(149 days)
The intra-oral camera system, Veracam, of Lumalite, Inc. is used to provide a view of the mouth so that it assists the dellife in describitits dollar procedures which the dentist has performed on him.
Veracam; Intra-Oral Camera System and Accessories
I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for the Veracam Intra-Oral Camera System and Accessories, stating that the device is substantially equivalent to a legally marketed predicate device.
It outlines general regulatory requirements, but it does not detail any performance studies, acceptance criteria, or specific metrics of the device's performance. Therefore, I cannot generate the requested table and answer the study-related questions based on this input.
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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
AUG 3 0 2002
Lumalite, Incorporated C/O Mr. W. Edward Johansen W. Edward Johansen 11661 San Vicente Boulevard Los Angeles, California 90049
Re: K021083
Trade/Device Name: Veracam; Intra-Oral Camera System and Accessories Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: July 5, 2002 Received: July 8, 2002
Dear Mr. Johansen:
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 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.
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Page 2 - Mr. Johansen
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 (OS) 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) 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613 . 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 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,
Timothy A. Ulatowski
Timothy A. Ulatowski 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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083
PRE-MARKET NOTIFICATION
INDICATIONS FOR USE
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: Veracam, intra-oral camera system and accessories
Indications for Use:
The intra-oral camera system, Veracam, of Lumalite, Inc. is used to provide a view of the mouth so that it I IIC intraction canced systems, Forecallites and to show a patient a before view and an after view of assists the dellife in describitits dollar procedures which the dentist has performed on him.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: ____________________________________________________________________________________________________________________________________________________________
Over The Counter Use: _ : (Per 21 CFR 801.109)
Robert Sbetz DDS for Dr Susan Lunner
Division Sian-Off Division of Anesthesiology, General Hospital. Infection Control. Dental I 510(k) Number:
§ 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.