The Endoscopic Water Pump is a peristaltic pump intended to supply fluid to compatible endoscopes or endotherapy devices for irrigation of the gastric and colonic mucosa during endoscopic or endotherapeutic procedures, allowing to aid in visualisation, diagnosis and treatment.

Device Description

AGS's Endoscopic Water Pump comprises:

A host machine (including drive system, peristaltic pump head, housing, etc.); -
Operating component (Rotatable Knob and Footswitch); -
-Hanger assembly(optional);
-An irrigation tube (optional)
The Endoscopic Water Pump is a motorized pump designed to transfer water from a bottle, via a tube, to an endoscope or EndoTherapy devices, and the pump is operated by a footswitch. It uses a peristaltic pump head to move the water through the tube. The speed of the rotation of the pump head is adjustable by the user, using flow control knob on the front of the pump.

AI/ML Overview

The provided text is a 510(k) summary for the Endoscopic Water Pump. It details the device's characteristics and compares it to a predicate device to demonstrate substantial equivalence. However, it does not contain information about acceptance criteria, a study that proves the device meets acceptance criteria, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or the type of ground truth used.

The document explicitly states:

"No Clinical test is included in this submission." (CH2.03.9)
And for Performance Data: "The Endoscopic Water Pump meets all design specifications and medical device standards for electrical safety and EMC (IEC 60601), and the Irrigation tube meet the standard for sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device." (CH2.03.8)

This indicates that the submission relies on adherence to design specifications and recognized standards, along with non-clinical performance (which is not detailed as a specific study with acceptance criteria in the requested format), rather than a clinical study or a study directly comparing algorithm performance against specific acceptance criteria.

Therefore, most of the requested information cannot be extracted from this document.

Here's a summary of what can be inferred or directly stated from the provided text, along with the information that is not present:

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

Not present in the requested format. The document states the device "meets all design specifications and medical device standards" and "non-clinical performance meets the design specification." It also provides a comparison of technical characteristics and performance with the predicate device (Table CH2.03.6), primarily focusing on maximum output flow for different endoscope types. However, explicit acceptance criteria with corresponding performance metrics are not presented in a table.

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

Not present. No test set or data provenance is mentioned as a clinical study was not performed. The performance evaluation seems to be based on engineering tests and adherence to standards.

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

Not applicable / Not present. Since no clinical test or test set requiring ground truth was conducted, this information is not available.

4. Adjudication method for the test set

Not applicable / Not present. Since no clinical test or test set requiring ground truth was conducted, this information is not available.

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 / Not present. This device is an Endoscopic Water Pump, a hardware device, not an AI or software device that assists human readers. No MRMC study was conducted.

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

Not applicable / Not present. This is a hardware device; the concept of "standalone algorithm performance" does not apply.

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

Not applicable / Not present. As no clinical study or test set requiring ground truth was performed, this information is not relevant.

8. The sample size for the training set

Not applicable / Not present. This is a hardware device, not a machine learning model, so there is no training set in the typical sense.

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

Not applicable / Not present. This is a hardware device, not a machine learning model, so there is no training set or ground truth for it.

Information provided in the document related to performance:

Performance Comparison (from Table CH2.03.6, "Performance" row):
- Proposed device (AGS):
  - Maximum output flow is generally higher than the predicate device.
  - For endoscopes with an auxiliary water channel and using irrigation tube AG-5247-3.2: approx. 240~248ml/min at flow setting 10 (maximum) with a new pump head. Recommended flow settings: 1-10.
  - For instrument channel flushing (GIF-Q260, 2.8mm diameter channel): approx. 240~258ml/min at flow setting 10 (maximum) with a new pump head. Recommended flow settings: 1-10.
- Predicate device (Olympus OFP-2):
  - Water feed controlled by footswitch. Flow rate variable, controlled from front panel.
  - For endoscopes with an auxiliary water channel and using tube MAJ-1608/MAJ-1651 (CF-Q180AL): approx. 230ml/min at flow setting 9 (maximum) with a new pump head. Recommended flow settings: 1-6.
  - For instrument channel flushing (1) (CF-Q260AL/DL, 3.2mm diameter channel): approx. 785ml/min at flow setting 9 (maximum) with a new pump head. Recommended flow settings: 5-9.
  - For instrument channel flushing (2) (GIF-Q260, 2.8mm diameter channel with 2.5mm ultrasound probe): approx. 100ml/min at flow setting 9 (maximum) with a new pump head. Recommended flow settings: 5-9.
- Comparison Note: The proposed device's maximum output flow is higher than the predicate. The submission states that "we confirmed that the proposed device can meet the clinical requirements through simulate the clinical use of proposed device," and that "the simulation test in Section 12 demonstrates the substantial equivalence of the Endoscopic Water Pump." (Section 12 is not provided in the excerpt).
Shelf Life:
- Proposed device: 5 years for host machine, 3 years for irrigation tubes.
- Predicate device: Unknown.
- Comparison Note: "we conducted the shelf life validation in Section 14 which can prove that the difference of shelf life doesn't raise different questions regarding its safety and effectiveness." (Section 14 is not provided in the excerpt).
Sterility/Single Use:
- Proposed device irrigation tube: Sterile supplied, Single use.
- Predicate device irrigation tube: MAJ-1608, MAJ-1651 is single day use item; MAJ-1607, MAJ-1681, MAJ-1682 is single use. MAJ-1651, MAJ-1681 and MAJ-1682 supplied sterile.
Biocompatibility:
- Proposed device materials contacting human body: ABS, PVC, PC. Biocompatibility tested to ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021.
- Predicate device: Biological information unknown.
- Comparison Note: "biological risks are acceptable, please refer to Section 15." (Section 15 is not provided in the excerpt).

In conclusion, the document emphasizes compliance with standards and non-clinical performance assessments rather than a detailed study with specific acceptance criteria and ground truth in the context of diagnostic accuracy, which would be typical for an AI/CADe 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: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized depiction of a human figure, while the text on the right is written in a clear, sans-serif font. The word "FDA" is in a blue box.

March 20, 2025

Hangzhou AGS MedTech Co., Ltd. Yanping Fu RA Manager Building 2, 5 and 7, No. 389, Xingzhong Road Linping District, Hangzhou, Zhejiang 311103 China

Re: K241704

Trade/Device Name: Endoscopic Water Pump Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OCX Dated: February 17, 2025 Received: February 18, 2025

Dear Yanping Fu:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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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

Enclosure

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Indications for Use

Submission Number (if known)

K241704

Device Name

Endoscopic Water Pump

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/4/Picture/0 description: The image shows the logo for AGS. The logo consists of a blue and green circular design on the left, followed by the letters "AGS" in bold, black font on the right. The circular design appears to be three curved shapes intertwined, with the top shape being blue, the middle shape being green, and the bottom shape being blue.

CH2.03 510(k) Summary
Endoscopic Water Pump

CH2.03 510(k) Summary

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Image /page/5/Picture/0 description: The image shows the logo for AGS. The logo consists of a blue circular design with a green triangle in the center, followed by the letters "AGS" in bold, black font. The logo is simple and modern, and the colors are eye-catching.

510(k) Summary

We submit this 510(k) Summary as per 21 CFR 807.92, it meets the content and format regulatory requirements.

CH2.03.1 Submitter

Submitted by/Owner:	Hangzhou AGS MedTech Co., Ltd.Building 2, 5 and 7, No.389, Xingzhong Road, LinpingDistrict, 311103 Hangzhou, Zhejiang, PEOPLE'SREPUBLIC OF CHINA
EstablishmentRegistration Number:	3010288205
Registration Status:	Active
Contact Person:	Yanping FuPhone: 0086-15958493282Fax: 0086-0571-87671230Email: fuyp@bioags.com
Date Prepared:	June 11, 2024

CH2.03.2 Proposed Device

Trade Name:	/
Device Name:	Endoscopic Water Pump
Common Name:	Endoscopic Water Pump
Regulation class:	Class II
Regulation Number:	876.1500
Regulation Description:	Endoscope and accessories
Review Panel:	Gastroenterology/Urology
Product Code:	OCX
Product Code Name:	Endoscopic Irrigation/Suction System

CH2.03.3 Predicate Device

Trade Name:	/
Device Name:	Olympus Endoscopic Flushing Pump(OFP-2)
Common Name:	Endoscopic Flushing or Lavage Pump
510(K) Number:	K100899
Regulation class:	Class II
Regulation Number:	876.1500
Regulation Description:	Endoscope and accessories
Review Panel:	Gastroenterology/Urology
Product Code:	FEQ
Product Code Name:	Pump, Air, Non-manual, For endoscope

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Image /page/6/Picture/0 description: The image contains the logo for AGS. The logo consists of a circular symbol on the left and the letters "AGS" on the right. The circular symbol is made up of three curved shapes in blue and green, arranged in a triangular pattern. The letters "AGS" are in a bold, sans-serif font and are black in color.

CH2.03.4 Device Description

AGS's Endoscopic Water Pump comprises:

A host machine (including drive system, peristaltic pump head, housing, etc.); -
Operating component (Rotatable Knob and Footswitch); -
-Hanger assembly(optional);
-An irrigation tube (optional)

The Endoscopic Water Pump is a motorized pump designed to transfer water from a bottle, via a tube, to an endoscope or EndoTherapy devices, and the pump is operated by a footswitch. It uses a peristaltic pump head to move the water through the tube. The speed of the rotation of the pump head is adjustable by the user, using flow control knob on the front of the pump.

CH2.03.5 Indication for use statement

CH2.03.6 Comparison of Technology Characteristics

Our proposed device Endoscopic Water Pump is substantially equivalent to the predicate devices. The differences between Endoscopic Water Pump and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below:

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Item		Proposed deviceHangzhou AGS MedTech Co., Ltd.	Predicate device (K100899)OLYMPUS AMERICA INC	Comparison
Technical	Configuration	AGS's Endoscopic Water Pump comprises:- A host machine (including drive system, peristaltic pump head, housing, etc.);- Operating component (Rotatable Knob and Footswitch);- Hanger assembly(optional)- An irrigation tube (optional)	Olympus Flushing Pump comprises:- Flushing Pump OFP-2 host machine;- Power cord;- Footswitch;- Water container (optional);- Water tube (optional);	Similar.AGS' Endoscopic Water Pump don't contain optional water container, while Olympus Flushing Pump contain optional water container, the difference don't raise question about safety and effectiveness.
	Performance	Maximum output flow	Water feed: controlled by footswitch.Flow rate: variable, controlled from front panel.Flow rate delivery from the pump will depend on the length and type of endoscopes or EndoTherapy Accessory attached.The operator must therefore assess the condition of the patient and use clinical judgement to set the flow rate from the pump to avoid causing patient trauma.For endoscopes incorporating an auxiliary water channel and using irrigation tube AG-5247-3.2:The flow rate when using the GIF-HQ290 should be approx. 240~248ml/min when the pump head is new and its flow setting is 10 (maximum). The	Variable, controlled from front panel.1.For endoscopes incorporating an auxiliary water channel and using auxiliary water channel tube MAJ-1608/MAJ-1651:The flow rate when using the CF-Q180AL should be approx. 230ml/min when the pump head is new and its flow setting is 9 (maximum). The flow rate will reduce as the pump head deteriorates.We recommend flow settings of 1 - 6 for auxiliary water channel use.2. For instrument channel flushing (1):The flow rate when using the CF-Q260AL/DL (3.2mm diameter channel) without an instrument inserted should be approx. 785ml/min when the pump head is new and
Item	Proposed deviceHangzhou AGS MedTech Co., Ltd.	Predicate device (K100899)OLYMPUS AMERICA INC	Comparison
	flow rate will reduce as the pump head deteriorates.We recommend flow settings of 1-10 for auxiliary water channel use.For instrument channel flushing (1): The flow rate when using the GIF-Q260 (2.8mm diameter channel) without an instrument inserted should be approx. 240~258ml/min when the pump head is new and its flow setting is 10 (maximum). The flow rate will reduce as the pump head deteriorates.We recommend flow settings of 1 - 10 for instrument channel use.	its flow setting is 9 (maximum). The flow rate will reduce as the pump head deteriorates.We recommend flow settings of 5 - 9 for instrument channel use.3. For instrument channel flushing (2):The flow rate when using the GIF-Q260 (2.8mm diameter channel) with a 2.5mm diameter ultrasound probe inserted should be approx. 100ml/min when the pump head is new and its flow setting is 9 (maximum). The flow rate will reduce as the pump head deteriorates.We recommend flow settings of 5 - 9 for instrument channel use.	proposed device is big than predicate device, we confirmed that the proposed device can meet the clinical requirements through simulate the clinical use of proposed device.Above all, the simulation test in Section 12 which demonstrates the substantial equivalence of the Endoscopic Water Pump.
Shelf life	5 years for host machine	/	Different, the shelf life of predicate device is unknown, but we conducted the shelf life validation in Section 14 which can prove that the difference of shelf life doesn't raise different questions regarding its safety and effectiveness.
Irrigation tube	Sterile Supplied	Yes.	MAJ-1608, MAJ-1651 is single day use item,MAJ-1607, MAJ-1681, MAJ-1682 is single use,	Different.Our Irrigation tubes are sterile
	Item	Proposed deviceHangzhou AGS MedTech Co., Ltd.	Predicate device (K100899)OLYMPUS AMERICA INC	Comparison
	Shelf Life	3 years	unknown	Different.Shelf life of Predicate device isunknown, but we conducted the shelflife validation in Section 14 whichcan prove that the difference of shelflife doesn't raise different questionsregarding its safety and effectiveness.
	Single Use	Yes	MAJ-1608, MAJ-1651 is single day use item	Different.Our Irrigation tubes are singleuse, substantially equivalent.
Biological	Materialscontacting withhumanbody	ABS, PVC, PC	unknown	DifferentThe biological information ofpredicate device is unknown. And the
	Biocompatibility	ISO 10993-5:2009, ISO 10993-10:2021,ISO 10993-23:2021	unknown	biological risks are acceptable, pleaserefer to Section 15.
			MAJ-1651, MAJ-1681 and MAJ-1682 suppliedsterile	supplied, substantially equivalent.

Table CH2.03.6 Comparison of technical characteristics

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Image /page/8/Picture/0 description: The image contains the logo for AGS. The logo consists of a circular design with three curved shapes in blue and green, resembling a stylized atom or a three-way intersection. To the right of the circular design, the letters 'AGS' are written in bold, black font.

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Image /page/9/Figure/0 description: The image contains the logo for AGS. The logo consists of a circular symbol with three curved shapes in blue and green, resembling a stylized recycling symbol. To the right of the symbol, the letters "AGS" are written in a bold, sans-serif font.

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Image /page/10/Picture/0 description: The image contains the logo for AGS. The logo consists of a circular graphic on the left and the letters "AGS" on the right. The circular graphic is blue and green and appears to be three curved shapes that are intertwined. The letters "AGS" are in a bold, sans-serif font and are black.

CH1.01 Cover Letter Endoscopic Water Pump

CH2.03.7 Applicable Guidance Document

CH2.03.8 Performance Data

The Endoscopic Water Pump meets all design specifications and medical device standards for electrical safety and EMC (IEC 60601), and the Irrigation tube meet the standard for sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device.

CH2.03.9 Clinical Test

No Clinical test is included in this submission.

CH2.03.10 Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Hangzhou AGS MedTech Co., Ltd has demonstrated that proposed device Endoscopic Water Pump is substantially equivalent to the predicate devices.

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.