(56 days)
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.
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.
The provided document describes the 510(k) summary for CIDEX® OPA Solution, a liquid chemical germicide, and its efficacy testing. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Defined by the FDA for high-level disinfectants) | Reported Device Performance (CIDEX® OPA Solution) |
|---|---|
| Sporicidal efficacy | Achieved |
| Mycobactericidal efficacy | Achieved |
| Minimum Effective Concentration (MEC) | 0.3% |
| Stability | 24 months at 15-30°C |
| Biocompatibility (residues) | Levels well below toxic effects in animals |
| Material Compatibility (with endoscopes) | No functional or compatibility issues at 25°C in AER |
Note: The document specifies the efficacy testing was performed with reused CIDEX® OPA Solution at concentrations at or below the MEC of 0.3% for a 5-minute cycle at 25°C. The "acceptance criteria" here are inferred from the types of efficacy and safety tests mandated for such devices to obtain market clearance.
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific "sample size" in terms of number of devices or number of tests for the efficacy studies. It mentions efficacy testing was performed using a disinfection cycle of 5 minutes at 25°C with reused CIDEX® OPA Solution, and data was generated on the microbiological efficacy.
The data provenance is not explicitly detailed regarding its country of origin. The submission is a 510(k) to the FDA, implying the tests were conducted to meet US regulatory requirements, likely by or for the manufacturer (Advanced Sterilization Products, located in Irvine, CA). The studies appear to be prospective as they were conducted specifically to demonstrate the product's efficacy for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For a liquid chemical germicide, the "ground truth" for efficacy is typically based on standardized microbiological testing protocols against specified microorganisms, rather than expert judgment on individual "cases" in the way an AI model for medical imaging would.
4. Adjudication method for the test set
This information is not applicable and not provided for this type of device and study. Adjudication methods like 2+1 or 3+1 are relevant for studies involving human interpretation of data, typically in diagnostic imaging or clinical trials where multiple readers assess outcomes and discrepancies need to be resolved. This document describes efficacy testing of a chemical disinfectant.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools that involve human interpretation. CIDEX® OPA Solution is a disinfectant, and its efficacy is determined through laboratory microbiological testing, not human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the efficacy testing described is implicitly a standalone performance evaluation of the chemical disinfectant itself. The "algorithm" here is the chemical formulation and its interaction with microorganisms under specific conditions (5 minutes at 25°C, 0.3% MEC). There is no "human-in-the-loop" once the disinfection cycle is initiated; the chemical acts independently.
7. The type of ground truth used
The ground truth used for this study is based on microbiological efficacy against target organisms (sporicidal and mycobactericidal activity) measured in laboratory settings according to established disinfectant testing standards. This is equivalent to "outcomes data" in a very specific sense, where the outcome is the inactivation or killing of microorganisms.
8. The sample size for the training set
This information is not applicable and not provided. CIDEX® OPA Solution is a chemical disinfectant, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of AI. The formulation and testing of the disinfectant are based on chemical principles and empirical biological studies.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" for a chemical disinfectant. The efficacy (ground truth) is established through standardized laboratory microbiological testing protocols.
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510(K) SUMMARY N.
1. 510(k) Summary of Safety and Effectiveness
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
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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.
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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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.
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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 (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
§ 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.