INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D

K040691 · Win-Us Technology Co., Ltd. · EIA · Mar 23, 2004 · Dental

Device Facts

• Record ID: K040691
• Device Name: INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D
• Applicant: Win-Us Technology Co., Ltd.
• Product Code: EIA · Dental
• Decision Date: Mar 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

Win-100D 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

The Win-100D is an intraoral camera system consisting of a handheld camera and a multi-docking station. The handpiece features a focusing mechanism and a capture button to acquire intraoral or full-face images. The device connects to a multi-docking system via cable, which then interfaces with a monitor or PC using a standard composite (RCA) connection. It captures high-definition images (460 TV-lines) with an 80-degree field of view. The system allows for display in 4-frame or full-screen modes and enables image orientation adjustment. Used in dental clinics, the device is operated by dental professionals to show patients their oral condition and procedure results, facilitating clinical communication and patient understanding.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Handheld intraoral camera with 80-degree field of view; 460 TV-line resolution; multi-docking system with composite (RCA) video output; 230mm x 12mm form factor; 0.6kg weight. Connectivity via standard analog video cable to external monitors/PCs. No sterilization required (non-invasive).

Indications for Use

Indicated for use by dentists to provide patients with visual documentation of the oral cavity before and after dental procedures to assist in patient communication and education.

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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#### MAR 2 3 2004

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

1-Submitter Name: WIN-US TECHNOLOGY CO., LTD

2-Address: 3F Younbg-Pung B/D, #225-1 Poi-Dong

Kangnam-Ku, Seoul, Korea

3-Phone: [phone]

4-Fax: [phone]

4-Fax: [phone]
5-Contact Person: (on behalf of the submitter) Jay Mansour, Mansour Consulting LLC
5-Contact Person: (on behalf of the Submitter) Jay Mansour, Mansour Co 5-Contact Person: (on behalf of the Submiter) buy Manocal, Marioun, Marines [phone]
1308 Morningside Park Dr Alpharetta, GA 30022 USA [phone] Fax [phone]-Date summary prepared: January 9th, 2004

7-Device Trade or Proprietary Name: Win-100D

7-Device Trade of Proprietary Nation in the 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 technical specifications, refer to the user manual) 11-DeSCH(ption of the Devices (rec: (rol technour spotheaters) in refer to User Manual)

Our device comprises of a light (0.6Kg), small (230mmX12mm), compact design and ergonomic handpiece along with a multi-docking system.

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

The handpiece connects to a multi-docking system via a cable.

The multi-docking system in turn can connect directly to a monitor and PC via a standard composite connection (RCA).

It uses high definition imaging (460 TV-lines) to capture images at 80 degrees field of view.

It can make the screen in 4 frames or full screen mode via a multi-docking system. It can change the side of the captured image.

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

Win-100D intra oral camera system and accessories is indicated for use to provide the ville 100D intra oral camora cystem atta before and after the dental procedure, dentist and the pations with a vieribing 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)

Page 6

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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 lease in a below a tablated compansement of 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 | Not Applicable |
| 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 | Not Applicable |

Page 7 revised

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird with three wing-like shapes.

MAR 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Win-US Technology Company Limited C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services 70 Codman Hill Road Boxborough, Massachusetts 01719

Re: K040691

Trade/Device Name: Intra-Oral Camera System and Accessories, WIN-100D Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: March 16, 2004 Received: March 17, 2004

Dear Mr. Lehtonen:

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 your 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 -- Ms. Rivkowich

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 vours.

Chiu Lin, Ph.D.

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

510(k) Number (if known): |(0 \0(0(0)

Device Name: Intra-Oral Camera System and Accessories, WIN-100D

Indications For Use:

Win-100D 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.

Prescription Use ﻟﺴﺎﻋﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ (Part 21 CFR 801 Subpart D) AND/OR -

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runny

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

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510(k) Number: K040691

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