The Moon Maestro System is a 2-arm system which utilizes software and hardware to provide support to surgeons for manipulating and maintaining instrument position. Motors compensate for gravitational force applied to laparoscopic instruments, while surgeon control is not affected. Conventional laparoscopic tools are exclusively controlled and maneuvered by the surgeon, who grasps the handle of the surgical laparoscopic instrument and moves it freely until the instrument is brought to the desired position. Once surgeon hand force is removed, the Maestro system reverts to maintenance of the specified tool position and instrument tip location. This 510(k) is being submitted to implement the ScoPilot feature. ScoPilot is an on-demand, optional, ease-of-use feature of the Maestro System, allowing the laparoscope which is attached to a Maestro Arm to seamlessly follow a desired instrument tip. The surgeon remains in control of laparoscope positioning, without having to disengage from the instrument in their hand, helping maintain surgical flow and focus.

AI/ML Overview

The provided text describes the Moon Surgical Maestro System, including its features and the testing performed for its 510(k) submission. However, the document does not contain a detailed table of acceptance criteria or the reported device performance against those criteria as would typically be found in a study summary with quantifiable results. It lists various tests performed but does not present the specific metrics and their outcomes in a structured format.

Therefore, I cannot fully complete the requested information for acceptance criteria and reported performance with quantitative data. I can, however, extract related information about the testing and ground truth establishment.

Here's an attempt to answer your questions based on the provided text, with limitations acknowledged:

1. Table of acceptance criteria and the reported device performance

The document states: "The ML model was trained and tuned through a K-fold cross-tuning process to optimize hyperparameters, until it reached our predefined performance requirements. An independent testing dataset containing videos was used to verify that the model performance (lower bound of the 95%CI for AP and AR) is compliant with our specification when using data including brands unseen during training/tuning."

While this indicates that performance requirements were predefined and that "AP" (presumably Average Precision) and "AR" (presumably Average Recall) were metrics, the specific numerical values for these "predefined performance requirements" (acceptance criteria) and the "compliant" reported performance are not detailed in the provided text.

Therefore, a table with specific numbers cannot be generated from the given information.

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

Sample Size for Test Set: The document mentions "An independent testing dataset containing videos" was used. The specific number of videos or cases in this test set is not provided.
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective.

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

The document mentions "ScoPilot Vision Performance" as one of the tests. For the ML model validation, it states: "The ML model was trained and tuned... An independent testing dataset containing videos was used to verify that the model performance...". However, the document does not specify the number of experts or their qualifications used to establish the ground truth for the test set.

4. Adjudication method for the test set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

The document mentions "Human factors testing" and "Cadaver testing." However, there is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study evaluating how much human readers improve with AI vs. without AI assistance. The described "ScoPilot" feature is an "on-demand, optional, ease-of-use feature" that allows the laparoscope to follow a desired instrument tip, aiming to help "maintain surgical flow and focus." This implies a focus on a specific functionality rather than a broad comparative effectiveness study with human readers.

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

Yes, a standalone performance evaluation of the ML model was performed. The text states: "An independent testing dataset containing videos was used to verify that the model performance (lower bound of the 95%CI for AP and AR) is compliant with our specification when using data including brands unseen during training/tuning." This describes an algorithm-only evaluation.

7. The type of ground truth used

For the "ScoPilot Vision Performance" and ML model validation, the ground truth would likely involve annotated video frames where the "desired instrument tip" is precisely identified. The text mentions "detection and tracking of specified instrument tips." However, it does not elaborate on how these ground truth annotations (e.g., expert consensus, pathology, outcomes data) were generated. Given the nature of the device (laparoscopic instrument tracking), it would most likely be based on expert manual annotation of video frames.

8. The sample size for the training set

The document states: "The ML model was trained and tuned through a K-fold cross-tuning process to optimize hyperparameters..." The specific sample size (number of videos/frames) for the training set is not provided.

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

The document states "Machine Learning methodology used to develop software algorithm responsible for identifying tool tip." While it indicates that an ML model was trained to identify the tool tip, it does not explicitly state how the ground truth was established for this training set. Similar to the test set, it would logically involve expert annotation of video data to delineate the "tool tip."

Summary

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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 Department of Health & Human Services - USA seal. To the right of the seal is the FDA logo in blue. The logo includes the words "U.S. FOOD & DRUG ADMINISTRATION".

March 14, 2025

Moon Surgical % Michael Daniel Consultant Daniel & Daniel Consulting P.O. Box 129 Minden, Nevada 89423

Re: K242323

Trade/Device Name: Maestro System (REF100) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: QZB Dated: January 14, 2025 Received: January 15, 2025

Dear Michael Daniel:

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. 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.

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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 (OS) 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 820.30 and 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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.

For comprehensive regulatory information about medical devices and radiation-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-regulatory

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assistance/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,

Digitally signed by Mark Mark Trumbore -S Date: 2025.03.14 15:18:19 Trumbore -S -04'00' Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control 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)

K242323

Device Name

Maestro System (REF100)

Indications for Use (Describe)

The Maestro System is intended to hold and position laparoscopes and laparoscopic instruments during laparoscopic surgical procedures.

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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Image /page/4/Picture/0 description: The image shows the logo for Moon Surgical. The logo features a stylized depiction of a moon, with the upper portion shaded to represent craters or lunar features. Below the moon graphic, the word "MOON" is written in a simple, sans-serif font, with the word "SURGICAL" appearing beneath it in a smaller font size.

510(k) Number: K242323

Applicant Information:

Date Prepared:	March 10, 2025
Name:	Moon Surgical
Address:	9 rue d'Enghien
	75010 Paris France
Contact Person:	Michael A Daniel, Consultant
	madaniel@clinregconsult.com
Mobile Number:	(415) 407-0223
Device Information:
Device Trade Name:	Maestro System
Common Name:	Maestro System

Classification Name(s): Endoscope And Accessories
Product Code/ Regulation: QZB 21 CFR 876.1500
Classification: Class II

Predicate Device:

Maestro System, Moon Surgical SAS (K240598)

Autolap System, Medical Surgery Technologies, Ltd. (K152848)

Subject Device Description

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is brought to the desired position. Once surgeon hand force is removed, the Maestro system reverts to maintenance of the specified tool position and instrument tip location. This 510(k) is being submitted to implement the ScoPilot feature. ScoPilot is an on-demand, optional, ease-of-use feature of the Maestro System, allowing the laparoscope which is attached to a Maestro Arm to seamlessly follow a desired instrument tip. The surgeon remains in control of laparoscope positioning, without having to disengage from the instrument in their hand, helping maintain surgical flow and focus.

Subject Device Intended Use / Indications for Use

The Maestro System is intended to hold and position laparoscopes and laparoscopic instruments during laparoscopic surgical procedures.

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Image /page/6/Picture/0 description: The image shows the logo for Moon Surgical. The logo consists of a stylized image of a moon with some craters on the surface. Below the moon image, the word "MOON" is written in a simple sans-serif font, and below that, the word "SURGICAL" is written in a smaller font.

510(k) summary

Predicate Device and Subject Device Comparison

The table below compares the Maestro System to the predicate devices.

ASPECT	MOON SURGICAL (SubjectDevice)	MOON SURGICAL (Primarypredicate Device)	MST - MEDICAL SURGERYTECHNOLOGIES LTD(Secondary predicate device)	COMPARISON
Device Name	Maestro System	Maestro System	Autolap System	N/A
510(k) Number	Not yet assigned	K221410	K152848	N/A
Product Code /	QZB / 876.1500 Endoscope	FQO / 878.4960	GCJ / 876.1500	Identical to 2nd
Regulation	And Accessories	Table Operating-room, Ac-Powered.	Endoscope And Accessories	predicate
BriefDescription	The Moon Surgical Maestrodevice is an electrically actuateddevice with movablecomponents intended forlaparoscopic surgical proceduresto support and positionlaparoscopic instruments.	Same	The Autolap system is a compactimage guided laparoscopemanipulator that is designed tohold and position thelaparoscope during laparoscopicsurgery. Its role is to hold andmove the laparoscope under thedirect control of surgeon.	Substantiallyequivalent
Intended Use /Indications forUse	The Maestro System is intendedto hold and position laparoscopicInstruments during laparoscopicsurgical procedures.	Same	[The Autolap is used] for thepurpose of holding andcontrolling the movement of astandard laparoscope or rigidendoscope for Generallaparoscopic, Gynecologic andUrologic procedures	Substantiallyequivalent
Technological characteristics
System basiccomponents	Two motorized Arms thathold and position thelaparoscope and/orlaparoscopic instruments	Same	A motorized Arm that holdsand positions the laparoscope(the Autolap ARM)A control unit that controls the	Substantiallyequivalent
ASPECT	MOON SURGICAL (SubjectDevice)	MOON SURGICAL (Primarypredicate Device)	MST - MEDICAL SURGERYTECHNOLOGIES LTD(Secondary predicate device)	COMPARISON
	Two stages, supporting andpositioning the armsA Control Unit that controlsthe movements of the armsInstrument CouplingA User interface for systemsetup and feature selection		movements of the ARMA positioning unit connectingthe Arm to the operation bedrail on either sideA hand-controlled CommandUnit that enables the surgeonto move the laparoscope tohis/her chosen target locationInstrument coupling
Method ofinstrumentattachment	Mechanical clamp aroundlaparoscopic instrument andmechanical attachment to arm	Same	Same	Identical
Mechanismsinvolved inphysicalpositioning	Electro-mechanical jointedarms driven by internalmotors that follow thephysician movements.	Same	Same	Identical
Method ofcontrol	Movement of the laparoscope isenabled only upon applied forceto the instrument handle.Endoscope can optionally becontrolled by selected handheldinstruments with Endoscopefollowing instrument tip.	Movement of the laparoscope isenabled only upon applied forceto the instrument handle.	Movement of the laparoscope isenabled only upon pressing thebutton on the joystick commandor the Manual Activation Buttonor be guided by the movement ofa designated tool within the fieldof view.	Substantiallyequivalent
EndoscopeMovement	Manual ControlControl algorithm applyingmotor current for instrumentmotion triggered by physiciandirect movementInstrument Based Control	Manual ControlControl algorithm applyingmotor current for instrumentmotion triggered by physiciandirect movement	Manual ControlControl algorithm applyingmotor current for instrument atmotion triggered by physiciandirect movement	Substantiallyequivalent
ASPECT	MOON SURGICAL (SubjectDevice)	MOON SURGICAL (Primarypredicate Device)	MST - MEDICAL SURGERYTECHNOLOGIES LTD(Secondary predicate device)	COMPARISON
	Image processing algorithms thatenable the detection of allsurgical tools within thedisplayed video image and whencommanded by the surgeon,follow the movement of thechosen tool.		Instrument Based Controlimage processing algorithms thatenable the detection of allsurgical tools within thedisplayed video image and whencommanded by the surgeon,follow the movement of thechosen tool.Joystick controlindirect instrument movementcommunicated via RF signal.
Video ImageHandling	The video image is transferredfrom the laparoscope cameraunit, through the framegrabber, to the ImageProcessing Algorithm	N/A	The video image is transferredfrom the laparoscope cameraunit, through the framegrabber, to the ImageProcessing Algorithm	Substantiallyequivalent
ImageProcessingAlgorithm	The Image ProcessingAlgorithm continuouslydetects the coordinates of thesurgical tools within the videoimage. Additionally, itcalculates the transformationmatrix, which correlates to thelaparoscope's movement fromimage to image	N/A	The Image ProcessingAlgorithm continuouslydetects the coordinates of thesurgical tools within the videoimage. Additionally, itcalculates the transformationmatrix, which correlates to thelaparoscope's movement fromimage to image	Substantiallyequivalent
Instrument tipidentification	Machine Learningmethodology used to develop	N/A	Computer Visionmethodology used to develop	Substantiallyequivalent
ASPECT	MOON SURGICAL (SubjectDevice)	MOON SURGICAL (Primarypredicate Device)	MST - MEDICAL SURGERYTECHNOLOGIES LTD(Secondary predicate device)	COMPARISON
softwarealgorithmdevelopmentmethod	software algorithmresponsible for identifyingtool tip. Once developed, thissoftware algorithm is fixedand static and added to therest of the system software.		software algorithmresponsible for identifyingtool tip. Once developed, thissoftware algorithm is fixedand static and added to the restof the system software.
Alarm andWarningConditionIndicators	The arms and lighthouse of theMaestro System are equippedwith eight LEDs that conveyinformation about the system'sstatus and conditions.If necessary, alerts,notifications, and faultmessages or graphics aredisplayed on the Touchscreensimultaneously to indicate thesystem's current status.	Same	Alerts, notifications, and faultmessages are displayed on thescreen to indicate the system'scurrent status.	Substantiallyequivalent
Single FaultTolerance	Automatic SystemPerformance Monitoring inreal-time with multiple faulttiers + visual supervision bysurgeon via LED indicatingsystem status.Examples include:- Redundant encoders onmotorized axes- Velocity, acceleration,	Same	Searching redacted 510(k) for"single fault" of "fault" doesnot yield useful information.Moon Surgical does not knowabout their design in thisregard other than thefollowing:"Motor current limitation -applying relatively heavyweight on the ARM will cause	Substantiallyequivalent
ASPECT	MOON SURGICAL (SubjectDevice)	MOON SURGICAL (Primarypredicate Device)	MST - MEDICAL SURGERYTECHNOLOGIES LTD(Secondary predicate device)	COMPARISON
	current and torque limitsBrakes engage if power isremoved		the motors' currents to riseabove a pre-defined threshold.As a response the system willelectronically shutdown themotors and no motorizedmovement will be enabled."
Back-up faultresponse	Brakes engage on motorizedaxis in the event of a faultstate to prohibit any armmotion	Same	No information	Substantiallyequivalent
MaximumApplied Load	4.4 lbs tested.	Same	600 grams	Substantiallyequivalent
Compatiblewith	5mm and 10mm laparoscopesand laparoscopic instruments5mm and 10mm laparoscopesfor Scopilot	5mm and 10mm laparoscopesand laparoscopic instruments	5mm and 10mm laparoscopes	Substantiallyequivalent
SterilizationMethod	Ethylene Oxide (EtO) – forcoupling devices used toattach laparoscopicinstruments	Same	Ethylene Oxide (EtO)	Substantiallyequivalent
Sterility barrier	Drape	Drape	Drape	Identical

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Image /page/11/Picture/0 description: The image shows the logo for Moon Surgical. The logo features a stylized image of a moon or globe at the top, with the word "MOON" in large, sans-serif font below it. Underneath "MOON" is the word "SURGICAL" in a smaller, sans-serif font.

510(k) summary

Testing Performed

Testing described in this 510(k) consisted of verification of the Scopilot input requirements and product specifications. All requirements were validated. Design verification testing included the following:

Payload Capacity
Malformed Input
Force Accuracy
· Drape Integrity
· Emergency Stop
Hold Position Accuracy
· IFU Inspection
Positioning Guidance & Collision Detection
· ScoPilot Motion Performance
System Positioning Accuracy
Bedside Joint Control Accuracy
End to End Workflow
· Design Inspection
· System Setup
· System Latency
Electro-Cautery Compatibility
· ScoPilot Latency
ScoPilot End to End
ScoPilot IFU Inspection
· System Endurance
ScoPilot Vision Performance
ScoPilot Malformed Input
· Cybersecurity
Coupler Performance
· Electrical safety and electromagnetic compatibility (EMC)

Software Verification and Validation Testing

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket

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Submissions for Device Software Functions" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions". Software testing included testing the software modifications made to implement the new ScoPilot features. This includes detection and tracking of specified instrument tips, generation of motion trajectories, safety limits and detection of malformed inputs at a video and frame level.

ScoPilot Validation testing

The ML model was trained and tuned through a K-fold cross-tuning process to optimize hyperparameters, until it reached our predefined performance requirements. An independent testing dataset containing videos was used to verify that the model performance (lower bound of the 95%CI for AP and AR) is compliant with our specification when using data including brands unseen during training/tuning.

Design validation testing included the following:

· Human factors testing
· Cadaver testing

Summary

Based upon the Intended Use, Indications for Use, product technical information, performance evaluation, and standards compliance provided in this premarket notification, the Maestro System has been shown to be substantially equivalent to the cited 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.