(29 days)
Not Found
No
The summary describes an automated endoscope processing system focused on washing and high-level disinfection using chemical processes. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a high-level disinfection system for endoscopes, not as a device used for treating disease or injury.
No
Explanation: The device is described as an endoscope processing system intended for washing and high-level disinfection of medical devices. It does not perform any diagnostic functions.
No
The device description clearly states it is a "high level disinfection system" and a "combination of products" used to wash and disinfect endoscopes, indicating it includes physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes and their accessories." This describes a process for cleaning and disinfecting medical devices, not for performing diagnostic tests on biological samples.
- Device Description: The description reinforces this by stating it's a "high level disinfection system" that "wash and high level disinfect flexible endoscopes and their accessories."
- 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 substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases
The device is clearly intended for the reprocessing of medical instruments, which falls under a different regulatory category than IVDs.
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 pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes 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 (comma separated list FDA assigned to the subject device)
NZA
Device Description
The Reliance Endoscope Processing System is a high level disinfection system that can wash and high level disinfect up to two manually precleaned, immersible, reusable, heatsensitive, 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 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 a 6 minutes of high level disinfecting solution exposure time.
-
Following the high level disinfection phase, the Reliance Endoscope Processor removes the high level disinfecting solution through a rinse phase which is nonoptional 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.
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 Testing: A Biocompatibility test with alternate ink used on the label of Reliance DG Dry Germicide was performed. The purpose was to ensure the alternate new ink used on the label of the Reliance DG Dry Germicide does not cause a cytotoxic response. The acceptance criteria was that extracts from devices processed in the Reliance EPS with Reliance DG with the alternate ink on the label shall meet the acceptance criteria for cytotoxicity in ISO 10993-5:2009, Annex A Neutral Red Assay. The result was PASS.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 14, 2020
STERIS Corporation Jennifer Nalepka Lead Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060
Re: K200989
Trade/Device Name: Reliance Endoscope Processing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NZA Dated: April 14, 2020 Received: April 15, 2020
Dear Jennifer Nalepka:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CAPT Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K200989
Device Name
Reliance Endoscope Processing System
Indications for Use (Describe)
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 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).
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
3
Image /page/3/Picture/0 description: The image shows the STERIS logo. The word "STERIS" is in a bold, serif font at the top of the image. Below the word is a graphic of several horizontal, wavy lines in blue. The lines are stacked on top of each other, creating a visual effect of water or waves.
510(k) Summary For Reliance Endoscope Processing System
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Telephone: 440-354-2600 Fax No: 440-357-9198
Contact: Jennifer Nalepka Lead Regulatory Affairs Specialist Telephone: 440-392-7458 Fax No: 440-357-9198
Summary Date: May 7, 2020
Premarket Notification Number: K200989
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
4
1. Device Name
Trade Name: Reliance Endoscope Processing System Device Classification: Class II Common/usual Name: Automated Endoscope Reprocessor Classification Name: Accessories, Germicide, Cleaning, For Endoscopes Classification Number: 21 CFR 876.1500 Product Code: NZA
2. Predicate Device
Reliance Endoscope Processing System, K102244
3. Description of Device
The Reliance Endoscope Processing System is a high level disinfection system that can wash and high level disinfect up to two manually precleaned, immersible, reusable, heatsensitive, 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 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
5
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 a 6 minutes of high level disinfecting solution exposure time.
- Following the high level disinfection phase, the Reliance Endoscope Processor removes the high level disinfecting solution through a rinse phase which is nonoptional 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.
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.
4. 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, semicritical 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).
6
5. Technological Characteristic Comparison Tables
The Reliance Endoscope Processing System (EPS) is the same as the predicate device; the specific modification described in this submission is for a change to the ink on the label of the Reliance DG Dry Germicide. A comparison between the predicate and proposed devices can be found in Tables 1 and 2.
| Table 1: Technological comparison for Reliance EPS | |||
|---|---|---|---|
| Feature | Proposed Device | ||
| Reliance EPS | Predicate Device | ||
| Reliance EPS | |||
| K102244 | Comparison | ||
| 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). | 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). | Identical | ||
| Operating | |||
| Principles/ | |||
| Technology | The Reliance EPS and its | ||
| integrated endoscope processing | |||
| support provide for delivery of | |||
| solutions and fluids to | |||
| endoscopes and their accessories. | |||
| Klenzyme and Reliance DG are | |||
| introduced into the Reliance EPS | |||
| to provide washing and high | |||
| level disinfection. | |||
| Decontamination cycles (D-Long | |||
| with CIP-200 and D-Short) are | |||
| used to prevent biofilm | |||
| formation in the Reliance EPS | |||
| Processor and ensure effective | |||
| processing following periods of | |||
| processor inactivity. | The Reliance EPS and its | ||
| integrated endoscope processing | |||
| support provide for delivery of | |||
| solutions and fluids to | |||
| endoscopes and their accessories. | |||
| Klenzyme and Reliance DG are | |||
| introduced into the Reliance EPS | |||
| to provide washing and high | |||
| level disinfection. | |||
| Decontamination cycles (D-Long | |||
| with CIP-200 and D-Short) are | |||
| used to prevent biofilm | |||
| formation in the Reliance EPS | |||
| Processor and ensure effective | |||
| processing following periods of | |||
| processor inactivity. | Identical | ||
| Process | |||
| Parameters | Standardized cycle parameters | ||
| cannot be altered by operator. | |||
| The critical process parameters | |||
| are: | |||
| ● Contact Time | |||
| ● Use Dilution Temperature | Standardized cycle parameters | ||
| cannot be altered by operator. | |||
| The critical process parameters | |||
| are: | |||
| ● Contact Time | |||
| ● Use Dilution Temperature | Identical |
| Table 1. Technological comparison for Reliance EPS | ||
|---|---|---|
7
| Feature | Proposed Device
Reliance EPS | Predicate Device
Reliance EPS
K102244 | Comparison |
|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | Cleaning solution and Reliance DG concentration Water filter integrity | Cleaning solution and Reliance DG concentration Water filter integrity | |
| | Control Handle Boot pressure alarms if pressure too low to process, or if too high and could potentially damage scopes (specification 6.5 to 10.5 PSI). Detection of a fresh Reliance DG container in every processing cycle Cleaning Solution level monitored; alarm indicates when container does not have sufficient amount to complete cycle Temperature alarms if outside of range Water filter integrity test at end of each high level disinfection cycle. | Control Handle Boot pressure alarms if pressure too low to process, or if too high and could potentially damage scopes (specification 6.5 to 10.5 PSI). Detection of a fresh Reliance DG container in every processing cycle Cleaning Solution level monitored; alarm indicates when container does not have sufficient amount to complete cycle Temperature alarms if outside of range Water filter integrity test at end of each high level disinfection cycle. | |
| Process
Monitors | | | Identical |
| Design
Features | Intended for use with Reliance DG only Microprocessor controlled Internal components constructed of stainless steel, silicone, polypropylene and PVDF. Processor provides 0.2 micron filtered water for washing, disinfection and rinsing Automated injection of cleaning solutions Automated generation and delivery of high level disinfecting solution Air intake for Air Purge is | Intended for use with Reliance DG only Microprocessor controlled Internal components constructed of stainless steel, silicone, polypropylene and PVDF. Processor provides 0.2 micron filtered water for washing, disinfection and rinsing Automated injection of cleaning solutions Automated generation and delivery of high level disinfecting solution Air intake for Air Purge is | Identical |
| Feature | Proposed Device
Reliance EPS | Predicate Device
Reliance EPS
K102244 | Comparison |
| Cycle
Description | Optional: Wash 1 with 1
• rinse or Wash 2 with 1 rinse
o Wash time can be
adjusted to be between 5
and 10 minutes, 40
second rinse
Additional "smart rinse"
• occurs after optional wash if
boot pressure Bacillus subtilis
Clostridium sporogenes | Meets efficacy requirements.5
Bacillus subtilis
Clostridium sporogenes | Identical |
| Confirmatory
Sporicidal
Activity of
Disinfectants
AOAC
Official
Method
966.04 | Meets efficacy requirements.5
Bacillus subtilis
Clostridium sporogenes | Meets efficacy requirements.5
Bacillus subtilis
Clostridium sporogenes | Identical |
| Fungicidal
Activity of
Disinfectants
AOAC
Official
Method
955.17 | Solution is fungicidal.
Trichophyton mentagrophytes | Solution is fungicidal.
Trichophyton mentagrophytes | Identical |
| 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 | Identical |
8
9
Table 2. Technological comparison of Reliance DG Dry Germicide
10
' Block, S. ed., Disinfection, Sterilization, and Preservation. 5ª edition, 2001
² Clapp et al., Free Rad. Res., (1994) 21:147-167
³ Maillard et al., J. Med Microbiol. (1996)
11
| Feature | Proposed Device
Reliance DG Dry Germicide | Predicate Device
Reliance DG Dry Germicide | Comparison | | |
|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--|--|
| EPA Virucidal
Testing
(DIS/TSS-7,
Nov. 1981) | Process conditions are virucidal.
Herpes simplex Type 1
Adenovirus Type 5
Poliovirus Type 1 | Process conditions are virucidal.
Herpes simplex Type 1
Adenovirus Type 5
Poliovirus Type 1 | Identical | | |
| Tuberculocidal
Activity of
Disinfectants
AOAC
Official
Method
965.12 | Solution is tuberculocidal.
Mycobacterium bovis | Solution is tuberculocidal.
Mycobacterium bovis | Identical | | |
| Tuberculocidal
Activity
Ascenzi
Quantitative
Suspension
Test | Solution is tuberculocidal
Mycobacterium terrae | Solution is tuberculocidal
Mycobacterium terrae | Identical | | |
| Simulated-Use
Test | Meets efficacy requirement
Mycobacterium terrae | Meets efficacy requirement
Mycobacterium terrae | Identical | | |
| Biocompatibility | | | | | |
| Cytotoxicity
Device
Extracts | Non-cytotoxic per ISO 10993-5 | Non-cytotoxic per ISO 10993-5 | Identical | | |
| Residue
Reduction | Automatic within the Reliance
Endoscope Processor, 2 x 15 L -
0.2 µ filtered water rinses after
HLD cycle effectively reduces
germicide residues to safe levels. | Automatic within the Reliance
Endoscope Processor, 2 x 15 L -
0.2 µ filtered water rinses after
HLD cycle effectively reduces
germicide residues to safe levels. | Identical | | |
| 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 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. | Identical | | |
12
6. Summary of Non-Clinical Testing
Shown in Table 3 is the new testing that was performed to evaluate the modified device.
| Test | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Biocompatibility | |||
| with alternate ink | |||
| used on the label | |||
| of Reliance DG | |||
| Dry Germicide | To ensure the alternate new | ||
| ink used on the label of the | |||
| Reliance DG Dry | |||
| Germicide does not cause a | |||
| cytotoxic response. | Extracts from devices | ||
| processed in the Reliance EPS | |||
| with Reliance DG with the | |||
| alternate ink on the label shall | |||
| meet the acceptance criteria for | |||
| cytotoxicity in ISO 10993- | |||
| 5:2009, Annex A Neutral Red | |||
| Assay | PASS |
Table 3. Summary of verification activities
7. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well or better than the legally marketed predicate device (K102244), Class II (21 CFR 876.1500), product code NZA.