(36 days)
Not Found
Not Found
No
The provided 510(k) summary does not mention AI, ML, or any related terms, and the device description is not available to infer such capabilities.
Yes
The "Intended Use" explicitly states that the system is for "therapy of periodontal disease."
Yes
Explanation: The "Intended Use / Indications for Use" states the system is for "direct visualization and therapy of periodontal disease and other situations that would require visualization of structures beneath an intact gumline within the oral cavity." The term "visualization" in the context of disease suggests its use in identifying or assessing the condition, which is a diagnostic function. While it also mentions "therapy," the initial visualization component is diagnostic.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the PerioView system is software-only or includes hardware components for visualization and therapy.
Based on the provided information, the PerioView system by DentalView is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- PerioView's Intended Use: The intended use of the PerioView system is for "direct visualization and therapy of periodontal disease and other situations that would require visualization of structures beneath an intact gumline within the oral cavity." This describes a system used within the body (in the oral cavity) for direct observation and potentially treatment, not for analyzing samples taken from the body.
Therefore, the PerioView system falls under the category of a medical device used for visualization and therapy in vivo, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The PerioView system by DentalView is a system intended for use in direct visualization and therapy of periodontal disease and other situations that would require visualization of structures beneath an intact gumline within the oral cavity.
Product codes
EIA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Wendell Ebling President/CEO Dentalview, Incorporated 15540-D Rockfield Boulevard Irvine, California 92618
OCT 21 1997
Re: K973492 Dentalview Perioview System Trade Name: Requlatory Class: I Product Code: EIA September 12, 1997 Dated: Received: September 15, 1997
Dear Mr. Ebling:
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 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 (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. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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
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Page 2 - Mr. Ebling
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.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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K973.492
INDICATIONS FOR USE STATEMENT
The PerioView system by DentalView is a system intended for use in direct visualization and therapy of periodontal disease and other situations that would require visualization of structures beneath an intact gumline within the oral cavity.
Angela Blockwell for Susan Sumner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number