The Triton 1 System is intended to provide visualization and diagnostic/therapeutic access to the adult lower gastrointestinal tract (including, but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery.
Device Story
Triton 1 System is a user-operated, electromechanically controlled, nested endoscope and overtube system; used in hospitals/clinics by physicians for lower GI tract endoscopy and surgery. System inputs include manual user control via handheld controller; device transforms inputs into electromechanical motion of distal tip for steering/torquing and independent advancement/retraction of endoscope and overtube. Both components feature selective rigidization to maintain shape within anatomy, preventing looping and increasing stability. Output is real-time visualization of the GI tract via a color CMOS imaging chip. System includes a robot cart, LED light engine, and camera control unit. Benefits include improved navigation and control during endoscopic procedures. Clinical decision-making is supported by direct visualization of the GI mucosa.
Clinical Evidence
Clinical evidence provided via the CARE I study, a prospective, single-arm, non-randomized, single-site first-in-human study. Study enrolled 50 patients (10 in Phase A, 40 in Phase B) aged 22+ years. Primary endpoints evaluated safety and efficacy for screening, surveillance, and diagnostic colonoscopies. Follow-up conducted at 14 days. Results demonstrated the device is safe and effective for its intended use.
Technological Characteristics
Electromechanically controlled nested endoscope/overtube system. Features: color CMOS imaging, forward viewing, 130° FOV, 5-100 mm depth of view. Materials comply with ISO 10993. Sterilization: Ethylene Oxide (EO) for specific components (fluidics lines, shape-sensing catheter). Electrical input: 110–240VAC; 50/60Hz. Connectivity: System includes robot cart, LED light engine, CCU, and monitoring station. Safety: IEC 60601-1 and IEC 60601-1-2 compliance.
Indications for Use
Indicated for adult patients (22 years and older) requiring visualization and diagnostic or therapeutic access to the lower gastrointestinal tract, including the anus, rectum, sigmoid colon, colon, cecum, and ileocecal valve.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
September 3, 2026
Neptune Medical, Inc.
Paige Maness
Senior Manager, Quality Assurance and Regulatory Compliance
Neptune Medical, Inc.
1828 El Camino Real, 5th Floor
Burlingame, CA 94010
Re: K260503
Trade/Device Name: Triton 1 System
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: FDF, FED, FET
Dated: July 31, 2026
Received: August 3, 2026
Dear Paige Maness:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K260503 - Paige Maness
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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K260503 - Paige Maness
Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
SIVAKAMI VENKATACHALAM -S
for
Shanil P. Haugen, Ph.D.
Assistant Director
DHT3A: Division of Renal, Gastrointestinal,
Obesity and Transplant Devices
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
{3}
| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K260503 | ? |
| Please provide the device trade name(s). | | ? |
| Triton 1 System | | |
| Please provide your Indications for Use below. | | ? |
| The Triton 1 System is intended to provide visualization and diagnostic/therapeutic access to the adult lower gastrointestinal tract (including, but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? |
{4}
Neptune
MEDICAL
K260503
Page 1 of 7
# K260503
510(k) Summary
TRITON 1 SYSTEM
# Name and Address of Submitter
Neptune Medical, Inc.
1828 Camino Real, 5th Floor
Burlingame, CA 94010 USA
Phone: +1 (650) 307-2176
Alex Tilson, CEO
alex@neptunemedical.com
# Correspondent/Primary Contact Person
Paige Maness, RAC
Neptune Medical, Inc.
1828 Camino Real, 5th Floor
Burlingame, CA 94010 USA
paige.maness@neptunemedical.com
Phone: +1 (858) 692-3884
# Submission Information
| **Subject Device** | |
| --- | --- |
| Date Summary Prepared | 31 July 2026 |
| Device Trade Name | Triton 1 System |
| Manufacturer | Neptune Medical, Inc. |
| Common Name | Endoscope and accessories |
| Regulation Number | 876.1500 |
| Classification | Class II |
| Product Code(s) | FDF, FED, FET |
| Classification Name | Colonoscope And Accessories, Flexible/Rigid |
| **Predicate Device (primary)** | |
| Device Trade Name | NeoGuide Endoscopy System (K070622) |
| Manufacturer | NeoGuide Systems, Inc. |
| Common Name | Endoscope and accessories |
| Regulation Number | 876.1500 |
| Classification | Class II |
| Product Code(s) | FDF |
| Classification Name | Colonoscope And Accessories, Flexible/Rigid |
| **Predicate Device** | |
| Device Trade Name | Evis Exera II 180 System (K100584) |
| Manufacturer | Olympus Medical Systems Corporation |
| Common Name | Endoscope and accessories |
| Regulation Number | 876.1500 |
| Classification | Class II |
| Product Code(s) | NWB, FDF, FDS |
| Classification Name | Endoscope, Accessories, Narrow Band Spectrum |
| **Reference Device** | |
| Device Trade Name | Pathfinder Endoscope Overtube (K211301) |
| Manufacturer | Neptune Medical, Inc. |
| Common Name | Endoscope and accessories |
| Regulation Number | 876.1500 |
| Classification | Class II |
| Product Code(s) | FED |
| Classification Name | Endoscopic Access Overtube, Gastroenterology-Urology |
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Neptune
MEDICAL
K260503
Page 2 of 7
## Valid Predicate Discussion
NeoGuide Endoscopy System was selected as the valid predicate device to support the 510(k) submission because it received FDA clearance using well-established methods. The predicate meets the expected predicate performance due to no reports of unexpected injury, deaths, or malfunctions associated with the device. After conducting a search on the Manufacturer and User Facility Device Experience (MAUDE) Database, Medical Device Reporting (MDR), MedSun Reports Database, Medical Device Safety and CBER Safety & Availability (Biologics) and Recall Database websites, it was found that there are no known unmitigated use-related or design safety issues and both primary and reference devices have not been subject to a design-related recall.
| Valid Predicate Device | A - Well established methods | B - Meets or exceeds expected predicate performance | C - Unmitigated use-related or design-related safety issues | D – Associated design-related recall |
| --- | --- | --- | --- | --- |
| NeoGuide Endoscopy System | Used relevant methods that were published in the public domain. | History of safe use established due to no reports of unexpected injury, deaths, or malfunctions associated with the device | No known - unmitigated use related or design-related safety issues | No design related recall identified |
## Device Description
The Triton 1 System is a user-operated, electromechanically controlled, rigidizing Endoscope with a rigidizing Overtube that is intended to provide visualization and diagnostic/therapeutic access to the adult lower gastrointestinal tract (including, but not limited to, the anus, rectum, sigmoid colon, descending, transverse and ascending colon, cecum, and ileocecal valve) for endoscopy and endoscopic surgery.
The Triton 1 System incorporates a flexible Endoscope nested within a flexible Overtube (Nested System), both of which are electromechanically advanced and retracted independently of one another while under the direct control of a physician user. Both Endoscope and Overtube can be selectively rigidized to temporarily hold their shape within the anatomy. The Endoscope has electromechanical motion of the distal tip that provides the ability to steer and torque.
Alternating rigidization of the Overtube and Endoscope allows the device to flexibly navigate and then rigidly maintain its shape along the curves of the colon, to provide increased control and stability, and prevent looping.
## Indications for Use
The Triton 1 System is intended to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract (including, but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery.
## Summary of Technological Characteristics
Tables 1 & 2 provide an overview of general technological characteristics in comparison to the predicate and reference devices. Any differences in the technological characteristics do not raise new questions of safety or effectiveness. Biocompatibility testing and evaluation, and performance testing have been performed on the subject device in order to establish substantial equivalence to the predicate.
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Neptune
MEDICAL
K260503
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Table 1: Summary of Technological Characteristics
| | Subject Device | Predicate Device | Reference Device |
| --- | --- | --- | --- |
| Manufacturer | Neptune Medical Inc. | NeoGuide Systems, Inc. | Neptune Medical Inc. |
| Trade Name | Triton 1 System | NeoGuide Endoscopy System | Pathfinder Endoscope Overtube |
| K# | K260503 | K070622 | K211301 |
| Device Classification Name | Colonoscope and Accessories, Flexible/Rigid | Colonoscope and Accessories, Flexible/Rigid | Endoscopic Access Overtube, Gastroenterology-Urology |
| Classification | Regulation No: 876.1500 Class: II | Regulation No: 876.1500 Class: II | Regulation No: 876.1500 Class: II |
| Product Code(s) | FDF, FED, FET | FDF | FED |
| Indications for Use | The Triton System is intended to provide visualization and diagnostic/therapeutic access to the adult lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery. | The NeoGuide Navigator Endoscopy System is intended to provide visualization and diagnostic/therapeutic access to the adult lower gastrointestinal tract (including, but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery. | The Pathfinder Endoscope Overtube is intended to be used with Endoscope to facilitate intubation, change of endoscopes, and treatment in gastrointestinal (GI) tract in adult patients (22 years of age and older). |
| Environment of Use | Hospitals, clinics, and/or doctor's offices | Hospitals, clinics, and/or doctor's offices | Hospitals, clinics, and/or doctor's offices |
| Prescriptive | Yes | Yes | Yes |
| Technological Characteristics | | | |
| Device Technology | Electromechanically controlled by the user with a handheld controller, air-assisted rigidizing endoscope and overtube nested system for endoscopic procedures in the lower GI tract | Electromechanically controlled by the user with a handheld joystick to provide visualization and diagnostic/therapeutic access to the adult lower gastrointestinal tract for endoscopy and endoscopic surgery. | Manually operated, vacuum-assisted rigidizing overtube for endoscopic procedures in the GI tract |
| Electrical Input | 110–240VAC; 50/60Hz | 115-230VAC; 50/60Hz | N/A |
| Field of View | 130° | 140° ± 10° | N/A |
| Depth of View | 5-100 mm | 8-80 mm | N/A |
| Patient Contacting Materials | Complies with ISO 10993 | Complies with ISO 10993 | Complies with ISO 10993 |
| Sterilization | Cart/Console/Endoscope/Overtube: Provided non-sterile Fluidics Line, Shape-sensing catheter: | Device is provided non-sterile and reprocessed between use | Ethylene Oxide |
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Neptune
MEDICAL
K260503
Page 4 of 7
| | Subject Device | Predicate Device | Reference Device |
| --- | --- | --- | --- |
| | Ethylene Oxide | | |
| Reprocessing | Cleaning and Intermediate-Level Disinfection: Endoscope and Overtube Drivers | Cleaning and High-Level Disinfection: Colonoscope | Disposable |
| | Cleaning and Low-Level Disinfection: Controller | | |
| | Wiping: Cart, Console, NDI Field Generator & Stand, Clinical Monitor & Stand, Endoscope Stand, System Monitoring Station | | |
| | Disposable: Endoscope/Overtube/Fluidics Line/Shape-sensing catheter | | |
Table 2: Summary of Vision System Technological Characteristics
| | Subject Device | Predicate Device |
| --- | --- | --- |
| Manufacturer | Neptune Medical Inc. | Olympus Medical Systems Corporation |
| Trade Name | Triton 1 System | Evis Exera II 180 System |
| K# | K260503 | K100584 |
| Device Classification Name | Colonoscope and Accessories, Flexible/Rigid | Endoscope, Accessories, Narrow Band Spectrum |
| Classification | Regulation No: 876.1500 Class: II | Regulation No: 876.1500 Class: II |
| Product Code(s) | FDF, FED, FET | NWB, FDF, FDS |
| Indications for Use | The Triton System is intended to provide visualization and diagnostic/therapeutic access to the adult lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery. | **Evis Exera II Xenon Light Source Olympus CLV-180** • This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation. **Evis Exera II Video System Center Olympus CV-180** • This video system center has been designed to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation. **Evis Exera II Colonovideoscope Olympus PCF Type H180AL** |
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MEDICAL
K260503
Page 5 of 7
| | Subject Device | Predicate Device |
| --- | --- | --- |
| | | (Pediatric) • This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). |
| Environment of Use | Hospitals, clinics, and/or doctor's offices | Hospitals, clinics, and/or doctor's offices |
| Prescriptive | Yes | Yes |
| Technological Characteristics | | |
| Vision System Components | • Software • Robot Cart ○ LED Light Engine ○ Camera Control Unit (CCU) • Endoscope ○ Camera • Integrated Fiber Optic Illumination | • Evis Exera II Xenon Light Source Olympus CLV-180 • Evis Exera II Video System Center Olympus CV-180 • Evis Exera II Colonovideoscope Olympus PCF Type H180AL (Pediatric) |
| Type of Imaging Chip | Color CMOS | Color CCD |
| Viewing Direction | Forward | Forward |
### Shelf Life and Sterilization
Neptune Medical is responsible for the sterilization of the following components of the Triton 1 System:
- Fluidics Suction Lines
- Ribbon Lines
- Tower Lines
- Fluidics Box Lines
- Shape Sensing Catheter
Ethylene Oxide (EO) is used as the method of Sterilization and the proposed shelf life of the device is 6 months from the date of manufacture.
### Summary of Biocompatibility Testing
The following components of the system are considered to have any indirect or direct contact with the patient:
- Endoscope
- Overtube
- Suction Line
- Ribbon Lines
- Box Lines
- Tower Lines
- Shape Sensing Catheter
Biocompatibility testing of the materials included:
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Neptune
MEDICAL
K260503
Page 6 of 7
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
Testing demonstrated that the materials used in the aforementioned components meet the requirements of the applicable ISO 10993 standard.
### Summary of Non-Clinical Functional and Performance Testing
Bench testing was conducted to verify that the Triton 1 System meets all design specifications and performance requirements. Testing was performed on product equivalent units under simulated use conditions. The Triton 1 System was subjected to extensive testing under applicable design control requirements including System Testing, Hardware Testing, and Software Testing.
The testing includes:
- Mechanical Performance and Motion Control
- Articulation Performance
- Dynamic Rigidization System
- Imaging System Performance
- Control System Performance
- Patient Safety – Force and Torque Limits
- Clinical Navigation Features
- Safety Systems and Fault Management
- Endoscopic Functions
- Electrical safety & EMC per IEC 60601-1 & IEC 60601-1-2
- Biocompatibility testing per ISO 10993
- Sterilization Validation
- Cleaning/disinfection validation
- Software Testing
Comprehensive bench testing was conducted to verify that the Triton 1 System meets all design specifications and performance requirements. The bench testing results support the finding of substantial equivalence to the predicate device.
### Summary of Clinical Data
The Triton 1 System was evaluated in a prospective, single-arm, non-randomized, single site first-in-human study conducted in two phases, known as the CARE I Study.
Phase A evaluated the safety of the Triton 1 System to perform screening, surveillance and diagnostic colonoscopies, and Phase B evaluated the safety and efficacy of the Triton 1 System to perform screening, surveillance and diagnostic colonoscopies. The study enrolled 10 patients in Phase A and 40 patients in Phase B, of both sexes, at least 22 years of age, meeting the screening criteria among those in whom screening, surveillance or diagnostic colonoscopy is indicated. Both phases included a 14-day follow-up period.
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Neptune
MEDICAL
K260503
Page 7 of 7
## Conclusion
On the basis of clinical and non-clinical testing Neptune Medical considers the Triton 1 System to be as safe as, as effective as, and substantially equivalent to the predicate.
In accordance with 21 CFR Part 807 it can be concluded that the subject device is substantially equivalent to the predicate.
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Learn the FDA Browser
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 ? 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 as a Medical Device, 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 as a Medical Device), 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.
