INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310

K032341 · Sota Precision Optics, Inc. · EIA · Aug 25, 2003 · Dental

Device Facts

• Record ID: K032341
• Device Name: INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310
• Applicant: Sota Precision Optics, Inc.
• Product Code: EIA · Dental
• Decision Date: Aug 25, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.6640
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

Claris i310 intra oral camera system and accessories is indicated for use to provide the dentist and the patient with a view of the mouth before and after the dental procedure, which assists the dentist in describing the dental procedure being performed as well as showing the results.

Device Story

Claris i310 is an ergonomic, lightweight intraoral camera system; includes handpiece with focusing mechanism and capture button; optional wireless version and footswitch available. Device captures intraoral or full-face images; connects to docking station via cable; docking station outputs to monitor, PC, or printer via S-Video or composite connection. Used in dental clinics by dentists to show patients oral conditions and procedure results; aids in patient education and procedure explanation. Images stored via third-party software. Benefits include improved patient understanding of dental procedures and outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological comparison and bench testing.

Technological Characteristics

Handpiece (0.1 lbs, 8"x0.86"); high-definition imaging (494 lines/inch); 60-degree field of view; wired or wireless connectivity; S-Video/composite output; docking station interface. No specific material standards or software algorithm details provided.

Indications for Use

Indicated for dental patients to provide visual documentation of oral conditions and procedure results to facilitate dentist-patient communication.

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

• DIGITAL DOC (K981663)

Submission Summary (Full Text)

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AUG 2 5 2003

# 510(k) Summary As Required by 21 section 807.92 ( c )

| 1-Submitter Name: | Sota Precision optics, Inc |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| 2-Address: | 1073 North Batavia Street<br>Orange, CA 92867 |
| 3-Phone: | 714-532-6100 |
| 4-Fax: | 714-532-6107 |
| 5-Contact Person: | Jay Mansour of Mansour Consulting LLC, on behalf of submitter<br>1308 Morningside Park Dr. Alpharetta, GA 30022. 770-777-4146 |
| 6-Date summary prepared: | July 22nd, 2003 |
| 7-Device Trade or Proprietary Name: | Claris i310 |

8-Device Common or usual name: Intra Oral Camera system and accessories

- 9-Device Classification Name: Unit, Operative, Dental
10-Substantial Equivalency is claimed against the following device:

- DIGITAL DOC from Digital Doc. Inc. . 510k # K981663
11-Description of the Device: (For tochnical specifications, refer to the user manual) (Full listing and photos of accessories is available within this submission- refer to User Manual pages 22 and 23)

Claris i310 comprises of a light (0.1 lbs), small (8"x0.86"), and ergonomic handpiece along with a docking station.

The handpiece consists of a focusing mechanism and a capture button to assist the doctor in taking intraoral or full face images of the patient.

The handpiece connects to a docking station via a cable. The docking station in turn can connect directly to a monitor. PC, or a printer via a S-Video or a standard composite connection.

Claris i310 is also available in a wireless option.

It uses high definition imaging (494 lines/inch) to capture images at 60 degrees field of view.

Images may be stored using third party software vendors.

Claris i310 includes also an optional footswitch.

### 12-Intended use of the device: (refer to FDA form attached)

Claris i310 intra oral camera system and accessories is indicated for use to provide the dentist and the patient with a view of the mouth before and after the dental procedure, which assists the dentist in describing the dental procedure being performed as well as showing the results.

### 13-Safety and Effectiveness of the device:

This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)

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## 14-Summary comparing technological characteristics with other predicate device:

Please find below a tabulated comparison supporting that this device is substantially r loase find b other medical devices in commercial distribution. Also, Equivalency overview chart path is attached. Refer to the detailed explanations within the main submission.

| FDA file reference number | 510k # K981663 |
|--------------------------------------------------|----------------------------|
| Attachments inside notification submission file | 510k FDA website print out |
| TECHNOLOGICAL CHARACTERISTICS | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Similar |
| Sterility | Not Applicable |
| Biocompatibility | Similar |
| Mechanical safety | Similar |
| Chemical safety | Similar |
| Anatomical sites | Identical |
| Human factors | Similar |
| Energy used and/or delivered | Similar |
| Compatibility with environment and other devices | Similar |
| Where used | Identical |
| Standards met | Similar |
| Electrical safety | Similar |
| Thermal safety | Similar |
| Radiation safety | Similar |

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Image /page/2/Picture/1 description: The image is a black and white logo. The logo is circular and contains an image of a bird with three lines above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2003

Sota Precision Optics. Incorporated C/O Mr. Donald J Sherratt Responsible Third Party Official Intertek Testing Services 70 Codman Hill Road Boxborough, Massachusetts 01779

Re: K032341

Trade/Device Name: Claris i310 Intra Oral Camera System and Accessories Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: August 15, 2003 Received: August 18, 2003

Dear Mr. Sherratt:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -Mr. Sherratt

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

SusaRuroer

Susan Runner, DDS, MA Interim 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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### Indications for use statement

510(k) Number (if known): K032341 Claris i310 Intra Oral Camera System and Accessories Device Name:

#### Indications For Use:

Claris i310 intra oral camera system and accessories is indicated for use to provide the dentist and the patient with a view of the mouth before and after the dental procedure, which assists the dentist in describing the dental procedure being performed as well as showing the results

Kein Mulvey for MSN

nesthesiology, General Hospital, Control. Dental D

510(k) Number: K032341

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)