The Pathfinder® CR System is a disposable endoscopy fluid management system for the 14mm ID Pathfinder®Endoscope Overtube. It is designed to evacuate retained blood, free-floating blood clots, and fluid from the stomach in adult patients (22 years of age or older). It also provides access for endoscopic device passage and exchange. The suction adapter is attached to the Overtube and connected to a foot pedal to control suction on/off functionality. The foot pedal is connected to a suction source with vacuum regulator that provides a range between 200 to 375 mmHg (26.7 to 50.0 kPa). It is for use only by medically licensed and trained gastroenterologists located in hospitals, clinics, and doctor offices. The Pathfinder® CR System consists of the following main components: Suction Adapter (CR, Adapter), Foot Pedal (Suction Controller), Suction Tubing (Tubing).

AI/ML Overview

The provided FDA 510(k) summary for the Neptune Medical Pathfinder® CR System primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, biocompatibility, and non-clinical functional and performance testing. It explicitly states that "No clinical testing was applicable to this submission" and "No animal testing was applicable to this submission." Therefore, the document does not contain information about a study with acceptance criteria of the type requested, which would typically involve human-in-the-loop performance or standalone algorithm performance.

However, based on the provided text, I can infer the "acceptance criteria" are related to successful functional and performance testing and biocompatibility, rather than a clinical performance study with metrics like sensitivity, specificity, or AUC.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The document describes several non-clinical functional and performance tests. While specific quantitative acceptance criteria are not explicitly listed in a table format with corresponding reported performance values, the overall conclusion states that the device "successfully demonstrated that the device correctly performs as designed, has been validated for its intended use, and raises no new questions regarding either safety or effectiveness."

To provide a table as requested, I'll interpret the successful completion of each test as meeting an implicit acceptance criterion.

Acceptance Criterion (Implicit)	Reported Device Performance and Evidence
Biocompatibility:
Meets ISO 10993 requirements for patient-contacting materials (Suction Adapter)	Testing demonstrated that the material used in the Suction Adapter meets the requirements of the applicable ISO 10993 standard. Tests included Cytotoxicity, Sensitization, Irritation Reactivity, Acute Systemic Toxicity, and Material Mediated Pyrogenicity.
Functional and Performance Testing:	It's important to note that specific PASS/FAIL criteria or numerical results for these tests are not provided in this summary. The summary states that these activities "successfully demonstrated that the device correctly performs as designed."
Dimensional Measurements	Successfully demonstrated (implied by overall conclusion).
Adapter Scope Installation	Successfully demonstrated (implied by overall conclusion).
Endoscope Trackability	Successfully demonstrated (implied by overall conclusion).
Device Trackability	Successfully demonstrated (implied by overall conclusion).
System Flow Rate	Successfully demonstrated (implied by overall conclusion). Includes specifications for maximum suction pressure of (-)0.5 Bar / (375mmHg).
Adapter Tubing Installation and Removal	Successfully demonstrated (implied by overall conclusion).
Adapter Tensile Integrity	Successfully demonstrated (implied by overall conclusion).
Adapter Cantilever Integrity	Successfully demonstrated (implied by overall conclusion).
Adapter Scope and Cantilever Seal	Successfully demonstrated (implied by overall conclusion).
Adapter Torque	Successfully demonstrated (implied by overall conclusion).
Foot Pedal Cyclic and Actuation Force	Successfully demonstrated (implied by overall conclusion).
Foot Pedal Tubing Installation and Removal	Successfully demonstrated (implied by overall conclusion).
Simulated Use	Successfully demonstrated (implied by overall conclusion).
Sterility & Shelf Life:
Sterilization effective for Suction Adapter	Ethylene Oxide (EO) used as the method of Sterilization. Neptune Medical is responsible for its sterilization.
Shelf life validation	Proposed shelf life of 6 months from the date of manufacture. (Implies satisfactory validation was performed, though details aren't provided).
Substantial Equivalence:
As safe, as effective, and performs as well as predicates	"Differences in design and technology do not raise any unanswered questions of safety or effectiveness and the intended use remains unchanged." Concluded to be substantially equivalent to Pathfinder Endoscope Overtube (K211301) and Pure-Vu EVS System (K232922) based on bench testing and biocompatibility.

Regarding the specific questions about evaluation studies:

2. Sample size used for the test set and the data provenance:

Not applicable / Information not provided. This document details non-clinical (bench) testing, not a clinical study involving a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No expert review of a "test set" to establish ground truth is described, as there was no clinical study.

4. Adjudication method for the test set:

Not applicable. No clinical test set or adjudication method is described.

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:

No. The document explicitly states, "No clinical testing was applicable to this submission." This device is a mechanical system, not an AI-assisted diagnostic tool, so an MRMC study related to AI assistance would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a mechanical system, not an algorithm. The testing described is functional performance testing of the device itself.

7. The type of ground truth used:

Bench Test Specifications / Engineering Requirements. For the functional tests, the "ground truth" would be the engineering specifications and design requirements against which the device's performance was measured. For biocompatibility, it's compliance with ISO 10993 standards.

8. The sample size for the training set:

Not applicable. This pertains to algorithm development. This device is a mechanical system.

9. How the ground truth for the training set was established:

Not applicable. This pertains to algorithm development. This device is a mechanical system.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".

June 27, 2024

Neptune Medical, Inc. % Keira Jessop Regulatory Affairs Consultant AlvaMed, Inc. 935 Great Plain Avenue, Unit 166 Needham, Massachusetts 02492

Re: K240853

Trade/Device Name: Pathfinder® CR System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FED, FDS Dated: May 24, 2024 Received: May 24, 2024

Dear Keira Jessop:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration. Iisting 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.

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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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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,

Sivakami Venkatachalam -S

for

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

Submission Number (if known)

K240853

Device Name

Pathfinder® CR System

Indications for Use (Describe)

It is for use only by medically licensed and trained gastroenterologists located in hospitals, clinics and doctors' offices.

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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510(k) Summary

Name and Address of Submitter

Neptune Medical, Inc. 1828 Camino Real, Suite 508 Burlingame, CA 94010 USA Phone: +1 (650) 307-2176 Alex Tilson, CEO alex@neptunemedical.com

Correspondent/Primary Contact Person

Keira Jessop, M.S., RAC Regulatory Affairs Consultant AlvaMed, Inc. 935 Great Plain Avenue, Unit 166 Needham, MA 02492 USA kjessop@alvamed.com Phone: +1 (888) 331-3485 Fax: +1 (617) 249-0955

Submission Information

Subject Device:

Date Summary Prepared:	27 March 2024
Trade/Device Name:	Pathfinder® CR System
Manufacturer:	Neptune Medical, Inc.
Common Name:	Pathfinder® CR System
Regulation Number:	876.1500
Classification:	Class II
Primary Product Code:	FED, FDS
Review Panel:	Gastroenterology and Urology

Primary Predicate Device:

Trade/Device Name:	Pathfinder Endoscope Overtube (K211301)
Manufacturer:	Neptune Medical, Inc.
Common Name:	Endoscopic Access Overtube
Regulation Number:	876.1500
Classification:	Class II
Primary Product Code:	FED
Review Panel:	Gastroenterology and Urology

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K240853 Page 2 of 7

Secondary Predicate Device:

Trade/Device Name: Manufacturer: Common Name: Regulation Number: Regulation Class: Product Code: Review Panel:

Pure-Vu EVS System (K232922) Motus GI Medical Technologies Ltd. Pure-Vu EVS System 876.1500 Class II FDF, FDS Gastroenterology and Urology

Valid Predicate Discussion

Pathfinder Endoscope Overtube was selected as the valid primary predicate device and Pure-Vu EVS System was selected as the secondary predicate device to support the 510(k) submission because they received FDA clearance using well-established methods. Both the predicates meet the expected predicate performance due to no reports of unexpected injury, deaths, or malfunctions associated with the device. After conducting a search on the Manufacturer and User Facility Device Experience (MAUDE) Database, Medical Device Reporting (MDR), MedSun Reports Database, Medical Device Safety and CBER Safety & Availability (Biologics) and Recall Database websites, it was found that there are no known unmitigated use-related or design safety issues and both primary and secondary predicate devices have not been subject to a design-related recall.

Valid PredicateDevice	A - Wellestablishedmethods	B - Meets or exceedsexpected predicateperformance	C - Unmitigateduse-related ordesign-relatedsafety issues	D –Associateddesign-related recall
PathfinderEndoscopeOvertube(PrimaryPredicate)	Usedrelevantmethods thatwerepublished inthe publicdomain.	History of safe useestablished due to noreports of unexpectedinjury, deaths, ormalfunctionsassociated with thedevice	No knownunmitigated userelated or design-related safetyissues	No design-related recallidentified
Pure-Vu EVSSystem(SecondaryPredicate)	Usedrelevantmethods thatwerepublished inthe publicdomain	History of safe useestablished due to noreports of unexpectedinjury, deaths, ormalfunctionsassociated with thedevice	No knownunmitigated userelated or design-related safetyissues	No design-related recallidentified

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Device Description

Suction Adapter (CR, Adapter)

The suction adapter (CR) is a disposable adapter is attached to the Overtube to allow for passage of an endoscope composed of a rigid cap and body and two sealing components: a seal that interfaces with the Overtube handle grip and a scope seal that interacts with the endoscope. It has a side port for attachment to a suction source with a vacuum regulator such as a vacuum canister or wall vacuum.

Foot Pedal (Suction Controller)

The foot pedal (suction controller) is a spring-loaded pedal for engaging vacuum on and off. When depressed, the vacuum is engaged and the material from the patient is suctioned around the endoscope through the Overtube and CR, through the tubing and into a suction canister. When released, the vacuum is disengaged.

Suction Tubing (Tubing)

The suction tubing allows for removal of blood and fluid. It is connected to the CR side port, suction controller barbs and a suction source with vacuum regulator.

Indications for Use

The Pathfinder® CR System is an accessory to the Pathfinder Endoscope Overtube, intended to be used with an endoscope to facilitate evacuation of retained blood, free-floating blood clots, and fluid from the stomach in adult patients (22 years of age or older). It is for use only by medically licensed and trained gastroenterologists located in hospitals, clinics, and doctors' offices.

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Summary of Technological Characteristics

The following table provides an overview of general technological characteristics in comparison to both primary and secondary predicate devices. Any differences in the technological characteristics are minor and reflect market strategy and/or perceived user preferences and do not impact the safety, effectiveness, or substantial equivalence of the device. Biocompatibility evaluation testing, and performance testing have been performed on the subject device in order to establish substantial equivalence to the predicate devices.

	Subject Device	Primary Predicate	Secondary Predicate
Manufacturer	Neptune Medical, Inc.	Neptune Medical, Inc.	Motus GI Medical Technologies Ltd.
Trade Name	Pathfinder CR System	Pathfinder Endoscope Overtube	Pure-Vu EVS System
K#	TBD	K211301	K232922
Device Classification Name	Endoscopic access overtube, gastroenterology- urology	Endoscopic access overtube, gastroenterology- urology	Colonoscope and accessories, flexible/rigid
Classification	Regulation No: 876.1500 Class: II Panel: Gastroenterology and Urology	Regulation No: 876.1500 Class: II Panel: Gastroenterology and Urology	Regulation No: 876.1500 Class: II Panel: Gastroenterology and Urology
Product Code	FED, FDS	FED	FDF, FDS
Indications for Use	The disposable Pathfinder® CR System is an accessory to the Pathfinder Endoscope Overtube, intended to be used with an endoscope to facilitate evacuation of retained blood, free-floating blood clots, and fluid from the stomach in adult patients (22 years of age or older)	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 Pure-Vu EVS System is intended to connect to standard or slim colonoscopes and gastroscopes to help facilitate intra- procedural cleansing of the GI tract by irrigating or cleaning and evacuating irrigation fluid (water), feces, and other bodily fluids and matter, e.g. blood
	It is for use only bymedically licensedand trainedgastroenterologistslocated in hospitals,clinics, and doctors'offices.		It is for use only bytrained medicalpersonnel located inhospitals, clinicsand doctors' offices.
Environment of Use	Hospitals, clinics,and/or doctor'soffices	Hospitals, clinics,and/or doctor'soffices	Hospitals, clinics,and/or doctor'soffices
Prescriptive	Yes	Yes	Yes
Technological Characteristics
Disposable	Yes	Yes	Yes, except forworkstation
Principle ofOperation	Proximal attachmentto PathfinderOvertube withinsertion ofendoscope throughboth Pathfinder CRSystem andPathfinder Overtube.Suction at any timeduring procedure.Debris and fluids areremoved through thesuction channel intoan external wastercontainer.	Insertion ofendoscope throughPathfinder Overtube.Vacuum-assistedrigidizing overtubefor endoscopicprocedures in the GITract.	Distal Attachment tothe endoscope.Vacuum Suction atany time during theprocedure withoutremoving any tools.Debris and fluids areremoved through thesuction channel intoan external wastercontainer
Maximum SuctionPressureSpecifications	(-)0.5 Bar /(375mmHg)	N/A - Closed system	(-)0.5 Bar /(375mmHg)
Sterilization ofPatient ContactingComponents	Sterile	Sterile	Clean, Non-Sterile
Material	Complies with ISO10993	Complies with ISO10993	Complies with ISO10993
Electrical Input	N/A	N/A	100V-240V/50/60 HZ

Table 1: Summary of Technological Characteristics

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K240853 Page 5 of 7

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Summary of Biocompatibility Testing:

The Suction Adapter is the only component of the system that is considered to have any indirect or direct contact with the patient.

Biocompatibility testing of the Suction Adapter materials included:

Cytotoxicity
Sensitization
Irritation Reactivity
Acute Systemic Toxicity ●
Material Mediated Pyrogenicity

Testing demonstrated that the material used in the Suction Adapter meets the requirements of the applicable ISO 10993 standard.

Summary of Non-Clinical Functional and Performance Testing

The Pathfinder® CR system was subject to extensive testing under applicable design control requirements, including:

. Dimensional Measurements
Adapter Scope Installation
Endoscope Trackability
Device Trackability
System Flow Rate
Adapter Tubing Installation and Removal ●
Adapter Tensile Integrity
Adapter Cantilever Integrity
Adapter Scope and Cantilever Seal
. Adapter Torque
. Foot Pedal Cyclic and Actuation Force
. Foot Pedal Tubing Installation and Removal
. Simulated Use

Together, these verification/validation activities successfully demonstrated that the device

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correctly performs as designed, has been validated for its intended use, and raises no new questions regarding either safety or effectiveness when compared to the predicate device. Therefore, the verification/validation testing conducted supports a determination of substantial equivalence for the subject device.

Summary of Clinical Data

No clinical testing was applicable to this submission.

Summary of Animal Data

No animal testing was applicable to this submission.

Shelf Life and Sterilization

Neptune Medical is responsible for the sterilization of the Suction Adapter component of the Pathfinder® CR system. The Suction tubing is purchased sterile, so Neptune Medical is not responsible for its sterilization process. The foot pedal is provided non-sterile; therefore, sterility validation is not applicable

Ethylene Oxide (EO) is used as the method of Sterilization and the proposed shelf life of the device is 6 months from the date of manufacture.

Conclusion

Neptune Medical considers the Pathfinder CR System to be substantially equivalent to the primary and secondary predicate. Like the primary predicate, Pathfinder Endoscope Overtube, and the secondary predicate, Pure-Vu EVS System, the Pathfinder® CR System has been shown to be safe and effective through bench testing and biocompatibility testing. Differences in design and technology do not raise any unanswered questions of safety or effectiveness and the intended use remains unchanged.

The information present in the 510(k) supports that the Pathfinder® CR System is as safe, as effective, and performs as well as the predicate devices and substantially equivalent to the identified primary and secondary predicate devices in design rationale, methodology of use, and performance.

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification it can be concluded that the subject device is substantially equivalent with predicate devices.

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.