Advantage Plus Pass-Thru Endoscope Reprocessing System tests, washes, disinfect and rinses endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus Pass-Thru system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes and related accessories. Manual cleaning of endoscopes is required prior to disinfection in the Advantage Plus Pass-Thru System.

The Advantage Plus Pass-Thru Endoscope Reprocessing System uses Rapicide PA High Level Disinfectant to provide high level disinfection of endoscopes when used according to the directions for use. The system uses Intercept Plus Detergent in its washing cycle at a concentration of 0.5%.

Rapicide PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (MRC) of 850 ppm peracetic acid; this ensures that the disinfectant was above MRC during the entire disinfection cycle. Rapicide PA should be used under the following contact conditions -Contact Time: 5 minutes Temperature: 30°C MRC: 850ppm

Device Description

The Advantage Plus Pass-Thru is an electro-mechanical Automatic Endoscope Reprocessor (AER) intended to high-level disinfect pre-cleaned endoscopes and their related accessories by exposing them to a peracetic acid based disinfectant – Rapicide PA disinfectant solution (cleared under 510k – K082988).

The subject device is closely related to its predicate the Advantage Plus Endoscope Reprocessing System cleared in 510k – K082988 and K102996 but differs in that it is designed in a "pass-thru" configuration. The subject device is intended to be built into a wall which separates 'clean' and 'dirty' sides. It provides the ability to load an endoscope from the dirty side and unload the disinfected endoscope from the clean side, thus preventing potential mix-up between high level disinfected and contaminated endoscopes.

Contaminated endoscopes are placed in the subject device from the 'dirty' side and appropriate connections to the endoscope channels are made. The system is designed to test for proper channel connectivity, channel blockages and leaks in the outer endoscope sheath. After the endoscope passes these tests, the system proceeds to the washing cycle with Intercept Plus detergent, and the highlevel disinfection cycle. In the high-level disinfection cycle, Rapicide PA HLD is diluted by the incoming water to a minimum concentration of 850 ppm of peracetic acid. The system measures and maintains the temperature of this disinfectant solution to ensure that it is above the minimum recommended temperature of 30℃ for Rapicide PA for effective High Level Disinfection to occur. Following the 5 minute disinfectant contact time, the user takes a sample to test for MRC (850 ppm of peracetic acid). Once the MRC test passes, the disinfectant is emptied from basin and drained out of the AER. The endoscope is then rinsed, dried and removed from the 'clean side' of the AER.

AI/ML Overview

The provided text describes the regulatory submission for the "Advantage Plus Pass-Thru Automated Endoscope Reprocessing System" (K172677). The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study involving human readers or expert consensus for AI performance.

Therefore, much of the requested information regarding AI-specific criteria, human expert involvement, ground truth establishment for training and test sets, and MRMC studies, is not applicable or not present in this document. This submission pertains to a medical device for high-level disinfection of endoscopes, not an AI/ML-driven diagnostic or image-analysis device.

However, I can extract the acceptance criteria and performance for the non-clinical performance tests that were conducted to demonstrate substantial equivalence of this device.

Here's the information based on the provided text:

Acceptance Criteria and Reported Device Performance

The device is an Automated Endoscope Reprocessor (AER) intended for high-level disinfection. The performance testing conducted was to demonstrate its physical and microbiological effectiveness in this context.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Testing	Acceptance Criteria	Reported Device Performance
Simulated-Use Testing (Demonstrates high-level disinfection with Rapicide PA HLD and Intercept Plus detergent)	Achieve 6-log reduction of the test organism in each endoscope channel and endoscope exterior.	Pass
Clinical In-Use Testing (Demonstrates high-level disinfection after patient/clinical use)	Demonstrate no viable organisms remain after reprocessing.	Pass
Water-Line/Self-Disinfection Cycle Testing (Evaluation of bactericidal effectiveness of the self-disinfection cycle and biofilm analysis)	Survivors after the SDC must be ≤ 10 CFU of test organism per 100 mL. Absence of biofilm formation following self-disinfection cycle.	Pass
Rinse Residual Testing (Evaluation of residual levels of Rapicide PA and Intercept Plus)	Any chemistry residuals must be equal to or lower than the lowest reported LD50 exposure with a 10-fold safety margin.	Pass
Material Compatibility (Demonstrates system compatibility with Rapicide PA HLD and Intercept Plus Detergent)	Acceptance criteria included dimensional and weight changes <5%, visual observations and FTIR spectra.	Pass
Critical Parameter/Component Functionality Testing (Demonstrates consistent and reliable delivery of physical process parameters)	All critical process parameters must achieve and maintain required specifications.	Pass

Since this is a submission for an endoscope reprocessing system rather than an AI/ML device, the following points are not applicable or not mentioned in the document:

2. Sample size used for the test set and the data provenance:
* Not applicable for AI/ML data sets. The "test set" here refers to the number of reprocessing cycles or endoscope samples tested in the described performance studies. The exact number of cycles/samples for each test type (Simulated-Use, Clinical In-Use, etc.) is not explicitly stated in this summary, nor is the country of origin or whether the data was retrospective/prospective in the context of an AI/ML clinical study. The studies are described as "Performance bench testing" and "Clinical In-Use Testing," implying a prospective experimental design for product validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. Ground truth for an AI/ML system, especially relating to expert consensus, is not relevant to the validation of an endoscope reprocessing device. The "ground truth" in this context is based on quantifiable microbiological reduction (e.g., 6-log reduction of test organisms, absence of viable organisms) and chemical residual levels, measured by laboratory methods, not human expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable. Adjudication methods are typically used to resolve discrepancies in human expert labeling or diagnoses for AI/ML ground truth, which is not relevant here.

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 pertains to the evaluation of AI assistance for human readers, which is outside the scope of this device's function.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
* Not applicable. The "performance" of this device is its ability to disinfect endoscopes, and its "standalone" performance is what these non-clinical tests evaluate – the device working as intended without human intervention in the disinfection process itself, beyond loading/unloading and initiation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* The ground truth for this device's performance relies on microbiological testing results (e.g., colony-forming unit (CFU) counts of test organisms to determine log reduction, confirmation of no viable organisms, biofilm analysis) and chemical analyses (e.g., measurement of chemical residuals, verification of minimum recommended concentration, material properties). It is not based on expert consensus, pathology, or patient outcomes data in the sense of a diagnostic device.

8. The sample size for the training set:
* Not applicable. This device is an electro-mechanical system, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:
* Not applicable. As above, there is no AI/ML training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping faces and flowing lines.

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

December 19, 2017

Medivators Inc. Megan Skaar Regulatory Affairs Specialist 14605 28th Avenue North Minneapolis, Minnesota 55447

Re: K172677

Trade/Device Name: Advantage Plus Pass Thru Automated Endoscope Reprocessing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: FEB Dated: November 20, 2017 Received: November 21, 2017

Dear Megan Skaar:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K172677

Device Name

Advantage Plus Pass Thru Endoscope Reprocessing System

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."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular icon with several curved lines inside, followed by the word "MEDIVATORS" in large, blue, sans-serif font. Below the company name is the text "A Cantel Medical Company" in a smaller, blue, sans-serif font.

510(k) Summary

510(k) Number:	K172677
Manufacturer:	Medivators Inc., a Cantel Medical Company
Address:	14605 28th Avenue NorthMinneapolis, MN 55447(763) 553-3300
Official Contact:	Megan SkaarRegulatory Affairs Specialist, Medivators Inc.
Date:	19 December 2017
Trade Name:Common Name:Classification Name:Product Code:Device Class:Regulation No:	Advantage Plus Pass Thru Endoscope Reprocessing SystemAccessories, Cleaning, For EndoscopeEndoscope and accessoriesFEBIISubject Device - Advantage Plus Pass Thru Endoscope Reprocessing System,876.1500Predicate Device Trade Name - Medivators Advantage Plus EndoscopeReprocessing System and Rapicide PA High Level Disinfectant (K082988 andK102996), 876.1500

1. Indications for Use

Advantage Plus Pass-Thru Endoscope Reprocessing System tests, washes, disinfects and rinses endoscopes, such as fiberoptic and video endoscopes, between patient uses. The Advantage Plus Pass-Thru system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes and related accessories. Manual cleaning of endoscopes is required prior to disinfection in the Advantage Plus Pass-Thru System.

Rapicide PA Test Strips are used after the disinfection cycle to ensure that the disinfectant is above the minimum recommended concentration (MRC) of 850 ppm peracetic acid when used; this confirms that the disinfectant was above MRC during the entire disinfection cycle. Rapicide PA should be used under the following contact conditions -

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic on the left, followed by the word "MEDIVATORS" in blue, sans-serif font. Below the word "MEDIVATORS" is the text "A Cantel Medical Company" in a smaller, sans-serif font, also in blue. The overall design is clean and corporate, conveying a sense of professionalism and reliability.

Contact Time: 5 minutes Temperature: 30°C MRC: 850ppm

2. Device Description

3. Comparison and Summary of Technological Characteristics for the Subject and Predicate Devices

The subject device – Advantage Plus Pass-Thru Endoscope Reprocessing System and its predicate device – Advantage Plus Endoscope Reprocessing System are very closely related and have the same intended use and fundamental technology.

Similarities Between Subject and Predicate Device

The Advantage Plus Pass-Thru and its predicate device have the same scientific technology including principle of operation, features and materials. Both devices have high level disinfection cycle. They use the same disinfectant chemistry – Rapicide PA under the same use conditions (30°C for 5 minutes at MRC of 850 ppm PAA) to high level disinfect endoscopes. They have identical chemistry dosing mechanisms to produce equivalent concentration of disinfection solution. Additionally, both

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic on the left, which has several curved lines inside. To the right of the graphic is the word "MEDIVATORS" in a bold, blue sans-serif font, with the text "A Cantel Medical Company" in a smaller font below it.

the devices have the same fluid flow rate and pathway. The Advantage Plus Pass-Thru System is constructed of the same materials, metals and polymers, as its predicate device.

Differences Between Subject and Predicate Device

The subject device provides the ability to load an endoscope into the AER from the dirty, contaminated side and unload the disinfected scope from the clean side - creating the pass-thru system. To facilitate this system configuration, the basin door arrangement was altered from the arrangement of the predicate device. There were no changes in critical parameters to achieve high level disinfection with the alteration of a pass-thru door configuration. Verification of software and performance testing on the subject device pass-thru configuration demonstrates the configuration difference between the subject device and the predicate device does not impact the safety and effectiveness profile of the devices. The pass-thru configuration of the subject AER physically separates the 'clean' and 'dirty' sides of the reprocessing unit and hence reduces the risk of cross contamination as demonstrated in the performance testing outlined in Table 2 below.

Performance bench testing, included in Section 4 of this summary, supports substantial equivalence of the pass-thru system configuration. A device comparison table which supports substantial equivalence of the subject device to the predicate device is provided below –

Important Parameters	Subject Device – Advantage PlusPass-Thru	Predicate Device - Advantage Plus(cleared under 510k - K082988and K102996)
Intended Use	Advantage Plus Pass-ThruEndoscope Reprocessing Systemtests, washes, disinfects and rinsesendoscopes, such as fiberoptic andvideo endoscopes, betweenpatient uses. The Advantage PlusPass-Thru system is indicated toprovide high level disinfection ofheat sensitive semi-criticalendoscopes and relatedaccessories. Manual cleaning ofendoscopes is required prior todisinfection in the Advantage PlusPass-Thru System.The Advantage Plus Pass-ThruEndoscope Reprocessing Systemuses Rapicide PA High LevelDisinfectant to provide high level	Medivators Advantage PlusEndoscope Reprocessing Systemtests, washes, disinfects and rinsesendoscopes, such as fiberoptic andvideo endoscopes, betweenpatient uses. The Advantage Plussystem is indicated to provide highlevel disinfection of heat sensitivesemi-critical endoscopes andrelated accessories. Manualcleaning of endoscopes is notrequired prior to disinfection in theAdvantage Plus Pass-Thru System.The Advantage Plus EndoscopeReprocessing System uses RapicidePA High Level Disinfectant toprovide high level disinfection of
disinfection of endoscopes whenused according to the directionsfor use.		endoscopes when used accordingto the directions for use.
Product Code	FEB	FEB
FDA Regulation	21 CFR§ 876.1500	21 CFR§ 876.1500
Pass-Thru Configuration/AER separates Clean andDirty Side?	Yes	No
Type of Machine Function	Electro-mechanical	Electro-mechanical
System Technology Features	The system performs endoscopeconnection test, leak and channelblockage test, washing (cleaning),disinfection and rinsing. The cyclesteps for each basin aremonitored. Built in safety featuresand alarms.	The system performs endoscopeconnection test, leak and channelblockage test, washing (cleaning),disinfection and rinsing. The cyclesteps for each basin aremonitored. Built in safety featuresand alarms.
	Disinfection time,temperature and minimumrecommendedconcentration	Rapicide PA - 5 minutes at 30°C;850ppm Peracetic acid MRC	Rapicide PA - 5 minutes at 30°C;850ppm Peracetic acid MRC
		Detergent used in cleaningcycle	Intercept Plus Detergent
	Disinfection efficacy		>106 log reduction ofMycobacterium terrae
Manual cleaning requiredbefore use?		Yes	Yes (per K082988) however if theautomated cleaning cycle is used,manual cleaning is not required(per K102988)
Performs leak test?	Yes	Yes
Performs channelconnection and blockagetest?	Yes	Yes
Post-disinfection treatment	Optional alcohol purge followed byair purge of endoscope channels	Optional alcohol purge followed byair purge of endoscope channels

Table 1 – Predicate Comparison Table

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic on the left, followed by the word "MEDIVATORS" in a bold, blue sans-serif font. Below the company name, in a smaller font, is the text "A Cantel Medical Company," also in blue. The overall design is clean and corporate, conveying a sense of professionalism and reliability.

4. Summary of Non-Clinical Performance Data

Medivators has conducted the following testing to demonstrate the substantial equivalence of Advantage Plus Pass Thru AER –

Performance Testing Identical performance testing has been conducted on the subject and . predicate devices to ensure the Advantage Plus Pass-Thru meets equivalent acceptance criteria as the Advantage Plus. This testing confirms the subject device performs with the same safety

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image contains the logo for MEDIVATORS, a Cantel Medical Company. The logo consists of a blue circular graphic on the left, featuring several curved lines. To the right of the graphic is the word "MEDIVATORS" in a bold, blue sans-serif font. Below "MEDIVATORS" is the text "A Cantel Medical Company" in a smaller, lighter blue font.

and effectiveness as the predicate device, please refer to the table below for a brief discussion of the performance testing.

	Table 2 – Comparison of Non-Clinical Performance Tests for the Predicate and Subject Devices
--	----------------------------------------------------------------------------------------------

Performance Testing	Acceptance Criteria	Results
Simulated-Use Testing -Demonstrates that when used as indicated, thesystem high level disinfects endoscopes usingRapicide PA HLD and Intercept Plus detergent.	Achieve 6-log reduction of the testorganism in each endoscopechannel and endoscope exterior.	Pass
Clinical In-Use Testing -Demonstrates that when used as indicated, thesystem high level disinfects nominal endoscopesusing Rapicide PA HLD after patient/clinical use.	Demonstrate no viable organismsremain after reprocessing.	Pass
Water-Line/Self-Disinfection Cycle Testing -Evaluation of the bactericidal effectiveness ofthe self-disinfection cycle (SDC) and additionalsubject device biofilm analysis by quantitativePolymerase Chain Reaction gene expression.	Survivors after the SDC must be ≤10 CFU of test organism per 100mL.Absence of biofilm formationfollowing self-disinfection cycle.	Pass
Rinse Residual Testing -Evaluation of residual levels of Rapicide PA andIntercept Plus to demonstrate that endoscopesreprocessed in the AER are safe for bothpatients and users.	Any chemistry residuals must beequal to or lower than the lowestreports LD50 exposure with a 10-fold safety margin.	Pass
Material Compatibility -Demonstrates the system compatibility withRapicide PA High Level Disinfectant and subjectdevice compatibility with Intercept PlusDetergent.	Acceptance criteria includeddimensional and weight changes<5%, visual observations and FTIRspectra.	Pass
Critical Parameter/Component FunctionalityTesting -Demonstrates the system consistently andreliably delivers the specified physical processparameters.	All critical process parameters mustachieve and maintain requiredspecifications.	Pass

Electrical Safety and Electromagnetic Compatibility – Electrical safety and electromagnetic compatibility testing has been conducted to demonstrate compliance with IEC 61010 and IEC 61326.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic on the left, followed by the word "MEDIVATORS" in blue, block letters. Below the company name is the text "A Cantel Medical Company" in a smaller font, also in blue. The logo is simple and professional, conveying a sense of trust and reliability.

Software Validation Software validation testing has been conducted to demonstrate ● compliance with IEC 62304.
Human Factors/Usability Evaluation Human factors testing has been conducted to ● demonstrate compliance with ISO 62366.

5. Conclusion

The Advantage Plus Pass-Thru intended use and fundamental scientific technology is the same as the predicate device, the Advantage Plus AER. Performance testing, software verification and validation testing and human factors validation demonstrate that the subject device pass-thru configuration is substantial equivalent to the predicate device. Therefore, based on the intended use, technology and performance data, the subject device is as safe and as effective as the legally marketed predicate device. The Advantage Plus Pass-Thru AER is substantially equivalent to predicate device Advantage Plus AER cleared in 510(k)s – K082988 and K102996.

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.