ANYVIEW-500R Fluoroscopic Mobile X-Ray System

K160279 · Ecotron Co., Ltd. · OWB · Oct 14, 2016 · Radiology

Device Facts

• Record ID: K160279
• Device Name: ANYVIEW-500R Fluoroscopic Mobile X-Ray System
• Applicant: Ecotron Co., Ltd.
• Product Code: OWB · Radiology
• Decision Date: Oct 14, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

Anyview-500R fluoroscopic mobile x-ray system is radiation medical equipment only used by professional radiologists. This product is designed to provide fluoroscopic and spot film images of the patient during diagnostic and interventional procedures. This system can be applied in emergency room, operation room, cast room or etc. of hospital.

Device Story

Mobile C-arm fluoroscopic X-ray system; utilizes X-ray generation based on tissue density/thickness attenuation; captures images via image intensifier and CCD camera; digital imaging system (cart with computer/monitor) processes and stores images. Operated by professional radiologists in hospitals (OR, ER, cast room). Provides real-time fluoroscopic and spot film images for diagnostic/interventional procedures; supports DICOM/PACS integration for review. Benefits include mobile access to patient imaging during procedures.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation included electrical safety (IEC 60601-1 series), electromagnetic compatibility, and FDA EPRC performance standards (21 CFR 1020.30-32).

Technological Characteristics

Mobile C-arm; HFG inverter X-ray generator (5kW); Toshiba XR-2551 X-ray tube; Toshiba E5830SD-P4A image intensifier (9-inch FOV); 1Kx1K CCD camera; motorized collimator; 220V-230V power; DICOM compatible; Class II laser pointer (655nm, 5mW).

Indications for Use

Indicated for professional radiologists to provide fluoroscopic and spot film imaging of patients during diagnostic and interventional procedures in hospital settings including emergency, operation, and cast rooms.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• KMC-950 (K032761)

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

October 14, 2016

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

Re: K160279

Trade/Device Name: Anyview-500R Fluoroscopic Mobile X-ray System Regulation Number: 21 CFR 892.1650 Regulation Name: Image intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA, OXO Dated: September 30, 2016 Received: October 05, 2016

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 O'Hara

For

Robert Ochs. Ph.D. 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) K160279

Device Name

Anyview-500R Fluoroscopic Mobile X-ray System

Indications for Use (Describe)

Anyview-500R fluoroscopic mobile x-ray system is radiation medical equipment only used by professional radiologists. This product is designed to provide fluoroscopic and spot film images of the patient during diagnostic and interventional procedures.

This system can be applied in emergency room, operation room, cast room or etc. of hospital.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image contains a logo for a company called "ecoTRON eco & electronics". The logo consists of a series of blue squares on the left, followed by the word "ecoTRON" in a bold, sans-serif font. Above the word "ecoTRON", there is smaller text that reads "eco & electronics". The overall design is clean and modern, suggesting a company that is involved in technology and environmental sustainability.

## SECTION 04

# 510(k) SUMMARY

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Image /page/4/Picture/0 description: The image is a logo for "eco & electronics eddotRON". The logo has a blue square design on the left side, followed by the text "eco & electronics" in a smaller font. Below the blue square design, the text "eddotRON" is written in a larger font. The logo is simple and modern, with a focus on the company's name and its association with electronics.

### 1. Traditional 510(k) SUMMARY

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

Date 510K summary prepared : September 30, 2016

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,<br>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:

| 510K Number: | K160279 |
|-----------------------------|-----------------------------------------------|
| Trade/proprietary name: | ANYVIEW-500R Fluoroscopic Mobile X-ray System |
| Regulation Name: | Image-intensified Fluoroscopic X-ray System |
| Regulation Number: | 21 CFR 892. 1650 |
| Regulatory Class: | II |
| Product Code: | OWB, JAA, OXO |
| Predicate Device Trade Name | KMC-950 |
| 510(k) Clearance # | K032761 |
| Clearance date | 05/14/2004 |
| Classification Name | Image Intensified Fluoroscopic X-ray System |
| Classification Panel | Radiology |
| CFR Section | 21CFR 892.1650 (Produce Code; JAA, OWB, OXO) |
| Device Class | Class II |

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## 2. Device Description

This device is a mobile x-ray fluoroscopic imaging system used by radiation experts. This device is a fluoroscopic imaging system to visualize human body's anatomical structure using a principle that x-ray qenerates hypophonesis difference when penetrating human body depending on tissue's density and thickness. The device is composed of main body, x-ray generating equipment (x-ray controller, high voltage generator, x-ray tube, motortype collimator), image collecting equipment (Image Intensifier, CCD Camera) and digital imaging system (cart including computer and monitor). The product's arm is mobile and rotatable in X, Y and Z axes, which facilitates use of x-ray in every direction.

ANYVIEW imaging software is a Digital Imaging System (DIS) designed for C-arm, Anyview-500R. ANYVIEW imaging software provides useful functions to manage X-ray images obtained from Anyview 500R C-arm.

ANYVIEW imaging software provides various image tools. One of the most noticeable features is that the C-arm images taken during an exam are stored in the database for further review. Image data is integrated with the patient information in DICOM(OPTION) compatible format which allows compatibility with existing DICOM and PACS system. All these features are available in a single application program, ANYVIEW.

#### 3. Indications for Use

Anvyiew-500R fluoroscopic mobile x-ray system is radiation medical equipment only used by professional radiologists. This product is designed to provide fluoroscopic and spot film images of the patient during diagnostic and interventional procedures.

This system can be applied in emergency room, operation room, cast room or etc. of hospital.

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

Anyview-500R Fluoroscopic Mobile X-ray System has been developed to provide the mobility of X-ray users for convenient access to patients while meeting the critical functional requirements and international safety standards. The risks and the hazardous impact of 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 overall 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:

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Image /page/6/Picture/0 description: The image shows the logo for "eco & electronics eddotron". The logo is in blue and gray. The word "eddotron" is in gray, with the "eco & electronics" in smaller blue font above it.

Anyview-500R Fluoroscopic Mobile X-ray System described in this 510(k) has the similar indications for use and technical characteristics as the predicate device, KMC-950 (K032761) manufactured by COMED Medical Systems, Inc.

#### 6. Substantial Equivalence

Anyview-500R Fluoroscopic 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-, software-, clinical-, and risk management, it's the sponsor's opinion that the Anyview-500R Fluoroscopic Mobile X-ray System is a safe and effective device.

| Characteristics | Anyview-500R Fluoroscopic<br>Mobile X-ray System<br>(K160279) | KMC-950 (K032761) | SE-# |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Intended Use | Anyview-500R mobile C-arm, fluoroscopic x-ray system, is radiation medical equipment only used by professional radiologists. This product is designed to provide fluoroscopic and spot film images of the patient during diagnostic and interventional procedures.<br>This system can be applied in emergency room, operation room, cast room or etc. of hospital. | The KMC-950 is intended to provided fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography, orthopedic, neurological, abdominal, vascular, cardiac, critical care and emergency room procedures.<br>The system may be used for other RF imaging application at physician's discretion. | Similar |
| Energy Source | 220V~230V, Single 50/60 Hz | 100V-120V or 200V-230V<br>Single 50/60 Hz | Similar |

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| X-ray<br>Generator<br>Type | HFG INVERTER TYPE | High frequency Inverter<br>type<br>(POSKOM) | Same |
|----------------------------|-----------------------|---------------------------------------------|-----------|
| Output power | 5kW | 12.5W | #1 |
| Fluoroscopy | | | |
| -Continuous<br>mode | 0.5-10mA | 0.5-5mA | Similar |
| -Pulsed mode | 0.5-20mA | 0.5-5mA | #2 |
| -Boost mode | 30mA | 20mA | Similar |
| Radiography<br>mode | | | |
| -kV range | 40-125 kV | 40-120kV | Similar |
| -mA range | 20-100 mA | 20-150 | Similar |
| -mAs range | 0.8~200mAs | 0.4~500 mAs | #3 |
| X-ray tube<br>type | TOSHIBA XR-2551 | Varian RAD-99 | |
| Max kV | 125kV | 120kV | Similar |
| Focal spot (S/L) | 0.3 / 0.6 | 0.3 / 0.6 | Same |
| Target angle | 10° | 10° | Same |
| Anode heat<br>сара | 210 kHU | 300 kHU (HU=1.4 x<br>Joule) | Similar |
| Collimator<br>type | Open/close motorized | Open/close motorized | Same |
| Rotation | 360 ° | 360 ° | Same |
| Image<br>Intensifier | E5830SD-P4A (TOSHIBA) | E5764SD-P4A (TOSHIBA) | |
| Input FOV | 9inch | 9inch | Same |
| Entrance field<br>size | 9/6/4.5 in | 9/6/4.5 in | Same |
| Central<br>resolution | 54/62/70 lp/cm | 54 lp/cm | Same |
| Contrast | 36:1 | 25:1 | #4 |
| CCD Camera<br>type | CCD | CCD | Same |
| Resolution | 1K x 1K | 512 x 512 | Different |
| Laser Pointer | Included | N/A | |
| (1) Laser Class | Class II | N/A | |
| (2) Max Power | 5mW | N/A | |
| (3) Wavelength | 655nM | N/A | |

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Image /page/8/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 a smaller font above the word "edotron". The word "edotron" is in a larger, gray font.

| Performance<br>Standard | 21CFR 1020.30 | 21CFR 1020.30 | Same |
|-----------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------|
| Electrical Safety<br>IEC 60601-1: | IEC 60601-1:<br>IEC 60601-1-2<br>IEC 60601-1-3<br>IEC 60601-2-28<br>IEC 60601-2-43<br>IEC 60601-2-54 | IEC 60601-1:<br>IEC 60601-1-2<br>IEC 60601-1-3<br>IEC 60601-2-28<br>IEC 60601-2-43<br>IEC 60601-2-54 | Same |

## Image intensifier Performance Comparison Data – TOSHIBA

| | | | Predicate device (KMC-950) (K032761) | | | Subject device (Anyview-500R) | | | | |
|----------------------------------|---------------|----------------------|------------------------------------------------|--------|---------|------------------------------------------------|--------|---------|--------|--------|
| Model Name | | | E5764SD-P4A (previously cleared under K032761) | | | E5830SD-P4A (previously cleared under K160065) | | | | |
| Manufacturer | | | TOSHIBA | | | TOSHIBA | | | | |
| Overall Length | | | 338±5 mm | | | 338±5 mm | | | | |
| Maximum Diameter | | | 304±2 mm | | | 304±2 mm | | | | |
| Parameters | | | | Normal | Magn.1 | Magn.2 | | Normal | Magn.1 | Magn.2 |
| Output image size | | | 20.0 ± 0.5 mm | | | 25.2 ± 0.2 mm | | | | |
| Nominal entrance field size | | | 230 | 160 | 120 | 230 | 160 | 125 | | |
| DQE | | | 65 | - | - | 65 | - | - | | |
| Conversion factor(cd.m2/μGy.s-1) | | | 28 | - | - | 26 | - | - | | |
| Central resolution | | | 48 | 56 | 66 | 52 | 58 | 68 | | |
| Contrast | 10% area | | 25 | - | - | 30 | - | - | | |
| ratio | 10mm dia. | | 16 | - | - | 19 | - | - | | |
| Weight(approx.) | | | 18 kg | | | 20 kg | | | | |
| Power | Input voltage | | 24±1 Vdc | | | 24±1 Vdc | | | | |
| supply | Output | Anode | 30 | 30 | 30 | 30 | 30 | 30 | | |
| | voltage | G3 Electrode<br>(kV) | 3 to 4 | 5 to 8 | 9 to 12 | 3 to 4 | 5 to 8 | 9 to 12 | | |
| | | G2 Electrode | 400 to | 400 to | 500 to | 400 to | 400 to | 500 to | | |
| | | (V) | 800 | 800 | 1200 | 800 | 900 | 1200 | | |
| | | G1 Electrode | 100 to | 100 to | 100 to | 150 to | 150 to | 100 to | | |
| | | (V) | 250 | 250 | 250 | 300 | 300 | 250 | | |
| | | Photocathode<br>(V) | 0 | 0 | 0 | 0 | 0 | 0 | | |
| Relevant standard | | | IEC 1262-1 to 7 | | | IEC 1262-1 to 7 | | | | |

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Image /page/9/Picture/0 description: The image is a 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, bolder font, with the "o" in "eddotRON" being a different color than the rest of the letters. The overall design is clean and modern.

#### 7. Difference Discussion

| SE-# | SE discussion |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SE-#1, #2, #3, #4 | Anyview-500R Fluoroscopic Mobile X-ray System is equipped with<br>high resolution CCD camera in comparison with the predicate device;<br>1K x 1K vs 512 x 512.<br>Anyview-500R Fluoroscopic Mobile X-ray System requires less X-ray<br>source and therefore less capacity for the X-ray generator and tube<br>heat storage compared to the predicate device. Such differences in<br>performance do not raise additional risk concerns. |

#### 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 Anyview-500R Fluoroscopic Mobile X-ray System described in this 510(k) are similar to those of the predicate device.

The primary differences are the specifications of X-ray tube, and X-ray generator of the subject device. The performance specifications of the subject device are lower than those of the predicate device such as the X-ray generator and X-ray tube anode heat content (Heating Unit). However Anyview-500R Fluoroscopic Mobile X-ray System is equipped with high resolution CCD camera in comparison with the predicate device: 1K x 1K vs 512 x 512. Anyview-500R Fluoroscopic Mobile X-ray System requires less X-ray source and therefore less capacity for the X-ray generator and tube heat storage compared to the predicate device.

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

#### 9. Performance Testing/Data

Testing for verification and validation of the device was found acceptable to support the claims of 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, the identified risk of electrical hazards was mitigated and it is the sponsor's opinion that Ayview 500-R appears to be as safety and effective as the predicate device.

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

Anyview-500R Fluoroscopic Mobile X-ray System has been tested for electrical safety and electromagnetic compatibility. The device also complies with FDA EPRC Performance Standard: 21 CFR 1020.30-32. The software validation and verification testing was also performed. The results of nonclinical testing indicate that the Anyview-500R Fluoroscopic Mobile X-ray System is as safe and effective as the predicate device.

Compliance evidences were submitted for the following standards:

- > IEC60601-1:2005 + A1 (2012)
- > IEC60601-1-2:2007
- > IEC60601-1-3:2008
- > IEC60601-2-28:2010
- > IEC60601-2-43:2010
- > IEC60601-2-54:2009
- > NEMA PS 3.1-3.20

#### 11. Description of clinical tests.

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

#### 12. Conclusion as to Substantial Equivalence

Anyview-500R Fluoroscopic Mobile X-ray System is substantially equivalent to the predicate device KMC-950 (K032761). Both devices are very similar in the intended use, the design principle, the performance and the applicable standards. Some characteristics, for example, their appearance, the user interfaces and the capacity of Xray generator and X-ray tube are different. However, the compliance reports, performance demonstrations and description of non-clinical review result in this submission STED provide demonstration that these differences do not raise any new questions of safety and effectiveness. Therefore, it is the sponsor's opinion that Anyview-500R Fluoroscopic Mobile X-ray System appears to be as safe and effective as the predicate device.