Disposable Air/Water Valve: This device intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases and water, whilst preventing backflow during a GI Endoscopic procedure.

Disposable Suction Valve: The device intended to be fitted to an endoscope suction channel to enable the operator to control suction whilst preventing inflow of air during a GI Endoscopic procedure.

Disposable Biopsy Valve: This device is intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of bio material during an endoscopic procedure.

Device Description

Disposable Valve Sets includes either one air/water and suction valve or one air/water, suction and biopsy valve. So we divided into two models for these devices. One suction valve, air/water valve and biopsy valve means model B, one suction valve and air/water valve means model A. These devices are supplied sterile. These valves easily incorporate into infection prevention policies as a single use item, and these valves are suitable for Olympus 140/160/190/240/260 series endoscopes.

AI/ML Overview

The document describes the acceptance criteria and study to demonstrate substantial equivalence for the Disposable Valve Sets (intended for use with endoscopes) by Zhejiang Chuangxiang Medical Technology Co., LTD. against the predicate device Endorate™ Valve Sets (K181509) by Smardata Suzhou Co., Ltd.

Here's the detailed breakdown as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" alongside "reported device performance" in a quantitative manner (e.g., specific thresholds and measured values). Instead, it states that "In-vitro Testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." and "The testing successfully demonstrated essential performance is achieved before and after the shelf life test."

The following tests were performed and implicitly form the basis of the acceptance criteria by ensuring the device meets required specifications:

Test Category	Specific Tests Performed	Reported Device Performance
Disposable Suction Valve	1. Endoscope Compatibility	Met required specifications (implicit)
	2. Vacuum Leak Test	Met required specifications (implicit)
	3. Suction Flow Test	Met required specifications (implicit)
	4. Depression Force Test	Met required specifications (implicit)
Disposable Air/Water Valve	1. Endoscope Compatibility	Met required specifications (implicit)
	2. Water Flow Test	Met required specifications (implicit)
	3. Air Flow Test	Met required specifications (implicit)
	4. Leak Test	Met required specifications (implicit)
	5. Depression Force Test	Met required specifications (implicit)
Disposable Biopsy Valve	1. Endoscope Compatibility	Met required specifications (implicit)
	2. Leak Test	Met required specifications (implicit)
	3. Squeegee Leak Test	Met required specifications (implicit)
Sterilization	EO residual measurement (ISO 10993-7)	Met criteria defined in ISO 10993-7
	Sterility Assurance Level (SAL)	10⁻⁶
Shelf-Life	Accelerated testing (ASTM F1980-16), Packaging (ISO 11607-1, ISO 11607-2)	Essential performance achieved before and after shelf life
Biocompatibility	Cytotoxicity, Sensitization, Intracutaneous Irritation (ISO 10993-1, FDA Guidance)	Device demonstrated biocompatibility
Overall Performance	In-vitro tests for performance and biocompatibility	Performs as well as the predicate in all testing performed

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes used for each of the in-vitro performance tests. It generally states that "In-vitro Testing has been performed" on "components, subassemblies, and/or full devices."

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature. However, given that "Zhejiang Chuangxiang Medical Technology Co., LTD." is located in Hangzhou, Zhejiang, China, it is highly probable that the testing was conducted in China. These would be considered prospective laboratory tests using newly manufactured device samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is a physical medical instrument (valve sets), not an AI algorithm or diagnostic tool that relies on expert interpretation of data or images to establish a "ground truth." Therefore, the concept of "number of experts used to establish the ground truth" is not applicable in this context. The "ground truth" for this device's performance is established by objective engineering and safety standards (e.g., flow rates, leak resistance, mechanical force, biocompatibility standards).

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in studies involving human interpretation (e.g., radiology reads), especially for AI clinical trials. The performance of these physical valves is assessed against predefined engineering and material standards through objective laboratory measurements.

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. This is a medical device (endoscope valve sets), not an artificial intelligence-powered diagnostic or assistive tool. MRMC studies are used to evaluate AI's impact on human reader performance.

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

Not applicable. This is a physical medical device. The concept of "standalone algorithm performance" does not apply. The performance tests evaluate the device itself.

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

The "ground truth" for the performance tests of the Disposable Valve Sets is based on objective engineering and safety specifications and recognized international standards. This includes:

Physical performance criteria: Such as vacuum leak rates, flow rates (water and air), depression force, and leak resistance (squeegee leak test). These are quantifiable measurements.
Sterilization standards: Meeting criteria defined in ISO 10993-7 for EO residual and achieving a SAL of 10⁻⁶.
Shelf-life standards: Compliance with ASTM F1980-16 for accelerated aging and ISO 11607-1/2 for packaging.
Biocompatibility standards: Compliance with FDA Guidance and ISO 10993-1 for cytotoxicity, sensitization, and intracutaneous irritation.

There is no "expert consensus" or "pathology" involved in determining if a valve leaks or if it's biocompatible beyond interpreting the results of the objective tests against established thresholds.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The device design and manufacturing processes are validated through engineering principles and testing.

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

Not applicable, as there is no training set for a physical medical device.

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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

December 30, 2019

Zhejiang Chuangxiang Medical Technology Co., LTD. Lucius Long RA Manager 301B, No.22, XinYan Road Hanzhou, Zhejiang 311100 CHINA

Re: K192258

Trade/Device Name: Disposable Valve Sets Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODC, OCX Dated: August 21, 2019 Received: November 26, 2019

Dear Lucius Long:

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 control's 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-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 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-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.

Shanil P. Haugen, Ph.D. Acting 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

Enclosure

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Indications for Use

510(k) Number (if known) K192258

Device Name Disposable Valve Sets

Indications for Use (Describe)

Disposable Valve Sets includes either one air/water and suction valve or one air/water, suction and biopsy valve.

Disposable Air/Water Valve

This device intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases and water, whilst preventing backflow during a GI Endoscopic procedure.

Disposable Suction Valve

The device intended to be fitted to an endoscope suction channel to enable the operator to control suction whilst preventing inflow of air during a GI Endoscopic procedure.

Disposable Biopsy Valve

This device is intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of bio material during an endoscopic procedure.

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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Image /page/3/Picture/1 description: The image shows a logo for a company called MEDNOVA. The logo consists of a geometric shape in shades of green and blue, along with the company name in blue and green text. The text "MEDNOVA" is in a sans-serif font, with "MED" in blue and "NOVA" in green. Below the logo is the text "Zhejiang Chuangxiang Medical Technolo", which is likely the full name of the company.

ng Medical Technology Co.,Ltd

Page:

Section 8 510(k) Summary( 21CFR 807.92)

1. Submitter's information

Name: Zhejiang Chuangxiang Medical Technology Co., LTD.

Address: 301B, No.22, XinYan Road Yuhang Economic And Technological Development Zone Hangzhou Zhejiang China

Contact person: Lucius.Long Telephone: 86-571-89167088 Fax: 86-571-89167086

Date of Submission Dec. 24, 2019

3. Device

Trade/Device Name: Disposable Valve Sets Regulation name: Endoscope and accessories Regulation class: II Regulation number:876.1500 Panel: Gastroenterology/Urology Product code: ODC, OCX

4. Predicative device

4.1) 510(k) Number: K181509, Device Name: Endorate™ Valve Sets

5. Device description

Disposable Valve Sets includes either one air/water and suction valve or one air/water, suction and biopsy valve, So we divided into two models for these devices. One suction valve, air/water valve and biopsy valve means model B, one suction valve and air/water valve means model A. These devices are supplied sterile. These valves easily incorporate into infection prevention policies as a single use item, and these valves are suitable for Olympus 140/160/190/240/260 series endoscopes. The following table shows the details information on the model.

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Image /page/4/Picture/0 description: The image contains a logo with a geometric shape on the left and text on the right. The geometric shape is a hexagon with a smaller hexagon inside, and it is filled with a gradient of blue and green. To the right of the shape, there is the text "MEDNOVA" in blue and green, with the word "MED" in blue and the word "NOVA" in green. Above the text "MEDNOVA", there are three Chinese characters in blue.

g Medical Technology Co.,Ltd

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Model	Specification	ENDOSCOPIC COMPATIBILITY	Sterilization(Y/N)
A	MD-A-AW01	Olympus	Y
B	MD-B-AW02	140/160/180/190/240/260	Y

6. Indications for use

Disposable Valve Sets includes either one air/water and suction valve or one air/water, suction and biopsy valve.

Disposable Air/Water Valve

This device intended to be fitted to an edoscope air/water channel to enable the operator to control inflow of medical gases and water, whilst preventing backflow during a GI Endoscopic procedure.

Disposable Suction Valve

The device intended to be fitted to an endoscope suction channel to enable the operator to control suction whilst preventing inflow of air during a GI Endoscopic procedure.

Disposable Biopsy Valve

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Image /page/5/Picture/1 description: The image contains a logo for a company called MEDNOVA. The logo consists of a hexagon shape with a white outline and a gradient fill of green and blue. To the right of the hexagon is the company name, with "MED" in blue and "NOVA" in green. Above the company name are three blue Chinese characters.

Zhejiang Chuangxiang Medical Technology Co.,Ltd

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7. Technological Characteristics

The following tables are summaries of the proposed device's technological characteristics as compared to the predicate devices.

Table 7.1 comparison of Disposable Air/Water Valve

Item	Proposed device	Predicate device	Comparison toPredicate Devices
Device name	Disposable Air/Water Valve	Andorate Disposable Air/Water valve	/
510(k) number	/	K181509	/
Manufacturer	Zhejiang ChuangxiangMedical Technology Co., LTD.	Smardata Suzhou Co., Ltd	/
Product Code	ODC	ODC	Same
Regulation No.	876.1500	876.1500	Same
Class	II	II	Same
Indications for Use	This device intended to befitted to an edoscopeair/water channel to enablethe operator to control inflowof medical gases and water,whilst preventing backflowduring a GI Endoscopicprocedure.	The ENDORATE™ DisposableAir/Water valve is intended to beused control the air/waterfunction of an endoscope during aGI Endoscopic procedure.	SubstantialEquivalence
Supplied Sterile	Sterile	Sterile	Same
Sterilization method	EO	EO	Same
Compatibility	Olympus®140/160/180/190/240/260series endoscopes	Olympus®140/160/180/190/240/260 seriesEndoscope	Same
Single Use	Yes	Yes	Same
Packaging	Suction, air/water and/orbiopsy valves are housed in asingle tray and packaged in asealed pouched	Suction, air/water, biopsy valves arehoused in a single tray andpackaged in a sealed pouched	SubstantialEquivalence
Shelf Life	Three years	Three years	SubstantialEquivalence

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Image /page/6/Picture/1 description: The image contains a logo for Zhejiang Chuangxiang Medical Technology Co., Ltd. The logo features a stylized hexagon shape in green and blue, with the text "MEDNOVA" underneath. The company name is written in a larger font below the logo.

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Item	Proposed device	Predicate device	Comparison toPredicate Devices
Device name	Disposable Suction Valve	Endorate™DisposableSuction Valve	/
510(k) number	/	K181509	/
Manufacturer	Zhejiang ChuangxiangMedical Technology Co.,LTD.	Smardata Suzhou Co., Ltd	/
Product Code	ODC	ODC	Same
Regulation No.	876.1500	876.1500	Same
Class	II	II	Same
Indications forUse	The device intended to befitted to an endoscopesuction channel to enablethe operator to controlsuction whilst preventinginflow of air during a GIEndoscopic procedure.	The ENDORATE™ DisposableSuction valve is intended tobe used control the suctionfunction of an endoscopeduring a GI Endoscopicprocedure.	SubstantialEquivalence
Supplied Sterile	Sterile	Sterile	Same
Sterilizationmethod	EO	EO	Same
Compatibility	Olympus®140/160/180/190/240/260series Endoscope	Olympus®140/160/180/190/240/260series Endoscope	Same
Single Use	Yes	Yes	Same
Packaging	Suction, air/water and/orbiopsy valves are housed in asingle tray and packaged in asealed pouched	Suction, air/water, biopsyvalves are housed in a singletray and packaged in a sealedpouched	SubstantialEquivalence
Shelf Life	Three years	Three years	SubstantialEquivalence

Table 7.2 comparison of Disposable Suction Valve

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Image /page/7/Picture/1 description: The image contains the logo for Zhejiang Chuangxiang Medical Technology Co., Ltd. The logo features a stylized hexagon shape in green and blue gradient, along with the company name in both Chinese and English. The Chinese characters are larger and in blue, while the English name "MEDNOVA" is in green. Below the logo, the full company name "Zhejiang Chuangxiang Medical Technology Co.,Ltd" is written in black text.

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Item	Proposed device	Predicate device	Comparisonto PredicateDevices
Device name	Disposable Biopsy Valve	Endorate™ Disposablebiopsy Valve	/
510(k) number	/	K181509	/
Manufacturer	Zhejiang ChuangxiangMedical Technology Co., LTD.	Smardata Suzhou Co.,Ltd	/
Product Code	OCX	OCX	Same
Regulation No.	876.1500	876.1500	Same
Class	II	II	Same
Indications forUse	This device is intended to befitted to an endoscope biopsyport to enable accessfor/exchange of endoscopicdevices while maintaininginsufflation and minimizingleakage of bio material duringan endoscopic procedure.	The Endorate™Disposable biopsy valve isintended to cover theendoscope biopsy portduring an endoscopyprocedure. In addition, thevalve provides access forendoscopic device passageand exchange, helpsmaintain insufflation andminimizes leakage ofbiomaterial from the biopsyport throughout theendoscopic procedure.	SubstantialEquivalence
Supplied Sterile	Sterile	Sterile	Same
Sterilizationmethod	EO	EO	Same
Compatibility	Olympus140/160/180/190/240/260series endoscopes	Olympus® / Fujinon®and Pentax ® Endoscopes	SubstantialEquivalence
Single Use	Yes	Yes	Same
Packaging	Suction, air/water and/or biopsyvalves are housed in a singletray and packaged in a sealedpouched	Suction, Air/Water, biopsyvalves are housed in a singletray and packaged in asealed pouch.Non Sterile Biopsy valve is	SubstantialEquivalence
			Page: 6 / 7
		also sold individuallypackaged in a sealed pouch.Biopsy valve is either in blueor black depending on theavailability.
Shelf Life	Three years	Three years		SubstantialEquivalence

Table 7.3 comparison of Disposable Biopsy Valve

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Image /page/8/Picture/1 description: The image shows the logo for MEDNOVA. The logo consists of a hexagon shape on the left, with the text "MEDNOVA" written in blue and green on the bottom. To the right of the hexagon and text is Chinese characters in blue.

iang Medical Technology Co.,Ltd

8. Performance data

In-vitro Testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests. A summary of the test results has been provided for:

Disposable Suction Valve

1. Endoscope Compatibility
1. Vacuum Leak Test
1. Suction Flow Test
1. Depression Force Test

Disposable Air/Water Valve

1. Endoscope Compatibility
1. Water Flow Test
1. Air Flow Test
1. Leak Test
1. Depression Force Test
Disposable Biopsy Valve
1. Endoscope Compatibility
1. Leak Test
1. Squeegee Leak Test

The EO residual was measured after sterilization of the device to meet the criteria defined in ISO 10993-7 Second Edition 2008-10-15.

The EO sterilization cycle has a Sterility Assurance Level (SAL) of 10 °.

The shelf-life for three years had been validated in accelerated testing according to ASTM F1980-16 (2016) and the requirements on packaging for terminally sterilized medical device per ISO 11607-1 First Edition 2006-04-15 and ISO 11607-2 First Edition 2006-04-15 are also met. The testing successfully demonstrated essential performance is achieved before and after the shelf life test.

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" issued on June 16, 2016. The cytotoxicity, sensitization and intracutaneous irritation test were performed to demonstrate the biocompatibility of the device.

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K192258 page 7 of 7

Image /page/9/Picture/1 description: The image contains the logo for Zhejiang Chuangxiang Medical Technology Co., Ltd. The logo features a stylized hexagon shape in green and blue, with the text "MEDNOVA" underneath. To the right of the logo are Chinese characters, and below the logo is the company name in English. The text is clear and legible.

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9. Non-Clinical Testing:

The device has undergone both bench testing of performance and laboratory biocompatibility testing for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity and pyrogen test in accordance with 21 CFR, Part 58. The Disposable Valve Sets results in no safety or efficacy concerns regarding biocompatibility or performance. Likewise, in conformance with 21 CFR 807.92(b)(3), the device performs as well as the predicate in all testing performed.

10. Conclusions

Chuangxiang medical has demonstrated that the proposed device Disposable Valve Sets is substantially equivalent to Smardata Suzhou Co., Ltd. currently marketed Endorate™ Valve Sets (K181509).

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.