(153 days)
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No
The provided text describes an antimicrobial surface treatment and its intended use with specific water types. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device controls the growth of bacteria, fungus, and algae on a treated article using pre-treatment products with specific water types, but it is not intended to provide sterile water or treat a medical condition directly.
No
Explanation: The provided text describes a treated article designed to control microbial growth in water and does not mention any diagnostic capabilities or functions.
No
The provided text describes a "treated article" that controls the growth of microorganisms on a surface. This implies a physical component (the surface) that is treated, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes controlling microbial growth on a surface using a water pre-treatment product. This is a function related to maintaining hygiene or preventing contamination, not diagnosing a disease or condition by examining samples from the human body.
- 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.)
- Providing information for diagnosis, monitoring, or screening of diseases
- Using reagents or kits designed for in vitro analysis
The device appears to be a treated article designed to maintain an antimicrobial surface when used with specific types of water and a pre-treatment product. This falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
"The treated article controls the growth of bacteria, fungus, and algae providing the antimicrobial surface is regenerated with the continuous use of a Sterisil water pre-treatment product. The Sterisil treated article is intended to be used with distilled, deionized, or reverse osmosis water. Efficacy for tap water has not been determined. This product is not intended to provide sterile water."
Product codes
EIA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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)
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§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with a serpent entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the caduceus. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 0 2003
Mr. Brad Downs Senior Vice President Sterisil 200 South Wilcox #417 Castle Rock, Colorado 80104
Re: K031681
Trade/Device Name: Sterisil® Antimicrobial Tubing and Bottle Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: October 02, 2003 Received: October 03, 2003
Dear Mr. Downs:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Brad Downs
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. In particular, please note that many water treatment products, such as your device, are also regulated by the Environmental Protection Agency's (EPA) Office of Pesticide Programs. You may wish to consult with EPA to determine if registration with the agency is necessary for your device. Regarding FDA, you must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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), please contact the Office of Compliance at (301) 594-4613. 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Chin S. Lin, Ph.D.
Chiu S. Lin. PhD Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/2/Picture/0 description: The image shows the logo for "Sierisil." The logo consists of a stylized water droplet on the left, with a sunburst pattern inside. To the right of the droplet is the word "Sierisil" in a stylized font. The overall impression is clean and modern.
22, Indications for Use
510(k) Number (if known): K031681
Device Name: Dental Operative Unit Antimicrobial Bottle and Tubing
Indications for Use: "The treated article controls the growth of bacteria, fungus, and algae providing the antimicrobial surface is regenerated with the continuous use of a Sterisil water pre-treatment product. The Sterisil treated article is intended to be used with distilled, deionized, or reverse osmosis water. Efficacy for tap water has not been determined. This product is not intended to provide sterile water."
Susan Bonner
(Division Sign Division of Ane Liesiology, General Hospital Infection Contri, De
510(k) Number:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)