(559 days)
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.
CIDEX® OPA Concentrate is formulated to contain 5.75% w/v of ortho-phthalaldehyde. The resultant solution contains a corrosion inhibitor, a chelating agent, 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.
Here's a breakdown of the acceptance criteria and study information for the CIDEX® OPA Concentrate, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by High-Level Disinfectant Claims) | Reported Device Performance (CIDEX® OPA Concentrate) |
|---|---|
| Microbiological Efficacy: | |
| * Sporicidal activity | Demonstrated sporicidal efficacy. |
| * Bactericidal activity | Demonstrated bactericidal efficacy. |
| * Fungicidal activity | Demonstrated fungicidal efficacy. |
| * Tuberculocidal activity (against Mycobacterium terrae) | Demonstrated tuberculocidal efficacy. Specifically, simulated use testing 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 was effective against Mycobacterium terrae in artificial soil. |
| * Virucidal activity | Demonstrated virucidal efficacy. |
| Clinical Efficacy (In-Use conditions): | 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. |
| Biocompatibility: | The active ingredient and formulated product were subjected to a panel of toxicological tests (acute oral/dermal toxicity, skin sensitization, genetic toxicity, subchronic oral toxicity, developmental toxicity). All animal toxicity data indicate the product is at least as safe for human use as the predicate device. Product residues absorbed onto materials were at levels well below those causing toxic effects in animals. |
| Material Compatibility: | Evaluated for effects on materials commonly used in washer/disinfectors and medical devices. Results showed minimal effect on test articles, similar to the predicate device. |
| Stability: | Stable for 15 months at 15-30°C. In-machine use life is 80 days. |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set:
- Microbiology Tests: Not explicitly stated as a number, but refers to "standard array of microbiology tests."
- Simulated Use Testing: Not explicitly stated as a number of endoscopes, but mentions "flexible endoscopes."
- In-Use Testing: Not explicitly stated as a number of endoscopes, but refers to "Endoscopes used in a clinical setting."
- Biocompatibility: Not explicitly stated for human subjects; refers to "animal toxicity data."
- Material Compatibility: Not explicitly stated, but refers to "test articles" representative of commonly used materials.
- Data Provenance: The document does not specify the country of origin for the data. "In-Use Testing" implies prospective clinical data in a real-world setting. "Simulated Use" implies laboratory-controlled prospective data. Microbiology tests are typically laboratory-based.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies described are laboratory and clinical efficacy tests against known microbial targets or using standard toxicological/materials testing methods, rather than expert-driven diagnostic interpretations.
4. Adjudication Method for the Test Set
This information is not applicable as the studies are focused on direct measurement of antimicrobial efficacy, toxicity, and material compatibility, not on human interpretation or diagnostic agreement.
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
Not Applicable. This device is a liquid chemical germicide, not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in essence. The performance data presented for CIDEX® OPA Concentrate, particularly the efficacy testing (sporicidal, bactericidal, fungicidal, tuberculocidal, virucidal) and simulated use testing, represents the standalone performance of the chemical disinfectant itself, without human intervention affecting its germicidal action beyond following the directions for use. Its effectiveness is based on its chemical properties, not an algorithm.
7. The Type of Ground Truth Used
- Microbiological Efficacy: Ground truth is established by standard microbiological methods that quantify the reduction or elimination of specific microorganisms (e.g., bacteria, fungi, spores, viruses, mycobacteria). This involves culturing and enumeration techniques.
- Simulated Use/In-Use Testing: The ground truth for effectiveness is validated through sterility testing (absence of microbial growth) on the reprocessed endoscopes.
- Biocompatibility: Ground truth is established by toxicological endpoints measured in animal models and in vitro systems, as well as comparison to established safety profiles of predicate devices and known toxic thresholds.
- Material Compatibility: Ground truth is established by direct observation and measurement of material degradation or changes after exposure, often compared against manufacturer specifications or predicate device effects.
8. The Sample Size for the Training Set
Not Applicable. This is a chemical disinfectant, not an AI model, so there is no "training set." Its effectiveness is based on its chemical formulation and validated through laboratory and clinical testing, not machine learning.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no training set for an AI model, this question does not apply.
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APR - 4 2005
ု၊ နဲ့ နို
510(K) SUMMARY A.
1. 510(k) Summary of Safety and Effectiveness
| Contact | Neelu Medhekar R.A.C.,Project Manager, Regulatory AffairsPhone: 949 789 3838Fax: 949 789 3900Advanced Sterilization ProductsDivision of Ethicon Inc.33 Technology DriveIrvine, Ca 92618 |
|---|---|
| Date | September 22, 2003 |
| Device name | Classification: Liquid chemical germicideTrade Name: CIDEX® OPA ConcentrateProprietary Name: 5.75% nominal ortho-phthalaldehyde Solution |
| Legally marketed device | CIDEX® OPA Concentrate In-Use solution claims equivalence to thefollowing legally marketed medical devices: CIDEX® OPA Solution(K991487) and Steris 20™ Sterilant/ Steris System 1™ (K875280) |
| Device description | CIDEX® OPA Concentrate is formulated to contain 5.75% w/v ofortho-phthalaldehyde . The resultant solution contains a corrosioninhibitor, a chelating agent, and a dye in a phosphate buffer.ortho-Phthalaldehyde is chemically related to glutaraldehyde in thatthey are both aldehydes. The mechanism of action of ortho-phthalaldehyde is postulated to be similar to glutaraldehyde and is basedon powerful binding of the aldehyde to the outer cell wall of theorganism. |
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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 forbiocompatibility. The active ingredient and the formulated product weresubjected to a panel of toxicological tests, including acute oral anddermal toxicity, skin sensitization, genetic toxicity, in vitro and in vivosystems, subchronic oral toxicity and developmental toxicity tests. Allanimal toxicity data indicate that the product is at least as safe forhuman use as the predicate device. |
|---|---|
| Biocompatibility of product residues testing was conducted. Resultsindicate that CIDEX® OPA Concentrate In-Use solution residualsabsorbed onto materials commonly used in reprocessed medical devicesare at levels well below those, which cause toxic effects in animals. | |
| Materialcompatibility | CIDEX® OPA Concentrate and the In-Use solution were evaluated foreffects on materials commonly used to fabricate washer/disinfectors andmedical devices. The results showed minimal effect on test articles andwere similar to those seen with the predicate device. |
| Stability | CIDEX® OPA Concentrate was tested and found stable for 15 months at15-30° C. The in machine use life is 80 days. |
| Conclusion | The data presented and the equivalence demonstrated to the predicatedevice support the claim of substantial equivalency for CIDEX® OPASolution. CIDEX® OPA Concentrate In Use solution is safe andeffective as a high level disinfectant when used as labeled forreprocessing semi-critical medical devices. |
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Image /page/3/Picture/1 description: The image shows the seal for the Department of Health and Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. In the center of the seal is a stylized caduceus symbol, which is a staff with two snakes coiled around it.
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 (240) 276-0115. 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/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
Page 1 of 1
§ 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.