(132 days)
No reference devices were used in this submission.
No
The description mentions a "Sponge Recognition Algorithm (SRA)" and updates to the "Hemoglobin Algorithm," but these are described as analyzing depth maps and performing scene normalization, which are typical image processing tasks and not explicitly indicative of AI/ML. The document does not mention training data, neural networks, or other common AI/ML terminology.
No
The device is described as an "adjunct in the estimation of blood loss and management of surgical sponges." It provides information (estimated blood loss, sponge counts) to aid medical professionals, but it does not directly treat or diagnose a disease or condition, which are characteristics of a therapeutic device.
No
Explanation: The device is intended to estimate blood loss and manage surgical sponges, not to diagnose a medical condition in a patient.
No
The device description explicitly states that the Triton Sponge System is intended to be used with "surgical sponges, software, hardware and accessory devices" and details the qualification of new hardware accessories (Apple's iPad Pro, 3D IR laser depth sensor, NUI mounting brackets) as part of the system. This indicates it is not solely software.
Based on the provided information, the Triton Sponge System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is a medical device intended for use in vitro for the examination of specimens, including blood and tissue, derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes.
- Triton Sponge System's Intended Use: The Triton Sponge System's primary intended use is to estimate blood loss and manage surgical sponges. While it uses information derived from blood (hemoglobin mass on sponges and user-entered patient serum Hb), it is not directly examining a specimen in vitro for diagnostic or monitoring purposes related to a patient's health status. It's focused on quantifying blood loss during a surgical procedure, which is a procedural measurement rather than a diagnostic test on a patient sample.
- Nature of the Measurement: The system is measuring the amount of hemoglobin on a surgical sponge, which is a discarded item from the surgical field, not a specimen taken from the patient for analysis of their physiological state.
- Adjunct Use: The system is described as an "adjunct" in the estimation of blood loss, further indicating it's a tool to assist in a process rather than a standalone diagnostic test.
While the system utilizes information about hemoglobin, the context and purpose of its use fall outside the typical definition of an IVD. It's a tool for surgical management and blood loss estimation during a procedure, not a device for diagnosing or monitoring a patient's condition through in vitro analysis of a biological specimen.
N/A
Intended Use / Indications for Use
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 the Triton Sponge System to estimate the hemoglobin (Hb) mass contained on used surgical sponge 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 surgical sponges, hardware, software, accessory devices and Hb mass ranges are listed in the Instructions for Use. The Triton Sponge 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 Sponge 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.
Product codes (comma separated list FDA assigned to the subject device)
PBZ
Device Description
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 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.
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
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)
a. Electromagnetic Compatibility (EMC) and Wireless Coexistence Testing
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. Testing demonstrated that the iPad Pro is EMC compatible with the operating room environment.
The iPad Pro (A1584) was also tested for Wireless Coexistence by confirming its performance in the presence of other in-band emitters covering co-channel and adjacent channel interference. 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. Testing demonstrated that the Structure Sensor is EMC compatible with the operating room environment.
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. 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). Software verification testing demonstrated that all specified requirements, including hazard mitigations for the Triton Sponge System have been fulfilled. 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.
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.
Known quantities of blood volume with a known Hb mass were deposited on surgical sponges and imaged with Triton Sponge using the NUI accessory and iPad Pro. 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 three different ambient lighting conditions and sponge illuminations.
The images were transferred to the server-based hemoglobin algorithm software, which calculated hemoglobin mass (Triton sHbL). The sHbL value obtained was then compared to the pre-measured Hb mass (Assay sHbL) of the samples.
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.
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. Whole blood samples of known Hb concentration were reconstituted to create various pre-specified blood volumes. Serial dilution with sterile saline yielded sponge blood samples representing clinically relevant ranges. Triton Sponge was used to capture scans of the surgical sponges in an operating room using the NUI Sensor and iPad Pro. User-entered baseline Hb was recorded. The images and user-entered volumes were transferred to the server-based software, and the Triton HB Algorithm calculated hemoglobin mass (Triton sHbL). This was compared 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
A usability study was conducted 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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)
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 the Triton Sponge System to estimate the hemoglobin (Hb) mass contained on used surgical sponge 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 surgical sponges, hardware, software, accessory devices and Hb mass ranges are listed in the Instructions for Use. The Triton Sponge 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 Sponge 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.
| 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)
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Section 6: 510(k) Summary (21 CFR § 807.92(c))
I. SUBMITTER INFORMATION
| Submitter: | Gauss Surgical, Inc.
334 State St., Suite 201
Los Altos, CA 94022 |
|------------|---------------------------------------------------------------------------------------------------------------------|
| Contact: | Artie Kaushik
Manager RA/QA
Gauss Surgical, Inc.
Phone: +1(408) 480 6017
Email: 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
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)
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.
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| ITEM
NO. | CHARACTERISTIC | SUBJECT DEVICE
TRITON SPONGE | PREDICATE DEVICE
TRITON SYSTEM
(K160338) | RATIONALE |
|-------------|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|-----------|
| i | Device
Manufacturer | 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 | Regulatory
Classification | 21 CFR § 880.2750 | 21 CFR § 880.2750 | N/A |
| vi | Regulation Name | Image Processing Device for
Estimation of External Blood Loss | Image Processing
Device for Estimation
of External Blood Loss | N/A |
| 1 | Indications for Use | | | |
| | Indications for Use
Statement | 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 the Triton Sponge System to
estimate the hemoglobin (Hb) mass | Same | No change |
6
| | | contained on surgical sponges. The
Triton Sponge 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 surgical sponges, hardware,
software accessory devices and Hb
mass ranges are listed in
the
Instructions for Use. | | | | |
|-----|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|----|---------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Technological Characteristics | | | | | |
| 2 | Identical
Features | | | | | |
| 2.1 | Fundamental
Scientific
Technology | Mobile App for use on mobile platform
to estimate intraoperative Hb loss and
blood loss on sponges | Same
device | as | subject | The fundamental technology of the device
remains the same. The enhancements made
to the device are so the same technology may
be used on the newer version of the iPad
tablet. In addition, changes have been made
to accommodate the new accessory for
imaging the used sponges. |
| 2.2 | Principle
of
Operation | Using the mobile platform camera, the
Triton Sponge System scans blood-
containing surgical sponges, counts
the sponges, and sends the images to
the cloud server for processing. On the
server,
the
image-processing
algorithm estimates the Hemoglobin
mass loss (sHbL) contained on the
sponges and sends results back to the
OR. | Same
device | as | subject | The work flow for system operation remains
unchanged. |
7
| 2.3 | System | A mobile App, Server, and Algorithm | Same as the subject
device | The core components of the system remain
unchanged. Change is to add new hardware
accessories and updates to system that have
been made to accommodate the functioning
of the System. |
|-------|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2.5 | Function of the
Image Processing
Software | App captures images and uses a visual
algorithm to estimate Hb mass | Same as the subject
device | Although software has been updated to
accommodate the new hardware accessories,
the core function of the image processing
software remains unchanged. |
| 2.6 | Function
of
Algorithm | Calculates Hb mass and EBL.
Requires user input of patient serum
Hb value. | Same as the subject
device | The function of the Algorithm remains the
same. The only change to the Algorithm has
been to include the scene normalization
feature. Details below (3.4) in this table.
Additionally, a Sponge Recognition Algorithm
was added, to interface with the IR camera
connected to the iPad and detect when a user
has presented a sponge for imaging. |
| 2.7 | Function of Server | The remote "cloud" Server computer
runs the Server software and
algorithm. The Server software
coordinates communication between
the Algorithm and the App. | Same as the subject
device | The function of the Server remains the same.
The updates to the Server are incremental. |
| 2.8 | Validated Ranges | Validated range specific to each
sponge type as listed in IFU | Same as the subject
device | Validated range specific to each sponge type
is confirmed using the same process as
detailed in the predicate 510(k) K 160338 and
the original 510(K) K 130190. |
| 2.9 | App to Server
Communication | App communicates wirelessly with
Gauss Surgical's cloud-based server | Same as the subject
device | No change to the app to Server
communication |
| 2.10 | Estimate
of | Estimated HbL and estimated EBL | Same as the subject | The display of estimated EBL and HBL errors |
| | Cumulative HBL
and EBL Errors | errors are displayed on the App using
the Bland-Altman method. | device | is a special requirement for this device
category and the method of display remains
the 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 or
operation. Safety and effectiveness are
demonstrated through verification and
validation testing. Per one of the special
controls detailed for this category of devices,
the iPad Pro and the Structure Sensor
successfully passed EMC testing and
wireless coexistence. |
| 3.1.2 | Operating System | Apple, Inc. iOS 10 or greater | Apple, Inc. iOS 5.0 and
greater | The Operating System is provided by Apple.
iPad Pro includes iOS 10. The system
verification and validation confirm that iOS 10
with iPad Pro platform is safe and effective. |
| 3.2 | Imaging
Accessories | NUI Sensor: Gauss qualified new 3D
IR laser depth sensor (NUI sensor) that
allows for automatic detection of
sponges as well as a touch-free
interface with the device to facilitate
imaging of the sponge. | Foot Pedals: PageFlip
Firefly Pedals and
AirTurn BT-105 with 2
ATFS-2 Pedals and
Pedal Board | A new accessory was qualified with the
Triton Sponge System to improve usability of
the device. Safety and effectiveness are
demonstrated through validation testing.
Since this accessory would be used in a
hospital setting along with the iPad Pro, it
was also tested for and passed EMC and
wireless coexistence. In addition, the System
Validation Testing confirmed the
performance of the entire system to meet the
same predetermined acceptance criteria as
the predicate system. Therefore, the modified
device is substantially equivalent to
predicate. |
| | | | | |
| 3.3 | Calibration
Placard | Added step to calibrate using a
calibration placard | New feature | The Calibration Placard was verified to be
designed according to hardware
requirements upon successful passing of the
Hardware Verification Protocol which called
out the dimensional and color requirements
for the Placard. System Validation Testing
confirmed the performance of the entire
System (including Calibration Placard) to
meet the same predetermined acceptance
criteria as the predicate system. |
| 3.4 | Scene
Normalization
feature to Hb
Algorithm | Added a scene normalization feature
to normalize background settings for
the sponge. | New feature | This feature was added as an incremental
improvement to improve product
performance.
This feature when used with the Calibration
Placard helps standardize each sponge
image for ambient lighting conditions.
This enhancement to the algorithm does not
have any impact to user-facing components
of the App. However, using the Calibration
Placard is a new step and was included in
the Human Factors Usability study. All Users
were successfully able to use the Calibration
Placard. In addition, the functioning of the
System Validation Testing which is
implemented with all the System accessories
including iPad Pro and Calibration Placard
confirmed the performance of the entire
system to meet the same predetermined
acceptance criteria as the predicate system. |
8
9
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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
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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.
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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
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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 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. | |
| Performance data under anticipated | |
| conditions of use demonstrate that the | |
| Triton Sponge System performs as | |
| intended. | |
| 2. Human factors testing and analysis must | |
| validate that the device design and labeling | Human factors testing and analysis |
| demonstrated that the Triton Sponge | |
| Special Control Required | Special Control Met |
| are sufficient for appropriate use by | |
| intended users of the device. | 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. | |
| 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. | |
| 4. Appropriate software verification, | |
| validation and hazard analysis must be | |
| performed. | Software verification, validation and hazard |
| analysis have been performed. | |
| 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. | |
| The results of verification testing and Bland- | |
| Altman methods inform the look-up tables | |
| and resultant values displayed on the user | |
| interface each time the Triton Sponge | |
| System is used for the estimation of | |
| hemoglobin mass and blood volume loss. | |
| 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. |
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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.
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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.