(90 days)
The A-dec 532/533 Delivery System Dental Unit and accessories are intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the dental chair and attached dental devices. The system delivers air, water, vacuum and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory.
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The provided text is a 510(k) premarket notification letter from the FDA regarding the A-DEC 532/533 Delivery System Model. This document confirms the substantial equivalence of the device to a legally marketed predicate device and grants market approval. However, it does not contain the detailed information about acceptance criteria, study design, or performance metrics that you requested.
The letter is focused on regulatory approval based on substantial equivalence, which primarily involves comparing the new device to existing ones rather than presenting a standalone study with specific performance criteria and results.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria or performance data.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical dental delivery system, not an algorithm.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not applicable as this is a physical device, not an AI/algorithm-based system requiring a training set in the typical sense.
- How the ground truth for the training set was established: Not applicable.
The document indicates that the device is a "Dental Operative Unit and Accessories" intended for "general dental applications by providing the dental practitioner a user interface to control operation of the dental chair and attached dental devices." Its function is described as delivering "air, water, vacuum and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory." This description details the function and intended use of the device but not its performance against specific clinical or technical metrics typically found in a study.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC = 4 2003
Mr. Tom Louisell A-dec, Incorporation 2601 Crestview Drive Newberg, Oregon 97132
Re: K032756
Trade/Device Name: A-DEC 532/533 Delivery System Model, 532/533 Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: October 29, 2003 Received: October 31, 2003
Dear Mr. Louisell:
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. Louisell
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,
Patricia Cucenite Flor
Chiu Lin, Ph.D. 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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Indications for Use
510(k) Number (if known):K032756
Device Name:
Indications For Use: The A-dec 532/533 Delivery System Dental Unit and accessories are intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the dental chair and attached dental devices. The system delivers air, water, vacuum and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory.
Susan Runoer
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K032756
Prescription Use
(Part 21 CFR 801 Subpart D) ✓
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ..
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.