(179 days)
No
The summary mentions image processing but does not explicitly mention AI, ML, or related terms like deep learning or neural networks. The performance studies focus on verification testing and equivalence to a predicate device, without describing the training or testing of an AI/ML model.
No
The device is a software application intended as an adjunct for estimating blood loss and managing surgical sponges, not for treating or diagnosing a medical condition.
No
The device is intended to aid in the estimation of blood loss and management of surgical sponges, not to diagnose a medical condition.
No
While the core of the Triton System is software, the description explicitly states it is intended to be used with "surgical sponges, software and accessory devices which have been validated for use with the Triton System" and mentions "validated surgical sponges, hardware, accessory devices". This indicates the system relies on and interacts with specific hardware components beyond just the iPad tablet running the software.
Based on the provided information, the Triton System is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is to "estimate the hemoglobin (Hb) mass contained on used surgical sponges" and "calculate an estimate of blood volume on used surgical sponges from the estimated Hb mass and a user-entered patient serum Hb value." This involves analyzing a biological sample (blood on surgical sponges) to provide information about a physiological state (blood loss).
- Analysis of Biological Samples: The system directly analyzes the blood present on surgical sponges to determine Hb mass and estimate blood volume. This is a key characteristic of an IVD.
- Providing Information for Diagnosis or Monitoring: While not a direct diagnosis, the estimation of blood loss is crucial information used by surgical personnel to monitor the patient's condition and manage the surgical procedure. This falls under the scope of IVD use.
While the system also has functions related to sponge counting and management, the core function of estimating blood loss through the analysis of biological material makes it an IVD.
N/A
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 surgical sponges, software 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 surgical sponges, hardware, 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.
Product codes
PBZ
Device Description
The Triton System is a software program (mobile medical application) used on an Apple iPad® tablet to capture images of used surgical sponges to assist surgical personnel in the management of surgical sponges after surgical use and to aid in the estimation of blood loss.
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
Surgical personnel
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)
Triton System was evaluated in accordance with Gauss Surgical's design controls process and risk management procedure. No new unacceptable risks were identified based on the changes incorporated into the software revision. Verification testing has been completed. No new safety or effectiveness issues were raised during the testing program. Triton System passed all verification. The results of the verification testing demonstrate that Triton meets established acceptance criteria and performs in a manner equivalent to its predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Pixel 3 System, K130190/DEN130015
Reference Device(s)
Triton Canister System , K142801
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a symbol that resembles a stylized caduceus or a representation of human profiles, suggesting health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 5, 2016
Gauss Surgical Inc. Ms. Artie Kaushik Manager, RA/QA 334 State Street Suite 201 Los Altos, California 94022
Re: K160338 Trade/Device Name: Triton 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: February 29, 2016 Received: March 2, 2016
Dear Ms. 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 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 yours,
Christopher J. Ronk -S
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) K160338
Device Name Triton System
Indications for Use (Describe)
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 surgical sponges, software 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 surgical sponges, hardware, 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.
| 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
| Submitter | Gauss Surgical Inc. |
|---|---|
| Submitter's | 334 State Street, Suite 201 |
| Address | Los Altos, CA 94022 |
| Telephone | (650) 949 4153 |
| Fax | (650) 887 0461 |
| Contact | |
| Person | Ms. Artie Kaushik |
| Date Prepared | May 04, 2016 |
| Device Trade | |
| Name | Triton System |
| Device | |
| Common | |
| Name | Image processing device for estimation of external blood loss |
| Device | |
| Classification | |
| Name and | |
| Description | Image processing device for estimation of external blood loss: 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. | |
| Regulation | |
| Number | 21 CFR 880.2750 |
| Device | |
| Classification | Class II |
| Product Code | PBZ |
| Predicate | Pixel 3 System, K130190/DEN130015, 9 May 2014 |
| Device | |
| Information | Triton Canister System , K142801 (Reference Device) |
510(k) Summary for Triton System
4
The purpose of this notification is to: Summary of substantial -Allow the Gauss Image Processing Device for the Estimation of External equivalence Blood Loss cleared under K130190/DEN130015 which estimated blood loss on sponges to also report information from our Image Processing Device for the Estimation of External Blood Loss cleared under K142801 which estimated blood loss in canisters (Triton Canister System). In this way, clinicians can look to only one screen to see a blood loss estimate which includes sponges and canisters -Update the option for recording user estimated blood loss values (in cases where the app cannot make the estimate e.g. oversaturated sponges) to provide a specific EBL range that takes into account the particular sponge type's fluid holding capacity -Include a View-Only Mode on the App to allow read-only monitoring of EBL events (including sponge, canister and other) -Allow usage of additional validated sponge types -Allow usage of validated non-square sponges -Allow usage of additional validated Bluetooth foot pedal The design, fundamental scientific technology, intended use and features of the new version of Triton System are substantially equivalent with regard to those features in the predicate device: the Pixel 3 System K 130190/DEN130015, May 13, 2014. The Triton System is a software program (mobile medical application) Device used on an Apple iPad® tablet to capture images of used surgical sponges description to assist surgical personnel in the management of surgical sponges after surgical use and to aid in the estimation of blood loss.
5
| 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 surgical 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 surgical
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. |
6
- Non-clinical performance data must demonstrate that the device Special Controls (for performs as intended under anticipated conditions of use. Demonstration Image of the performance characteristics must include a comparison to a Processing scientifically valid alternative method for measuring deposited Device for hemoglobin mass. The following use conditions must be tested: A. Estimation of Lighting conditions; B. Range of expected hemoglobin concentrations; C. External Blood Range of expected blood volume absorption; and D. Presence of other Loss) non-sanguineous fluids (e.g., saline irrigation fluid)
There is no change to the performance data of the product with the device modifications subject to this submission. Therefore previous non clinical testing validate that device performs as intended under anticipated conditions of use.
- 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 validate the device design and labeling are appropriate for use by intended users of device.
- Appropriate analysis and non-clinical testing must validate the electromagnetic compatibility (EMC) and wireless performance of the device.
No modifications made to the device that would change EMC compatibility or wireless performance of device.
Appropriate software verification, validation and hazard analysis 4. must be performed.
Software verification and hazard analysis was performed.
Software display must include an estimate of the cumulative error 5. 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 Bland-Altman methods inform the look-up tables and resultant values displayed on the user interface each time the Triton System is used for the estimation of hemoglobin mass and blood volume loss.
Labeling must include: 6.
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, information, and precautions
Labeling includes all details as required by the special controls.
7
| Summary of
Performance
Data and
Rationale for
Substantial
Equivalence | Triton System was evaluated in accordance with Gauss Surgical's design
controls process and risk management procedure. No new unacceptable
risks were identified based on the changes incorporated into the software
revision. Verification testing has been completed. No new safety or
effectiveness issues were raised during the testing program. Triton System
passed all verification. The results of the verification testing demonstrate
that Triton meets established acceptance criteria and performs in a manner
equivalent to its predicate device. |
|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | Triton System has the same indications for use as the predicate (Pixel 3
System). Both the subject and predicate devices are used as adjunctive
tools to estimate blood loss on surgical materials. The new version shares
the same technological characteristics as the predicate. Any differences
between the subject and predicate devices do not raise different safety or
effectiveness questions. Therefore, the devices are substantially
equivalent. |