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.)

Device Description

The 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 Endoscope Cleaner and Reprocessor is capable of cleaning endoscopes that have not been manually cleaned prior to placing in the system.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the EVOTECH® ECR Endoscope Cleaner and Reprocessor, based on the provided text:

Important Note: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" discussed are largely in reference to meeting established standards and demonstrating performance comparable to previously cleared devices, rather than a novel, bespoke set of criteria for this specific submission's unique functionality. The "study" largely refers to a compilation of previous testing and new verification for the minor modification.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a device with minor modifications (specifically, DCHP network capability), much of the performance data refers to studies conducted for previous iterations of the device (K040883, K061889, K140977). The "acceptance criteria" are derived from relevant FDA guidance and established standards for endoscope reprocessors.

Acceptance Criteria Category	Specific Acceptance Criteria (Derived/Implied)	Reported Device Performance
Software Verification & Validation	Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate Level of Concern)	Software verification and validation conducted, showing no significant effect on safety or effectiveness due to software changes (for DHCP network connectivity).
Electrical Safety & Electromagnetic Compatibility (EMC)	Compliance with EN 60601-1-2:2007 Class A, IEC 60601-1-2:2014 Class A, CISPR 11:2009 (Amended by A1: 2010) Class A, CAN/CSA-C22.2 No.: 61010-1 2004, UL 61010-1/R: 2008-10, EN 61010-1:2001	All test results met the requirements of the standards for radiated/conducted emissions and safety.
High-Level Disinfection Efficacy (Simulated Use)	≥ 6 Log10 reduction of Mycobacterium terrae when exposed to CIDEX® OPA Concentrate in use solution (0.055% OPA at 50°C) with artificial soil.	Achieved and demonstrated a 6 Log10 reduction of Mycobacterium terrae within 5 minutes at 50-52°C using CIDEX® OPA Concentrate (0.042% concentration with 5% fetal bovine serum organic soil load). (Referenced from K040883 and K140977 studies)
High-Level Disinfection Efficacy (Clinical/In-Use)	Sterility testing demonstrates no growth after reprocessing clinically used endoscopes without manual cleaning.	Sterility testing demonstrated no growth. (Referenced from K040883 study)
Cleaning Efficacy (Residual Soil)	Residual protein and Total Organic Carbon (TOC) below predefined limit (e.g., < 8.5 ug/cm² for protein).	In all instances, residuals were below the predefined limit of 8.5 ug/cm² for protein and TOC. Reduced residual protein and TOC in all channels and surfaces to less than predefined acceptance criteria. (Referenced from K061889 study)
Cleaning Efficacy (Non-inferiority to Manual Cleaning)	Non-inferiority to manual cleaning using SGNA procedures.	Washing of endoscopes in EVOTECH® ECR was determined to be non-inferior to washing following SGNA procedure. (Referenced from K061889 study)
Biocompatibility (Residual OPA)	Level of OPA residual not likely to cause toxic effects in humans.	Analysis indicated that OPA residual remaining on an endoscope after rinse phase is not likely to cause toxic effects in humans. (Referenced from K040883 study)
Material Compatibility with Disinfectant/Detergent	Minimal effect on materials commonly used in medical devices after multiple disinfection cycles over extended periods.	Minimal effect on test articles, similar to previous predicate device (K991487). (Referenced from K040883 study)
Duodenoscope Cleaning (Residual Protein/Hemoglobin)	< 6.4 µg/cm² residual protein and "no residue" for Hemoglobin at the distal tip of duodenoscopes.	All test samples met the acceptance criteria post EVOTECH® ECR wash-only cycle. (Newer study indicated in K152189 summary)
Duodenoscope Disinfection (M. terrae reduction)	6 log10 reduction of M. terrae for duodenoscopes with closed and open elevator wire channels after "disinfect only" cycle without cleaning.	A 6 log10 reduction of M. terrae was achieved for all tested duodenoscopes (Olympus, Pentax, Fujinon) in worst-case simulated use tests. (Newer study indicated in K152189 summary)

2. Sample Size Used for the Test Set and the Data Provenance

The document refers to multiple studies conducted for prior versions of the device, making it difficult to extract a single "test set" and provenance for this specific 510(k). However, based on the descriptions:

Simulated Use Testing for Disinfection (K040883 & K140977): The number of endoscopes or channels tested for the log reduction of Mycobacterium terrae is not explicitly stated as a number (e.g., "N=X"). Similarly, the provenance (country) is not specified, but these are generally conducted in a controlled lab environment. This would be considered prospective for the original studies.
In-Use Clinical Testing for Disinfection (K040883): It mentions "endoscopes used in a clinical environment" were reprocessed and sterility tested. No specific number ("N") is provided. The provenance is not specified. This would be prospective data collection.
Cleaning Efficacy (K061889): Mentions "endoscopes were contaminated" and "clinically used endoscopes" were processed. No explicit sample size (N) is given for either the simulated or clinical cleaning studies. Provenance not specified. This would be prospective data collection for those specific cleaning studies.
Duodenoscope Cleaning and Disinfection (K152189 summary): Tested Olympus, Pentax, and Fujinon duodenoscopes. The number of each type or total number of endoscopes is not specified. This suggests multiple units were tested to cover device variations. Provenance not specified, likely lab-based prospective studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The ground truth in these studies is primarily based on microbiological testing (colony counts for Mycobacterium terrae), chemical analysis (residual protein, TOC, OPA), and physical observations (sterility). These types of ground truth are established by laboratory procedures and measurements, not typically by human expert consensus or adjudication in the medical imaging sense. Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth is not directly applicable to this type of device testing, which relies on objective, measurable scientific parameters.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation, such as image analysis for disease detection. For device performance evaluations like cleaned surfaces, disinfection efficacy, or chemical residue, the "ground truth" is determined by direct measurement against established quantitative thresholds or qualitative observations by trained laboratory personnel/standardized assays, rather than a consensus or adjudication among multiple expert reviewers. So, none in the traditional sense.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This type of study (AI assistance for human readers) is relevant for diagnostic AI tools that aid human interpretation. The EVOTECH® ECR Endoscope Cleaner and Reprocessor is an automated cleaning and disinfection device; it does not involve human "readers" or "AI assistance" in its operation or the assessment of its output in a diagnostic context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself is a standalone automated system. The performance data presented (disinfection efficacy, cleaning efficacy, residual levels) directly represent the standalone performance of the EVOTECH® ECR Endoscope Cleaner and Reprocessor as an algorithm-controlled machine, without human intervention during the reprocessing cycle itself (beyond loading and selecting the cycle).

7. The Type of Ground Truth Used

The types of ground truth used were primarily:

Microbiological Culture/Counts: For disinfection efficacy (e.g., Mycobacterium terrae log reduction, sterility testing).
Chemical Analysis: For cleaning efficacy (quantification of residual protein, total organic carbon, hemoglobin) and biocompatibility (OPA residual levels).
Physical Observation/Measurement: For material compatibility (assessing effects on materials).
Compliance with Standards: For electrical safety and EMC.

8. The Sample Size for the Training Set

This document describes a medical device, not an AI/ML algorithm that requires a "training set" in the conventional machine learning sense for its core function. The software component mentioned (for DHCP network connectivity) would have undergone standard software development, verification, and validation, rather than "training" using a specific dataset. Therefore, the concept of a "training set sample size" as typically understood for AI models is not applicable to this device.

9. How the Ground Truth for the Training Set Was Established

As mentioned above, the concept of a "training set" and its associated ground truth is not applicable to this device's regulatory submission, which focuses on hardware and software (for control and networking) function rather than a machine learning model's performance on a training dataset. The "ground truth" for verifying the software related to network connectivity would be established through functional testing against specified requirements and network protocols.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K152189

Device Name

EVOTECH® Endoscope Cleaner and Reprocessor

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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| | 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

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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.

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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: K140977EVOTECH® ECR EndoscopeCleaner and Reprocessor	New Device: K152189EVOTECH® ECR EndoscopeCleaner and Reprocessor
System Design	Automated, stand-alone systemwith two operating reprocessingbasin comprising hardware,software, and consumables,designed to perform cleaningand high level disinfection offlexible endoscopes. Thesystem can reprocess twoendoscopes at a time.	Same as predicate device

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Disinfectant Used	CIDEX® OPA ConcentrateSolution (Single Use)	Same as predicate device
SystemPerformance	The system can perform blocktest, leak and endoscopeconnection test, washing(cleaning) and disinfection offlexible endoscopes. Thesystem has a self-disinfectcycle. The cycle steps for eachbasin are monitored andseparately controlled by thesystem software.	Same as predicate device
Endoscope and theEndoscope Cleanerand ReprocessorMaterials andcomposition incontact withfluid pathways	powder coated aluminum glass,stainless steel, polyethylene,Neoprene, polypropylene,polyamide, Ultem,polycarbonate, polypropylene	Same as predicate device
Systemcompatibility withassociated chemicalconsumable	System material is compatiblewith CIDEX® OPA Concentratehigh level disinfectant and anenzymatic detergent(CIDEZYME GI) for cleaningmedical instruments	Same as predicate device
NetworkConnectivity	Static IP network connectivity.	Dynamic host configurationprotocol (DHCP) networkcapability.

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

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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

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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

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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 < 6.4 µg/cm- residual protein and "no residue" for Hemoglobin.

Due to the complexity of the manual cleaning instructions for duodenoscopes, it is recommended that endoscopes with open/closed elevator wire channels be manually cleaned as per manufacturer's instructions in addition to using the cleaning cycle of the EVOTECH® System.

High level disinfection: Worst case simulated use tests demonstrated that EVOTECH® ECR Endoscope Cleaner and Reprocessor achieved cleaning and high level disinfection of duodenoscopes with closed and open elevator wire channels. Olympus, Pentax and Fujinon duodenoscopes with closed and open elevator wire channels were contaminated with Mycobacterium terrae and reprocessed using the "disinfect only" cycle in the EVOTECH® ECR without cleaning. A 6 log10 reduction of M. terrae was achieved for all tested duodenoscopes.

IX. CONCLUSIONS

There is no change to the proposed device intended use/indication for use or fundamental scientific technology compared to the predicate device. The software verification and validation performed demonstrated that the software changes in the proposed device could not have a significant effect on the safety or effectiveness of the system. Therefore data presented in this submission indicate that the EVOTECH® ECR Endoscope Cleaner and Reprocessor is substantially equivalent to the Predicate Device, EVOTECH® ECR Endoscope Cleaner and Reprocessor (K140977).

Regulation Number and Section

§ 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.