(29 days)
Not Found
Not Found
No
The device is a liquid chemical germicide and the description focuses on its chemical composition and germicidal effectiveness, with no mention of AI or ML.
No.
Amerse 2 is a disinfectant used to inactivate microorganisms on surfaces and devices, not to treat a disease or condition in a patient.
No
Amerse 2 is a disinfectant, not a diagnostic device. It is used to inactivate microorganisms on surfaces and medical devices, 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, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of Amerse 2 is to inactivate microorganisms on hard inanimate surfaces and medical devices. This is a disinfection and reprocessing function, not a diagnostic test performed on biological samples from a patient.
- Device Description: Amerse 2 is a liquid chemical germicide. IVDs are typically reagents, instruments, or systems used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Performance Studies: The performance studies described focus on the germicidal, tuberculocidal, fungicidal, and virucidal effectiveness of the product against various microorganisms on surfaces. This is consistent with a disinfectant, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
In summary, Amerse 2 is a disinfectant intended for use on surfaces and medical devices, not a diagnostic tool used to test biological samples.
N/A
Intended Use / Indications for Use
Amerse 2 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 with a 10 minute contact time at 20°C by housekeeping, nurses, and emergency medical personnel.
Amerse 2 is a general purpose disinfectant used to reprocess noncritical devices and medical equipment surfaces and to preclean or decontaminate critical or semi-critical medical devices prior to sterilization or high-level disinfection with a 10 minute contact time at 20°C.
Product codes (comma separated list FDA assigned to the subject device)
LRJ
Device Description
Amerse 2 is a liquid chemical germicide concentrate utilizing phenolic 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
housekeeping, nurses, and emergency medical personnel.
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 LDso (Rats) = 4,500 mg/kg
Acute Inhalation LC50 (Rats) > 54.3 mg/l
Dermal Irritation (Rabbit) = The product tested neat was corrosive to the skin. At a 1:128 dilution the product showed a Primary Irritation Index of 1.10 (Draize Scale), Slight Irritation Eye Irritation (Rabbit) = At a 1:128 dilution showed irritation reversible within 7 days.
Effectiveness Data: Germicidal: Passes AOAC Germicidal Use-Dilution Test against S. aureus. S. choleraesuis, Ps. aeruginosa and other bacteria.
Tuberculocidal: Passes AOAC Tuberculocidal Test.
Fungicidal: Passes AOAC Fungicidal Test against T. mentagrophytes and other fungi. Virucidal: Passes Virucidal Qualification Test against Influenza A2 (Japan), Herpes Simplex Type 2, Vaccinia Virus, and Adenovirus Type 2, Avian Infectious Bronchitis. Avian Laryngotracheitis, Avian Newcastle Disease, and Porcine Pseudorabies Passes EPA approved Dilution Method against the HIV-1 (AIDS) 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
4 1998 DEC
510(k) Summary
K98 3947
Trade Name: Amerse 2
Common/Usual Name: General Purpose Disinfectant
Submitter/Manufacturer: STERIS Corp.
5035 Manchester Avenue St. Louis, MO 63110 Establishment Registration Number: 1940768
Contact: Mike Ebers, Manager Regulatory Affairs (314) 535-1390
Description: Amerse 2 is a liquid chemical germicide concentrate utilizing phenolic compounds as active ingredients.
Intended Use: Amerse 2 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 with a 10 minute contact time at 20°C by housekeeping, nurses, and emergency medical personnel.
Substantial Equivalence to: (1) Bulk Lysol® Brand Disinfectant, (2) LF-10 Hospital Disinfectant Concentrate, Reckitt & Coleman (3) Micro Bac Phenolic Detergent Disinfectant, Ecolabs and (4) Sporicidin Brand Disinfectant Solution, Sporicidin International.
Comparison to Listed Substantially Equivalent Products: Listed products are also liquid chemical germicides utilizing phenolic compounds as active ingredients to inactivate specific bacteria, fungi, and viruses on hard inanimate surfaces.
Safety Data: Acute Oral LDso (Rats) = 4,500 mg/kg
Acute Inhalation LC50 (Rats) > 54.3 mg/l
Dermal Irritation (Rabbit) = The product tested neat was corrosive to the skin. At a 1:128 dilution the product showed a Primary Irritation Index of 1.10 (Draize Scale), Slight Irritation Eye Irritation (Rabbit) = At a 1:128 dilution showed irritation reversible within 7 days.
Effectiveness Data: Germicidal: Passes AOAC Germicidal Use-Dilution Test against S. aureus. S. choleraesuis, Ps. aeruginosa and other bacteria.
Tuberculocidal: Passes AOAC Tuberculocidal Test.
Fungicidal: Passes AOAC Fungicidal Test against T. mentagrophytes and other fungi. Virucidal: Passes Virucidal Qualification Test against Influenza A2 (Japan), Herpes Simplex Type 2, Vaccinia Virus, and Adenovirus Type 2, Avian Infectious Bronchitis. Avian Laryngotracheitis, Avian Newcastle Disease, and Porcine Pseudorabies Passes EPA approved Dilution Method against the HIV-1 (AIDS) virus.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 4 1998
Mr. Michael G. Sarli Regulatory Specialist Steris Corporation 5035 Manchester Avenue St. Louis. Missouri 63110
K983947 Re : Amerse 2 Trade Name: Requlatory Class: Unclassified Product Code: LRJ Dated: November 2, 1998 November 5, 1998 Received:
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 legally marketed predicate 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 of the Act. The general controls provisions 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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: this response to your premarket notification submission does not affect any obligation you might have under sections 531
2
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 finding of substantial equivalence of your device to a legally rinding of babbeandial equiresults 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) 594-4692. 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" (21CFR 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/dsma/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): 《983947
Device Name: Amerse 2
Indications For Use: Amerse 2 is a general purpose disinfectant used to reprocess noncritical devices and medical equipment surfaces and to preclean or decontaminate critical or semi-critical medical devices prior to sterilization or high-level disinfection with a 10 minute contact time at 20°C.
(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 K983947
ription Use
1 CER 801 109)
OR
Over-The-Counter Use X
(Optional Format 1-2-96)
Prescription Use (per 21 CFR 801.109)