MultiScan G-Arm System

K160984 · Beijing East Whale Imaging Technology Co., Ltd. · OXO · Jul 20, 2016 · Radiology

Device Facts

• Record ID: K160984
• Device Name: MultiScan G-Arm System
• Applicant: Beijing East Whale Imaging Technology Co., Ltd.
• Product Code: OXO · Radiology
• Decision Date: Jul 20, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The B5 S is a mobile digital X-ray diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning and monitoring operations in trauma surgery, orthopedics, spine surgery, and chest surgery. It is not intended to be used in interventional procedures. The B5 S permits a qualified doctor or technologist to take a range of diagnostic exposures of spinal column, chest, abdomen, extremities, and other body parts on the patients.

Device Story

Mobile digital X-ray diagnostic system (B5 S) used in surgical/clinical settings by physicians or technologists. Device features G-Arm configuration with two perpendicular X-ray tube assemblies and image intensifiers, allowing simultaneous or separate operation for real-time fluoroscopic imaging. Inputs consist of X-ray radiation passing through patient anatomy; system transforms these into digital fluoroscopic images displayed on two viewing monitors. Provides real-time visual feedback for surgical positioning and monitoring. Benefits include intraoperative guidance for orthopedic, trauma, spine, and chest procedures. System includes control unit, footswitch, and optional laser indicators. Output used by clinicians to guide surgical interventions and diagnostic assessments.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance demonstrated through performance testing against AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-3, and IEC 60601-2-54 standards, covering electrical safety, electromagnetic compatibility, radiation leakage, and dosimetric accuracy.

Technological Characteristics

Mobile digital fluoroscopic X-ray system. Features G-Arm with two rotating anode X-ray tubes and triple-field image intensifiers (23cm, 16cm, 12cm). Power: 110/120VAC. Connectivity: DICOM compliant. Standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54. Components: control unit, viewing/control monitors, footswitch, optional laser indicators.

Indications for Use

Indicated for patients requiring X-ray fluoroscopic imaging for real-time positioning and monitoring in trauma, orthopedic, spine, and chest surgery, or diagnostic exposures of the spinal column, chest, abdomen, and extremities. Not for interventional procedures.

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

• MultiScan G-Arm System (K151280)

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 20, 2016

Beijing East Whale Imaging Technology Co., Ltd. % Miss Sharon Fan Regulatory Engineer B2-2 New City Industrial Park, No. 9 Kechuang 2nd St., YiZhuang, 100023 Beijing CHINA

Re: K160984

Trade/Device Name: MultiScan G-Arm System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OXO, JAA Dated: May 24, 2016 Received: May 31, 2016

Dear Miss Fan:

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)

K160984

Device Name MultiScan G-Arm System

#### Indications for Use (Describe)

The B5 S is a mobile digital X-ray diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning operations in trauma surgery, orthopedics, spine surgery, and chest surgery. It is not intended to be used in interventional procedures.

The B5 S permits a qualified doctor or technologist to take a range of diagnostic exposures of spinal column, chest, abdomen, extremities, and other body parts on the patients .

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

| <span style="font-family:ZapfDingbats">❌</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family:ZapfDingbats">❍</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|

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Image /page/3/Picture/1 description: The image shows the word "WHALE" in large, bold, blue letters. To the right of the word is a small, stylized logo. The logo is a white square with a blue outline, and inside the square are two green rectangles stacked on top of each other.

# 510(k) Summary of Safety and Effectiveness

[As required by 21 CFR 807.92]

## 1. Date Prepared [21 CFR807.92 (a) (1)]

May 17th 2016

#### 2. Submitter's Information [21 CFR807.92 (a) (1)]

Name of Sponsor: Beijing East Whale Imaging Technology Co., Ltd.

Address: B2-2 New City Industrial Park, No.9 KeChuang 2nd St.,

YiZhuang, 100023, Beijing, China.

Contact Name: Sharon Fan

+ 86 (10) 67892355- 8866 Telephone No.:

Fax No.: + 86 (10) 67082218

Email Address: [e-mail]

#### 3. Trade Name, Common Name, Classification [21 CFR807.92(a)(2)]

| Trade Name: | B5 S |
|-----------------|---------------------------------------------|
| Common Name: | MultiScan G-Arm System |
| Classification: | Image-intensified fluoroscopic X-ray system |
| Product code: | OXO, JAA |

510(k) Summary of Safety and Effectiveness

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Classification Panel: Radiology

ll Device Class:

#### 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[

#### Table 1- Predicate Devices

| 510(k) Number | K151280 |
|---------------|-------------------------------------------------|
| Applicant | Beijing East Whale Imaging Technology Co., Ltd. |
| Device Name | MultiScan G-Arm System |

# 5. Description of the Device [21 CFR 807.92(a)(4)]

The B5 S is a mobile digital X-ray diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning and monitoring operations in trauma surgery, orthopedics, spine surgery, and chest surgery. It is not intended to be used in interventional procedures.

There are two sets of X-ray tube assemblies and Image Intensifiers which are perpendicularly distributed on the G-Arm, acting as two sets of vertical X-ray source and receptor systems and providing fluoroscopy image of the patient. The two sets of X-ray tube assemblies and Image Intensifiers can operate simultaneously and separately.

The B5 S is comprised of control unit and G-Arm, the control unit and G-Arm 510(k) Summary of Safety and Effectiveness 004-2

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include below primary components.

# Table 2-1 control unit Primary components list

| Control Unit Major Component | Qty. |
|------------------------------|------|
| Viewing monitor | 2 |
| Exposure lamp | 2 |
| Control monitor | 1 |
| Keyboard | 1 |
| Footswitch subassembly | 1 |
| Printer(optional) | 1 |

# Table 2-2 G-Arm Primary components list

| G-Arm Major Component | Qty. |
|---------------------------------|------|
| Image intensifier assembly | 2 |
| X-Ray tube assembly | 2 |
| Laser light indicator(optional) | 2 |
| Steering unit (optional) | 1 |

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# 6. Intended Use [21 CFR 807.92(a)(5)]

The B5 S is a mobile digital X-ray diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning and monitoring operations in trauma surgery,

orthopedics, spine surgery, and chest surgery. It is not intended to be used in

interventional procedures.

The B5 S permits a qualified doctor or technologist to take a range of diagnostic exposures of spinal column, chest, abdomen, extremities, and other body parts on the patients.

## 7. Technological Characteristics [21 CFR 807.92(a)(6)]

| Item | Predicate Device | Subject Device (B5 S) | Remark |
|------------------------|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|--------|
| Applicable<br>Standard | AAMI / ANSI ES60601-1<br>IEC60601-1-2<br>IEC60601-1-3<br>IEC60601-2-54 | AAMI / ANSI ES60601-1<br>IEC60601-1-2<br>IEC60601-1-3<br>IEC60601-2-54 | Same |
| Power apply | 110/120VAC±10%, 50/60Hz | 110/120VAC±10%, 50/60Hz | Same |
| Primary<br>components | Image gantry + X-ray tube +<br>image intensifier + view<br>monitor + control monitor +<br>footswitch | Image gantry + X-ray tube + image<br>intensifier + view monitor + control monitor<br>+ footswitch | Same |

Table 3- Major similarities and differences between subject and predicate devices

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| Mobile or<br>stationary | Mobile | Mobile | Same | | |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-----------------------|------|
| Entrance<br>Field Size of<br>image<br>intensifier | 23cm(9") | Triple-field | | | SE |
| | | Normal:<br>23cm(9") | Magn. 1:<br>16cm(6") | Magn.2:<br>12cm(4.5") | |
| X-ray Output:<br>Fluoroscopy | Range of X-ray tube voltage:<br>40–120 kV<br>Range of X-ray tube current:<br>0.1–15mA<br>Manual Pulse Fluoroscopy<br>kV: 40–120, step: 1kV<br>mA: 0.1–15.0, step: 0.1 mA | Range of x-ray tube voltage:<br>40–120 kV<br>Range of x-ray tube current:<br>0.1-8.0ma<br>Manual Pulse Fluoroscopy<br>kV: 40–120, step: 1kV<br>mA: 0.1-8.0, step: 0.1 mA | | | SE |
| | Automatic Pulse Fluoroscopy<br>kV:40–120, step: 1kV<br>mA : fixed at 8.0mA(AP<)<br>or fixed at 15 mA(AP/LT) | Automatic Pulse Fluoroscopy<br>kV: 40–120, step: 1kV<br>mA: 8.0mA | | | |
| Type of X-ray<br>tube | Stationary anode | Rotating anode | | | SE |
| SID | 950-1250mm | 890-1190mm | | | SE |
| Total<br>equivalent<br>filtration | 7.1 mmAl(at 80kV) | 7.0 mmAl(at 80kV) | | | SE |
| Over-Rotation | +/- 17 degrees | +/- 13 degrees | | | SE |
| Others | --- | | | | Same |

The B5 S have the same technological characteristics as the predicate device except items in table3- Major similarities and differences between subject and predicate devices. However, the B5 S employs the same imaging concepts and fundamental scientific technology with the predicate device and has

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passed all the tests in according to relevant standards. The differences will not impact the safety and effectiveness of the device.

# 8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]

Results of performance and compliance testing conducted on B5 S indicate conformance to all applicable standards recognized by FDA for this device.

Testing result from non-clinical demonstrates that the proposed device B5 S is as safe and effective as the predicate devices.

#### Non-clinical testing:

The proposed device has been tested to compliance to the following safety and performance standards:

a) AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012

And A2:2010/(R)2012

Table 4-- Performed testing items of ANSI/AAMI ES60601-1

| Testing items | Result |
|-------------------------------------------------------------------------|--------|
| Power input | Pass |
| Humidity preconditioning treatment | Pass |
| Determination of applied parts and accessible parts | Pass |
| Legibility of markings | Pass |
| Durability of markings | Pass |
| ME equipment for connection to a power source by a plug | Pass |
| Internal capacitive circuits | Pass |
| Protective earth connection | Pass |
| Leakage currents | Pass |
| Dielectric strength | Pass |
| Ball pressure test | Pass |
| Measurement of creepage distance and air clearance | Pass |
| Cord anchorage | Pass |
| Gaps | Pass |
| Instability-overbalance in transport position | Pass |
| Instability-overbalance excluding transport position | Pass |
| Instability-overbalance from horizontal and vertical forces | Pass |
| Castors and wheels -force for propulsion | Pass |
| Castors and wheels -movement over a threshold | Pass |
| Instability from unwanted lateral movement in transport position | Pass |
| Instability from unwanted lateral movement excluding transport position | Pass |
| Audible acoustic energy | Pass |
| Support system | Pass |
| Maximum temperature during normal use | Pass |
| Spillage | Pass |
| Ingress of water or particulate matter | Pass |
| Cleaning | Pass |
| Interruption of the power supply/supply mains to ME equipment | Pass |
| Single fault conditions | Pass |
| Mechanical strength test | Pass |
| Transformer short circuit | Pass |
| Transformer overload test | Pass |
| ME system-leakage measurements | Pass |
| Testing items | Result |
| Mains terminal continuous disturbance voltage | Pass |
| Radiated emission | Pass |
| Electrostatic discharge | Pass |
| RF electromagnetic field immunity test | Pass |
| Fast transients on AC power line, signal line and interconnecting line | Pass |
| Injected current into AC power line, signal line and interconnecting | Pass |
| Surges to AC power port, signal line and interconnecting line | Pass |
| Variations of power frequency | Pass |

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#### b) IEC 60601-1-2 Edition 3:2007-03

#### Table 5 – Performed testing items of IEC 60601-1-2

#### c) IEC 60601-1-3 Edition 2.1 2013

# Table 6--Performed testing items of IEC60601-1-3

| Testing items | Result |
|-------------------------------------------------|--------|
| Half-value layer | Pass |
| Leakage radiation in the loading state | Pass |
| Leakage radiation when not in the loading state | Pass |

#### d) IEC 60601-2-54 Edition 1.0 2009-06

#### Table 7—Performed testing items of IEC 60601-2-54

| Testing items | Result |
|---------------------------------|--------|
| Test for dosimetric information | Pass |
| Accuracy of X-ray tube voltage | Pass |

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Image /page/11/Picture/1 description: The image shows the word "WHALE" in large, bold, blue letters. To the right of the word, there is a white square with two horizontal green rectangles inside. The green rectangles are stacked on top of each other, and the white square has a slight shadow effect, giving it a three-dimensional appearance. The overall design is simple and clean, with a focus on the word "WHALE" and the green rectangles.

| Accuracy of X-ray tube current | Pass |
|---------------------------------------------------|------|
| Determining the attenuation of residual radiation | Pass |

Also the proposed device meets the provisions of Digital Imaging

communications in Medicine (DICOM)

# 9. Conclusion [21 CFR 807.92(b) (3)]

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the non-clinical result and relative information provided in this premarket notification, we concludes that B5 S is substantially equivalent to predicate devices with regard to safety and effectiveness.