counting both in total and by type and allowed visual review and management (re-tagging, deletion) of all images as appropriate. Results of performance testing through the software verification and validation process demonstrate that the Gauss Pixel App functions as intended and is substantially equivalent to the predicate device.
Substantial Equivalence
The Gauss Pixel App is as safe and effective as the predicate. The Gauss Pixel App has the same intended uses and indications and utilizes a new technological method (software) which complements current clinical practices and does not raise new issues of safety or effectiveness. Software verification and validation demonstrate that the Gauss Pixel App functions as intended. Thus, the Gauss Pixel App has been shown to be substantially equivalent to the predicate device.
3/3
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three overlapping profiles facing left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Gauss Surgical, Inc. % Ms. Peggy McLaughlin Consulting VP, Clinical and Regulatory Affairs 22700 Alcalde Road Cupertino, California 95014
Re: K120473
Trade/Device Name: Gauss Pixel App Regulation Number: 21 CFR 880.2740 Regulation Name: Surgical sponge scale Regulatory Class: I Product Code: LWH Dated: March 16, 2012 Received: March 19, 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 or any 1 vith all the Act's requirements, including, but not limited to: registration and listing (21
APR - 9 2012
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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/CDRH0ffices/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/ReportaProblem/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. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Attachment 1
16 Mar 2012 revised section for K120473
4.0 Indications for Use Statement
Indications for Use Form
510(k) Number: K120473
Device Name: Gauss Pixel App
Indications for Use:
The Gauss Pixel App is indicated for use to aid current 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)
Richard P. Bell for Ned Ogden
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
ic,
510(k) Number_k 120473
Gauss Surgical, Inc. Traditional 510(k) Submission
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K 120473 16 Mar 2012