(149 days)
Opaciden 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. Opaciden may be used or reused at or above its Minimum Recommended Concentration (MRC) of 0.3%, as determined by Opaciden OPA Reagent Strips, in manual reprocessing with an immersion time of at least 12 minutes at a minimum of 20° C (68° F), for a reuse period not to exceed 14 days. Opaciden may also be used or reused in a legally marketed automatic endoscope reprocessor (that can be set to a minimum of 25° C), at or above its Minimum Recommended Concentration (MRC), as determined by Opaciden OPA Reagent Strips, with an immersion time of at least 5 minutes at a minimum of 25° C (77° F), for a reuse period not to exceed 14 days.
Opaciden Solution is a clear, pale blue liquid with a pH of 7.5. It contains 0.60% ortho-Phthalaldehyde in an aqueous base containing buffers, chelating agents and a corrosion inhibitor. It is stable at 15-30°C (59-86°F) for its labeled shelf life. The product may be used or reused (up to 14 days) for manual or automated reprocessing, according to the Directions for Use. Opaciden Solution must be used at or above its Minimum Recommended Concentration (MRC), as determined by Opaciden OPA Reagent Strips, with the immersion time and temperature specified for the disinfection method.
The provided text describes a 510(k) summary for a high-level disinfectant called Opaciden Solution. However, it does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically found in a clinical study report or a more comprehensive performance study summary.
The document primarily focuses on establishing substantial equivalence to a predicate device (CIDEX® OPA Solution) and describes the device's intended use and technological characteristics. It mentions "performance testing" but does not provide specific acceptance criteria or detailed results.
Here's a breakdown of what can and cannot be extracted from the provided text, based on your request:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. While it states, "All test results were acceptable and demonstrated performance in accordance with the product labeling," it does not specify what those acceptance criteria were (e.g., specific log reduction values for microorganisms) or the quantitative performance results (e.g., "achieved X log reduction for Y organism").
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The text mentions "tested, in both the manual and automated reprocessing modes," but does not give details about the samples (e.g., number of devices disinfected, types of microorganisms tested, or specific test conditions). It also does not specify data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. For a chemical disinfectant, "ground truth" typically refers to the confirmed microbial reduction or inactivation, which is determined through laboratory assays, not by expert consensus on images or clinical assessments. The document doesn't detail the methodology for establishing the efficacy ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation of medical images or clinical outcomes, where disagreements need to be resolved. For a disinfectant performance study, the outcome is usually based on quantitative laboratory measurements.
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
This information is not applicable. An MRMC study is relevant for medical imaging AI devices where human readers interpret cases. Opaciden Solution is a high-level disinfectant, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This question is for AI algorithms. Opaciden Solution is a chemical disinfectant. Its performance is inherent to the chemical formulation and its interaction with microorganisms, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for a chemical disinfectant's performance would be established through microbiological assays, demonstrating the reduction or inactivation of specific challenge microorganisms (e.g., bacteria, viruses, fungi, spores) to a certain log reduction level, as specified by regulatory standards for high-level disinfectants. However, the document does not explicitly state the type of ground truth used, only that "All test results were acceptable."
8. The sample size for the training set
This information is not applicable/provided. Training sets are relevant for machine learning or AI models. Opaciden Solution is a chemical product, not an AI system.
9. How the ground truth for the training set was established
This information is not applicable/provided. Same as above, training sets and their ground truth establishment are for AI/ML models.
In summary:
The provided 510(k) summary for Opaciden Solution indicates that performance testing was conducted according to FDA guidance for high-level disinfectants. It claims that "All test results were acceptable and demonstrated performance in accordance with the product labeling, as well as substantial equivalence to the predicate device." However, it lacks the specific details of these performance tests, including quantitative acceptance criteria, actual performance metrics, sample sizes, and detailed methodology, which would be necessary to answer the questions comprehensively. The document is a summary focused on regulatory clearance based on substantial equivalence, not a detailed scientific study report.
{0}------------------------------------------------
K070627
page 1 of 2
AUG - 2 2007
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
Submitter's Name: Ciden Technologies, LLC 360 Cold Spring Avenue West Springfield, MA 01089 Telephone: (413) 747-7086 Fax: (413) 747-9721 Contact person: Damon D'Amico, President
Date of Summary: May 30, 2007
Device Names: Trade Name: Opaciden® Solution Common Name: High level disinfectant Classification Name: Liquid chemical germicide/high level disinfectant (21 CFR & 880.6885, Product Code MED)
Legally Marketed Device to which Equivalence is Claimed: The legally marketed predicate device is CIDEX® OPA Solution (K030004), manufactured by Advanced Sterilization Products, determined to be substantially equivalent to a legally marketed (preAmendment) device on February 27, 2003.
Device Description: Opaciden Solution is a clear, pale blue liquid with a pH of 7.5. It contains 0.60% ortho-Phthalaldehyde in an aqueous base containing buffers, chelating agents and a corrosion inhibitor. It is stable at 15-30°C (59-86°F) for its labeled shelf life. The product may be used or reused (up to 14 days) for manual or automated reprocessing, according to the Directions for Use. Opaciden Solution must be used at or above its Minimum Recommended Concentration (MRC), as determined by Opaciden OPA Reagent Strips, with the immersion time and temperature specified for the disinfection method.
Intended Use: Opaciden 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. Opaciden may be used or reused at or above its Minimum Recommended Concentration (MRC) of 0.3%, as determined by Opaciden OPA Reagent Strips, in manual reprocessing with an immersion time of at least 12 minutes at a minimum of 20° C (68° F), for a reuse period not to exceed 14 days. Opaciden may also be used or reused in a legally marketed automatic endoscope reprocessor (that can be set to a minimum of 25° C), at or above its Minimum Recommended Concentration (MRC), as determined by Opaciden OPA Reagent Strips, with an immersion time of at least 5 minutes at a minimum of 25° C (77° F), for a reuse period not to exceed 14 days.
{1}------------------------------------------------
K070627
page 21)2
Descriptive Summary of Technological Characteristics and Those of Predicate Device: The indications for use of Opaciden Solution are identical to those of the predicate device. The chemical formulation of Opaciden is very similar to that of the predicate device. There are no substantial technical or functional differences between the two products. Based on this information and the results of performance testing, it is expected that Opaciden will be compatible with all automated endoscope reprocessors currently validated for use with Cidex OPA.
Performance Data: Opaciden Solution has been tested, in both the manual and automated reprocessing modes, in accordance with applicable sections of the January 2000, FDA guidance for these products. All test results were acceptable and demonstrated performance in accordance with the product labeling, as well as substantial equivalence to the predicate device.
Conclusion: The information and data provided in this 510(k) Notification establish that Opaciden Solution is substantially equivalent to the legally marketed predicate device.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 2 2007
Ciden Technologies, LLC C/O Ms. Lisa S. Jones Regulatory Affairs Consultant Devices for the Future 540 College Street Bellaire, Texas 77401-5010
Re: K070627
Trade/Device Name: Opaciden Solution Regulation Number: 21 CFR 880.6885 Regulation Name: Liquid Chemical Sterilants/High Level Disinfectants Regulatory Class: II Product Code: MED Dated: July 20, 2007 Received: July 23, 2007
Dear Ms. Jones:
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.
{3}------------------------------------------------
Page 2 - Ms. Jones
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 your 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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
{4}------------------------------------------------
Attachment 7
Indications for Use
510(k) Number: K070627
Device Name: Opaciden Solution
Indications for Use: Opaciden Solution is a high level disinfectant for reprocessing heat sensitive semi-critical medical devices for which sterilization is not suitable, and when used according to the Directions for Use. Opaciden may be used or reused at or above its Minimum Recommended Concentration (MRC) of 0.3%, as determined by Opaciden OPA Reagent Strips, in manual reprocessing with an immersion time of at least 12 minutes at a minimum of 20° C (68° F), for a reuse period not to exceed 14 days. Opaciden may also be used or reused in a legally marketed automatic endoscope reprocessor (that can be set to a minimum of 25° C), at or above its Minimum Recommended Concentration (MRC), as determined by Opaciden OPA Reagent Strips, with an immersion time of at least 5 minutes at a minimum of 25° C (77° F), for a reuse period not to exceed 14 days.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Stevie Murphy, RD
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K070627
67
§ 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.