(17 days)
Not Found
No
The device description and performance studies focus on the chemical composition and germicidal effectiveness of the liquid cleaner, with no mention of AI or ML.
No
This device is a chemical germicide used to disinfect surfaces and non-critical medical devices, not to treat a disease or condition in a patient.
No
This device is a liquid chemical germicide used to inactivate microorganisms on surfaces, not to diagnose medical conditions.
No
The device is a liquid chemical germicide, which is a physical substance, 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 "inactivate specific bacteria, fungi and viruses on hard inanimate surfaces including reusable non-critical medical devices and environmental surfaces in healthcare facilities." This describes a disinfectant for surfaces and devices, not a test performed on biological samples to diagnose a condition.
- Device Description: It's a "liquid chemical germicide." This aligns with a disinfectant, not an IVD.
- 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 or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of a disease or condition
The information provided clearly indicates that this device is a disinfectant intended for environmental and device surface cleaning and sterilization, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Coverage HBV is used to inactivate specific bacteria, fungi and viruses on hard inanimate surfaces including reusable non-critical medical devices and environmental surfaces in healthcare facilities.
Product codes
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Device Description
Coverage HBV is a liquid chemical germicide 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
Not Found
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
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Key Metrics
Not Found
Predicate Device(s)
(1)Tor Germicidal Cleaner, Huntington Laboratories, (2) Quat-Syl 256, National Laboratories, (3) Futron 25, Hysan Corp.
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
DEC 1 3 1996
510(k) Summary
Trade Name: Coverage HBV
Common/Usual Name: General Purpose Disinfectant
ConvaTec, Division of E.R. Squibb and Sons, Inc. Submitter/Manufacturer: 5035 Manchester Avenue St. Louis, MO 63110 Establishment Registration Number: 1940768
Contact: Mike Ebers, Manager Regulatory Affairs (314) 535-1390
Description: Coverage HBV is a liquid chemical germicide utilizing quatinary ammonium chloride compounds as active ingredients.
Intended Use: Coverage HBV is used to inactivate specific bacteria, fungi and viruses on hard inanimate surfaces including reusable non-critical medical devices and environmental surfaces 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, fungi, and viruses on hard inanimate surfaces.
Safety Data: Acute Oral LDso (Rats) = 5,000 mg/kg Acute Dermal LDso (Rabbits) = 2,000 mg/kg Dermal Irritation (Rabbit) neat = Corrosive. Direct contact can cause moderate to severe redness and swelling. Eye Irritation (Rabbit) neat = Severe nonreversible irritation. Eye Irritation (Rabbit) 1:64 aqueous dilution = No irritation Dermal Sensitization (Guinea Pig) = Negative as sensitizer
Effectiveness Data: Germicidal: Approved by EPA as effective against S. aureus, S. choleraesuis and Ps. aeruginosa and other bacteria.
Fungicidal: Approved by EPA as effective against T. mentagrophytes. Also Aspergillus candidus. Aspergillus niger, Candida albicans, Penicillium chermesinum, Penicillin oxalicum, Penicillium spinulosum and Ulocladium sp.
Virucidal: Approved by EPA as effective against Avian Influenza/Turkey/Wisconsin Virus, Cytomegalovirus, Hepatitis B Virus, Herpes Simplex type 2 Virus, Influenza A Virus, Influenza B Virus, Influenza C Virus, Measles Virus, Newcastle Disease Virus, Parainfluenza type 1 Virus, Poliovirus type 1, Porcine Parovirus, Pseudorabies Virus, T1 bacteriophage, T4 bacteriophage and Vaccinia.