C-1890 by ANODIA SYSTEMS | FDA 510(k) Summary

The C-1890 is a pressurized bottle system capable of supplying a solution or pressurized air to the dental unit water lines. The system can be used with solutions to clean the dental unit waterlines by air purging the waterlines and/or injecting a cleaning solution.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called C-1890, a pressurized bottle system for dental unit water lines. It's a regulatory document demonstrating substantial equivalence to a predicate device, not a study report with acceptance criteria and performance data in the typical sense of AI/algorithm performance.

Therefore, many of the requested sections about acceptance criteria, study details, expert involvement, and ground truth for an AI device are not applicable to the provided document.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Not applicable. This document is a premarket notification comparing a new device (C-1890) to an existing predicate device (K962665 A-Dec Self-Contained Water System) to demonstrate substantial equivalence, not an AI performance study with acceptance criteria. The "performance" discussed is in terms of functionality and safety, not statistical metrics like sensitivity or specificity. The substantial equivalence is based on comparing design features and intended use.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. There is no "test set" in the context of an algorithm's performance evaluation. The comparison is feature-based against a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. There is no ground truth establishment for a test set in this kind of device submission. The FDA reviews the provided information to determine substantial equivalence.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. There is no test set or adjudication process for performance evaluation in this context.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a pressurized bottle system for dental water lines, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a hardware device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. Ground truth, in the context of algorithm performance, is not relevant here. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI device that requires a training set or ground truth establishment in that manner.

Information that can be extracted from the document related to the device and its comparison:

Device Name: C-1890 (Trade Name), Pressurized bottle system (Common Name)
Predicate Device: K962665 A-Dec Self-Contained Water System
Intended Use/Indications for Use: The C-1890 is designed to clean the dental unit water lines by means of injecting pressurized air and then a solution.
Key Comparisons with Predicate Device:
- Both are pressurized systems supplying solution from a reservoir.
- Both use similar fittings of similar materials.
- Both control water with a switch.
- C-1890 can inject pressurized air by a switch (K962665 does not have this switch).
- C-1890 has a shroud covering tubing and valves.
- Both include a heavy-duty reservoir.
- C-1890 has a preset air pressure regulator.
Regulatory Classification: Class I, Product Code: EIA, Regulation Number: 872.6640 (Dental Operative Unit and Accessories)

In summary, the provided document is a regulatory submission for a physical medical device, not a study evaluating the performance of an algorithm or AI system. Therefore, most of the requested information regarding acceptance criteria and study design for AI are not present or applicable.

Summary

{0}------------------------------------------------

JUN 1 9 2003

K023896

Dr. Thad Overmyer 514 South Third Street Danville, Ky 40422

Phone: 1-866-246-2548 Fax: 1-866-926-8246

"Premarket Notification 510{k} Summary"

1. Submitter:
  November 12, 2002 Dr. Thad Overmyer 514 South Third Street Danville, Kentucky 40422 Tel: 859-236-4778 Fax: 859-236-9136

2. Name of Device

A. Trade Name-C-1890
B. Common name-Pressurized bottle system
C. Classification Name: Unit, Operative Dental

C-1890 is compared to the Class I device K962665 A-Dec Self-Contained Water System
The C-1890 is a pressurized bottle system capable of supplying a solution or pressurized air to the dental unit water lines. The system can be used with solutions to clean the dental unit waterlines by air purging the waterlines and/or injecting a cleaning solution.
Both systems are pressurized 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-1890 can inject pressurized air by a switch. The K962665 does not bave this switch for air purging. A shroud covers the tubing and valves of the C-1890 to prevent tampering. A heavy duty reservoir is included in both systems. The C-1890 has a preset air pressure regulator to assure the correct air pressure enters the system.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the head, body, and tail feathers.

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: K023896

Trade/Device Name: C-1890 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.

{2}------------------------------------------------

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 (OS) 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 Range

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

{3}------------------------------------------------

510(k) Number (if known): _K023896

Device Name: C-1890

Indications for Use:

The C-1890 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)

Saser Quares
(Division Sign Off

Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number: K023896

Regulation Number and Section

§ 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.