(41 days)
Not Found.
Not Found.
No
The provided 510(k) summary does not mention AI, ML, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No.
The intended use of the device focuses on providing information, education, and documentation, as well as assisting in diagnosis, rather than directly treating or alleviating a disease or condition.
Yes
The device is described as "to assist the clinician in the diagnosis of oral cancer and gum diseases," which indicates a diagnostic function.
No
The device is described as a "Dental Camera system," which inherently implies the presence of hardware (the camera itself) in addition to any potential software components. The intended use also focuses on capturing images, which is a hardware function.
Based on the provided information, the Viola II Dental Camera system 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.
- Device Function: The Viola II Dental Camera is a camera system used to capture images of the oral cavity. It operates by directly imaging the anatomical site (oral) and does not involve testing samples taken from the body.
- Intended Use: The listed intended uses are related to visualization, documentation, education, and assisting in diagnosis based on visual information, not on the analysis of biological samples.
Therefore, the Viola II Dental Camera falls under the category of a medical device, but not specifically an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Viola II Dental Camera system is designed for use in the following applications:
-
To allow the clinician to provide the patient with accurate information
-
To allow the clinician to provide educational information to the patient as well as other clinical personnel
-
To provide documentation for patient records
-
To assist the clinician in the diagnosis of oral cancer and gum diseases
-
To provide documentation for insurance companies
There are no known contraindications or product warnings for the Viola II Dental Camera system.
Product codes
EIA
Device Description
Not Found.
Mentions image processing
Not Found.
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Not Found.
Anatomical Site
oral
Indicated Patient Age Range
Not Found.
Intended User / Care Setting
clinician
Description of the training set, sample size, data source, and annotation protocol
Not Found.
Description of the test set, sample size, data source, and annotation protocol
Not Found.
Summary of Performance Studies
Not Found.
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.
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
K9 73035
24 SEP 97
Mr. Kevin T. Spurgeon Quality Assurance & Regulatory Affairs Manager Innovative Medical Systems Corporation 55 Steamwhistle Drive 18974 Ivyland, Pennsylvania
K973035 Re : Viola II Dental Camera System Trade Name: Regulatory Class: I Product Code: EIA Dated: August 12, 1997 August 14, 1997 Received:
Dear Mr. Spurgeon:
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 Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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
i
1
Page 2 - Mr. Spurgeon
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 regulation (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,
Clm. E.
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
Premarket Notification 510(k) for the Viola II Dental Camera System
807.87(e)
Statement of Indications for use
The Viola II Dental Camera system is designed for use in the following applications:
-
To allow the clinician to provide the patient with accurate information
-
To allow the clinician to provide educational information to the patient as well as other clinical personnel
-
To provide documentation for patient records
-
To assist the clinician in the diagnosis of oral cancer and gum diseases
-
To provide documentation for insurance companies
There are no known contraindications or product warnings for the Viola II Dental Camera system.
The end user must insure that any peripheral equipment (i.e. monitor, printer or computer ) used with the Viola II is approved for medical applications under the respective national regulations.
Chun-Lin
IND4USE.DOC