K210915 · Neptune Medical, Inc. · FDS · May 25, 2021 · Gastroenterology, Urology
Device Facts
Record ID
K210915
Device Name
Pathfinder Endoscope Cap
Applicant
Neptune Medical, Inc.
Product Code
FDS · Gastroenterology, Urology
Decision Date
May 25, 2021
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
The Pathfinder Endoscope Cap is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
Device Story
Pathfinder Endoscope Cap is a single-use, distal attachment for endoscopes used in gastrointestinal (GI) procedures. Constructed from Pebax, the device features a symmetrical, tapering shape with a soft stop for tactile depth positioning and a side hole for fluid drainage. It attaches to the distal tip of compatible endoscopes (e.g., Olympus PCF-H180A/H190) to maintain the field of view during mucosal resection. The device is also compatible with the Pathfinder Endoscope Overtube. By providing a clear, stable view, it assists clinicians in performing endoscopic treatments. It is intended for single-use and is sterilized via ethylene oxide.
Clinical Evidence
Bench testing only. Testing included dimensional and visual verification, cap tracking force through the overtube, and cap tensile strength. Biocompatibility testing was performed per ISO 10993-1, including cytotoxicity, sensitization, irritation, and systemic toxicity for contact with breached or compromised surfaces for <24 hours.
Technological Characteristics
Material: Pebax. Form factor: Symmetrical, tapering distal attachment with side drainage hole and soft stop tactile indicator. Sterilization: Ethylene Oxide. Connectivity: None (mechanical attachment).
Indications for Use
Indicated for use in combination with compatible endoscopes to maintain the field of view during endoscopic procedures, such as mucosal resection, in the gastrointestinal tract.
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.
Predicate Devices
FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR (K162749)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 25, 2021
Neptune Medical, Inc. % Ian Broome Regulatory Consultant AlvaMed, Inc. 935 Great Plain Ave, Ste 166 Needham. MA 02492
Re: K210915
> Trade/Device Name: Pathfinder Endoscope Cap Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDS, FDF, FTY Dated: March 26, 2021 Received: March 29, 2021
Dear Ian Broome:
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. 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 located 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.
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,
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
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## Indications for Use
510(k) Number (if known) K210915
Device Name Pathfinder Endoscope Cap
Indications for Use (Describe)
The Pathfinder Endoscope Cap is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------|-----------------------------------------------------------------------|
| <div> </div> | |
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |
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Traditional 510(k): Pathfinder® Endoscope Cap
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## TRADITIONAL 510(K) SUMMARY FOR PATHFINDER® ENDOSCOPE CAP 1.0
- Name and Address of Submitter 1.1
Neptune Medical, Inc. 1828 El Camino Real, Suite 508 Burlingame, CA 94010 Phone: +1 (888) 202-8401
Alex Tilson, CEO alex@neptunemedical.com Phone: +1 (650) 307-2176
- Correspondent/Primary Contact Person 1.2
lan Broome. M.S. Requlatory Affairs Consultant AlvaMed, Inc. ibroome@alvamed.com Phone: +1 (888) 331-3485, ext. 700 Fax: +1 (617) 249-0955
- 1.3 Date Summary Prepared March 26, 2021
- 1.4 Predicate Device
FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR (K162749)
- Device Description 1.5
The Pathfinder Endoscope Cap is single-use distal attachment for endoscopes. It is an aid to endoscopic visualization and treatment in the gastrointestinal (GI) tract. The Pathfinder Endoscope Cap consists of a single piece of Pebax® in a symmetrical, tapering shape for placement on the distal tip of an endoscope. It is a short, transparent tube with an attaching portion used to connect the cap to an applicable endoscope, a distal portion that tapers into a narrower diameter opening, and a side hole for drainage to prevent fluids lodging on the surface of the endoscope. The device is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection in the GI tract.
The Pathfinder Endoscope Cap has the following physical and performance characteristics:
- . Sterilized by ethylene oxide
- For single use o
- Tapering distal tip ●
- Soft stop (tactile indicator of correct depth position) ●
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Image /page/4/Picture/0 description: The image shows the text "Traditional 510(k): Pathfinder® Endoscope Cap". The text is in blue font and is left-aligned. The Pathfinder word has a registered trademark symbol next to it.
- Compatible with endoscopes with 11.7 mm outer diameter distal ends, such as the ● Olympus PCF-H180A and PCF-H190
- Compatible with the Pathfinder Endoscope Overtube, which is intended for use with the ● same size endoscopes.
| | Subject Device: Pathfinder<br>Endoscope Cap | Predicate Device: FUJIFILM Hood<br>Models DH-28GR, DH-29CR and<br>DH-30CR |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | K210915 | K162749 |
| Manufacturer | Neptune Medical, Inc. | Fujifilm Medical Systems USA, Inc. |
| Device Trade Name | Pathfinder Endoscope Cap | FUJIFILM Hood Models DH-28GR,<br>DH-29CR and DH-30CR |
| Catalog Number/Ref | GI EC-0412-1 | DH-28GR, DH-29CR and DH-30CR |
| Common Name | Endoscope distal attachment<br>(cap/hood) and Measuring Tape | Endoscope distal attachment<br>(cap/hood) |
| Regulation Number | 21 CFR 876.1500 and 878.4800 | 21 CFR 876.1500 |
| Regulation<br>Description | Endoscope and accessories;<br>Manual surgical instruments for general use | Endoscope and accessories |
| Product Code | FDS, FDF, FTY | FDS, FDF |
| Device Class | Class II and Class I | Class II |
| Device Panel | 78, Gastroenterology and Urology | 78, Gastroenterology and Urology |
| Indications for Use | The Pathfinder Endoscope Cap is<br>intended to be used in<br>combination with compatible<br>endoscopes to maintain the field of<br>view during endoscopic<br>procedures such as mucosal<br>resection. | The FUJIFILM Hood Models DH-<br>28GR, DH-29CR and DH-30CR are<br>intended to be used in combination<br>with compatible endoscopes to<br>maintain the field of view during<br>endoscopic procedures such as<br>mucosal resection. |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide |
| Single Use or<br>Reusable | Single use | Single use |
| Materials | Pebax® | Silicone |
| Outer diameter | 12.04 mm | 11.8-14.8 mm |
| Inner diameter of<br>distal end | 9.76 mm | 8.0 mm |
| Total length | 8.05 mm | 17.0 mm |
- 1.6 Comparison of Predicate Device and Subject Device
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Traditional 510(k): Pathfinder® Endoscope Cap
Summary of Substantial Equivalence Comparison to the Predicate Device 1.7
Both devices are distal attachments for endoscopes. The subject Pathfinder Endoscope Cap is comparable to the predicate in the following areas based on the following same technological and performance criteria:
- Constructed of soft, atraumatic material suitable for GI endoscopy ●
- Designed and labeled specifically for use with compatible endoscopes
- Tapering distal end design
- Sterile (EO)
- Single use
- Identical indications for use
While there are minor dimensional differences between the subject device and the predicate device, these differences are due to the need for compatibility with different manufacturers' endoscopes and for the subject device's compatibility with the Pathfinder Endoscope Overtube. These minor differences do not affect the safety and effectiveness of the Pathfinder Endoscope Cap in any way.
Performance Data: Summary of Functional and Performance Testing - Bench 1.8
The Pathfinder Endoscope Cap was subjected to the following mechanical testing.
- Dimensional and visual testing
- Cap tracking force (through compatible overtube) ●
- o Cap tensile strength with tape
- Performance Data: Summary of Biocompatibility Testing 1.9
The biocompatibility evaluation for the Pathfinder Endoscope Cap was conducted in accordance with the guidance document "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process,"" September 2020, and ISO 10993-1, as recognized by the FDA and other applicable standards for laboratory practice and quality control. The battery of testing included:
- Cytotoxicity
- Sensitization ●
- Irritation ●
- Systemic Toxicity ●
The Pathfinder Endoscope Cap is contact breached or compromised surfaces for a duration of less than 24 hours.
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1.10 Substantial Equivalence and Conclusion
The enclosed biocompatibility and performance testing results demonstrate that the subject device is safe and effective for its intended use and substantially equivalent to the predicate. Any superficial differences between the Pathfinder Endoscope Cap and the predicate cleared in K162749 are minor and do not raise questions of safety and effectiveness.
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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.
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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.
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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.
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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.
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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.
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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.
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A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
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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.
