(84 days)
The Suni Digital Radiography System is used to collect dental x-rays photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.
Not Found
This FDA letter, K021718, is a 510(k) premarket notification which indicates that the device, Suni Intraoral Imaging System, has been found substantially equivalent to a legally marketed predicate device. This type of FDA clearance does not typically include detailed studies proving specific performance acceptance criteria, as the primary goal of a 510(k) is to demonstrate equivalence to an already approved device, rather than novel efficacy.
Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods.
Here's why and what's missing:
- Acceptance Criteria & Reported Performance: The letter states the device is substantially equivalent to a predicate, meaning its performance is expected to be similar to that predicate. It does not define specific new performance metrics or report the Suni Intraoral Imaging System's performance against them.
- Sample Size, Data Provenance, Expert Numbers/Qualifications, Adjudication, MRMC, Standalone, Ground Truth (Test & Training), Training Sample Size, Training Ground Truth: These are all details of specific performance studies that are characteristic of a premarket approval (PMA) application or a de novo classification, where a device is novel and needs to prove its safety and effectiveness. A 510(k) relies on comparison to an existing device, and extensive new clinical studies with these details are often not required if substantial equivalence can be demonstrated through other means (e.g., technical specifications, non-clinical tests, existing clinical data on the predicate).
In summary, the provided document does not contain the specific information required to complete your request. It is a regulatory clearance letter, not a scientific study report.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. F.A. (Al) Bettencourt Vice President and General Manager SUNI Imaging Microsystems, Inc. 6840 Via Del Oro SAN JOSE CA 95119
Re: K021718
Trade/Device Name: Suni Intraoral Imaging System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 MUH Dated: May 13, 2002 Received: May 23, 2002
Dear Mr. Bettencourt:
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 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.
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.
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This letter will allow you to begin marketing your device as described in your 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 one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21 CFR Part 807.97). 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,
Yenry C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 (k) Number (if Known)
Device Name: Suni Intraoral Imaging System
Indications For Use:
The Suni Digital Radiography System is used to collect dental x-rays photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
David h. Seymour
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.