CIDEX OPA SOLUTION

K991487 · Advanced Sterilization Products · MED · Oct 8, 1999 · General Hospital

Device Facts

• Record ID: K991487
• Device Name: CIDEX OPA SOLUTION
• Applicant: Advanced Sterilization Products
• Product Code: MED · General Hospital
• Decision Date: Oct 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6885
• Device Class: Class 2

Indications for Use

CIDEX® OPA Solution is a high level disinfectant for reprocessing heat sensitive medical devices, for which sterilization is not suitable, and when used according to the Directions for Use. High level disinfectant: CIDEX® OPA Solution is a high level disinfectant when used or reused, according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by the CIDEX® OPA Solution Test Strips, at 20℃ (68 F) with an immersion time of at least 12 minutes for a reuse period not to exceed 14 days.

Device Story

CIDEX® OPA Solution is a 0.55% ortho-phthalaldehyde liquid chemical germicide used for high-level disinfection of heat-sensitive medical devices. It contains a corrosion inhibitor, chelating agents, and a dye in a phosphate buffer. The mechanism of action involves binding of the aldehyde to the outer cell wall of microorganisms. The solution is used by immersing devices for at least 12 minutes at 20°C. Effectiveness is monitored using CIDEX® OPA Solution Test Strips to ensure the concentration remains at or above the 0.3% Minimum Effective Concentration (MEC). The solution is stable for 14 days of reuse. It provides sporicidal, bactericidal, fungicidal, tuberculocidal, and virucidal activity. The device benefits patients by ensuring medical instruments are properly disinfected, reducing the risk of cross-contamination during procedures like bronchoscopy, gastroscopy, and colonoscopy.

Clinical Evidence

Clinical evidence includes in-use testing on 100 endoscopes used for bronchoscopy, gastroscopy, and colonoscopy, confirming high-level disinfection efficacy. Microbiology testing demonstrated sporicidal, bactericidal, fungicidal, tuberculocidal, and virucidal activity under various conditions (end of shelf life, reuse stressed, and MEC of 0.3%). Biocompatibility was evaluated via a panel of toxicological tests, including acute oral/dermal toxicity, skin sensitization, genetic toxicity, and subchronic/developmental toxicity. Material compatibility was assessed through extended soak testing. Results indicate the solution is safe and effective for its intended use.

Technological Characteristics

Liquid chemical germicide containing 0.55% ortho-phthalaldehyde, corrosion inhibitor, chelating agents, and dye in a phosphate buffer. Operates via chemical binding to microbial cell walls. Stable for 24 months at 15-30°C. Requires use with CIDEX® OPA Solution Test Strips to verify 0.3% MEC. Non-electronic, chemical-based disinfection.

Indications for Use

Indicated for high-level disinfection of heat-sensitive medical devices that cannot be sterilized. Suitable for use in clinical settings for reprocessing devices such as endoscopes.

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® Activated Dialdehyde Solution
• Peract 20

Submission Summary (Full Text)

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K991487

#### 0CT 8 1999

#### 510(K) SUMMARY ·N.

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

| Contact | John E. Friend, R.A.C.<br>Vice President, Worldwide Regulatory Affairs<br>[phone] (Telephone)<br>[phone] (Fax)<br><br>Advanced Sterilization Products<br>Division of Ethicon Inc.<br>33 Technology Drive<br>Irvine, Ca 92618 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date | October 6, 1999 |
| Statement | Information supporting claims of substantial equivalence, as defined<br>under the Federal Food, Drug and Cosmetic Act, respecting safety and<br>effectiveness is summarized below.<br><br>For the convenience of the Reviewer, this summary is formatted in<br>accordance with the Agency's final rule “...510(k) Summaries and<br>510(k) Statements...” (21 CFR §807) and can be used to provide a<br>substantial equivalence summary to anyone requesting it from the<br>Agency. |
| Device name | Classification: Liquid chemical germicide<br>Trade Name: CIDEX® OPA Solution<br>Proprietary Name: 0.55% ortho-phthalaldehyde Solution |
| Legally marketed device | CIDEX® OPA Solution claims equivalence to the following legally<br>marketed medical devices: CIDEX® Activated Dialdehyde Solution and<br>Peract 20. |

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Device

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CIDEX® OPA Solution is formulated to contain 0.55% w/v of orthophthalaldehyde. The resultant solution contains a corrosion inhibitor, description chelating agents, and a dye in a phosphate buffer, ortho-Phthalaldehyde is chemically related to glutaraldehyde in that they are both aldehydes. The mechanism of action of ortho-phthalaldehyde is postulated to be similar to glutaraldehyde and is based on powerful binding of the aldehyde to the outer cell wall of the organism.

#### CIDEX® OPA Solution is a high level disinfectant for reprocessing heat Intended use sensitive medical devices, for which sterilization is not suitable, and when used according to the Directions for Use.

High level disinfectant: CIDEX® OPA Solution is a high level disinfectant when used or reused, according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by the CIDEX® OPA Solution Test Strips, at 20℃ (68 F) with an immersion time of at least 12 minutes for a reuse period not to exceed 14 days.

Minimum Effective Concentration (MEC): 0.3%

Page 234 10/6/1999

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K991487

page 3 of

- CIDEX® OPA Solution was tested using the standard array of Efficacy Testing microbiology tests for germicidal efficacy. Tests demonstrated sporicidal, bactericidal, fungicidal, tuberculocidal and virucidal efficacy of CIDEX® OPA Solution. The CIDEX® OPA Solution used within the test protocols represented end of shelf life, reuse stressed, and MEC concentration of 0.3% conditions.
Sporicidal: CIDEX® OPA Solution is a sporicidal agent as defined by the AOAC Sporicidal Activity Test with an exposure time of at least 32 hours at 20°C.

Simulated Use: The reused and diluted CIDEX® OPA Solution at an MEC of 0.3% concentration at 20℃ is effective against Mycobacterium terrae in artificial soil.

In Use Testing: One hundred endoscopes used for bronchoscopy, gastroscopy, and colonoscopy were studied to determine the efficiency of CIDEX® OPA Solution for high level disinfection. The results support the claim of high level disinfectant for CIDEX® OPA Solution.

CIDEX® OPA Solution was evaluated for biocompatibility. The active Biocompatibility ingredient and the formulated product were subjected to a panel of toxicologic tests, including acute oral and dermal toxicity, skin sensitization, genetic toxicity, in vitro and in vivo systems, subchronic oral toxicity and developmental toxicity tests. All animal toxicity data indicate that the product is at least as safe for human use as the predicate device.

> Biocompatibility of product residues testing was conducted. Results indicate that CIDEX® OPA Solution residuals absorbed onto materials commonly used in reprocessed medical devices are at levels well below those, which cause toxic effects in animals.

> > Page 235 10/6/1999

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CIDEX® OPA Solution was evaluated for its effect on materials Material commonly used to fabricate medical devices. Multiple disinfection compatibility soaks over extended periods of time resulted in minimal effect on the test articles. The effects seen were similar to those seen with the predicate device. CIDEX® OPA Solution was tested and found stable for 24 months at Stability 15-30℃. The data presented and the equivalence demonstrated to the predicate Conclusion device support the claim of substantial equivalency for CIDEX® OPA Solution. CIDEX® OPA Solution is safe and effective as a high level disinfectant when used as labeled for reprocessing heat sensitive AOAC Sporicidal Test results showed sporicidal medical devices. activity.

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Image /page/4/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 that resembles an eagle or a stylized human profile, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1999 OCT

John E. Friend, M.Sc., R.Ph., R.A.C. Vice President, Worldwide Regulatory Affairs Advanced Sterilization Products® A Johnson & Johnson Company Requlatory Affairs Department Division of Ethicon, Inc. 33 Technoloqy Drive Irvine, CA 92618

Re: K991487

> CIDEX® OPA Solution Trade Name: Requlatory Class: Unclassified Product Code: MED September 28, 1999 Dated: September 29, 1999 Received:

Dear Mr. Friend:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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### Page 2 - Mr. Friend

the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# ADVANCED STERILIZATION PRODUCTS®

a Johnson Johnson company

REGULATORY AFFAIRS DEPARTMENT

# Indications for Use

510(k) Number: K991487

Device Name: CIDEX® OPA Solution (0.55% ortho-phthalaldehyde solution)

## Indications For Use:

CIDEX® OPA Solution is a high level disinfectant for reprocessing heat sensitive medical devices, and when used according to the Directions for Use.

High Level Disinfectant: CIDEX® OPA Solution is a high level disinfectant when used or reused, according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by CIDEX® OPA Solution Test Strips, at 20° C (68° F) with an immersion time of at least 12 minutes for a reuse period not to exceed 14 days.

Minimum Effective Concentration (MEC): 0.3%.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-the-Counter Use X

(Optional Format 1-2-96)

Olia S. Lin

(Division Sign-Off) Division of Dental, Infection Co and General Hospita 5 1 O(k) Number