K Number
K030004
Device Name
0.55% ORTH-PHTHALALDEHYDE SOLUTION
Date Cleared
2003-02-27

(56 days)

Product Code
Regulation Number
880.6885
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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.
Device Description
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 to be similar to glutaraldehyde and is based on powerful binding of the aldehyde to the outer cell wall of the organism.
More Information

No
The document describes a chemical disinfectant solution and its use in manual and automated reprocessing systems. There is no mention of any software, algorithms, or data processing that would indicate the presence of AI or ML. The focus is on the chemical composition and efficacy of the solution.

No.
The device is a high-level disinfectant used for reprocessing heat-sensitive medical devices, not a therapeutic device intended for treating or diagnosing patients.

No

Explanation: The document describes CIDEX® OPA Solution as a high-level disinfectant used for reprocessing heat-sensitive medical devices. Its purpose is to kill microorganisms on these devices, not to diagnose a condition or disease.

No

The device is a chemical solution intended for high-level disinfection, not a software program.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is clearly stated as a "high level disinfectant for reprocessing heat sensitive medical devices." This describes a product used to clean and disinfect medical equipment, not a product used to diagnose a condition or collect information about a patient's health from a sample taken from the body.
  • Device Description: The description details the chemical composition and mechanism of action as a disinfectant. It does not mention any components or functions related to analyzing biological samples.
  • Performance Studies: The performance studies focus on the efficacy of the solution in killing microorganisms and its compatibility with medical devices. There are no studies related to diagnostic accuracy, sensitivity, specificity, or other metrics typically associated with IVDs.

IVDs are devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This description does not align with the function of CIDEX® OPA Solution.

N/A

Intended Use / Indications for 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.

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°C (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.

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.

Product codes

MED

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K991487

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 880.6885 Liquid chemical sterilants/high level disinfectants.

(a)
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.(b)
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.

0

510(K) SUMMARY N.

1. 510(k) Summary of Safety and Effectiveness

K030004

CONTACT a.

Neelu Medhekar, R.A.C. Project Manager, Regulatory Affairs (949) 789-3838 (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

1

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.


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.

2

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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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is facing to the right, and its wings are composed of three curved lines. The logo is simple and clean, and it is easily recognizable.

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.

4

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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 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