(57 days)
Not Found
No
The device description and performance studies focus solely on the physical and mechanical properties of a passive endoscope attachment. There is no mention of any computational analysis, image processing, or learning algorithms.
No.
The device is an accessory for endoscopes intended to aid visualization during endoscopic procedures, rather than directly treating a disease or condition.
No
The device is described as an aid to endoscopic visualization and treatment, specifically to maintain the field of view during endoscopic procedures. It does not perform any diagnostic function itself, such as detecting or identifying disease.
No
The device is a physical, single-use attachment made of Pebax® for endoscopes, not a software program.
Based on the provided information, the Pathfinder Endoscope Cap is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Pathfinder Endoscope Cap Function: The Pathfinder Endoscope Cap is a physical accessory used during an endoscopic procedure. Its purpose is to aid in visualization and maintain the field of view by attaching to the endoscope. It does not analyze or test any biological samples.
- Intended Use: The intended use clearly states it's for use "in combination with compatible endoscopes to maintain the field of view during endoscopic procedures." This is a procedural aid, not a diagnostic test.
- Device Description: The description focuses on the physical characteristics and function of the cap as a distal attachment for the endoscope.
- Lack of Diagnostic Information: There is no mention of the device providing any diagnostic information based on analysis of biological samples.
Therefore, the Pathfinder Endoscope Cap falls under the category of a medical device used in a surgical or procedural context, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
FDS, FDF, FTY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal (GI) tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The Pathfinder Endoscope Cap was subjected to the following mechanical testing:
- Dimensional and visual testing
- Cap tracking force (through compatible overtube)
- Cap tensile strength with tape
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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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
2
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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3
Traditional 510(k): Pathfinder® Endoscope Cap
Image /page/3/Picture/1 description: The image shows the text "K210915" on the first line, followed by the text "Page 1 of 4" on the second line. The text is in a simple, sans-serif font and is aligned to the left. The image appears to be a header or footer from a document, indicating a page number and possibly a document identifier.
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) ●
4
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
Endoscope Cap | Predicate Device: FUJIFILM Hood
Models DH-28GR, DH-29CR and
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,
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 |
| Regulation
Description | 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 is
intended to be used in
combination with compatible
endoscopes to maintain the field of
view during endoscopic
procedures such as mucosal
resection. | The FUJIFILM Hood Models DH-
28GR, DH-29CR and DH-30CR are
intended to be used in combination
with compatible endoscopes to
maintain the field of view during
endoscopic procedures such as
mucosal resection. |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide |
| Single Use or
Reusable | Single use | Single use |
| Materials | Pebax® | Silicone |
| Outer diameter | 12.04 mm | 11.8-14.8 mm |
| Inner diameter of
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
5
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.
6
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.