(30 days)
No
The document describes a microprocessor-based controller for automated cycles, which is standard for automated systems and does not indicate AI/ML. There is no mention of AI, ML, or related terms, nor any description of training or test data sets typically associated with AI/ML development.
No.
Explanation: The device is an endoscope processing system designed for washing and high-level disinfection of medical devices, not for therapeutic intervention in patients.
No
The device is described as a high-level disinfection system for endoscopes, not a diagnostic device. Its function is to clean and disinfect, not to diagnose medical conditions or analyze patient data.
No
The device description clearly states it is an "electromechanical washer/high level disinfector" and a "combination of products" including hardware components like the processor and chemical components.
Based on the provided text, the Reliance Endoscope Processing System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for washing and high-level disinfection of medical devices (endoscopes and accessories). This is a process applied to medical devices, not a test performed on biological samples to diagnose a condition.
- Device Description: The description details a system for cleaning and disinfecting medical equipment. It involves chemical processes and automated cycles, not the analysis of biological specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
- Using reagents or assays to detect specific analytes
The system is a medical device used for reprocessing other medical devices to ensure they are safe for reuse. While it plays a crucial role in patient care by preventing the spread of infection, its function is not diagnostic.
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 bronchoscopes, GI flexible endoscopes including duodenoscopes, 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 disinfects 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 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 washing 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 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)
Summary of Non-Clinical Testing
| Test | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Fit test | Confirm components made with new raw material can be installed without interference or issue | No impact on fit of components made with new raw material as compared to device originally cleared in K040049. | PASS |
| Technical specifications | Confirm specifications of new raw material | Technical specifications must be the same or better than current raw material as compared to device originally cleared in K040049. | PASS |
| Biocompatibility and Chemical Compatibility | Confirm biocompatibility and chemical compatibility | Biocompatibility and chemical compatibility are unaltered as described in ANSI/AAMI/ISO 10993-1:2018 and ANSI/AAMI/ISO 10993-5:2009. | PASS |
Summary of Clinical Testing
Clinical testing was not performed because it is not applicable for this submission.
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.
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.
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March 10, 2022
STERIS Corporation Jennifer Nalepka Lead Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060
Re: K220361
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: February 7, 2022 Received: February 8, 2022
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 mediation-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,
For Clarence W. Murray, III, Ph.D. 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
Indications for Use
510(k) Number (if known) K220361
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 bronchoscopes, Gl flexible endoscopes including duodenoscopes, 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)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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510(k) Summary For Reliance Endoscope Processing System
STERIS 5960 Heisley Road Mentor, OH 44060 Telephone: 440-354-2600
Jennifer Nalepka Contact: Lead Regulatory Affairs Specialist Telephone: 440-392-7458
Summary Date: March 10, 2022
Premarket Notification Number: K220361
STERIS ▪ 5960 Heisley Road ▪ Mentor, OH 44060-1834 USA ▪ 440-354-2600
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1. Device Name
Trade Name: Reliance Endoscope Processing System Device Classification: Class II Common/usual Name: Automated Endoscope Reprocessor Accessories, Germicide, Cleaning, For Endoscopes Classification Name: Classification Number: 21 CFR 876.1500 Product Code: NZA
Predicate Device 2.
Reliance Endoscope Processing System, K203223
3. Description of Device
The Reliance Endoscope Processing System is a high level disinfection system that can wash and high level disinfects 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 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.
5
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 washing 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 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.
6
4. 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, semicritical devices such as bronchoscopes, GI flexible endoscopes including duodenoscopes, 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).
5. Technological Characteristic Comparison Tables
The Reliance Endoscope Processing System (EPS) is the same as the predicate device; this submission is provided to demonstrate the validity of the system's ongoing use to process duodenoscopes. A comparison between the predicate and proposed devices can be found in Tables 1 and 2.
| Feature | Proposed Device
Reliance EPS | Predicate Device
Reliance EPS
K203223 | Comparison | | |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 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 bronchoscopes, GI
flexible endoscopes, including
duodenoscopes, 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 bronchoscopes, GI
flexible endoscopes, including
duodenoscopes, 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 | 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 | Identical | |
| | | Feature | Proposed Device
Reliance EPS | Predicate Device
Reliance EPS
K203223 | Comparison |
| | | | and D-Short) are used to
prevent biofilm formation in the
Reliance EPS Processor and
ensure effective processing
following periods of processor
inactivity. | and D-Short) are used to prevent
biofilm formation in the
Reliance EPS Processor and
ensure effective processing
following periods of processor
inactivity. | |
| | | Process
Parameters | Standardized cycle parameters
cannot be altered by operator.
The critical process parameters
are:
• Contact Time
• Use Dilution Temperature
• Cleaning solution and
Reliance DG concentration
• Water filter integrity | Standardized cycle parameters
cannot be altered by operator.
The critical process parameters
are:
• Contact Time
• Use Dilution Temperature
• Cleaning solution and
Reliance DG concentration
• Water filter integrity | Identical |
| | | Process
Monitors | • Control Handle Boot
pressure alarms if pressure
too low to process, or if too
high and could potentially
damage scopes
(specification 6.5 – 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 – 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. | 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 | • 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 | Identical |
| | Feature | Proposed Device
Reliance EPS | Predicate Device
Reliance EPS
K203223 | Comparison | |
| | | Automated injection of cleaning solutions Automated generation and delivery of high level disinfecting solution Air intake for Air Purge is HEPA filtered | Automated injection of cleaning solutions Automated generation and delivery of high level disinfecting solution Air intake for Air Purge is HEPA filtered | | |
| Cycle
Description | Optional: Wash 1 with 1 rinse or Wash 2 with 1 rinse 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 |
| 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 |
| Feature | Proposed Device
Reliance DG Dry Germicide | Predicate Device
Reliance DG Dry Germicide | Comparison |
| 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 |
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
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6. Summary of Non-Clinical Testing
Shown in Table 3 is the new testing that was performed to evaluate the device.
| Test | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Fit test | Confirm components | ||
| made with new raw | |||
| material can be | |||
| installed without | |||
| interference or issue | No impact on fit of components | ||
| made with new raw material as | |||
| compared to device originally | |||
| cleared in K040049. | PASS | ||
| Technical specifications | Confirm specifications | ||
| of new raw material | Technical specifications must | ||
| be the same or better than | |||
| current raw material as | |||
| compared to device originally | |||
| cleared in K040049. | PASS | ||
| Biocompatibility and | |||
| Chemical Compatibility | Confirm | ||
| biocompatibility and | |||
| chemical compatibility | Biocompatibility and chemical | ||
| compatibility are unaltered as | |||
| described in ANSI/AAMI/ISO | |||
| 10993-1:2018 and | |||
| ANSI/AAMI/ISO 10993- | |||
| 5:2009. | PASS |
Table 3. Summary of verification activities
7. Summary of Clinical Testing
Clinical testing was not performed because it is not applicable for this submission.
8. 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 as or better than the legally marketed predicate device (K203223), Class II (21 CFR 876.1500), product code NZA.