The EvoTech™ System, a washer/disinfector, is indicated for use with highlevel 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 System when selecting those cycles that contain a wash stage. (Manual cleaning is required when selecting the Disinfect Only or Disinfect/Alcohol Flush Cycles.)

Device Description

The EvoTech™ System 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 System is capable of cleaning endoscopes that have not been manually cleaned prior to placing in the EvoTech System.

AI/ML Overview

Here's a summary of the acceptance criteria and study details for the EvoTech™ System based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Cleaning (Simulated and In-Use Studies): Residual soil (protein and Total Organic Carbon - TOC) below a predefined limit.	In all instances, residuals were below the predefined limit of 8.5ug/cm².
Cleaning (Non-inferiority to manual cleaning): The washing of endoscopes in the EvoTech System to be non-inferior to washing following SGNA procedures.	The washing of endoscopes in the EvoTech System was determined to be non-inferior to washing of endoscopes following the SGNA procedure.
Cleaning (Clinically used endoscopes): Residual protein and TOC in all channels and surfaces to be less than predefined acceptance criteria.	Processing in the EvoTech System reduced the residual protein and TOC in all channels and surfaces to less than the predefined acceptance criteria.
High-Level Disinfection: A >10⁶ reduction in Mycobacterium terrae when endoscopes were contaminated with ≥8.5ug/cm² protein and >10 cfu/mL M. terrae.	After processing the contaminated endoscopes through the disinfect cycle only in the EvoTech System, there was a >10⁶ reduction in M. terrae.

Study Details:

Sample sizes for the test set and data provenance:
- Cleaning Studies (Simulated Use): Specific numbers are not provided, but it states "Both simulated use and in-use studies were completed." Endoscopes were "contaminated" for these tests. Data provenance is not specified but implies laboratory testing.
- Cleaning Studies (In-Use/Clinical): Specific numbers are not provided, but it states "Endoscopes used in clinical procedures were processed through the 'wash only' cycle." This indicates prospective, clinical data. Data provenance (country of origin) is not specified.
- High-Level Disinfection Study: Specific numbers are not provided, but it states "Endoscopes were contaminated with Mycobacterium terrae imbedded in soil." This implies laboratory testing.
Number of experts used to establish the ground truth for the test set and their qualifications:
- This information is not provided in the given text. For the cleaning and disinfection studies, the ground truth was based on quantitative measures of residual soil (protein, TOC) and microbial reduction, not expert consensus in the traditional sense of image interpretation.
Adjudication method for the test set:
- Adjudication methods (e.g., 2+1, 3+1) are typically relevant for qualitative assessments or disagreements in expert interpretation. Since the ground truth for cleaning and disinfection was based on quantitative measurements (ug/cm² and cfu/mL reduction), an adjudication method is not applicable and therefore not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- This is a device for endoscope reprocessing, not an AI or diagnostic imaging device. Therefore, an MRMC study and effects on human reader improvement with AI assistance are not applicable and no such study was described.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is a standalone device (automated endoscope reprocessor) where its performance is evaluated directly without human intervention in the core reprocessing function. The studies described are essentially standalone performance evaluations of the EvoTech System's ability to clean and disinfect effectively.
The type of ground truth used:
- Cleaning Studies: Quantitative measurement of residual protein and Total Organic Carbon (TOC) (ug/cm²).
- High-Level Disinfection Study: Quantitative measurement of microbial reduction (colony-forming units per milliliter - cfu/mL reduction for Mycobacterium terrae).
The sample size for the training set:
- This information is not applicable as the EvoTech System is an automated physical device, not a machine learning algorithm that requires a "training set" in the context of data-driven model development.
How the ground truth for the training set was established:
- This information is not applicable for the same reason as point 7.

Summary

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J. 510(k) Summary

Image /page/0/Picture/2 description: The image shows the word "CONFIDENTIAL" in all caps at the top. Below that is a handwritten number "K061899". At the bottom right of the image is the text "page 1 of 3", also handwritten.

Contact:

Joseph M. Ascenzi, Ph.D., RAC. Sr. Manager, Regulatory Affairs Advanced Sterilization Products 33 Technology Dr. Irvine, CA 92618

Phone: 949-453-6352 949-789-3900 Fax:

Device Name:

EvoTech™ System Trade Name: Proprietary Name: EvoTech™ Integrated Endoscope Disinfection System Classification: Endoscopes and accessories

Predicate Device:

The EvoTech™ System claims equivalence to the EvoTech™ System (K040883) found substantially equivalent on April 5, 2005. The predicate device is cleared to high-level disinfect endoscopes that have been manually cleaned using the high level disinfectant CIDEX OPA Concentrate Solution.

Device Description:

OCT 26 2006

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CONFIDENTIAL

Intended Use:

The EvoTech™ System is intended for use as a washer/disinfector for reprocessing flexible endoscopes that do not contact normally sterile areas of the body

Performance Data:

The EvoTech™ System 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 System was tested to determine its ability to 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 System. 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 System. In non-inferior trial, the washing of endoscopes in the EvoTech System 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 System and then extracted for residual organic material. Processing in the EvoTech System reduced the residual protein and TOC in all channels and surfaces to less than the predefined acceptance criteria, indicating that the EvoTech System 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 System without manual or automated washing. After processing the contaminated endoscopes through the disinfect cycle only in the EvoTech System, there was a >106 reduction in M. terrae.

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Advanced Sterilization Products EvoTech™ System 510(k) Submission

Conclusion:

CONFIDENTIAL 12 5

Data presented in this submission indicate that the EvoTech System is substantially equivalent to the Predicate Device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 6 2006

Dr. Joseph M. Ascenzi Senior Manager, Regulatory Affairs Advanced Sterilization Products 33 Technology Drive Irvine, California 92618

Re: K061899

Trade/Device Name: EvoTech™ Integrated Endoscope Disinfection System Regulation Number: 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FEB Dated: October 6, 2006 Received: October 10, 2006

Dear Dr. Ascenzi:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 -Dr. Ascenzi

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Susan Yuan
Chiu-Lin, Ph.D.

7 Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Device Name: EvoTech™ Integrated Endoscope Disinfection System KO61899 Indications for Use:

The EvoTech™ System, a washer/disinfector, is indicated for use with highlevel 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 System when selecting those cycles that contain a wash stage. (Manual cleaning is required when selecting the Disinfect Only or Disinfect/Alcohol Flush Cycles.)

Shila K. Murphy, MD 10/26/06

esiology, General Hospi

AND/OR

F.C.C. V.C.M.C.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Appendix 1-1

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.