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.

Device Description

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 include below primary components.

Control Unit Major Component: Viewing monitor (2), Exposure lamp (2), Control monitor (1), Keyboard (1), Footswitch subassembly (1), Printer(optional) (1).

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

AI/ML Overview

The provided document is a 510(k) premarket notification for the MultiScan G-Arm System, which is an Image-intensified fluoroscopic x-ray system. The document focuses on demonstrating substantial equivalence to a predicate device and provides information on non-clinical testing for safety and performance standards. It does not contain information about acceptance criteria for a device's diagnostic performance, a study to prove it meets those criteria, or details regarding ground truth establishment, expert-based evaluation, or AI integration.

Therefore, many of the requested items cannot be extracted from this document.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Cannot be extracted. This document reports on compliance with safety and performance standards relevant to an x-ray system (e.g., electrical safety, EMC, radiation safety), not on diagnostic performance metrics like sensitivity, specificity, or AUC which would typically be associated with acceptance criteria for a device that provides diagnostic interpretations.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be extracted. This document describes non-clinical testing against standards. There is no "test set" of patient data in the context of diagnostic performance. The tests performed are on the device itself (e.g., electrical measurements, radiation output).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be extracted. There is no "ground truth" establishment in the context of diagnostic imaging outcomes mentioned in this document, as it focuses on the engineering and safety performance of the X-ray system.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be extracted. Not applicable as there is no diagnostic test set or expert evaluation described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Cannot be extracted. This document describes an X-ray fluoroscopic imaging system, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI performance metrics are included.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Cannot be extracted. Not applicable as this is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be extracted. Not applicable as this document pertains to the physical and electrical performance of an X-ray system, not diagnostic accuracy.

8. The sample size for the training set

Cannot be extracted. Not applicable as this is not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Cannot be extracted. Not applicable as this is not an AI algorithm.

Summary of available information from the document:

The provided document details the non-clinical testing performed on the MultiScan G-Arm System (B5 S) to demonstrate its safety and effectiveness for substantial equivalence to a predicate device (K151280).

Acceptance Criteria and Reported Device Performance (Non-clinical Standards Compliance):

The device was tested for compliance with several accepted safety and performance standards. The "acceptance criteria" in this context are the requirements of these standards, and the "reported device performance" is that the device "Pass"ed all these tests.

Testing Item Category	Standard Reference	Result
Electrical Safety & Mechanical Stability	AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012	Pass (for all 33 listed items, including power input, leakage currents, dielectric strength, instability tests, mechanical strength, etc.)
Electromagnetic Compatibility (EMC)	IEC 60601-1-2 Edition 3:2007-03	Pass (for all 7 listed items, including mains terminal continuous disturbance voltage, radiated emission, electrostatic discharge, RF electromagnetic field immunity, fast transients, injected current, surges, variations of power frequency)
Radiation Protection in Diagnostic X-ray	IEC 60601-1-3 Edition 2.1 2013	Pass (for all 3 listed items: Half-value layer, Leakage radiation in the loading state, Leakage radiation when not in the loading state)
Specific Requirements for X-ray Equipment	IEC 60601-2-54 Edition 1.0 2009-06	Pass (for all 4 listed items: Test for dosimetric information, Accuracy of X-ray tube voltage, Accuracy of X-ray tube current, Determining the attenuation of residual radiation)
Digital Imaging Communications	DICOM	Meets the provisions

Study Description (Non-clinical Testing for Substantial Equivalence):

The study was a non-clinical testing process designed to show conformance to recognized safety and performance standards. This is not a clinical study involving patient data for diagnostic accuracy.

Sample Size for Test Set / Data Provenance: Not applicable. The "tests" were conducted on the device hardware itself against predefined engineering and safety specifications, not on a set of patient cases.
Number of Experts / Qualifications / Adjudication: Not applicable. Evaluation was against technical standards, not diagnostic interpretation by human experts.
MRMC / Standalone / AI: Not applicable. The device is a traditional X-ray fluoroscopic system, not an AI-driven diagnostic tool.
Ground Truth Type: Not applicable in the diagnostic sense. The "ground truth" for the tests performed is the adherence to the specified technical parameters and safety limits defined by the IEC/AAMI standards.
Training Set Size / Ground Truth for Training Set: Not applicable. The device is a hardware system, not a machine learning model.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 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):

❌ Prescription Use (Part 21 CFR 801 Subpart D)	❍ Over-The-Counter Use (21 CFR 801 Subpart C)
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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: fanxiaoyan@whaleimaging.com

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 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)]

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
ApplicableStandard	AAMI / ANSI ES60601-1IEC60601-1-2IEC60601-1-3IEC60601-2-54	AAMI / ANSI ES60601-1IEC60601-1-2IEC60601-1-3IEC60601-2-54	Same
Power apply	110/120VAC±10%, 50/60Hz	110/120VAC±10%, 50/60Hz	Same
Primarycomponents	Image gantry + X-ray tube +image intensifier + viewmonitor + control monitor +footswitch	Image gantry + X-ray tube + imageintensifier + view monitor + control monitor+ footswitch	Same

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

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Mobile orstationary	Mobile	Mobile	Same
EntranceField Size ofimageintensifier	23cm(9")	Triple-field			SE
		Normal:23cm(9")	Magn. 1:16cm(6")	Magn.2:12cm(4.5")
X-ray Output:Fluoroscopy	Range of X-ray tube voltage:40–120 kVRange of X-ray tube current:0.1–15mAManual Pulse FluoroscopykV: 40–120, step: 1kVmA: 0.1–15.0, step: 0.1 mA	Range of x-ray tube voltage:40–120 kVRange of x-ray tube current:0.1-8.0maManual Pulse FluoroscopykV: 40–120, step: 1kVmA: 0.1-8.0, step: 0.1 mA			SE
	Automatic Pulse FluoroscopykV:40–120, step: 1kVmA : fixed at 8.0mA(AP<)or fixed at 15 mA(AP/LT)	Automatic Pulse FluoroscopykV: 40–120, step: 1kVmA: 8.0mA
Type of X-raytube	Stationary anode	Rotating anode			SE
SID	950-1250mm	890-1190mm			SE
Totalequivalentfiltration	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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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.

Regulation Number and Section

N/A