(29 days)
The Pathfinder Endoscope Overtube is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and treatment in the gastrointestinal (GI) tract in adult patients (22 years of age and older).
The Pathfinder Endoscope Overtube (Pathfinder) device consists of a flexible overtube that may be connected to vacuum for rigidization. It is used with an endoscope for procedures in the gastrointestinal tract. The handle includes a vacuum line which is connected to free space within the device that is completely contained, forming the vacuumable volume. The handle rotator has two positions: the first connects the vacuumable volume within the device to atmosphere (vent) to stay in the flexible position, and the second position connects the vacuumable volume to a source of vacuum to transition to the rigid condition. When transitioned to the rigid condition, the device maintains its shape at the time of rigidization, allowing the endoscope to advance or withdraw relative to the overtube with minimal disturbance to the surrounding anatomy. When transitioned to the flexible condition, the device is able to move relative to the patient anatomy and endoscope for navigation through the GI tract. The device is provided sterile (EO). After use, the device is discarded and disposed of in accordance with local regulations.
The provided document describes a Special 510(k) submission for modifications to the Pathfinder Endoscope Overtube, specifically the addition of new sizes and a change in material durometer for the vacuum and irrigation line. This is NOT a typical AI/ML medical device submission, and therefore, many of the requested fields related to AI/ML performance, ground truth, and expert evaluation are not applicable.
Here's the breakdown of the information that can be extracted from the provided text, and where it indicates non-applicability for AI/ML specific criteria:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a device modification submission for physical characteristics (sizes, material), the "acceptance criteria" are related to the functional and performance testing of the physical properties of the device, rather than a quantifiable performance metric like sensitivity or specificity for an AI algorithm. The document states that the "line extension was the subject of extensive testing under applicable design control requirements."
| Acceptance Criteria Category | Reported Device Performance / Evaluation | Notes |
|---|---|---|
| Lubricity | Tested | Demonstrated through bench testing. Specific quantitative results are not provided in the summary. |
| Insufflation | Tested | Demonstrated through bench testing. Specific quantitative results are not provided in the summary. |
| Insertion/Removal | Tested | Demonstrated through bench testing. Specific quantitative results are not provided in the summary. |
| Navigation | Tested | Demonstrated through bench testing. Specific quantitative results are not provided in the summary. |
| Rigidization/De-Rigidization | Tested | Demonstrated through bench testing. Specific quantitative results are not provided in the summary. |
| Dimensional Measurements | Confirmed to specification | Nine new sizes, from 65 to 145 cm long and 11 to 16 mm inner diameter, were designed and tested. |
| Endoscope Compatibility | Tested | Demonstrated through bench testing. Specific quantitative results are not provided in the summary. |
| Device Safety & Effectiveness | Shown to be safe; no unanswered questions of safety or effectiveness. | Conclusion statement after all testing. |
2. Sample size used for the test set and the data provenance
The document mentions "extensive testing" but does not provide specific sample sizes for each type of functional and performance testing (e.g., how many devices were tested for lubricity, how many cycles for rigidization).
- Sample Size (Test Set): Not specified in the provided summary.
- Data Provenance: The testing appears to be bench testing (laboratory-based) as stated in section 1.10: "the modified Pathfinder Endoscope Overtube has been shown to be safe through bench testing." This is not retrospective or prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as this submission is for a physical medical device (endoscope overtube) and not an AI/ML device that requires human interpretation for ground truth.
4. Adjudication method for the test set
This question is not applicable for the same reason as point 3.
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 question is not applicable as this is not an AI-assisted device requiring human interpretation of results. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This question is not applicable as there is no "ground truth" in the context of an AI algorithm's performance. The "truth" for this device modification is adherence to design specifications and successful functional performance as measured by engineering tests.
8. The sample size for the training set
This question is not applicable as this is not an AI/ML device, and therefore, there is no "training set."
9. How the ground truth for the training set was established
This question is not applicable as there is no "training set" and no "ground truth" in the AI/ML context.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
May 28, 2021
Neptune Medical, Inc. % Ian Broome, M.S. Regulatory Consultant AlvaMed. Inc. 935 Great Plain Ave, Ste. 166 Needham. MA 02492
Re: K211301
Trade/Device Name: Pathfinder Endoscope Overtube Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FED Dated: April 28, 2021 Received: April 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) K211301
Device Name Pathfinder Endoscope Overtube
Indications for Use (Describe)
The Pathfinder Endoscope Overtube is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and treatment in the gastrointestinal (GI) tract in adult patients (22 years of age and older).
| Type of Use (Select one or both, as applicable) | |
|---|---|
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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K211301 Page 1 of 3
Page:
Image /page/3/Picture/1 description: The image shows the logo for Neptune Medical. The word "Neptune" is written in a stylized, futuristic font in blue. Below it, the word "MEDICAL" is written in smaller, orange letters. To the right of the text is a circular graphic depicting a planet with a ring around it, set against a dark blue, starry background.
Special 510(k): Modification to Pathfinder Endoscope Overtube
1.0 SPECIAL 510(K) SUMMARY
This Special 510(k) for the Pathfinder Endoscope Overtube is submitted based on the FDA Guidance document "The Special 510(k) Program: Guidance for Industry and Food and Drug Administration Staff" (issued September 13, 2019).
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Name and Address of Owner/Sponsor 1.1
Neptune Medical, Inc. 1828 Camino Real, Suite 508 Burlingame, CA 94010 USA Phone: +1 (650) 307-2176 Alex Tilson, CEO alex@neptunemedical.com -
1.2 Correspondent/Primary Contact Person
lan Broome, M.S. Regulatory Affairs Consultant
AlvaMed, Inc. (consultant to Neptune Medical) 935 Great Plain Avenue, Unit 166 Needham, MA 02492 USA ibroome@alvamed.com Phone: +1 (888) 331-3485 Fax: +1 (617) 249-0955
- Submission Information 1.3
| Date Summary Prepared: | May 20, 2021 |
|---|---|
| Name of Device: | Pathfinder Endoscope Overtube |
| Device Classification Name: | Endoscope and Accessories |
| Common or Usual Name: | Endoscopic Access Overtube |
| Classification: | Class II |
| Product Code: | FED (21 CFR 876.1500) |
| Predicate Device: | Pathfinder Endoscope Overtube (K191415) |
Device Description 1.4
The Pathfinder Endoscope Overtube (Pathfinder) device consists of a flexible overtube that may be connected to vacuum for rigidization. It is used with an endoscope for procedures in the gastrointestinal tract. The handle includes a vacuum line which is connected to free space within the device that is completely contained, forming the vacuumable volume. The handle rotator has two positions: the first connects the vacuumable volume within the device to atmosphere (vent) to stay in the flexible position, and the second position connects the vacuumable volume to a source of vacuum to transition to the rigid condition. When transitioned to the rigid condition, the device maintains its shape at the time of rigidization, allowing the endoscope to advance or withdraw relative to the overtube with minimal disturbance to the surrounding anatomy. When transitioned to the flexible
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Image /page/4/Picture/1 description: The image shows the Neptune Medical logo on the left, followed by the text "Special 510(k): Modification to Pathfinder Endoscope Overtube" in blue. On the right side of the image, the word "Page:" is written above the number 2. The Neptune Medical logo features the company name in blue and red, along with an image of a planet.
condition, the device is able to move relative to the patient anatomy and endoscope for navigation through the GI tract. The device is provided sterile (EO). After use, the device is discarded and disposed of in accordance with local regulations.
There are no associated device accessories included as a part of this submission.
-
Indications for Use 1.5
The Pathfinder Endoscope Overtube is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and treatment in the gastrointestinal (GI) tract in adult patients (22 years of age and older). -
1.6 Comparison of Manufacturer's Cleared Device and Modified Device
Table 1. Comparison of Modified Device to Cleared Device
| SubjectPathfinder Endoscope Overtube(Gen. 2.0) | Predicate DevicePathfinder Endoscope Overtube(Gen. 1.0) | |
|---|---|---|
| 510(k) Number | K211301 | K191415 |
| 510k Submitter/Holder | Same as predicate | Neptune Medical, Inc. |
| Product Code | Same as predicate | FED |
| Regulation No. | Same as predicate | 876.1500 |
| Regulation Description | Same as predicate | Endoscope and accessories. |
| CommonName | Same as predicate | Endoscopic Access Overtube,Gastroenterology-urology |
| Indications for Use | Same as predicate | The Pathfinder Endoscope Overtube isintended to be used with an endoscopeto facilitate intubation, change ofendoscopes, and treatment in thegastrointestinal (GI) tract in adultpatients (22 years of age and older). |
| Sterility | Same as predicate | Ethylene Oxide (EO) Sterilization |
| Single-Use | Same as predicate | Yes |
| Device Technology | Same as predicate | Vacuum-assisted rigidizing overtube foendoscopic procedures in the GI Tract. |
| Dimensions | Nine sizes, from 65 to 145 cm longand 11 to 16 mm inner diameter. | One size, 85 cm long and 14 mm innerdiameter. |
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Image /page/5/Picture/1 description: The image shows the logo for Neptune Medical on the left. The logo includes the company name and an image of a planet. To the right of the logo is the text "Special 510(k): Modification to Pathfinder Endoscope Overtube". On the right side of the image is the word "Page:" followed by the number 3.
- 1.7 Summary of Modification
The primary modification being addressed by this submission is the creation of eight new sizes of Pathfinder Endoscope Overtube of various combinations of three different diameters and four different lengths.
The durometer of the vacuum and irrigation line material was increased. Lastly, additional modifications to labeling driven by the new sizes and/or clinical feedback on the earlier device are included in this submission.
| REF (CatalogNumber) | Description | Inner Diameter(mm) | Length (cm) |
|---|---|---|---|
| GI 065110-2 | Pathfinder® Endoscope Overtube, 11 mm ID x 65 cm Length | 65 | |
| GI 085110-2 | Pathfinder® Endoscope Overtube, 11 mm ID x 85 cm Length | 11 | 85 |
| GI 145110-2 | Pathfinder® Endoscope Overtube, 11 mm ID x 145 cm Length | 145 | |
| GI 065140-2 | Pathfinder® Endoscope Overtube, 14 mm ID x 65 cm Length | 65 | |
| GI 085140-2(original size) | Pathfinder® Endoscope Overtube, 14 mm ID x 85 cm Length | 14 | 85 |
| GI 110140-2 | Pathfinder® Endoscope Overtube, 14 mm ID x 110 cm Length | 110 | |
| GI 065160-2 | Pathfinder® Endoscope Overtube, 16 mm ID x 65 cm Length | 65 | |
| GI 085160-2 | Pathfinder® Endoscope Overtube, 16 mm ID x 85 cm Length | 16 | 85 |
| GI 110160-2 | Pathfinder® Endoscope Overtube, 16 mm ID x 110 cm Length | 110 |
Table 2. New Sizes, Compared with Original Size Cleared in K191415
Summary of Functional and Performance Testing 1.8
The line extension was the subject of extensive testing under applicable design control requirements, including:
- Lubricity ●
- Insufflation ●
- Insertion/Removal ●
- Navigation
- Rigidization/De-Rigidization ●
- Dimensional Measurements
- Endoscope Compatibility ●
- Summary of Clinical Testing 1.9
No clinical testing was applicable to this submission.
- 1.10 Conclusion
Like the predicate first-generation device originally cleared by the FDA, the modified Pathfinder Endoscope Overtube has been shown to be safe through bench testing. Design changes made to the device do not raise any unanswered questions of safety or effectiveness. Test data support substantial equivalence of the modified Pathfinder to the legally marketed predicate device.
§ 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.