(36 days)
Not Found
Not Found
No
The summary describes a disinfectant and does not mention any computational or analytical capabilities, let alone AI/ML.
No
This device is an intermediate-level disinfectant used for environmental control of bacteria and viruses in healthcare settings, not for treating a disease or condition.
No
The device is described as an "intermediate level disinfectant" for environmental control of bacteria and viruses, not for diagnosing medical conditions.
No
The device description and intended use clearly indicate a chemical disinfectant, not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "environmental control of bacteria and viruses and the prevention of crosscontamination" in a healthcare setting. This describes a disinfectant used on surfaces and the environment, not a test performed on biological samples from a patient to diagnose or monitor a medical condition.
- Device Description: The description simply names the product "Control III® Elite". There is no mention of it being used to analyze biological samples.
- Lack of IVD Characteristics: The document lacks information typically found in IVD descriptions, such as:
- Input Imaging Modality (not applicable to a disinfectant)
- Anatomical Site (not applicable to a disinfectant)
- Indicated Patient Age Range (not applicable to a disinfectant)
- Descriptions of training and test sets, performance studies, and key metrics (these are relevant for devices that analyze data or samples, not for a chemical disinfectant).
In summary, Control III Elite is a disinfectant for environmental use, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
Control III Elite is indicated for use in healthcare setting for environmental control of bacteria and viruses and the prevention of crosscontamination. Control III Elite is an intermediate level disinfectant. Active ingredients are a combination of quaternary ammonium chlorides requiring a 10-minute contact at 20° C. (68°F).
Product codes
LRJ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare setting
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of three human profiles forming the shape of a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the image.
SEP 1 4 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Anne R. Whitehair Director Maril Products, Incorporated 320 West 6th Street Tustin, California 92780
Re : K992661 Control III® Elite Trade Name: Requlatory Class: II Product Code: LRJ Dated: July 29, 1999 Received: August 9, 1999
Dear Ms. Whitehair:
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. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of
1
Page 2 —Ms. Whitehair
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 described in your sia equivalence of your device to a legally finding of bubbeandlariesults in a classification for your marketed predicate and the your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. Additionally, for questions on compriated as (oo advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to the regulacion entifica, "Mibbianding by sorbility", "Other general information on your responsibilities under the Act may be Information of your wise of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at at feb corr free namber (e: //www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timo N. A. Ulatowski
Timo Direct or Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATION FOR USE STATEMENT
510(K) Number (if known): Unknown
Device Name: Control III® Elite
Indication For Use:
Control III Elite is indicated for use in healthcare setting for environmental control of bacteria and viruses and the prevention of crosscontamination. Control III Elite is an intermediate level disinfectant. Active ingredients are a combination of quaternary ammonium chlorides requiring a 10-minute contact at 20° C. (68°F).
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: __ or Over-The-Counter Use X
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices K99261
510(k) Number __