The KARL STORZ Endoscopic ICG System enables surgeons to perform minimally invasive surgery using standard endoscopic visible 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 KARL STORZ Endoscopic ICG System 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.

The KARL STORZ VITOM II ICG System is intended for capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures. The VITOM II ICG System is intended to provide a magnified view of the surgical field in standard white light.

Device Description

The KARL STORZ ICG Imaging System is used to provide real-time high definition (HD) endoscopic or telescope images of visible (VIS) and near-infrared (NIR) indocyanine green (ICG) dye fluorescence during minimally invasive or open surgery. The system components are a HOPKINS ICG/NIR Endoscope and a VITOM II ICG/NIR Telescope for VIS and NIR illumination and imaging, a light source with foot switch for emission of VIS and NIR illumination, a color video camera head capable of capturing both VIS and NIR imaging, and KARL STORZ ICG Kit. Additional accessories used with the KARL STORZ ICG Imaging System include a standard fiber-optic light cable for transmission of VIS and NIR light and the Image1S Camera Control Unit (CCU). All components except for the VITOM II ICG/NIR Telescope were cleared in K152583. The KARL STORZ ICG Imaging System can be used with any medical grade HD monitor with a DVI-D or 3G-SDI input. The VITOM II ICG/NIR Telescope is a Class I device under 21 CFR 878.4700.

AI/ML Overview

The provided text describes a 510(k) submission for the "KARL STORZ ICG Imaging System". This document focuses on demonstrating the substantial equivalence of the new device to previously cleared predicate devices, rather than proving that the device meets specific acceptance criteria through a standalone clinical or "algorithm only" study. Therefore, much of the requested information about acceptance criteria, detailed study design, ground truth establishment, and multi-reader multi-case studies is not present in the provided text.

Specifically, the document states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to assess safety and effectiveness and to establish the substantial equivalence of the modifications."

This indicates that the submission relies on demonstrating comparable performance to predicate devices through non-clinical (bench and animal) testing, rather than establishing specific performance metrics against a predefined acceptance criterion in human clinical data.

However, I can extract information about the non-clinical testing performed and how it aims to demonstrate equivalence, which implicitly serves as the "study" proving the device's acceptable performance in the context of this 510(k).

Here's the information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" in the format of a table with specific metrics (e.g., minimum sensitivity, maximum false positive rate). Instead, the performance is demonstrated by showing that the new system is "as safe as and as effective as" the predicate devices in various non-clinical tests. The reported 'performance' is qualitative: the system "successfully tested for its functions and performance" and "enable a selective visualization of the ICG fluorescence signal."

Category	Acceptance Criteria (Implicit / Demonstrated Equivalence)	Reported Device Performance (Qualitative)
Device Function	The device should function as intended, providing real-time VIS and NIR fluorescence imaging, and selectively visualize ICG fluorescence signal.	"The KARL STORZ ICG Imaging System has been successfully tested for its functions and performance, including verification that the spectral characteristics of the ICG system illumination light source, light transmission system, and telescope enable a selective visualization of the ICG fluorescence signal as detected by the camera system."
Key Performance Aspects	Parameters such as UV Exposure, Color Reproduction, Irradiance Levels, Depth Dependency, and Visualization of ICG Signal should be comparable to predicate devices.	Comparative testing was conducted for: • UV Exposure • Color Reproduction • Irradiance Levels • Depth Dependency • Visualization of ICG Signal While specific quantitative results are not provided, the conclusion states that these tests "demonstrated that the subject device is as safe as and as effective as the primary predicate device," implying satisfactory performance on these aspects.
Biocompatibility	Should not change from the previously cleared system.	"The addition of the VITOM II ICG Telescope to the system does not change the biocompatibility... conducted for the KARL STORZ Endoscopic ICG System cleared in K152583."
Electromagnetic Compatibility (EMC)	Should not change from the previously cleared system.	"The addition of the VITOM II ICG Telescope to the system does not change the ... electromagnetic compatibility... conducted for the KARL STORZ Endoscopic ICG System cleared in K152583."
Electrical Safety	Should not change from the previously cleared system.	"The addition of the VITOM II ICG Telescope to the system does not change the ... electrical safety... conducted for the KARL STORZ Endoscopic ICG System cleared in K152583."
Software Validations	Should not change from the previously cleared system.	"The addition of the VITOM II ICG Telescope to the system does not change the ... software validations conducted for the KARL STORZ Endoscopic ICG System cleared in K152583."
Cleaning & Sterilization	Validation for the new component (VITOM II ICG Telescope) is required.	"Cleaning method validation and sterilization validation were performed on the VITOM II ICG Telescope."
Animal Study Performance	Performance in animal model should be adequate for evaluation.	"a GLP animal study was successfully performed by the NAMSA testing facility to evaluate the performance of the KARL STORZ ICG Imaging System with the VITOM II ICG Telescope in the porcine open surgery laparoscopy model."
Compliance with Standards	Device must meet relevant safety standards.	The device (and its predicates) are listed as meeting IEC 60601-1-2 and IEC 60601-1. The Visionsense predicate also met IEC 60825-1. "Bench testing was performed per IEC 62471."

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

Sample Size: Not explicitly stated with numerical values. The document refers to "comparative testing" and a "GLP animal study" without specifying the number of samples or animals used.
Data Provenance:
- Bench Testing: Conducted in-house or by testing laboratories (e.g., "NAMSA testing facility"). The country of origin is not specified but implied to be within the scope of FDA regulations (likely USA or a country with recognized testing standards).
- Animal Study: Performed by "NAMSA testing facility" using a "porcine open surgery laparoscopy model."
- Retrospective/Prospective: All described tests are non-clinical and would be conducted prospectively as part of the device development and submission process.

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

Not applicable. This was a non-clinical study for substantial equivalence. The "ground truth" was based on the physical and optical properties of the device and its ability to visualize ICG fluorescence as measured by established testing methods and verified by the testing facility. There's no mention of human experts establishing "ground truth" in the diagnostic sense for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This was a non-clinical study. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical imaging studies involving multiple human readers.

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

Not applicable. No MRMC study was performed as this was a 510(k) submission based on non-clinical substantial equivalence. The device is an imaging system, not an AI-powered diagnostic tool, and the submission explicitly states "Clinical testing was not required."

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

This concept doesn't directly apply here. The device itself is an integrated imaging system (camera, endoscope/telescope, light source). Its "standalone performance" is demonstrated through its physical and optical characteristics (e.g., light transmission, spectral characteristics, visualization of ICG signal) as measured in bench and animal studies, rather than an "algorithm."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests would have been based on:

Physical measurements and optical properties: For tests like "spectral characteristics," "irradiance levels," and "depth dependency," the ground truth is derived from established physics principles and calibrated measurement equipment.
Known ICG fluorescence: For "visualization of ICG signal," the ground truth is the known presence and location of the fluorescent dye.
Biological outcomes (animal model): In the GLP animal study, the "performance" would have been evaluated based on the ability of the system to correctly visualize blood flow/perfusion and biliary ducts as expected in the porcine model, potentially against direct observation or other validated methods if used in the study.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a "training set."

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

Not applicable, as this is not an AI/machine learning device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three profiles of human faces incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 26, 2017

Karl Storz Endoscopy-America, Inc. Annalisa Smullin Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, CA 90245

Re: K162882

Trade/Device Name: Karl Storz ICG Imaging System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: OWN Dated: December 13, 2016 Received: December 14, 2016

Dear Annalisa Smullin,

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Charles Viviano -S

For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162882

Device Name KARL STORZ ICG Imaging System

Indications for Use (Describe)

The KARL STORZ ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging.

The KARL STORZ Endoscopic ICG System enables surgeons to perform minimally invasive surgery using standard endoscopic visible 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 KARL STORZ Endoscopic ICG System 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.

The KARL STORZ VITOM II ICG System is intended for capturing fluorescent mages for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures. The VITOM II ICG System is intended to provide a magnified view of the surgical field in standard white light.

CONTINUE ON A SEPARATE PAGE IF NEEDED.
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
Type of Use (Select one or both, as applicable)

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Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font.

510(k) Summary

This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.

Submitter:	KARL STORZ Endoscopy-America, Inc.2151 E. Grand AvenueEI Segundo, CA 90245		KARL STORZICG ImagingSystem	KARL STORZEndoscopic ICGSystem	VisionsenseVS3-IR System
Contact:	AnnaLisa SmullinRegulatory Affairs SpecialistPhone: (424) 218-8376Fax: (424) 218-8519		(Proposed)	(K152583)	(K152204)
Date ofPreparation:	December 13, 2016	Manufacturer	KARL STORZEndoscopy	KARL STORZEndoscopy	Visionsense Ltd.
Type of 510(k)Submission:	Traditional	SystemComponents	• Camera head• Endoscope /Telescope• External lightsource (viafiber optic lightcable)	• Camera head• Endoscope• External lightsource (viafiber opticlight cable)	• Camera head• Endoscope/Telescope• External lightsource (viafiber opticlight cable)
DeviceIdentification:	Trade Name: KARL STORZ ICG Imaging SystemClassification Name: Confocal Optical Imaging	Anatomical Sites	General surgicalsites, majorextra-hepaticbile ducts,general tissueand free flaps	General surgicalsites, majorextra-hepaticbile ducts	General surgicalsites, brain,spine, shoulder,knee, generaltissue and freeflaps
Regulatory Class:	II	Sterilization	Steam Autoclave	Steam Autoclave	Steam Autoclave
Product Code:	OWN	Focal Distance ofTelescope	VIS: 25-75 cmNIR: 20-30 cm	N/A	VIS & NIR: 20-40cm
Regulation:	21 CFR part 876.1500 (Endoscope and Accessories)	Imaging Agent	IR Fluorescencedye (i.e.indocyaninegreen-ICG)	IR Fluorescencedye (i.e.indocyaninegreen-ICG)	IR Fluorescencedye (i.e.indocyaninegreen-ICG)
PredicateDevice(s):	Primary Predicate Device: KARL STORZ Endoscopic ICG System(K152583)	Imaging Head	Silicon ImageSensor in thecamera	Silicon ImageSensor in thecamera	Silicon ImageSensor in thecamera
	Second Predicate Device: Visionsense VS3-IR System (K152204)	Light Source	Xenon Lamp	Xenon Lamp	Infrared Laser
	These predicate devices have not been subject to a design-relatedrecall.	Imaging	Fluorescent andWhite LightImaging	Fluorescent andWhite LightImaging	Fluorescent andWhite LightImaging
Device Description:	The KARL STORZ ICG Imaging System is used to provide real-timehigh definition (HD) endoscopic or telescope images of visible(VIS) and near-infrared (NIR) indocyanine green (ICG) dyefluorescence during minimally invasive or open surgery. Thesystem components are a HOPKINS ICG/NIR Endoscope and aVITOM II ICG/NIR Telescope for VIS and NIR illumination andimaging, a light source with foot switch for emission of VIS andNIR illumination, a color video camera head capable of capturingboth VIS and NIR imaging, and KARL STORZ ICG Kit. Additionalaccessories used with the KARL STORZ ICG Imaging System	Display bothVisible and IRImages	Yes	Yes	Yes (Overlay)
	include a standard fiber-optic light cable for transmission of VISand NIR light and the Image1S Camera Control Unit (CCU). Allcomponents except for the VITOM II ICG/NIR Telescope werecleared in K152583. The KARL STORZ ICG Imaging System can beused with any medical grade HD monitor with a DVI-D or 3G-SDIinput. The VITOM II ICG/NIR Telescope is a Class I device under21 CFR 878.4700.	Standards Met	IEC 60601-1-2IEC 60601-1	IEC 60601-1-2IEC 60601-1	IEC 60601-1-2IEC 60601-1IEC 60825-1
Intended Use:	The KARL STORZ ICG Imaging System is intended to provide real-time visible and near-infrared fluorescence imaging.
Indications ForUse:	The KARL STORZ ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging.
	The KARL STORZ Endoscopic ICG System enables surgeons toperform minimally invasive surgery using standard endoscopicvisible light as well as visual assessment of vessels, blood flow andrelated tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and commonhepatic duct), using near infrared imaging. Fluorescence imagingof biliary ducts with the KARL STORZ Endoscopic ICG System 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.The KARL STORZ VITOM II ICG System is intended for capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures. The VITOM II ICG System is intended to provide a magnified view of the surgical field in standard white light.
TechnologicalCharacteristics:	The KARL STORZ ICG Imaging System is substantially equivalentto the KARL STORZ Endoscopic ICG System (K152583) and theVisionsense VS3-IR System (K152204) in terms of its indicationsfor use, design technology, and performance specifications.The main difference between the subject and the primarypredicate device is that the subject device includes a VITOM IIICG/NIR Telescope whereas the primary predicate device onlyconsists of an endoscope. The secondary predicate device was chosen as it includes a telescope with its ICG Imaging System.

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Image /page/4/Picture/0 description: The image contains the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font.

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Image /page/5/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The word "STORZ" is written in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are written in smaller, blue letters.

Bench and comparative testing were used to demonstrate substantial equivalence to the primary and secondary predicate devices. Therefore, the differences between the subject device and the predicate device do not raise any new issues of safety and effectiveness.

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Image /page/6/Picture/0 description: The image shows the logo for STORZ. The word "STORZ" is in large, bold, blue letters. Below that, in smaller blue letters, is the phrase "KARL STORZ - ENDOSKOPE".

Non-ClinicalPerformance Data:	The KARL STORZ ICG Imaging System has been successfully testedfor its functions and performance, including verification that thespectral characteristics of the ICG system illumination lightsource, light transmission system, and telescope enable a selectivevisualization of the ICG fluorescence signal as detected by thecamera system.The following comparative testing was conducted for the subjectdevice:• UV Exposure• Color Reproduction• Irradiance Levels• Depth Dependency• Visualization of ICG SignalFurthermore, a GLP animal study was successfully performed bythe NAMSA testing facility to evaluate the performance of theKARL STORZ ICG Imaging System with the VITOM II ICG Telescopein the porcine open surgery laparoscopy model.The addition of the VITOM II ICG Telescope to the system does notchange the biocompatibility, electromagnetic compatibility,electrical safety, or software validations conducted for the KARLSTORZ Endoscopic ICG System cleared in K152583. Cleaningmethod validation and sterilization validation were performed onthe VITOM II ICG Telescope. Bench testing was performed per IEC62471.
ClinicalPerformance Data:	Clinical testing was not required to demonstrate the substantialequivalence to the predicate devices. Non-clinical bench testingwas sufficient to assess safety and effectiveness and to establishthe substantial equivalence of the modifications.
Conclusion:	The conclusions drawn from the non-clinical tests such as thesterilization data, the bench top performance data, and the animalstudy performance data, demonstrated that the subject device isas safe as and as effective as the primary predicate device. Assuch, we concluded that the substantial equivalence of the subjectand the predicate devices has been met, and the differencesbetween the subject and the predicate devices do not raise newquestions of safety and effectiveness.

Non-ClinicalPerformance Data:

The KARL STORZ ICG Imaging System has been successfully testedfor its functions and performance, including verification that thespectral characteristics of the ICG system illumination lightsource, light transmission system, and telescope enable a selectivevisualization of the ICG fluorescence signal as detected by thecamera system.The following comparative testing was conducted for the subjectdevice:• UV Exposure• Color Reproduction• Irradiance Levels• Depth Dependency• Visualization of ICG SignalFurthermore, a GLP animal study was successfully performed bythe NAMSA testing facility to evaluate the performance of theKARL STORZ ICG Imaging System with the VITOM II ICG Telescopein the porcine open surgery laparoscopy model.The addition of the VITOM II ICG Telescope to the system does notchange the biocompatibility, electromagnetic compatibility,electrical safety, or software validations conducted for the KARLSTORZ Endoscopic ICG System cleared in K152583. Cleaningmethod validation and sterilization validation were performed onthe VITOM II ICG Telescope. Bench testing was performed per IEC62471.

ClinicalPerformance Data:

Clinical testing was not required to demonstrate the substantialequivalence to the predicate devices. Non-clinical bench testingwas sufficient to assess safety and effectiveness and to establishthe substantial equivalence of the modifications.

Conclusion:

The conclusions drawn from the non-clinical tests such as thesterilization data, the bench top performance data, and the animalstudy performance data, demonstrated that the subject device isas safe as and as effective as the primary predicate device. Assuch, we concluded that the substantial equivalence of the subjectand the predicate devices has been met, and the differencesbetween the subject and the predicate devices do not raise newquestions of safety and effectiveness.

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.