The Pathfinder Endoscope Overtube with Balloon 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).

Device Description

The Pathfinder Endoscope Overtube with Balloon device consists of a hollow tube with a balloon at the distal end for use over a flexible gastrointestinal endoscope. The purpose of the balloon is to contact the lumen walls to provide stabilization to the distal end of the overtube within the GI tract. The endoscope is inserted through the proximal end of the device and comes out the distal end. The free space between the overtube and the endoscope is lubricated with water through the irrigation line by connecting to the irrigation/water Luer (female Luer lock fitting) and injecting water. The vacuum line is connected to free space within the device and is completely contained. A source of vacuum must be connected to the barb fitting per the diagram below for the overtube to transition between the flexible and rigid conditions. The balloon line is connected to an extrusion within the device that creates an air pathway from handle to the balloon. An inflation device must be connected to the Luer (male Luer lock fitting) to inflate and/or deflate the balloon. The handle rotator has two positions. The first position connects the device to atmosphere (vent) to stay in the flexible condition. The second position connects the device 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 surrounding anatomy. Balloon inflation and deflation are actuated and controlled by an existing balloon controller unit within the endoscopy suite. The device must be connected to the balloon controller to transition into the inflated and deflated condition.

AI/ML Overview

The provided text does not contain information about a study that proves a device meets acceptance criteria related to AI/algorithm performance.

The document is a 510(k) Premarket Notification from the FDA to Neptune Medical, Inc. for their "Pathfinder Endoscope Overtube with Balloon Device." It describes the device, its intended use, comparison to predicate devices, and summaries of functional and performance bench testing, and biocompatibility testing. It explicitly states:

"No clinical testing was applicable to this submission."
The entire submission focuses on a physical medical device, not an AI or algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study for an AI-powered device's performance, as the provided text pertains to a traditional medical device not involving AI.

Summary

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July 28, 2023

Neptune Medical, Inc. % Eric Bannon Regulatory Consultant Alvamed. Inc. 935 Great Plain Ave, Suite 166 Needham, MA 02492

Re: K230801

Trade/Device Name: Pathfinder Endoscope Overtube with Balloon Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FED Dated: June 28, 2023 Received: June 29, 2023

Dear Eric Bannon:

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 -S

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)

K230801

Device Name

Pathfinder Endoscope Overtube with Balloon

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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1-1

1.0 510(K) SUMMARY

1.1 Name and Address of Owner/Submitter

Neptune Medical, Inc. 1828 El 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

Eric Bannon Vice President of Regulatory and Clinical Affairs AlvaMed, Inc. ebannon@alvamed.com Phone: +1 (781) 710-8243 Fax: +1 (617) 249-0955

1.3 Submission Information

Date Summary Prepared:	March 22, 2023
Name of Device:	Pathfinder Endoscope Overtube with Balloon
Device Classification Name:	Endoscope and Accessories
Common or Usual Name:	Endoscope Accessory Overtube
Classification:	Class II
Product Code:	FED (21 CFR 876.1500)
Predicate Device:	Pathfinder Endoscope Overtube (K211301)
Reference Device:	Dilumen Endolumenal Interventional Platform (K210851)

1.4 Predicate/Reference Device

	510(k) Number	Code	Device Name	Submitter Name
PredicateDevice	K211301	FED	PathfinderEndoscope Overtube	Neptune Medical,Inc.
ReferenceDevice	K210851	FDF	DilumenEndolumenalInterventionalPlatform	Lumendi

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Image /page/4/Picture/1 description: The image contains the logo for Neptune Medical. The word "Neptune" is written in blue, and the word "Medical" is written in red below it. To the right of the text is a circular graphic that depicts a planet with rings in space.

Traditional 510(k): Pathfinder Endoscope Page: Overtube with Balloon Device

1.5 Device Description

1.6 Comparison of Subject Predicate, and Reference Device

	Subject Device:	Predicate Device:	Reference Device:
	Pathfinder EndoscopeOvertube with Balloon	Pathfinder EndoscopeOvertube	Dilumen EndoluminalInterventional Platform
510(k)Number	TBD	K211301	K210851
510(k)Submitter/Holder	Same as predicate	Neptune Medical, Inc.	Lumendi
RegulationCode	Same as predicate	FED	FDF
RegulationNumber	Same as predicate/reference	876.1500	876.1500
Common Name	Same as predicate	Endoscope Access Overtube, Gastroenterology-urology	Colonoscope and accessories, flexible/rigid
Regulation Description	Same as predicate/ reference	Endoscope and accessories	Endoscope and accessories
Device Classification	Same as predicate/ reference	Class II	Class II
Indicationsfor Use	The Pathfinder EndoscopeOvertube with Balloon isintended to be used withan endoscope to facilitateintubation, change ofendoscopes, andtreatment in thegastrointestinal (GI) tractin adult patients (22 yearsof age and older).	The Pathfinder EndoscopeOvertube is intended to beused with an endoscopeto facilitate intubation,change of endoscopes,and treatment in thegastrointestinal (GI) tractin adult patients (22 yearsof age and older)	The Lumendi DiLumen isan accessory to anendoscope. The DiLumendual balloon accessory isintended for use with anystandard endoscope thathas a distal tip outerdiameter of 12.5 – 14.3mm. The device isindicated to ensurecomplete positioning of anendoscope duringnavigation in the largeintestine, while assistingwith optical visualization,diagnosis, tissuemanipulation, andendoscopic treatment.
Intended Population	Same as predicate	Adult patients undergoinggastrointestinal endoscopy	Not Available
SterilizationMethod	Same as predicate	Ethylene Oxide (EO)Sterilization	Non-Sterile
Single Use	Yes	Yes	Yes
DeviceTechnology	Vacuum-assistedrigidizing overtube withballoon for endoscopicprocedures in the GITract.	Vacuum-assistedrigidizing overtube forendoscopic procedures inthe GI Tract.	The DiLumen utilizes twoballoons to position andstabilize the endoscopewithin a patient's largeintestine. After theDiLumen is installed overthe endoscope, theendoscope and DiLumenare navigated to the target

Table 1.6: Comparison of Predicate/Reference Device to Subject Device

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K230801 Page 3 of 5

Image /page/5/Picture/1 description: The image shows the logo for Neptune Medical. The word "Neptune" is written in blue, with the word "Medical" written in red underneath. To the right of the text is an image of a planet with rings around it, set against a background of stars.

Traditional 510(k): Pathfinder Endoscope Page: Overtube with Balloon Device

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Image: Neptune Medical Logo	Traditional 510(k): Pathfinder EndoscopeOvertube with Balloon Device	Page:	1-4
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			zone with the balloonsdeflated.
Dimensions	Two Sizes, with totallength of 85cm and110cm. With nominal innerdiameter of 14mm.Nominal balloon outerdiameter of 40mm.	Nine sizes, with totallength from 65 cm to 145cm. With nominal innerdiameter of 11mm to 16mm.	Fore and aft balloonouter diameter: 60mmFore inner diameter:17.6mm Working length:168 cm, 130 cm, 103 cm

1.7 Environment of Use, and Contraindications
The intended environment of use for the Pathfinder Endoscope Overtube with Balloon Device is the Gastrointestinal tract.

The contraindications are patients with esophageal bleeding, lesion(s), and/or laceration; esophageal strictures and/or varices; laryngeal perforation; trauma to teeth, gums, and/or pharynx; aspiration pneumonia; or any other condition that may preclude endoscopy.

1.8 Performance Data: Summary of Functional and Performance Testing

The following Functional and Performance Bench has been completed:

· Simulated use testing
· Lubricity
Insufflation
Insertion/Removal
Navigation
Rigidization/De-Rigidization
Endoscope Compatibility
Balloon Reliability
· Balloon Pressure Stability
Balloon Inflation/Deflation
Balloon dimensions
1.9 Performance Data: Summary of Biocompatibility Testing

The biocompatibility evaluation for the Pathfinder Endoscope Overtube with Balloon device 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

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Process," June 16, 2016, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA and other applicable standards. The testing included the following:

· Cytotoxicity
· Sensitization
Irritation
· Systemic Toxicity
· Material Mediated Pyrogenicity

The Pathfinder Endoscope Overtube with Balloon Device is considered to contact breached or compromised surfaces for a duration of less than 24 hours.

1.10 Performance Data: Summary of Clinical Testing
No clinical testing was applicable to this submission.
1.11 Conclusions
Like the predicate originally cleared by the FDA, the modified Pathfinder Endoscope Overtube with Balloon Device has been shown to be safe through performance testing. Design changes made to the device do not raise any questions of safety or effectiveness. Verification and validation data support substantial equivalence of the modified Pathfinder Endoscope Overtube with Balloon Device to the legally marketed predicate device.

Regulation Number and Section

§ 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.