HAWK INTRAORAL CAMERA AND ACCESSORIES

K040116 · Dxm Co., Ltd. · EIA · Apr 20, 2004 · Dental

Device Facts

• Record ID: K040116
• Device Name: HAWK INTRAORAL CAMERA AND ACCESSORIES
• Applicant: Dxm Co., Ltd.
• Product Code: EIA · Dental
• Decision Date: Apr 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The Hawk Intraoral Camera and Accessories are indicated for use to provide a view of mouth to assist the dentist in describing dental procedures and to show the patient the mouth before and after dental procedures.

Device Story

Hawk Intraoral Camera is a lightweight (25g), small (185x10mm) handheld device used by dentists in clinical settings. It captures video of the oral cavity using a focusing mechanism and high-definition imaging (480 lines, 78-degree field of view). The handpiece connects via cable to a docking station, which outputs to a monitor, TV, or computer via standard composite connection. A footswitch is included for operation. The device provides real-time visual feedback to assist dentists in patient communication and procedure explanation, potentially improving patient understanding of dental conditions and treatment outcomes.

Clinical Evidence

No clinical data. Safety and effectiveness supported by bench testing in accordance with EN 60601-1, EN 60601-2, EN 61000-3-2, and EN 61000-3-3.

Technological Characteristics

Handheld intraoral camera; 25g weight; 185x10mm dimensions; 480-line resolution; 78-degree field of view. Connectivity via cable to docking station with standard composite video output. Energy source: electrical. Standards: EN 60601-1, EN 60601-2, EN 61000-3-2, EN 61000-3-3.

Indications for Use

Indicated for dental patients to provide intraoral visualization to assist dentists in describing procedures and demonstrating pre- and post-procedure oral conditions.

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

• Veracan Intraoral camera and accessories (K021083)

Submission Summary (Full Text)

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Exhibit #1

## 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:

#### Submitter's Identification: 1.

DXM Co.,Ltd 1016.Ilsantechnotwon Bldg., 1141-1, Baekseok-dong ,Ilsan-gu, Govang-si .Gyeongqi-do, Korea. PHONE : [phone] FAX: [phone]

Date Summary Prepared: January 19, 2004

#### 2. Name of the Device:

### Trade/Proprietary Name:

Hawk Intraoral Camera and Accessories

### Classification Name:

Dental Operative Unit and Accessories

### Class in which Device has been placed:

The Dental devices panel has classified this device as Class I, 21 CFR Part 820.6640, Product Code EIA.

#### 3. Predicate Device Information:

The Hawk Intraoral Camera and Accessories is substantially equivalent to the Veracan Intraoral camera and accessories distributed by Lumalite, Inc., K 021083.

#### Device Description: 4.

Hawk Intraoral Camera composed of light (25g), small (185 x10mm) hand piece along with docking station.

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The hand piece consists of a focusing mechanism to assist the doctor in taking video of the patient's mouth. The hand piece connects to docking station via cable. The docking station attaches directly to monitor, TV, or computer via standard composite connection. It uses high definition imaging (480 lines) to capture images at 78 degrees field of view. Hawk Intraoral Camera includes also footswitch.

#### 5. Intended Use:

The Hawk Intraoral Camera and Accessories are indicated for use to provide a view of mouth to assist the dentist in describing dental procedures and to show the patient the mouth before and after dental procedures.

#### 6. Comparison to Predicate Device:

The Hawk Intraoral Camera is substantially identical to the predicate in intended use, operation, safety and function.

### Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:

Testing information demonstrating safety and effectiveness of the Hawk Intraoral Camera in the intended environment of use is supported by testing that was conducted in accordance with EN 60601-1, EN 60601-2, EN 61000-3-2 and EN 61000-3-3.

None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazards.

#### 8. Discussion of Clinical Tests Performed:

Clinical testing was not conducted.

#### 9. Conclusions:

The Hawk Intraoral Camera is substantially equivalent to the predicate and is safe and effective for it's intended use.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 0 2004

DXM Company Limited C/O Ms. Carolann Kotula Official Correspondents MDI Consultants, Incorporated 55 Northern Boulevard Suite 200 Great Neck, New York 11021

Re: K040116

Trade/Device Name: Hawk Intraoral Camera and Accessories Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: April 8, 2004 Received: April 9, 2004

Dear Ms. Kotula:

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. Kotula

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. or the rece of 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 and listing (21 CF read in the quality systems (QS) regulation (21 CFR Part 820); and if requirences as betternic 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) Fins letter will 210 w J The FDA finding of substantial equivalence of your device to a premainter noticate 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), 11 you donte 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 may overn 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,

Kein Mely

Sor-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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Exhibit B

# Indications for Use

## 510(k) Number (if known): 510

Device Name: Hawk Intraoral Camera

### Indications For Use:

The Hawk Intraoral Camera and Accessories are indicated for use to provide a view of mouth to assist the dentist in describing dental procedures and to show the patient the mouth before and after dental procedures.

Prescription Use X (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)

Robert Shitz DDS for Dr. Susan Kinner
(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K040116