-OLYMPUS URF-V3/V3R: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter and kidney.
-OLYMPUS URF-P7/P7R: This instrument has been designed to be used with an Olympus light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct).

Device Description

URF-V3 and URF-V3R have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter and kidney. This endoscope is a videoscope, composed of flexible insertion tube, control section, light guide connector and video connector, and equipped CCD for image transfer system. The difference between URF-V3 and URF-V3R is angle overation direction. The bending section of the URF-V3R moves towards the direction oppositely to that of the URF-V3.

URF-P7 and URF-P7R have been designed to be used with an Olympus light source, documentation equipment. Monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct). This endoscope is a fiberscope, composed of flexible insertion tube, control section and eyepiece section, and equipped light fiber bundle for image transfer system. Besides, it has eyepiece frame on eyepiece section for directly visual observation or video camera connection. The difference between URF-P7 and URF-P7R is angle operation direction. The bending section of the URF-P7R moves towards the direction oppositely to that of the URF-P7.

AI/ML Overview

The provided text is a 510(k) Pre-market Notification for medical devices, specifically uretero-reno videoscopes and fiberscopes. It outlines the company's claim of "substantial equivalence" of these new devices (OLYMPUS URF-V3/V3R and URF-P7/P7R) to previously cleared predicate devices (OLYMPUS URF-V2/V2R and URF-P6/P6R).

However, the document does not contain information about a study proving that an AI-powered device meets specific acceptance criteria related to a diagnostic or treatment outcome. Instead, it focuses on the engineering and safety aspects for a medical device being cleared through the 510(k) pathway, which primarily demonstrates that a new device is as safe and effective as a legally marketed predicate device.

Therefore, I cannot extract the information required to answer your request about acceptance criteria and a study proving an AI device's performance against specific clinical metrics, because this document does not describe such a study.

The closest information provided related to "testing" or "studies" are:

Non-clinical testing: This includes reprocessing instruction validation, biocompatibility testing, software verification and validation (including cybersecurity), electrical safety, electromagnetic compatibility (EMC), and performance testing. These are engineering and safety tests, not clinical performance studies measuring diagnostic accuracy or treatment effectiveness.
Risk analysis: Stated as carried out in accordance with ISO 14971:2007, and design verification tests and their acceptance criteria were identified and performed as a result of this. Again, this points to product design and safety, not clinical performance metrics for an AI.

In summary, none of the requested information regarding an AI device's performance study (acceptance criteria as specific performance metrics, sample sizes for test/training sets, expert ground truth establishment, MRMC study, standalone performance, etc.) is present in this 510(k) notification.

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, 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.

January 16, 2019

Olympus Medical Systems Corp. % Sheri L. Musgnung Regulatory Affairs Manager Olympus Surgical Technologies America 3500 Corporate Parkway P.O. Box 610 Center Valley, PA 18034-0610

Re: K181451

Trade/Device Name: OLYMPUS URF-V3/V3R, OLYMPUS URF-P7/P7R Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB, NWB Dated: December 5, 2018 Received: December 6, 2018

Dear Sheri L. Musgnung:

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 mav, 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 avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark R. Kreitz -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) K181451

Device Name OLYMPUS URF-V3/V3R, OLYMPUS URF-P7/P7R

Indications for Use (Describe) -OLYMPUS URF-V3/V3R

This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter and kidney.

-OLYMPUS URF-P7/P7R

This instrument has been designed to be used with an Olympus light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct).

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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

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May 31, 2018

Section 5 510(k) Summary

5.1 GENERAL INFORMATION

Applicant: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047
Official Sheri L. Musgnung Correspondent: Olympus Surgical Technologies America 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-3147 Fax: 484-896-7128 Email: sheri.musgnung@olympus.com
. Manufacturer Aizu Olympus Co., Ltd., 500 Muranishi, Niidera, Monden-machi, Aizuwakamatsu-shi, Fukushima 965-8520, Japan Establishment Registration No .: 9610595

5.2 DEVICE IDENTIFICATION

URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R

Device Name OLYMPUS URF-V3/V3R
URETERO-RENO VIDEOSCOPE ■ Common Name
Regulation Number 876.1500
Regulation Name Endoscope and Accessories
Regulatory Class II
Product Code FGB (Ureteroscope And Accessories, Flexible/Rigid) NWB (Endoscope, accessories, narrow band spectrum) ■ Classification Panel Gastroenterology and urology

Section 5 510(k) Summary Page 1 of 9

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URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R

OLYMPUS URF-P7/P7R Device Name
Common Name URETERO-RENO FIBERSCOPE
Regulation Number 876.1500
Regulation Name Endoscope and Accessories
Regulatory Class II
Product Code FGB (Ureteroscope And Accessories, Flexible/Rigid) FBN (Choledochoscope And Accessories, Flexible/Rigid) ■ Classification Panel Gastroenterology and urology

5.3 PREDICATE DEVICE

URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R

Table 5-1 Predicate device

Device name	510(k) Submitter	510(k) No.
OLYMPUS URF-V2/V2R	OLYMPUS MEDICAL SYSTEMS CORP.	K172246

URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R

Table 5-2 Predicate device

Device name	510(k) Submitter	510(k) No.
OLYMPUS URF-P6/P6R	OLYMPUS MEDICAL SYSTEMS CORP.	K172298

5.4 DEVICE DESCRIPTION

URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R

This endoscope is a videoscope, composed of flexible insertion tube, control section, light guide connector and video connector, and equipped CCD for image transfer system. The difference between URF-V3 and URF-V3R is angle overation direction. The bending section of the URF-V3R moves towards the direction oppositely to that of the URF-V3.

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Image /page/5/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are closely spaced together, creating a solid block of text. A registered trademark symbol is present to the right of the word. The background is white.

URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R

This endoscope is a fiberscope, composed of flexible insertion tube, control section and eyepiece section, and equipped light fiber bundle for image transfer system. Besides, it has eyepiece frame on eyepiece section for directly visual observation or video camera connection.

The difference between URF-P7 and URF-P7R is angle operation direction. The bending section of the URF-P7R moves towards the direction oppositely to that of the URF-P7.

5.5 INDICATIONS FOR USE

URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R

URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R

5.6 COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE

The URF-V3/V3R and URF-P7/P7R have the same technological characteristics and design as their predicate devices except for the following main features:

Improvement of passive bending section in the insertion section.
Addition of compatible sterilization methods.

Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety or effectiveness of the subject device.

All other technological characteristics of both the subject and predicate devices are identical.

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A side by side comparison of the subject devices and the predicate devices is provided below.

Item	OLYMPUS URF-V3/V3R	OLYMPUS URF-V2/V2R(K172246)
Indications for use	This instrument has beendesigned to be used with anOlympus video system center,light source, documentationequipment, monitor,EndoTherapy accessories, andother ancillary equipment forendoscopic diagnosis andtreatment within the ureter andkidney.	This instrument has beendesigned to be used with anOlympus video system center,light source, documentationequipment, monitor,EndoTherapy accessories, andother ancillary equipment forendoscopic diagnosis andtreatment within the ureter andkidney.
Common name	URETERO-RENOVIDEOSCOPE	URETERO-RENOVIDEOSCOPE
Regulation number	876.1500	876.1500
Regulation name	Endoscope and Accessories	Endoscope and Accessories
Regulatory class	II	II
Classification panel	Gastroenterology and urology	Gastroenterology and urology
Product code	FGB, NWB	FGB, NWB
Environment of use	Healthcare facility/hospital	Healthcare facility/hospital
Single/repeat use	Repeat use	Repeat use
Sterile/non-sterile	Marketed as non-sterile	Marketed as non-sterile
Sterilization method	Ethylene oxide;Hydrogen peroxide includingV-PRO maX and STERRADNX/100NX (with or withoutALLClear Technology).	Ethylene oxide;Hydrogen peroxide includingSTERRAD NX/100NX.
Energy source	Electricity	Electricity

Table 5-3 Comparison of URF-V3/V3R and their predicate devices.

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Traditional 510(k) Notification URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R

Item	OLYMPUS URF-V3/V3R	OLYMPUS URF-V2/V2R(K172246)
Materialcomposition ofmainpatient-contact parts	Material composition of mainpatient-contact parts	Material composition of mainpatient-contact parts
mainpatient-contact partsand duration andtype of contact	Distal end: Stainless steelInsertion tube: Fluoro resinBending section rubber: FluororubberLens: GlassGlue: Epoxy glue	Distal end: Stainless steelInsertion tube: Fluoro resinBending section rubber: FluororubberLens: GlassGlue: Epoxy glue
	Surface-contacting device incontact with mucosalmembranes. The contactduration is limited exposure(i.e. contact is up to 24 hours).	Surface-contacting device incontact with mucosalmembranes. The contactduration is limited exposure (i.e.contact is up to 24 hours).

Table 5-4 Comparison of URF-P7/P7R and their predicate devices

Item	OLYMPUS URF-P7/P7R	OLYMPUS URF-P6/P6R(K172298)
Indications for use	This instrument has beendesigned to be used with anOlympus light source,documentation equipment,monitor, EndoTherapyaccessories, and other ancillaryequipment for endoscopicdiagnosis and treatment withinthe ureter, kidney and biliarytract (common bile duct andhepatic duct).	This instrument has beendesigned to be used with anOlympus light source,documentation equipment,monitor, EndoTherapyaccessories, and other ancillaryequipment for endoscopicdiagnosis and treatment withinthe ureter, kidney and biliarytract (common bile duct andhepatic duct).
Common name	URETERO-RENOFIBERSCOPE	URETERO-RENOFIBERSCOPE
Regulation number	876.1500	876.1500
Regulation name	Endoscope and Accessories	Endoscope and Accessories
Regulatory class	II	II
Classification panel	Gastroenterology and urology	Gastroenterology and urology
Product code	FGB, FBN	FBN, FGB
Environment of use	Healthcare facility/hospital	Healthcare facility/hospital

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Traditional 510(k) Notification ETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R RETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R

Item	OLYMPUS URF-P7/P7R	OLYMPUS URF-P6/P6R(K172298)
Single/repeat use	Repeat use	Repeat use
Sterile/non-sterile	Marketed as non-sterile	Marketed as non-sterile
Sterilization method	Ethylene oxide; Hydrogenperoxide including V-PROmaX and STERRADNX/100NX.	Ethylene oxide; Hydrogenperoxide including STERRADNX/100NX.
Energy source	Electricity	Electricity
Material compositionof mainpatient-contact partsand duration and typeof contact	Material composition of mainpatient-contact partsDistal end: PolysulfoneInsertion tube: Fluoro resinBending section rubber: FluororubberLens: GlassGlue: Epoxy glueSurface-contacting device incontact with mucosalmembranes. The contactduration is limited exposure(i.e. contact is up to 24 hours).	Material composition of mainpatient-contact partsDistal end: PolysulfoneInsertion tube: Fluoro resinBending section rubber: FluororubberLens: GlassGlue: Epoxy glueSurface-contacting device incontact with mucosalmembranes. The contactduration is limited exposure(i.e. contact is up to 24 hours).

5.7 Summary of non-clinical testing

The technological characteristic differences between the predicate devices and the subject devices have been confirmed that they are substantially equivalent through the following tests and standards.

·Reprocessing instruction and reprocessing method validation testing for the URF-V3/V3R and, URF-P7/P7R were assessed and documentation was provided as recommended by Guidance for Industry and Food and Drug Administration Staff, "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling".
· Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" issued on June 16 2016.

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standards for electrical safety.

K181451 Page 7 of 9

•Software verification and validation testing including the requirement of cybersecurity for the URF-V3/V3R were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
· Electrical safety and electromagnetic compatibility (EMC) Electrical safety and EMC were assessed for the URF-V3/V3R. The system complies with the ANSI/AAMI ES 60601-1:2005/A2:2010/(R) 2012 and IEC 60601-2-18:2009 standards for electrical safety and the IEC 60601-1-2:2014 standards for EMC. Electrical safety was assessed for the URF-P7/P7R The system complies with the ANSI/AAMI ES 60601-1:2005/A2:2010/(R) 2012 and IEC 60601-2-18:2009
·Performance testing was carried out to verify the safety and the effectiveness of the subject device.
·Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.

The results of the above performance testing demonstrated that the subject devices have no concerns on safety and effectiveness.

· The following standards have been applied to the URETERO-RENO VIDEOSCOPES

Standard number	Standard Title
ISO 10993-1 FourthEdition:2009-10-15	Biological Evaluation Of Medical Devices - Part1:Evaluation And Testing Within A Risk ManagementProcess [Including: Technical Corrigendum 1 (2010)]
	ISO 10993-5 ThirdEdition:2009-06-01
ISO 10993-7 SecondEdition:2008-10-15
	ISO 10993-10 Third Edition:2010-08-01

Table 5.3 Standards for URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R

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Image /page/10/Picture/1 description: The image contains the word "OLYMPUS" in large, bold, blue letters. The word is positioned at the top of the image. There is a thin, horizontal, yellow bar located underneath the word.

Traditional 510(k) Notification URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R

ISO 14971 SecondEdition:2007-03-01	Medical Device-Application Of Risk Management ToMedical Device
AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012,	C1:2009/(R)2012 And A2:2010/(R)2012 (ConsolidatedText) Medical Electrical Equipment - Part 1: GeneralRequirements For Basic Safety And EssentialPerformance (IEC 60601-1:2005, MOD)
IEC 60601-1-2 Edition 4:2014-02	Medical Electrical Equipment - Part 1-2: GeneralRequirements For Basic Safety And EssentialPerformance - Collateral Standard: ElectromagneticCompatibility - Requirements And Tests
IEC 60601-2-18 Edition 3.0:2009-08	Medical Electrical Equipment - Part 2-18: ParticularRequirements For The Basic Safety And EssentialPerformance Of Endoscopic Equipment
ISO 11135 SecondEdition:2014	Sterilization Of Health-Care Products EthyleneOxide-Requirements For The Development, ValidationAnd Routine Control Of A Sterilization Process ForMedical Devices

·The following standards have been applied to the URETERO-RENO VIDEOSCOPE

Standard number	Standard Title
ISO 10993-1 FourthEdition:2009-10-15	Biological Evaluation Of Medical Devices - Part1:Evaluation And Testing Within A Risk ManagementProcess [Including: Technical Corrigendum 1 (2010)]
ISO 10993-5 ThirdEdition:2009-06-01	Biological Evaluation Of Medical Devices – Part5: TestsFor In Vitro Cytotoxicity
ISO 10993-7 SecondEdition:2008-10-15	Biological Evaluation Of Medical Devices - Part 7:Ethylene Oxide Sterilization
ISO 10993-10 Third Edition:2010-08-01	Biological Evaluation Of Medical Devices - Part10: Tests For Irritation And Skin Sensitization
ISO 14971 SecondEdition:2007-03-01	Medical Device-Application Of Risk Management ToMedical Device
AAMI ANSI ES60601-1:	C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated

Table 5.4 Standards for URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R

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Traditional 510(k) Notification URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R

2005/(R)2012 and A1:2012,	Text) Medical Electrical Equipment - Part 1: GeneralRequirements For Basic Safety And EssentialPerformance (IEC 60601-1:2005, MOD)
IEC 60601-2-18 Edition 3.0:2009-08	Medical Electrical Equipment - Part 2-18: ParticularRequirements For The Basic Safety And EssentialPerformance Of Endoscopic Equipment
ISO 11135 SecondEdition:2014	Sterilization Of Health-Care Products EthyleneOxide-Requirements For The Development, ValidationAnd Routine Control Of A Sterilization Process ForMedical Devices

5.8 CONCLUSIONS

Based on the intended use and technological comparison to the predicate devices, the subject devices OLYMPUS URF-V3/V3R and OLYMPUS URF-P7/P7R are demonstrated to raise no new issue of safety and effectiveness and are substantially equivalent to their predicate devices in terms 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.