(11 days)
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No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses solely on the intended use of an ultrasonic scaler.
No
The device is an 'Ultra Scaler' used for periodontic, endodontic, scaling and ultra (prosthesis) use. While these are dental procedures, the device itself is described as a scaler which is not typically classified as a therapeutic device. It is more of a diagnostic or procedural tool.
No
Explanation: The device is described as an "Ultra Scaler intended for use with an appropriate tip for Periodontic, Endodontic, Scaling and Ultra (Prosthesis) use," which are all treatment-oriented functions, not diagnostic ones.
No
The device is described as an "Ultra Scaler" and an "AZ Ultrasonic System," which strongly implies a hardware component for generating ultrasonic vibrations. The description does not mention software as the primary or sole component.
Based on the provided information, the AZ Ultrasonic System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as an "Ultra Scaler intended for use with an appropriate tip for Periodontic, Endodontic, Scaling and Ultra (Prosthesis) use." These are all procedures performed directly on a patient's teeth and gums, within the body.
- Definition of IVD: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
The AZ Ultrasonic System is a device used for dental procedures performed in vivo (within the living body), not in vitro (in glass or outside the body).
N/A
Intended Use / Indications for Use
The AZ Ultrasonic System is an Ultra Scaler intended for use with an appropriate tip for Periodontic, Endodontic, Scaling and Ultra (Prosthesis) use.
Product codes
ELC
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle image. The text is in all capital letters.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 7 2005
Mr. Howard Rowe Quality Systems Consultant J. Morita USA, Incorporated 9 Mason Irvine, California 92618
Re: K053030
Trade/Device Name: AZ Ultrasonic System Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: October 26, 2005 Received: October 27, 2005
Dear Mr. Rowe:
We have reviewed your Section 510(k) premarket notification of intent to market the device w one re rewse 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 as or 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 nate beth 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 Eederal Register.
1
Page 2 - Mr. Howard Rowe
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act or that F Dri has mude a acternalations 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); lan the Act of equirements) ; 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) I ms letter will and in your he FDA finding of substantial equivalence of your device to a legally premated 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/industry/support/index.html.
Sincerely yours,
signature
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
Enclosure
2
Indications For Use Statement
| 510(k) Number (if known): | Not Assigned to date K053030 |
|---|---|
| --------------------------- | ------------------------------ |
Device Name:
AZ Ultrasonic System_
Indications For Use:
The AZ Ultrasonic System is an Ultra Scaler intended for use with an appropriate tip for Periodontic, Endodontic, Scaling and Ultra (Prosthesis) use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | --- | ---- | ---------------------- |
(Per 21 CFR 801.109)
Ken Mulay for MSR
(Print Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices