(90 days)
AdvanceCAM intra oral camera system and accessories is indicated for use to provide the dentist and the patient with a view of the mouth before and after the dental procedure, which assists the dentist in decribing the dental procedure being performed as well as showing the results
AdvanceCAM Intra Oral Camera System and Accessories
The provided text is a 510(k) premarket notification letter from the FDA to TPC Advanced Technology, Incorporated, concerning their "AdvanceCAM Intra Oral Camera System and Accessories." This document primarily establishes that the device is substantially equivalent to legally marketed predicate devices and therefore can be marketed.
Crucially, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, or details regarding the training set for an AI/algorithm.
The letter focuses on regulatory approval based on substantial equivalence to existing devices. It lists the components of the AdvanceCAM system and states its intended use: "to provide the dentist and the patient with a view of the mouth before and after the dental procedure, which assists the dentist in describing the dental procedure being performed as well as showing the results."
Therefore, I cannot provide the requested information from this document. The sections of your request that a typical AI/algorithm medical device submission would include are entirely absent from this 510(k) clearance letter for an intraoral camera system.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
JAN - 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Scott Beckley Vice President TPC Advanced Technology, Incorporated 18525 East Gale Avenue City of Industry, California 91748
Re: K071485
Trade/Device Name: AdvanceCAM Intra Oral Camera System and Accessories Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: April 17, 2007 Received: May 30, 2007
Dear Mr. Beckley:
This letter corrects our substantially equivalent letter of August 28, 2007.
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.
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Page 2 - Mr. Beckley
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.
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), please contact the Office of Compliance at (240) 276-0115. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sutta Y. Michin Davis
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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Page 3 – Mr. Beckley
AdvanceCAM Intra Oral Camera System and accessories found to be substantially equivalent:
| MODEL | DESCRIPTION |
|---|---|
| AIC 888 | Optic unit |
| AIC 810 | Docking station |
| AIC 700 | Analog to digital converter |
| AIC 705 | Wireless analog to digital converter |
| AIC 720 | Analog to digital converter |
| AIC 750 | Analog to digital converter |
| AIC 650 | Docking station |
| AIC 665 | Wireless docking station |
| AIC 600 | Docking station |
| AIC 900 | Wireless transmitter |
| AIC 805 | Docking station |
| AIC 815 | Wireless docking station |
| AIC 899 | Optic unit |
| AIC 835 | Wireless docking station |
| AIC 825 | Docking station |
:
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Image /page/3/Picture/0 description: The image shows a logo with the letters "TPC" in a stylized font. Below the letters, the words "UNITED TECH" are written in a smaller, blockier font. The logo appears to be for a technology company, given the "TECH" abbreviation. The background is dark, which makes the logo stand out.
18525 E. Gale Ave. City of Industry, CA 91748 800.560.8222 626.810.4337 Fax: 626.810.4245
Dental Equipment Manufacturer Chairs, Units, Lights, Intraoral Cameras, etc.
Indications for Use
510(k) Number (if known):
Device Name:
AdvanceCAM Intra Oral Camera System and accessories
Indications for Use:
AdvanceCAM intra oral camera system and accessories is indicated for use to provide the dentist and the patient with a view of the mouth before and after the dental procedure, which assists the dentist in decribing the dental procedure being performed as well as showing the results
Prescription Use W (Part 21 CFR 801 Subpart D)
and/or
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Savar Kumar
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K071485
w w w . t p c d e n t a l . c o m
§ 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.