K160338 · Gauss Surgical, Inc., · PBZ · Aug 5, 2016 · General Hospital
Device Facts
Record ID
K160338
Device Name
Triton System
Applicant
Gauss Surgical, Inc.,
Product Code
PBZ · General Hospital
Decision Date
Aug 5, 2016
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.2750
Device Class
Class 2
Attributes
AI/ML, Software as a Medical Device
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.
Device Story
Triton System is a mobile medical application running on an Apple iPad; captures images of used surgical sponges to estimate hemoglobin (Hb) mass and blood volume. System integrates data from sponges and canisters (via Triton Canister System) into a single display for clinicians. Features include sponge counting, recording of infused blood components, and manual entry of sponge weights for fluid volume estimation. Operates in surgical environments; used by surgical personnel to monitor blood loss events. Provides visual records of sponges and cumulative error estimates. Output aids clinical decision-making regarding patient blood loss management. Includes a view-only mode for monitoring.
Clinical Evidence
No clinical data. Performance validated via non-clinical bench testing, including evaluation of lighting conditions, Hb concentration ranges, blood volume absorption, and presence of non-sanguineous fluids. Bland-Altman methods used to inform look-up tables for Hb mass and blood volume estimation. Software verification, validation, and hazard analysis performed.
Technological Characteristics
Software application (mobile medical app) for iPad. Uses image processing to estimate Hb mass and blood volume. Connectivity includes Bluetooth (e.g., for foot pedal). Features include cumulative error estimation and visual sponge record. Complies with special controls for image processing devices for blood loss estimation.
Indications for Use
Indicated for use as an adjunct in the estimation of blood loss and management of surgical sponges in surgical settings. Used by surgical personnel to estimate hemoglobin mass on used sponges, calculate blood volume based on patient serum Hb, count sponges, record infused blood components, and estimate fluid volume via sponge weight.
Regulatory Classification
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.
Special Controls
In combination with the general controls of the Food, Drug & Cosmetic Act, the Image processing device for estimation of external blood loss is subject to the following special controls:
*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.
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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
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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
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## 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) | |
|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| <div> <span> <b> \[X] Prescription Use (Part 21 CFR 801 Subpart D) </b> </span> </div> | <div> <span> [] Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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| 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<br>Person | Ms. Artie Kaushik |
| Date Prepared | May 04, 2016 |
| Device Trade<br>Name | Triton System |
| Device<br>Common<br>Name | Image processing device for estimation of external blood loss |
| Device<br>Classification<br>Name and<br>Description | Image processing device for estimation of external blood loss: An image<br>processing device for estimation of external blood loss is a device to be<br>used as an aid in estimation of patient external blood loss. The device may<br>include software and/or hardware that is used to process images capturing<br>externally lost blood to estimate the hemoglobin mass and/or the blood<br>volume present in the images. |
| Regulation<br>Number | 21 CFR 880.2750 |
| Device<br>Classification | Class II |
| Product Code | PBZ |
| Predicate | Pixel 3 System, K130190/DEN130015, 9 May 2014 |
| Device<br>Information | Triton Canister System , K142801 (Reference Device) |
# 510(k) Summary for Triton System
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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.
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| Indications<br>for Use | The Triton System is a software application intended to be used as an<br>adjunct in the estimation of blood loss and management of surgical<br>sponges. |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Triton System is intended to be used with surgical sponges, software,<br>hardware and accessory devices which have been validated for use with<br>the Triton System to estimate the hemoglobin (Hb) mass contained on<br>used surgical sponges. The Triton System is also intended to calculate an<br>estimate of blood volume on used surgical sponges from the estimated Hb<br>mass and a user-entered patient serum Hb value. The validated surgical<br>sponges, hardware, software, accessory devices and Hb mass ranges are<br>listed in the Instructions for Use. |
| | The Triton System is also indicated for use to aid in counting surgical<br>sponges and may be used to record and display case-specific blood<br>components infused over time. The Triton System is additionally<br>indicated for use to aid in managing surgical sponges, including providing<br>a visual record of sponge images, and to record the user-entered weight of<br>used surgical sponges in order to calculate an estimate of fluid volume on<br>the sponges. |
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1. 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.
> 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 validate the device design and labeling are appropriate for use by intended users of device.
3. 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.
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| Summary of<br>Performance<br>Data and<br>Rationale for<br>Substantial<br>Equivalence | Triton System was evaluated in accordance with Gauss Surgical's design<br>controls process and risk management procedure. No new unacceptable<br>risks were identified based on the changes incorporated into the software<br>revision. Verification testing has been completed. No new safety or<br>effectiveness issues were raised during the testing program. Triton System<br>passed all verification. The results of the verification testing demonstrate<br>that Triton meets established acceptance criteria and performs in a manner<br>equivalent to its predicate device. |
|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | Triton System has the same indications for use as the predicate (Pixel 3<br>System). Both the subject and predicate devices are used as adjunctive<br>tools to estimate blood loss on surgical materials. The new version shares<br>the same technological characteristics as the predicate. Any differences<br>between the subject and predicate devices do not raise different safety or<br>effectiveness questions. Therefore, the devices are substantially<br>equivalent. |
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
