EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR

K082392 · Advanced Sterilization Products · FEB · Nov 13, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K082392
• Device Name: EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR
• Applicant: Advanced Sterilization Products
• Product Code: FEB · Gastroenterology, Urology
• Decision Date: Nov 13, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The EVOTECH™ 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°C) 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 of mystical devices (endoscopes) is required when selecting the Disinfect only or Disinfect/Alcohol Flush Cycle.)

Device Story

Automated washer/disinfector for heat-sensitive semi-critical endoscopes; performs connection, leak, and lumen blockage testing; executes cleaning, high-level disinfection, and automated alcohol flush cycles. Features self-disinfection cycle to prevent biofilm. System modifications include updated disinfectant dispenser, spray arm guard, MEC monitor detector, and lid motor control circuitry for safety. Operated by clinical staff in healthcare settings. Output provides cleaned/disinfected endoscopes for reuse. Benefits include standardized, automated reprocessing and reduced manual cleaning requirements.

Clinical Evidence

Bench testing only. Performance of modified subsystems (disinfectant dispenser, spray arm guard, MEC monitor) verified against specifications. Risk analysis confirmed no impact on cleaning or high-level disinfection efficacy.

Technological Characteristics

Washer/disinfector system. Components: disinfectant dispenser, spray arm, MEC monitor detector, lid motor control. Software-controlled cycles. Materials evaluated for compatibility with CIDEX OPA Concentrate. Automated fluid pathway management.

Indications for Use

Indicated for cleaning and high-level disinfection of heat-sensitive (>60°C) semi-critical endoscopes using CIDEX® OPA Concentrate and CIDEZYME GI detergent.

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™ Endoscope Cleaner and Reprocessor (K061899)

Submission Summary (Full Text)

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082392

Special 510(k) Advanced Sterilization Products

NOV 1 3 2008

pla 3 CONFIDENTIAL EVOTECH™ ECR

# K. 510(k) Summary

# Applicant's Name, Address, Telephone, FAX, Contact Information

Advanced Sterilization Products A Johnson & Johnson Company Division of Ethicon, Inc. 33 Technology Dr. Irvine, CA 92618

## Contact Person:

Joseph M. Ascenzi, Ph.D., RAC Sr. Manager, Regulatory Affairs Phone: [phone] FAX: [phone] Email: [e-mail]

## Submission Date

August 18, 2008

## Trade Name

EVOTECH™ Endoscope Cleaner and Reprocessor

# Common Name Washer Disinfector

# Classification

Class II

### Legally Marketed Equivalent Device

EVOTECHTM Endoscope Cleaner and Reprocessor (K061899)

### Description of Device

The EVOTECH™ Endoscope Cleaner and Re-processor was cleared under the Premarket Notification process (K040883) found substantially equivalent on March 15, 2005. Subsequent to that the EVOTECH ECR was granted a cleaning claim in Premarket Notification K061899 (found substantially equivalent on October 26, 2006).

The system is designed to clean and disinfect endoscopes. The system performs tests to check for connection of endoscopes, for leaks in endoscopes, and for blockage of lumens. The device will clean and high-level disinfect endoscopes and provides for automated alcohol flush of the lumens. The system

88

K-1

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# Special 510(k) Advanced Sterilization Products

K082392 p2/f3
CONFIDENTIAL
EVOTECH™ ECR

also has a self-disinfection cycle that can be selected (recommended to be performed every 5 days) to prevent the build up of biofilm in fluid pathways.

# 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°C) 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 of medical devices (endoscopes) is required when selecting the Disinfect only or Disinfect/Alcohol Flush Cycle.)

# Description of Modification

Several subsystems have been modified in order to increase reliability of the device. No changes to the device have been made that will affect the cleaning and high-level disinfection performance of the device.

# Summary of Non-clinical Tests

Verification of all physical and electrical changes were done to ensure that they did not affect the performance of the device with respect to cleaning and highlevel disinfection. Non-clinical testing was not done since risk analysis of the changes did not implicate a change to performance with respect to cleaning and high-level disinfection claims.

Changes to critical parts were evaluated.

#### Disinfectant dispenser-

The change was made after determining that the material was compatible with CIDEX OPA Concentrate Solution and that the change did not impact the performance to this part, i.e. it met the specification for dispensing volume and reproducibility.

#### Spray arm guard-

The addition of the spray arm guard was evaluated to show that it did not impact the rotation of the arm or affect the spray pattern and hence would not affect the cleaning and disinfection performance of the device.

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Special 510(k) Advanced Sterilization Products

K082392

CONFIDENTIAL p³ of 3
EVOTECH™ ECR

### MEC Monitor-

A manufacturing change to the MEC monitor detector was made and evaluated for performance. Data indicate that the performance is equivalent to the previous device.

## Lid Motor Control-

Changes to the circuitry of the lid motor driver were made so that the lid would not open while the machine was in operation. This was to prevent a potential safety issue.

Software was validated for the changes made.

# Substantial Equivalence

Based on the data obtained from the studies described above, the Modified Device, EVOTECH™ Endoscope Cleaner and Reprocessor 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 stylized eagle with its wings spread, surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The eagle is depicted in black and white, and the text is also in black. The logo is simple and recognizable, representing the department's role in providing health and human services to the United States.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 1 3 2008

Advanced Sterilization Products A Johnson & Johnson Company Division of Ethicon, Incorporated Joseph M. Ascenzi, Ph.D., RAC Senior Manager, Regulatory Affairs 33 Technology Drive Irvine, California 92618

Re: K082392

Trade/Device Name: EVOTECH™ Endoscope Cleaner and Reprocessor Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FEB Dated: October 13, 2008 Received: October 14, 2008

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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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 (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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Clrs

Chiu S. Lin. Ph. D Division 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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# Indications for Use

510(k) Number (if known): K082392

Device Name: EVOTECH™ Endoscope Cleaner and Reprocessor

Indications for Use:

The EVOTECH™ 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°C) 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 of mystical devices (endoscopes) is required when selecting the Disinfect only or Disinfect/Alcohol Flush Cycle.)

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K082392