(350 days)
No
The document describes a washer/disinfector for endoscopes and focuses on its cleaning and disinfection capabilities, software validation, electrical safety, and performance studies related to microbial reduction and residue levels. There is no mention of AI, ML, image processing, or any data analysis techniques typically associated with AI/ML.
No
The device is an endoscope cleaner and reprocessor, not a device used to treat a disease or condition in a patient.
No
This device is an endoscope cleaner and reprocessor. Its function is to clean and high-level disinfect medical devices (endoscopes), not to diagnose medical conditions in patients.
No
The device description clearly states it is a "washer/disinfector" and describes physical components and processes involving liquids (detergent, disinfectant). While it mentions software verification and validation, this is in the context of software contained within a physical medical device, not a standalone software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to clean and high-level disinfect endoscopes, which are medical devices used for examining internal body cavities. This process is about preparing the endoscope for reuse on a patient, not about analyzing a sample taken from a patient to diagnose a condition.
- Device Description: The device is a washer/disinfector that uses detergents and disinfectants to clean and reprocess endoscopes. This aligns with the intended use of preparing a medical device for patient use.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of analytes, or diagnostic purposes. IVDs are typically used to test blood, urine, tissue, or other body fluids to provide information for diagnosis, monitoring, or screening.
The device is clearly a medical device used for reprocessing other medical devices (endoscopes) to ensure they are safe for subsequent patient use. This falls under the category of device sterilization or disinfection, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The EVOTECH® ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX® OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level disinfection of heat sensitive (>60°C) semi-critical endoscopes. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the EVOTECH® ECR Endoscope Cleaner and Reprocessor System when selecting those cycles that contain a wash stage. (Manual cleaning of medical devices (endoscopes) is required when selecting the Disinfect only or Disinfect/Alcohol Flush Cycle.)
Product codes (comma separated list FDA assigned to the subject device)
FEB
Device Description
EVOTECH® ECR Endoscope Cleaner and Reprocessor is a two-basin washer/disinfector utilizing an enzymatic detergent and a concentrated high level disinfectant, CIDEX® OPA Concentrate Solution. Both the detergent and high level disinfectant are diluted in the system to in-use concentrations. The EVOTECH® ECR Endoscope Cleaner and Reprocessor is capable of cleaning endoscopes that have not been manually cleaned prior to placing in the system.
Endoscopes that have been qualified for processing in the EVOTECH® ECR Endoscope Cleaner and Reprocessor must go through manual bedside pre-cleaning according to SGNA and facility guidelines prior to being placed in the EVOTECH® ECR Endoscope Cleaner and Reprocessor. If automatic cleaning is not available, or desired for the device by the user, the endoscope must also be manually cleaned by the user according to the endoscope manufacturer's instructions prior to being placed in the EVOTECH® ECR Endoscope Cleaner and Reprocessor.
After the endoscopes are connected to the EVOTECH® ECR Endoscope Cleaner and Reprocessor, the detergent is sprayed onto the surface of the device, and pumped through the lumens of the device, at sufficient pressure levels to remove soil present on or in the device.
The disinfectant is then mixed with incoming water, which is monitored to ensure that the temperature of the solution that is sprayed onto the surface of the device, and pumped through the lumens of the device, is at sufficient time and temperature to achieve high level disinfection. The temperature is monitored to ensure operating parameters of 50°C are met. A sample of the diluted CIDEX® OPA Concentrate Solution is extracted to ensure minimum effective concentration levels have been achieved. Following disinfection. the endoscopes are rinsed by the machine and air pumped through the lumens to facilitate drying of the endoscope. If selected by the user, an alcohol flush cycle may also be run to facilitate drying of the endoscope. The endoscope may then be removed, dried and used. The onboard printer generates a cycle printout summarizing the cycle results for the user's records. EVOTECH® ECR has Data Transfer Interface (DTI) capability which provide dynamic host configuration protocol (DHCP) for connecting the EVOTECH® ECR system to hospital networks.
The machine has built in safety features which cancel the cycle and notify the user if parameters are not met. These notifications, their causes, and next steps for the user, are defined in the EVOTECH® ECR Endoscope Cleaner and Reprocessor User Guide.
The network connectivity software revision part of this 510(k) premarket notification allows the Hospital IT Department to connect the EVOTECH® ECR Endoscope Cleaner and Reprocessor to a Hospital Local Area Network (LAN) for transfer of cycle parameters to a server and if desired, to an Instrument Tracking System.
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)
Software Verification and Validation Testing: Software verification and validation testing were conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern since prior to mitigation of hazards a failure of the software could result in Minor Injury, either to a patient or to a user of the device.
Electrical Safety and Electromagnetic Compatibility (EMC): The modified device has been tested for Radiated and Conducted Emissions according to the Standards EN 60601-1-2:2007 Class A and IEC 60601-1-2:2014 Class A, method CISPR 11:2009 (Amended by A1: 2010) Class A. All test results met the requirements of the Standards. The modified device has been evaluated for safety in accordance with CAN/CSA-C22.2 No.: 61010-1 2004, UL 61010-1/R: 2008-10 and EN 61010-1:2001. The system meets the standards' requirements.
Other Testing:
Simulated Use Testing: A 6 Log10 reduction of Mycobacterium terrae was achieved when flexible endoscopes, contaminated with Mycobacterium terrae and artificial soil and were exposed to CIDEX® OPA Concentrate in use solution without cleaning. The diluted CIDEX® OPA Concentrate at an MEC of 0.055% OPA concentration at 50°C is effective against Mycobacterium terrae in artificial soil.
In Use Testing: Endoscopes used in a clinical environment were reprocessed in the EVOTECH® ECR Endoscope Cleaner and Reprocessor without manual cleaning. Sterility testing demonstrated no growth.
Biocompatibility: An endoscope reprocessed in the EVOTECH® ECR Endoscope Cleaner and Reprocessor was evaluated for residue levels. The analysis indicates that the level of OPA residual remaining on an endoscope following the rinse phase is not likely to cause toxic effects in humans.
Material Compatibility: The EVOTECH® ECR Endoscope Cleaner and Reprocessor using CIDEX® OPA Concentrate In-Use solution was evaluated for its effect on materials commonly used in medical devices. Multiple disinfection cycles over extended periods of time resulted in minimal effect on the test articles. The effects seen were similar to those seen with the predicate device for the high level disinfectant CIDEX® OPA Solution K991487.
Cleaning Studies: The EVOTECH® ECR Endoscope Cleaner and Reprocessor was further tested in K061889 to determine its ability to high level disinfect and clean endoscopes. Both simulated use and in-use studies were completed. In both instances, endoscopes were contaminated and then processed in the "wash only" cycle in the EVOTECH® ECR Endoscope Cleaner and Reprocessor. Residual soil was quantified for both protein and total organic carbon (TOC). In all instances the residuals were below the predefined limit of 8.5ug/cm².
Non-inferiority Trial: Studies were completed comparing the residual soil after manual cleaning according to the procedures of the Society for Gastroenterology Nurses and Associates (SGNA) and cleaning in the EVOTECH® ECR Endoscope Cleaner and Reprocessor. In a non-inferiority trial, the washing of endoscopes in the EVOTECH® ECR Endoscope Cleaner and Reprocessor was determined to be non-inferior to washing of endoscopes following the SGNA procedure.
Clinical Cleaning Study: Endoscopes used in clinical procedures were processed through the "wash only" cycle of the EVOTECH® ECR Endoscope Cleaner and Reprocessor and then extracted for residual organic material. Processing in the EVOTECH® ECR Endoscope Cleaner and Reprocessor reduced the residual protein and TOC in all channels and surfaces to less than the predefined acceptance criteria, indicating that the EVOTECH® ECR Endoscope Cleaner and Reprocessor can clean clinically used endoscopes.
High-Level Disinfection Studies (K061889): Endoscopes were contaminated with Mycobacterium terrae imbedded in soil. Soil was inoculated in channels and on the surfaces of endoscopes so that each endoscopes contained ≥8.5ug/cm² protein with >10^6 cfu/mL M. terrae. Endoscopes were disinfected in the EVOTECH® ECR Endoscope Cleaner and Reprocessor without manual or automated washing. After processing the contaminated endoscopes through the disinfect cycle only in the EVOTECH® ECR Endoscope Cleaner and Reprocessor, there was a >10^6 reduction in M. terrae.
High-Level Disinfection Testing and Quantitative Tuberculocidal Testing (K140977): Demonstrated effectiveness of the OPA Concentrate solution at 0.042% concentration in the presence of 5% fetal bovine serum organic soil load within 5 minutes at 50-52°C using CIDEX® OPA Concentrate solution.
Cleaning of Duodenoscopes: Olympus, Pentax and Fujinon duodenoscopes (preconditioned by repeated articulation of the wire mechanisms with the distal tip immersed in artificial test soil and inoculated at the distal tip with a biopsy forceps in place), were cleaned using the EVOTECH® ECR System wash-only cycle. Residual protein and hemoglobin were extracted from the distal tip of all tested endoscopes and results showed that all test samples met the acceptance criteria of
§ 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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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three overlapping profiles facing to the right. The profiles are arranged in a way that creates a sense of depth and movement. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 20, 2016
Advanced Sterilization Products (ASP) Nazanin Yacobi Senior Regulatory Affairs Program Lead 33 Technology Drive Irvine, California 92618
Re: K152189
Trade/Device Name: EVOTECH® ECR Endoscope Cleaner and Reprocessor Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: FEB Dated: July 7, 2016 Received: July 11, 2016
Dear Nazanin Yacobi:
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.
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
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael D. Ryan -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152189
Device Name
EVOTECH® Endoscope Cleaner and Reprocessor
Indications for Use (Describe)
The EVOTECH® ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX® OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level disinfection of heat sensitive (>60°C) semi-critical endoscopes. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the EVOTECH® ECR Endoscope Cleaner and Reprocessor System when selecting those cycles that contain a wash stage. (Manual cleaning of medical devices (endoscopes) is required when selecting the Disinfect only or Disinfect/Alcohol Flush Cycle.)
| 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)
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510(k) Summary for K152189
I. SUBMITTER
Advanced Sterilization Products Division of Ethicon, Inc., a Johnson and Johnson Company 33 Technology Drive Irvine, CA 92618
Contact Person: Nazanin Yacobi Senior Regulatory Affairs Program Lead Tel: (949) 453-8672
Alternate Contact: Laurie Cartwright Associate Director Regulatory Affairs Tel: (949) 789-8545
Summary Date
July 12, 2016
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME II.
Trade Name: EVOTECH® ECR Endoscope Cleaner and Reprocessor Common/Usual Name: Endoscope Cleaner and Reprocessor Classification Name: Endoscope and Accessories (21 CFR 876.1500) Product Code FEB Product Classification: Class II 510(k) Number: K152189
III. PREDICATE DEVICE
EVOTECH® ECR Endoscope Cleaner and Reprocessor (K140977)
IV. DESCRIPTION OF DEVICE
EVOTECH® ECR Endoscope Cleaner and Reprocessor is a two-basin The washer/disinfector utilizing an enzymatic detergent and a concentrated high level disinfectant, CIDEX® OPA Concentrate Solution. Both the detergent and high level disinfectant are diluted in the system to in-use concentrations. The EVOTECH® ECR
4
Endoscope Cleaner and Reprocessor is capable of cleaning endoscopes that have not been manually cleaned prior to placing in the system.
Endoscopes that have been qualified for processing in the EVOTECH® ECR Endoscope Cleaner and Reprocessor must go through manual bedside pre-cleaning according to SGNA and facility guidelines prior to being placed in the EVOTECH® ECR Endoscope Cleaner and Reprocessor. If automatic cleaning is not available, or desired for the device by the user, the endoscope must also be manually cleaned by the user according to the endoscope manufacturer's instructions prior to being placed in the EVOTECH® ECR Endoscope Cleaner and Reprocessor.
After the endoscopes are connected to the EVOTECH® ECR Endoscope Cleaner and Reprocessor, the detergent is sprayed onto the surface of the device, and pumped through the lumens of the device, at sufficient pressure levels to remove soil present on or in the device.
The disinfectant is then mixed with incoming water, which is monitored to ensure that the temperature of the solution that is sprayed onto the surface of the device, and pumped through the lumens of the device, is at sufficient time and temperature to achieve high level disinfection. The temperature is monitored to ensure operating parameters of 50°C are met. A sample of the diluted CIDEX® OPA Concentrate Solution is extracted to ensure minimum effective concentration levels have been achieved. Following disinfection. the endoscopes are rinsed by the machine and air pumped through the lumens to facilitate drying of the endoscope. If selected by the user, an alcohol flush cycle may also be run to facilitate drying of the endoscope. The endoscope may then be removed, dried and used. The onboard printer generates a cycle printout summarizing the cycle results for the user's records. EVOTECH® ECR has Data Transfer Interface (DTI) capability which provide dynamic host configuration protocol (DHCP) for connecting the EVOTECH® ECR system to hospital networks.
The machine has built in safety features which cancel the cycle and notify the user if parameters are not met. These notifications, their causes, and next steps for the user, are defined in the EVOTECH® ECR Endoscope Cleaner and Reprocessor User Guide.
The network connectivity software revision part of this 510(k) premarket notification allows the Hospital IT Department to connect the EVOTECH® ECR Endoscope Cleaner and Reprocessor to a Hospital Local Area Network (LAN) for transfer of cycle parameters to a server and if desired, to an Instrument Tracking System.
5
v. INDENTED USE
The EVOTECH® ECR Endoscope Cleaner and Reprocessor is designed to automatically clean and high level disinfect flexible, submersible video or fiber-optic endoscopes. High level disinfection requires that the system be used with CIDEX® OPA Concentrate Solution.
The new device has the same intended use as the predicate device.
VI. INDICATION FOR USE
The EVOTECH® ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high level disinfectant CIDEX® OPA Concentrate and an enzymatic detergent (CIDEZYME GI) to achieve cleaning and high level disinfection of heat sensitive (>60 ℃) semi-critical endoscopes. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the EVOTECH® ECR System when selecting those cycles that contain a wash stage. (Manual cleaning of medical devices (endoscopes) is required when selecting the Disinfect only or Disinfect/Alcohol Flush Cycle.)
The new device has the same indication for use as the predicate device.
VII. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The EVOTECH® ECR Endoscope Cleaner and Reprocessor that is this subject of this submission is the same model as the predicate device cleared in K140977. The fundamental technological characteristics of the predicate devices are same as the device that is the subject of this 510(k). Design, materials, and functions of the Endoscope Cleaner and Reprocessor have not changed.
Table below contains a summary of the technological characteristics of the new device compared to the predicate device.
| Feature | Predicate Device: K140977
EVOTECH® ECR Endoscope
Cleaner and Reprocessor | New Device: K152189
EVOTECH® ECR Endoscope
Cleaner and Reprocessor |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| System Design | Automated, stand-alone system
with two operating reprocessing
basin comprising hardware,
software, and consumables,
designed to perform cleaning
and high level disinfection of
flexible endoscopes. The
system can reprocess two
endoscopes at a time. | Same as predicate device |
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| Disinfectant Used | CIDEX® OPA Concentrate
Solution (Single Use) | Same as predicate device |
|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| System
Performance | The system can perform block
test, leak and endoscope
connection test, washing
(cleaning) and disinfection of
flexible endoscopes. The
system has a self-disinfect
cycle. The cycle steps for each
basin are monitored and
separately controlled by the
system software. | Same as predicate device |
| Endoscope and the
Endoscope Cleaner
and Reprocessor
Materials and
composition in
contact with
fluid pathways | powder coated aluminum glass,
stainless steel, polyethylene,
Neoprene, polypropylene,
polyamide, Ultem,
polycarbonate, polypropylene | Same as predicate device |
| System
compatibility with
associated chemical
consumable | System material is compatible
with CIDEX® OPA Concentrate
high level disinfectant and an
enzymatic detergent
(CIDEZYME GI) for cleaning
medical instruments | Same as predicate device |
| Network
Connectivity | Static IP network connectivity. | Dynamic host configuration
protocol (DHCP) network
capability. |
VIII. PERFORMANCE DATA
The modified device has the same intended use, indications for use, materials, design features and fundamental technological characteristics as the predicate device. The following performance data were provided in support of the substantial equivalence determination:
Software Verification and Validation Testing
Software verification and validation testing were conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern since prior to mitigation of hazards a
7
failure of the software could result in Minor Injury, either to a patient or to a user of the device.
Electrical Safety and Electromagnetic Compatibility (EMC)
The modified device has been tested for Radiated and Conducted Emissions according to the Standards EN 60601-1-2:2007 Class A and IEC 60601-1-2:2014 Class A, method CISPR 11:2009 (Amended by A1: 2010) Class A. All test results met the requirements of the Standards.
The modified device has been evaluated for safety in accordance with CAN/CSA-C22.2 No.: 61010-1 2004, UL 61010-1/R: 2008-10 and EN 61010-1:2001. The system meets the standards' requirements.
Other Testing
The EVOTECH® ECR Endoscope Cleaner and Reprocessor is a washer/disinfector for use with an enzymatic detergent and the high level disinfectant CIDEX® OPA Concentrate Solution at 50° with an exposure time of 5 min to achieve cleaning and high level disinfection of flexible endoscopes.
The EVOTECH® ECR Endoscope Cleaner and Reprocessor was tested in K040883 using the standard array of tests defined in the FDA Guidance on Premarket Notification [510(k)] Submission for Automated Endoscope Washer / Disinfectors, and Disinfectors Intended for Use in Health Care Facilities, August, 1993.
For simulated use testing, the high level disinfectant indicated for use with the EVOTECH® ECR Endoscope Cleaner and Reprocessor was tested for efficacy in a simulated use environment. A 6 Logio reduction of Mycobacterium terrae was achieved when flexible endoscopes, contaminated with Mycobacterium terrae and artificial soil and were exposed to CIDEX® OPA Concentrate in use solution without cleaning. The diluted CIDEX® OPA Concentrate at an MEC of 0.055% OPA concentration at 50°C is effective against Mycobacterium terrae in artificial soil.
For in use testing, endoscopes used in a clinical environment were reprocessed in the EVOTECH® ECR Endoscope Cleaner and Reprocessor without manual cleaning. Sterility testing demonstrated no growth.
For biocompatibility, an endoscope reprocessed in the EVOTECH® ECR Endoscope Cleaner and Reprocessor was evaluated for residue levels. The analysis indicates that the
8
level of OPA residual remaining on an endoscope following the rinse phase is not likely to cause toxic effects in humans.
For material compatibility, the EVOTECH® ECR Endoscope Cleaner and Reprocessor using CIDEX® OPA Concentrate In-Use solution was evaluated for its effect on materials commonly used in medical devices. Multiple disinfection cycles over extended periods of time resulted in minimal effect on the test articles. The effects seen were similar to those seen with the predicate device for the high level disinfectant CIDEX® OPA Solution K991487.
The EVOTECH® ECR Endoscope Cleaner and Reprocessor was further tested in K061889 to determine its ability to high level disinfect and clean endoscopes. Both simulated use and in-use studies were completed. In both instances, endoscopes were contaminated and then processed in the "wash only" cycle in the EVOTECH® ECR Endoscope Cleaner and Reprocessor. Residual soil was quantified for both protein and total organic carbon (TOC). In all instances the residuals were below the predefined limit of 8.5ug/cm2.
Additionally, because the wash cycle is intended to eliminate the need for manual cleaning, studies were completed comparing the residual soil after manual cleaning according to the procedures of the Society for Gastroenterology Nurses and Associates (SGNA) and cleaning in the EVOTECH® ECR Endoscope Cleaner and Reprocessor. In a non-inferiority trial, the washing of endoscopes in the EVOTECH® ECR Endoscope Cleaner and Reprocessor was determined to be non-inferior to washing of endoscopes following the SGNA procedure.
Endoscopes used in clinical procedures were processed through the "wash only" cycle of the EVOTECH® ECR Endoscope Cleaner and Reprocessor and then extracted for residual organic material. Processing in the EVOTECH® ECR Endoscope Cleaner and Reprocessor reduced the residual protein and TOC in all channels and surfaces to less than the predefined acceptance criteria, indicating that the EVOTECH® ECR Endoscope Cleaner and Reprocessor can clean clinically used endoscopes.
High level disinfection of cleaned endoscopes was achieved. Endoscopes were contaminated with Mycobacterium terrae imbedded in soil. Soil was inoculated in channels and on the surfaces of endoscopes so that each endoscopes contained ≥8.5ug/cm² protein with >10' cfu/mL M. terrae. Endoscopes were disinfected in the EVOTECH® ECR Endoscope Cleaner and Reprocessor without manual or automated washing. After processing the contaminated endoscopes through the disinfect cycle only
9
in the EVOTECH® ECR Endoscope Cleaner and Reprocessor, there was a >10° reduction in M. terrae.
Further high level disinfection testing and quantitative tuberculocidal testing were completed for K140977 demonstrating effectiveness of the OPA Concentrate solution at 0.042% concentration in the presence of 5% fetal bovine serum organic soil load within 5 minutes at 50-52°C using CIDEX® OPA Concentrate solution.
Additional cleaning and disinfection studies utilizing duodenoscopes with open and closed elevator wire channels were conducted.
Cleaning: Olympus, Pentax and Fujinon duodenoscopes (preconditioned by repeated articulation of the wire mechanisms with the distal tip immersed in artificial test soil and inoculated at the distal tip with a biopsy forceps in place), were cleaned using the EVOTECH® ECR System wash-only cycle. Residual protein and hemoglobin were extracted from the distal tip of all tested endoscopes and results showed that all test samples met the acceptance criteria of