(21 days)
Not Found
Not Found
No
The device description and performance studies focus on the chemical composition and germicidal effectiveness of the spray, with no mention of AI or ML.
No
The device is described as a liquid chemical germicide used to inactivate microorganisms on hard inanimate surfaces and reusable non-critical medical devices, not for therapeutic use on a patient.
No
This device is a liquid chemical germicide used to inactivate bacteria, fungi, and viruses on surfaces and non-critical medical devices. It is intended for cleaning and disinfection, not for diagnosing 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 bacteria, fungi, and viruses on hard inanimate surfaces and reusable non-critical medical devices. This is a disinfectant for surfaces and equipment, not a test performed on biological samples from a patient to diagnose a condition.
- Device Description: It's a liquid chemical germicide. IVDs are typically kits or instruments used to analyze biological samples (blood, urine, tissue, etc.).
- Performance Studies: The performance studies focus on safety (toxicity, irritation) and effectiveness as a germicide (killing microorganisms on surfaces). IVD performance studies would focus on metrics like sensitivity, specificity, accuracy, etc., related to detecting or measuring substances in biological samples.
In summary, Coverage Spray HBV is a disinfectant, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Coverage Spray 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
Not Found
Device Description
Coverage Spray 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety Data: Acute Oral LD .o (Rats) = 5,000 mg/kg Acute Dermal LDsg = > 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. choleraesuis and Ps. aeruginosa and other bacteria.
Fungicidal: Approved by EPA against pathogenic fungi and Aspergillus niger
Virucidal: Approved by EPA against Hepatitis B Virus, HIV-1, Herpes simplex Type 1 and Type 2 Virus, Parainfluenza Type 1 Virus, Pseudorabies Virus, Influenza A, Virus, Influenza B Virus, and Measles Virus
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Trade Name: Coverage Spray HBV
DEC 1 6 1996 K964835
Common/Usual Name: General Purpose Disinfectant
Submitter/Manufacturer: ConvaTec. Division of E.R. Squibb and Sons, Inc. 5035 Manchester Avenue St. Louis, MO 63110 Establishment Registration Number: 1940768
Contact: Mike Ebers, Manager Regulatory Affairs (314) 535-1390
Description: Coverage Spray HBV is a liquid chemical germicide utilizing quatinary ammonium chloride compounds as active ingredients.
Intended Use: Coverage Spray 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 LD .o (Rats) = 5,000 mg/kg Acute Dermal LDsg = > 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. choleraesuis and Ps. aeruginosa and other bacteria.
Fungicidal: Approved by EPA against pathogenic fungi and Aspergillus niger
Virucidal: Approved by EPA against Hepatitis B Virus, HIV-1, Herpes simplex Type 1 and Type 2 Virus, Parainfluenza Type 1 Virus, Pseudorabies Virus, Influenza A, Virus, Influenza B Virus, and Measles Virus