Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions a "microprocessor-based controller" for automated cycles, which is standard for automated systems and does not indicate AI/ML. There is no mention of learning, adaptation, or data-driven decision making beyond pre-programmed cycles.

Therapeutic

No.
This device is for washing and high-level disinfection of medical devices, primarily endoscopes, not for treating diseases or conditions in patients.

Diagnostic

No

The device is a system for cleaning and high-level disinfection of medical devices, specifically endoscopes. It is not used to diagnose a medical condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly states that the system includes hardware components such as the "Reliance Endoscope Processor," which is described as an "electromechanical washer/high level disinfector." While it has a microprocessor-based controller (software component), it is integrated into a physical device.

IVD (In Vitro Diagnostic)

Based on the provided text, the Reliance Endoscope Processing System is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is for washing and high-level disinfection of medical devices (endoscopes and accessories). This is a process applied to the device itself, not a test performed on a biological sample to diagnose a condition.
Device Description: The description details an electromechanical washer/disinfector and the chemicals used in the process. It does not describe a device that analyzes biological samples.
Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes (biomarkers, pathogens, etc.)
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
Performance Studies: The performance studies focus on the efficacy of the disinfection process (killing microorganisms on the endoscopes) and the performance of the processing system itself. They do not involve evaluating the device's ability to accurately measure or detect substances in biological samples.

The Reliance Endoscope Processing System is a device used to prepare medical devices for reuse, ensuring they are safe for subsequent patient procedures. This falls under the category of medical device reprocessing, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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, 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).

Product codes

NZA

Device Description

The Reliance Endoscope Processing System includes:

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.
The processor utilizes a proprietary, single use, dry, germicide package (Reliance DG Dry Germicide) that generates the active ingredient, peracetic acid, upon automatic dilution in water by the processor.
In the optional washing phase of the endoscope processing cycle, washing is provided through the automated delivery of Klenzyme Enzymatic Presoak and Cleaner, a currently marketed product for manual cleaning of medical devices.
CIP 200 Acid-Based Process and Research Cleaner, a currently marketed general cleaning agent, is used in one of the two self-decontamination cycles provided by the processor.

The Reliance Endoscope Processing System provides for cycles with the following features:

Endoscope Processing Cycle:
- 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 pre-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 Dry Germicide components, provided in a single use container, are dissolved with water at ~50°C and circulated throughout the processor and through device lumens for a 6 minute exposure time.
- Following high level disinfection, 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 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.
Decontamination Cycles: The processor also 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

GI flexible endoscopes, bronchoscopes

Indicated Patient Age Range

Not Found

Intended User / Care Setting

US hospital

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Non-clinical Tests:
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 testing was performed at conditions of use that were worst case with respect to germicide concentration, contact time, circulation, water hardness, temperature, and artificial soiling.

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 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.

Germicide Biocompatibility, Material Compatibility and Stability:

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, 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 similar to those seen with the predicate device (STERIS 20). No functional changes in flexible endoscopes were observed.
Reliance DG Dry Germicide Stability: Reliance DG Dry Germicide was tested and found stable for 18 months in the unopened moisture-resistant foil pouch 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.

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).
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 described above, as well as in the in-use study described below.
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 P. aeruginosa followed by a 5-day inactive period.
- D-SHORT cycle - can kill bacteria that have potential to form biofilm.

Clinical Tests:
The 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.

Key Metrics

Sporicidal activity meets efficacy requirements for Bacillus subtilis and Clostridium sporogenes.
Fungicidal activity demonstrated against Trichophyton mentagrophytes.
Bactericidal activity demonstrated against Salmonella choleraesuis, Staphylococcus aureus, Pseudomonas aeruginosa.
Virucidal activity demonstrated against Herpes simplex Type 1, Adenovirus Type 5, Poliovirus Type 1.
Tuberculocidal activity demonstrated against Mycobacterium bovis and Mycobacterium terrae.
Simulated-Use Test: Meets efficacy requirement for Mycobacterium terrae.
Clinical In-Use: No surviving microorganisms on any of the endoscopes or accessories tested.
Rat Acute Oral Toxicity - Use Dilution: LD50 = >5000 mg/kg
Rabbit Eye Irritation: Minimally irritating
Rabbit Skin Irritation: Non-irritating
Cytotoxicity: Dilution Cytotoxicity Score 1:1 to 1:2 3 - moderate, 1:4 to 1:16 2 - mild, 1:20 1:40 1 - slight, 0 - nontoxic.
Residue Reduction: Automatic within the Reliance Endoscope Processor, 2 x 15 L - 0.2 micron filtered water rinses effectively reduces germicide residues to safe levels.

Predicate Device(s)

Custom Ultrasonic System 83 Plus, K921559

Reference Device(s)

Sterilox Liquid Chemical HLD System

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

Certification to electromagnetic standards, continued: Non-clinical Tests: Limits and Methods of Processor CISPR 22 (1997) Measurements of Radio Performance, (equivalent to EN 55022:1998) Disturbance Characteristics of continued Information Technology Equipment The Reliance Endoscope Processing System was evaluated in an inuse 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 Clinical Tests evaluations of each endoscope, no orqanisms 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 108 CFU/device. The above data document that the Reliance Endoscope Processing System meets the FDA requirements of the quidance 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 Conclusion Automated Endoscope Washers (1993). Conformity to the requirements of these quidances demonstrates the safety and effectiveness of the Reliance Endoscope Processing System. Based on the results of all testing conducted, this system is as safe and effective as the predicate devices.

L-69

1

Date	July 5, 2006
Submitter	STERIS Corporation
5960 Heisley Road
Mentor Ohio 44060 USA

Telephone: 440-354-2600 |
| Contact | Nancy A. Robinson
Director, Advanced Sterilization
STERIS Corporation
5960 Heisley Road
Mentor, OH 44060 USA

Tel.: 440-392-7742
Fax: 440-392-8955
E-mail: nancy_robinson@steris.com |
| | Trade name: The Reliance® Endoscope Processing System |
| | Common name: Automated endoscope reprocessing system |
| Device Name | The System includes the following
Classification names:
Processor: Medical Washer-Disinfector for High Level Disinfection of Medical Devices Germicide: Liquid Chemical Germicide Cleaners: Accessories to the Medical Washer-Disinfector |
| Legally Marketed
Devices to which
Substantial
Equivalence is
Claimed | The Reliance Endoscope Processing System is substantially
equivalent to the following legally marketed Class II medical devices:
Reliance Processor:
Custom Ultrasonic System 83 Plus, based on similar indications for use, designs, and features Reliance™ DG Dry germicide:
STERIS 20™ Sterilant Concentrate, with respect to device design, active ingredient, conditions of use, and chemical monitoring and
Sterilox Liquid Chemical HLD System, with respect to indications for use (high level disinfectant) and in situ generation of the active ingredient |

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L-70

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2

| | Property ▼ | STERIS
Reliance Endoscope
Processor | | Custom Ultrasonics
System 83 Plus | |
|-----------------------------------------------------------------------------------------------------------------|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| | Intended Use | Wash and high level
disinfect 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). | | Clean and high level
disinfect one or two
submersible flexible
endoscopes intended
used to treat and
diagnose disorders of the
gastrointestinal and/or
pulmonary tracts.
High level disinfection
contact conditions vary
with the germicide used
in the processor. | |
| Summary of
technological
characteristics for
comparison to
predicate:
a) Processor | Operational
Principles | Pressure in control
handle boot drives
washing/disinfecting/rinse
solutions through lumens.
Circulation pump sprays
exterior surfaces. | | Fluid connectors/
attachments flow
cleaning/disinfecting/rinse
solution through lumens.
Immersion system with
ultrasonic cavitations
during all phases except
disinfection. | |
| | | Flow units are required
only for endoscope
channels that do not open
in the endoscope control
handle and when
mechanical action is
required for valve
operation | | Adaptors are required to
flow solutions through
lumens. | |
| | Cycle Description | Phase | Time | Phase | Time |
| | | | Optional:
Washing 1
(Wash with
rinse) | Wash time
can be
adjusted to
be between
5 and 10
minutes | Wash |
| | | Rinse | 40 seconds | Rinse | 1.5 minutes |
| | Property ▼ | STERIS
Reliance Endoscope
Processor | | Custom Ultrasonics
System 83 Plus | |
| | Cycle Description,
continued | Phase | Time | Phase | Time |
| | | Optional:
Washing 2
(Wash with
rinse) | Wash time
can be
adjusted to
be between
5 and 10
minutes | Not applicable | |
| | | Rinse | 40 seconds | | |
| | | Dry Germicide
Generation | 4 minutes | | |
| | | Dry Germicide
Exposure | 6 minutes | Chemical
Immersion | Varies with
germicide
used |
| | | Rinse 1 | 40 seconds | Rinse 1 | 1 minute |
| Summary of
technological
characteristics for
comparison to
predicate:
a) Processor,
continued | | Rinse 2 | 40 seconds | Rinse 2 | 1.5 minutes |
| | | Air purge | Air purge
time can be
adjusted to
be between
4 and 30
minutes | Air purge | 40 seconds |
| | | Alcohol Flush: Product
labeling instructs the user to
follow departmental
procedures regarding
flushing the endoscope
channels with alcohol and
storage of the endoscope
before use. | | Alcohol Flush: Product
labeling indicates that an
alcohol rinse can be
performed manually by the
user while the device is
attached to the processor. | |
| | Critical Design
Features | Intended for use with
Reliance DG Dry Germicide
only | | Intended for use with
different types of liquid
chemical germicides
(aldehydes and most
oxidizing germicides) | |
| | | Microprocessor controlled | | Microprocessor controlled | |
| | | Internal components
constructed of stainless steel
and silicone | | Internal components
constructed of stainless
steel | |

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L-72

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4

RELIANCE® ENDOSCOPE PROCESSING SYSTEM

| | Property ▼ | STERIS
Reliance Endoscope
Processor | Custom Ultrasonics
System 83 Plus |
|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Critical Design
Features,
continued | Processor provides
0.2 micron filtered water
for washing, disinfection
and rinsing | Water filtration system
external to device
(customer supplied) |
| | | Automated injection of
washing solution | Manual injection of
cleaning solution |
| | | Automated generation
and delivery of high level
disinfection solution | High level disinfectant
selected and added by
operator |
| | | Air intake for Air Purge is
HEPA filtered | No air cleaning option |
| Summary of
technological
characteristics for
comparison to
predicate:
a) Processor,
continued | Process
Parameters | Can select the following
endoscope processing
cycles:
• Disinfect only
• Wash and disinfect
Processor also provides
the following self-
decontamination cycles:
• D-SHORT (must be
run every 54 hours)
• D-LONG (must be
run when D-SHORT
has not been run in
the past 54 hours) | Can select the following
endoscope processing
cycles:
• Wash only
• Wash and disinfect
• Disinfect only |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | Disinfection time not
adjustable | Adjustable disinfection
time to accommodate
different HLD solutions. |
| | | Washing and air purge
times adjustable | Cleaning and air purge
times adjustable |
| | | Temperature not
adjustable | Temperature is
adjustable |
| | Property ▼ | STERIS
Reliance Endoscope
Processor | Custom Ultrasonics
System 83 Plus |
| Summary of
technological
characteristics for
comparison to
predicate:
a) Processor,
continued | Process
Parameters,
continued | Washing solution
concentration not adjustable
Reliance DG Dry Germicide
solution concentration not
adjustable | Cleaning solution is added by
operator (3 oz. Tergal 800)
Liquid chemical germicide
solution is adjustable |
| | | Water quality is not
adjustable; filtration systems
are provided with processor | Water quality external to
processor and provided by
customer |
| | Process Monitors | Control Handle Boot pressure
alarms if pressure too low to
process, or if too high and
could potentially damage
scopes | Pressure monitor cut off at
5 psi
Flow sensor for air/water
channel to detect
backpressure
Air restrictor allowing for
visual confirmation of flow (air
bubbles) through the air/water
channel. |
| | | Detection of a fresh Reliance
DG Dry Germicide container
in every processing cycle | No on-board monitoring for
presence of germicide or
germicide components |
| | | Washing solution level
monitored; alarm indicates
when container does not
have sufficient amount to
complete cycle | Cleaner solution level not
monitored |
| | | Temperature alarms if out of
range | No temperature monitoring
other than heater
thermocouple |
| | | Water filter integrity test | No water filter integrity test |
| | Maintenance
Requirements | D-SHORT decontamination
cycle required every 54 hours
D-LONG decontamination
cycle required if D-SHORT
not performed within past 54
hours. | Daily decontamination of
internal plumbing using
disinfectant solution |
| | | Periodic cleaning of debris
screen and spray arms | Daily cleaning with "Comet"
or "Ajax"
Cleaning when changing
disinfectant |
| | | Periodic replacement of
water and air filters | Filters provided by customer |

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6

| | Device▶ | Reliance DG Dry
Germicide | STERIS 20 | Sterilox Liquid
Chemical HLD
System |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| | General Features: The general features of Reliance DG Dry Germicide and the
predicate germicides are similar in that they are intended to process pre-
cleaned, immersible, reusable medical devices. The germicides are supplied in a
ready to use, single use dose. | | | |
| | Intended Use: | Dry germicide for
use only in the
Reliance
Endoscope
Processor. | Sterilant for use
only in the
SYSTEM 1
Processor. | High level
disinfectant for use
only with the
Sterilox Generator. |
| Summary of
technological
characteristics
for
comparison to
predicate:
b) Reliance
DG Dry
Germicide | | Provides high level
disinfection of up to
two manually pre-
cleaned,
immersible,
reusable, heat-
sensitive, semi-
critical medical
devices such as
endoscopes and
their accessories. | Provides sterile
processing of
manually pre-
cleaned
immersible,
reusable, semi-
critical and critical
devices. | Provides for high
level disinfection of
pre-cleaned,
immersible,
reusable, heat-
sensitive, semi-
critical medical
devices. |
| | Labeling: | Dry Germicide | Liquid Chemical
Sterilant | High Level
Disinfectant |
| | Germicide
Exposure Time
(min) for
intended use
(High Level
Disinfection or
Sterile
Processing) | 10
(4-minute
generation
sequence followed
by a 6-minute
exposure
sequence) | 12 | 10 |
| | Use
Temperature | 50 - 57°C | 50 - 56°C | 25°C |
| | Reuse | Single use | Single use | Single use |
| | Device▶ | Reliance DG Dry
Germicide | STERIS 20 | Sterilox Liquid
Chemical HLD
System |
| Human
Factors | | Dispensed ready to
use.
Container opened
automatically by
the processor,
limiting user
exposure to the
germicide. | Dispensed ready
to use.
Container opened
automatically by
the processor,
limiting user
exposure to the
germicide | Dispensed ready to
use. |
| Physical and Chemical Properties: The physical and chemical properties of
Reliance DG Dry Germicide and the predicate germicides are similar in that they
are supplied in a single use, ready to use dose in a form that is readily soluble in
water and results in a ~ pH neutral solution | | | | |
| Summary of
technological
characteristics
for
comparison to
predicate:
b) Reliance
DG Dry
Germicide,
continued | Container | Single-use,
2 Compartment
Container | Single-use,
2 Compartment
Container | Single use. |
| | Composition,
Packaged
Product | Dry/Dry | Dry/Liquid | Liquid |
| | Appearance | Translucent liquid | Lime green liquid | Colorless liquid |
| | Odor | Slightly acidic | Slightly acidic | odorless |
| | pH | 7.0 - 8.5 | 6 - 8 | 5 – 7 |
| | Solubility in
Water | Complete | Complete | Complete |
| Operational Principles - The operational principles of Reliance DG Dry
Germicide and the predicate devices are similar in that they result in high level
disinfection (or sterile processing for STERIS 20) of the intended devices by
direct contact of the germicides with the device surfaces for a specified period of
time and temperature, under dynamic conditions. The active ingredient is
generated (predicate, Sterilox System) in situ from a ready to use dose of
germicide | | | | |
| | Software
controlled
parameters | Yes | Yes | Yes |
| | Form | Water and
germicide. | Water and
germicide. | Water and
germicide. |
| | Contact | Dynamic liquid
contact. | Dynamic liquid
contact. | Dynamic or static
liquid contact. |
| | Purpose | Provides high level
disinfection when
used in the
Reliance
Endoscope
Processor
according to
labeling. | Provides liquid
chemical
sterilization when
used in the
System 1
according to
labeling. | Provides High
Level Disinfection
when used
according to
labeling. |
| Summary of
technological
characteristics
for
comparison to
predicate:
b) Reliance
DG Dry
Germicide,
continued | Device▶ | Reliance DG Dry
Germicide | STERIS 20 | Sterilox Liquid
Chemical HLD
System |
| | Active
Ingredient | Chemical
generation of
peracetic acid from
acetylsalicylic acid
and sodium
perborate when
combined with
water in the
Reliance
Endoscope
Processor (in situ). | 35% peroxyacetic
acid diluted to
0.2 % for use in
the SYSTEM 1
Processor. | Electrolytic
generation of
active (mainly
hypochlorous acid)
from saline
solution in the
Sterilox Generator
(in situ). |
| | Mode of Action | It is believed that
peracetic acid
exerts its
germicidal effect by
several
mechanisms:
-oxidizing sulfhydral
and sulfur bonds in
proteins and
enzymes,
particularly in the
cell walls6
-hydroxyl radicals
produced from PAA
are bactericidal9
-PAA damages the
viral capsid and
viral nucleic
acid10,11 | It is believed that
peracetic acid
exerts its
germicidal effect
by several
mechanisms:
-oxidizing
sulfhydral and
sulfur bonds in
proteins and
enzymes,
particularly in the
cell walls1
-hydroxyl radicals
produced from
PAA are
bactericidal2
-PAA damages the
viral capsid and
viral nucleic acid3,4 | Attacking the
surface and
plasma membrane
proteins impairs
transport of solutes
and the salt
balance of
bacterial cells 12. |
| | Rinses | Automatic, 0.2
micron filtered
water. | Automatic, sterile
filtered water. | Dependent upon
use. |
| | Microbiology: The microbial efficacy of Reliance DG Dry Germicide and the
predicate devices was demonstrated using standard test methodologies.
Potency and simulated use tests for Reliance DG Dry Germicide were
conducted under worst case operating conditions of the Reliance Endoscope
Processor at or below the minimum effective dose of 9000 mg/L PAA min.
Standards tests were modified to minimal operating conditions obtained within
the Reliance Endoscope Processor. Dacron sutures rather than black waxed
silk suture loops were used in sporicidal activity tests as described13. | | | |
| | Device▶ | Reliance DG Dry
Germicide | STERIS 20 | Sterilox Liquid
Chemical HLD
System |
| Summary of
technological
characteristics
for
comparison to
predicate:
b) Reliance
DG Dry
Germicide,
continued | Sporicidal
Activity of
Disinfectants
AOAC Official
Method 966.04 | Meets efficacy
requirements'.
Bacillus subtilis
Clostridium
sporogenes | Meets efficacy
requirements'.
Bacillus subtilis
Clostridium
sporogenes | Meets efficacy
requirements'.
Bacillus subtilis
Clostridium
sporogenes |
| | Confirmatory
Sporicidal
Activity of
Disinfectants
AOAC Official
Method 966.04 | Meets efficacy
requirements14.
Bacillus subtilis
Clostridium
sporogenes | Meets efficacy
requirements'.
Bacillus subtilis
Clostridium
sporogenes | Meets efficacy
requirements'.
Bacillus subtilis
Clostridium
sporogenes |
| | Fungicidal
Activity of
Disinfectants
AOAC Official
Method 955.17 | Solution is
fungicidal.
Trichophyton
mentagrophytes | Solution is
fungicidal.
Trichophyton
mentagrophytes | Solution is
fungicidal.
Trichophyton
mentagrophytes |
| | Use-Dilution
Method
AOAC, Official
Methods
955.14,
955.15, 964.02 | Solution is
bactericidal.
Salmonella
choleraesuis
Staphylococcus
aureus
Pseudomonas
aeruginosa | Solution is
bactericidal.
Salmonella
choleraesuis
Staphylococcus
aureus
Pseudomonas
aeruginosa | Solution is
bactericidal.
Salmonella
choleraesuis
Staphylococcus
aureus
Pseudomonas
aeruginosa |
| | EPA Virucidal
Testing
(DIS/TSS-7,
Nov. 1981) | Process conditions
are virucidal.
Herpes simplex
Type 1
Adenovirus Type 5
Poliovirus Type 1 | Solution is
virucidal.
Herpes simplex
Type 2
Poliovirus Type 1
Influenza A | Solution is virucidal
Herpes simplex
Type 1
Poliovirus Type 2
Human
immunodeficiency
virus Type I |
| | Tuberculocidal
Activity of
Disinfectants
AOAC Official
Method 965.12 | Solution is
tuberculocidal.
Mycobacterium
bovis | Solution is
tuberculocidal.
Mycobacterium
bovis | Solution is
tuberculocidal.
Mycobacterium
bovis |
| | Tuberculocidal
Activity
Ascenzi
Quantitative
Suspension
Test | Solution is
tuberculocidal
Mycobacterium
terrae | Not performed | Unknown |

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8 Block, S. ed., Disinfection, Sterilization, and Preservation. 5th edition, 2001.

ಿ Clapp et al., Free Rad. Res., (1994) 21:147-167.

10 Maillard et. al., J. Med. Microbiol (1995) 42:415-420.

11 Maillard et. al., J. Appl Bacteriol (1996) 80:540-5540-5540-5540-

12 Pieterson et al., Water SA (1996) 22(1); 43-48.

. (2000) 83:26) Water SF (1930) 22(17) 10-16:
13 McDonnell et al., J. AOAC International (2000) 83:269-275.

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10

RELIANCE® ENDOSCOPE PROCESSING SYSTEM

	Device▶	Reliance DG Dry Germicide	STERIS 20
Summary of
technological
characteristics
for
comparison to
predicate:
b) Reliance
DG Dry
Germicide,
continued	Simulated-Use
Test	Meets efficacy
requirement
Mycobacterium
terrae	Meets efficacy
requirement
Bacillus subtilis
spores
Geobacillus
stearothermophil
us spores	Meets efficacy
requirement
Mycobacterium
terrae
	Clinical In-Use	No surviving
microorganisms on
any of the
endoscopes or
accessories tested	Not required at
time of
submission.	No surviving
microorganisms on
the endoscopes
tested.
	Toxicology: Toxicology of the Reliance DG Dry Germicide use dilution and its
predicate devices were characterized with acute toxicity tests.
	Rat Acute Oral
Toxicity - Use
Dilution	LD50 = >5000 mg/kg	LD50 =>10,000
mg/kg	LD50 = >5000
mg/kg
	Rabbit Eye
Irritation	Minimally irritating	Minimally
irritating	Non-irritating
	Rabbit Skin
Irritation	Non-irritating	Non-irritating	Non-irritating
	Cytotoxicity	Dilution Cytotoxicity Score 1:1 to 1:2 3 - moderate 1:4 to 1:16 2 - mild 1:20
1:40 1 - slight
0 - nontoxic				Not tested
		Residues: Residues of Reliance DG Dry Germicide and its predicate devices
have been shown to be effectively reduced to safe levels through chemical
analysis of medical device extracts.
		Residue
Reduction	Automatic within
the Reliance
Endoscope
Processor,
2 x 15 L - 0.2 $\mu$
filtered water rinses
effectively reduces
germicide residues
to safe levels.	Automatic within
SYSTEM 1
Processor, 4 x 10
L sterile filtered
water rinses
effectively reduce
germicide
residues to safe
levels.	Effectively
removed from
devices by the
rinses following
disinfection.
		Reusable Device Compatibility: The medical device compatibility of Reliance
DG Dry Germicide and its predicate devices was established through testing
with finished devices or device materials of construction.

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| Summary of
technological
characteristics
for
comparison to
predicate:
b) Reliance
DG Dry
Germicide,
continued | Device▶ | Reliance DG | STERIS 20 | Sterilox Liquid
Chemical HLD
System |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Device
Material
Compatibility | Compatible with
intended flexible
endoscopes and
accessories
established through
testing finished
medical devices.
No device
functional changes.
Some materials
show cosmetic
changes such as
fading of external
markings but all
remained legible,
and bleaching of
black anodized
aluminum without
harm to the base
material. | Compatible with
medical devices
and materials of
their construction.
No device
functional
changes.
Some materials
show cosmetic
changes such as
fading of external
markings but all
remained legible,
and bleaching of
black anodized
aluminum without
harm to the base
material. | Does not produce
any corrosion or
other visible
damage in the
majority of
endoscope
components.
Color changes and
the "tack" of the
coating of the outer
endoscope
sheaths were
noted on some
endoscopes.
Corrosion was
noted on anodized
aluminum. |
| Chemical Indicator: Chemical monitoring of Reliance DG Dry Germicide and its
predicate device (STERIS 20) is accomplished through a chemical reaction on
an indicator pad in the presence of active ingredient. | | | | |
| Chemical
Monitoring | Reliance PI,
Process Indicator
(separate
submission).
Chemical reaction
on indicator pad to
produce color
change. | STERIS
PROCESS
Indicator
Chemical Monitor
(K921559).
Chemical reaction
on indicator pad to
produce color
change. | Pre-programmed
colorimetric for
direct-reading of
chlorine
concentration. | |

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| | Device
Description | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| • 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. | | |
| • The processor utilizes a proprietary, single use, dry, germicide package
(Reliance DG Dry Germicide) that generates the active ingredient, peracetic
acid, upon automatic dilution in water by the processor. | | |
| • In the optional washing phase of the endoscope processing cycle, washing is
provided through the automated delivery of Klenzyme Enzymatic Presoak
and Cleaner, a currently marketed product for manual cleaning of medical
devices. | | |
| • CIP 200 Acid-Based Process and Research Cleaner, a currently marketed
general cleaning agent, is used in one of the two self-decontamination cycles
provided by the processor. | | |
| The Reliance Endoscope Processing System provides for cycles with the
following features: | | |
| | • Endoscope Processing Cycle | |
| | ⇒ 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 pre-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 Dry Germicide components, provided in a single
use container, are dissolved with water at ~50°C and circulated
throughout the processor and through device lumens for a 6 minute
exposure time. | |
| | ⇒ Following high level disinfection, 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. | |
| Device Description,
continued | ⇒ 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. | |
| | Decontamination Cycles The processor also 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. | |
| Intended 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, 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). | |
| 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 Disinfectant (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 testing was
performed at conditions of use that were worst case with respect to
germicide concentration, contact time, circulation, water hardness,
temperature and artificial soiling. ⇒ 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 $log_{10}$ .
⇒ 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 $log_{10}$
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. | |
| Non-clinical tests:
Germicide
Biocompatibility,
Material
Compatibility and
Stability | • 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,
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 similar to
those seen with the predicate device (STERIS 20). No functional
changes in flexible endoscopes were observed. | |
| | • Reliance DG Dry Germicide Stability:
Reliance DG Dry Germicide was tested and found stable for 18 months
in the unopened moisture-resistant foil pouch 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 | |
| Non-clinical Tests:
Processor
Performance | 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).
⇒ 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 described above, as
well as in the in-use study described below.
⇒ 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 P. aeruginosa followed by a 5 day
inactive period;
D-SHORT cycle - can kill bacteria that have potential to form
biofilm. | |
| Non-clinical Tests:
Processor
Performance,
continued | In addition, the Reliance Endoscope Processor has been certified to the
following electrical standards: | |
| | UL 3101-1
First Edition (1993) | The Standard for Safety of Laboratory
Use Electrical Equipment |
| | CAN/CSA C22.2
No. 1010.1-92 (1992) | Safety Requirements for Electrical
Equipment for Measurement, Control
and Laboratory Use |
| | CENELEC
EN 61010-1: 1993 + A2: 1995 | Safety Requirements for Electrical
Equipment for Measurements, Control
and Laboratory Use Part 1: General
Requirements (IEC 61010-1:1990 +
A1: 1992, modified +A2:1995) |
| | IEC 61010-2-045 (2000) | Safety Requirements for Electrical
Equipment for Measurement, Control,
and Laboratory Use - Part 2-045:
Particular Requirements for Washer
Disinfectors Used in Medical,
Pharmaceutical, Veterinary and
Laboratory Fields |
| | CENELEC EN 61326 (1998) | Electrical Equipment for
Measurement Control and Laboratory
Use, EMC Requirements Part:
General Requirements Including
Amendments A1:1998; IEC
61326:1997 + A1: 1998 |
| | EN 55011 (1998) | Industrial, Scientific and Medical
(ISM) Radio-Frequency Equipment -
Radio Disturbance Characteristics -
Limits and Methods of Measurement |
| | EN 50082 (1997) | Electromagnetic Compatibility -
Generic Immunity Standard - Part 1
Residential, Commercial and Light
Industry |
| | EN 61000 | Testing and Measurement
Techniques |
| | Part 4-2 (1999) | Electrostatic Discharge Immunity
Test, Level 3 |
| | Part 4-3 (1996) | Radiated, Radio-Frequency,
Electromagnetic Field Immunity Test
(in situ) |
| | Part 4-4 (1995) | Electrical Fast Transient/Burst
Immunity Test, Level 3 |
| | Part 4-5 (1995) | Surge Immunity Test, Level 3 |
| | Part 4-6 (1996) | Conducted RF Immunity Test, Level 2 |
| | Certification to electromagnetic standards, continued: | |
| Non-clinical Tests:
Processor
Performance,
continued | CISPR 22 (1997)
(equivalent to EN 55022:1998) | Limits and Methods of
Measurements of Radio
Disturbance Characteristics of
Information Technology Equipment |
| Clinical Tests | The 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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Image /page/19/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The seal is encircled by the text "HEALTH AND HUMAN SERVICES. USA" in a circular arrangement. The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

STERIS Corporation c/o Mark A. Heller Wilmer Cutler Pickering Hale and Dorr, LLP The Willard Office Building 1455 Pennsylvania Avenue, N.W. Washington, D.C. 20004

JUL 2 1 2006

Re: K040049

Trade/Device Name: Reliance® Endoscope Processing System Regulation Number: 21 CFR 876.1500 Regulation Name: For Endoscopes Cleaning Germicide Accessories Regulatory Class: Class Il Product Code: NZA Dated: October 31. 2005 Received: October 31, 2005

Dear Mr. Heller:

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.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

20

Page 2 -- Mark A. Heller

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electroni product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your dev to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), plea contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely vours.

Miriam C. Provost

( Donna-Bea Tillman, Ph.D., M.P.A.
Director Director Office of Device Evaluation Center for Devices and Radiological Health

21

Reliance® Endoscope Processing System Revised July 5, 2006

510(k) Section 3.3

Indications for Use

510(k) Number (if known): K040049

Device Name: Reliance® Endoscope Processing System

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, 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).

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use × (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost for bBT

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . "n of Anesthesiology, General Hospi con Control. Dental Devices

Number: K040049

Page 1 of 1

(Posted November 13, 2003)