(68 days)
CITREX® HOSPITAL SPRAY DISINFECTANT Is to be used as a general-purpose intermediate level disinfectant for use as a cleaner/disinfectant of Non-Critical devices such as medical instrument and equipment surfaces, and hard surfaces such as stainless steel, porcelain, and indualities and in intended for use in healthcare settings for environmental control of bacteria only of over of coss-contamination. Intermediate level disinfection using CITREX® requires one minute contact time at room temperature (68-77°F, 20-25°C).
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The provided text is a US FDA 510(k) clearance letter for a device named "CITREX® Hospital Spray Disinfectant". This document primarily deals with the regulatory approval of a disinfectant and does not contain information about the acceptance criteria or a study proving that a device meets those criteria in the context of AI/ML performance.
The questions you've asked are typically relevant to the evaluation of AI/ML-powered medical devices, which are a different category of product from a chemical disinfectant. Therefore, most of the information requested cannot be extracted from this document because it describes a different type of product and approval process.
Here's a breakdown of what can be inferred from the document regarding its intended use:
1. Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria or provide performance metrics like sensitivity, specificity, or accuracy that are typical for AI/ML devices. Instead, the "performance" is implicitly tied to its function as an "intermediate level disinfectant" and its ability to act as a "cleaner/disinfectant of Non-Critical devices" and hard surfaces, intended for "environmental control of bacteria." The key performance characteristic mentioned is a "one minute contact time at room temperature."
2. Sample size used for the test set and the data provenance: Not applicable. This is a chemical disinfectant, not an AI/ML device relying on a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML system is irrelevant for a disinfectant. Its efficacy would typically be established through microbiology lab tests, not expert consensus on data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For a disinfectant, the "ground truth" would be established through standard microbiological assaysdemonstrating antimicrobial efficacy against specific pathogens under defined conditions. The document does not detail these studies, but FDA clearance implies such testing was performed and reviewed.
8. The sample size for the training set: Not applicable. This is a chemical product, not an AI/ML algorithm.
9. How the ground truth for the training set was established: Not applicable.
In summary: The provided document is a regulatory approval for a chemical disinfectant, not an AI/ML medical device. Therefore, the questions posed, which are designed for evaluating AI/ML systems, are largely not applicable to this context, and the document does not contain the specific information requested.
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Image /page/0/Picture/1 description: The image shows a logo with a stylized eagle or bird symbol on the left and the letters 'DE' on the right. The bird symbol is composed of three curved lines that suggest the shape of a bird in flight. The letters 'DE' are in a simple, sans-serif font and are positioned to the right of the bird symbol. The logo appears to be a simple and clean design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 1998 NOV
Mr. Gregory S. Cross Environmental Chemist Caltech™ Industries, Incorporated 2420 Schuette Drive Midland, Michigan 48642
K982985 Re : CITREX® Hospital Spray Disinfectant Trade Name: Regulatory Class: Unclassified Product Code: LJR Dated: Auqust 21, 1998 Received: August 26, 1998
Dear Mr. Cross:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Cross
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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مَ مَ سَاسْتَهِ الْسَتَّهِ الْسَتَّةِ الْقَالَ الْمَاسْ وَ الْسَتَّةِ الْقَالَ الْمَاسْ وَ الْسَتَّةِ الْقَالَ الْمَاسْ وَ الْسَوْةِ الْأَمْرُ الْأَمْرُ الْأَمْرَةِ الْأَمْرَ
Page
510(k) Number (if known): K982985
Device Name: _CITREX® HOSPITAL SPRAY DISINEECTANT
Indications For Use:
CITREX® HOSPITAL SPRAY DISINFECTANT Is to be used as a general-purpose intermediate level disinfectant for use as a cleaner/disinfectant of Non-Critical devices such as medical instrument and equipment surfaces, and hard surfaces such as stainless steel, porcelain, and indualities and in intended for use in healthcare settings for environmental control of bacteria only of over of coss-contamination. Intermediate level disinfection using CITREX® requires one minute contact time at room temperature (68-77°F, 20-25°C).
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Olin S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use X
(Optional Format 1-2-96)
§ 880.6890 General purpose disinfectants.
(a)
Identification. A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. A general purpose disinfectant can be used to preclean or decontaminate critical or semicritical medical devices prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.