PORTA 100HF

K122697 · Job Corporation · IZL · Oct 5, 2012 · Radiology

Device Facts

• Record ID: K122697
• Device Name: PORTA 100HF
• Applicant: Job Corporation
• Product Code: IZL · Radiology
• Decision Date: Oct 5, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1720
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

PORTA 100HF is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic X-rays.

Device Story

PORTA 100HF is a portable, monobloc high-frequency X-ray unit designed for diagnostic imaging. It operates via AC power (100-120V or 200-240V) and utilizes a high-frequency inverter to generate X-rays. The device features a control panel with rotary switches for kV and mAs selection, an APR switch with 8 memory settings for exposure data, and a dual-stage deadman hand switch. It is intended for use by physicians or technicians in clinical settings, mounted on a portable stand. The system is compatible with conventional X-ray film or digital imaging media. By providing controlled X-ray exposure, the device assists clinicians in obtaining diagnostic images for patient assessment.

Clinical Evidence

Bench testing only. The device underwent electrical safety and electromagnetic compatibility testing per IEC 60601-1:2005, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-54, CISPR11, and UL 2601-1. Software verification and validation were also performed.

Technological Characteristics

Monobloc high-frequency inverter system; Toshiba D-124 X-ray tube; 40-100kV potential; 1.2mm focal spot; 20,000HU anode heat storage; 2.5mm Al equivalent filtration at 100kV. Operates on AC100-120V/15A or AC200-240V/10A. Software-based control system with 8 APR memory settings. Complies with 21 CFR 1020.30 and IEC/UL safety standards.

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic X-ray imaging. Intended for use by qualified physicians or technicians.

Regulatory Classification

Identification

A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• MinXray HF100H+ (K052721)

Submission Summary (Full Text)

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#### 510(k) Summary

OCT 5 2012

# 510(k) Submitter:

JOB Corporation 1-19-8 Shinyokohama, Kohoku-ku, Yokohama, Kanagawa, Postal code 222-0033, Japan Tel: [phone] Fax: [phone] Date Prepared: August 16, 2012 Contact: Hiroya Obana, Senior Manager

#### Trade/Proprietary name: PORTA 100HF

Common/usual name: Portable general purpose diaqnostic X-ray unit Classification name: Mobile X-ray system, Product Code IZL

## Equivalent Legally Marketed Device:

This product is similar in function to the Mikasa X-Ray Co., LTD.'s MinXray HF100H+ (K052721.)

## Intended Use:

PORTA 100HF is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic X-rays.

#### Description of the Device:

PORTA 100HF is an X-ray unit which operates from AC100-120V/15A or AC200-240V/10A. The device consists of the control panel with the kV and mAs selectors (a rotary switch system) and display for radiographic operations, and the APR switch with 8 memory settings (kV/mAs) to store the exposure data. The device also consists of the X-ray tube, the collimator, power code, and the hand switch, comprising the mono-tank type of a portable X-ray unit. The unit utilizes a high frequency inverter designed to be mounted on a stand. The device can be used with conventional X-ray film or digital imaging media. The usual safety precautions regarding X-rays must be observed by the operator.

#### Nonclinical Tests for a Determination of Substantial Equivalence:

PORTA 100HF has been tested for electrical safety and electromagnetic compatibility (IEC 60601-1-2, CISPR11, IEC 60601-2-7, IEC 60601-2-54, IEC 60601-1-3, IEC 60601-2-28, and IEC 60601-1:2005.) The device also complies with Underwriters Laboratories Standards for Safety (UL2601-1.) The software validation and verification testing was also performed. The results of nonclinical testing indicate that the PORTA 100HF is as safe and effective as the predicate device.

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# Substantial Equivalence Chart:

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| Characteristics | (Mikasa X-Ray Co., LTD.)<br>MinXray HF 100H+<br>(K052721) | (JOB Corporation)<br>PORTA 100HF |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended use by a<br>qualified/technician on both<br>adult and pediatric subjects<br>for taking diagnostic X-rays | Same |
| Physical Characteristics | | |
| Size/weight | 406mmx222mmx241mm<br>18.6Kgs | 160mmx161mmx291mm<br>9.2Kgs |
| Energy Source<br>(Input Voltage) | AC100-140V or<br>AC200-260V | AC100-120V/15A or<br>AC200-240V/10A |
| Mounting<br>Method | Unit is usually mounted to<br>MinXray XGS MKIII portable<br>stand | Unit is mounted to a<br>commercially available<br>portable stand |
| Technical Characteristics | | |
| User Interface | Up-down pushbottons for<br>kVp selections and<br>exposure time selections<br>with LED indicators and<br>mAs indicators | Up and down Rotary switch<br>for kV and mAs value with 7<br>segment LED |
| Exposure times | 0.03-2.00 sec.<br>0.01 increments | 0.01-2.50 second<br>32 steps |
| Exposure switch | Dual-stage deadman type | Dual stage, deadman type<br>with curled cable. |
| Controls | Software based | Software based |
| Construction | Monobloc HF generator,<br>Medical full bridge inverter<br>system | Monobloc HF generator,<br>Medical full bridge inverter<br>system |
| High Voltage<br>Adjustment | High frequency (60kHz)<br>inverter | High frequency inverter |
| Line Voltage<br>Adjustment | Automatic, dynamic | Automatic, dynamic |
| Tube Potential<br>(kV) | 40-100kV (2kVstep) | 40-100kV (2kV step). |
| kV step | 31(2kV-step) | 31(2kV-step) |
| Tube current | 30mA (40-60kV)<br>25mA (62-80kV)<br>20mA (82-100kV) | 30mA (40-66kV)<br>20mA (68kV-100kV) |
| X-ray tube | Toshiba D-124S | Toshiba D-124 |
| Anode heat<br>Storage | 20,000HU | 20,000HU |
| Focal Spot Size | 1.2mm | 1.2mm |
| mAs | 0.6-120mAs | 0.3mAs-50mAs |
| Total Filtration | 3.2mm Al equivalent | 2.5mm Al. eq. at 100kV |
| Collimator | Continuously adjustable (30 sec.) light beam type with<br>central X-ray indicator | Complete with 30 sec. timer<br>and cross indication line. |
| Source to Skin<br>Distance (SSD) | 300mm | 216mm |
| KvP | 100KvP | 100KvP |
| Performance<br>Standard | 21CFR 1020.30<br>UL 2601 | 21CFR 1020.30<br>UL 2601-1 |
| Electrical Safety | IEC 60601-1<br>IEC 60601-1-2 | IEC 60601-1:2005<br>IEC 60601-1-3<br>IEC 60601-2-28<br>IEC 60601-1-2<br>CISPR11<br>IEC 60601-2-7<br>IEC 60601-2-54 |
| X-ray<br>Radiography | Conventional X-ray film or<br>digital imaging media | Conventional X-ray film or<br>digital imaging media |

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## Conclusion:

The PORTA 100HF is intended for the same indications for use as the predicate device and the results of the nonclinical testing demonstrate that the PORTA 100HF is as safe and effective as the predicate device. It is the conclusion of JOB Corporation that the PORTA 100HF is as safe and effective as the predicate device and has few technological differences, thus rendering it substantially equivalent to the predicate device.

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Image /page/3/Picture/0 description: The image shows a logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around a stylized eagle symbol. The eagle is depicted with its wings spread, and its body is formed by three curved lines. The text is in a bold, sans-serif font, and the eagle is in black. The logo is likely used to represent the U.S. Department of Health and Human Services.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

JOB Corporation
% Mr. Takahiro Haruyama
President
Globizz Corporation
1411 West 190th Street, Suite 120
GARDENA CA 90248

ڪ

Re: K122697

Trade/Device Name: PORTA 100HF Regulation Number: 21 CFR 892.1750 . Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: IZL Dated: August 27, 2012 Received: September 4, 2012

Dear Mr. Haruyama:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 Parts 801 and 809); medical device reporting (reporting of

OCT 5 2012

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.

Sincerely Yours.

Michael D'Hara for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use Form

510(k) Number (if known): __

Device Name: PORTA 100HF

Indications for Use:

PORTA 100HF is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic X-rays.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

1

Ahn AD Oh

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_

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