MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR

K102996 · Medivators Reprocessing Systems · FEB · Jan 13, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K102996
• Device Name: MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR
• Applicant: Medivators Reprocessing Systems
• Product Code: FEB · Gastroenterology, Urology
• Decision Date: Jan 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

Medivators Advantage Plus Endoscope Reprocessing System tests, cleans, disinfects and rinses endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes and related accessories. Manual cleaning of endoscopes is not required prior to placement in the Advantage Plus system. The scopes must be precleaned immediately after use. The Advantage Plus Endoscope Reprocessing System uses Rapicide PA High Level Disinfectant to provide high level disinfection of endoscopes when used according to the directions for use. The system uses Intercept Detergent in its cleaning cycle at a concentration of 0.5%. Rapicide PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (MRC) of 850ppm peracetic acid; this ensures that the disinfectant was above MRC during the entire disinfection cycle. Rapicide PA should be used in the Advantage Plus System under the following contact conditions: Contact Time: 5 minutes Temperature: 30℃ MRC: 850ppm

Device Story

Electro-mechanical system for automated testing, cleaning, high-level disinfection, and rinsing of fiberoptic and video endoscopes. Operates by circulating Rapicide PA (peracetic acid-based) disinfectant and Intercept Detergent (0.5% concentration). Eliminates need for manual cleaning prior to machine placement, provided scopes are precleaned immediately post-use. Used in clinical settings by healthcare personnel. System verifies disinfectant concentration via Rapicide PA Test Strips (MRC 850ppm) post-cycle. Ensures endoscope safety for subsequent patient use.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including simulated use testing with major endoscope brands, testing of used clinical scopes, and evaluation of soil recovery procedures to validate the efficacy of the cleaning cycle.

Technological Characteristics

Electro-mechanical endoscope washer/disinfector. Uses peracetic acid-based high-level disinfectant (Rapicide PA) and detergent (Intercept). Operates at 30°C with 5-minute contact time. Manual cleaning replaced by automated cleaning cycle. No specific materials or connectivity standards provided.

Indications for Use

Indicated for high-level disinfection of heat-sensitive semi-critical fiberoptic and video endoscopes and related accessories between patient uses. Requires precleaning of scopes immediately after use.

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™ Integrated Endoscope Disinfection System (K061899)

Submission Summary (Full Text)

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K102996

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# Medivators Advantage Plus Endoscope Reprocessing System

## 510(k) Summary of Safety and Effectiveness Prepared December 27, 2010

JAN 1 3 2011

510(k) Number: K 102996 Manufacturer: Medivators Reprocessing Systems, a Division of Minntech Corporation Address: 14605 28th Avenue North Mpls., MN 55447 USA Official Contact: Lynn Lueders Director, Regulatory Affairs [phone] Device Name: Trade or proprietary name: Medivators Advantage Plus Endoscope Reprocessing System

Common or usual name: Endoscope washer/disinfector

Medivators has supplied the following information to the U.S. Food and Drug Administration to support the substantial equivalence of a cleaning claim for the Advantage Endoscope Reprocessing System to other endoscope reprocessors currently marketed in the U.S.

## 1. Device Description

The Advantage AER is an electro-mechanical system intended to test, clean, and high level disinfect fiberoptic and video endoscopes and their related accessories between uses.

The Advantage system uses the peracetic acid based Rapicide PA High Level Disinfectant.

The AER machine has the capability of cleaning endoscopes as part of the overall cleaning/disinfection cycle of the machine. The users may use the cleaning cycle to replace manual cleaning of the endoscope, however, the users are instructed that they need to preclean the endoscope immediately after use to the SGNA and facility guidelines.

### 2. Intended Use

Medivators Advantage Plus Endoscope Reprocessing System tests, cleans, disinfects and rinses endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes and related accessories. Manual cleaning of endoscopes is not required prior to placement in the Advantage Plus system. The scopes must be precleaned immediately after use.

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K102996
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The Advantage Plus Endoscope Reprocessing System uses Rapicide PA High Level Disinfectant to provide high level disinfection of endoscopes when used according to the directions for use. The system uses Intercept Detergent in its cleaning cycle at a concentration of 0.5%.

Rapicide PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (MRC) of 850ppm peracetic acid; this ensures that the disinfectant was above MRC during the entire disinfection cycle. Rapicide PA should be used in the Advantage Plus System under the following contact conditions:

| Contact Time: | 5 minutes |
|---------------|-----------|
| Temperature: | 30℃ |
| MRC: | 850ppm |

## 3. Comparison to Another Device in Commercial Distribution Within the United States

The Advantage Plus with a cleaning claim is the same machine as the original Advantage Plus AER. The machine function has not been changed. It has been shown to be equivalent to the Advanced Sterilization Products' EvoTech™ Integrated Endoscope Disinfection System (K061899). The machines have the same indications for use and the same methods of providing disinfection. The ASP EvoTech system and the Advantage system cleans the endoscopes, allowing the placement of the endoscopes into the machine without manual cleaning.

### 4. Summary of Testing

Medivators has provided testing to show that the Advantage Endoscope Reprocessing system cleaning cycle is safe and effective for its intended use.

Testing was presented to show that the cleaning cycle is efficacious and allows users to place used endoscopes into the machine without prior manual cleaning (users do need to preclean the scopes immediately following use).

This testing included simulated use testing with the major brands of endoscopes and testing of used clinical scopes. Testing also included the evaluation of our soil recovery procedures.

### Summary of Substantial Equivalence న.

Medivators has provided the above information in the form of a 510(k) to support the claim that the Advantage Endoscope Reprocessing System will clean endoscopes in order to eliminate manual cleaning.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Lynn Lueders Director, Regulatory Affairs Medivators Reprocessing Systems 14605 28th Avenue North Minneapolis, Minnesota 55447

JAN 1 3 2011

Re: K102996

Trade/Device Name: Medivators Advantage Plus Endoscope Reprocessing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FEB Dated: December 28, 2010 Received: December 29, 2010

Dear Ms. Lueders:

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. .

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Page 2- Ms. Lueders

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 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 go to

http://www.fda.goy/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Jeen I Robets
Fez

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if Known): K 102996

Device Name: Medivators Advantage Plus Endoscope Reprocessing System

Indications for Use:

Medivators Advantage Plus Endoscope Reprocessing System tests, cleans, disinfects and rinses endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes and related accessories. Manual cleaning of endoscopes is not required prior to placement in the Advantage Plus system. The scopes must be precleaned immediatelv after use.

The Advantage Plus Endoscope Reprocessing System uses Rapicide PA High Level Disinfectant to provide high level disinfection of endoscopes when used according to the directions for use. The system uses Intercept Detergent in its cleaning cycle at a concentration of 0.5%.

Rapicide PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (MRC) of 850ppm peracetic acid; this ensures that the disinfectant was above MRC during the entire disinfection cycle. Rapicide PA should be used in the Advantage Plus System under the following contact conditions:

Contact Time: Temperature: MRC:

5 minutes 30℃ 850ppm

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

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

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

Evelyth. D. Fleming-Will

Concurrence of CDRH, Office of Device Eval Anesthesiology, General Hos; it's

Infection Control, Dental Devices

KID2996 510(k) Number: _