VIVID, MODELS 40-A0001, 40-A0004, 40-A0006

K090079 · Progeny, Inc. · EIA · May 1, 2009 · Dental

Device Facts

• Record ID: K090079
• Device Name: VIVID, MODELS 40-A0001, 40-A0004, 40-A0006
• Applicant: Progeny, Inc.
• Product Code: EIA · Dental
• Decision Date: May 1, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The Vivid Intraoral Video Camera is intended to provide a dentist with the ability to view the oral cavity prior to and subsequent to dental procedures.

Device Story

Vivid Intraoral Video Camera is a dental imaging system used by dentists to visualize the oral cavity. The system consists of a handpiece with a 1/4 in. CCD image sensor and LED light source, a USB-Video converter, and cabling. It connects to a computer via a USB hub or direct USB port. The device captures full-motion NTSC video, which is transmitted to a compatible software application for viewing and storage in patient files. An integrated frame capture button on the handpiece allows the operator to save specific images. The device is used in a clinical dental setting to assist in pre- and post-procedural assessment, aiding the clinician in documenting oral conditions and treatment progress.

Clinical Evidence

No clinical data. Safety and effectiveness were demonstrated through bench testing, performance verification against product specifications, and certification to safety standards.

Technological Characteristics

Handpiece with 1/4 in. CCD sensor; LED light source; NTSC video output; 768 x 494 pixel resolution; 7–50 mm focus range; USB 2.0 PC interface; compatible with MS Direct X video software. System includes USB-Video converter, powered USB hub, and disposable sheaths. Sterilization/disinfection via disposable sheaths.

Indications for Use

Indicated for dentists to visualize the oral cavity before and after dental procedures.

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.

Predicate Devices

• Gendex EZ CAM (K032904)
• SCHICK USB CAM (K963778)

Submission Summary (Full Text)

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K090079

Progeny Inc.

Proprietary and Confidential

# 510(k) Summary

as required by CFR section 807.92(c)

MAY - 1 2009

### I. General Information

Date:

December 23, 2008

Progeny, Inc. Applicant: 675 Heathrow Dr. Lincolnshire, III. (೧೧೯೪

Alan Krema Contact Person:

Telephone: [phone]

847-415-9800 Fax:

II. Names

Device Name:

Trade Name: Vivid Intra Oral Camera System Common Name: Classification Name: Intraoral Video Camera

## III. Predicate Devices

Gendex EZ CAM Schick USB CAM

### IV. Product Description

The Progeny, Inc. Vivid Intraoral Video Camera is a state-of-the-art dental video camera. When used with a compatible software application, the operator will be able to capture and store video images into a patient's file.

The Progeny, Inc. Vivid Intraoral Camera Systern consists of the following main components:

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### System Configurations

The Vivid Intraoral Video Camera is intended to be connected to a USB hub that is connected to a computer's USB port or to be directly connected to a computer's USB ports.

Connecting the Vivid camera using a USB hub requires that only one USB port on the computer be used for the Vivid camera.

Image /page/1/Figure/5 description: This image shows a diagram of a Vivid camera system connected to a computer. The system includes a Vivid camera handpiece, a USB-Video converter, a powered USB hub, and a computer. The camera is connected to the converter via a Vivid Camera Cable, and the converter is connected to the USB hub via two USB cables. Finally, the USB hub is connected to the computer via a USB cable.

### Components List

| Part Number | Description |
|-------------|--------------------------------------------|
| 40-A0002 | Handpiece, Vivid USB Camera |
| 40-A0003 | USB Video Converter |
| 40-08010 | Vivid Camera Cable and Handpiece Connector |
| 40-08030 | Vivid Camera Cable and Handpiece Connector |
| 40-08003 | USB Cable |
| 40-07001 | USB 4-port Hub |
| 195-059 | Color Chart |
| 00-02-1591 | Installation and User Manual CD ROM |
| 40-S0006 | Sheath package |
| 40-A2005 | Wall Mount Holder |
| 40-A2006 | Monitor/Delivery Unit Holder |

### V. Indications for Use / Rationale for Substantial Equivalence

The Vivid Intraoral Video Camera is intended to provide a dentist with the ability to view the oral cavity prior to and subsequent to dental procedures. The Vivid shares the same indications for use, materials, design, operational and functional features and is therefore substantially equivalent to the predicate devices listed in section III of this summary.

There are several major independent manufacturers of Intrainal Video Camera Systems on the U.S. market. One is the Gendex EZ CAM. The 510(k) number is K032904 . The classification of this device is listed as product code ElA.

The other currently marketed device is the SCHICK USB CAM, manufactured by Schick Technologies, Inc. the 510(k) number is K963778. The classification of this device5 is listed as product code EIA .

Labeling for the currently marketed devices is included as Appendix B.

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Progeny Inc.

| Characteristic | Schick USB CAM | Gendex EX CAM | Progeny Vivid |
|---------------------------------|-----------------------|-------------------|-------------------|
| Image sensor | 1/4 in. CCD | 1/3 in. CCD | 1/4 in. CCD |
| Video output | USB full motion video | NTSC video | NTSC video |
| Pixel Area | 659 x 494 | 768 x 494 NTSC | 768 x 494 NTSC |
| Focus Range | 8 – 40 mm | 10 - 50 mm | 7 – 50 mm |
| PC Interface | USB 1.1 | USB 2 | USB 2 |
| PC Compatibility | MS Direct X video | MS Direct X video | MS Direct X video |
| Light Source | LED | LED | LED |
| Integrated Frame Capture Button | YES | YES | YES |

Comparison Table:

#### Safety and Effectiveness Information VI.

Safety and effectiveness is demonstrated by:

Performance testing and verification to meet product specifications. Same indications for use as predicate devices. Certification to Safety Standards.

All of the above steps and evaluations combine to demonstrate that the Vivid Intraoral Video Camera System is safe and effective when the device is used as labeled.

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## VII. Conclusion

.

The Progeny, Inc. Vivid Intraoral Video Camera System is determined to be substantially equivalent to the predicate devices, the Gendex EZ CAM, and the Schick USB CAM. The Vivid shares the same indications for use, materials, design, operational and functional features to the currently marketed predicate devices listed in section III of this summary. The Vivid Intraoral Video Camera System is safe and effective when the device is used as labeled.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized emblem resembling an eagle or bird in flight, composed of three curved lines. The emblem is positioned in the center of the circle, slightly offset to the right.

### Public Health Service

MAY - 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Alan Krema Director, Products Development Progeny, Incorporated 675 Heathrow Drive Lincolnshire, Illinois 60069

Re: K090079

Trade/Device Name: Vivid Intraoral Video Camera Regulation Number: 872.6640 Regulatory Class: I Product Code: EIA Dated: April 14, 2009 Received: April 17, 2009

Dear Mr. Krema:

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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### Page 2- Mr. Krema

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Gunner

Susan Runner, D.D.S., M.A. Acting 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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K 0900 791

Progeny

Vivid Intraoral Video Camera

510k number: K090079

# Statement of Indications for Use:

Intended Use for the Progeny Vivid Camera:

The Vivid Intraoral Video Camera is intended to provide a dentist with the ability to view the oral cavity prior to and subsequent to dental procedures.

Rai Muling San Mse

(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices

**510(k) Number:** JC090079