CIDEX OPA CONCENTRATE

K032959 · Advanced Sterilization Products · MED · Apr 4, 2005 · General Hospital

Device Facts

• Record ID: K032959
• Device Name: CIDEX OPA CONCENTRATE
• Applicant: Advanced Sterilization Products
• Product Code: MED · General Hospital
• Decision Date: Apr 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6885
• Device Class: Class 2

Intended Use

CIDEX® OPA Concentrate is intended for use as a high level disinfectant for reprocessing heat sensitive (<60°C) endoscopes. CIDEX® OPA Concentrate is intended for use only in the washer/disinfector, the EvoTech System. This product is not intended for manual use or in automatic endoscope reprocessors that re-use their high level disinfectant.

Device Story

CIDEX® OPA Concentrate is a 5.75% ortho-phthalaldehyde solution containing corrosion inhibitors, chelating agents, and dye in a phosphate buffer. It functions as a high-level disinfectant for heat-sensitive endoscopes. The device is used exclusively within the ASP EvoTech™ System (automated washer/disinfector). The mechanism of action involves the binding of aldehyde to the outer cell wall of microorganisms. The solution is processed within the EvoTech system to achieve high-level disinfection, ensuring the safety of semi-critical medical devices for reuse. It benefits patients by providing effective sporicidal, bactericidal, fungicidal, tuberculocidal, and virucidal reprocessing of endoscopes, reducing the risk of cross-contamination.

Clinical Evidence

No clinical trials were performed. Evidence is based on bench testing and simulated-use studies. Efficacy was validated using a standard array of microbiology tests demonstrating sporicidal, bactericidal, fungicidal, tuberculocidal, and virucidal activity. Simulated-use testing on flexible endoscopes contaminated with cells and artificial soil showed a >6 Log10 reduction of Mycobacterium terrae at an MEC of 0.055% at 50°C. In-use testing in a clinical setting confirmed no microbial growth on endoscope surfaces/channels after reprocessing.

Technological Characteristics

Liquid chemical germicide; 5.75% ortho-phthalaldehyde active ingredient; phosphate buffer with corrosion inhibitors, chelating agents, and dye. Stability: 15 months at 15-30°C; in-machine use life: 80 days. Designed for use in the ASP EvoTech™ System washer/disinfector. Biocompatibility evaluated per standard toxicological panels.

Indications for Use

Indicated for high-level disinfection of heat-sensitive (<60°C) semi-critical endoscopes at a minimum in-use concentration of 0.055% with a 5-minute contact time at 50°C. Intended for use exclusively in the ASP EvoTech™ System; not for manual use.

Regulatory Classification

Identification

A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.

Special Controls

*Classification.* Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.

Predicate Devices

• CIDEX® OPA Solution (K991487)
• Steris 20™ Sterilant/ Steris System 1™ (K875280)

Submission Summary (Full Text)

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K032959

## APR - 4 2005

ု၊ နဲ့ နို

## 510(K) SUMMARY A.

## 1. 510(k) Summary of Safety and Effectiveness

| Contact | Neelu Medhekar R.A.C.,<br>Project Manager, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>Advanced Sterilization Products<br>Division of Ethicon Inc.<br>33 Technology Drive<br>Irvine, Ca 92618 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date | September 22, 2003 |
| Device name | Classification: Liquid chemical germicide<br>Trade Name: CIDEX® OPA Concentrate<br>Proprietary Name: 5.75% nominal ortho-phthalaldehyde Solution |
| Legally marketed device | CIDEX® OPA Concentrate In-Use solution claims equivalence to the<br>following legally marketed medical devices: CIDEX® OPA Solution<br>(K991487) and Steris 20™ Sterilant/ Steris System 1™ (K875280) |
| Device description | CIDEX® OPA Concentrate is formulated to contain 5.75% w/v of<br><i>ortho-phthalaldehyde</i> . The resultant solution contains a corrosion<br>inhibitor, a chelating agent, and a dye in a phosphate buffer.<br><i>ortho-Phthalaldehyde</i> is chemically related to glutaraldehyde in that<br>they are both aldehydes. The mechanism of action of <i>ortho-</i><br><i>phthalaldehyde</i> is postulated to be similar to glutaraldehyde and is based<br>on powerful binding of the aldehyde to the outer cell wall of the<br>organism. |

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CIDEX® OPA Concentrate is intended for use as a high level Intended use disinfectant for reprocessing heat sensitive (<60°C) endoscopes. CIDEX® OPA Concentrate is intended for use only in the washer/disinfector, the EvoTech System. This product is not intended for manual use or in automatic endoscope reprocessors that re-use their high level disinfectant. High level disinfectant: CIDEX® OPA Concentrate is a high level Performance data disinfectant at its In-Use concentration when used according to the Directions for Use and the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contributi CIDEX® OPA Concentrate In-Use solution was tested using the Efficacy Testing standard array of microbiology tests for germicidal efficacy. Tests demonstrated sporicidal, bactericidal, fungicidal, tuberculocidal and virucidal efficacy of CIDEX® OPA Concentrate In-Use solution. The CIDEX® OPA Concentrate used within the test protocols represented oldest available product. Simulated Use: Simulated use testing prior to cleaning, exposure to CIDEX® OPA Concentrate In-Use solution resulted in a >6 Log10 reduction of Mycobacterium terrae when flexible endoscopes were contaminated with cells and artificial soil. The diluted CIDEX® OPA Concentrate at an MEC of 0.055% concentration at 50° C is effective against Mycobacterium terrae in artificial soil. In-Use Testing: Endoscopes used in a clinical setting were subjected to high level disinfection without cleaning. Sterility testing showed no growth on all endoscope surfaces and channels after reprocessing in CIDEX OPA Concentrate In Use solution.

< 03.29541

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| Biocompatibility | CIDEX® OPA Concentrate and the In-Use solution were evaluated for<br>biocompatibility. The active ingredient and the formulated product were<br>subjected to a panel of toxicological tests, including acute oral and<br>dermal toxicity, skin sensitization, genetic toxicity, <i>in vitro</i> and <i>in vivo</i><br>systems, subchronic oral toxicity and developmental toxicity tests. All<br>animal toxicity data indicate that the product is at least as safe for<br>human use as the predicate device. |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Biocompatibility of product residues testing was conducted. Results<br>indicate that CIDEX® OPA Concentrate In-Use solution residuals<br>absorbed onto materials commonly used in reprocessed medical devices<br>are at levels well below those, which cause toxic effects in animals. |
| Material<br>compatibility | CIDEX® OPA Concentrate and the In-Use solution were evaluated for<br>effects on materials commonly used to fabricate washer/disinfectors and<br>medical devices. The results showed minimal effect on test articles and<br>were similar to those seen with the predicate device. |
| Stability | CIDEX® OPA Concentrate was tested and found stable for 15 months at<br>15-30° C. The in machine use life is 80 days. |
| Conclusion | The data presented and the equivalence demonstrated to the predicate<br>device support the claim of substantial equivalency for CIDEX® OPA<br>Solution. CIDEX® OPA Concentrate In Use solution is safe and<br>effective as a high level disinfectant when used as labeled for<br>reprocessing semi-critical medical devices. |

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APR - 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Advanced Sterilization Products Ms. Neelu Medhekar Project Manager, Regulatory Affairs Ethicon, Incorporated 33 Technology Drive Irvine, California 92618

Re: K032959

Trade/Device Name: CIDEX OPA Concentrate Regulation Number: 880.6885 Regulation Name: Liquid Chemical Sterilants High Level Disinfectants Regulatory Class: II Product Code: MED Dated: March 16, 2005 Received: March 17, 2005

Dear Ms. Medhekar:

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 cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 mr), it and 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 Eederal Register.

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Page 2 - Ms. Medhekar

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 and ilsuing (21 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 Iegally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), nlease 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,

Suette M, chui Davis

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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## Indications for Use

510(k) Number (if known): K032959

Device Name: CIDEX® OPA Concentrate

Indications For Use:

CIDEX® OPA Concentrate is a high level disinfectant (HLD) at the minimum IN USE concentration of 0.055% with a contact time of 5 minutes at 50°C for reprocessing heat sensitive (<60°C) semi-critical endoscopes when used according to the Directions for Use.

CIDEX® OPA Concentrate is intended for use in the ASP EvoTech™ System. THIS PRODUCT IS NOT INTENDED FOR MANUAL USE. See Directions for Use.

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

Over-The-Counter Use V (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)

Shelli H. Mayberry R 4/4/05
Division Sign-Off

) Infaction Control Dental Dental Devices

510(k) Number K032959

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