(18 days)
T.B.Q. RTU is a general purpose disinfectant used to reprocess noncritical devices and medical equipment surfaces and to preciesn or decomationate cattical medical devices prior to sterilization or high-level disinfection with a 10 minute contact time at 20°C.
T.B.Q. RTU is a liquid chemical geamicide pump spray unilizing quatinary ammonium chloride compounds as active ingredients.
The provided document is a 510(k) summary for T.B.Q. RTU, a liquid chemical germicide. It describes the product, its intended use, and effectiveness data, but it does not describe an AI device or a study involving human readers. Therefore, I cannot generate the specific information requested in your prompt (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone algorithm performance, acceptance criteria for an AI device).
However, I can extract the effectiveness data that serves as the "acceptance criteria" and "reported device performance" for this chemical germicide, as well as the types of studies performed, which are analogous to how a device's performance would be evaluated.
Here's the information based on the provided document, adapted to your requested format where possible:
Chemical Germicide Performance and Testing
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Standard) | Reported Device Performance (Result) |
|---|---|
| Germicidal: AOAC Germicidal Use-Dilution Test against S. aureus, S. choleraesuis and Ps. aeruginosa | Passes |
| Tuberculocidal: AOAC Tuberculocidal Test | Passes |
| Fungicidal: AOAC Fungicidal Test against T. mentagrophytes | Passes |
| Virucidal: Virucidal Qualification Test against Herpes simplex, Vaccinia and Adenovirus Type 5 | Passes |
| Virucidal: EPA approved Dilution Method against the HIV-1 (AIDS) virus | Passes |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the document. The tests refer to standardized methods (e.g., AOAC, EPA approved methods) which would have defined sample sizes for microbial cultures, but these specifics are not provided here.
- Data Provenance: Not specified. Standardized laboratory tests are generally conducted under controlled conditions, likely in the country of the manufacturer or a certified testing lab. The document does not indicate if the testing was retrospective or prospective, but these types of germicide efficacy tests are typically prospective laboratory studies.
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 question is not applicable to a chemical germicide efficacy study. The "ground truth" is established by the presence or absence of microbial growth based on laboratory culture methods, not by expert consensus or interpretation of images. The "experts" would be trained microbiologists performing the standardized assays. The number and qualifications are not listed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable to chemical germicide testing. Adjudication methods like 2+1 or 3+1 are used for human interpretation tasks (e.g., radiology reads), not for laboratory efficacy assays where results are typically objective (e.g., growth vs. no growth).
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 document describes a chemical germicide, not an AI device. Therefore, no MRMC study, human readers, or AI assistance is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document describes a chemical germicide, not an algorithm or AI device. The efficacy testing is inherently "standalone" in the sense that it evaluates the chemical product's performance directly, without human intervention in the outcome determination beyond performing the assay.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth: For this chemical germicide, the "ground truth" is established by the survival or inactivation of specific microorganisms (bacteria, fungi, viruses) under controlled laboratory conditions, as determined by standardized microbiological culture and assay methods. For example, in the AOAC Use-Dilution Test, the ground truth is whether bacterial growth occurs in subculture tubes.
8. The sample size for the training set
- Not applicable. This document describes a chemical germicide, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for a chemical germicide.
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8314 535 1094 09:27
198
510(k) Summary
FEB 17 1998
Trade Name: T.B.Q. RTU
Common/Usual Name: General Purpose Disinfectant
Submitter/Manufacturer:
STERIS Corp. Calgon Vestal Division 5035 Manchester Avenue St. Louis, MO 63110 Establishment Registration Number: 1940768
Contact: Mike Ebers, Manager Regulatory Affairs (314) 535-1390
Description: T.B.Q. RTU is a liquid chemical geamicide pump spray unilizing quatinary ammonium chloride compounds as active ingredients.
Intended Use: T.B.Q. RTU is used to inactivate specific bacteria, fungi and viruses on hard inanimate surfaces including reusable non-critical medical devices and environmental surfaces in manimate surfaces with a 10 minute contact time at 20°C by housekeeping, mirses, and emergency medical personnel.
Substantial Equivalence to: (1)Tor Germicidal Cleaner, Huntington Laboratories, (2) Quat-Syl 256, National Laboratories, (3) Futron 25, Hysan Corp.
Comparison to Listed Substantially Equivalent Products: Listed products are also liquid chemical germicides utilizing quatinary ammonium chloride compounds as active ingredients to inactivate specific bacteria, fungi, and viruses on hard inanimate surfaces.
Safety Data: Acute Oral LDgo (Rats) > 1,900 mg/kg
Acute Inhalation LC<o =>2.2 ml/ft
Dermal Irritation (Rabbit) = Primary Irritation Index of 0.09 (Draize Scale), Barely Perceptible Initation .
Eye Irritation (Rabbit) = No initation
Dermal Sensitization (Guinea Pig) = Negative as sensitizer
Effectiveness Data: Germicidal: Passes AOAC Germicidal Use-Dilution Test against S. aureus, S. choleraesuis and Ps. aeruginosa
Tuberculocidal: Passes AOAC Tuberculocidal Test
Fungicidal: Passes AOAC Fungicidal Test against T. mentagrophytes.
Virucidal: Passes Virucidal Qualification Test against Herpes simplex, Vaccinia and Adenovinus Type S
Passes EPA approved Dilution Method against the HIV-1 (AIDS) vinus.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 7 1998
Mr. Michael G. Sarli Regulatory Specialist Steris Corporation 5035 Manchester Avenue St. Louis, Missouri 63110
K980369 Re : T.B.O. RTU Trade Name: Requlatory Class: Unclassified Product Code: LRJ Dated: January 14, 1998 Received: January 30, 1998
Dear Mr. Sarli:
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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with ........ the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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
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Page 2 - Mr. Sarli
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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) 594-4618. 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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510(k) Number (if known):K980369
Device Name: I B.Q. RTU
Indications For Use: T.B.Q. RTU is a general purpose disinfectant used to reprocess noncritical devices and medical equipment surfaces and to preciesn or decomationate cattical medical devices prior to sterilization or high-level disinfection with a 10 minute contact time at 20°C.
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Conquirence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Dental, Inf ction Control. and General Hoop 510(k) Number
Prescription Use (per 21 CFR 801.109)
OR
Over-The Counter Use
(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.