The Single-use Video Pancreaticobiliary Scope is used in combination with the PB digital controller, which is designed to provide imaging for the diagnosis and treatment application of endoscopic surgery process of pancreatic biliary system, and provide working channel for other diagnosis and treatment accessories.

The PB Digital Controller can be used together with the Single-use Video Pancreaticobiliary Scope of Micro-Tech to process the image collected by the scope and transmit it to the display.

Device Description

Pancreaticobiliary Video System consists of:

Single-Use Video Pancreaticobiliary Scope:

CDS11001
CDS11002
CDS11003
CDS11004
CDS11005
CDS22001 ●
CDS22002
CDS22003
CDS22004
CDS22005

PB Digital Controller:

BS-W-100

The Single-Use Video Pancreaticobiliary Scope is a sterile single use flexible scope and PB Digital Controller is a reusable device.

The Single-Use Video Pancreaticobiliary Scope has the following physical and performance characteristics:

Maneuverable tip controlled by the user
Insertion port
Suction port
Camera at the distal tip and LED light source in the handle of the pancreaticobiliary scope

The light emitted by the cold light source located in the handle is transmitted to the distal end of the pancreaticobiliary scope through the glass fiber, and irradiates the human tissue from the distal end. CMOS and glass fiber are located at the same position at the distal end. CMOS transmits the collected image information to the PB Digital Controller through cable, and the PB Digital Controller displays the image on the display after processing.

CMOS and optical components are identical for all specifications of products.

Working channel port
Lever which can lock the control

The Single-Use Video Pancreaticobiliary Scope have different size as follows:

Maximum insertion portion width
Effective working length
Minimum accessories channel width

The PB Digital Controller has the following physical and performance characteristics:

Displays the image from The Single-Use Video Pancreaticobiliary Scope on the screen
Can record screenshots or video of image from the Single-Use Video Pancreaticobiliary Scope
Can connect to an external monitor
Reusable device

AI/ML Overview

The provided text describes a 510(k) summary for the Micro-Tech (Nanjing) Co., Ltd.'s Single-use Video Pancreaticobiliary Scope and PB Digital Controller. This is a premarket notification for a medical device seeking substantial equivalence to existing devices, not a study proving an AI device meets acceptance criteria.

The document discusses bench testing to demonstrate the performance of the proposed device against a predicate, but it does not involve an AI device or a study structured to prove an AI's performance against specific acceptance criteria, including human expert evaluation.

Therefore, I cannot extract the information required by your prompt, such as acceptance criteria for an AI device, sample sizes for AI test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, or training set details.

The relevant sections of the document explicitly state:

"No animal study is included in this submission."
"No clinical study is included in this submission."

This indicates that clinical (human) performance data, which would be crucial for evaluating an AI device's effectiveness, was not part of this submission for market clearance. The "Performance Data" section (page 10-11) lists a series of bench tests for physical and electrical characteristics of the scope and controller, not for an AI algorithm.

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). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

February 16, 2023

Micro-Tech (Nanjing) Co., Ltd Sally He RA Engineer No. 10 Gaoke Third Road Nanjing National Hi-tech Industrial Development Zone Nanjing, Jiangsu 210032 CHINA

Re: K221784

Trade/Device Name: Single-use Video Pancreaticobiliary Scope, PB Digital Controller Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FBN, NTN, KQM Dated: August 26, 2022 Received: January 17, 2023

Dear Sally He:

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. 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 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.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 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 https://www.fda.gov/medical-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-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-devices/device-advicecomprehensive-regulatory-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.

Shanil P. Haugen -S

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known)

K221784

Device Name Pancreaticobiliary Video System

Indications for Use (Describe)

The Pancreaticobiliary Video System consists of PB Digital Controller and Single-use Video Pancreaticobiliary Scope.

The PB Digital Controller can be used together with the Single-use Video Pancreaticobiliary Scope of Micro-Tech to process the image collected by the scope and transmit it to the display.

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.

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Image /page/3/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be made of solid blocks, giving them a bold and modern look. A registered trademark symbol (®) is positioned in the upper right corner of the logo. The logo is simple, clean, and easily recognizable.

510K Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K221784

1. Date of Preparation: 2023-02-08

2. Sponsor Identification

Micro-Tech (Nanjing) Co., Ltd.

No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone, Nanjing, Jiangsu Province, PRC

Establishment Registration Number: 3004837686

Contact Person: Sally He

Position: RA Engineer

Tel: +86-25-58646395

Fax: +86-25-58350006

Email: RA.Micro-Tech@outlook.com

3. Identification of Proposed Device

Trade Name: Single-use Video Pancreaticobiliary Scope, PB Digital Controller

Common Name: Pancreaticobiliary Video System

Regulatory Information

Device Classification Name: Endoscope and accessories

Classification regulation: 876.1500(FBN, NTN, FET), 874.4160(KQM)

Class and Review Panel: Class II, Gastroenterology/Urology (FBN, NTN, FET)

Class I, General and plastic surgery (KQM)

Product code: FBN, KQM, NTN, FET

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Image /page/4/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, blocky font. The letters are interconnected and have a three-dimensional appearance, suggesting depth and solidity. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.

4. Identification of Predicate Device and Reference Device

Predicate Device:

510(k) Number: K142922

Product Name: SpyGlass DS Direct Visualization System

Manufacturer: Boston Scientific Corporation.

Reference Device:

510(k) Number: K200483

Product Name: SpyGlass Discover Digital System

Manufacturer: Boston Scientific Corporation.

5. Indications for Use

The Pancreaticobiliary Video System consists of PB Digital Controller and Single-use Video Pancreaticobiliary Scope.

The Single-use Video Pancreaticobiliary Scope is used in combination with the PB Digital Controller, which is designed to provide imaging for the diagnosis and treatment application of endoscopic surgery process of pancreatic biliary system, and provide working channel for other diagnosis and treatment accessories.

The PB Digital Controller can be used together with the Single-use Video Pancreaticobiliary Scope of Micro-Tech to process the image collected by the scope and transmit it to the display.

Device Description 6.

Pancreaticobiliary Video System consists of:

Single-Use Video Pancreaticobiliary Scope:

CDS11001
CDS11002
CDS11003
CDS11004
CDS11005

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Image /page/5/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be made of solid blocks. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo. The logo has a clean and modern design.

CDS22001 ●
CDS22002
CDS22003
CDS22004
CDS22005

PB Digital Controller:

BS-W-100
The Single-Use Video Pancreaticobiliary Scope is a sterile single use flexible scope and PB Digital Controller is a reusable device.

The Single-Use Video Pancreaticobiliary Scope has the following physical and performance characteristics:

Maneuverable tip controlled by the user
Insertion port
Suction port
Camera at the distal tip and LED light source in the handle of the pancreaticobiliary scope

CMOS and optical components are identical for all specifications of products.

Working channel port
Lever which can lock the control

The Single-Use Video Pancreaticobiliary Scope have different size as follows:

Maximum insertion portion width
Effective working length
Minimum accessories channel width

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Image /page/6/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be made of solid blocks. A registered trademark symbol (®) is located in the upper right corner of the logo.

The PB Digital Controller has the following physical and performance characteristics:

Displays the image from The Single-Use Video Pancreaticobiliary Scope on the screen
Can record screenshots or video of image from the Single-Use Video Pancreaticobiliary Scope
Can connect to an external monitor
Reusable device

7. Comparison of Technological Characteristics

The Pancreaticobiliary Video System substantially equivalent device materials, design, configuration,

sterilization process and intended use as those featured in the predicate device SpyGlass DS Direct

Visualization System (K142922) and SpyGlass Discover Digital System (K200483).

Comparison to Predicate Device and Reference Device:

Table 1 Substantial Equivalence Comparison between Proposed Single-Use Video Pancreaticobiliary

	Proposed Device	Predicated Device	Reference Device
Characteristics	Single-UseVideoPancreaticobiliary Scope	SpyGlass DS Accessand Delivery Catheter(K142922)	SpyGlass DiscoverDigital Catheter(K200483)	Remark
Product Code	FBN, KQM, NTN	FBN, KQM, NTN	FBM,KQM, NTN	Same
Class	II	II	II	Same
RegulationDescription	Pancreaticobiliary Scope(flexible or rigid) andaccessories	Pancreaticobiliary Scope(flexible or rigid) andaccessories	PancreaticobiliaryScope (flexible or rigid)and accessories	Same
Regulationnumber	21 CFR 876.1500	21 CFR 876.1500	21 CFR 876.1500	Same
IlluminationSource	LED	LED	LED	Same
IndicationforUse	The Single-use VideoPancreaticobiliary Scopeis used in combinationwith the PB DigitalController, which isdesigned to provideimaging for the diagnosisand treatment applicationof endoscopic surgeryprocess of pancreaticbiliary system, and	Intended to providedirect visualization andto guide both optical andaccessory devices fordiagnostic andtherapeutic applicationsduring endoscopicprocedures in thepancreatico-biliarysystem including thehepatic ducts.	The Spyglass DiscoverDigital Catheter isintended to providedirect visualization andto guide both optical andaccessory devices fordiagnostic andtherapeutic applicationsduring endoscopicprocedures in thepancreatico-biliary	Similar
	Proposed Device	Predicated Device	Reference Device
Characteristics	Single-UseVideoPancreaticobiliary Scope	SpyGlass DS Accessand Delivery Catheter(K142922)	SpyGlass DiscoverDigital Catheter(K200483)	Remark
	provide working channelfor other diagnosis andtreatment accessories.		system including thehepatic ducts.
Operatingmethod	ERCP, PTC	ERCP	LCBDE, PTC, OpenSurgical procedure	Similar
Working length	2200mm800mm650mm600mm400mm	2140mm	650mm	Similar
Images Sensor	CMOS	CMOS	CMOS	Same
Reusability	Single-Use	Single-Use	Single-Use	Same
Sterile	Yes	Yes	Yes	Same
Anatomic sites	Pancreatic biliary system	Pancreatic biliary system	Pancreaticbiliarysystem	Same
Targetpopulation	Adults	Adults	Adults	Same
Rx-only	Yes	Yes	Yes	Same
Tip Diameter	3.7mm3.1mm	3.5mm	3.5mm	Similar
Shaft Diameter	3.9mm3.2mm	3.6mm	3.6mm	Similar
WorkingChannelDiameter	2.0mm1.2mm	1.2mm	1.2mm	Similar
	Proposed Device	Predicated Device	Reference Device
Characteristics	Single-UseVideoPancreaticobiliary Scope	SpyGlassDS Accessand Delivery Catheter(K142922)	SpyGlassDiscoverDigitalCatheter(K200483)	Remark
MinimumDuodenoscopeWorkingchannel	4.2mm3.7mm	4.2mm	Notusedthroughduodenoscope	Similar
MinimumSheath WorkingChannel	4.0mm3.3mm	Not used through sheath	3.6mm	Similar
Deflection	4way≥45°	4way≥30 °	4way≥30 °	Greater
DirectionofView	0	0	0	Same
Field of view	120	120	120	Same
Resolution	12.7lines/mm@5mmobject distance	7.13 lines/mm@5mmobject distance	Unknown	Greater
Biocompatibility	Comply with ISO 10993-1	Comply with ISO 10993-1	Comply with ISO 10993-1	Same
Shelf Life	2 Years	2 Years	2 Years	Same
ElectricalPerformance	Comply withANSI AAMI ES60601-1IEC60601-1-2IEC 60601-2-18	Comply withANSI AAMI ES60601-1IEC60601-1-2IEC 60601-2-18	Comply withANSI AAMI ES60601-1IEC60601-1-2IEC 60601-2-18	Same

Scope and Predicate/Reference Device

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Image /page/7/Picture/1 description: The image shows a logo with the letters 'MT' in a stylized, three-dimensional design. The letters are white and stand out against a blue background. A registered trademark symbol is located in the upper right corner of the logo.

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Image /page/8/Picture/1 description: The image shows a blue logo with the letters 'MT' in a stylized, three-dimensional font. The letters are connected and appear to be leaning slightly to the right, creating a sense of depth. A small 'R' in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.

Table 2 Substantial Equivalence Comparison between Proposed PB Digital Controller and

Characteristics	Proposed Device	Predicate/Reference Device
	PB Digital Controller	Predicated Device	Reference Device	Remark
		SpyGlass DS DigitalController(K142922)	SpyGlass DiscoverDigitalController(K200483)
Product Code	FBN,FET	FBN	FBN	PB DigitalController is
Characteristics	Proposed Device	Predicated Device	Reference Device	Remark
	PB Digital Controller	SpyGlass DS DigitalController(K142922)	SpyGlass DiscoverDigitalController(K200483)
Class	II	II	II	a videoprocessorregulatedunder FET.
RegulationDescription	Pancreaticobiliary Scope(flexible or rigid) andaccessoriesEndoscopic VideoImagingSystem/Component,Gastroenterology-Urology	Pancreaticobiliary Scope(flexible or rigid) andaccessories	PancreaticobiliaryScope (flexible or rigid)and accessories	SamePB DigitalController isonecomponentofendoscopicVideoImagingSystem
Regulationnumber	21 CFR 876.1500	21 CFR 876.1500	21 CFR 876.1500	Same
IndicationforUse	The PB Digital Controllercan be used together withthe Single-use VideoPancreaticobiliary Scopeof Micro-Tech to processthe image collected by thescope and transmit it to thedisplay.	The SpyGlass DS DigitalController is intended toprovide illumination andreceive, process, andoutput images from theSpyScope DS Access andDelivery Catheter fordiagnostic andtherapeutic applicationsduring endoscopicprocedures in thepancreaticobiliarysystem including thehepatic ducts.	The Spyglass DiscoverDigital Controller isintended to provideillumination and receive,process, and outputimages from theSpyglass DiscoverDigital Catheter fordiagnostic andtherapeutic applicationsduring endoscopicprocedures in thepancreaticobiliarysystem including thehepatic ducts.	Similar
	Proposed Device	Predicated Device	Reference Device
Characteristics	PB Digital Controller	SpyGlass DS DigitalController(K142922)	SpyGlass DiscoverDigitalController(K200483)	Remark
Video Formats	PAL and NTSC	PAL and NTSC	PAL and NTSC	Same
Video Outputs	DVI, CVBS	S-Video, VGA, DVI	S-Video, VGA, DVI	Similar
Characteristics	Proposed Device	Predicated Device	Reference Device
	PB Digital Controller	SpyGlass DS DigitalController(K142922)	SpyGlassDiscoverDigitalController(K200483)	Remark
WhiteBalancing	Automatic	Automatic	Automatic	Same
BrightnessControl	5 settings	5 settings	5 settings	Same
Separatemonitor	Yes	Yes	Yes	Same
Energyused/Powersource	Yes	Yes	Yes	Same
Reusability	Reusable	Reusable	Reusable	Same
Rx-only	Yes	Yes	Yes	Same
Shelf Life	5 Years	5 Years	5 Years	Same
ElectricalPerformance	Comply withANSI AAMI ES60601-1IEC60601-1-2IEC 60601-2-18	Comply withANSI AAMI ES60601-1IEC60601-1-2IEC 60601-2-18	Comply withANSI AAMI ES60601-1IEC60601-1-2IEC 60601-2-18	Same

Predicate/Reference Device

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Image /page/9/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be part of a single, solid shape. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.

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Image /page/10/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be leaning slightly to the right. A small registered trademark symbol is visible in the upper right corner of the logo. The logo has a clean and modern design.

8. Performance Data

Performance testing was conducted to demonstrate the essential performance of the proposed device Pancreaticobiliary Video System and confirmed that the proposed device works as intended with the compatible devices.

The bench tests below were tested and evaluated as substantially equivalent to the predicate device.

Diameter
Working length
Working channel diameter
Liquid injection and aspiration
Field of view
Resolution
Articulation direction

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Image /page/11/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be angled slightly, giving the logo a dynamic look. A registered trademark symbol (®) is positioned in the upper right corner of the logo.

Articulation angle A
Surface and edges
Leakage
Attachment to duodenoscope reliability
A Duodenoscope compatibility
Irrigation pump compatibility
Accessory compatibility

Shelf-life testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. A oneyear aging test was performed to demonstrate longer stability and support the results of the accelerated aging test.

Sterilization validation was carried out in accordance with ISO 11135:2014 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization Processes for Medical Devices"

Biocompatibility testing was performed in accordance with the FDA Guidance, Use of international Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".

Electrical performance was performed in accordance with ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance", IEC 60601-2-18:2009 "Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment", IEC 60601-1-2:2014 "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests"

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Image /page/12/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be leaning slightly to the right. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.

9. Animal Study

No animal study is included in this submission.

10. Clinical Study

No clinical study is included in this submission.

11. Substantially Equivalent (SE) Conclusion

Based on the indications for use, technological characteristics, and safety and performance testing, the Pancreaticobiliary Video System has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate device SpyGlass DS Direct Visualization System under K142922 and reference device SpyGlass Discover Digital System under K200483, the subject device is as safe, as effective, and performs as well as the predicate/reference device.

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.