(57 days)
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.
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
- Tapering distal tip
- Soft stop (tactile indicator of correct depth position)
- 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.
The provided text describes the 510(k) premarket notification for the "Pathfinder Endoscope Cap" and its substantial equivalence comparison to a predicate device. However, it does not include the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning performance metrics like sensitivity, specificity, or reader improvement with AI.
The document focuses on the Pathfinder Endoscope Cap's physical characteristics, materials, and a comparison with a predicate device based on general technological and performance criteria. It also mentions mechanical testing and biocompatibility testing.
Here's a breakdown of what is and is not in the provided text, structured as requested:
1. Table of acceptance criteria and the reported device performance:
This information is not provided in the text. The document states that the device underwent "mechanical testing" and "biocompatibility evaluation," but it does not list specific acceptance criteria (e.g., minimum tensile strength, maximum tracking force) or the quantitative results from these tests. It only lists the types of tests performed.
2. Sample size used for the test set and the data provenance:
This information is not provided in the text. The document mentions "mechanical testing" and "biocompatibility evaluation" but gives no details about the sample sizes used for these tests or the origin of any data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the text. The device is a physical endoscope cap, not an AI or diagnostic tool that would typically involve expert ground truth for performance evaluation in the context of medical image analysis.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the text. Similar to point 3, this type of method is relevant for expert-based evaluation of diagnostic or AI performance, which is not described for this physical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not provided in the text. The device is a physical endoscope cap, not an AI system. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not provided in the text. As noted, this is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not provided in the text. Given the device is a physical cap, typical "ground truth" as applied to diagnostic or AI performance evaluation (e.g., pathology, expert consensus) would not be relevant. The "ground truth" for its performance would likely be engineering specifications and functional testing results (e.g., does it fit correctly, does it maintain integrity during use), but these specific details are not elaborated.
8. The sample size for the training set:
This information is not provided in the text. Since this is not an AI device, there is no "training set."
9. How the ground truth for the training set was established:
This information is not provided in the text. As above, this is not an AI device, so this concept is not applicable.
Summary of available information regarding the "study" for the Pathfinder Endoscope Cap:
The document describes the following types of testing that were performed:
- Mechanical Testing:
- Dimensional and visual testing
- Cap tracking force (through compatible overtube)
- Cap tensile strength with tape
- Biocompatibility Testing: Conducted in accordance with ISO 10993-1 and relevant standards.
- Cytotoxicity
- Sensitization
- Irritation
- Systemic Toxicity
The stated conclusion (Section 1.10) is: "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."
However, the specific quantitative results of these tests and the acceptance criteria that those results met are not detailed in the provided FDA letters and summary. This document primarily serves as a notification of a 510(k) clearance and outlines the general characteristics and comparison to a predicate device, rather than a detailed study report.
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: PathfinderEndoscope Cap | Predicate Device: FUJIFILM HoodModels DH-28GR, DH-29CR andDH-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,DH-29CR and DH-30CR |
| Catalog Number/Ref | GI EC-0412-1 | DH-28GR, DH-29CR and DH-30CR |
| Common Name | Endoscope distal attachment(cap/hood) and Measuring Tape | Endoscope distal attachment(cap/hood) |
| Regulation Number | 21 CFR 876.1500 and 878.4800 | 21 CFR 876.1500 |
| RegulationDescription | Endoscope and accessories;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 isintended to be used incombination with compatibleendoscopes to maintain the field ofview during endoscopicprocedures such as mucosalresection. | The FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR areintended to be used in combinationwith compatible endoscopes tomaintain the field of view duringendoscopic procedures such asmucosal resection. |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide |
| Single Use orReusable | Single use | Single use |
| Materials | Pebax® | Silicone |
| Outer diameter | 12.04 mm | 11.8-14.8 mm |
| Inner diameter ofdistal 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.
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.