VIOLA II DENTAL CAMERA SYSTEM

K973035 · Innovative Medical Systems, Inc. · EIA · Sep 24, 1997 · Dental

Device Facts

• Record ID: K973035
• Device Name: VIOLA II DENTAL CAMERA SYSTEM
• Applicant: Innovative Medical Systems, Inc.
• Product Code: EIA · Dental
• Decision Date: Sep 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The Viola II Dental Camera system is designed for use in the following applications: 1. To allow the clinician to provide the patient with accurate information 2. To allow the clinician to provide educational information to the patient as well as other clinical personnel 3. To provide documentation for patient records 4. To assist the clinician in the diagnosis of oral cancer and gum diseases 5. To provide documentation for insurance companies

Device Story

Viola II Dental Camera system; intraoral imaging device. Captures visual images of oral cavity; displays images on external monitor/printer for clinician and patient viewing. Used in dental clinic settings by clinicians. Facilitates patient education, clinical documentation, and assistance in diagnosing oral cancer and gum diseases. System requires peripheral equipment (monitor, printer, computer) to be approved for medical applications. Output provides visual evidence for clinical decision-making and patient communication.

Clinical Evidence

No clinical data provided; device is a Class I dental camera system.

Technological Characteristics

Intraoral camera system; visual imaging technology. Requires external peripheral equipment (monitor, printer, computer) for image display and documentation. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for use by clinicians to assist in the diagnosis of oral cancer and gum diseases, patient education, and documentation of oral conditions for patient records and insurance purposes. No specific patient population or contraindications identified.

Regulatory Classification

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.

Submission Summary (Full Text)

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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

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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:

1. To allow the clinician to provide the patient with accurate information

2. To allow the clinician to provide educational information to the patient as well as other clinical personnel

3. To provide documentation for patient records

4. To assist the clinician in the diagnosis of oral cancer and gum diseases

5. 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