(28 days)
Not Found
No
The device description mentions a "microprocessor-based controller" which is standard for automated systems and does not indicate the use of AI or ML. The performance studies focus on germicidal efficacy and system performance, not on learning or adaptive capabilities.
No.
The device is intended for washing and high-level disinfection of semi-critical medical devices like endoscopes, not for treating a disease or condition.
No
The device is described as an "Endoscope Processing System" intended for washing and high-level disinfection of medical devices. Its function is to clean and disinfect, not to diagnose a condition or disease.
No
The device description explicitly states that the Reliance Endoscope Processing System is an "electromechanical washer/high level disinfector with a microprocessor-based controller," indicating the presence of significant hardware components beyond just software.
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 reusable medical devices (endoscopes and accessories). This is a process to prepare devices for subsequent use on patients, not to perform a diagnostic test on a sample taken from a patient.
- Device Description: The description details an electromechanical washer/disinfector and associated chemicals used for cleaning and disinfection. It does not describe a device that analyzes biological samples for diagnostic purposes.
- 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.)
- Providing information about a patient's health status, disease, or condition
- Using reagents or assays to detect specific analytes
- Outputting diagnostic results
The device is clearly intended for the reprocessing of medical devices to ensure they are safe for use, which falls under the category of medical device sterilization and disinfection, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Reliance Endoscope Processing System is intended for washing and high level disinfection of up to two manually cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes, bronchoscopes and their accessories. High level disinfection is achieved within the 50 - 57°C HLD Phase of the Endoscope Processing Cycle (4 minute generation sequence followed by a 6minute exposure sequence).
Product codes (comma separated list FDA assigned to the subject device)
NZA
Device Description
The Reliance Endoscope Processing System is an economical, easy-to-use high level disinfection system intended to wash and high level disinfect up to two manually cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes and related accessories. The system utilizes Reliance™ DG Dry Germicide, a proprietary, safe, and dry peracetic acid generating oxidative chemistry. The Reliance Endoscope Processing System was designed to be versatile in meeting the growing demands of the modern flexible endoscope processing department, while offering the highest level of patient and staff safety. The Reliance Endoscope Processing System is a combination of products that are used to wash and high level disinfect flexible endoscopes and their accessories.
- The Reliance Endoscope Processor is an electromechanical washer/high level . disinfector with a microprocessor-based controller that provides for automated endoscope processing cycles and processor self-decontamination cycles.
- Reliance DG Dry Germicide is a proprietary, two-part, dry, single-use . oxidative chemistry, designed to generate the high level disinfection solution upon automatic dilution in water within the Reliance Endoscope Processor.
- Optional washing is provided through the automated delivery of Klenzyme . Enzymatic Presoak and Cleaner during the wash phase of the cycle.
- CIP 200 Acid-Based Process and Research Cleaner, a general cleaning agent, . is used in one of the two self-decontamination cycles provided by the processor.
- Various accessories are available to accommodate the processing needs of . specific endoscopes and endoscopic accessories.
- Verify Reliance CI Process Indicator is available to monitor for the presence of the Reliance DG active ingredient, peracetic acid.
The Reliance Endoscope Cycle has the following features: - The first part of this cycle is an optional programmable washing phase. This phase consists of a wash that uses Klenzyme, followed by a rinse. The washing phase can be programmed on or off. In the "on" mode, the user can choose either one or two washing phases per processing cycle, and the wash time can be adjusted to be between 5 and 10 minutes. The Reliance cleaning phase does not replace manual cleaning by the user.
- The second part is a high level disinfection phase that is non-optional and the parameters cannot be changed by the user. In this phase, the proprietary Reliance DG components, provided in a single use container, are dissolved with water at ~50°C for four minutes of generation time and circulated throughout the processor and through device lumens for 6 minutes of high level disinfection solution exposure time.
- Following the high level disinfection phase, the Reliance Endoscope Processor removes the high level disinfection solution through a rinse phase which is non-optional and the parameters cannot be changed by the user. The processor filters the rinse water (as well as all of the water used throughout the cycle) through a 0.2 micron bacterial-retentive filter. It also incorporates an automatic internal integrity check of this filter at the end of each processing cycle. If the integrity check fails, an alarm alerts the user, and the processor does not complete the cycle.
- The last step in the processing cycle is an air purge phase using HEPAfiltered air. The air purge helps to remove excess rinse water from the processed devices. The final air purge is preset to run for 4 minutes; additional air purge time may be selected by the operator.
- The processor will print a detailed cycle summary at the end of each cycle that includes information such as processor number, cycle date, start and stop times, as well as phase parameters. With an optional bar code reader, the printouts can also include identification numbers for the operator, patient, device, doctor and procedure.
The processor features two decontamination cycles that are to be used without endoscopes in the processor: - The first, called D-SHORT, consists of hot water circulating through the processor for 10 minutes, followed by a 10-minute hot air purge. This cycle is to be run every 54 hours. D-SHORT is intended to prevent biofilm from forming.
- The second, called D-LONG, consists of a cycle in which CIP 200 Acid-Based Process and Research Cleaner is added to hot water. The cleaning solution is then circulated through the processor for 20 minutes; this is followed by three rinses to remove the solution from the processor and a 10-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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Tests: Germicide Efficacy:
The Reliance Endoscope Processing System was developed and validated in accord with two primary FDA Guidance documents:
- Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants (2000), and
- Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers (1993).
Summary of this testing follows:
Reliance DG Dry Germicide Efficacy:
Reliance DG Dry Germicide was tested and shown to generate an effective high level disinfection solution using the standard array of microbiological tests for germicidal efficacy. The following testing was performed at conditions of use that were worst case with respect to contact time, circulation, water hardness, temperature, artificial soiling, and germicide concentration (at or below the minimum effective dose of 9000 mg/L PAA minutes): - Sporicidal: Reliance DG Dry Germicide was proven to be sporicidal as defined by AOAC Sporicidal Activity Test with an in situ exposure time of 6 minutes. Confirmatory testing was completed successfully and supplemental confirmatory testing was completed in the Reliance Endoscope Processor. Potency was subsequently confirmed in the processor using Reliance DG Dry Germicide containers that were aged beyond the end of its shelf life.
- Tuberculocidal: Reliance DG Dry Germicide was proven to be tuberculocidal as defined by the AOAC Tuberculocidal Activity Test with an exposure time of 6 minutes. Potency was subsequently confirmed using Reliance DG Dry Germicide aged beyond the end of its shelf life.
- Virucidal: The Reliance Process was proven to reduce the viable population of poliovirus Type 1, adenovirus Type 5, and herpes simplex virus Type 1 by > 4 log₁₀.
- Bactericidal: Reliance DG Dry Germicide was proven to be bactericidal as defined by the AOAC Bactericidal Activity Test with an exposure time of 6 minutes at worst case conditions, whether performed in situ or in vitro.
- Fungicidal: Reliance DG Dry Germicide was proven to be fungicidal as defined by the AOAC Fungicidal Activity Test with an exposure time of 6 minutes, whether performed in situ or in vitro.
Simulated-Use: Reliance DG Dry Germicide, at the minimum recommended dose, reproducibly achieved greater than a 6 log₁₀ reduction of Mycobacterium tarrae in triplicate trials within the Reliance Endoscope Processor for selected clinically relevant flexible endoscopes and their accessories. The test articles represented the range of most challenging devices, accessories, and processing situations.
In-Use: Reliance Endoscope Processing System was evaluated in an in use study in a US hospital. Three flexible endoscopes representing the range of types indicated in the product labeling were used in clinical procedures and processed according to instructions for use. In triplicate evaluations of each endoscope, no organisms were recovered after processing. Bioburden levels on the clinically used endoscopes after manual cleaning and before high level disinfection were determined to be as high as 10⁵ CFU/device.
Biocompatibility:
The Reliance chemical formulations, as supplied in packaging as well as in use dilutions, can be safely handled and used by customers. Residues that may remain on medical endoscopes and accessories are below established residue limits and do not pose a risk to patients. Safety statements in product labeling are appropriate to the potential risk.
- Reliance DG Dry Germicide, its components, reaction products, fi and residuals remaining on medical devices were evaluated for biocompatibility and possible risks to users. Testing included acute oral and ocular toxicity tests, dermal irritation studies, in vitro bacterial mutation genotoxicity studies, sensitization tests, and in vitro cytotoxicity evaluations; literature reviews of raw material toxicity data were also performed. Certain components in the single-use container, which under normal use conditions never contact the user, have the potential for irritation or skin sensitization: therefore appropriate warnings and instructions are displayed on labeling for the unusual event of a spill or container breakage.
- Use dilution reaches non-cytotoxic levels with minimal dilution.
- Biocompatibility testing of extracts from processed medical devices demonstrated that no toxic residuals remain on devices under worst case circumstances. The test data indicate that the worst case residue levels for the components of maximum potential risk are far below the allowable limits. Furthermore, the processor final rinse water was found to be non-cytotoxic.
Reliance Endoscope Processing System Material Compatibility:
The Reliance System was evaluated for its effect on intact medical devices, including flexible endoscopes and/or common materials of device construction. After 300 processing cycles, no deleterious effects were observed other than minor cosmetic changes. No functional changes in flexible endoscopes were observed.
Reliance DG Dry Germicide Stability:
Reliance DG was tested and found stable for 18 months in the unopened moisture-resistant packaging at the stated conditions for storage. Once opened, the individual cups within each tray are to be used within 2 weeks, or by the expiration date on the Reliance DG cup, whichever comes first.
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
§ 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.
0
K110453 STERIS®
p1 of 7
MAR 1 6 2011
510(k) Summary For Reliance® Endoscope Processing System
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Contact:
Robert F. Sullivan Senior Director, Regulatory Affairs Telephone: (440) 392-7695 Fax No:
Summary Date:
February 15, 2011
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
1
Image /page/1/Picture/0 description: The image shows the word "STERIS" in large, bold letters. Above the word "STERIS" is the text "K110453 p.2 of 7" in a handwritten font. Below the word "STERIS" is a graphic of several horizontal wavy lines stacked on top of each other.
1. Device Name
| Trade Name: | Reliance Endoscope Processing System |
|---|---|
| Common/usual Name: | Automated Endoscope Reprocessor |
| Classification Name: | 21 CFR 876.1500 |
| Endoscope and Accessories |
2. Predicate Device
Reliance Endoscope Processing System K102244
3. Description of Device
The Reliance Endoscope Processing System is an economical, easy-to-use high level disinfection system intended to wash and high level disinfect up to two manually cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes and related accessories.
The system utilizes Reliance™ DG Dry Germicide, a proprietary, safe, and dry peracetic acid generating oxidative chemistry. The Reliance Endoscope Processing System was designed to be versatile in meeting the growing demands of the modern flexible endoscope processing department, while offering the highest level of patient and staff safety. The Reliance Endoscope Processing System is a combination of products that are used to wash and high level disinfect flexible endoscopes and their accessories.
- The Reliance Endoscope Processor is an electromechanical washer/high level . disinfector with a microprocessor-based controller that provides for automated endoscope processing cycles and processor self-decontamination cycles.
- Reliance DG Dry Germicide is a proprietary, two-part, dry, single-use . oxidative chemistry, designed to generate the high level disinfection solution upon automatic dilution in water within the Reliance Endoscope Processor.
- Optional washing is provided through the automated delivery of Klenzyme . Enzymatic Presoak and Cleaner during the wash phase of the cycle.
- CIP 200 Acid-Based Process and Research Cleaner, a general cleaning agent, . is used in one of the two self-decontamination cycles provided by the processor.
- Various accessories are available to accommodate the processing needs of . specific endoscopes and endoscopic accessories.
2
- . Verify Reliance CI Process Indicator is available to monitor for the presence of the Reliance DG active ingredient, peracetic acid.
The Reliance Endoscope Processing Cycle has the following features:
-
The first part of this cycle is an optional programmable washing phase. This phase consists of a wash that uses Klenzyme, followed by a rinse. The washing phase can be programmed on or off. In the "on" mode, the user can choose either one or two washing phases per processing cycle, and the wash time can be adjusted to be between 5 and 10 minutes. The Reliance cleaning phase does not replace manual cleaning by the user.
-
The second part is a high level disinfection phase that is non-optional and the parameters cannot be changed by the user. In this phase, the proprietary Reliance DG components, provided in a single use container, are dissolved with water at ~50°C for four minutes of generation time and circulated throughout the processor and through device lumens for 6 minutes of high level disinfection solution exposure time.
-
Following the high level disinfection phase, the Reliance Endoscope Processor removes the high level disinfection solution through a rinse phase which is non-optional and the parameters cannot be changed by the user. The processor filters the rinse water (as well as all of the water used throughout the cycle) through a 0.2 micron bacterial-retentive filter. It also incorporates an automatic internal integrity check of this filter at the end of each processing cycle. If the integrity check fails, an alarm alerts the user, and the processor does not complete the cycle.
-
The last step in the processing cycle is an air purge phase using HEPAfiltered air. The air purge helps to remove excess rinse water from the processed devices. The final air purge is preset to run for 4 minutes; additional air purge time may be selected by the operator.
-
The processor will print a detailed cycle summary at the end of each cycle that includes information such as processor number, cycle date, start and stop times, as well as phase parameters. With an optional bar code reader, the printouts can also include identification numbers for the operator, patient, device, doctor and procedure.
The processor features two decontamination cycles that are to be used without endoscopes in the processor:
-
The first, called D-SHORT, consists of hot water circulating through the processor for 10 minutes, followed by a 10-minute hot air purge. This cycle is to be run every 54 hours. D-SHORT is intended to prevent biofilm from forming.
-
The second, called D-LONG, consists of a cycle in which CIP 200 Acid-Based Process and Research Cleaner is added to hot water. The cleaning solution is then circulated through the processor for 20 minutes; this is followed by three rinses to remove the solution from the processor and a 10-
3
minute hot air purge. D-LONG is to be used on those occasions when the D-SHORT cycle has not been run within the past 54 hours.
4. Intended Use
The Reliance Endoscope Processing System is intended for washing and high level disinfection of up to two manually cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes, bronchoscopes and their accessories. High level disinfection is achieved within the 50 - 57°C HLD Phase of the Endoscope Processing Cycle (4 minute generation sequence followed by a 6minute exposure sequence).
5. Description of Safety and Substantial Equivalence
The Reliance Endoscope Processing System has the same technological characteristics as the predicate device.
The redesigned Reliance DG Dry Germicide secondary packaging configuration has been tested through the labeled shelf life of the product under defined storage conditions that represent a range of environmental stresses. After removal from the packaging throughout its shelf life, as well as after an additional two-week use life outside the packaging, Reliance DG containers met established acceptance criteria for visual physical integrity of the package and its contents, component concentrations, pH, and chelation capacity. At end of shelf life the product met its performance criteria in the Reliance EPS processor. The proposed modification does not change the integrity of the Reliance DG Dry Germicide over its labeled shelf life. The device is substantially equivalent to its predicate.
A summary of performance testing applicable to both the proposed Reliance Endoscope Processing System and its predicate Reliance Endoscope Processing System is provided in the Table attached.
4
K110453
p547
Non-clinical
Tests:
Germicide
Efficacy
The Reliance Endoscope Processing System was developed and validated
in accord with two primary FDA Guidance documents:
- Content and Format of Premarket Notification [510(k)] Submissions for
Liquid Chemical Sterilants/High Level Disinfectants (2000), and - Guidance on Premarket Notification [510(k)] Submissions for Automated
Endoscope Washers (1993).
A summary of this testing follows:
Reliance DG Dry Germicide Efficacy:
Reliance DG Dry Germicide was tested and shown to generate an effective
high level disinfection solution using the standard array of microbiological tests
for germicidal efficacy. The following testing was performed at conditions of
use that were worst case with respect to contact time, circulation, water
hardness, temperature, artificial soiling, and germicide concentration (at or
below the minimum effective dose of 9000 mg/L PAA minutes):
⇒ Sporicidal: Reliance DG Dry Germicide was proven to be sporicidal
as defined by AOAC Sporicidal Activity Test with an in situ exposure
time of 6 minutes. Confirmatory testing was completed successfully
and supplemental confirmatory testing was completed in the Reliance
Endoscope Processor. Potency was subsequently confirmed in the
processor using Reliance DG Dry Germicide containers that were
aged beyond the end of its shelf life.
⇒ Tuberculocidal: Reliance DG Dry Germicide was proven to be
tuberculocidal as defined by the AOAC Tuberculocidal Activity Test
with an exposure time of 6 minutes. Potency was subsequently
confirmed using Reliance DG Dry Germicide aged beyond the end of
its shelf life.
⇒ Virucidal: The Reliance Process was proven to reduce the viable
population of poliovirus Type 1, adenovirus Type 5, and herpes
simplex virus Type 1 by > 4 log₁₀.
⇒ Bactericidal: Reliance DG Dry Germicide was proven to be
bactericidal as defined by the AOAC Bactericidal Activity Test with an
exposure time of 6 minutes at worst case conditions, whether
performed in situ or in vitro.
⇒ Fungicidal: Reliance DG Dry Germicide was proven to be fungicidal
as defined by the AOAC Fungicidal Activity Test with an exposure
time of 6 minutes, whether performed in situ or in vitro.
Simulated-Use: Reliance DG Dry Germicide, at the minimum recommended
dose, reproducibly achieved greater than a 6 log₁₀ reduction of Mycobacterium
tarrae in triplicate trials within the Reliance Endoscope Processor for selected
clinically relevant flexible endoscopes and their accessories. The test articles
represented the range of most challenging devices, accessories, and
processing situations.
In-Use: Reliance Endoscope Processing System was evaluated in an in use
study in a US hospital. Three flexible endoscopes representing the range of
types indicated in the product labeling were used in clinical procedures and
processed according to instructions for use. In triplicate evaluations of each
endoscope, no organisms were recovered after processing. Bioburden levels
on the clinically used endoscopes after manual cleaning and before high level
disinfection were determined to be as high as 10⁵ CFU/device.
5
10453
Biocompatibility:
The Reliance chemical formulations, as supplied in packaging as well as in use dilutions, can be safely handled and used by customers. Residues that may remain on medical endoscopes and accessories are below established residue limits and do not pose a risk to patients. Safety statements in product labeling are appropriate to the potential risk.
- Reliance DG Dry Germicide, its components, reaction products, fi and residuals remaining on medical devices were evaluated for biocompatibility and possible risks to users. Testing included acute oral and ocular toxicity tests, dermal irritation studies, in vitro bacterial mutation genotoxicity studies, sensitization tests, and in vitro cytotoxicity evaluations; literature reviews of raw material toxicity data were also performed. Certain components in the single-use container, which under normal use conditions never contact the user, have the potential for irritation or skin sensitization: therefore appropriate warnings and instructions are displayed on labeling for the unusual event of a spill or container breakage.
-
Use dilution reaches non-cytotoxic levels with minimal dilution.
-
Biocompatibility testing of extracts from processed medical devices demonstrated that no toxic residuals remain on devices under worst case circumstances. The test data indicate that the worst case residue levels for the components of maximum potential risk are far below the allowable limits. Furthermore, the processor final rinse water was found to be non-cytotoxic.
Reliance Endoscope Processing System Material Compatibility:
The Reliance System was evaluated for its effect on intact medical devices, including flexible endoscopes and/or common materials of device construction. After 300 processing cycles, no deleterious effects were observed other than minor cosmetic changes. No functional changes in flexible endoscopes were observed.
Reliance DG Dry Germicide Stability:
Reliance DG was tested and found stable for 18 months in the unopened moisture-resistant packaging at the stated conditions for storage. Once opened, the individual cups within each tray are to be used within 2 weeks, or by the expiration date on the Reliance DG cup, whichever comes first.
6
K110453
p7f7
| 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 Pseudomonas aeruginosa followed by a 5 day inactive period; D-SHORT cycle - can kill bacteria that have potential to form biofilm. | |
|---|---|
| ANSI/UL -61010-1, 2nd Ed., | Electrical equipment for measurement, control and laboratory use Part 1, 2nd Edition |
| CAN/CSA C22.2 61010-1, 2nd Ed. | Electrical equipment for measurement, control and laboratory use Part 1, 2nd Edition |
| IEC 61010-1:2001 | Safety requirements for electrical equipment for measurement, control and laboratory use, Part 1: General requirements, |
| IEC 61010-2-40, 1st Ed. | Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials |
| IEC 61326-1:2005, 1st Ed. | Electrical equipment for measurement, control and laboratory use, EMC requirements Part 1: General requirements |
:
. - -
। -
7
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Robert Sullivan Senior Director, Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060
MAR 1 6 231
Re: K110453
Trade/Device Name: Reliance® Endoscope Processing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: NZA Dated: February 15, 2011 Received: February 16, 2011
Dear Mr. Sullivan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
8
Page 2- Mr. Sullivan
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Juns J. Koscielniak
for R
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if known):
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℃ 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)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth F. Clausing Williams
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
KII 0453 510(k) Number:
Page 1 of 1