(59 days)
The VistaCam Omni™ system is primarily a tool to provide visual information to dental patients so they may be better equipped to make decisions about the quantity and quality of the healphed co they receive.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a medical device called "Vistacam Omni™ and Vistacam Omni (IC)". This type of letter confirms that the device is substantially equivalent to a previously marketed device and does not inherently contain information about specific acceptance criteria or detailed study results. The document focuses on regulatory approval rather than technical performance data.
Therefore, most of the information requested in your prompt is not available within this document.
Here's what can be inferred or explicitly stated based on the provided text:
- Acceptance Criteria and Reported Device Performance: This information is not present. A 510(k) clearance generally relies on demonstrating substantial equivalence to a predicate device, which implies the new device performs at least as well as the predicate for its intended use, but specific quantitative acceptance criteria or detailed performance metrics are typically not detailed in the final clearance letter itself. These would be part of the original 510(k) submission, which is not provided here.
- Sample size used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method: Not available.
- Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned and typically not the primary focus of a 510(k) for a device like this, which primarily provides "visual information to dental patients."
- Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable as this is a physical imaging device, not an AI algorithm.
- Type of ground truth used: Not available.
- Sample size for the training set: Not applicable (not an AI device with a training set).
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document does not contain the detailed study information or acceptance criteria you've requested. It is purely a regulatory clearance document.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joseph Carey ·Director/Quality Assurance Air Techniques, Incorporated 70 Cantiaque Rock Road Hicksville, New York 11802
JAN - 8 1998
Re : K974204 Vistacam Omni™ and Vistacam Omni (IC) Trade Name: Requlatory Class: I Product Code: EIA November 4, 1997 Dated: November 10, 1997 Received:
Dear Mr. Carey:
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, Drug, 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 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. A substantially equivalent determination assumes compliance with ----the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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. Carey
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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) 594-4618. 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Directdr 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): | K979204 |
|---|---|
| Device Name: | VISTACAM OMNI & OMNI IC |
Indications For Use:
The VistaCam Omni™ system is primarily a tool to provide visual information to dental patients so they may be better equipped to make decisions about the quantity and quality of the healphed co they receive.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Swerlumn
(Division Sign=Off) -Division of Dental, Infection Contro Division of Dental, Infocusion
and General Hospital Devices
510(k) Number 510(k) Number _$
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.