The Triton Sponge System is a software application intended to be used as an adjunct in the estimation of blood loss and management of surgical sponges. The Triton Sponge System is intended to be used with surgical sponges, software, hardware and accessory devices which have been validated for use with Triton Sponge System to estimate the hemoglobin (Hb) mass contained on used surgical sponges. This version of the Triton Sponge System includes 4 updates from the predicate Triton System (K160338): Qualified new hardware accessory: Apple's iPad Pro to be used with Triton Sponge System. Qualified new accessory for imaging sponges: Users will use a commercially available 3D IR laser depth sensor (referred to as the Natural User Interface or NUI Sensor in the submission) that allows for automatic detection of sponges as well as a touch-free interface with the device to facilitate imaging of the sponge on Apple's iPad Pro device. To allow the use of the NUI Sensor with the Triton Sponge System, a new algorithm called the Sponge Recognition Algorithm (SRA) was added to the System. The SRA analyzes the depth maps provided by the NUI Sensor to determine whether or not a User is presenting a sponge for imaging. To allow the NUI Sensor to securely connect to the iPad Pro, NUI mounting brackets are provided to connect the NUI Sensor to the iPad Pro. Addition of a step to include imaging a calibration placard with Triton Sponge App to normalize ambient light settings. The calibration card is provided to standardize the image of each sponge. Updates to the Hemoglobin Algorithm to improve hemoglobin mass estimates by performing scene normalization as well as utilizing new data provided by the calibration palette and NUI Sensor.

AI/ML Overview

The provided text describes the Triton Sponge System, a software application intended to be used as an adjunct in the estimation of blood loss and management of surgical sponges. It explains the acceptance criteria for this device and the studies conducted to prove it meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the "Special Controls Required for 21 CFR §880.2750" (Table 6-1 on page 14). The device performance is summarized from the "Special Control Met" column and the "PERFORMANCE DATA" section (pages 10-14).

Special Control Required (Acceptance Criteria)	Reported Device Performance
1. Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. Demonstration of the performance characteristics must include a comparison to a scientifically valid alternative method for measuring deposited hemoglobin mass. The following use conditions must be tested: A. Lighting conditions; B. Range of expected hemoglobin concentrations; C. Range of expected blood volume absorption; and D. Presence of other non-sanguineous fluids (e.g., saline irrigation fluid)	Non-clinical performance testing using the iPad Pro and the NUI sensor was conducted and demonstrated that the device performs as intended under anticipated conditions of use including expected lighting conditions, range of expected hemoglobin values, range of expected blood volume absorption and presence of other non-sanguineous fluids. A strong positive linear correlation and acceptable agreement via Bland-Altman analysis were found between Triton sHbL and Assay sHbL.
2. Human factors testing and analysis must validate that the device design and labeling are sufficient for appropriate use by intended users of the device.	Human factors testing and analysis demonstrated that the Triton Sponge System, labeling, and the NUI sensor as an accessory to support scanning of images with the Triton Sponge System are sufficient for appropriate use by intended users of the Triton Sponge System. All users successfully completed tasks per protocol pass/fail criteria in a simulated setting.
3. Appropriate analysis and non-clinical testing must validate the electromagnetic compatibility (EMC) and wireless performance of the device.	EMC and wireless performance of the Triton Sponge System with new iPad Pro and accessory NUI Sensor have been validated against IEC 60601-1-2:2007. The iPad Pro maintained essential wireless functionality under all test conditions.
4. Appropriate software verification, validation and hazard analysis must be performed.	Software verification, validation and hazard analysis have been performed. Software verification demonstrated that all specified requirements, including hazard mitigations, have been fulfilled. Validation testing demonstrated that all device specifications conform with user needs and intended uses.
5. Software display must include an estimate of the cumulative error associated with estimated blood loss values.	An estimate of the cumulative error associated with blood loss values is displayed to the user with each estimated hemoglobin mass and blood loss value. This is informed by Bland-Altman methods from verification testing.
6. Labeling must include: A. Warnings, cautions, and limitations needed for safe use of the device; B. A detailed summary of the performance testing pertinent to use of the device, including a description of the bias and variance the device exhibited during testing; C. The validated surgical materials, range of hemoglobin mass, software, hardware, and accessories that the device is intended to be used with; and D. EMC and wireless technology instructions and information.	Labeling includes all details as required by the special controls. This includes prescription statement, warnings, cautions, limitations, performance testing summary (bias and variance), validated materials/ranges/hardware/accessories, and EMC/wireless information.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for performance testing (bench-top and system validation): The document states "Testing involved running the software app/system test protocol with sample specimens" for bench testing and for system validation, it used "mock surgical case simulated by reconstituting whole blood samples of known Hb concentration from units of human packed red blood cells and plasma to create various pre-specified blood volumes. Serial dilution with sterile saline yielded sponge blood samples reconstituted to ranges of fluid volume, dilution, and Hb mass representative of a surgical operation."
- The exact number of "sample specimens" or "blood volumes" / "dilution levels" is not explicitly stated in the provided text.
Data Provenance: The data used for performance testing (bench-top and system validation) appears to be prospective and simulated in a laboratory/mock surgical setting. The blood samples were "reconstituted" and "serial dilution with sterile saline" was performed. There is no indication of patient data or data from a specific country of origin, suggesting it's synthetic or laboratory-generated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The ground truth for the performance tests (bench and system validation) was established using "pre-measured Hb mass (Assay sHbL)" of the samples. This indicates a direct quantitative measurement rather than expert interpretation.

Therefore, no experts were used to establish the ground truth in the traditional sense of clinical assessment (e.g., radiologists, pathologists). The ground truth was based on laboratory assay measurements.
The qualifications of individuals performing these assays are not specified, but it's implied to be standard laboratory practice for measuring hemoglobin mass.

4. Adjudication Method for the Test Set

Since the ground truth for performance testing was based on pre-measured laboratory assays, there was no adjudication method involving multiple human readers or experts. The comparison was directly between the device's output and the established objective measurement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted involving human readers with and without AI assistance to measure effect size. The studies described are primarily technical performance validation (accuracy of Hb estimation) and human factors usability of the device itself.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Yes, standalone performance testing was done for the algorithm's core function. The bench-top and system validation tests evaluated the algorithm's ability to estimate hemoglobin mass (sHbL) from imaged sponges by comparing "Triton sHbL" (algorithm output) to "Assay sHbL" (pre-measured ground truth).

The process involved the App capturing images, transferring them to a server-based hemoglobin algorithm software, which then calculated the Triton sHbL. This calculated value was then compared to the Assay sHbL. This effectively represents the algorithm's standalone performance in estimating Hb mass from image input.

7. The Type of Ground Truth Used

The type of ground truth used for the quantitative performance studies (bench-top and system validation) was objective laboratory measurement of hemoglobin mass, referred to as "pre-measured Hb mass (Assay sHbL)". This involved depositing known quantities of blood with known Hb mass on surgical sponges.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for the training set used to develop or refine the Hemoglobin Algorithm, nor does it specify if a separate training set was used for the Sponge Recognition Algorithm (SRA). The text focuses on the testing and validation of the device.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for any training set was established. It primarily details the methods for creating test data and establishing ground truth for validation purposes.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, forming a symbol that resembles a stylized caduceus.

Public Health Service

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

April 25, 2017

Gauss Surgical, Inc. Artie Kaushik Manager RA/QA 334 State St., Suite 201 Los Altos, California 94022

Re: K163507

Trade/Device Name: Triton Sponge System Regulation Number: 21 CFR 880.2750 Regulation Name: Image Processing Device for Estimation of External Blood Loss Regulatory Class: Class II Product Code: PBZ Dated: December 12, 2016 Received: December 14, 2016

Dear Artie Kaushik:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Image /page/1/Picture/8 description: The image shows the name "Jennifer R. Stevenson -S" in a large, clear font. The text is black and stands out against a white background. In the background, the letters "FDA" are faintly visible in a light blue color, creating a subtle watermark effect.

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K163507

Device Name Triton Sponge System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Section 6: 510(k) Summary (21 CFR § 807.92(c))

I. SUBMITTER INFORMATION

Submitter:	Gauss Surgical, Inc.334 State St., Suite 201Los Altos, CA 94022
Contact:	Artie KaushikManager RA/QAGauss Surgical, Inc.Phone: +1(408) 480 6017Email: artie@gausssurgical.com

Date Summary Prepared: March 31, 2016

II. SUBJECT DEVICE INFORMATION

Device Trade Name: Gauss Surgical Triton Sponge System

Common Name: Triton Sponge System Image Processing Device for Estimation of External Blood Loss in used surgical sponges
Classification Name: Image Processing Device for Estimation of External Blood Loss (21 CFR §880.2750)
Product Code: PBZ

III. PREDICATE DEVICE INFORMATION

Equivalent Devices: Triton Svstem K160338, August 5, 2016. This predicate device has not been subject to a recall.

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

Qualified new hardware accessory: Apple's iPad Pro to be used with Triton Sponge System.

Qualified new accessory for imaging sponges: Users will use a commercially available 3D IR laser depth sensor (referred to as the Natural User Interface or NUI Sensor in the submission)

{4}------------------------------------------------

that allows for automatic detection of sponges as well as a touch-free interface with the device to facilitate imaging of the sponge on Apple's iPad Pro device.

To allow the use of the NUI Sensor with the Triton Sponge System, a new algorithm O called the Sponge Recognition Algorithm (SRA) was added to the System. The SRA analyzes the depth maps provided by the NUI Sensor to determine whether or not a User is presenting a sponge for imaging.
o To allow the NUI Sensor to securely connect to the iPad Pro, NUI mounting brackets are provided to connect the NUI Sensor to the iPad Pro.

Addition of a step to include imaging a calibration placard with Triton Sponge App to normalize ambient light settings. The calibration card is provided to standardize the image of each sponge.

Updates to the Hemoglobin Algorithm to improve hemoglobin mass estimates by performing scene normalization as well as utilizing new data provided by the calibration palette and NUI Sensor.

V. INDICATIONS FOR USE

Intended Use / Indications for Use:

The Triton System is a software application intended to be used as an adjunct in the estimation of blood loss and management of surgical sponges. The Triton System is intended to be used with surqical sponges, software, hardware and accessory devices which have been validated for use with the Triton System to estimate the hemoglobin (Hb) mass contained on used surgical sponges. The Triton System is also intended to calculate an estimate of blood volume on used surgical sponges from the estimated Hb mass and a user-entered patient serum Hb value. The validated surqical sponges, hardware, software, accessory devices and Hb mass ranges are listed in the Instructions for Use. The Triton System is also indicated for use to aid in counting surgical sponges and may be used to record and display case-specific blood components infused over time.

The Triton System is additionally indicated for use to aid in managing surgical sponges, including providing a visual record of sponge images, and to record the user-entered weight of used surgical sponges in order to calculate an estimate of fluid volume on the sponges.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Gauss Surgical Triton Sponge System is substantially equivalent to the Triton System which was cleared for commercialization via K160338. Both systems have the same indication for use, have the same technology, namely image processing software, to estimate blood loss on used surgical sponges in surgical procedures and run on the same mobile platform to estimate blood loss in surgical procedures.

Triton Sponge System is an incremental improvement to the Triton System. The changes to the system and the rationale for change are discussed below.

{5}------------------------------------------------

ITEMNO.	CHARACTERISTIC	SUBJECT DEVICETRITON SPONGE	PREDICATE DEVICETRITON SYSTEM(K160338)	RATIONALE
i	DeviceManufacturer	Gauss Surgical, Inc.	Gauss Surgical, Inc.	N/A
ii	510(k) Clearance	K163507	K160338	N/A
iii	Product Code	PBZ	PBZ	N/A
iv	Regulatory Class	II	II	N/A
v	RegulatoryClassification	21 CFR § 880.2750	21 CFR § 880.2750	N/A
vi	Regulation Name	Image Processing Device forEstimation of External Blood Loss	Image ProcessingDevice for Estimationof External Blood Loss	N/A
1	Indications for Use
	Indications for UseStatement	The Triton Sponge System is asoftware application intended to beused as an adjunct in the estimation ofblood loss and management ofsurgical sponges.The Triton Sponge System is intendedto be used with surgical sponges,software, hardware and accessorydevices which have been validated foruse with the Triton Sponge System toestimate the hemoglobin (Hb) mass	Same	No change

{6}------------------------------------------------

		contained on surgical sponges. TheTriton Sponge System is also intendedto calculate an estimate of bloodvolume on used surgical sponges fromthe estimated Hb mass and a user-entered patient serum Hb value. Thevalidated surgical sponges, hardware,software accessory devices and Hbmass ranges are listed intheInstructions for Use.
	Technological Characteristics
2	IdenticalFeatures
2.1	FundamentalScientificTechnology	Mobile App for use on mobile platformto estimate intraoperative Hb loss andblood loss on sponges	Samedevice	as	subject	The fundamental technology of the deviceremains the same. The enhancements madeto the device are so the same technology maybe used on the newer version of the iPadtablet. In addition, changes have been madeto accommodate the new accessory forimaging the used sponges.
2.2	PrincipleofOperation	Using the mobile platform camera, theTriton Sponge System scans blood-containing surgical sponges, countsthe sponges, and sends the images tothe cloud server for processing. On theserver,theimage-processingalgorithm estimates the Hemoglobinmass loss (sHbL) contained on thesponges and sends results back to theOR.	Samedevice	as	subject	The work flow for system operation remainsunchanged.

{7}------------------------------------------------

2.3	System	A mobile App, Server, and Algorithm	Same as the subjectdevice	The core components of the system remainunchanged. Change is to add new hardwareaccessories and updates to system that havebeen made to accommodate the functioningof the System.
2.5	Function of theImage ProcessingSoftware	App captures images and uses a visualalgorithm to estimate Hb mass	Same as the subjectdevice	Although software has been updated toaccommodate the new hardware accessories,the core function of the image processingsoftware remains unchanged.
2.6	FunctionofAlgorithm	Calculates Hb mass and EBL.Requires user input of patient serumHb value.	Same as the subjectdevice	The function of the Algorithm remains thesame. The only change to the Algorithm hasbeen to include the scene normalizationfeature. Details below (3.4) in this table.Additionally, a Sponge Recognition Algorithmwas added, to interface with the IR cameraconnected to the iPad and detect when a userhas presented a sponge for imaging.
2.7	Function of Server	The remote "cloud" Server computerruns the Server software andalgorithm. The Server softwarecoordinates communication betweenthe Algorithm and the App.	Same as the subjectdevice	The function of the Server remains the same.The updates to the Server are incremental.
2.8	Validated Ranges	Validated range specific to eachsponge type as listed in IFU	Same as the subjectdevice	Validated range specific to each sponge typeis confirmed using the same process asdetailed in the predicate 510(k) K 160338 andthe original 510(K) K 130190.
2.9	App to ServerCommunication	App communicates wirelessly withGauss Surgical's cloud-based server	Same as the subjectdevice	No change to the app to Servercommunication
2.10	Estimateof	Estimated HbL and estimated EBL	Same as the subject	The display of estimated EBL and HBL errors
	Cumulative HBLand EBL Errors	errors are displayed on the App usingthe Bland-Altman method.	device	is a special requirement for this devicecategory and the method of display remainsthe same with this update.
3	New Features
3.1	Mobile Hardware	iPad Pro (A1584)	iPad 2 (A1395)	Change does not affect indications for use,fundamental scientific technology oroperation. Safety and effectiveness aredemonstrated through verification andvalidation testing. Per one of the specialcontrols detailed for this category of devices,the iPad Pro and the Structure Sensorsuccessfully passed EMC testing andwireless coexistence.
3.1.2	Operating System	Apple, Inc. iOS 10 or greater	Apple, Inc. iOS 5.0 andgreater	The Operating System is provided by Apple.iPad Pro includes iOS 10. The systemverification and validation confirm that iOS 10with iPad Pro platform is safe and effective.
3.2	ImagingAccessories	NUI Sensor: Gauss qualified new 3DIR laser depth sensor (NUI sensor) thatallows for automatic detection ofsponges as well as a touch-freeinterface with the device to facilitateimaging of the sponge.	Foot Pedals: PageFlipFirefly Pedals andAirTurn BT-105 with 2ATFS-2 Pedals andPedal Board	A new accessory was qualified with theTriton Sponge System to improve usability ofthe device. Safety and effectiveness aredemonstrated through validation testing.Since this accessory would be used in ahospital setting along with the iPad Pro, itwas also tested for and passed EMC andwireless coexistence. In addition, the SystemValidation Testing confirmed theperformance of the entire system to meet thesame predetermined acceptance criteria asthe predicate system. Therefore, the modifieddevice is substantially equivalent topredicate.

3.3	CalibrationPlacard	Added step to calibrate using acalibration placard	New feature	The Calibration Placard was verified to bedesigned according to hardwarerequirements upon successful passing of theHardware Verification Protocol which calledout the dimensional and color requirementsfor the Placard. System Validation Testingconfirmed the performance of the entireSystem (including Calibration Placard) tomeet the same predetermined acceptancecriteria as the predicate system.
3.4	SceneNormalizationfeature to HbAlgorithm	Added a scene normalization featureto normalize background settings forthe sponge.	New feature	This feature was added as an incrementalimprovement to improve productperformance.This feature when used with the CalibrationPlacard helps standardize each spongeimage for ambient lighting conditions.This enhancement to the algorithm does nothave any impact to user-facing componentsof the App. However, using the CalibrationPlacard is a new step and was included inthe Human Factors Usability study. All Userswere successfully able to use the CalibrationPlacard. In addition, the functioning of theSystem Validation Testing which isimplemented with all the System accessoriesincluding iPad Pro and Calibration Placardconfirmed the performance of the entiresystem to meet the same predeterminedacceptance criteria as the predicate system.

{8}------------------------------------------------

{9}------------------------------------------------

{10}------------------------------------------------

VII. PERFORMANCE DATA

The following performance data was provided in support of the substantial equivalence determination and to demonstrate the Triton Sponge System performs as anticipated for its intended use conditions as detailed below.

a. Electromagnetic Compatibility (EMC) and Wireless Coexistence Testing

Electromagnetic Compatibility and Wireless Coexistence Testing was completed for Gauss Surgical's Triton Sponge System.

iPad Pro EMC Testing: The new iPad Pro, A1584, manufactured by Apple, Inc., was tested per the relevant requirements of IEC 60601-1-2:2007 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.

Testing demonstrated that the iPad Pro is EMC compatible with the operating room environment. This testing is considered sufficient to demonstrate the electromagnetic compatibility of the iPad Pro in the surgical suite.

The iPad Pro (A1584) was also tested for Wireless Coexistence by confirming the performance of the iPad Pro in the presence of other in-band emitters. The test addressed environmental specifications including co-channel and adjacent channel interference from other devices and users of the RF band to demonstrate that the iPad Pro performs properly in proximity to other RF wireless in-band sources. The iPad Pro was found to maintain essential wireless functionality under all test conditions.

Distance requirements for all interferers are noted in the Instructions for Use. The system was not tested in the presence of MRI, CT, diathermy and electromagnetic security systems such as metal detectors; this is noted in the Instructions for Use.

NUI Sensor EMC testing: The new Structure Sensor (ST01) manufactured by Occipital, Inc., (i.e. "NUI Sensor") was tested per the relevant requirements of IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests.

Testing demonstrated that the Structure Sensor is EMC compatible with the operating room environment. This testing is considered sufficient to demonstrate the electromagnetic compatibility of the iPad Pro in the surgical suite.

Wireless Coexistence testing was not necessary for the Structure Sensor as it has no wireless functionalities or components.

b. Magnetic Resonance (MR) Compatibility

No testing has been conducted to demonstrate whether the device is MR compatible. The labeling includes a warning that states "The device is MR Unsafe. Do not bring the device into an MR environment. The device must not be used in an MR environment."

c. Software Verification and Validation Testing

The software is considered a moderate level of concern (LOC) because inaccurate estimated blood loss may result in consequences to health. All of the elements of software information

{11}------------------------------------------------

corresponding to moderate LOC devices as outlined in FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005) are provided. Documentation describing the software development program are provided.

Software verification testing demonstrated that all specified requirements, including hazard mitigations for the Triton Sponge System have been fulfilled. Testing included verification of the special control to display a correct estimate of the cumulative error associated with estimated blood loss values. Verification demonstrated that this functionality displays correctly and as designed.

Validation testing, including performance and human factors validation, demonstrated that all device specifications conform with user needs and intended uses.

All testing demonstrated the software performs as intended and all software related risks have been adequately mitigated.

d. Performance Testing Bench

Bench testing demonstrated that the Triton Sponge performs as intended under anticipated conditions of use. Bench top validation studies were performed to evaluate the accuracy of the device's estimation of hemoglobin mass loss on sponges (sHbL, g) and blood volume loss on sponges (sEBL, ml) in comparison to known Hb mass and blood volume contained on the surgical sponges.

Bench top performance validation testing confirmed the ability of the Triton Sponge to estimate sponge hemoglobin mass loss and sponge blood volume loss by comparing Triton generated results to known quantities of hemoglobin mass and blood contained on surgical sponges. Testing was performed using the new automatic imaging method (NUI Sensor) for imaging and the iPad Pro. This testing was completed for the expected conditions of use as labeled for the product. The bench-top validation performed on the system was the same protocol performed on the predicate product with the addition of testing across sponge illuminations, and used the same clinically justified acceptance criteria cleared for the predicate device.

Testing involved running the software app/system test protocol with sample specimens to ensure all specifications were met.

Briefly, this testing was undertaken by depositing known quantities of blood volume with a known Hb mass on surgical sponges and imaging them with Triton Sponge using the NUI accessory and iPad Pro. As is common in surgical procedures, saline is often also part of the fluid on these sponges and therefore known volumes of saline were added to some samples. The fluid samples represented the clinically-expected ranges and distributions of fluid volume, dilution (by saline), Hb mass, ambient light, sponge illumination, and serum patient Hb. For each sponge type, the Triton Sponge App was used to capture scans of the sponges under the three different ambient lighting conditions and sponge illuminations to confirm the ability of the algorithm to operate consistently across a range of intraoperative ambient illuminance. User-entered volumes input into the app were recorded as well.

The images were then transferred to the server-based hemoglobin algorithm software, which was used to calculate hemoglobin mass (Triton sHbL) for each imaged sponge. The sHbL value obtained via the algorithm for each sponge was then compared to the pre-measured Hb mass (Assay sHbL) of the samples.

{12}------------------------------------------------

A plot of the association between Triton sHbL and Assay sHbL demonstrated a strong positive linear correlation between the two methods of measurement and the predicate across the range of expected intraoperative conditions. Bland-Altman analysis demonstrated acceptable agreement between the sHbL and the pre-determined Hb mass and evaluation of the parameters via the acceptance criteria.

The results of this performance validation testing using Bland-Altman methods inform the lookup tables and resultant "error estimate" values displayed on the user interface each time that the Triton Sponge System is used intraoperatively.

System validation testing of the Triton Sponge followed a similar protocol to performance validation, demonstrating the device met the user requirements under expected conditions of use. A mock surgical case was simulated by reconstituting whole blood samples of known Hb concentration from units of human packed red blood cells and plasma to create various pre-specified blood volumes. Serial dilution with sterile saline vielded sponge blood samples reconstituted to ranges of fluid volume, dilution, and Hb mass representative of a surgical operation. For each dilution level achieved, Triton Sponge was used to capture scans of the surgical sponges in an operating room. User-entered baseline Hb was recorded into the App. System validation testing was performed using the new automatic imaging method (NUI Sensor) and iPad Pro.

The images and corresponding user-entered volumes were then transferred automatically to the server-based software via the App/Server interfaces, and the Triton HB Algorithm automatically calculated hemoglobin mass (Triton sHbL) within each sponge type. The live sHbL returned to the App from the Algorithm and displayed to the user on the screen was then recorded for comparison with the Assay (pre-measured) Hb mass (Assay sHbL) of the reconstituted samples.

Triton sHbL vs. Assay sHbL demonstrated a strong positive linear association between the two methods of measurement across the range of expected intraoperative conditions. Bland-Altman analysis demonstrated acceptable agreement between the sHbL and the predetermined Hb mass and evaluation of the parameters via the acceptance criteria.

In summary, the device was tested within the anticipated use conditions including variable lighting, range of expected patient serum hemoglobin concentrations, range of expected blood volume and the presence of other non-sanguineous fluids, and the resulting data demonstrated acceptable performance.

e. Human Factors Testing

The Triton Sponge System software was developed to conform to the Human Interface Guidelines (HIG) as published by Apple for iOS Apps. Additionally, human factors usability testing and analysis validated that the device design (i.e. user interface) and labeling are sufficient for appropriate use by intended users of the Triton Sponge System.

A usability study was conducted to explore critical and frequently used functions associated with the Triton Sponge System in a simulated setting using hardware (iPad Pro) and the validated accessory (NUI Sensor). Both quantitative survey data was collected and analyzed. Participants included personnel who are typically required to track blood loss during surgical procedures. All users were able to successfully complete the tasks per the

{13}------------------------------------------------

protocol pass/fail criteria demonstrating the product meets applicable Human Factors requirements and customer design requirements per product specifications.

Human factors testing validated that the device design and labeling are sufficient for appropriate use by intended users of the device.

f. Labeling

Labeling has been provided which includes the special controls as called out in K160338 and in the original de novo petition clearance for the predicate device. Specifically, the labeling includes:

An appropriate prescription statement as required by 21 CFR 801.109;
Warnings, cautions and limitations needed for safe use of the device;
A detailed summary of the performance testing pertinent to the use of the device, including a description of the bias and variance the device exhibited during testing;
. The validated surgical materials, range of hemoglobin mass, software, hardware, imaging methodologies, and accessories that the device is intended to be used with; and
EMC and wireless technology instructions and information. ●

VIII. SUMMARY OF SPECIAL CONTROLS REQUIRED FOR 21 CFR §880.2750

With the granting of Gauss Surgical's de novo petition for the original Pixel 3 System, the FDA established special controls for products cleared under this classification. As summarized in this notification, the Triton Sponge System has met the six (6) special controls as specified and detailed below in Table 6-1 below.

TABLE 6-1: SPECIAL CONTROLS REQUIRED FOR 12 CFR §880.2750

Special Control Required	Special Control Met
1. Non-clinical performance data mustdemonstrate that the device performs asintended under anticipated conditions ofuse. Demonstration of the performancecharacteristics must include a comparisonto a scientifically valid alternative methodfor measuring deposited hemoglobin mass.The following use conditions must betested:A. Lighting conditions;B. Range of expected hemoglobinconcentrations;C. Range of expected blood volumeabsorption; andD. Presence of other non-sanguineousfluids (e.g., saline irrigation fluid)	Non-clinical performance testing using theiPad Pro and the NUI sensor wasconducted and demonstrated that thedevice performs as intended underanticipated conditions of use includingexpected lighting conditions, range ofexpected hemoglobin values, range ofexpected blood volume absorption andpresence of other non-sanguineous fluids.Performance data under anticipatedconditions of use demonstrate that theTriton Sponge System performs asintended.
2. Human factors testing and analysis mustvalidate that the device design and labeling	Human factors testing and analysisdemonstrated that the Triton Sponge
Special Control Required	Special Control Met
are sufficient for appropriate use byintended users of the device.	System, labeling, and the NUI sensor as anaccessory to support scanning of imageswith the Triton Sponge System aresufficient for appropriate use by intendedusers of the Triton Sponge System.
3. Appropriate analysis and non-clinicaltesting must validate the electromagneticcompatibility (EMC) and wirelessperformance of the device.	EMC and wireless performance of theTriton Sponge System with new iPad Proand accessory NUI Sensor have beenvalidated.
4. Appropriate software verification,validation and hazard analysis must beperformed.	Software verification, validation and hazardanalysis have been performed.
5. Software display must include anestimate of the cumulative error associatedwith estimated blood loss values.	An estimate of the cumulative errorassociated with blood loss values isdisplayed to the user with each estimatedhemoglobin mass and blood loss value.The results of verification testing and Bland-Altman methods inform the look-up tablesand resultant values displayed on the userinterface each time the Triton SpongeSystem is used for the estimation ofhemoglobin mass and blood volume loss.
6. Labeling must include:A. Warnings, cautions, and limitationsneeded for safe use of the device;B. A detailed summary of the performancetesting pertinent to use of the device,including a description of the bias andvariance the device exhibited duringtesting;C. The validated surgical materials, rangeof hemoglobin mass, software, hardware,and accessories that the device is intendedto be used with; andD. EMC and wireless technologyinstructions and information.	Labeling includes all details as required bythe special controls.

{14}------------------------------------------------

IX. CONCLUSIONS

The Triton Sponge introduces no new indication for use and is substantially equivalent in terms of Indications for Use as the identified predicate device.

{15}------------------------------------------------

The Triton Sponge System was verified in its operating environments. Verification and validation activities related to the device modification were performed on the applicant device, and the predetermined acceptance criteria were met in all cases.

From the testing data included in this submission, it can be concluded that the Gauss Surgical Triton Sponge System his substantially equivalent to the currently marketed predicate device in indications for use, design, technological characteristics, mechanism of action and performance. In addition, all special controls as required for products under this classification, image processing devices for estimation of external blood loss, have been addressed. The differences between the subject and predicate device do not raise different types of safety or effectiveness questions.

Regulation Number and Section

§ 880.2750 Image processing device for estimation of external blood loss.

(a)
Identification. An image processing device for estimation of external blood loss is a device to be used as an aid in estimation of patient external blood loss. The device may include software and/or hardware that is used to process images capturing externally lost blood to estimate the hemoglobin mass and/or the blood volume present in the images.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. Demonstration of the performance characteristics must include a comparison to a scientifically valid alternative method for measuring deposited hemoglobin mass. The following use conditions must be tested:
(i) Lighting conditions;
(ii) Range of expected hemoglobin concentrations;
(iii) Range of expected blood volume absorption; and
(iv) Presence of other non-sanguineous fluids (
e.g., saline irrigation fluid).(2) Human factors testing and analysis must validate that the device design and labeling are sufficient for appropriate use by intended users of the device.
(3) Appropriate analysis and non-clinical testing must validate the electromagnetic compatibility (EMC) and wireless performance of the device.
(4) Appropriate software verification, validation, and hazard analysis must be performed.
(5) Software display must include an estimate of the cumulative error associated with estimated blood loss values.
(6) Labeling must include:
(i) Warnings, cautions, and limitations needed for safe use of the device;
(ii) A detailed summary of the performance testing pertinent to use of the device, including a description of the bias and variance the device exhibited during testing;
(iii) The validated surgical materials, range of hemoglobin mass, software, hardware, and accessories that the device is intended to be used with; and
(iv) EMC and wireless technology instructions and information.