(139 days)
The DigiArc 100AU/ 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/ 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.
The DigiArc 100AU/ 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 provided FDA 510(k) summary describes the "MultiScan G-Arm System" (DigiArc 100AU & DigiArc 100AU+) by Beijing East Whale Imaging Technology Co., Ltd. The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance and safety testing against recognized standards. It does not detail specific acceptance criteria for diagnostic accuracy or device performance in the context of clinical image interpretation or AI-assisted diagnoses, nor does it present a study proving the device meets such criteria. The device is a standard X-ray fluoroscopic imaging system, not an AI-powered diagnostic tool.
Therefore, the requested information regarding acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance is not present in this document. The provided text exclusively covers the device's technical specifications, safety, and compliance with general medical device standards.
However, I can extract the information that is present concerning the device's compliance with safety and performance standards, which are the "acceptance criteria" discussed in this 510(k) submission.
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" in this context are compliance with various recognized safety and performance standards for medical electrical equipment and X-ray systems. The reported device performance for these criteria is consistently "Pass."
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (General Requirements for Basic Safety and Essential Performance of Medical Electrical Equipment) | Pass |
| - 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 |
| - Audible acoustic energy | 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 |
| - Half-value layer | Pass |
| - Focal spot to image receptor distance | Pass |
| - Leakage radiation in the loading state | Pass |
| - Leakage radiation when not in the loading state | Pass |
| IEC 60601-1-3 Edition 2.0 2008 (Radiation protection in diagnostic X-ray equipment) | Pass |
| IEC 60601-2-54 Edition 1.0 2009-06 (Specific requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy) | Pass |
| - Test for dosimetric information | Pass |
| - Accuracy of X-ray tube voltage | Pass |
| - Accuracy of X-ray tube current | Pass |
| - Determining the attenuation of residual radiation | Pass |
| IEC 60601-1-2 Edition 3: 2007-03 (Electromagnetic compatibility - Requirements and tests) | Pass |
| - Harmonics on AC mains | Pass |
| - Voltage fluctuations on AC mains | Pass |
| - 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 line | Pass |
| - Surges to AC power port, signal line and interconnecting line | Pass |
| - Voltage dips and interruptions to AC power port | Pass |
| - Variations of power frequency | Pass |
| Digital Imaging Communications in Medicine (DICOM) provisions | Meets |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is non-clinical performance and safety testing for the device itself, not a study involving patient data or clinical images for diagnostic accuracy assessment.
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)
This information is not provided in the document. This type of information would be relevant for studies evaluating diagnostic performance, which is not the subject of this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods are used in clinical studies to establish ground truth for diagnostic decisions, which is not applicable to the non-clinical testing presented here.
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
An MRMC comparative effectiveness study was not done. This device is an X-ray imaging system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm was not done. This device is an imaging system, not an algorithm, and the submission does not describe any AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as it relates to diagnostic accuracy is not applicable to the non-clinical performance and safety testing described. The "ground truth" for these tests are the objective pass/fail criteria defined by the respective international and national standards (e.g., specific voltage/current ranges, radiation leakage limits, insulation resistance, etc.).
8. The sample size for the training set
This information is not provided and is not applicable, as this device itself is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not provided and is not applicable, as this device itself is not an AI algorithm.
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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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design, symbolizing the department's focus on health and human well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 30, 2015
Beijing East Whale Imaging Technology Co., Ltd. % Miss June Li Official Correspondent B2-2 New City Industrial Park, No. 9 KeChuang 2nd Street YiZhuang, Beijing, 100023 CHINA
Re: K151280
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: August 31, 2015 Received: September 2, 2015
Dear Miss 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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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,
Robert Ocko
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) K151280
Device Name MultiScan G-Arm System
Indications for Use (Describe)
The DigiArc 100AU/ 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/ 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.
Type of Use (Select one or both, as applicable)
X 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/1 description: The image shows the word "WHALE" in large, bold, blue letters. To the right of the word is a logo that appears to be a stylized letter "E" in green, enclosed in a white square with a blue border. The logo is smaller than the word "WHALE" and is positioned slightly above the baseline of the text.
510(k) Summary of Safety and Effectiveness
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
Aug 28th 2015
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: 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 & DigiArc 100AU+
- Common Name: MultiScan G-Arm System
- Classification: Image-intensified fluoroscopic X-ray system
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Image /page/4/Picture/1 description: The image shows the word "WHALE" in large, bold, blue letters. To the right of the word is a logo that appears to be a stylized letter "E" inside of a rounded square. The letter "E" is made up of two horizontal green bars.
Product code: OXO, JAA 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 | K131423K141672 |
|---|---|
| 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 DigiArc 100AU/ 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
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Image /page/5/Picture/1 description: The image shows the word "WHALE" in large, bold, blue letters. To the right of the word is a small, white square with rounded corners. Inside the square are two horizontal green bars, stacked on top of each other. The logo appears to be for a company or organization named "WHALE".
simultaneously and separately.
The DigiArc 100AU & DigiArc 100AU+ include below primary components.
Table 2- Primary components list
| Component | Quantity |
|---|---|
| Control unit | 1 |
| Viewing monitor | 2 |
| Control monitor | 1 |
| Control panel | 1 |
| G-Arm | 1 |
| Image intensifier assembly | 2 |
| X-ray tube assembly | 2 |
| Foot switch subassembly | 1 |
| Laser aimer system(optional) | 1 |
| Tracking wheel system(optional) | 1 |
| Printer (optional) | 1 |
6. Intended Use [21 CFR 807.92(a)(5)]
The current modifications do not change the indications for use. As previously reported and cleared: the DigiArc 100AU/ 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/ DigiArc
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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.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
| Item | Predicate deviceDigiArc 100AU | Predicate deviceDigiArc 100AU+ | Proposed deviceDigiArc 100AUProposed deviceDigiArc 100AU+ | Note |
|---|---|---|---|---|
| Trackingwheel systemand Laseraimer system | No | Yes | Optional | SE |
| X-ray Output:Fluoroscopy | Range of X-rayvoltage: 40—110kVRange of X-raycurrent: 0.1—15mA | Range of X-rayvoltage: 40—110kVRange of X-raycurrent: 0.1—15mA | Range of X-rayvoltage:40—110 kV (AU)40—120 kV (AU+)Range of X-raycurrent: 0.1—15mA | SE |
| Totalequivalentfiltration | 4.0 mmAl(at 80kV) | 4.0 mmAl(at 80kV) | 7.1 mmAl(at 80kV) | SE |
| Softwareversion | 1.1.0 | 1.3.0 | DigiArc 100AU:V1.6.0.1DigiArc 100AU+:V1.6.0.2 | SE |
Table 3- Major similarities and differences between subject and predicate devices
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Image /page/7/Picture/1 description: The image shows the word "WHALE" in large, bold, blue letters. To the right of the word is a small, white square with a green design inside. The green design appears to be two horizontal bars with a white line in between them.
| Others | -- | Same |
|---|---|---|
| -------- | ---- | ------ |
The design modifications do not alter the device's fundamental scientific technology, and the updated device has passed all the tests in according to relevant standards. The DigiArc 100AU & DigiArc 100AU+ employs the same technological characteristics as the predicate devices.
8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]
Results of performance and compliance testing conducted on DigiArc 100AU & DigiArc 100AU+ indicate conformance to all applicable standards recognized by FDA for this device.
Testing result from non-clinical demonstrates that the proposed device DigiArc 100AU & DigiArc 100AU+ are 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- Major testing items of AAMI/ANSI ES 60601-1
| Testing items | result |
|---|---|
| Power input | Pass |
| Humidity precondiitioning 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 |
| Audible acoustic energy | 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 |
| Half-value layer | Pass |
| Focal spot to image receptor distance | Pass |
| Leakage radiation in the loading state | Pass |
| Leakage radiation when not in the loading state | Pass |
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Image /page/8/Picture/1 description: The image shows the word "WHALE" in large, bold, blue letters. To the right of the "E" is a small, white square with two horizontal green bars inside. The logo is simple and clean, with a focus on the company name.
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Image /page/9/Picture/1 description: The image shows the word "WHALE" in large, bold, blue letters. To the right of the word is a small, square graphic with a white background and two horizontal green bars inside. The graphic is positioned next to the letter "E" in "WHALE."
b) IEC 60601-1-3 Edition 2.0 2008
Table 5- Major testing items of IEC 60601-1-3
c) IEC 60601-2-54 Edition 1.0 2009-06
Table 6- Major testing items of IEC 60601-2-54
| Testing items | result |
|---|---|
| Test for dosimetric information | Pass |
| Accuracy of X-ray tube voltage | Pass |
| Accuracy of X-ray tube current | Pass |
| Determining the attenuation of residual radiation | Pass |
d) IEC 60601-1-2 Edition 3: 2007-03
Table 7- Major testing items of IEC 60601-1-2
| Testing items | result |
|---|---|
| Harmonics on AC mains | Pass |
| Voltage fluctuations on AC mains | Pass |
| Mains terminal continuous disturbance voltage | Pass |
| Radiated emission | Pass |
| Electrostatic discharge | Pass |
| RF electromagnetic field immunity test | Pass |
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Image /page/10/Picture/1 description: The image shows the word "WHALE" in large, bold, blue letters. To the right of the word is a logo that appears to be a stylized letter "E" in green, enclosed in a white box with a gray border. The logo is positioned so that the "E" is partially obscured by the last letter of the word "WHALE".
| Fast transients on AC power line, signal line and interconnecting line | Pass |
|---|---|
| Injected current into AC power line, signal line and interconnecting line | Pass |
| Surges to AC power port, signal line and interconnecting line | Pass |
| Voltage dips and interruptions to AC power port | Pass |
| Variations of power frequency | 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 DigiArc 100AU & DigiArc 100AU+ are substantially equivalent to predicate devices with regard to safety and effectiveness.
N/A