EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM

K061899 · Advanced Sterilization Products · FEB · Oct 26, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K061899
• Device Name: EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM
• Applicant: Advanced Sterilization Products
• Product Code: FEB · Gastroenterology, Urology
• Decision Date: Oct 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

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

Device Story

EvoTech™ System is a two-basin washer/disinfector for flexible endoscopes. Device automates cleaning and high-level disinfection processes, eliminating the need for manual pre-cleaning when using wash-enabled cycles. System utilizes enzymatic detergent and CIDEX® OPA Concentrate high-level disinfectant. Operates by diluting chemicals to in-use concentrations and processing endoscopes through wash and/or disinfection cycles. Healthcare providers place endoscopes into the system; device performs automated cycles. Output is a cleaned and high-level disinfected endoscope, ready for clinical use. Benefits include standardized cleaning/disinfection, reduced manual labor, and consistent removal of organic soil and microbial contaminants from endoscope channels and surfaces.

Clinical Evidence

Bench testing only. Studies evaluated cleaning efficacy and high-level disinfection. Cleaning performance: simulated and in-use studies measured residual protein and total organic carbon (TOC) after 'wash only' cycles; all residuals were <8.5µg/cm². Non-inferiority trial compared system cleaning to manual SGNA procedures. Disinfection performance: endoscopes contaminated with M. terrae (>10⁶ cfu/mL) and soil (≥8.5µg/cm² protein) achieved >6 log reduction of M. terrae after disinfection cycle without prior manual or automated washing.

Technological Characteristics

Two-basin washer/disinfector. Uses enzymatic detergent and CIDEX® OPA Concentrate. Operates at 50°C with 5-minute exposure time for disinfection. Designed for heat-sensitive (>60°C) semi-critical endoscopes. Automated chemical dilution system. No specific materials or software architecture details provided.

Indications for Use

Indicated for cleaning and high-level disinfection of heat-sensitive (>60°C) semi-critical flexible endoscopes using CIDEX® OPA Concentrate and CIDEZYME GI enzymatic detergent. Manual cleaning is not required when using cycles containing a wash stage; manual cleaning is required for Disinfect Only or Disinfect/Alcohol Flush cycles.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• EvoTech™ System (K040883)

Submission Summary (Full Text)

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# J. 510(k) Summary

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### Contact:

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

Phone: [phone] 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:

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.

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 [phone]. 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 [phone] or [phone] 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