(57 days)
Germicidal Cloth is a general purpose disinfectant used to reprocess noncritical devices and medical equipment surfaces.
Germicidal Cloth is a liquid chemical germicide saturated, disposable cloth utilizing quatinary ammonium chloride compounds as active ingredients.
This document describes a 510(k) submission for a germicidal cloth and does not contain detailed information about a study with acceptance criteria, sample sizes, ground truth establishment, or expert involvement as typically found for complex medical devices with AI components. The provided text is a regulatory submission for a disinfectant product, focusing on its formulation, intended use, and comparison to substantially equivalent products, along with safety and basic effectiveness data.
Therefore, an elaborate table of acceptance criteria, device performance, and details about a "study" as requested, particularly in the context of AI/machine learning, cannot be extracted directly from the provided text. The "Effectiveness Data" section acts as the closest equivalent to performance metrics based on standard disinfectant testing.
However, I will extract relevant information that can be framed as "acceptance criteria" and "reported device performance" based on the product's regulatory approval as a germicide.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied by EPA Approval) | Reported Device Performance (Status from Effectiveness Data) |
|---|---|---|
| Germicidal Efficacy | Inactivation of specific bacteria | Approved by EPA against S. aureus, S. cholejacans, Ps. aeruginosa, and other bacteria. |
| Tuberculocidal Efficacy | Inactivation of Mycobacterium bovis | Approved by EPA against Mycobacterium bovis (BCG). |
| Fungicidal Efficacy | Inactivation of pathogenic fungi | Approved by EPA against pathogenic fungi. |
| Virucidal Efficacy | Inactivation of specific viruses | Approved by EPA against Adenovirus Type 5, Canine Distemper, Herpes simplex Type 2 Virus, HIV-1, Influenza A-HK Virus, Pseudorabies Virus, and Vaccinia Virus. |
| Acute Oral Toxicity | LD50 (Rats) > 5,000 mg/kg | 5,000 mg/kg |
| Acute Dermal Toxicity | LD50 > 2,000 mg/kg | > 2,000 mg/kg |
| Dermal Irritation | Mild or no irritation | Produced mild transient redness and swelling |
| Eye Irritation | Mild or no irritation | Produced mild transient eye irritation |
| Dermal Sensitization | Negative as sensitizer | Negative as sensitizer |
Based on the provided text, the following information is either not applicable or not available:
- 2. Sample size used for the test set and data provenance: Not mentioned. Effectiveness data refers to EPA approvals, implying testing was done, but details of sample size and data provenance (e.g., country, retrospective/prospective) are not provided in this summary.
- 3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. For germicidal efficacy, "ground truth" is established through standardized laboratory assays (e.g., AOAC methods for disinfectants) rather than expert consensus on medical images or clinical outcomes.
- 4. Adjudication method for the test set: Not applicable. Standardized lab protocols are followed, not expert adjudication methods common in diagnostic device studies.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for diagnostic devices involving human interpretation of results, not for chemical germicides.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a chemical disinfectant, not an algorithm.
- 7. The type of ground truth used: For efficacy, the "ground truth" is determined by the results of standardized microbiological assays (e.g., quantitative suspension tests, carrier tests) that measure the reduction of viable microorganisms under specified conditions. For safety, it's based on animal toxicology studies.
- 8. The sample size for the training set: Not applicable. This document describes a chemical product, not a machine learning model.
- 9. How the ground truth for the training set was established: Not applicable for this type of device.
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510(k) Summary
Trade Name: Germicidal Cloth
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: Germicidal Cloth is a liquid chemical germicide saturated, disposable cloth utilizing quatinary ammonium chloride compounds as active ingredients.
Intended Use: Germicidal Cloth is used to inactivate specific bacteria, fungi and viruses on hard inanimate surfaces including reusable non-critical medical devices and environmental suffaces in healthcare facilities.
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, fimgi, and viruses on hard inammate surfaces.
Safety Data: Acute Oral LD40 (Rats) = 5,000 mg/kg Acute Dermal LD30 = > 2,000 mg/kg Dermal Irritation (Rabbit) neat = Produced mild transient redness and swelling Eye Irritation (Rabbit) neat = Produced mild transient eye irritation. Dermal Sensitization (Guinea Pig) = Negative as sensitizer
Effectiveness Data: Germicidal: Approved by EPA against S. aureus, S. cholejacans and Ps. aeruginosa and other bacteria.
Tuberculocidal: Approved by EPA against Mycobacterium bovis (BCG)
Fungicidal: Approved by EPA against pathogenic fimgi
Virucidal: Approved by EPA against Adenovirus Type 5, Canine Distemper, Herpes simplex Type 2 Virus, HIV-1, Influenza A-HK Virus, Pseudorabies Virus, and Vaccinia Virus.
JAN 1 3 1998
01/07/98
74304
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three heads, each head facing to the right.
- $k=2$ $k=4$
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael Ebers Manager Regulatory Affairs STERIS Corporation Calgon Vestal Division 5035 Manchester Avenue St. Louis, Missouri 63110
K974304 Re : Germicidal Cloth Trade Name: Regulatory Class: Unclassified LRJ Product Code: Dated: November 11, 1997 November 17, 1997 Received:
Dear Mr. Ebers:
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 result i 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
JAN 1 3 1998
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Page 2 - Mr. Ebers
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.
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 leqally 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 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 qeneral 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.qov/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):
Device Name: Germicidal Cloth
Indications For Use: Germicidal Cloth is a general purpose disinfectant used to reprocess noncritical devices and medical equipment surfaces.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | K974304 |
|---|---|
| --------------- | --------- |
| 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.