REXTAR X

K132041 · Meta Biomed, Inc. · EHD · Jul 31, 2013 · Dental

Device Facts

• Record ID: K132041
• Device Name: REXTAR X
• Applicant: Meta Biomed, Inc.
• Product Code: EHD · Dental
• Decision Date: Jul 31, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

REXTAR X is a portable X-ray system to be used by trained dentists and dental technicians as a mobile, extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. It is intended for both adult and pediatric subjects.

Device Story

REXTAR X is a handheld, portable, DC-powered extraoral X-ray system. It comprises an X-ray tube, tube assembly, and controller in a camera-like housing. The device generates X-rays (70kV, 2mA) to penetrate oral structures, creating images on conventional film or digital sensors (not included). Operated by dentists or dental technicians in clinical settings, field hospitals, or emergency environments. The device features a high-frequency generator, 0.4mm focal spot, and rechargeable battery. Output is an X-ray beam; healthcare providers use the resulting images for diagnosis of dental diseases. Portability eliminates the need for multiple fixed X-ray units in a practice.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance with UL/IEC 60601-1, 60601-2-7, 60601-2-28, 60601-2-32, and EN/IEC 60601-1-2 (EMC) standards was demonstrated.

Technological Characteristics

High-frequency X-ray generator (70kV, 2mA); 0.4mm focal spot; 12° target angle; DC 11.1V rechargeable battery; 3.5-inch BTN LCD display; dimensions 146x155x139mm; weight 2kg. Complies with 21 CFR 1020.30/1020.31 and IEC 60601 series standards.

Indications for Use

Indicated for adult and pediatric patients requiring dental radiographic examination of teeth, jaw, and oral structures (e.g., bite wing, periapical, occlusal, panoramic). Used by trained dentists and dental technicians.

Regulatory Classification

Identification

An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

Predicate Devices

• Rextar LCD (K122016)

Submission Summary (Full Text)

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K132041

JUL 3 1 2013

Section 9

Attachment 5

510(k) Summary

(Rest left blank)

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| 1. 510(k) Owner: | Metabiomed, Inc.<br>110 Gibraltar Road, suite 106<br>Horsham, PA 19044<br>USA |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Ph: | 267-282-5893 |
| Fax: | 267-282-5899 |
| Email: | [e-mail] |
| 2. Company Contact: | Ian Yun |
| Title: | Sales Director |
| 3. 510(k) Preparer: | Blix Winston<br>ACMD Consulting, LLC.<br>2600 Mullinix Mill Road<br>Mt. Airy, MD 21771<br>USA |
| Ph: | 301-607-9185 |
| Email: | [e-mail] |
| 4. Date of Submission | June 25, 2013 |
| 5. Device Name and Classification: | Trade name - REXTAR X<br>Common name - Portable X-Ray System<br>Classification name - Extraoral source x-ray system |
| 6. Predicate Devices: | Manufacturer : Poskom Co. Ltd.<br>Device : Rextar LCD<br>510(k) Number : K122016 (Decision Date - |

7. Classifications Names & Citations: 21CFR 872.1800, EHD - Extraoral source x-ray system, Class 2

- 8. Compliance with performance standards All components to which the standard applies are certified to conform to diagnostic equipment standards, 21 CFR 1020.30 and 1020.31.
03/01/2013)

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- 9. Device Description:
- a. General:

The REXTAR X consists of an X-ray tube, X-Ray tube assembly, X-Ray Controller built into a hand held camera-like device. The Rextar model contains additional accessories.

- b. Outline:
The REXTAR X is an extraoral source x-ray system with a DC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source a, X-ray camera, is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

- c. Features:
REXTAR X has the following qualities:

- · High Frequency X-ray Generator (70kV-2mA Fixed)
- · High Quality Toshiba Tube used (Tube Focal Spot (0.4mm))
- · Target Angle 12°
- · Easy to Move
- · Eliminates the need for multiple X-Ray units in doctor's office
- · Efficient to use
- · Compact Size & Light Weight Design for Ultimate Portability
- · Long Battery Life Hundreds of images can be obtained from one time charge
- · Diverse Applications (Field Hospital, Emergency, Forensic Science, Operation Room)
- · Can use conventional film or digital sensors to obtain images
- · Images from digital sensors are displayed on a computer that is not included as a part of the camera for the Rextar X
- d. Operating principle:

Operating principle is that X-ray generated by high voltage electricity into X-ray tube, which penetrates hand, tooth and jaw, and makes X-ray images on receptor (Chemical Film or Digital Sensor).

## 10. Indications for use:

REXTAR X is to be used by trained dentists and dental technicians as a mobile. extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. It is intended for both adult and pediatric subjects.

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- 11. Substantial equivalence:
The REXTAR devices have been tested to demonstrate substantial equivalence with the predicate devices. A comparison of features is included below.

## Comparison Table: REXTAR, REXTAR LCD and the Predicate Devices

| Parameter | Rextar X | Rextar LCD |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | Submitted for marketing<br>clearance | K122016 |
| Intended Use | To be used by trained dentists<br>and dental technicians as a<br>mobile, extraoral x-ray source<br>for producing diagnostic x-ray<br>images using intraoral image<br>receptors. It is intended for<br>both adult and pediatric<br>subjects. | To be used by trained dentists<br>and dental technicians as a<br>mobile, extraoral x-ray source<br>for producing diagnostic x-ray<br>images using intraoral image<br>receptors. It is intended for both<br>adult and pediatric subjects. |
| Indications | X-ray system designed to<br>provide images of the patients<br>undergoing dental procedures.<br>Clinical uses include Bite wing,<br>periapical, occlusal and<br>panoramic images. | X-ray system designed to<br>provide images of the patients<br>undergoing dental procedures.<br>Clinical uses include Bite wing,<br>periapical, occlusal and<br>panoramic images. |
| Dentist/dental<br>assistant<br>Involvement | Supervision | Supervision |
| Labeling | Submitted | Submitted |
| X-ray<br>Generator | High-Frequency | High-Frequency |
| Tube Power | 70kV /2mA | 70kV /2mA |
| Tube Type | Stationary | Stationary |
| Tube Focal<br>Spot | 0.4mm | 0.4mm |
| Target Angle | 12° | 12° |
| Exposure<br>Time | 0.01 ~ 1.30 (sec)<br>(43 steps) | 0.01 ~ 1.3 (sec)<br>(43 Steps) |
| Power<br>Requirement | DC 11.1 V | DC 11.1 V |
| Picture<br>Quality | Good | Good |
| Battery Type | Rechargeable | Rechargeable |
| Parameter | Rextar X | Rextar LCD |
| Display | LCD Panel Display<br>( 3.5 Inch, BTN LCD, 1/4Duty,<br>1/3BIAS ) | LCD Panel Display (4 Digits, 0.5<br>Inch Character Height) |
| Size | 146×155×139mm | 404× 234× 198mm |
| Weight (kg) | 2 | 1.88 |

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12. Standards:

The portable x-ray system, REXTAR X will comply with applicable requirements of the Underwriters Laboratories Standard for Safety-UL/IEC 60601-1, IEC 60601-2-7, IEC 60601-2-28 and IEC 60601-2-32.

EMC testing was conducted by (EMC Compliance Co., Ltd. in accordance with Standard EN/IEC 60601-1-2). All test results were satisfactory.

- 13. Conclusion: Based on comparison with the predicate devices and the results of testing Metabiomed believes its REXTAR and REXTAR LCD devices are substantially equivalent

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 31, 2013

Meta Biomed. Incorporated C/O Mr. Blix Winston ACMD Consulting, Limited Liability Company 2600 Mullinix Mill Road MT AIRY MD 21771

Re: K132041

Trade/Device Name: Rextar X Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: II Product Code: EHD Dated: June 24, 2013 Received: July 2, 2013

Dear Mr. Winston:

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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Mr. Winston

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 devicerelated 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number (if known): )x 1 32 OY |

Device Name: REXTAR X

Indications for Use:

REXTAR X is a portable X-ray system to be used by trained dentists and dental technicians as a mobile, extraoral x-ray source for producing diagnostic x-ray lmages using intraoral image receptors. It is intended for both adult and pediatric subjects.

Prescription Use Yes AND/OR

(Part 21 CFR 810 Subpart D)

(21 CFR 801 Subpart C)

. . . . . . . . . .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Andrew I. Steen -S 2013.07.30 14:51:48 -04'00'

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anast.lessons Bevices

113204 510(k) Number:

A1-03