WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM

K981937 · Welch Allyn, Inc. · EIA · Aug 24, 1998 · Dental

Device Facts

• Record ID: K981937
• Device Name: WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM
• Applicant: Welch Allyn, Inc.
• Product Code: EIA · Dental
• Decision Date: Aug 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The purpose of the Welch Allyn Reveal Intraoral Camera System is to provide video images of the mouth and oral structures. Video images aid in patient education and insurance documentation. The intended use of the Welch Allyn Reveal Intraoral Camera System is to provide video images during dental examinations and procedures.

Device Story

The Welch Allyn Reveal Intraoral Camera System captures video images of the mouth and oral structures during dental examinations and procedures. The device functions as an intraoral camera, providing visual output to assist clinicians in patient education and insurance documentation. It is operated by dental professionals in a clinical setting. The output is viewed by the clinician and patient to facilitate communication and record-keeping regarding oral health status.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Intraoral video camera system. Complies with IEC 601-1, EN 60601-1-2, and UL 2601 safety standards.

Indications for Use

Indicated for use during dental examinations and procedures when a video image is desired for patients undergoing dental care.

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

• UltraCam Intraoral Camera System (K933671)

Submission Summary (Full Text)

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KA81937

## "510(k) SUMMARY" Summary of Safety and Effectiveness

| Submitter's Name & Address: | Welch Allyn Inc.<br>4619 Jordan Road, Box 187<br>Skaneateles Falls, New York 13153-0187 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person & Telephone: | Kathy Lowther<br>[phone] |
| Date Summary Prepared: | May 27, 1998 |
| Device Name: | Classification Name - Unit, Operative Dental<br>Common/Usual Name - Intraoral Camera<br>Proprietary Name - Welch Allyn Reveal Intraoral Camera System |

#### UltraCam Intraoral Camera System (510(k) number K933671) Predicate Device:

# Device Description, intended Use & Effectiveness:

The purpose of the Welch Allyn Reveal Intraoral Camera System is to provide video images of the mouth and oral structures. Video images aid in patient education and insurance documentation. The intended use of the Welch Allyn Reveal Intraoral Camera System is to provide video images during dental examinations and procedures. The Welch Allyn Reveal Intraoral Camera System is effective in its intended use.

#### Technological Characteristics:

See Attachment "A" for a comparison of the features and specifications of the Welch Allyn Reveal Intraoral Camera System and the predicate device.

### Summary of Safety:

The Welch Allyn Reveal Intraoral Camera System was designed to provide safety to the patient as well as the user. The system complies with IEC 601-1, EN 60601-1-2, and UL 2601.

#### Summary of Effectiveness:

The Welch Allyn Reveal Intraoral Camera System is effective for its intended use of providing video images during dental examinations and procedures.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 1998

Ms. Kathy Lowther Quality Engineer Welch Allyn, Incorporated 4619 Jordan Road, Box 187 Skaneateles Falls, New York 13153-0187

Re : K981937 Welch Allyn Reveal Intraoral Camera System Trade Name: Regulatory Class: I Product Code: EIA Dated: May 29, 1998 Received: June 2, 1998

Dear Ms. Lowther:

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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug 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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Ms. Lowther

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 qeneral 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,

S. Butman for

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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510(k) Number (if known): _________________

Device Name: Welch Allyn Reveal Intraoral Camera System

#### Indications For Use:

The Welch Allyn Reveal Intraoral Camera System is indicated for use during dental examinations and procedures when a video image is desired.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Susan Roemer

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 98192 510(k) Number