0.55% ORTH-PHTHALALDEHYDE SOLUTION

K030004 · Advanced Sterilization Products · MED · Feb 27, 2003 · General Hospital

Device Facts

• Record ID: K030004
• Device Name: 0.55% ORTH-PHTHALALDEHYDE SOLUTION
• Applicant: Advanced Sterilization Products
• Product Code: MED · General Hospital
• Decision Date: Feb 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6885
• Device Class: Class 2

Intended 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. Manual Processing: High Level Disinfectant at a minimum of 20℃ (68°F): 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, with an immersion time of at least 12 minutes for a reuse period not to exceed 14 days. Automatic Endoscope Reprocessors that can be set to 25°C: High Level Disinfectant at a minimum of 25°C (77°F): CIDEX® OPA Solution is a high level disinfectant when used or reused in a legally marketed automatic endoscope reprocessor (that can be set to 25°C) according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by CIDEX® OPA Solution Test Strips, with an immersion time of at least 5 minutes for a reuse period not to exceed 14 days.

Device Story

CIDEX® OPA Solution; 0.55% ortho-phthalaldehyde liquid chemical germicide; formulated with corrosion inhibitor, chelating agents, dye, phosphate buffer. Mechanism: aldehyde binding to outer cell wall of organisms. Used for high-level disinfection of heat-sensitive medical devices; manual trays/buckets or automated endoscope reprocessors (AER). Clinicians/technicians immerse devices for 12 minutes at 20°C (manual) or 5 minutes at 25°C (AER). Effectiveness monitored via test strips to ensure concentration at or above 0.3% Minimum Effective Concentration (MEC). Reuse period up to 14 days. Benefits: rapid high-level disinfection of heat-sensitive equipment; material compatibility with common endoscopes.

Clinical Evidence

Bench testing only. Sporicidal and mycobactericidal efficacy testing performed using reused solution at or below 0.3% MEC. Biocompatibility evaluation of residues confirmed levels below toxic thresholds. Material compatibility testing conducted in AER at 25°C showed no functional issues.

Technological Characteristics

Liquid chemical germicide; 0.55% ortho-phthalaldehyde; phosphate buffer; corrosion inhibitor; chelating agents; dye. Stable for 24 months at 15-30°C. Manual or AER-based application.

Indications for Use

Indicated for high-level disinfection of heat-sensitive medical devices where sterilization is not suitable. Used in manual systems or automatic endoscope reprocessors (AER).

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)

Submission Summary (Full Text)

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# 510(K) SUMMARY N.

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

K030004

# CONTACT a.

Neelu Medhekar, R.A.C. Project Manager, Regulatory Affairs [phone] (Telephone)

Advanced Sterilization Products Division of Ethicon Inc. 33 Technology Drive Irvine, Ca 92618

### b. DATE

December 26, 2002

#### DEVICE NAME C.

Classification: Liquid chemical germicide Trade Name: CIDEX® OPA Solution Proprietary Name: 0.55% ortho-phthalaldehyde Solution

#### d. LEGALLY MARKETED DEVICE

CIDEX® OPA Solution claims equivalence to the following legally marketed medical device: CIDEX® OPA Solution (K991487).

#### DEVICE DESCRIPTION e.

CIDEX® OPA Solution is formulated to contain 0.55% w/v of ortho-phthalaldehyde. The resultant solution contains a corrosion inhibitor, 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 ortho-phthalaldehyde is postulated

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to be similar to glutaraldehyde and is based on powerful binding of the aldehyde to the outer cell wall of the organism.

# f. INTENDED USE

CIDEX® OPA Solution is intended for use as a high level disinfectant for reprocessing heat sensitive medical devices.

CIDEX® OPA Solution can be used in manual systems (trays and buckets) and automated endoscope reprocessors.

#### EFFICACY TESTING g.

CIDEX® OPA Solution was tested for sporicidal and mycobactericidal efficacy using a disinfection cycle of 5 minutes at 25℃. The efficacy testing was performed with reused CIDEX® OPA Solution. Data generated on the microbiological efficacy of orthophthalaldehyde employed concentrations at or below the minimum effective concentration (MEC) of 0.3%.

#### h. BIOCOMPATIBILITY

Biocompatibility evaluation of product residues 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.

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### i. MATERIAL COMPATIBILITY

CIDEX® OPA Solution was evaluated for its effect on functionality and compatibility with endoscopes commonly used in medical facilities at 25°C in an AER (that can be set to 25℃). No functional or compatibility issues were found.

# j. STABILITY

CIDEX® OPA Solution was tested and found stable for 24 months at 15-30° C.

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# k. CONCLUSION

The data presented and the equivalence demonstrated to the predicate 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 medical devices.

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Public Health Service

FEB 2 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Neelu Medhekar Project Manager, Regulatory Affairs Advanced Sterilization Products A Johnson & Johnson /Div. of Ethicon, Inc 33 Technology Drive Irvine, California 92618

Re: K030004

Trade/Device Name: CIDEX® OPA Solution Regulation Number: 880.6885 Regulation Name: Liquid Chemical Ssterilants Regulatory Class: II Product Code: MED Dated: December 31, 2002 Received: January 2, 2003

Dear Mr. 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 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 - Mr. 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 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 vour 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/dsma/dsmamain.html

Sincerely yours,

Susan Rurser

Susan Runner, DDS, MA Interim 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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ADVANCED STERILIZATION PRODUCTS® a Johnson John on company

REGULATORY AFFAIRS DEPARTMENT

# 510(k) Number: K030004 Device Name: CIDEX® OPA Solution Indications-For-Use:

This Premarket Notification is a modification to the previously cleared CIDEX® OPA Solution. This submission expands the cleared Indications for Use to include a 5-minute claim at 25°C for the high level disinfectant in automatic endoscope reprocessors:

High Level Disinfectant at a minimum of 25°C (77°F): CIDEX® OPA Solution is a high level disinfectant when used or reused in a legally marketed automatic endoscope reprocessor (that can be set to 25°C) according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by CIDEX® OPA Solution Test Strips, with an immersion time of at least 5 minutes for a reuse period not to exceed 14 days.

The modified Indications for Use for CIDEX® OPA Solution now reads:

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.

Manual Processing: High Level Disinfectant at a minimum of 20℃ (68°F): 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, with an immersion time of at Jeast 12 minutes for a reuse period not to exceed 14 days.

Automatic Endoscope Reprocessors that can be set to 25°C: High Level Disinfectant at a minimum of 25°C (77°F): CIDEX® OPA Solution is a high level disinfectant when used or reused in a legally marketed automatic endoscope reprocessor (that can be set to 25°C) according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by CIDEX® OPA Solution Test Strips, with an immersion time of at least 5 minutes for a reuse period not to exceed 14 days.

Minimum Effective Concentration (MEC): 0.3%.

Note: If your AER cannot be set to a minimum of 25°C please follow the time and temperature stated in Indications for Use, Manual Processing.

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR

Over-the-Counter Use

(Optional Format 1-2-96)

Clive So Lim

Division Sign-Off Division of Anesthesiology, General Hospital Infection Control, Dental Device

510(k) Number. K030004