← Product Code [NZA](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/NZA) · K123768
# RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM (K123768)
_STERIS Corporation · NZA · Jul 26, 2013 · Gastroenterology, Urology · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-b%E2%80%94diagnostic-devices/NZA/K123768
## Device Facts
- **Applicant:** STERIS Corporation
- **Product Code:** [NZA](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/NZA.md)
- **Decision Date:** Jul 26, 2013
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1500
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology
## Intended Use
The Reliance™ Advance Endoscope Processing System is intended for cleaning and high level disinfection of up to two immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes, bronchoscopes and their accessories. During the system's standardized Endoscope Processing Cycle, cleaning is achieved within the Cleaning phase, and high level disinfection is achieved within the 50 - 57°C HLD phase (4 minute generation sequence followed by a 6-minute exposure sequence). Manual cleaning is not required prior to processing in Reliance Advance Endoscope Processing System.
## Device Story
Automated endoscope reprocessor (AER) for cleaning and high-level disinfection (HLD) of up to two flexible endoscopes/accessories; utilizes proprietary enzymatic detergent and Reliance DG Dry Germicide (peracetic acid-generating oxidative chemistry). System features microprocessor-controlled cycles: cleaning phase (enzymatic detergent injection, flow-meter verified), HLD phase (50-57°C, 6-minute exposure), rinse phase (0.2-micron bacterial-retentive filter with integrity check), and HEPA-filtered air purge. Operated by healthcare staff in clinical settings; provides printed cycle summaries (optional barcode reader for tracking). Eliminates need for manual pre-cleaning. Includes self-decontamination cycles (D-SHORT/D-LONG) to prevent biofilm. Benefits include standardized processing, reduced manual labor, and validated HLD efficacy.
## Clinical Evidence
Bench testing included simulated-use studies on 15 heat-sensitive endoscopes/accessories under worst-case conditions (soil levels, drying, detergent concentration). All articles visually clean; protein, carbohydrate, and TOC levels met acceptance criteria. Clinical in-use study at a US hospital evaluated four endoscope types (bronchoscopes, gastroscopes, colonoscopes, duodenoscopes) processed after clinical use; all met visual and chemical cleanliness endpoints. Microbiological efficacy (sporicidal, tuberculocidal, virucidal, bactericidal, fungicidal) confirmed >6 log10 reduction of M. terrae. Biocompatibility testing confirmed non-cytotoxic residuals.
## Technological Characteristics
Electromechanical washer/disinfector; microprocessor-controlled. Uses proprietary enzymatic detergent and Reliance DG (peracetic acid). Features: peristaltic pump with flow meter, 0.2-micron bacterial-retentive water filter, HEPA air filter. Connectivity: printer output, optional barcode reader. Electrical safety: ANSI/UL 61010-1, CAN/CSA C22.2 61010-1, IEC 61010-1, IEC 61010-2-40, IEC 61326-1. Software: Major Level of Concern.
## Regulatory 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.
## Special Controls
*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.
## Predicate Devices
- Reliance Endoscope Processing System (EPS) ([K102244](/device/K102244.md))
- EVOTECH Endoscope Cleaner and Reprocessor (ECR) ([K061899](/device/K061899.md))
## Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the word "STERIS" in a bold, sans-serif font. There is a registered trademark symbol to the right of the word. Below the word is a graphic of several horizontal lines that are stacked on top of each other. The lines are not straight, but have a slight wave to them.
JUL 2 6 2013
# 510(k) Summary For Reliance™ Advance Endoscope Processing System
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Contact:
Marcia L. Benedict Senior Director, Regulatory Affairs Telephone: (440) 392-7063 Fax No:
July 26, 2013 Summary Date:
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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#### 1. Device Name
| Trade Name: | Reliance Advance Endoscope Processing System |
|----------------------|-------------------------------------------------------------|
| Common/usual Name: | Automated Endoscope Reprocessor |
| Classification Name: | 21 CFR 876.1500
Endoscope Cleaning Germicide Accessories |
| Device Class: | II |
| Product Code: | NZA |
#### 2. Predicate Device
Reliance Endoscope Processing System (EPS) - K102244 EVOTECH Endoscope Cleaner and Reprocessor (ECR) - K061899
#### 3. Description of Device
The Reliance Advance Endoscope Processing System is an economical, easy-to-use cleaning and high level disinfection system that can clean and high level disinfect up to two 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, dry peracetic acid generating oxidative chemistry. The Reliance Advance 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 Advance Endoscope Processing System is a combination of products that are used to clean and high level disinfect flexible endoscopes and their accessories.
- The Reliance Advance Endoscope Processor is an electromechanical . washer/high level disinfector with a microprocessor-based controller that provides for automated endoscope processing cycles and processor selfdecontamination cycles.
- . The proprietary enzymatic detergent is dispensed automatically during the Cleaning phase of the cycle to effectively clean endoscope(s) and accessories.
- . 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.
- . Various accessories are available to accommodate the processing needs of specific endoscopes and endoscopic accessories.
- VERIFY Process Indicator for Reliance EPS is available to monitor for the . effective dose of the Reliance DG active ingredient, peracetic acid.
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- 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.
The Reliance Advance Endoscope Processing Cycle can perform endoscope leak testing and integrity monitoring throughout the following standardized cycle:
- > The first part of this cycle is a standardized, non-optional cleaning phase that consists of a dynamic wash using proprietary enzymatic detergent, followed by a rinse. In this phase, a controlled quantity of the concentrated enzymatic detergent is dispensed into the circulating warm water volume in the processor. forming an effective cleaning solution that is directed through endoscope lumens and onto all device surfaces.
The Reliance cleaning phase can be used in place of manual cleaning by the user. It does not replace the bedside pre-cleaning performed in the procedure room.
- > The second part is a non-optional high level disinfection phase; its 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℃ to create the peracetic acid disinfection solution that is circulated throughout the processor and through device lumens for a 6 minute exposure time.
- => Following high level disinfection, the Reliance Advance Endoscope Processor removes the germicide use-dilution through a rinse phase which is nonoptional; 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. There is 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 cvcle.
- > 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.
- > At the end of each cycle the processor prints a detailed evcle summary with information such as processor number, date, start and stop times, and 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:
- > 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 cvcle in which CIP 200 Acid-Based Process and Research Cleaner is added to hot water and circulated through the processor for 20 minutes; this is followed by three rinses to
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remove the solution, and a 10-minute hot air purge. D-LONG is used when the D-SHORT cycle has not been run within the past 54 hours.
#### 4. Intended Use
The Reliance Advance Endoscope Processing System is intended for cleaning and high level disinfection of up to two immersible, reusable, heat-sensitive, semicritical devices such as GI flexible endoscopes, bronchoscopes and their accessories.
During the system's Endoscope Processing Cycle, cleaning is achieved within the Cleaning Phase, and high level disinfection is achieved within the 50 - 57°C HLD Phase (4 minute generation sequence followed by a 6 minute exposure sequence).
Manual cleaning is not required prior to processing in Reliance Advance Endoscope Processing System.
#### Technological Characteristics న.
The Reliance Advance Endoscope Processing System is not significantly different from the predicate Reliance EPS in technology. Technological modifications of the Reliance EPS design for the Reliance Advance Endoscope Processing System are summarized below:
| Property
▼ | Proposed Reliance Advance
Endoscope Processor | K102244 STERIS
Reliance Endoscope Processor |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Endoscope
Processing
Cycle | The standardized Endoscope Processing
Cycle (with one or two endoscopes)
includes a Cleaning phase and its rinse,
which is followed by the HLD phase,
final rinses, and air purge. | In the Endoscope Processing Cycle (with
one or two endoscopes) the user has the
option to select zero, one or two Wash
phases of 5 - 10 minutes each including
a rinse, which is followed by the HLD
phase, final rinses, and air purge. |
| Enzymatic
Detergent
and Dose
Control | Peristaltic pump injects a metered
volume of the proprietary new enzymatic
detergent during the Cleaning phase.
A flow meter provides feedback to the
microprocessor to verify that the
required volume of enzymatic detergent
was injected by the peristaltic pump. | Peristaltic pump injects a metered
volume of Klenzyme during Wash
phases. |
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The Reliance Advance Endoscope Processing System is technologically similar to the EvoTech Endoscope Cleaner and Reprocessor (ECR) predicate, as shown in the comparison table below.
| Property ▼ | Proposed Reliance Advance
Endoscope Processor | K061899
EvoTech Endoscope Processor |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Control | Microprocessor-controlled
programmable processor monitors and
controls critical cycle parameters and
provides a printed record upon cycle
completion. | Microprocessor-controlled
programmable processor monitors and
controls critical cycle parameters and
provides a printed record upon cycle
completion. |
| Capacity | One or two endoscopes and accessories | One or two endoscopes and accessories |
| Mechanism
for channel
access | Uses a pressurized control handle boot
such that operation is largely connector-
less. Flow Units are used for specialized
device processing needs. | Relies upon multiple tubings and
connectors to provide flow to inner
channels of endoscopes. |
| Enzymatic
Detergent | Requires use of a proprietary enzymatic
detergent for cleaning. | Requires use of a proprietary enzymatic
detergent for cleaning. |
| Germicide | Requires Reliance DG Dry Germicide. | Requires Cidex OPA. |
| Monitoring | Requires use of a VERIFY Process
Indicator for Reliance EPS strip with
each Endoscope Processing Cycle. | Has an on-board concentration monitor. |
| Rinsing | Devices are rinsed with filtered water. | Devices are rinsed with filtered water. |
| Leak Test | Automated leak test is selectable. | Automated test assures absence of major
leaks in the endoscope body. |
| Alcohol flush | Not provided | Selectable in this system |
| Self-
Disinfection | Has capacity to perform self-
disinfection. | Has capacity to perform self-
disinfection. |
#### 6. Description of Safety and Substantial Equivalence
The Reliance Advance Endoscope Processing System has the same intended use for cleaning and high level disinfection of flexible endoscopes as the predicate EvoTech ECR. It is substantially equivalent to the EvoTech ECR with respect to achieving cleaning and high level disinfection of a wide range of flexible endoscopes and accessories.
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#### 7. Performance Testing Summary
| Reliance Advance Endoscope Processing System Performance Testing Summary | |
|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cleaning
Phase
Efficacy | • Cleaning Phase Effectiveness in Simulated Use Studies
Reliance Advance EPS has been tested and shown to achieve effective cleaning
of soiled flexible endoscopes and their accessories. Testing was performed on a
diverse array of OEM endoscopes incorporating the most challenging design
features for cleaning, and under worst case simulated use conditions with respect
to soil levels, drying, enzymatic detergent concentration, water condition, and
cleaning phase exposure time. |
| | Fifteen (15) heat-sensitive flexible endoscopes, dilators, and their accessories
were soiled with select test soils at levels appropriate to the intended use of the
instrument. After the worst case Reliance Advance EPS cleaning phase in
simulated use, 1) all test articles were visually clean, and 2) all samples recovered
from previously soiled areas for all test articles met the established acceptance
levels defined as "clean" for protein, carbohydrates, and total organic carbon in
validated assays for those components. |
| | • Cleaning Phase Effectiveness in Clinical In-Use Studies
Efficacy of the Reliance Advance EPS Cleaning Phase was evaluated in use in a
US hospital. Four types of flexible endoscopes (bronchoscopes, gastroscopes,
colonoscopies, and duodenoscopes) and their accessories as listed in Reliance
Advance EPS labeling were used in clinical procedures, pre-cleaned at the
bedside, allowed to dry for 47 – 100 minutes, and then processed through the
Reliance Advance Endoscope Processing Cycle's Cleaning phase only, according
to the instructions for use. Cleaning endpoints were evaluated. |
| | In triplicate evaluations, each of the tested clinically soiled endoscopes 1) was
visually clean, and 2) met the soil pre-determined "clean" acceptance levels for
protein, carbohydrates, and total organic carbon in validated assays. |
| Enzymatic
Detergent
Stability | • Enzymatic Detergent Stability:
The proprietary enzymatic detergent has been shown to be stable in its Bag-in-Box packaging through 12 months under representative storage conditions. This protocol of testing continues; the shelf life may be extended based on additional data meeting established acceptance criteria. |
| Software
Validation | The Reliance Advance EPS software was developed and validated in accordance with the FDA requirements for a Major Level of Concern determination based on the recommendation in the FDA Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities dated August 1993.
All acceptance criteria were met. |
.
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T
| Reliance Advance Endoscope Processing System Performance Testing Summary | | | | |
|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Material
Compatibility | Enzymatic Detergent Material Compatibility | | | |
| | The proprietary enzymatic detergent was evaluated for its effect on common
materials of endoscope and accessory 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 Material Compatibility: | | | |
| | | The system was previously 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. | | |
| | specifications. | The critical process parameters for the processor (water temperature and volume,
fresh DG container detection, boot pressure, water filter integrity testing, and
delivery of cleaning and high level disinfection solutions) have each been
evaluated in replicate under worst case conditions, and found to be within required | | |
| | Each processor phase or cycle has been separately evaluated and shown to be
effective under worst case conditions: | | | |
| Processor
Performance | The standard Cleaning phase using STERIS's proprietary enzymatic
î
detergent had no effect on generation of the active from Reliance DG in
Reliance Advance EPS during the HLD phase of the Endoscope Processing
Cycle. | | | |
| | The HLD and Rinse phases of the Endoscope Processing Cycle have been
ी
shown to be effective. The air purge phase effectively removes rinse water
from processed devices. The filter integrity test system has been shown to
reliably detect filter failure. | | | |
| | The two self-decontamination cycles were shown to be effective as follows in
ੀ
prior studies: | | | |
| | 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. | | |
| Certification
to electrical
safety
standards | ANSI/UL -61010-1, 200 | Electrical equipment for measurement, control and
laboratory use Part 1, 200 Edition | | |
| | CAN/CSA C22.2 61010-1,
2" 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, 136 Ed. | Electrical equipment for measurement, control and
laboratory use, EMC requirements Part 1: General
requirements | | |
.
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| Reliance Advance Endoscope Processing System Performance Testing Summary | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Reliance DG
Dry
Germicide
Efficacy | Reliance DG Dry Germicide Use Solution Microbial Efficacy: | |
| | Potency: Reliance DG has been tested and shown to generate an effective high
level disinfection solution using the standard array of microbiological tests for
germicidal efficacy. Prior to the current submission, the following 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 was proven to be sporicidal as defined by AOAC
Sporicidal Activity Test with 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 and in vitro using Reliance DG containers that
were aged beyond the end of its shelf life. | |
| | ⇒ Tuberculocidal: Reliance DG 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 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 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 was proven to be tuberculocidal as defined by the
AOAC Tuberculocidal Activity Test with an exposure time of 6 minutes,
whether performed in situ or in vitro. | |
| | Simulated-Use: Reliance DG, at its minimum recommended concentration,
reproducibly achieved greater than a 6 $log^{10}$ reduction of Mycobacterium terrae in
triplicate trials within the Reliance Endoscope Processor for each selected
clinically relevant flexible endoscope and its accessory. The test articles
represented the range of most challenging devices, accessories, and processing
situations. | |
| | In-Use: 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. | |
| Reliance DG Stability: | | |
| Reliance DG
Stability | Reliance DG has been shown to be stable for 18 months in the unopened
moisture-resistant package at the stated conditions for storage. Once opened, the
five Reliance DG containers within each package are to be used within two (2)
weeks, or by the expiration date on the container, whichever comes first. | |
| Reliance Advance Endoscope Processing System Performance Testing Summary | | |
| Bio-
compatibility | Biocompatibility:
The Reliance chemical formulations, as supplied in packaging as well as in use
dilutions, can be safely handled and used by customers. Residues that may
remain on medical endoscopes and accessories are below established residue
limits and do not pose a risk to patients. Safety statements in product labeling are
appropriate to the potential risk. | |
| | ⇒ Enzymatic detergent components, reaction products, and residuals remaining
on medical devices were evaluated for biocompatibility and possible risks to
users including literature reviews of raw material toxicity data. Testing
included in vitro cytotoxicity evaluations on extracts of processed devices and
rinse water, and analysis for chemical residuals. | |
| | ⇒ Reliance DG, its components, reaction products, and residuals remaining on
medical devices have previously been 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 DG 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,
and the processor final rinse water was found to be non-cytotoxic. | |
| | Performance
of VERIFY CI
for Reliance
EPS | |
| NOT colorless (incomplete change) at end of Reliance Advance Endoscope
Processing Cycle using the minimum effective PAA dose of 9000 mg/L PAA
min, or in a processing cycle without PAA | | |
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### Conclusion:
The completed nonclinical performance testing has demonstrated that the device is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate devices.
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Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined strands and a single wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 26, 2013
STERIS Corporation Ms. Marcia L. Benedict Senior Director, Regulatory Affairs 5960 Heislev Road Mentor OH 44060
Re: K123768
Trade/Device Name: Reliance™ Advance Endoscope Reprocessing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NZA Dated: June 27, 2013 Received: June 28, 2013
Dear Ms. Benedict:
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 - Ms. Benedict
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/10/Picture/8 description: The image shows the name "Mary S. Runner - S" in a bold, sans-serif font. The letters are black, and the background is white. The letters "S.R" are partially obscured by a faded, patterned design. The name appears to be a signature or a title.
Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, 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): | 23 7 レタ
Device Name:
Reliance™ Advance Endoscope Processing System
Indications For Use:
The Reliance™ Advance Endoscope Processing System is intended for cleaning and high level disinfection of up to two immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes, bronchoscopes and their accessories.
During the system's standardized Endoscope Processing Cycle, cleaning is achieved within the Cleaning phase, and high level disinfection is achieved within the 50 - 57°C HLD phase (4 minute generation sequence followed by a 6-minute exposure sequence).
Manual cleaning is not required prior to processing in Reliance Advance Endoscope Processing System.
Prescription Use (Part 2) 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) : r
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sreekanth Gutala -S 2013.07.25 14:42:31 -04'00'
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K183768
Page 1 of 1
December 6, 2012
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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-b%E2%80%94diagnostic-devices/NZA/K123768](https://fda.innolitics.com/submissions/HO/subpart-b%E2%80%94diagnostic-devices/NZA/K123768)
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