The LIC Instrument Processor when used with the Manzi Detergent MD10, the Manzi Sterilant MS10 concentrate ( MEC 0.49% PAA, minimum contact temperature of 120° F for a contact time of 5 minutes), and filtered and ozonated final rinse water, is indicated for cleaning and high level disinfection of heat sensitive semi-critical endoscopes used in health care settings by health care workers. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the LIC Instrument Processor.

The Manzi Detergent MD10 concentrate when used with the LIC Instrument Processor is indicated for the cleaning of heat sensitive semi-critical endoscopes used in health care settings by health care workers.

The Manzi Sterilant MS10 concentrate when used in the LIC Instrument Processor is indicated for high level disinfection of heat sensitive semi-critical endoscopes used in health care settings by health care workers.

The filtered ozonated final rinse water generated by the LIC Instrument Processor is indicated for the final rinsing in the LIC Instrument Processor of of heat sensitive semi-critical endoscopes used in health care settings by health care workers.

Device Description

The LIC Instrument Processing System consists of a LIC Instrument Processor, a proprietary Manzi sterilant, MS10; a proprietary enzymatic Manzi Detergent, MD10; and internally generated filtered ozonated final rinse water. The LIC Instrument Processing System requires no connectors to be attached to the endoscope.

The LIC Instrument Processor is a self-contained stand-alone system designed to clean and provide high level disinfection of semi-critical endoscopes using the MD10 detergent, the MS10 sterilant, and a patented push-pull agitation system. The push-pull agitation system effectively scrubs the interior and exterior surfaces of the semi-critical endoscopes without the use of special connectors. The scope is placed in a processing chamber where it is exposed to a push-pull agitation cleaning cycle that provides cleaning to a protein residual level ≤ 6.4 ug / cm², followed by hot water rinses, a push-pull agitation disinfection cycle that provides high level disinfection of the instrument being processed and final rinses with filtered ozonated water.

The hardware for the LIC Instrument Processor consists of a stainless steel processing chamber, a push-pull agitation pump, an ozonator, a neutralization tank, and a variety of components that are mounted in a movable covered frame. The cleaner-processor system utilizes accessories such as disposable water filters, reusable semi-critical endoscopes trays, baffle inserts, and printer paper.

The LIC Instrument Processor is designed to: (1) be used in accordance with the reprocessing instructions provided in the operator's manual of the instruments being processed, and (2) facilitate the health care facility's compliance with reprocessing guidelines published by SGNA, APIC, AORN, ASGE, CDC, and other professional organizations.

MD10 is a low foaming enzyme chemical detergent packaged in single use containers for attachment to the LIC Instrument Processor. MD10 is intended to be used with the LIC Instrument Processor only.

MS10 is a peracetic acid based liquid chemical sterilant packaged in single use containers for attachment to the LIC Instrument Processor. MS10 is intended to be used with the LIC Instrument Processor.

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance:

Requirement	Acceptance Criteria	Reported Device Performance
Cleaning Efficacy (Protein Laden Soil)	Remaining protein < 3.7 ug/cm² when challenged with up to 1080 µg/cm²	Remaining protein levels were < 3.7 ug/cm² when challenged with endoscopes contaminated with Protein Laden Soil up to 1080 µg/cm².
Cleaning Efficacy (TOC Laden Soil)	Remaining TOC < 1.5 ug/cm² when challenged with up to 160 µg/cm²	Remaining TOC levels were < 1.5 ug/cm² when challenged with endoscopes contaminated with TOC Laden Soil up to 160 µg/cm².
Cleaning Efficacy (In-use clinical soil)	Remaining protein < 1.2 ug/cm²	Remaining protein levels were < 1.2 ug/cm² after processing through the system's cleaning step.
Disinfection Efficacy (Simulated Use)	≥ 6 logs spore reduction with no CFUs for Mycobacterium terrae at ≥ 10^6 microbial loading	≥ 6 spore log reduction with no CFUs was achieved for Mycobacterium terrae (≥ 10^6 microbial loading) when processed through the disinfection step. Additionally, the full cycle (cleaning, disinfecting, and final rinse) also achieved ≥ 6 spore log reduction with no CFUs for Mycobacterium terrae at ≥ 10^6 microbial loading.
Disinfection Efficacy (In-use clinical soil)	No viable organisms or CFUs recovered	No viable organisms or CFUs were recovered from clinically used endoscopes following processing through the full cycle.
Filtered Ozonated Final Rinse Water Efficacy	> 6 logs spore reduction with no CFUs when challenged with > 10^0 microbial loading	> 6 spore log reduction with no CFUs was achieved when challenged with > 10^0 microbial loading and processed to operational specifications.
Toxicological Evaluation of Residues	Detergent and sterilant residuals reduced to non-toxic levels	Detergent and sterilant residuals were reduced to non-toxic levels.
Process Parameter Tests	Device performs as intended, achieves/maintains specified parameters, aborts for faults, detects faults, provides alarms/instructions	Device achieved and maintained specified physical process parameters, automatically aborted cycles if parameters not achieved, detected defined fault conditions, and provided designated alarms and instructions in the event of fault condition detection.
Manzi MS10 Sterilant Potency	Passed	Passed
Manzi MS10 Sterilant Simulated Use Tests	Passed	Passed
Manzi MS10 Sterilant In-Use Tests	Passed	Passed
Manzi MS10 Sterilant Biocompatibility	Passed	Passed
Manzi MS10 Sporicidal Activity	Sporicidal (for Bacillus subtilis and Clostridium sporogenes)	MS10 is sporicidal.
Manzi MS10 Fungicidal Activity	Fungicidal (for Trichophyton mentagrophytes)	MS10 is fungicidal.
Manzi MS10 Bactericidal Activity	Bactericidal (for Salmonella choleraesuis, Staphylococcus aureus, Pseudomonas aeruginosa)	MS10 is bactericidal.
Manzi MS10 Virucidal Testing	Virucidal (for Poliovirus Type I)	MS10 is virucidal.
Manzi MS10 Tuberculocidal Testing	Tuberculocidal (for Mycobacterium bovis)	MS10 is tuberculocidal.

2. Sample Size for Test Set and Data Provenance:

Sample Size: Not explicitly stated for each test beyond "endoscopes" or "inoculated endoscope" in various simulated use and in-use tests.
Data Provenance: The document does not specify the country of origin. The study includes both simulated use testing (laboratory-controlled conditions with specific microbial loading) and in-use testing (using endoscopes contaminated by clinical endoscopy with naturally occurring soils). This indicates a mix of prospective (potentially for the simulated use) and retrospective/observational (for in-use samples) approaches.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable as the ground truth for this device (an instrument processing system) is based on quantitative laboratory measurements and microbiological assays, not expert interpretation of images or clinical assessments.

4. Adjudication Method for Test Set:

Not applicable, as ground truth is established through quantitative measurements and laboratory tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC study was not done. This device is an automated instrument processing system, not a diagnostic imaging AI tool that assists human readers. Therefore, the concept of human readers improving with AI vs. without AI assistance does not apply.

6. Standalone Performance:

Yes, a standalone performance evaluation was done. The entire study describes the performance of the LIC Instrument Processing System (the algorithm/device itself) in cleaning and high-level disinfection. All efficacy tests (cleaning, disinfection, rinse water) and residue evaluations directly assess the device's capabilities without human intervention during the processing cycle.

7. Type of Ground Truth Used:

The ground truth used is primarily quantitative laboratory measurements and microbiological assays, including:

Protein residual levels (µg/cm²)
Total Organic Carbon (TOC) levels (µg/cm²)
Microbial loading reduction (log reduction, absence of CFUs)
Detection of viable organisms
Chemical residue levels

8. Sample Size for the Training Set:

Not applicable. This document describes the validation of an automated instrument processing system, not a machine learning or AI model that requires a training set. The system operates based on established physical and chemical principles, not learned patterns from data.

9. How Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Summary

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LIC INSTRUMENT PROCESSOR Page XV - 1 Pre-Market Notification 510(k) K101158 IC Systems, in Section XV. 510(k) Summary Applicant's Name, Address, Telephone, Fax, Contact Person Langford IC Systems, Inc. 310 S. Williams Blvd, Suite 270 Tucson, Arizona 85711 MAY - 6 2011

Contact Person

E-mail:

Tel: Fax:

Terry Langford President and CEO, Langford IC Systems, Inc. Tel: 520-745-6201 520-745-6286 Fax: terrylangford(@licsystems.com E-mail:

terrylangford@licsystems.com

520-745-6201

520-745-6286

Preparation Date: April 21, 2011

1.0 CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Classification Name: Pending Name - Class II Common / Usual Name: Washer - Endoscope and Accessories Device Classification: 21 CFR § 876.1500. - Endoscope and accessories Product Code: FEB Proprietary Name: LIC Instrument Processing System; and Proprietary Name: Manzi MS10 Sterilant

2.0 PREDICATE DEVICE

The LIC Instrument Processing System (K101158) claims equivalence to the Manzi Mach 1 Instrument Cleaner - Processor System (K060458) found substantially equivalent on 10/12/2006. The predicate device is cleared for use with the MS10 Sterilant concentrate (MEC 0.49% PAA, minimum contact temperature of 120° F for a contact time of 15 minutes) for cleaning and high level disinfecting flexible bronchoscopes used in health care settings by health care workers.

3.0 INDICATIONS FOR USE

The LIC Instrument Processing System consists of the LIC Instrument Processor, the Manzi Detergent MD10, the Manzi Sterilant MS10, and filtered ozonated final rinse water.

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LANCFORD IC Systems, INC.
---------------------------

LIC INSTRUMENT PROCESSOR

Pre-Market Notification 510(k) K101158 Section XV. 510(k) Summary

The filtered ozonated final rinse water generated by the LIC Instrument Processor is indicated for the final rinsing in the LIC Instrument Processor of heat sensitive semi-critical endoscopes used in health care settings by health care workers.

4.0 DESCRIPTION OF THE DEVICE

MD10 is a low foaming enzyme chemical detergent packaged in single use containers for attachment to the LIC Instrument Processor. MD10 is intended to be used with the LIC Instrument Processor only.

5.0 COMPARISON TO THE PREDICATE DEVICE

The LIC Instrument Processing System is equivalent in operational principles to the Manzi Mach 1 Instrument Cleaner-Processor System cleared in K060458 10/12/2006. Both devices are intended for high quality cleaning and high level disinfection of flexible endoscopes, use no connectors, operate with the endoscopes in submerged solution, and utilize a detergent and sterilant cleared by the FDA. Both devices process one endoscope at a time. The devices differ in the Indications for Use as described in the table below:

Manzi Mach 1 as Configured in K060458	LIC Instrument Processor
The Manzi Mach 1 Instrument Cleaner Processor	The LIC Instrument Cleaner Processor System is
System is indicated for use with the MD10 Detergent	indicated for use with the MD10 Detergent and the
and the High Level Disinfectant MS10 concentrate (	High Level Disinfectant MS10 concentrate ( MEC
MEC 0.49% PAA, minimum contact temperature of	0.49% PAA, minimum contact temperature of 120° F
120° F for a contact time of 15 minutes) for cleaning	for a contact time of 5 minutes) for cleaning and high
and high level disinfecting flexible bronchoscopes used	level disinfecting of heat sensitive flexible endoscopes
in health care settings by health care workers.	used in health care settings by health care workers.

6.0 SUMMARY OF NONCLINICAL TESTS FOR THE LIC INSTRUMENT PROCESSOR

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6.1 Qualification Testing - FDA Guidance

The LIC Instrument Processing System was tested and found to conform to the requirements of the "Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer / Disinfectors, and Disinfectors Intended for Use in Health Care Facilities", dated August, 1993". The table below identifies the qualifications performed and the results obtained:

Requirement		Results
G.	Performance Data
	1 Process Parameter Tests	Passed
	2 Simulated Use Tests	Passed
	2.c. Effectiveness Tests
	2.c.(1) Cleaning Efficacy	Passed
	2.c.(2) Disinfection Efficacy	Passed
	2.c.(3) Rinsing Efficacy	Passed
	2.c.(4) Other Tests	Passed
	2.c.(5) Combined Process	Passed
	3. In - Use Tests	Passed
H.	Software Documentation	Passed
I.	Toxicological Evaluation of Residues	Passed

6.2 Process Parameter Test

The LIC Instrument Processing System was tested to demonstrate that the device performs as intended. The test results showed that the LIC Instrument Processing System achieves and maintains the specified physical process parameters, automatically aborts the cycle if the specified parameters are not achieved, detects the defined fault conditions, and provides the designated alarms and instructions in the event of fault condition detection.

6.3 Cleaning Efficacy Testing -- LIC Instrument Processing System Cleaning Step

The LIC Instrument Processing System's cleaning step was challenged by endoscopes containing both protein loaded soil and TOC loaded soil and tested for cleaning efficacy. The test results demonstrate that the LIC Instrument Processing System when challenged with endoscopes contaminated with a Protein Laden Soil up to 1080 µg/cm² yielded remaining protein levels of < 3.7 ug/cm³. The test results also demonstrate that the LIC Instrument Processing System when challenged with endoscopes contaminated with a TOC Laden Soil up to 160 µg/cm² yielded remaining TOC levels of < 1.5 ug/cm2.

The LIC Instrument Processing System's cleaning step was also challenged using endoscopes contaminated by clinical endoscopy with naturally occurring soils in in-use testing. The in-use test results demonstrated remaining protein levels < 1.2 ug/cm² after processing through the LJC Instrument Processing System's cleaning step.

6.4 Disinfection Efficacy Testing - LIC Instrument Processing System Disinfection Step

The LIC Instrument Processing System was tested to evaluate its ability to high level disinfect endoscopes contaminated to ≥ 10 6 microbial loading of Mycobacterium terrae in simulated use testing. The simulated use testing demonstrated that ≥ 6 spore log reduction with no CFUs was achieved with the inoculated endoscope when processed through the disinfection step of the LJC Instrument Processing System.

6.5 Disinfection Efficacy Testing - LIC Instrument Processing System Full Cycle

The LIC Instrument Processing System was tested to evaluate its ability through its full cleaning, disinfecting, and final rinse cycle to high level disinfect endoscopes contaminated to ≥ 10 microbial

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loading of Mycobacterium terrae in simulated use testing and to disinfect endoscopes contaminated by clinical endoscopy with naturally occurring soils in in-use testing. The simulated use testing demonstrated that ≥ 6 spore log reduction with no CFUs was achieved with the inoculated endoscopes when processed through the full cycle of the LIC Instrument Processing System. The inuse testing demonstrated that no viable organisms or CFUs were recovered from the clinically used endoscopes following processing through the LIC Instrument Processing System's full cycle.

6.6 Filtered Ozonated Final Rinse Water Efficacy Testing - Microbiological Challenge

Simulated use testing was conducted to demonstrate the efficacy of the Filtered Ozonated Final Rinse Water of the LIC Instrument Processing System. The LIC Filtered Ozonated Final Rinse Water System was challenged where > 10 € microbial loading was introduced into the Filtered Ozonated Final Rinse Water System and tested after the water was processed to the systems operational specifications. The test results showed a > 6 spore log reduction with no CFUs.

6.7 Toxicological Evaluation of Residues

The safety of residual chemicals remaining on endoscopes after processing in the LJC Instrument Processing System was evaluated. The test results showed that that the LJC Instrument Processing System processing cycle reduces detergent and sterilant residuals to non-toxic levels.

7.0 SUMMARY OF NONCLINICAL TESTS for the MANZI MS10

7.1 Qualification Testing - FDA Guidance

The Manzi MS 10 Sterilant was tested to and met the requirements of the current edition of "Guidance for Industry and FDA Reviewers, Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants / High Level Disinfectants", dated January 3, 2000. The table below identifies the qualifications performed, the applicable Guidance Section, and the results obtained:

	FDA Guidance Requirement	Results
5.4	Potency Test	Passed
5.5	Simulated Use Tests	Passed
5.6	In-Use Tests	Passed
6.0	Biocompatibility	Passed

7.2 Qualification Testing - AOAC Tests

Microbiological Efficacy Summary
Test Method	Test Organisms	Results
Sporicidal Activity of Sterilants; AOACOfficial Method 966.04	Bacillus subtilisClostridium sporogenes	MS10 is sporicidal
Fungicidal Activity of Sterilants;AOAC Official Method 955.17	Trichophyton mentagrophytes	MS10 is fungicidal
Use-Dilution Method; AOAC OfficialMethod 955.14, 955.15, 964.02	Salmonella choleraesuisStaphylococcus aureusPseudomonas aeruginosa	MS10 is bactericidal
Virucidal Testing	Poliovirus Type I	MS10 is virucidal
Quantitative Tuberculocidal Test	Mycobacterium bovis	MS10 is tuberculocidal

8.0 OVERALL PERFORMANCE CONCLUSIONS

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K101158 p 5 of 5
Summary of FDA Requests and LIC Responses - Telecon April 20, 2011 Page 6
LIC LANGFORD IC SYSTEMS, INC	LIC INSTRUMENT PROCESSORPre-Market Notification 510(k) K101158Section XV. 510(k) Summary Page XV - 5

The studies demonstrate that the LIC Instrument Processing System is safe and effective for the cleaning and high level disinfection of heat sensitive semi-critical endoscopes within the stated indications for use for the LIC Instrument Processor, the Manzi MS10 Sterilant, and the Manzi Detergent, MD10, and establishes substantial equivalence of the LJC Instrument Processing System to the predicate device identified in Section 2.0 above.

LIC qualification and validation testing has demonstrated that the LIC Instrument Processing System will clean endoscopes to a remaining protein level of < 3.7 ug/cm²; significantly reduce the residual TOC level; high level disinfect endoscopes to reduce the microbial load by greater than 6 logs with no remaining CFUs, and rinse the instrument with filtered ozonated water.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three wing-like shapes above a wavy line, representing water. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the graphic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY - 6 2011

Ms. Terry Langford President and CEO Langford IC Systems, Incorporated 310 S. Williams Boulevard. Suite 270 Tucson, Arizona 85711

Re: K101158

Trade/Device Name: LIC Instrument Processing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FEB Dated: April 16, 2010 Received: April 26, 2010

Dear Ms. Langford:

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. 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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Page 2 - Ms. Langford

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): K#101158 .

Device Name: LIC Instrument Processing System

Indications for Use: The LIC Instrument Processing System consists of the LIC Instrument Processor, the Manzi Detergent MD10, the Manzi Sterilant MS10, and filtered ozonated final rinse water.

The LIC Instrument Processor when used with the Manzi Detergent MD10, the Manzi Sterilant MS10 concentrate ( MEC 0.49% PAA, minimum contact temperature of 120° F for a contact time of 5 minutes), and filtered and ozonated final rinse water, is indicated for cleaning and high level disinfection of heat sensitive semi-critical endoscopes used in health care settings by health care workers. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the LIC Instrument Processor.

The Manzi Detergent MD10 concentrate when used with the LIC Instrument Processor is indicated for the cleaning of heat sensitive semi-critical endoscopes used in health care settings by health care workers.

The Manzi Sterilant MS10 concentrate when used in the LIC Instrument Processor is indicated for high level disinfection of heat sensitive semi-critical endoscopes used in health care settings by health care workers.

The filtered ozonated final rinse water generated by the LIC Instrument Processor is indicated for the final rinsing in the LIC Instrument Processor of of heat sensitive semi-critical endoscopes used in health care settings by health care workers.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital	Page 1 of
Infection Control, Dental Devices
510(k) Number:	K101158

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.