(216 days)
The C-1805M is designed to clean the dental unit water lines by means of injecting pressurized air and than a solution
The C-1805M is a pressurized bottle system capable of supplying a solution to the dental unit water lines or pressurized air. The system is used with solutions to clean the dental unit waterlines by air purging the waterlines or injecting a solution. The system can be used to supply water to the dental unit if necessary.
The provided text is a 510(k) premarket notification summary and an FDA clearance letter for a dental device called "C-1805M." This documentation asserts equivalence to a predicate device and does not contain information about a study proving the device meets specific acceptance criteria in the context of AI or diagnostic performance.
The device described, the C-1805M, is a "Pressurized bottle system" for cleaning dental unit water lines. It is a Class I medical device (Dental Operative Unit and Accessories) and its function is mechanical/fluid handling, not diagnostic or AI-driven.
Therefore, the requested information cannot be extracted from this document. The concepts of "acceptance criteria," "device performance," "sample size," "experts," "ground truth," "MRMC study," "standalone performance," and "training set" as they relate to AI effectiveness studies are not applicable to the content provided.
Summary of why the requested information cannot be provided:
The provided text describes a mechanical dental device and its FDA clearance process, which relies on demonstrating substantial equivalence to a predicate device, not on proving diagnostic accuracy or AI performance through a detailed study with acceptance criteria. Therefore, the information requested in the prompt, which is relevant to AI/diagnostic device performance studies, is not present in the given document.
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ANODIA SYSTEMS
JUN 1 9 2003
"Premarket Notification 510{k} Summary"
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- Submitter:
November 12, 2002 Dr. Thad Overmyer 514 South Third Street Danville, Kentucky 40422 Tel: 859-236-4778 Fax: 859-236-9136
- Submitter:
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- Name of Device
- A. Trade Name-C-1805M
- B. Common name-Pressurized bottle system
- C. Classification Name: Unit, Operative Dental
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- C-1805M is compared to the Class I device K962665 A-Dec Self-Contained Water System
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- The C-1805M is a pressurized bottle system capable of supplying a solution to the dental unit water lines or pressurized air. The system is used with solutions to clean the dental unit waterlines by air purging the waterlines or injecting a solution. The system can be used to supply water to the dental unit if necessary.
- Both Systems are pressurize systems capable of supplying a solution from its reservoir. Both systems use similar fittings of similar materials. Both systems control the water with a switch. The C-1805M can inject pressurized air by a switch. The K962665 does not have this switch for air purging.
Dr. Thad Overmyer 514 South Third Street Danville, Ky 40422
Phone: 1-866-246-2548 Fax: 1-866-926-8246
KA2 3815
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 9 2003
Dr. Thad Overmyer Anodia Systems 514 South Third Street Danville, Kentucky 40422
Re: K023815
Trade/Device Name: C-1805M Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: May 7, 2003 Received: May 9, 2003
Dear Dr. Thad Overmyer:
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 - Dr. Thad Overmyer
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. 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. 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 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,
Susan Rumm
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K023815
Device Name: C-1805M
Indications for Use:
The C-1805M is designed to clean the dental unit water lines by means of injecting pressurized air and than a solution
(PLEASE DO NOT WIRTE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109 OR
Over-The-Counter Use
(Optional Format 1-2-9)
Suar Rior
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control. Den
510(k) Number: K0623815
§ 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.