(30 days)
Provide access, illumination and allow observation or manipulation of body cavities, hollow organs and canals
SOPRO feels the S575 Dental Camera is substantially equivalent to the many marketed devices already in commercial distribution. The design of the S575 is virtually identical to the comparative devices.
The provided text is a 510(k) summary for the SOPRO S575 Dental Camera. It states that the device is substantially equivalent to existing marketed devices. However, the document does not contain any information regarding acceptance criteria, device performance studies, or the methodologies used to establish ground truth or training data.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide the details on sample sizes, expert qualifications, adjudication methods, or MRMC studies.
The document primarily focuses on establishing "substantial equivalence" based on the device's design, technology, specifications, and intended use being "virtually identical" or "very similar" to predicate devices. It mentions that "these minors differences have no impact on the safe use and/or effectiveness of the device," but it does not provide any data or studies to support this claim or any specific performance metrics.
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4/21/99
Exhibit 9.
510(k) Summary
SOPRO feels the S575 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, Rosch, Welch Allyn, Air Technologies just to name a few.
The design of the S575 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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing right, with flowing lines above and below the profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 1999
Mr. Pierre MONTILLOT C.E.O. SOPRO Place Saint Christophe - Les Accates - La Valentine F-13011 Marseille FRANCE
Re : K990948 SOPRO 575 Intraoral Docking Dental Camera Trade Name: Requlatory Class: I Product Code: EIA Dated: March 19, 1999 March 22, 1999 Received:
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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. MONTILLOT
This letter will allow you to beqin 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 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" (21 CFR 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/dsmamain.html".
Sincerely yours,
Timothy A. 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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K990948
Page _ of _
510(k) Number (if known): K990948
Device Name: SOPRO 575 Docking Dental Camera
Indications For Use:
"Provide access, illumination and allow observation
or manipulation of body cavities, hollow organs
and canals"
(PLEASE DO NOT WRITE 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_
. Susan Buay (Optional Format 1-2-96)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K990948
A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
§ 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.