Upon intravenous administration of ICG(Indocyanine green for injection) consistent with its approved label, the OPTOVISION provides real-time endoscopic visible and near-infrared fluorescence imaging. The OPTOVISION enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the OPTOVISION is intended for use with standard-of-care white light and, when indicated, intraoperative cholangioaraphy. The device is not intended for standalone use for biliary duct visualization.

Upon interstitial administration and use of ICG consistent with its approved label, the OPTOVISION is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Device Description

OPTOVISION is an endoscopic light source that enables real-time endoscopic visible and nearinfrared fluorescence imaging minimally invasive surgical procedures. Near-infrared illumination is used for fluorescence imaging using indocyanine green (ICG). This device is largely composed of a power circuit, a control circuit, and a lighting lamp (light source). A power circuit provides power to the lighting lamp and cuts off the power in an emergency, a control circuit controls the light output (intensity)/other settings of light rays, and a light source unit irradiates light directly to the Light Guide Cable (K111342) for observation of the affected area. With the configuration above, the power input from the initial power source is transmitted to the light source unit and the main body, and rays of white light and near-infrared light are directly irradiated through the Light Guide Cable to the affected area for observation. This device is designed for use in the following applications: standard endoscopic visible-light imaging and near-infrared fluorescence imaging.

AI/ML Overview

The provided FDA 510(k) summary (K243591) for the "OPTOVISION Endoscopic Light Source Unit" describes the device and its comparison to a predicate device, but it does not present an acceptance criteria table or report specific device performance metrics in the way typically seen for AI/ML device studies (e.g., sensitivity, specificity, AUC).

Instead, this submission is for an endoscopic light source, and its "performance" is demonstrated through compliance with established electrical, electromagnetic, usability, photobiological safety, and software validation standards, as well as a general "Performance - Bench" test. This type of device, an endoscopic light source, does not inherently involve an AI algorithm with output metrics like those you've requested. Thus, many of the specific questions about sample sizes, expert ground truth, adjudication, MRMC studies, and standalone performance are not applicable to the information provided.

However, I can extract and present the available information in a structured format as best as possible, noting where the requested details are not present in the document.

Explanation regarding the absence of typical AI/ML study information:

The "OPTOVISION Endoscopic Light Source Unit" is classified as an "Endoscope And Accessories" (21 CFR 876.1500) with product code OWN, which refers to "Confocal Optical Imaging". This device is a light source that enables real-time endoscopic visible and near-infrared fluorescence imaging using Indocyanine green (ICG). While it uses near-infrared light for fluorescence imaging, the document does not describe it as an AI/ML device that performs diagnosis or prediction, hence the absence of metrics like sensitivity, specificity, and the related study design details. Its "performance" is primarily assessed against safety and engineering standards.

Acceptance Criteria and Device Performance (Based on available information)

Since this is an endoscopic light source, the "acceptance criteria" are compliance with relevant safety and performance standards for medical electrical equipment and usability. The "reported device performance" is the successful passing of these tests.

Acceptance Criteria Category	Specific Standard/Test	Reported Device Performance
Electrical Safety	ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021], IEC 60601-2-18: Edition 3.0 2009-08, IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION	PASS
Electromagnetic Compatibility (EMC)	IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION	PASS
Usability	IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION	PASS
Photobiological Safety	IEC 62471 First edition 2006-07	PASS
Software Validation & Verification	IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION	PASS
Performance - Bench	In accordance with device input specifications	PASS

Study Details (Based on available information)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The "performance data" describes compliance with engineering and safety standards, not a clinical study on a population of patients or data sets in the context of AI/ML.
- Data Provenance: Not applicable. The "tests" are engineering and safety evaluations of the device itself.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a light source, not an AI/ML algorithm requiring expert-established ground truth for its output. The "ground truth" for these tests would be the specifications and requirements of the standards themselves.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This type of adjudication is for disagreements in expert readings/labeling, which does not apply to compliance testing against engineering standards.
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 MRMC study was done, as this device is a light source and not an AI assistant intended to improve human reader performance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm performing a standalone task. Its function is to provide illumination for human visualization.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" for the performance data are the requirements and specifications defined by the referenced international and national standards (e.g., IEC, ES standards) for medical device safety, EMC, usability, photobiological safety, and software.
The sample size for the training set:
- Not applicable. The device is not an AI/ML model that requires a training set.
How the ground truth for the training set was established:
- Not applicable. As above, there is no AI/ML training set.

Summary

{0}------------------------------------------------

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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 19, 2025

Optosurgical LLC Yoseph Kim Chief Executive Officer and R&D Administrator 6751 Columbia Gateway Dr, Suite 300 Office 313 Columbia, Maryland 21046

Re: K243591

Trade/Device Name: OPTOVISION Endoscopic Light Source Unit Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OWN Dated: October 31, 2024 Received: November 20, 2024

Dear Yoseph Kim:

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/cdrb/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.

{1}------------------------------------------------

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 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 (OS) 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.

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.

{2}------------------------------------------------

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,

Digitally signed by TANISHA TANISHA L. HITHE -S L. HITHE -> Date: 2025.02.19
16:05:57 -05'00'

Tanisha Hithe 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

{3}------------------------------------------------

Indications for Use

Submission Number (if known)

K243591

Device Name

OPTOVISION Endoscopic Light Source Unit

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

l. 510(k) Submitter

Applicant: OPTOSURGICAL LLC. 6751 Columbia Gateway Drive Suite 300, Office 313, Columbia, MD 21046

Contact Person: Yoseph Kim / Chief Executive Officer and R&D Administrator Phone: +1-203-675-7089 Email: voseph.kim@optosurqical.com Date Prepared: February 17, 2025

II. Subject Device

Name of Device: OPTOVISION Endoscopic Light Source Unit ●
Common or Usual Name: Light Source, Illuminator ●
Classification Name: Confocal Optical Imaging ●
Regulation Name: Endoscope and accessories (21 CFR 876.1500) ●
Regulatory Class: II
Product Code: OWN ●

III. Predicate Device

Proprietary Name: AIM Light Source and SafeLight™ Cable ●
510(k) Number: K192292 ●
Common Name: Light Source, Illuminator ●
Classification Name: Confocal Optical Imaging & Fiberoptic light ureteral catheter .
& Light Source. Fiberoptic. Routine
Regulation Name: Endoscope and accessories & Fiberoptic light ureteral catheter ●
Regulation: 21 CFR 876.1500 & 21 CFR 876.4020 & 21 CFR 876.4020
Product Code: OWN, FSC, FCW ●

IV. Description

V. Indications for Use

Upon intravenous administration of ICG (Indocyanine green for injection) consistent with its

{5}------------------------------------------------

approved label, the OPTOVISION provides real-time endoscopic visible and near-infrared fluorescence imaging. The OPTOVISION enables surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the OPTOVISION is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

VI. Comparison of Technological Characteristics with the Predicate Device

The subject device is substantially equivalent to AIM Light Source and SafeLight™ Cable (K192292). The subject device has the same indications for use and technological characteristics as the predicate device. It also has identical specifications as the predicate device in almost all parameters. The imaging mode is a minor difference between the subject and predicate device [AIM Light Source and SafeLight™ Cable (K192292)]. However, these differences do not raise a question in substantial equivalence.

	Subject device	Predicate Device	Comment
Manufacturer	OPTOSURGICAL LLC.	Stryker Endoscopy
Common or Usual Name	Light Source, Illuminator	Light Source, Illuminator
Classification Name	Confocal Optical Imaging	Confocal Optical Imaging
Brand Name	OPTOVISION EndoscopicLight Source Unit	AIM Light Source andSafeLight™ Cable
Model Name	OPSFI2241	L10 & L11
Regulatory Class	II	II
CFR Regulation	21 CFR 876.1500	21 CFR 876.1500
Product Code	OWN	OWN, FSC, FCW
510(k) Number	K243591	K192292
Intended Use	Endoscopic white light andnear-infrared illuminationand imaging duringendoscopic procedures.	Endoscopic white light andnear-infrared illuminationand imaging duringendoscopic procedures.	Same as predicate
Indications for Use	NOTE 1	NOTE 2	Similar to predicateAlthough the predicatedevice includes theadditional intended use oftransilluminating the ureter,the subject device sharesthe same intended use asthe predicate device in usingICG fluorescence imagingfor real-time endoscopicvisible and near-infraredfluorescence imaging ofvessels, blood flow, relatedtissue perfusion, and bileducts.This difference does notraise different questions ofsafety and effectiveness.

	Subject deviceAn electronic driver controls	Predicate DeviceAn electronic driver controls	Comment
Principles of Operation	near-infrared laser diodewhich are combined throughdichroic mirrors andprojected onto an outputlight collimator. A fiberoutput bundle can beinserted into the light sourceto couple light to the distalend and into an endoscope.	Red/Green/Blue LEDs and a Red/Green/Blue LEDs and anear-infrared laser diodewhich are combined throughdichroic mirrors andprojected onto an outputlight collimator. A fiberoutput bundle can beinserted into the light sourceto couple light to the distalend and into an endoscope.	Same as predicate
			Similar to predicate
Components	Light Source UnitLight Guide Cable	Light Source and SafeLightCableCamera SystemLaparoscopesIRIS Ureteral KitImaging Agent	The OPTOVISION consistsof a Light Source Unit andoffers a light guide cable(K111342). This light guidecable is universallymanufactured by a thirdparty, and thus follows thereprocessing proceduresestablished by therespective manufacturer.This difference does notraise different questions ofsafety and effectiveness, asdiscussed above.
Safety Standards	IEC 60601-1IEC 60601-2-18IEC 60601-1-2IEC 62471	IEC 60601-1IEC 60601-2-18IEC 60601-1-2IEC 60825-1	Similar to predicateSafety related toOPTOVISION's light sourcehas been evaluated anddemonstrated in compliancewith IEC 62471.This difference does notraise different questions ofsafety and effectiveness, asdiscussed above.
Light Source / Laser	RGB LEDs	RGB LEDs	Same as predicate
	Infrared Laser	Infrared Laser	Similar to predicate
Infrared Wavelengths	808nm (used for NIRfluorescence)	806nm (used for NIRfluorescence)830nm (used for NIRtransillumination)	Both the 808nm and 806nmwavelengths are used forNIR fluorescence imagingwith ICG, and the differencebetween these wavelengthsis substantially the same interms of the functionalityprovided by the subjectdevice and the predicatedevice.This difference does notraise different questions ofsafety and effectiveness, asdiscussed above.
		Subject device	Predicate Device	Comment
	White Light	ManualAutolight	ManualAutolight	Same as predicate
ImagingMode	NIRFluorescence	NIRખાટFUSION	ENVContrastOverlay	Similar to predicateBoth the subject device andpredicate device passed thebench test criteria accordingto the recognized consensusstandard EN/IEC 60601-1-2.The "NIR" mode of thesubject device is functionallyequivalent to the "Contrast"mode of the predicatedevice, and the "FUSION"mode of the subject deviceis functionally equivalent tothe "Overlay" mode of thepredicate device. While thesubject device does notsupport the "ENV" mode,this does not result in anytechnical differences in theprimary function of providingNIR fluorescence imagingusing ICG between the twodevices.This difference does notraise different questions ofsafety and effectiveness, asdiscussed above.
Light GuideCable	Single-Use/Reusable	Reusable	Reusable	Same as predicate
	Type of Use	Prescription Use	Prescription Use	Same as predicate

{6}------------------------------------------------

{7}------------------------------------------------

NOTE 1: Upon intravenous administration of ICG (Indocyanine green for injection) consistent with its approved label, the OPTOVISION provides real-time endoscopic visible and near-infrared fluorescence imaging. The OPTOVISION enables surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging of billiary ducts with the OPTOVISION is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

NOTE 2: Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLight™ Cable is used with SPY AGENT GREEN to provide real-time endoscopic visible and near-infrared fluorescence imaging. The AlM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic duct, common bile duct and common hepatic duct), using near-infrared imaging.

Fluorescence imaging of biliary ducts with the AIM Light Source and SafeLight Cable is intended for use with standardof-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.

Upon interstitial administration of SPY AGENT GREEN (ICG drug product), the AIM Light Source and SafeLight Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic

{8}------------------------------------------------

vessels and lymph nodes.

The AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

VII. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Testing	Method	Result
Electrical Safety	ES60601-1:2005/(R)2012 & A1:2012C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text)[Incl. AMD2:2021]IEC 60601-2-18: Edition 3.0 2009-08IEC 60601-1-6 Edition 3.2 2020-07CONSOLIDATED VERSION	PASS
Electromagnetic Compatibility(EMC) test	IEC 60601-1-2 Edition 4.1 2020-09CONSOLIDATED VERSION	PASS
Usability	IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATEDVERSION	PASS
Photobiological Safety	IEC 62471 First edition 2006-07	PASS
Software Validation &Verification	IEC 62304 Edition 1.1 2015-06 CONSOLIDATEDVERSION	PASS
Performance - Bench	In accordance with device input specifications	PASS

All conducted tests demonstrated compliance with applicable standards, and no safety concerns were identified.

VIII. Conclusions

Based on the information provided in this premarket notification, OPTOVISION Endoscopic Light Source Unit is substantially equivalent to the predicate device as described herein in safety and effectiveness. The OPTOVISION Endoscopic Light Source Unit has the same intended use and similar indications for use as its predicate device, AIM Light Source and SafeLight™ Cable (K192292). Further, the OPTOVISION Endoscopic Light Source Unit has very similar technological characteristics and principles of operation as its predicate device. AIM Light Source and SafeLight™ Cable (K192292). The minor technological differences between the subject and the predicate devices do not raise different questions of safety or effectiveness. Performance testing of the device has demonstrated that the device performs as intended and thus, is substantially equivalent.

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.