(98 days)
The STV PRO 2 is:
- a camera which delivers color images of the oral cavity,
- a communication tool which allows the patient and dentist to view the patient's oral cavity
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the STV PRO 2 dental operative unit and accessories. It confirms the device's substantial equivalence to a legally marketed predicate device.
The document discusses the regulatory aspects of the device, its classification, and requirements for marketing. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. These details would typically be found in the manufacturer's 510(k) submission, but they are not present in the FDA's response letter provided.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or information regarding the study.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 2 2004
Ms. Marie-Pierre Labat- Camy Regulatory Affairs Manager Trophy Radiologie 4, Rue F. Pelloutier Croissy Beaubourg 77437 Marne-la-Vallée Cedex 2 FRANCE
Rc: K033419
Trade/Device Name: STV PRO 2 Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: January 15, 2004 Received: January 20, 2004
Dear Ms. Labat-Camy:
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 Ecderal Register.
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Page 2 - Ms. Labat- Camy
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 mean that it Dri nas made a autes and regulations administered by other Federal agencies. of the Act of ally I occuration and sequirements, including, but not limited to: registration I ou must comply will w 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 OF R Far our), equality systems (QS) regulation (21 CFR Part 820); and if requirements as bet retur 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 has letter wriftation. The FDA finding of substantial equivalence of your device to a premarket notification. The rice 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), If you desire specific at not compliance at (301) 594-4618. 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 Intar 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,
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
KO33 419 510 (k) Number (if known):
Device Name: STV PRO 2
Indication For Use :
The STV PRO 2 is:
- <> a camera which delivers color images of the oral cavity,
- <> a communication tool which allows the patient and dentist to view the patient's oral cavity
AND/OR Prescription Use x (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PI.E.A.SE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ruma
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K023419
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.