(35 days)
CIDEX® Activated Dialdehyde Solution is a liquid chemical sterilant and a high level disinfectant for reprocessing heat sensitive medical/dental devices such as endoscopes, respiratory therapy equipment and ultrasonic transducers.
Sterilant:
CIDEX Solution is a sterilant when used or reused, according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by the CIDEX® Solution Test Strip, at 25°C (77°) with an immersion time of at least 10 hours with a reuse period not to exceed 14 days.
High Level Disinfectant:
CIDEX 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 the CIDEX® Solution Test Strip, at 25°C (77°) with an immersion time of at least 45 minutes with a reuse period not to exceed 14 days.
CIDEX Solution is intended for use in manual systems as well as in automated endoscope reprocessors.
CIDEX Solution is a liquid chemical sterilant/high level disinfectant used for sterilization/high-level disinfection of heat sensitive semi-critical medical devices that cannot be processed by another process. The active ingredient is not specified in the provided text. The modification to the device incorporates an anti-oxidant and solubilizing agent to increase the shelf life of the product beyond the current 2 years.
The provided text describes a Special 510(k) submission for an advanced sterilization product. However, it does not contain the detailed information typically associated with acceptance criteria and study designs for algorithmic or AI-powered medical devices. Instead, it focuses on the performance of a chemical sterilant/disinfectant. As such, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from the given text.
Here's the information that can be extracted and how it relates to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Predicate) | Reported Device Performance (Modified) |
|---|---|---|
| Sterilization Claim | Achieve sterilization (implied by "legally marketed equivalent device" K924434, which is also CIDEX Activated Dialdehyde Solution, and the statement "The sterilization claim...for the Modified Device was confirmed to be the same as the Predicate Device"). Specific log reduction for predicate not explicitly stated but must meet regulatory standards for sterilization. | Achieved sterilization: Sampling of surface and lumens indicated a >10^6 log reduction in viable Bacillus subtilis spores after 10 hours soaking at 25°C. |
| High-Level Disinfection Claim | Achieve high-level disinfection (implied by "legally marketed equivalent device" K924434 and the statement "The high level disinfection claim for the Modified Device was confirmed to be the same as the Predicate Device"). Specific log reduction for predicate not explicitly stated but must meet regulatory standards for high-level disinfection. | Achieved high-level disinfection: Exposure to the Modified Device for 45 minutes at 25°C reduced viable M. terrae by >6 log10 (assumed, as "610g10" likely a typo for ">6 log10" or similar). |
| Shelf Life (Accelerated Stability) | At least 6 months (based on predicate performance, though not explicitly stated for predicate; the modified device "increase over the stability of the Predicate Device" implies the predicate had at least 6 months). | Improved: Accelerated stability studies (40°C/75%RH) indicate the product is stable for 6 months, which is an increase over the stability of the Predicate Device. |
| Shelf Life (Real-Time Stability) | At least 18 months (based on predicate performance; implied by real-time data for modified device already reaching 18 months). | Ongoing, currently stable: Real-time stability (30°C/60%RH) is ongoing. Data at 18 months indicates the product is stable. Data will be collected out to 3 years. (Goal is expected to be 3 years, exceeding the predicate's 2 years as previously mentioned for increased shelf-life). |
| Active Ingredients | Based on CIDEX Activated Dialdehyde Solution (K924434) | Active ingredient is a liquid chemical sterilant described as "the active ingredient" in the Description of Device. The modification adds "an anti-oxidant and solubilizing agent." The core chemistry remains similar to the predicate, as implied by substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For sterilization and high-level disinfection simulated use studies, three types of endoscopes were used. For each endoscope type, external surfaces and internal lumens were inoculated. The actual number of individual endoscopes tested is not specified (e.g., if one of each type, or multiple of each type).
- Data Provenance: The studies were conducted internally as part of the 510(k) submission, likely in the United States by Advanced Sterilization Products. The data is prospective for the modified device, as it was specifically generated to support this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable / Not explicitly stated. This device is a chemical sterilant/disinfectant. Its effectiveness is measured through microbiological assays rather than expert interpretation of medical images or other subjective data. Therefore, "experts" in the context of establishing ground truth for human-interpretable data (like radiologists) are not relevant here. The "ground truth" is determined by direct microbiological testing (colony forming units, log reduction).
4. Adjudication Method for the Test Set
- Not applicable. As the ground truth is established by direct microbiological measurement, there is no human interpretation or adjudication process required in the sense of consensus among experts.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- Not applicable. This is a chemical sterilant/disinfectant, not an AI or imaging device that would involve human readers.
6. Standalone (Algorithm Only) Performance
- Not applicable. This is a chemical product, not an algorithm. The performance described is inherently "standalone" in that it is the performance of the chemical itself.
7. Type of Ground Truth Used
- Microbiological laboratory data. The ground truth for effectiveness claims (sterilization and high-level disinfection) was established through quantitative measurement of microbial reduction (log reduction in Bacillus subtilis spores and Mycobacterium terrae) on inoculated endoscopes. This is a direct, objective measurement.
8. Sample Size for the Training Set
- Not applicable. Chemical sterilants do not have "training sets" in the context of machine learning. The product formulation is developed through chemical research and development, and its performance is validated through specific studies, not "trained" on data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See #8.
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Special 510(k) Advanced Sterilization Products CIDEX® Activated Dialdehyde Solution
J. 510(k) Summarv
APR 1 2 2006
Applicant's Name, Address, Telephone, FAX, Contact Information
Advanced Sterilization Products A Johnson & Johnson Company Division of Ethicon, Inc. 33 Technology Dr. Irvine, CA 92618
Contact Person:
Joseph M. Ascenzi, Ph.D., RAC Sr. Manager, Regulatory Affairs Phone: (949) 453-6352 (949) 789-3900 FAX: Email: jascenzi@aspus.jnj.com
Submission Date
March 7, 2006
Trade Name CIDEX® Activated Dialdehyde Solution
Common Name
Liquid Chemical Sterilant
Classification
Class II
Legally Marketed Equivalent Device
CIDEX® Activated Dialdehyde Solution, K924434
Description of Device
CIDEX Solution is a liquid chemical sterilant/high level disinfectant used for sterilization/high-level disinfection of heat sensitive semi-critical medical devices that cannot be processed by another process. The active ingredient
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Page 2 of 3
Indications for Use
CIDEX® Activated Dialdehyde Solution is a liquid chemical sterilant and a high level disinfectant for reprocessing heat sensitive medical/dental devices such as endoscopes, respiratory therapy equipment and ultrasonic transducers.
Sterilant:
CIDEX Solution is a sterilant when used or reused, according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by the CIDEX® Solution Test Strip, at 25°C (77°) with an immersion time of at least 10 hours with a reuse period not to exceed 14 days.
High Level Disinfectant:
CIDEX 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 the CIDEX® Solution Test Strip, at 25°C (77°) with an immersion time of at least 45 minutes with a reuse period not to exceed 14 days.
CIDEX Solution is intended for use in manual systems as well as in automated endoscope reprocessors.
Description of Modification
The modification to the device incorporates an anti-oxidant and solubilizing agent to increase the shelf life of the product beyond the current 2 years.
Summary of Non-clinical Tests
Microbiological activity of the Modified Device was evaluated using the required standard test methods. The sterilization claim and high level disinfection claim for the Modified Device was confirmed to be the same as the Predicate Device.
Simulated use studies were conducted to validate the sterilization and high-level disinfection claim. The external surface and internal lumens of three types of endoscopes were inoculated with >10° cfu Bacillus subtilis spores and subjected to 10 hours soaking at 25℃. Sampling of the surface and lumens indicated a >106 log reduction in viable spores. High-level disinfection was verified in a simulated use study using the same three types of scopes whose surfaces and internal lumens were inoculated with >106 cfu Mycobacterium terrae. Exposure to the Modified Device for 45 min at 25℃ reduced the viable M. terrae by >610g10.
Stability studies of the Modified Device are in progress. Accelerated stability studies (40°C/75%RH) indicate that the product is stable for 6 months, and increase over the stability of the Predicate Device. Real time stability
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(30°C/60%RH) is on going. Data at 18 months indicates the product is stable. Data will be collected out to 3 years.
Substantial Equivalence
Based on the data obtained from the studies described above, the Modified Device, CIDEX Activated Dialdehyde Solution is substantially equivalent to the Predicate Device.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle faces right and is positioned to the right of the department's name, which is arranged in a circular pattern around the left side of the logo. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 2006
Dr. Joseph M. Ascenzi Senior Manager, Regulatory Affairs Advanced Sterilization Products Johnson & Johnson Company Division of Ethicon, Incorporated 33 Technology Drive Irvine, California 92618
Re: K060618
Trade/Device Name: CIDEX® Activated Dialdehyde Solution Regulation Number: 880.6885 Regulation Name: Liquid Chemical Sterilants/High Level Disinfectants Regulatory Class: II Product Code: MED Dated: March 28, 2006 Received: March 29, 2006
Dear Dr. Ascenzi:
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 vour device in the Federal Register.
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Page 2 - Dr. Ascenzi
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 (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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sujite Y. Mchia M.D.
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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Device Name: CIDEX® Activated Dialdehyde Solution
Indications for Use:
CIDEX® Activated Dialdehyde Solution is a liquid chemical sterilant and a high level disinfectant for reprocessing heat sensitive medical/dental devices such as endoscopes, respiratory therapy equipment and ultrasonic transducers.
Sterilant:
CIDEX Solution is a sterilant when used or reused, according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by the CIDEX® Solution Test Strip, at 25℃ (77°) with an immersion time of at least 10 hours with a reuse period not to exceed 14 days.
High Level Disinfectant:
CIDEX 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 the CIDEX® Solution Test Strip, at 25℃ (77°) with an immersion time of at least 45 minutes with a reuse period not to exceed 14 days.
CIDEX Solution is intended for use in manual systems as well as in automated endoscope reprocessors.
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)
4/12/06
any, General Hospi
K0406 18
Apr
§ 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.