Telescopes for adults
KARL STORZ HOPKINS Telescopes for Urology when used with sheaths, obturators, accessories, and instruments are intended to provide visualization and operative access during diagnostic and therapeutic urological procedures in adults.

Telescopes for adults and pediatrics
KARL STORZ HOPKINS Telescopes for Urology when used with sheaths, obturators, accessories, and instruments are intended to provide visualization and operative access during diagnostic and therapeutic urological procedures in adults and pediatrics.

Device Description

The KARL STORZ HOPKINS Telescopes for Urology are rigid cystoscope systems, which provide visualization and operative access during urological procedures in adults and pediatrics. Urological devices consist of sheaths, obturators, accessories, and instruments, which are combined into a cystoscope system for diagnostic or therapeutic procedures in the lower urinary tract such as prostate, bladder, and urethra. The sheath provides a working channel for therapeutic instruments, as well as ports for irrigation and aspiration. The obturator is inserted through the sheath for atraumatic insertion to the surgical site, then removed after placement. The telescope is inserted through the sheath for visualization of the surgical site. All instruments subject to this submission are optical instruments, and compatible with telescopes; the optical instruments are only compatible with adult systems. Compact telescopes are all-in-one cystoscopes with built-in sheaths, obturators, and optics, they do not require device compilation for use.

AI/ML Overview

The provided text is an FDA 510(k) clearance letter and its accompanying summary for the KARL STORZ HOPKINS Telescopes for Urology. This document details the regulatory pathway for a medical device, specifically rigid endoscopes, not an AI software or system. Therefore, most of the questions regarding acceptance criteria and study design for AI performance are not applicable.

Here's an analysis of the provided information:

Analysis of Acceptance Criteria and Study for a Medical Device (Endoscope):

Given that this is a medical device (endoscope), the "acceptance criteria" are typically related to meeting established performance standards for such devices. The "study" refers to non-clinical bench testing to demonstrate compliance with these standards and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of acceptance criteria with specific numerical performance targets and reported values in the way you might see for an AI algorithm's accuracy or sensitivity/specificity. Instead, the acceptance criteria are implicit in the adherence to international and national standards for medical devices, particularly endoscopes. The reported device performance is that it complies with these standards.

Acceptance Criteria (based on standards)	Reported Device Performance
Biocompatibility: Complies with ISO 10993 series (biological evaluation, cytotoxicity, skin sensitization, systemic toxicity, chemical characterization, irritation).	The system complies with the listed ISO 10993 standards.
Reprocessing Validation: Complies with ISO 11138-1, ISO 14937, ISO 17664-1/2, ISO 17665-1, ISO 11737-1/2/3, ISO 22441, AAMI TIR12, ASTM F3208-20, ANSI/AAMI ST8/ST77/ST79/ST98 (sterilization, cleaning, microbiological methods, endotoxin testing).	Reprocessing data submitted complies with the listed ISO, AAMI, ASTM, and ANSI/AAMI standards.
Bench Performance Testing: Complies with ISO 8600-1/3/5, IEC 62471, IEC 60601-2-18 (thermal safety, general requirements, field of view, direction of view, optical resolution, photobiological safety, basic safety of endoscopic equipment).	Bench performance data (including thermal safety) submitted complies with the listed ISO and IEC standards.

2. Sample Size for the Test Set and Data Provenance:

Sample Size: Not applicable in the context of an endoscope's non-clinical bench testing. The "test set" here refers to the actual device prototypes or representative samples tested in a laboratory setting to verify compliance with engineering and safety standards. The number of units tested isn't specified but typically involves a sufficient number to ensure reproducibility and meet statistical requirements for the specific test (e.g., several samples for biocompatibility, multiple cycles for reprocessing).
Data Provenance: The testing is non-clinical bench testing, meaning it does not involve human subjects or real-world patient data. It is performed in a controlled laboratory environment by the manufacturer (KARL STORZ SE & Co. KG), likely in Germany given their address.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Experts for Ground Truth: Not applicable. For a rigid endoscope, "ground truth" is defined by established engineering specifications and compliance with recognized national and international standards. The "truth" is whether the device performs according to these measurable standards, not a subjective interpretation by experts.
Qualifications of Experts: Not applicable. The "experts" involved are likely engineers, quality assurance personnel, and regulatory specialists within Karl Storz and external testing laboratories who are qualified to conduct and interpret the specified tests according to the standards.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in medical image diagnosis). For physical device testing, the results are typically quantitative measurements that either pass or fail against predefined criteria in the standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

MRMC Study: No. MRMC studies are used to evaluate the impact of a new diagnostic aid (like an AI system) on human reader performance across multiple readers and cases. This is not relevant for a rigid endoscope, which is a physical visualization and access tool.

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

Standalone Performance: Not applicable. This device is a physical endoscope, not an AI algorithm. Its function is to provide visualization, which inherently involves a human user (the clinician) in the loop.

7. The type of ground truth used:

Type of Ground Truth: The "ground truth" is adherence to established engineering specifications, safety standards (e.g., thermal safety), optical performance metrics (e.g., field of view, resolution), biocompatibility requirements, and validated reprocessing protocols as defined by the numerous ISO, IEC, AAMI, ASTM, and ANSI standards listed. It is a technical and regulatory compliance "ground truth."

8. The sample size for the training set:

Training Set Sample Size: Not applicable. This is a physical medical device, not an AI algorithm that undergoes training.

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

Training Set Ground Truth: Not applicable. As this is not an AI device, there is no "training set" or "ground truth for the training set."

In summary, the provided document is a regulatory submission for a physical medical device (an endoscope) and not for an AI/software device. Therefore, the specific questions related to AI performance metrics, sample sizes for AI training/test sets, expert adjudication, and MRMC studies are not applicable to this submission. The "acceptance criteria" are demonstrated through non-clinical bench testing proving compliance with relevant industry standards and substantial equivalence to a predicate device.

Summary

FDA 510(k) Clearance Letter - KARL STORZ HOPKINS Telescopes for Urology

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

August 13, 2025

Karl Storz SE & Co. KG
Emily Rhiel
Regulatory Affairs Specialist
Dr. Karl-Storz-Straße 34
Tuttlingen, BW 78532
GERMANY

Re: K243653
Trade/Device Name: KARL STORZ HOPKINS Telescopes for Urology
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: II
Product Code: FAJ
Dated: July 15, 2025
Received: July 15, 2025

Dear Emily Rhiel:

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"

Page 2

K243653 - Emily Rhiel
Page 2

(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 QS 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 (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-reporting-combination-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 Rule"). 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-advice-comprehensive-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-devices/medical-device-safety/medical-device-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-devices/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

Page 3

K243653 - Emily Rhiel
Page 3

the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-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,

Mark R. Kreitz -S

for Mark J. Antonino, M.S.
Assistant Director
DHT3B: Division of Reproductive,
Gynecology, and Urology Devices
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

Food and Drug Administration
Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Submission Number (if known)	K243653

Device Name
KARL STORZ HOPKINS Telescopes for Urology

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

KARL STORZ Premarket Notification

HOPKINS Telescopes for Urology

510(k) Summary K243653

510(k) Summary

This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92 and the FDA guidance document titled "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" issued on July 28, 2014. All data included in this document is accurate and complete to the best of KARL STORZ SE & Co. KG knowledge.

Submitter:	KARL STORZ SE & Co. KG
	Dr.-Karl-Storz-Straße 34
	78532 Tuttlingen, Germany
Contact:	Emily Rhiel
	Regulatory Affairs Specialist
	Phone: (774) 318-2820
	Email: emily.rhiel@karlstorz.com
Date of Preparation:	August 6, 2025
Type of 510(k) Submission:	Traditional
Device Trade name:	KARL STORZ HOPKINS Telescopes for Urology
Regulatory Class:	II
Product Code:	FAJ
Classification Name:	Cystoscope and accessories, Flexible/Rigid (21 CFR Part 876.1500)
Common Name:	Endoscope and accessories
Device Panel:	Gastroenterology & Urology
Predicate Device(s):	K943176 KARL STORZ HOPKINS I&II/OPER/AUTOCLAVABLE TELESCOPES

Device Description: The KARL STORZ HOPKINS Telescopes for Urology are rigid cystoscope systems, which provide visualization and operative access during urological procedures in adults and pediatrics. Urological devices consist of sheaths, obturators, accessories, and instruments, which are combined into a cystoscope system for diagnostic or therapeutic procedures in the lower urinary tract such as prostate, bladder, and urethra. The sheath provides a working channel for therapeutic instruments, as well as ports for irrigation and aspiration. The obturator is inserted through the sheath for atraumatic insertion to the surgical site, then removed after placement. The telescope is inserted through the sheath for visualization of the surgical site. All instruments subject to this submission are optical instruments, and compatible with telescopes; the optical instruments are only compatible with adult systems. Compact telescopes are all-in-one cystoscopes with built-in sheaths, obturators, and optics, they do not require device compilation for use. Model numbers are provided in the table below.

Device Type	Model Numbers
HOPKINS Rigid Telescope	27005AA/BA/BGA/CA/EA/FA,

Page 6

KARL STORZ Premarket Notification

HOPKINS Telescopes for Urology

510(k) Summary K243653

Indications for Use:

Page 7

KARL STORZ Premarket Notification

HOPKINS Telescopes for Urology

510(k) Summary K243653

Physical and Technological Characteristics:	Subject Device Type: Rigid Endoscope	Telescope Predicate: K943176 KARL STORZ HOPKINS I&II/OPER/AUTOCLAVABLE TELESCOPES
Endoscope Type	Rigid, rod lens	Same as subject
Outer Diameter	1.9 – 4mm Compact telescopes: 6.6 & 7.9mm	Same as subject (No compact telescopes)
Working Length	11.7 – 30.3cm	11.7 – 36.3cm
Direction of View	0 -120°	-3.7 – 120.5°
Field of View	37.1 - 100°	36 – 109.3°
Light Source	External	Same as subject
Primary Patient Contacting Material	Stainless steel	Chromium Plated Monel 400
Cleaning & Sterilization	Cleaning: required Sterilization: • Steam • STERRAD modalities • V-PRO modalities	Cleaning: required Sterilization: • Steam • EtO

Non-Clinical Performance Data:

The following non-clinical performance data were provided in support of the substantial equivalence determination.

Biocompatibility Evaluation
The system complies with the following standards:

ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
ISO 10993-2: Biological evaluation of medical devices – Part 2: Animal welfare requirements
ISO 10993-5: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests skin sensitization
ISO 10993-11: Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
ISO 10993-12: Biological evaluation of medical devices – Part 12: Sample preparation and reference materials
ISO 10993-18: Biological evaluation of medical devices – Part 18: Chemical characterization of materials
ISO 10993-23 Biological evaluation of medical devices – Part 23: Tests for irritation 2021

Reprocessing Validation
The reprocessing data submitted complies with the following standards:

ISO 11138-1: Sterilization of health care products - Biological indicators - Part 1: General requirements

Page 8

KARL STORZ Premarket Notification

HOPKINS Telescopes for Urology

510(k) Summary K243653

ISO 14937: Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 17664-1: Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices
ISO 17664-2: Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices
ISO 17665-1: Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11737-1: Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products
ISO 11737-2: Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11737-3: Sterilization of health care products. Microbiological methods – bacterial endotoxin testing"
ISO 22441: Sterilization of Health Care Products – General Requirements for Characterization of a Sterilization Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices
AAMI TIR12: Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
ASTM F3208-20: Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices.
ANSI / AAMI ST8: "Hospital Steam Sterilizers
ANSI / AAMI ST77: Containment Devices for Reusable Medical Device Sterilization
ANSI / AAMI ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities
ANSI / AAMI ST98: Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices

Bench Performance Testing
The bench performance data submitted includes thermal safety and complies with the following standards:

ISO 8600-1: Endoscopes - Medical endoscopes and endotherapy

Page 9

KARL STORZ Premarket Notification

HOPKINS Telescopes for Urology

510(k) Summary K243653

ISO 14937: Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 17664-1: Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices
ISO 17664-2: Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices
ISO 17665-1: Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11737-1: Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products
ISO 11737-2: Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11737-3: Sterilization of health care products. Microbiological methods – bacterial endotoxin testing"
ISO 22441: Sterilization of Health Care Products – General Requirements for Characterization of a Sterilization Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices
AAMI TIR12: Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
ASTM F3208-20: Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices.
ANSI / AAMI ST8: "Hospital Steam Sterilizers
ANSI / AAMI ST77: Containment Devices for Reusable Medical Device Sterilization
ANSI / AAMI ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities
ANSI / AAMI ST98: Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices

Bench Performance Testing

The bench performance data submitted includes thermal safety and complies with the following standards:

ISO 8600-1: Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General requirements
ISO 8600-3: Endoscopes - Medical endoscopes and endotherapy devices Part 3: Determination of field of view and direction of view of endoscopes with optics
ISO 8600-5: Optics and photonics — Medical endoscopes and endotherapy devices -Part 5: Determination of optical resolution of endoscopes with optics
IEC 62471: Photobiological safety of lamps and lamp systems
IEC 60601-2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

Clinical Performance Data:

Clinical testing was not required to demonstrate the substantial equivalence to the predicate device. Non-clinical bench testing was sufficient to assess safety and effectiveness and to establish the substantial equivalence of the modifications.

Conclusion:

The conclusions drawn from the non-clinical performance data demonstrates that the subject device is as safe as and as effective as the predicate devices. As such, we conclude that the substantial equivalence of the subject and the predicate devices has been met, and the differences between the subject and the predicate devices do not raise new questions 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.