The Reliance Endoscope Processing System is intended for washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as bronchoscopes, GI flexible endoscopes including duodenoscopes, and their accessories. High level disinfection is achieved within the 50-57°C HLD phase of the endoscope processing cycle (4-minute generation sequence followed by a 6-minute exposure sequence).

Device Description

The Reliance Endoscope Processing System is a high level disinfection system that can wash and high level disinfects up to two manually precleaned, immersible, reusable, heatsensitive, semi-critical devices such as GI flexible endoscopes and related accessories. The system utilizes Reliance™ DG Dry Germicide, a proprietary, safe, and dry peracetic acid generating oxidative chemistry. The Reliance Endoscope Processing System was designed to be versatile in meeting the growing demands of the modern flexible endoscope processing department, while offering patient and staff safety. The Reliance Endoscope Processing System is a combination of products that are used to wash and high level disinfect flexible endoscopes and their accessories.

The Reliance Endoscope Processor is an electromechanical washer/high level disinfector with a microprocessor-based controller that provides for automated endoscope processing cycles and processor self-decontamination cycles.
Reliance DG Dry Germicide is a proprietary, two-part, dry, single-use oxidative chemistry, designed to generate the high level disinfection solution upon automatic dilution in water within the Reliance Endoscope Processor.
Optional washing is provided through the automated delivery of Klenzyme Enzymatic Presoak and Cleaner during the wash phase of the cycle.
CIP 200 Acid-Based Process and Research Cleaner, a general cleaning agent, is used in one of the two self-decontamination cycles provided by the processor.
Various accessories are available to accommodate the processing needs of specific endoscopes and endoscopic accessories.
VERIFY Reliance CI Process Indicator is available to monitor for the presence of the Reliance DG active ingredient, peracetic acid.

AI/ML Overview

The provided document is a 510(k) summary for the STERIS Reliance Endoscope Processing System. It outlines the device's indications for use, technological characteristics, and a summary of non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Key takeaway for your request: This document primarily focuses on showing the equivalence of a slightly modified device (due to a raw material change) to an already cleared predicate device. It is not a study demonstrating the initial performance acceptance criteria for the original device for the purpose of a device efficacy study in terms of AI performance. The device in question is an endoscope reprocessing system, not an AI-powered diagnostic device. Therefore, a significant portion of your requested information, particularly relating to AI performance, ground truth, expert readers, and MRMC studies, is not applicable to this document.

However, I can extract the acceptance criteria and performance results directly from the provided Table 3, which summarizes the new testing performed for this 510(k) submission (related to a raw material change).

Here's the relevant information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Purpose	Acceptance Criteria	Result
Fit test	Confirm components made with new raw material can be installed without interference or issue	No impact on fit of components made with new raw material as compared to device originally cleared in K040049.	PASS
Technical specifications	Confirm specifications of new raw material	Technical specifications must be the same or better than current raw material as compared to device originally cleared in K040049.	PASS
Biocompatibility and Chemical Compatibility	Confirm biocompatibility and chemical compatibility	Biocompatibility and chemical compatibility are unaltered as described in ANSI/AAMI/ISO 10993-1:2018 and ANSI/AAMI/ISO 10993-5:2009.	PASS

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify quantitative sample sizes for the "Fit test," "Technical specifications," or "Biocompatibility and Chemical Compatibility" evaluations. These typically involve material evaluations, bench testing, and potentially a limited number of device assemblies rather than large-scale patient-based test sets as would be seen for an AI diagnostic.
Data Provenance: The document does not explicitly state the country of origin for this specific testing data beyond it being a submission to the U.S. FDA by a company based in Mentor, Ohio, USA. The testing would have been conducted by or for STERIS Corporation. The nature of these tests (material properties, component fit, chemical compatibility) suggests laboratory or manufacturing facility-based evaluations, not clinical data. The document indicates this was non-clinical testing (Page 12, Section 6).

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

Not Applicable. This document pertains to the mechanical, chemical, and material compatibility performance of an endoscope processing system, not an AI diagnostic device that requires expert-established ground truth from images or other medical data.

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

Not Applicable. As above, this type of adjudication is relevant for human interpretation of medical data (e.g., radiology reads), not for the engineering and material performance tests described.

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 device is an automated endoscope reprocessing system, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant for this type of device.

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

Not Applicable. This device does not involve an AI algorithm; it is a physical system for high-level disinfection of endoscopes.

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

For the tests conducted (Fit test, Technical specifications, Biocompatibility/Chemical Compatibility), the acceptance criteria inherently define the "truth." For example, for "Fit test," the ground truth is simply whether the components physically fit and function as intended without interference, consistent with the original design. For "Technical specifications," it's comparison to established material specifications. For "Biocompatibility/Chemical Compatibility," it's compliance with ISO standard requirements for non-cytotoxicity and resistance to the processing chemicals. These are not clinical "ground truths" in the diagnostic sense.

8. The sample size for the training set:

Not Applicable. This is not an AI/machine learning device; therefore, there is no training set.

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

Not Applicable. As there is no training set for an AI model, this question is not relevant.

In summary, the provided document is a regulatory submission for an endoscope reprocessing system, focusing on demonstrating substantial equivalence after a minor material change. It does not involve AI or diagnostic imaging, and therefore, most of the requested information regarding AI performance testing (MRMC, standalone performance, expert ground truth) is outside the scope of this document.

Summary

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March 10, 2022

STERIS Corporation Jennifer Nalepka Lead Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060

Re: K220361

Trade/Device Name: Reliance Endoscope Processing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NZA Dated: February 7, 2022 Received: February 8, 2022

Dear Jennifer Nalepka:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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

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

For comprehensive regulatory information about 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).

Sincerely,

For Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220361

Device Name Reliance Endoscope Processing System

Indications for Use (Describe)

The Reliance Endoscope Processing System is intended for washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as bronchoscopes, Gl flexible endoscopes including duodenoscopes, and their accessories. High level disinfection is achieved within the 50-57°C HLD phase of the endoscope processing cycle (4-minute generation sequence followed by a 6-minute exposure sequence).

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/3/Picture/0 description: The image shows the STERIS logo. The word "STERIS" is in a bold, serif font at the top of the image. Below the word is a graphic of several horizontal, wavy lines in blue. The lines are stacked on top of each other, creating a visual effect of water or waves.

510(k) Summary For Reliance Endoscope Processing System

STERIS 5960 Heisley Road Mentor, OH 44060 Telephone: 440-354-2600

Jennifer Nalepka Contact: Lead Regulatory Affairs Specialist Telephone: 440-392-7458

Summary Date: March 10, 2022

Premarket Notification Number: K220361

STERIS ▪ 5960 Heisley Road ▪ Mentor, OH 44060-1834 USA ▪ 440-354-2600

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1. Device Name

Trade Name: Reliance Endoscope Processing System Device Classification: Class II Common/usual Name: Automated Endoscope Reprocessor Accessories, Germicide, Cleaning, For Endoscopes Classification Name: Classification Number: 21 CFR 876.1500 Product Code: NZA

Predicate Device 2.

Reliance Endoscope Processing System, K203223

3. Description of Device

The system utilizes Reliance™ DG Dry Germicide, a proprietary, safe, and dry peracetic acid generating oxidative chemistry. The Reliance Endoscope Processing System was designed to be versatile in meeting the growing demands of the modern flexible endoscope processing department, while offering patient and staff safety. The Reliance Endoscope Processing System is a combination of products that are used to wash and high level disinfect flexible endoscopes and their accessories.

The Reliance Endoscope Processor is an electromechanical washer/high level ● disinfector with a microprocessor-based controller that provides for automated endoscope processing cycles and processor self-decontamination cycles.
Reliance DG Dry Germicide is a proprietary, two-part, dry, single-use oxidative . chemistry, designed to generate the high level disinfection solution upon automatic dilution in water within the Reliance Endoscope Processor.
Optional washing is provided through the automated delivery of Klenzyme Enzymatic ● Presoak and Cleaner during the wash phase of the cycle.
. CIP 200 Acid-Based Process and Research Cleaner, a general cleaning agent, is used in one of the two self-decontamination cycles provided by the processor.
Various accessories are available to accommodate the processing needs of specific endoscopes and endoscopic accessories.
. VERIFY Reliance CI Process Indicator is available to monitor for the presence of the Reliance DG active ingredient, peracetic acid.

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The Reliance Endoscope Processing Cycle has the following features:

The first part of this cycle is an optional programmable washing phase. This phase consists of a wash that uses Klenzyme, followed by a rinse. The washing phase can be programmed on or off. In the "on" mode, the user can choose either one or two washing phases per processing cycle, and the wash time can be adjusted to be between 5 and 10 minutes. The Reliance washing phase does not replace manual cleaning by the user.
. The second part is a high level disinfection phase that is non-optional and the parameters cannot be changed by the user. In this phase, the proprietary Reliance DG components, provided in a single use container, are dissolved with water at ~50°C for four minutes of generation time and circulated throughout the processor and through device lumens for 6 minutes of high level disinfecting solution exposure time.
Following the high level disinfection phase, the Reliance Endoscope Processor removes the high level disinfecting solution through a rinse phase which is nonoptional and the parameters cannot be changed by the user. The processor filters the rinse water (as well as all of the water used throughout the cycle) through a 0.2 micron bacterial-retentive filter. It also incorporates an automatic internal integrity check of this filter at the end of each processing cycle. If the integrity check fails, an alarm alerts the user, and the processor does not complete the cycle.
. The last step in the processing cycle is an air purge phase using HEPA-filtered air. The air purge helps to remove excess rinse water from the processed devices. The final air purge is preset to run for 4 minutes; additional air purge time may be selected by the operator.
. The processor will print a detailed cycle summary at the end of each cycle that includes information such as processor number, cycle date, start and stop times, as well as phase parameters. With an optional bar code reader, the printouts can also include identification numbers for the operator, patient, device, doctor and procedure.

The processor features two decontamination cycles that are to be used without endoscopes in the processor:

The first, called D-SHORT, consists of hot water circulating through the processor for ● 10 minutes, followed by a 10-minute hot air purge. This cycle is to be run every 54 hours. D-SHORT is intended to prevent biofilm from forming.
. The second, called D-LONG, consists of a cycle in which CIP 200 Acid-Based Process and Research Cleaner is added to hot water. The cleaning solution is then circulated through the processor for 20 minutes; this is followed by three rinses to remove the solution from the processor and a 10-minute hot air purge. D-LONG is to be used on those occasions when the D-SHORT cycle has not been run within the past 54 hours.

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4. Intended Use/Indications for Use

The Reliance Endoscope Processing System is intended for washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semicritical devices such as bronchoscopes, GI flexible endoscopes including duodenoscopes, and their accessories. High level disinfection is achieved within the 50-57°C HLD phase of the endoscope processing cycle (4-minute generation sequence followed by a 6-minute exposure sequence).

5. Technological Characteristic Comparison Tables

The Reliance Endoscope Processing System (EPS) is the same as the predicate device; this submission is provided to demonstrate the validity of the system's ongoing use to process duodenoscopes. A comparison between the predicate and proposed devices can be found in Tables 1 and 2.

Feature	Proposed DeviceReliance EPS	Predicate DeviceReliance EPSK203223	Comparison
Intended Use /Indications forUse	The Reliance EndoscopeProcessing System is intendedfor washing and high leveldisinfection of up to twomanually pre-cleaned,immersible, reusable, heat-sensitive, semi-critical devicessuch as bronchoscopes, GIflexible endoscopes, includingduodenoscopes, and theiraccessories. High leveldisinfection is achieved withinthe 50-57°C HLD phase of theendoscope processing cycle (4-minute generation sequencefollowed by a 6-minuteexposure sequence).	The Reliance EndoscopeProcessing System is intendedfor washing and high leveldisinfection of up to twomanually pre-cleaned,immersible, reusable, heat-sensitive, semi-critical devicessuch as bronchoscopes, GIflexible endoscopes, includingduodenoscopes, and theiraccessories. High leveldisinfection is achieved withinthe 50-57°C HLD phase of theendoscope processing cycle (4-minute generation sequencefollowed by a 6-minuteexposure sequence).	Identical
	OperatingPrinciples/Technology	The Reliance EPS and itsintegrated endoscope processingsupport provide for delivery ofsolutions and fluids toendoscopes and theiraccessories. Klenzyme andReliance DG are introduced intothe Reliance EPS to providewashing and high leveldisinfection. Decontaminationcycles (D-Long with CIP-200	The Reliance EPS and itsintegrated endoscope processingsupport provide for delivery ofsolutions and fluids toendoscopes and theiraccessories. Klenzyme andReliance DG are introduced intothe Reliance EPS to providewashing and high leveldisinfection. Decontaminationcycles (D-Long with CIP-200	Identical
		Feature	Proposed DeviceReliance EPS	Predicate DeviceReliance EPSK203223	Comparison
			and D-Short) are used toprevent biofilm formation in theReliance EPS Processor andensure effective processingfollowing periods of processorinactivity.	and D-Short) are used to preventbiofilm formation in theReliance EPS Processor andensure effective processingfollowing periods of processorinactivity.
		ProcessParameters	Standardized cycle parameterscannot be altered by operator.The critical process parametersare:• Contact Time• Use Dilution Temperature• Cleaning solution andReliance DG concentration• Water filter integrity	Standardized cycle parameterscannot be altered by operator.The critical process parametersare:• Contact Time• Use Dilution Temperature• Cleaning solution andReliance DG concentration• Water filter integrity	Identical
		ProcessMonitors	• Control Handle Bootpressure alarms if pressuretoo low to process, or if toohigh and could potentiallydamage scopes(specification 6.5 – 10.5PSI).• Detection of a freshReliance DG container inevery processing cycleCleaning Solution levelmonitored; alarm indicateswhen container does nothave sufficient amount tocomplete cycle• Temperature alarms ifoutside of range• Water filter integrity test atend of each high leveldisinfection cycle.	• Control Handle Bootpressure alarms if pressuretoo low to process, or if toohigh and could potentiallydamage scopes(specification 6.5 – 10.5PSI).• Detection of a freshReliance DG container inevery processing cycleCleaning Solution levelmonitored; alarm indicateswhen container does nothave sufficient amount tocomplete cycle• Temperature alarms ifoutside of range• Water filter integrity test atend of each high leveldisinfection cycle.	Identical
		DesignFeatures	• Intended for use withReliance DG only• Microprocessor controlled• Internal componentsconstructed of stainlesssteel, silicone,polypropylene and PVDF.• Processor provides 0.2micron filtered water forwashing, disinfection andrinsing	• Intended for use withReliance DG only• Microprocessor controlled• Internal componentsconstructed of stainlesssteel, silicone,polypropylene and PVDF.• Processor provides 0.2micron filtered water forwashing, disinfection andrinsing	Identical
	Feature	Proposed DeviceReliance EPS	Predicate DeviceReliance EPSK203223	Comparison
		Automated injection of cleaning solutions Automated generation and delivery of high level disinfecting solution Air intake for Air Purge is HEPA filtered	Automated injection of cleaning solutions Automated generation and delivery of high level disinfecting solution Air intake for Air Purge is HEPA filtered
CycleDescription	Optional: Wash 1 with 1 rinse or Wash 2 with 1 rinse Wash time can be adjusted to be between 5 and 10 minutes, 40 second rinse Additional "smart rinse" occurs after optional wash if boot pressure < 7.0 psi is detected during the heating phase prior to generation phase: 40 second rinse HLD Generation: 4 minutes HLD Exposure: 6 minutes Rinse 1: 40 seconds Rinse 2: 40 seconds Air purge Can be adjusted to be between 4 and 30 minutes	Optional: Wash 1 with 1 rinse or Wash 2 with 1 rinse Wash time can be adjusted to be between 5 and 10 minutes, 40 second rinse Additional "smart rinse" occurs after optional wash if boot pressure < 7.0 psi is detected during the heating phase prior to generation phase: 40 second rinse HLD Generation: 4 minutes HLD Exposure: 6 minutes Rinse 1: 40 seconds Rinse 2: 40 seconds Air purge Can be adjusted to be between 4 and 30 minutes	Identical
MaintenanceRequirements	D-SHORT decontamination cycle required every 54-hours D-LONG decontamination cycle required if D-SHORT not performed within past 54 hours Periodic cleaning of debris screen and spray arms Periodic replacement of water and air filters	D-SHORT decontamination cycle required every 54-hours D-LONG decontamination cycle required if D-SHORT not performed within past 54 hours Periodic cleaning of debris screen and spray arms Periodic replacement of water and air filters	Identical
Accessories
ChemicalIndicator	VERIFY Process Indicator forReliance EPS, K063285.Peracetic acid dose indicator forroutine monitoring of RelianceEPS using Reliance DG.	VERIFY Process Indicator forReliance EPS, K063285.Peracetic acid dose indicator forroutine monitoring of RelianceEPS using Reliance DG.	Identical
Feature	Proposed DeviceReliance EPS	Predicate DeviceReliance EPSK203223	Comparison
	Chemical reaction on indicatorpad to produce color change.	Chemical reaction on indicatorpad to produce color change.
Flow Units	Flow units are required only forscope channels that do not openin the endoscope control handleor mechanical action is requiredfor valve operation. ElevenFlow Units are available.	Flow units are required only forscope channels that do not openin the endoscope control handleor mechanical action is requiredfor valve operation. ElevenFlow Units are available.	Identical

Table 1. Technological comparison for Reliance EPS

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Table 2. Technological comparison of Reliance DG Dry Germicide

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' Block, S. ed., Disinfection, Sterilization, and Preservation. 5ª edition, 2001
² Clapp et al., Free Rad. Res., (1994) 21:147-167
³ Maillard et al., J. Med Microbiol. (1996)

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6. Summary of Non-Clinical Testing

Shown in Table 3 is the new testing that was performed to evaluate the device.

Test	Purpose	Acceptance Criteria	Result
Fit test	Confirm componentsmade with new rawmaterial can beinstalled withoutinterference or issue	No impact on fit of componentsmade with new raw material ascompared to device originallycleared in K040049.	PASS
Technical specifications	Confirm specificationsof new raw material	Technical specifications mustbe the same or better thancurrent raw material ascompared to device originallycleared in K040049.	PASS
Biocompatibility andChemical Compatibility	Confirmbiocompatibility andchemical compatibility	Biocompatibility and chemicalcompatibility are unaltered asdescribed in ANSI/AAMI/ISO10993-1:2018 andANSI/AAMI/ISO 10993-5:2009.	PASS

Table 3. Summary of verification activities

7. Summary of Clinical Testing

Clinical testing was not performed because it is not applicable for this submission.

8. Conclusion

Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device (K203223), Class II (21 CFR 876.1500), product code NZA.

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.

	Proposed Device	Predicate Device	Comparison
Feature	Reliance DG Dry Germicide	Reliance DG Dry Germicide
Indications forUse	The Reliance EndoscopeProcessing System is intendedfor washing and high leveldisinfection of up to twomanually pre-cleaned,immersible, reusable, heat-sensitive, semi-critical devicessuch as bronchoscopes, GIflexible endoscopes, includingduodenoscopes, and theiraccessories. High leveldisinfection is achieved withinthe 50-57°C HLD phase of theendoscope processing cycle (4-minute generation sequencefollowed by a 6-minuteexposure sequence).	The Reliance EndoscopeProcessing System is intendedfor washing and high leveldisinfection of up to twomanually pre-cleaned,immersible, reusable, heat-sensitive, semi-critical devicessuch as bronchoscopes, GIflexible endoscopes, includingduodenoscopes, and theiraccessories. High leveldisinfection is achieved withinthe 50-57°C HLD phase of theendoscope processing cycle (4-minute generation sequencefollowed by a 6-minute exposuresequence).	Identical.
GermicideExposure Time(min) for HLD	10 minutes(4-minute generation sequencefollowed by a 6-minuteexposure sequence)	10 minutes(4-minute generation sequencefollowed by a 6-minute exposuresequence)	Identical
UseTemperature	50 - 57°C	50 - 57°C	Identical
Reuse	Single use	Single use	Identical
Human Factors	Dispensed ready to use.Container opened automaticallyby the processor, limiting userexposure to the germicide.	Dispensed ready to use.Container opened automaticallyby the processor, limiting userexposure to the germicide.	Identical
Physical and Chemical Properties
Container	Single-use,2 Compartment Container	Single-use,2 Compartment Container	Identical
Composition,Packagedproduct	Dry/Dry	Dry/Dry	Identical
Feature	Proposed DeviceReliance DG Dry Germicide	Predicate DeviceReliance DG Dry Germicide	Comparison
ActiveIngredient	Peracetic acid, generated in situ	Peracetic acid, generated in situ	Identical
Mode of Action	It is believed that peracetic acidexerts its germicidal effect byseveral mechanisms:-oxidizing sulfhydral and sulfurbonds in proteins and enzymes,particularly in the cell walls1 -hydroxyl radicals producedfrom PAA are bactericidal2-PAA damages the viral capsidand viral nucleic acid3,4	It is believed that peracetic acidexerts its germicidal effect byseveral mechanisms:-oxidizing sulfhydral and sulfurbonds in proteins and enzymes,particularly in the cell walls1-hydroxyl radicals produced fromPAA are bactericidal2-PAA damages the viral capsidand viral nucleic acid3,4	Identical
Rinses	2 rinses, 40 seconds each, with0.2µ filtered water.	2 rinses, 40 seconds each, with0.2µ filtered water.	Identical
	Microbial Efficacy
SporicidalActivity ofDisinfectantsAOAC OfficialMethod 966.04	Meets efficacy requirements.5Bacillus subtilisClostridium sporogenes	Meets efficacy requirements.5Bacillus subtilisClostridium sporogenes	Identical
ConfirmatorySporicidalActivity ofDisinfectantsAOAC OfficialMethod 966.04	Meets efficacy requirements.5Bacillus subtilisClostridium sporogenes	Meets efficacy requirements.5Bacillus subtilisClostridium sporogenes	Identical
FungicidalActivity ofDisinfectantsAOAC OfficialMethod 955.17	Solution is fungicidal.Trichophyton mentagrophytes	Solution is fungicidal.Trichophyton mentagrophytes	Identical
Use-DilutionMethod AOAC,OfficialMethods 955.14,955.15, 964.02	Solution is bactericidal.Salmonella choleraesuisStaphylococcus aureusPseudomonas aeruginosa	Solution is bactericidal.Salmonella choleraesuisStaphylococcus aureusPseudomonas aeruginosa	Identical
EPA VirucidalTesting(DIS/TSS-7,Nov. 1981)	Process conditions arevirucidal.Herpes simplex Type 1Adenovirus Type 5Poliovirus Type 1	Process conditions are virucidal.Herpes simplex Type 1Adenovirus Type 5Poliovirus Type 1	Identical
Feature	Proposed DeviceReliance DG Dry Germicide	Predicate DeviceReliance DG Dry Germicide	Comparison
TuberculocidalActivity ofDisinfectantsAOAC OfficialMethod 965.12	Solution is tuberculocidal.Mycobacterium bovis	Solution is tuberculocidal.Mycobacterium bovis	Identical
TuberculocidalActivity AscenziQuantitativeSuspension Test	Solution is tuberculocidalMycobacterium terrae	Solution is tuberculocidalMycobacterium terrae	Identical
Simulated-UseTest	Meets efficacy requirementMycobacterium terrae	Meets efficacy requirementMycobacterium terrae	Identical
Biocompatibility
CytotoxicityDevice Extracts	Non-cytotoxic per ISO 10993-5	Non-cytotoxic per ISO 10993-5	Identical
ResidueReduction	Automatic within the RelianceEndoscope Processor, 2 x 15 L– 0.2 µ filtered water rinsesafter HLD cycle effectivelyreduces germicide residues tosafe levels.	Automatic within the RelianceEndoscope Processor, 2 x 15 L -0.2 µ filtered water rinses afterHLD cycle effectively reducesgermicide residues to safe levels.	Identical
Device MaterialCompatibility	Compatible with intendedflexible endoscopes andaccessories established throughtesting finished medicaldevices. No device functionalchanges.Some materials show cosmeticchanges such as fading ofexternal markings but allremained legible, and bleachingof black anodized aluminumwithout harm to the basematerial.	Compatible with intendedflexible endoscopes andaccessories established throughtesting finished medical devices.No device functional changes.Some materials show cosmeticchanges such as fading ofexternal markings but allremained legible, and bleachingof black anodized aluminumwithout harm to the basematerial.	Identical