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℃ 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.

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 text describes the STERIS® Reliance® Endoscope Processing System, an automated endoscope reprocessor. The document is a 510(k) summary submitted to the FDA, demonstrating substantial equivalence to a predicate device and providing performance data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the success of the tests conducted according to FDA guidance documents for germicidal efficacy, simulated-use, and in-use studies. The reported device performance indicates that these criteria were met.

Acceptance Criterion (Implicit)	Reported Device Performance
Germicide Efficacy (Reliance DG Dry Germicide):
Sporicidal activity (defined by AOAC Sporicidal Activity Test with 6 minutes exposure).	Proven sporicidal in situ. Confirmatory testing completed, supplemental confirmatory testing in the processor with aged germicide.
Tuberculocidal activity (defined by AOAC Tuberculocidal Activity Test with 6 minutes exposure).	Proven tuberculocidal. Potency confirmed with aged germicide.
Virucidal activity (reduction of poliovirus Type 1, adenovirus Type 5, and herpes simplex virus Type 1 by > 4 log₁₀).	Proven to reduce viable population by > 4 log₁₀.
Bactericidal activity (defined by AOAC Bactericidal Activity Test with 6 minutes exposure at worst case conditions).	Proven bactericidal in situ or in vitro.
Fungicidal activity (defined by AOAC Fungicidal Activity Test with 6 minutes exposure).	Proven fungicidal in situ or in vitro.
Simulated-Use Study (High-Level Disinfection performance within the processor):
Greater than a 6 log₁₀ reduction of Mycobacterium terrae within the Reliance Endoscope Processor.	Reproducibly achieved greater than a 6 log₁₀ reduction of Mycobacterium terrae in triplicate trials using selected clinically relevant flexible endoscopes and accessories (representing most challenging devices).
In-Use Study (Clinical effectiveness after manual cleaning and high-level disinfection):
No organisms recovered after processing clinically used endoscopes.	In triplicate evaluations of each of three flexible endoscopes (representing the product labeling range) used in clinical procedures, no organisms were recovered after processing. Bioburden levels prior to processing were as high as 10⁵ CFU/device.
Biocompatibility (Residues on medical devices):
Residues remaining on medical endoscopes and accessories below established residue limits and non-cytotoxic.	Residues remaining on medical endoscopes and accessories are below established residue limits and do not pose a risk. Biocompatibility testing of extracts from processed devices demonstrated no toxic residuals. Processor final rinse water was found to be non-cytotoxic.
Material Compatibility:
No deleterious effects or functional changes on medical devices (e.g., flexible endoscopes) after repeated processing cycles (e.g., 300 cycles).	After 300 processing cycles, no deleterious effects were observed other than minor cosmetic changes. No functional changes in flexible endoscopes were observed.
Processor Performance (Critical Process Parameters):
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 within required specifications under worst-case conditions.	Each critical parameter was evaluated in replicate under worst case conditions and found to be within required specifications.
Washing phase effectiveness: Devices pre-soiled with combination of eggs, blood, mucin, and serum in saline are visually clean and achieve greatly reduced yield of extractable protein per cm² device area (e.g., reduced from >173 to < 5 μg/cm²).	Documented that after the shortest possible washing phase, devices were visually clean and achieved greatly reduced yield of extractable protein per cm² device area (reduced from >173 to < 5 μg/cm²).
Rinse phase effectiveness: Levels of residuals remaining on devices below allowable limits and non-cytotoxic.	Evaluated 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.
Air purge phase effectiveness: Ability to remove rinse water from processed medical devices.	Validated to confirm the ability to remove rinse water from processed medical devices.
Filter integrity test system reliability: Reliably detect filter failure.	Documented to reliably detect filter failure.
D-LONG cycle effectiveness: Disinfect the processor after a high-level challenge with Pseudomonas aeruginosa followed by 5 days inactive period.	Proven effective to disinfect the Reliance Endoscope Processor after a high level challenge with Pseudomonas aeruginosa followed by a 5 day inactive period.
D-SHORT cycle effectiveness: Kill bacteria that have the potential to form biofilm.	Proven effective to kill bacteria that have potential to form biofilm.

2. Sample Sizes Used for the Test Set and Data Provenance

Germicide Efficacy Tests (Sporicidal, Tuberculocidal, Virucidal, Bactericidal, Fungicidal): "Standard array of microbiological tests" and "triplicate trials" are mentioned for simulated-use. Specific sample sizes for each in vitro test are not explicitly quantified in the provided text beyond these general statements.
Simulated-Use Study: "Triplicate trials" for Mycobacterium terrae reduction. No specific number of endoscopes or accessories is explicitly stated, other than "selected clinically relevant flexible endoscopes and their accessories" and "represented the range of most challenging devices."
In-Use Study: "Three flexible endoscopes representing the range of types indicated in the product labeling" were used. "In triplicate evaluations of each endoscope." This indicates a total of 9 clinical processing events (3 endoscopes x 3 evaluations).
Material Compatibility: "After 300 processing cycles."
Processor Performance: "Each critical process parameter... evaluated in replicate." Specific number of replicates not provided beyond "replicate."
Data Provenance:
- In-Use Study: Conducted in a "US hospital" (prospective, clinical).
- All other tests (Germicide Efficacy, Simulated-Use, Biocompatibility, Material Compatibility, Processor Performance, Stability): These appear to be laboratory-based studies (likely prospective, conducted by the manufacturer or contract labs). The text does not specify external data sources or retrospective analysis for primary efficacy/safety testing.

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

The provided text does not mention the use of human experts to establish ground truth for the test sets (i.e., for determining sterility, log reduction, etc.). The ground truth for these studies is based on quantitative microbiological assays and analytical chemistry methods, which are objective and do not require expert consensus for interpretation.

4. Adjudication Method for the Test Set

Not applicable. The ground truth is objective (microbiological tests, chemical analysis, visual inspection for cleanliness, etc.), rather than expert-derived or needing adjudication.

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 reprocessor, not an AI-assisted diagnostic device that would involve human readers interpreting images.

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

Yes, the primary studies described (Germicide Efficacy, Simulated-Use, Processor Performance, Material Compatibility) are all "standalone" in the sense that they evaluate the device's performance directly, independent of a human operator's judgment in the final assessment of disinfection efficacy or product integrity. The "in-use" study has a manual cleaning step by a human prior to automated processing, but the outcome assessment (microbiological culture) is objective and independent of human interpretation.

7. The Type of Ground Truth Used

The ground truth used in these studies is primarily objective laboratory measurements and outcomes data:

Microbiological Culture and Assays: For sporicidal, tuberculocidal, virucidal, bactericidal, fungicidal, simulated-use (Mycobacterium terrae reduction), and in-use studies (recovery of organisms).
Chemical Analysis: For germicide concentration, pH, chelation capacity, and detection of residues on devices.
Visual Inspection: For visual cleanliness after the washing phase.
Protein Assays: For measuring extractable protein per cm² device area.
Functional Testing: For assessing functional changes in endoscopes after repeated processing.
Measurements against Specifications: For critical process parameters (temperature, volume, pressure, filter integrity).

8. The Sample Size for the Training Set

Not applicable. This device is an electromechanical system with chemical efficacy, not a machine learning or AI-based system that requires a "training set" in the context of algorithm development. Its performance is based on physical and chemical principles and verified through empirical testing.

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

Not applicable, as no training set (in the context of AI/ML) was used.

Summary

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K110453 STERIS®
p1 of 7

MAR 1 6 2011

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 Fax No:

Summary Date:

February 15, 2011

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

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Image /page/1/Picture/0 description: The image shows the word "STERIS" in large, bold letters. Above the word "STERIS" is the text "K110453 p.2 of 7" in a handwritten font. Below the word "STERIS" is a graphic of several horizontal wavy lines stacked on top of each other.

1. Device Name

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

2. Predicate Device

Reliance Endoscope Processing System K102244

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.

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. Verify Reliance CI Process Indicator is available to monitor for the presence of the Reliance DG active ingredient, peracetic acid.

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.
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 10-

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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.

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.

The redesigned Reliance DG Dry Germicide secondary packaging configuration has been tested through the labeled shelf life of the product under defined storage conditions that represent a range of environmental stresses. After removal from the packaging throughout its shelf life, as well as after an additional two-week use life outside the packaging, Reliance DG containers met established acceptance criteria for visual physical integrity of the package and its contents, component concentrations, pH, and chelation capacity. At end of shelf life the product met its performance criteria in the Reliance EPS processor. The proposed modification does not change the integrity of the Reliance DG Dry Germicide over its labeled shelf life. The device is substantially equivalent to its predicate.

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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K110453
p547

Non-clinical
Tests:
Germicide
Efficacy

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
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 AOAC 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
tarrae 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.

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10453

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.

Reliance DG Dry Germicide, its components, reaction products, fi 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.
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 individual cups within each tray are to be used within 2 weeks, or by the expiration date on the Reliance DG cup, whichever comes first.

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K110453
p7f7

Reliance Endoscope Processor PerformanceThe 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).⇒ 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.
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

. - -

। -

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

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

MAR 1 6 231

Re: K110453

Trade/Device Name: Reliance® Endoscope Processing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: NZA Dated: February 15, 2011 Received: February 16, 2011

Dear Mr. Sullivan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Page 2- 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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

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

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

Sincerely yours,
Juns J. Koscielniak
for R

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)

Elizabeth F. Clausing Williams

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

KII 0453 510(k) Number:

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.