(57 days)
Not Found
Not Found
No
The device is a chemical disinfectant and the summary contains no mention of AI or ML.
No.
The device is a germicidal cloth used for disinfecting surfaces of noncritical devices and medical equipment, not for treating any specific medical condition or disease in a patient.
No
A diagnostic device is used to identify or detect a disease or condition. This device is a germicidal cloth, which is used for disinfection and reprocessing surfaces, not for diagnosis.
No
The device description clearly states it is a "liquid chemical germicide saturated, disposable cloth," indicating a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to reprocess noncritical devices and medical equipment surfaces." This describes a disinfectant for cleaning and sanitizing surfaces, not a test performed on biological samples to diagnose a condition or provide information about a patient's health.
- Device Description: The device is a "liquid chemical germicide saturated, disposable cloth." This aligns with a cleaning product, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, antibodies, etc.)
- Providing diagnostic information about a patient
- Using reagents or assays for testing
The information provided clearly describes a disinfectant product used for environmental cleaning in healthcare settings.
N/A
Intended Use / Indications for 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.
Germicidal Cloth is a general purpose disinfectant used to reprocess noncritical devices and medical equipment surfaces.
Product codes
LRJ
Device Description
Germicidal Cloth is a liquid chemical germicide saturated, disposable cloth utilizing quatinary ammonium chloride compounds as active ingredients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Acute Oral LD40 (Rats) = 5,000 mg/kg
Acute Dermal LD30 = > 2,000 mg/kg
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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
3
Page 1 of 1
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)