REXTAR, REXTAR LCD

K122016 · Meta Biomed, Inc. · EHD · Mar 1, 2013 · Dental

Device Facts

• Record ID: K122016
• Device Name: REXTAR, REXTAR LCD
• Applicant: Meta Biomed, Inc.
• Product Code: EHD · Dental
• Decision Date: Mar 1, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

REXTAR LCD is a portable X-ray systems 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 LCD is a portable, DC-powered, handheld extraoral X-ray system. Device comprises X-ray tube, tube assembly, and controller. Operator (dentist/technician) positions device outside patient's mouth to generate X-rays; radiation penetrates teeth/jaw to expose conventional film or digital sensors. System features high-frequency generator (70kV/2mA), 0.4mm focal spot, and integrated LCD panel for exposure settings. Used in clinics, field hospitals, emergency settings, or ORs. Digital images are displayed on external computer (not included). Device eliminates need for multiple fixed X-ray units; provides diagnostic images for dental procedures including bite wing, periapical, occlusal, and panoramic views. Benefits include portability, battery operation, and compatibility with existing digital sensors.

Clinical Evidence

Bench testing only. Device performance verified through compliance with international safety and performance standards, including IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-1-3 (radiation protection), and 21 CFR 1020.30/31. No clinical data required for this device type.

Technological Characteristics

Portable handheld X-ray system; DC-powered (11.1V battery). High-frequency generator (70kV/2mA); Toshiba X-ray tube with 0.4mm focal spot and 12° target angle. Includes LCD display for settings. Complies with IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-7, 60601-2-28, 60601-2-32. Connectivity via USB for digital sensor integration. Wireless transmission is not supported.

Indications for Use

Indicated for adult and pediatric patients requiring dental radiographic examination (bite wing, periapical, occlusal, panoramic) using intraoral image receptors. To be 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

• PORTX-II (K063121)
• DIOX (K082167)

Submission Summary (Full Text)

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# K122016

MAR 0 1 2013

## Attachment 3

## Section 5: 510(k) Summary

lan Yun

Sales Director

- 1. 510(k) Owner:
Metabiomed, Inc. 110 Gibraltar Road, suite 106 Horsham, PA 19044 USA Ph: 267-282-5893 Fax: [phone] Email: [e-mail]

- 2. Company Contact: Title:
- 3. 510(k) Preparer:

Blix Winston ACMD Consulting, LLC. 2600 Mullinix Mill Road Mt. Airy, MD 21771 USA Ph: 301-607-9185 Email: [e-mail]

4. Date of Submission

5. Device Name and Classification:

Trade name - REXTAR LCD Common name - Portable X-Rav System Classification name - Extraoral source x-ray system

- 6. Predicate Devices:
Manufacturer : Device : 510(k) Number :

July 7, 2012

Genoray Co. Ltd. PORTX-II K063121 (Decision Date -01/11/2007)

Manufacturer: Device: 510(k) number:

Digimed Corporation DIOX K082167 (Decision Date-04/08/2011)

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## 7. Classifications Names & Citations:

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21CFR 872.1800, EHD - Extraoral source x-ray system, Class 2

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- 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.

#### 9. Device Description:

- a. General:
The REXTAR LCD consists of an X-ray tube, X-Ray tube assembly, X-Ray Controller built into a hand held camera-like device.

## b. Outline:

The REXTAR LCD 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 LCD is a portable X-ray system that 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 LCD

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- · REXTAR also has:
- Compatibility with all Digital Sensors All Digital Imaging . Sensor (USB Type) existing in the world can be used for Rextar LCD unlike other products.
- Easy & Simple Installation by USB Memory Stick & ODD, . Memory Cards (SD,MMC)
- Samsung Ultra Q1 (UMPC) Embedded .
- Wireless data transmission has Not been tested with this device . and should not be used
- 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 LCD 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 xray images using intraoral image receptors. It is intended for both adult and pediatric subjects.

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

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## Comparison Table: REXTAR LCD and the Predicate Devices

| Parameter | Rextar LCD | PORTX-II | DIOX |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | Submitted for<br>marketing<br>clearance | K063121 | K103600 |
| Intended<br>Use | REXTAR LCD is<br>a portable X-ray<br>system to be<br>used by trained<br>dentists and<br>dental technicians<br>as a mobile,<br>extraoral x-ray<br>source for<br>producing<br>diagnostic x-ray<br>images using<br>intraoral image<br>receptors. It is<br>intended for both<br>adult and<br>pediatric subjects. | To be used by<br>trained dentists<br>and dental<br>technicians a<br>mobile,<br>extraoral x-ray<br>source for<br>producing<br>diagnostic x-ray<br>images using<br>intraoral image<br>receptors. It is<br>intended for<br>both adult and<br>pediatric<br>subjects. | To be used by<br>trained dentists<br>and dental<br>technicians as a<br>mobile,<br>extraoral x-ray<br>source for<br>producing<br>diagnostic x-ray<br>images using<br>intraoral image<br>receptors. It is<br>intended for<br>both adult and<br>pediatric<br>subjects. |
| Indications | X-ray system<br>designed to<br>provide images<br>of the patients<br>undergoing<br>dental<br>procedures.<br>Clinical uses<br>include Bite<br>wing, periapical,<br>occlusal and<br>panoramic<br>images. | X-ray system<br>designed to<br>provide images<br>of the patients<br>undergoing<br>dental<br>procedures.<br>Clinical uses<br>include Bite<br>wing, periapical,<br>occlusal and<br>panoramic<br>images. | X-ray system<br>designed to<br>provide images<br>of the patients<br>undergoing<br>dental<br>procedures.<br>Clinical uses<br>include Bite<br>wing, periapical,<br>occlusal and<br>panoramic<br>images. |
| Dentist/dental assistant<br>Involvement | Supervision | Supervision | Supervision |
| Labeling | Submitted | Original,<br>Cleared | Original,<br>Cleared |
| X-ray<br>Generator | High-Frequency | High-Frequency | High-Frequency |
| Tube Power | 70kV /2mA | 60kV /2mA | 60kV /2mA |
| Tube Type | Stationary | Stationary | Stationary |
| Tube Focal<br>Spot | 0.4mm | 0.8 mm | 0.8 mm |
| Target<br>Angle | 12° | 20 ° | 20° |
| Exposure<br>Time | 0.01 ~ 1.3 (sec)<br>(43 Steps) | 0.02 ~ 2.00 (sec)<br>(24Steps) | 0.01~1.60 (sec)<br>(0.01 sec/ step) |
| Parameter<br>Power<br>Requirement | Rextar LCD<br>DC 11.1 V | PORTX-II<br>DC 22.2V | DIOX<br>DC 24 V |
| Weight (kg) | 1.88 | 2.95 | 1.80 |
| Picture<br>Quality | Good | Normal | Normal |
| Battery<br>Type | Rechargeable | Rechargeable | Rechargeable |
| Digital<br>Sensor | X | X | X |
| LCD | LCD Panel<br>Display (4<br>Digits, 0.5 Inch<br>Character<br>Height) | X | X |
| Chipset &<br>Graphics | | X | X |
| Memory | | X | X |
| Storage | | X | X |
| Communication<br>-tions | | X | X |

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## 11. Standards:

The portable x-ray system, REXTAR LCD, 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.

A complete list of performance standards is listed below.

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| No. | OEN | Reference | Title of standard | Year of<br>ratificatio |
|-----|---------|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| 1 | IEC | IEC 60601-1 | Medical electrical equipment-Part<br>1: | 1990 |
| 2 | IEC | Amendment<br>A1 to EN<br>60601-1 | Medical electrical equipment-<br>Part 1: General requirement<br>for safety | 1991 |
| 3 | IEC | Amendment A2 | Medical electrical equipment-Part<br>1: | 1995 |
| No. | OEN | Reference | Title of standard | Year of<br>ratificatio |
| 4 | IEC | IEC 60601-1-2 | Medical electrical equipment-<br>Part 1: General requirement<br>for safety - 2<br>Collateral standard:<br>Electromagnetic<br>Compatibility - Requirements and<br>test. | 2001 |
| 5 | IEC | IEC 60601-1-3 | Medical electrical equipment-<br>Part 1: General requirement<br>for safety - 3<br>Collateral standard: General<br>requirements for radiation<br>protection in diagnostic X-ray<br>equipment. | 1994 |
| 6 | IEC | IEC 60601-1-4 | Medical electrical equipment-<br>Part 1: General requirement<br>for safety - 4<br>Collateral standard:<br>Programmable electrical medical<br>systems | 1996 |
| 7 | IEC | IEC 60601-2-7 | Medical electrical equipment-<br>Part 2: Particular requirements<br>for the safety of High-voltage<br>generators of diagnostic X-ray<br>generators | 1998 |
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| 8 | IEC | IEC 60601-2-28 | Medical electrical equipment-<br>Part 2: Particular requirements<br>for the safety of X-ray source<br>assemblies and X-ray tube<br>assemblies for medical<br>diagnosis | 1993 |
| 9 | IEC | IEC 60601-2-32 | Medical electrical equipment-<br>Part 2: Particular requirements<br>for the safety of associated<br>equipment of X-ray equipment | 1995 |
| 10 | Cenelec | EN 980 | Graphical symbols for use<br>in the labeling of medical | 2003 |
| 11 | Cenelec | EN 1041 | Information supplied by the<br>manufacturer with medical<br>devices | 1998 |
| No. | OEN | Reference | Title of standard | Year of<br>ratificatio |
| 12 | ISO | ISO 14971 | Medical devices - Application<br>of risk | 2007 |
| 13 | ISO | ISO 13485 | Medical devices. Quality<br>management systems.<br>Requirements for regulatory<br>purposes. | 2003 |
| 14 | FDA | 21 CFR 1020.30<br>and 1020.31 | Diagnostic equipment standards | N/A |

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12. Conclusion: Based on comparison with the predicate devices and the results of testing Metabiomed believes its REXTAR LCD device is substantially equivalent to the predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/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 pattern around the symbol. The logo is black and white and appears to be a scanned image.

#### Public Health Service

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

March 1, 2013

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

Re: K122016

Trade/Device Name: REXTAR LCD

Regulation Number: 21 CFR 872.1800

Regulation Name: Extraoral Source X-Ray System

Regulatory Class: II

Product Code: EHD

Dated: February 7, 2013

Received: February 12, 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Reportal roblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/9/Picture/7 description: The image shows the name "Kwame O. Ulmer" in bold, black font. The letters "FDA" are in the background, with a complex, patterned design. To the right of the name, there is the text "fc" in a smaller, regular font.

Anthony D. Watson, B.S., M.S., M.B.A. 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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# Attachment 2

## Indications for Use Statement

510(k) Number (if known): K122016

Device Name: REXTAR LCD

Indications for Use:

REXTAR LCD is a portable X-ray systems 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use: | X |
|---------------------------|---------------|
| (Per-21MFR S01usubpart D) | |
| Susan Runner, DOSMA | 2013.02.22 |
| | 11:44:41-0500 |

AND.OR Over-The-Counter Use: (21 CFR 801 Subpart C)

(Division Sign-On) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division Control Dental Devices Division of Anesules.org
Infection Control, Dental Devices - 11

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