The current modifications do not change the indications for use. As previously reported and cleared: the DigiArc 100AU+ is a mobile digital X-ray G-Arm 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 DigiArc 100AU+ 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 at the age of at least eighteen.

Device Description

The DigiArc 100AU+ is a mobile digital X-ray G-Arm 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 DigiArc 100AU+ includes below primary components.
Control unit
Viewing monitor
Control monitor
Control panel
G-Arm
Image intensifier assembly
X-ray tube assembly
Foot switch subassembly
Laser aimer system
Tracking wheel system
Printer (optional): thermal or laser printer

AI/ML Overview

The medical device in question is the DigiArc 100AU+, a mobile digital X-ray G-Arm diagnostic system. This 510(k) summary focuses on demonstrating that the updated DigiArc 100AU+ is substantially equivalent to its predicate device, the DigiArc 100AU (K131423), and does not delve into detailed clinical performance studies for diagnostic accuracy.

Here's an analysis of the provided information regarding acceptance criteria and supportive studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Electrical Safety & Performance Standards	Compliance with AAMI / ANSI ES60601-1:2005 (Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance)	The updated G-arm has passed all tests according to AAMI / ANSI ES60601-1:2005.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2:2007 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests)	The proposed device has been tested to compliance.
Radiation Protection in Diagnostic X-ray Equipment	Compliance with IEC 60601-1-3:2008 (Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment)	The proposed device has been tested to compliance.
X-ray Equipment for Radiography and Radioscopy	Compliance with IEC 60601-2-54:2009 (Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy)	The proposed device has been tested to compliance.
Digital Imaging & Communications in Medicine (DICOM)	Compliance with DICOM provisions	The proposed device meets the provisions of DICOM.
Laser Aimer System Safety	Compliance with IEC 60950-1:2006 (Information technology equipment - Safety - Part 1: General requirements) and IEC 60825-1:2007 (Safety of laser products - Part 1: Equipment classification and requirements)	The laser aimer system has passed all tests according to IEC 60950-1:2006 and IEC 60825-1:2007. The laser classification of the laser component is 2.
Impact of Device Modifications on Safety & Effectiveness	Demonstrating that the "Tracking wheel system" and "Laser aimer system" additions do not adversely affect safety and effectiveness.	The tracking wheel system is a mechanical difference and passed AAMI / ANSI ES60601-1:2005 tests, thus not affecting safety and effectiveness. The laser aimer system does not change fundamental scientific technology, passed IEC 60950-1:2006 and IEC 60825-1:2007 tests, and the updated device passed AAMI / ANSI ES60601-1:2005, thus not affecting safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

This submission does not describe a clinical study with a "test set" in the context of diagnostic accuracy. Instead, the "testing" refers to non-clinical performance testing for compliance with recognized safety and performance standards. Therefore, information on sample size for a test set (e.g., number of patients/images) and data provenance (country of origin, retrospective/prospective) related to clinical diagnostic performance is not applicable and not provided. The testing described is largely hardware-focused, ensuring the device itself meets established engineering and safety benchmarks.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Given that this is a non-clinical 510(k) submission focused on hardware modifications and compliance with engineering standards (not diagnostic accuracy), there is no mention of experts or radiologists establishing ground truth for a test set. The "ground truth" here is the adherence to the specifications of the various IEC and ANSI standards.

4. Adjudication Method for the Test Set

As no clinical test set requiring expert interpretation or ground truth establishment is described, an adjudication method is not applicable and not provided.

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

No MRMC comparative effectiveness study was done or reported. This device primarily focuses on imaging equipment and its functionality, not AI assistance for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No standalone algorithm performance study was done or reported. This device is an X-ray system, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is compliance with recognized electrical, safety, and performance standards for medical electrical equipment and laser products (e.g., AAMI / ANSI ES60601-1:2005, IEC 60601-1-2:2007, IEC 60601-1-3:2008, IEC 60601-2-54:2009, IEC 60950-1:2006, IEC 60825-1:2007) and adherence to DICOM provisions.

8. The Sample Size for the Training Set

Not applicable and not provided. As this is a hardware device compliance demonstration, there is no AI algorithm being "trained" on a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable and not provided. There is no training set for an AI algorithm in this submission.

Summary

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JUL 3 1 2014

510(k) Summary of Safety and Effectiveness

[As required by 21 CFR 807.92]

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

June 19th 2014

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, Beijing, 100023, China

Contact Name: June Li

Telephone No .: + 86 (10) 67892355- 8968

Fax No.: + 86 (10) 67082218

Email Address: jqli@whaleimaging.com

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

Trade Name:	DigiArc 100AU+
Common Name:	MultiScan G-Arm System
Classification:	Image-intensified fluoroscopic X-ray system
Product code:	OXO, JAA
Classification Panel:	Radiology
Device Class:	II

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

510(k) Number	K131423
Applicant	Beijing East Whale Imaging Technology Co., Ltd.
Device Name	G-Arm MultiScan System

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

The DigiArc 100AU+ includes below primary components.

	Table 1- Primary components list
--	----------------------------------

Component	Quantity
Control unit	1
Viewing monitor	2
Control monitor	1
Control panel	1

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G-Arm	1
Image intensifier assembly	2
X-ray tube assembly	2
Foot switch subassembly	1
Laser aimer system	1
Tracking wheel system	1
Printer (optional): thermal or laser printer	1

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

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

The design modifications do not alter the device's fundamental scientific technology.

The DigiArc 100AU+ employs the same technological characteristics as the predicate devices except items in table 2. However, it employs the same imaging concepts and fundamental scientific technology with the predicate device and the differences do not impact the safety and effectiveness of the device.

Table 2. Major differences between proposed device and predicate device

ltem	Predicate deviceDigiArc 100AU ( K131423 )	Proposed deviceDigiArc 100AU+	Note
Tracking wheelsystem	No	Yes	Note 1
Laser aimersystem	No	Yes	Note 2

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Note1: The tracking wheel system is fixed on the G-Arm, it helps users move the G-Arm easily, design change concerning tracking wheel system is mechanical difference. There is no new technology on the mechanical design and the updated G-arm has passed all the tests in according to AAM / ANSI ES60601-1:2005, thus this difference will not affect safety and effectiveness.

Note 2: The laser aimer system contains two sets of laser emitter. The two sets of laser emitter are respectively fixed on enclosure of the two intensifiers, acts as a patient positioning system. The laser aimer system does not change the fundamental scientific technology and has nothing to do with the imaging process. The laser classification of the laser component is 2, and it has past all the tests in according to IEC 60950-1:2006 and IEC 60825-1:2007, besides the updated device has passed all the tests in according to AAMI / ANSI ES60601-1:2005, thus this difference will not affect safety and effectiveness.

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

Results of performance and compliance testing conducted on DigiArc 100AU+ indicates conformance to all applicable standards recognized by FDA for this device.

Testing result from non-clinical demonstrates that the proposed device DigiArc 100AU+ is as safe and effective as the predicate devices.

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WHALE

Non-clinical testing:

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

AAMI / ANSI ES60601-1:2005

IEC 60601-1-2:2007

IEC 60601-1-3:2008

IEC 60601-2-54:2009

And 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 DigiArc 100AU+ is substantially equivalent to predicate devices with regard to safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

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

July 31, 2014

Beijing East Whale Imaging Technology Co., Ltd. % Ms. June Li RA Engineer B2-2 New City Industrial Park No. 9 Kechuang 2nd Street Yizhuang, Beijing 100023 CHINA

Re: K141672

Trade/Device Name: DigiArc 100AU+ Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic system Regulatory Class: II Product Code: OXO, JAA Dated: June 30, 2014 Received: July 2, 2014

Dear Ms. Li:

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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Page 2-Ms. Li

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/ResourcesforYou/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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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510(k) submission

WHALE

Indications for Use

510(k) Number (if known): in process K141672 MultiScan G-Arm System Device Name: Indications for Use: The current modifications do not change the indications for use , as previously reported and cleared. The DigiArc 100AU+ is a mobile digital X-ray G-Arm 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 DigiArc 100AU+ 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 at

Prescription Use な (Part 21 CFR 801 Subpart D) AND/OR

the age of at least eighteen.

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices and Radiological Health (OIR)

Sm.h.7)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological I lealth

K141672 510(k)

Page 1 of 1

Indications for Use

008-1

Regulation Number and Section

N/A