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 GI flexible endoscopes, bronchoscopes 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 an economical, easy-to-use high level disinfection system intended to wash and high level disinfect up to two manually cleaned, immersible, reusable, heat-sensitive, 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 the highest level of 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Reliance® Endoscope Processing System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a formal table of "acceptance criteria," but rather describes various performance validations and their successful outcomes. I've synthesized this information into a table format based on the description of safety and substantial equivalence testing.

Acceptance Criterion (Implicit)	Reported Device Performance
Microbiological Efficacy - Reliance DG Dry Germicide:
Sporicidal activity	Proven sporicidal as defined by AOAC Sporicidal Activity Test with a 6-minute in situ exposure time, confirmed with supplemental testing in the processor and using aged germicide.
Tuberculocidal activity	Proven tuberculocidal as defined by AOAC Tuberculocidal Activity Test with a 6-minute exposure time, confirmed using aged germicide.
Virucidal activity	Reduced viable population of poliovirus Type 1, adenovirus Type 5, and herpes simplex virus Type 1 by > 4 log10.
Bactericidal activity	Proven bactericidal as defined by AOAC Bactericidal Activity Test with a 6-minute exposure time at worst-case conditions, both in situ and in vitro.
Fungicidal activity	Proven fungicidal as defined by AOAC Fungicidal Activity Test with a 6-minute exposure time, both in situ and in vitro.
Processor Performance - Endoscope Processing Cycle:
Simulated-Use (Mycobacterium terrae reduction)	Reliably achieved > 6 log10 reduction of Mycobacterium terrae in triplicate trials using selected clinically relevant flexible endoscopes and accessories (representing challenging devices) within the processor, at minimum recommended germicide dose.
In-Use (no organism recovery)	No organisms recovered after processing of three flexible endoscopes in an in-use study in a US hospital.
Washing phase effectiveness (visual cleanliness & protein removal)	Devices pre-soiled with eggs, blood, mucin, and serum were visually clean and achieved greatly reduced extractable protein (< 5 µg/cm²) after the shortest possible washing phase (reduced from >173 µg/cm²).
Rinse phase effectiveness (residue removal, non-cytotoxicity)	Residuals remaining on devices were far below allowable limits and non-cytotoxic, even under worst-case exposure conditions. Processor final rinse water was found to be non-cytotoxic.
Air purge phase effectiveness	System's ability to remove rinse water from processed medical devices confirmed.
Filter integrity test system reliability	Documented to reliably detect filter failure.
Critical process parameters (e.g., temp, volume, boot pressure)	Each critical parameter was found to be within required specifications in replicate under worst-case conditions.
Processor Performance - Self-Decontamination Cycles:
D-LONG cycle effectiveness	Can disinfect the processor after a high-level challenge with Pseudomonas aeruginosa followed by a 5-day inactive period.
D-SHORT cycle effectiveness	Can kill bacteria with the potential to form biofilm.
Biocompatibility:
Safe handling and use of chemicals	Chemical formulations (as supplied and in-use dilutions) can be safely handled. Residues on medical endoscopes are below established limits and do not pose a risk. Safety statements are appropriate.
Residual toxicity on medical devices	Biocompatibility testing of extracts from processed medical devices demonstrated no toxic residuals remain under worst-case circumstances. Worst-case residue levels for high-risk components are far below allowable limits. Use dilution reaches non-cytotoxic levels with minimal dilution.
Material Compatibility:
Effect on medical devices (e.g., endoscopes)	After 300 processing cycles, no deleterious effects were observed on intact medical devices, including flexible endoscopes and/or common materials of device construction, other than minor cosmetic changes. No functional changes were observed.
Germicide Stability:
Shelf life	Found stable for 18 months in unopened moisture-resistant packaging at stated conditions. Once opened, containers must be used within 2 weeks or by expiration, whichever comes first.
Electrical Standards Compliance:	Certifield to ANSI/UL -61010-1, CAN/CSA C22.2 61010-1, IEC 61010-1:2001, IEC 61010-2-40, 1st Ed., and IEC 61326-1:2005, 1st Ed.

2. Sample Sizes and Data Provenance

Test Set (Simulated-Use): Triplicate trials for the Mycobacterium terrae reduction study, using "selected clinically relevant flexible endoscopes and their accessories." The document states these "represented the range of most challenging devices, accessories, and processing situations." No specific number of endoscopes or accessories is provided beyond "selected."
Test Set (In-Use): Three flexible endoscopes were used, representing the range of types indicated in the product labeling. Triplicate evaluations were performed for each endoscope.
Test Set (Material Compatibility): "300 processing cycles" were performed on medical devices, including flexible endoscopes and/or common materials of device construction.
Data Provenance:
- The "In-Use" study was conducted in a "US hospital."
- Other studies (Sporicidal, Tuberculocidal, Virucidal, Bactericidal, Fungicidal, Simulated-Use, Biocompatibility, Material Compatibility, Stability) appear to be laboratory-based studies.
- All data are prospective as they are part of a premarket notification for a new device.

3. Number of Experts and Qualifications

The document does not specify the number or qualifications of experts used to establish ground truth for any of the described tests. The studies rely on established microbiological test methods (e.g., AOAC) and standard laboratory and in-use protocols rather than expert consensus on diagnostic imaging or similar subjective assessments.

4. Adjudication Method

Adjudication methods (like 2+1 or 3+1 for resolving discrepancies) are typically used in studies involving human interpretation or subjective assessment where a "ground truth" needs to be established from multiple readers. This document describes performance testing of a physical device and chemical efficacy, which relies on objective measurements (e.g., bacterial reduction, presence of residues, visual cleanliness, functional integrity) rather than subjective human interpretation. Therefore, no adjudication method as typically described in imaging studies was used or mentioned.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document is for an automated endoscope processing system, which does not involve human readers interpreting cases or images.

6. Standalone (Algorithm Only) Performance Study

The entire document describes the standalone performance of the "Reliance Endoscope Processing System," which is an automated device performing the washing and high-level disinfection process. All the performance figures reported (microbiological efficacy, cleaning efficacy, cycle performance, material compatibility) characterize the device's inherent capabilities without human intervention during the defined processing cycle (though human manual pre-cleaning and loading/unloading are explicit parts of the overall process).

7. Type of Ground Truth Used

The ground truth for the various tests was established using:

Microbiological assays: For sporicidal, tuberculocidal, virucidal, bactericidal, fungicidal, and Mycobacterium terrae reduction (quantitative measures of organism reduction/kill).
Visual inspection and quantitative protein assays: For cleaning efficacy (visual cleanliness and µg/cm² protein).
Chemical analysis and cytotoxicity testing: For residue levels and biocompatibility.
Functional and visual inspection after repeated cycles: For material compatibility.
Analytical measurements: For critical process parameters (temperature, volume, pressure, etc.) and germicide stability.
Clinical observation/microbiological cultures: For the in-use study (recovery of organisms).
Standardized electrical tests: For electrical standards compliance.

8. Sample Size for the Training Set

The document focuses on validation studies, not on the development of a machine learning algorithm that would require a distinct "training set." Therefore, no training set sample size is applicable or mentioned. The device's operational parameters and design would have been developed iteratively, but not through a formal "training set" in the context of AI/ML.

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

As there is no training set for an AI/ML algorithm involved, the question of how its ground truth was established is not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the word "STERIS" in large, bold, capital letters. Above the word "STERIS" is the text "K102244". To the right of the word "STERIS" is the text "p1 of 7". Below the word "STERIS" is a logo that consists of several horizontal lines.

DEC 3 2010

510(k) Summary For Reliance® Endoscope Processing System

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198

Contact:

Robert F. Sullivan Senior Director, Regulatory Affairs Telephone: (440) 392-7695 (440) 357-9198 Fax No:

October 14, 2010 Summary Date:

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

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Device Name 1.

Trade Name:	Reliance Endoscope Processing System
Common/usual Name:	Automated Endoscope Reprocessor
Classification Name:	21 CFR 876.1500Endoscope Cleaning Germicide Accessories

2. Predicate Device

Reliance Endoscope Processing System K040049

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 the highest level of 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 cleaning phase does not replace manual cleaning by the user.
K102244
=> 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 disinfection solution exposure time.
Following the high level disinfection phase, the Reliance Endoscope Processor removes the high level disinfection solution through a rinse phase which is non-optional 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 HEPAfiltered 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 10minute 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

The Reliance Endoscope Processing System is intended for washing and high level disinfection of up to two manually cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes, bronchoscopes 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 6minute exposure sequence).

5. Description of Safety and Substantial Equivalence

The Reliance Endoscope Processing System has the same technological characteristics as the predicate device.

A summary of performance testing applicable to both the proposed Reliance Endoscope Processing System and its predicate Reliance Endoscope Processing System is provided in the Table attached.

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The Reliance Endoscope Processing System was developed and validated in accord with two primary FDA Guidance documents: Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants (2000), and · Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers (1993). A summary of this testing follows: · Reliance DG Dry Germicide Efficacy: Reliance DG Dry Germicide was tested and shown to generate an effective high level disinfection solution using the standard array of microbiological tests for germicidal efficacy. The following testing was performed at conditions of use that were worst case with respect to contact time, circulation, water hardness, temperature, artificial soiling, and germicide concentration (at or below the minimum effective dose of 9000 mg/L PAA minutes): Sporicidal: Reliance DG Dry Germicide was proven to be sporicidal as defined by AOAC Sporicidal Activity Test with an in situ exposure time of 6 minutes. Confirmatory testing was completed successfully and supplemental confirmatory testing was completed in the Reliance Endoscope Processor. Potency was subsequently confirmed in the processor using Reliance DG Dry Germicide containers that were aged beyond the end of its shelf life. > Tuberculocidal: Reliance DG Dry Germicide was proven to be tuberculocidal as defined by the AOAC Tuberculocidal Activity Test on-clir with an exposure time of 6 minutes. Potency was subsequently confirmed using Reliance DG Dry Germicide aged beyond the end of its shelf life. > Virucidal: The Reliance Process was proven to reduce the viable population of poliovirus Type 1, adenovirus Type 5, and herpes simplex virus Type 1 by > 4 log10-> Bactericidal: Reliance DG Dry Germicide was proven to be bactericidal as defined by the AOAC Bactericidal Activity Test with an exposure time of 6 minutes at worst case conditions, whether performed in situ or in vitro. > Fungicidal: Reliance DG Dry Germicide was proven to be fungicidal as defined by the AQAC Fungicidal Activity Test with an exposure time of 6 minutes, whether performed in situ or in vitro. Simulated-Use: Reliance DG Dry Germicide, at the minimum recommended dose, reproducibly achieved greater than a 6 log10 reduction of Mycobacterium terrae in triplicate trials within the Reliance Endoscope Processor for selected clinically relevant flexible endoscopes and their accessories. The test articles represented the range of most challenging devices, accessories, and processing situations. In-Use: Reliance Endoscope Processing System was evaluated in an in use study in a US hospital. Three flexible endoscopes representing the range of types indicated in the product labeling were used in clinical procedures and processed according to instructions for use. In triplicate evaluations of each endoscope, no organisms were recovered after processing. Bioburden levels on the clinically used endoscopes after manual cleaning and before high level disinfection were determined to be as high as 105 CFU/device.

Appendix A: Page 6 of 8

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Non-clinica Germicide Biocompatibili Material Compatibility

Biocompatibility:

The Reliance chemical formulations, as supplied in packaging as well as in use dilutions, can be safely handled and used by customers. Residues that may remain on medical endoscopes and accessories are below established residue limits and do not pose a risk to patients. Safety statements in product labeling are appropriate to the potential risk.

56077

Reliance DG Dry Germicide, its components, reaction products, and residuals remaining on medical devices were evaluated for biocompatibility and possible risks to users. Testing included acute oral and ocular toxicity tests, dermal irritation studies, in vitro bacterial mutation genotoxicity studies, sensitization tests, and in vitro cytotoxicity evaluations; literature reviews of raw material toxicity data were also performed. Certain components in the single-use container, which under normal use conditions never contact the user, have the potential for irritation or skin sensitization; therefore appropriate warnings and instructions are displayed on labeling for the unusual event of a spill or container breakage.
Use dilution reaches non-cytotoxic levels with minimal dilution. îî
Biocompatibility testing of extracts from processed medical devices demonstrated that no toxic residuals remain on devices under worst case circumstances. The test data indicate that the worst case residue levels for the components of maximum potential risk are far below the allowable limits. Furthermore, the processor final rinse water was found to be non-cytotoxic.

· Reliance Endoscope Processing System Material Compatibility:

The Reliance System was evaluated for its effect on intact medical devices. including flexible endoscopes and/or common materials of device construction. After 300 processing cycles, no deleterious effects were observed other than minor cosmetic changes. No functional changes in flexible endoscopes were observed.

· Reliance DG Dry Germicide Stability:

Reliance DG was tested and found stable for 18 months in the unopened moisture-resistant packaging at the stated conditions for storage. Once opened, the containers within each pouch are to be used within 2 weeks, or by the expiration date on the container, whichever comes first.

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	Reliance Endoscope Processor Performance
	The critical process parameters for the processor (water temperature and volume, fresh Reliance DG Dry Germicide container detection, boot pressure, delivery of washing solutions and high level disinfection solution and water filter integrity testing) were each evaluated in replicate under worst case conditions and found to be within required specifications.
	Each processor phase or cycle was separately evaluated and documented to be effective under worst case conditions:
	⇒ Validation of the washing phase of the Endoscope Processing Cycle documented that after the shortest possible washing phase, devices pre-soiled with a combination of eggs, blood, mucin and serum in saline: 1) were visually clean, and 2) achieved greatly reduced yield of extractable protein per cm2 device area (assayed to be reduced from >173 to < 5 µg/cm2).
Non-clinical Tests:Processor Performance	⇒ Validation of the high level disinfection phase of the Endoscope Processing Cycle was performed through a simulated-use study in challenging clinically relevant endoscopes, as well as in an in-use study.
	⇒ The rinse phase of the endoscope processing cycle was shown to be effective. Evaluations of extracts of devices exposed to worst case conditions in the Endoscope Processing Cycle documented that levels of residuals remaining on devices were far below allowable limits and were not cytotoxic.
	⇒ The air purge phase was validated to confirm the ability to remove rinse water from processed medical devices.
	⇒ The filter integrity test system of the processor was documented to reliably detect filter failure.
	⇒ The two self-decontamination cycles were shown to be effective as follows:
	D-LONG cycle - can disinfect the Reliance Endoscope Processor after a high level challenge with Pseudomonas aeruginosa followed by a 5 day inactive period; D-SHORT cycle - can kill bacteria that have potential to form biofilm.
Reliance Endoscope Processor is certified to the following electrical standards	ANSI/UL -61010-1, 2nd Ed.,	Electrical equipment for measurement, control and laboratory use Part 1, 2nd Edition
	CAN/CSA C22.2 61010-1, 2nd Ed.	Electrical equipment for measurement, control and laboratory use Part 1, 2nd Edition
	IEC 61010-1:2001	Safety requirements for electrical equipment for measurement, control and laboratory use, Part 1: General requirements,
	IEC 61010-2-40, 1st Ed.	Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
	IEC 61326-1:2005, 1st Ed.	Electrical equipment for measurement, control and laboratory use, EMC requirements Part 1: General requirements

K102244

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

Mr. Robert F. Sullivan Senior Director, Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060

Re: K102244

Trade/Device Name: Reliance® Endoscope Processing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II DEC - 3 2010 Product Code: NZA Dated: October 26, 2010 Received: October 27, 2010

Dear Mr. Sullivan:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your secures of the device is substantially equivalent (for the relerched doove and have a trennilosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate conmisered prof to may 20, 10, 10, 10, 10, 10, 20, 20, 2011, 10, 2019, 10, 2019, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 1 Amendinents, or to de riocs that navis Act (Act) that do not require approval of a premarket the Federal Food, Drug, and Cosment . At (Prec) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . approval uppireation (1 Milly). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, requirencens for annual rogistration, including 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 (FINA), It may be subject to ademicined Regulations, Title 21, Parts 800 to 898. In device can be found in the Code of Pourial Regarmers, concerning your device in the Federal Register.

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Page 2- Mr. Sullivan

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 incall that it DAT has made a determand regulations administered by other Federal agencies. Of the Act of ally I ederal banks in requirements, including, but not limited to: registration 1 ou must comps) with 807); labeling (21 CFR Part 801); medical device reporting allu listing (21 OF R F ar vor ); lated adverse events) (21 CFR 803); good manufacturing (reporting of modical device to 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sincerery yours,

Anthony D. 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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Reliance® Endoscope Processing System

Indications for Use:

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)

Elzath & Clamine-Wels

vision Sign-Off)
ivision of Anesthesiology, General Hospital
Anesthes
fection Control, Dental Devices

510(k) Number: K102244
Page 1 of 1

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.