EPX-Series Mobile X-ray System

K151038 · Ecotron Co., Ltd. · IZL · Jul 24, 2015 · Radiology

Device Facts

• Record ID: K151038
• Device Name: EPX-Series Mobile X-ray System
• Applicant: Ecotron Co., Ltd.
• Product Code: IZL · Radiology
• Decision Date: Jul 24, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1720
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

This product, diagnostic X-ray system, is radiation medical equipment used by a qualified / trained physician or technician on both adult and pediatric subjects for taking diagnostic X-rays. This product is used on hand (wrist), foot (ankle), shoulder, elbow, knee, and other body parts.

Device Story

Portable X-ray generator; used by radiologists, physicians, or technicians in clinical settings. Device consists of monobloc high-frequency generator and full-bridge inverter system; mounted on stand for positioning. Inputs: user-selected kV and mAs values via rotary switch interface. Device controls X-ray dose within hardware-limited ranges; processes output via internal software. Outputs: X-ray radiation for capture on conventional film or digital imaging detectors. Benefits: mobility allows bedside/point-of-care imaging; higher anode heat storage and performance specs compared to predicate enable efficient imaging workflows. Healthcare providers use output images for diagnostic decision-making.

Clinical Evidence

No clinical data provided. Substantial equivalence established via bench testing, including electromagnetic compatibility (IEC 60601-1-2), electrical/mechanical safety (IEC 60601-1, 60601-1-3, 60601-2-28, 60601-2-54), and compliance with FDA EPRC performance standards (21 CFR 1020.30 and 1020.31).

Technological Characteristics

Monobloc high-frequency generator; medical full-bridge inverter system; automatic dynamic line voltage adjustment. User interface: rotary switch with 7-segment LED. Exposure switch: dual-stage deadman type. Compliance: IEC 60601-1, 60601-1-3, 60601-2-28, 60601-2-54. Software-based control. Dimensions/form factor: portable, stand-mountable.

Indications for Use

Indicated for use by qualified/trained physicians or technicians on adult and pediatric patients for diagnostic X-ray imaging of extremities (hand, wrist, foot, ankle, shoulder, elbow, knee) and other body parts.

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

• PORTA 100HF (K122697)

Submission Summary (Full Text)

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

July 24, 2015

ECOTRON Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025

Re: K151038

Trade/Device Name: EPX-Series Mobile X-ray System Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: June 19, 2015 Received: June 25, 2015

Dear Mr. Kim:

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.

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 device-related 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. Acting 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

510(k) Number (if known) K151038

Device Name Epx-series Mobile X-ray System

#### Indications for Use (Describe)

This product, diagnostic X-ray system, is radiation medical equipment used by a qualified / trained physician or technician on both adult and pediatric subjects for taking diagnostic X-rays.

This product is used on hand (wrist), foot (ankle), shoulder, elbow, knee, and other body parts.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|------------------------------------------------------------------------------------|
| <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/0 description: The image is a logo for a company called "ecoTRON." The logo has a blue square with three vertical lines on the left side. To the right of the square is the text "eco & electronics" in a smaller font. Below the square and text is the word "ecoTRON" in a larger font, with "eco" in blue and "TRON" in gray.

EPX Series Diagnostic X-ray System: F1600, F2400, F2800, F3200, F4000, F5000

## SECTION 07

510(k) SUMMARY

SECTION 07 Page 1 / 8

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Image /page/4/Picture/0 description: The image shows the logo for "eco & electronics eddTRON". The logo has a blue square design on the left side of the logo. The text "eco & electronics" is in black font and is located above the word "eddTRON". The word "eddTRON" is in a gray font.

#### 1. Traditional 510(k) SUMMARY

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

Date 510K summary prepared : April 10, 2015

Submitter's Name, address, telephone number, a contact person:

| Submitter's Name : | ECOTRON Co, Ltd. |
|-------------------------|-------------------------------------------------------------------------------|
| Submitter's Address: | Rm 504, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-gu, Seoul, Korea |
| Submitter's Telephone: | Tel:[phone] / Fax:[phone] |
| Contact person: | Mr. Sang Bong Lee / RA Assist Mgr |
| Official Correspondent: | Dave Kim ([e-mail]) |
| Address: | 8310 Buffalo Speedway, Houston, TX 77025 |
| Telephone: | [phone] |
| Fax: | [phone] |

Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:

| Trade/proprietary name: | EPX Series Mobile X-ray System<br>F1600, F2400, F2800, F3200, F4000, F5000 |
|-----------------------------------|----------------------------------------------------------------------------|
| Regulation Name: | Mobile X-ray System |
| Regulation Number: | 21 CFR 892.1720 |
| Regulatory Class: | II |
| Product Code: | IZL |
| Predicate Device<br>Manufacturer: | JOB Corporation |
| Device: | PORTA 100HF |
| 510(k) Number: | K122697 |
| Decision Date: | Oct. 5, 2012 |

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Image /page/5/Picture/0 description: The image shows the logo for "eco & electronics eddTRON". The logo features a series of blue squares on the left, followed by the text "eco & electronics" in a smaller font. Below this, the word "eddTRON" is displayed in a larger, gray font.

## 2. Device Description

This product, portable X-ray generator, is radiation medical equipment which can only be used by professional radiologists. It controls and marks Xray dose within the range of X-ray exposure limited by hardware. Also it uses algorithm of X-ray output for processing and control. This portable Xray generator requires equipment for X-ray images. Small in size, this product is convenient to carry with, and suitable for being moved around. The main body used with a stand. And when attached to a stand, it is easy to adjust positioning for medical imaging.

#### 3. Indications for Use

This rroduct, diagnostic X-ray system, is radiation ment used by a qualified / trained physician or technician on both adult and pediatric subjects for taking diagnostic X-rays.

This product is used on hand (wrist), foot (ankle), shoulder, elbow, knee, and other body parts.

#### 4. Summary of Design Control Risk management

EPX mobile X-ray series have been developed to provide the mobility of X-ray users to patients while meeting the critical functional requirements and international safety standards The risks and the device design were analyzed with FMEA method. The specific risk control and protective measures to mitigate the risks from the device design and production phase were reviewed and implemented in the new product design phase. The overal assessment concluded that all risks and hazardous conditions identified arising from the design and production were successfully mitigated and accepted.

#### 5. Summary of the technological characteristics of the device compared to the predicate device:

EPX mobile X-ray series escribed in this 510(k) have the similar indications for use and technical characteristics as the predicate device, PORTA 100HF (K122697) manufactured by JOB Corporation.

#### 6. Substantial Equivalence

EPX Series mobile X-ray system conforms to the FDA recognized standards as like the predicate device. Based on the recognized standard conformity evidences related to electro-, mechanical-, clinical-, and risk management, it is confirmed that EPX Series is substantially equivalent to the predicate device.

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Image /page/6/Picture/0 description: The image shows the logo for "eco & electronics eddTRON". The logo features a blue square design on the left, followed by the text "eco & electronics" in black. Below this, the word "eddTRON" is displayed in a larger, gray font, creating a visually distinct and modern brand identity.

| Characteristics | EPX series Mobile X-ray System<br>(F1600, F2400, F2800, F3200, F4000, F5000) | | | | | | PORTA 100HF (K122697) , JOB<br>Corporation | SE-# | |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|------------------------------|-----------------------------|-----------------------------|-----------------------------|----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|------|
| Intended Use | This product, diagnostic X-ray system, is radiation medical equipment used by<br>a qualified / trained physician or technician on both adult and pediatric subjects<br>for taking diagnostic X-rays.<br>This product is used on hand (wrist), foot (ankle), shoulder, elbow, knee, and<br>other body parts. | | | | | | Intended use by a<br>qualified/technician on both adult and pediatric subjects for taking<br>diagnostic X-rays | Simil<br>ar | |
| Energy Source | 110V~120V / 220V~240V,<br>Single 50/60 Hz | | | | | | 100V-120V or 200V-240V<br>Single 50/60 Hz | Same | |
| User Interface | Up and down Rotary switch for kV and mAs value with 7 segment LED | | | | | | Up and down Rotary switch for kV<br>and mAs value with 7 segment<br>LED | Same | |
| Exposure switch | Dual stage, deadman type with curled cable. | | | | | | Dual stage, deadman type with<br>curled cable. | Same | |
| Controls | Software based | | | | | | Software based | Same | |
| Construction | Monobloc HF generator, Medical full bridge inverter system | | | | | | Monobloc HF generator, Medical<br>full bridge inverter system | Same | |
| High Voltage<br>Adjustment | High frequency inverter | | | | | | High frequency inverter | Same | |
| Line Voltage<br>Adjustment | Automatic, Dynamic | | | | | | Automatic, Dynamic | Same | |
| Exposure times | F1600 | F2400 | F2800 | F3200 | F4000 | F5000 | 0.01 - 2.50 sec, 32 steps | | |
| (sec) | 0.01~2.46<br>sec,<br>20steps | 0.01-4.0<br>sec,<br>25steps | 0.01-3.57<br>sec,<br>25steps | 0.01-3.2<br>sec,<br>25steps | 0.01-4.0<br>sec,<br>25steps | 0.01-5.0<br>sec,<br>25steps | | Simil<br>ar | |
| Tube Potential | F1600 | F2400 | F2800 | F3200 | F4000 | F5000 | 40-100kV (2kV step) | Simil<br>ar | |
| (kV) | 40-90kV<br>(1kV step) | 40-100kV<br>(1kV step) | 40-120kV<br>(1kV step) | 40-100kV<br>(1kV step) | 50~110kV<br>(1kV step) | 50~110kV<br>(1kV step) | | | |
| Tube current | F1600 | F2400 | F2800 | F3200 | F4000 | F5000 | 30mA (40-66kV)<br>20mA (68kV – 100kV) | #1 | |
| | 12~30mA | 20~40mA | 14~40mA | 25~60mA | 20~80mA | 20~<br>100mA | | | |
| | F1600 | F2400 | F2800 | F3200 | F4000 | F5000 | | | |
| mAs | 0.4~32mAs | 0.4~100mAs | 0.4~100mAs | 0.4~100mAs | 0.4~100mAs | 0.4~100mAs | 0.3 mAs – 50 mAs | #2 | |
| X-ray tube | F1600 | F2400 | F2800 | F3200 | F4000 | F5000 | Toshiba D-124 | #3 | |
| | D-125 | D-125 | D-125 | D-205B | OX/110-15 | OX/110-15 | | | |
| Anode heat<br>storage | F1600 | F2400 | F2800 | F3200 | F4000 | F5000 | 20K HU | #4 | |
| | 50K HU | 50K HU | 50K HU | 40k HU | 42k HU | 42k HU | | | |
| Focal Spot | F1600 | F2400 | F2800 | F3200 | F4000 | F5000 | 1.2mm | #5 | |
| | 1.2mm | 1.2mm | 1.2mm | 2.0mm | 1.8mm | 1.8mm | | | |
| Total Filtration | F1600 | F2400 | F2800 | F3200 | F4000 | F5000 | | | |
| | 3.3mm AL.Eq<br>@75kV | 3.3mm ALEq<br>@75kV | 3.3mm ALEq<br>@75kV | 3.3mm ALEq<br>@75kV | 3mm ALEq<br>@75kV | 3mm ALEq<br>@75kV | 2.5mm AL. eq. at 100kV | #6 | |
| Collimator | Complete with 30 sec. timer and cross indication line | | | | | | | Complete with 30 sec. timer and<br>cross indication line | Same |
| Performance<br>Standard | 21CFR 1020.30 | | | | | | | 21CFR 1020.30 | same |
| Electrical Safety | IEC 60601-1:<br>IEC 60601-1-3<br>IEC 60601-2-28<br>IEC 60601-1-2<br>IEC 60601-2-54 | | | | | | | IEC 60601-1:<br>IEC 60601-1-3<br>IEC 60601-2-28<br>IEC 60601-1-2<br>IEC 60601-2-7<br>IEC 60601-2-54 | #7 |
| X-ray Radiography | Conventional X-ray film or digital imaging detector | | | | | | | Conventional X-ray film or digital<br>imaging detector | same |

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Image /page/7/Picture/0 description: The image shows the logo for eco & electronics edotron. The logo has a blue square design on the left side of the logo. The text "eco & electronics" is in black and is located on the top right side of the logo. The text "edoTRON" is in gray and is located on the bottom right side of the logo.

# EPX Series Diagnostic X-ray System:
F1600, F2400, F2800, F3200, F4000, F5000

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Image /page/8/Picture/0 description: The image is a logo for "eco & electronics edoTRON". The logo has a blue icon on the left, followed by the text "eco & electronics" in black. Below that is the word "edoTRON", with "edo" in blue and "TRON" in gray. The logo is simple and modern, with a focus on the company's name and its connection to electronics.

## 7. Difference Discussion

| SE-# | SE discussion |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SE-#1, #2, | EPX Series mobile X-ray system performs similar or better compared to the predicate device in terms of performance<br>specifications. For EPX-F1600, the performance specification is almost identical to the predicate device In terms<br>of kV, tube current. EPX-F1600 provides more segmented kV step control compared to the predicate.<br>EPX-F2400<br>and EPX-F2800 have similar or higher capacity than the predicate device in terms of KV and tube current setting<br>which may require shorter patient exposure time.<br>EPX-F3200, EPX-4000 and EPX-F5000 are equipped with even higher performance specifications and higher tube<br>current control is possible. The high voltage controls X-ray penetration and thus the image. The<br>tube current and exposure time affect the dose and therefore the darkness of the image.<br>Such differences in performance do not raise additional risk concerns. |
| SE-#3, #4, #5 | F1600, F2400, and F2800 show the same effective focal spot. The effective focal spot for F3200, F4000, and<br>F5000 is larger than the predicate device. The effective focal spot size is controlled by the size of the actual focal<br>spot and the anode target angle. Larger effective focal spot results wider useful beam. EPX series has larger<br>anode heat storage than the predicate device. It refers to the capacity of the thermal energy of which the X-ray<br>tube must be able to support and dissipate during and after an exam. |
| SE-#6 | The minimum filtration reduces patient radiation dose by eliminating low energy that would otherwise be<br>absorbed by the patient's skin.<br>Positive means are determined through linear interpolation to provide that at least the minimum filtration needed<br>to achieve the above beam quality requirements is in the useful beam during each exposure, according to the HVL<br>provisions of 1020.30(m)(1). |
| SE-# 7 | IEC 60601-2-7 is withdrawn and replaced with IEC 60601-1 3rd Ed. |

#### 8. Summary of the technological characteristics of the device compared to the predicate device:

The indications for use, mechanical components, performances and safety characteristics of EPX mobile X-ray series described in this 510(() are similar to those of the predicate device.

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Image /page/9/Picture/0 description: The image is a logo for "eco & electronics eddoTRON". The logo features a series of blue squares on the left side, followed by the text "eco & electronics" in a smaller font size. Below this text is the word "eddoTRON" in a larger, bolder font. The color of "eddoTRON" is gray.

EPX Series Diagnostic X-ray System: F1600, F2400, F2800, F3200, F4000, F5000

The primary differences are the specifications of X-ray generator of the subject device. The performance specifications of the subject device are similar or higher than that of the such as the X-ray generator and X-ray tube ande heat content (Heating Unit),

These differences do not have an effect on safety and effectiveness compared to the predicate device.

## 9. Performance Testing/Data

Testing for verfication and validation of the device was found acceptable to substantial equivalence. Safety compliance checking (including EMC, and so on) was evaluated according to the IEC Standards. ECOTRON Co., Ltd certifies conformance to Voluntary Standards covering electrical and Mechanical safety. In conclusion is of electrical hazards was mitiqated and is substantially equivalent of the predicate device in terms of safety and effectiveness.

#### 10. Description of non-clinical tests.

EPX series diagnostic X-ray system has been tested for electromagnetic compatibility (IEC 60601-1-2, IEC 60601-2-54, IEC 60601-1-3, IEC 60601-2-28, and IEC 60601-1:2005.) The device also complies with FDA EPRC Performance Standard: 21 CFR 1020.30 and 31. The software validation and verification was also performed. The results of nonclinical testing indicate that the EPX series mobile X-ray system is as safe and effective as the predicate device.

Compliance evidences were submitted for the following standards:

- IEC 60601-1: Test Report issued by 3rd party testing lab A
- IEC 60601-1-2: Test Report issued by 3rd party testing lab A
- IEC 60601-1-3: Test Report issued by 3rd party testing lab A
- IEC 60601-2-54: Test Report issued by 3rd party testing lab A
- EPRC Standard: 21 CFR 1020.30 and 31: In-house Test Report A
- ISO 14971: Risk management file A

#### 11. Description of clinical tests.

No cinical data is necessary to effectiveness for purposes of determining substantial equivalence of the proposed modification. Bench testing was performed to assess the device safety and effectiveness.

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Image /page/10/Picture/0 description: The image shows the logo for "eco & electronics eddoTRON". The logo features a blue square design on the left, followed by the text "eco & electronics" in a smaller font size. Below this text is the word "eddoTRON" in a larger, bold font, with the "eddo" part in blue and the "TRON" part in gray. The overall design is clean and modern.

EPX Series Diagnostic X-ray System: F1600, F2400, F2800, F3200, F4000, F5000

#### 12. Conclusion as to Substantial Equivalence

EPX SERIES are substantially equivalent to the predicate device PORTA 100 HF (K122697). These 2 devices are very similar in the intended use, the design principle, the perfornance and the applicable standards. Some characteristics, for exer interfaces and the capacity of X-ray generator and X-ray tube are different. However the compliance demonstrations and description of nonclinical review result in this submission that these differences do not raise any new questions of safety and effectiveness. Therefore, ECOTRON CO., LTD. concludes EPX series of mobile X-ray system are substantially equivalent with the predicate device PORTA 100 HF (K122697) of JOB Corporation.