(88 days)
Provide access, illumination and allow observation or manipulation of body cavities, hollow organs and canals.
SOPRO feels the S555 Dental Camera is substantially equivalent to the many marketed devices already in commercial distribution. The design of the S555 is virtually identical to the comparative devices, which are listed and displayed in Exhibit 2 and 3. Since the design is comparable, technology virtually identical, the specifications very similar, and the intended use the sames, SOPRO feels that these minors differences have no impact on the safe use and/or effectiveness of the device.
This 510(k) submission for the SOPRO S555 Dental Camera does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria.
The provided document is a 510(k) summary and the FDA's response letter. It primarily focuses on demonstrating substantial equivalence to predicate devices based on design, technology, specifications, and intended use. Performance data, clinical studies, or specific acceptance criteria are not detailed within this submission.
Therefore, I cannot provide the requested information, including:
- Table of acceptance criteria and reported device performance: Not present.
- Sample size, data provenance, number of experts, adjudication method for the test set: No test set performance data is described.
- MRMC comparative effectiveness study: Not mentioned.
- Standalone (algorithm only) performance: Not applicable as this is a dental camera, not an AI algorithm.
- Type of ground truth used: Not applicable as no performance study is detailed.
- Sample size for the training set: Not applicable as no AI algorithm or training is discussed.
- How ground truth for the training set was established: Not applicable.
The submission states: "SOPRO feels that these minors differences have no impact on the safe use and/or effectiveness of the device," implying that the substantial equivalence argument, rather than new performance data, is the basis for market clearance.
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JAN 1 1 1999
Exhibit 9.
510(k) Summary
SOPRO feels the S555 Dental Camera is substantially equivalent to the many marketed devices already in commercial distribution. The legally marketed devices already in commercial distribution are : Dentsply, Dynamic, Rösch, Welch Allyn, Air Technologies just to name a few.
The design of the S555 is virtually identical to the comparative devices, which are listed and displayed in Exhibit 2 and 3. Since the design is comparable, technology virtually identical, the specifications very similar, and the intended use the sames, SOPRO feels that these minors differences have no impact on the safe use and/or effectiveness of the device.
For information purposes and completeness, SOPRO has also incorporated other legally marketed devices in the filling to illustrate the wide general use of similar other devices. This wide use had led us to the safe use of this device in many practitioner's hands.
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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement. The overall design is simple and conveys a sense of professionalism and authority.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 1 1999
Mr. Pierre Montillot C.E.O. SOPRO Place Saint Christophe & Les Accates F-13011 Marseille FRANCE
K983625 Re : Trade Name: S555 Intraoral Dental Camera Regulatory Class: I Product Code: EIA Dated: October 6, 1998 Received: October 15, 1998
Dear Mr. Montillot:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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), 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਖ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Montillot
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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
Timothy A. Ulatowski
Timothv Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: SOPRO 555 Dental Camer.
Indications For Use:
- Provide access, illumination and allow observation or manipulation
of body cavities, hollow organs and canals.
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CORH, Office of Device Evaluation (ODE) | |
|---|---|
| Susan Rung (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K983625 |
| Prescription Use | |
| (Per 21. CFR 801.109) | OR |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) |
§ 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.