Not Found
No
The summary describes a standard mobile digital X-ray system with various operational modes and positioning features. There is no mention of AI, ML, or any related concepts like deep learning, neural networks, or algorithms that learn from data. The "image process" mentioned is likely standard digital image processing techniques common in X-ray systems, not AI/ML-based analysis.
No
The device is described as a "digital X-ray diagnostic system" intended to "generate X-ray fluoroscopic image of a patient" for "real-time positioning and monitoring operations" and "diagnostic exposures." Its primary function is imaging for diagnosis and guidance, not direct therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The B6 is a mobile digital X-ray diagnostic system" and that it "permits a qualified doctor or technologist to take a range of diagnostic exposures."
No
The device description clearly outlines numerous hardware components including X-ray tube assemblies, Image Intensifiers, monitors, a keyboard, footswitch, and a G-Arm system with motor-driven positioning features. This is a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The B6 is a mobile digital X-ray diagnostic system that generates X-ray fluoroscopic images of a patient. It directly interacts with the patient's body to produce images, rather than analyzing samples taken from the body.
- Intended Use: The intended use clearly states it's for generating X-ray fluoroscopic images of a patient for real-time positioning and monitoring operations and taking diagnostic exposures of various body parts. This is a form of in vivo (within the living body) diagnostic imaging.
The device's function and intended use align with medical imaging devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The B6 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 B6 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.
Product codes (comma separated list FDA assigned to the subject device)
OXO, JAA
Device Description
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 B6 is comprised of control unit and G-Arm, the control unit and G-Arm include below primary components.
Control Unit Major Component:
Viewing monitor (Qty. 2)
Control monitor (Qty. 1)
Keyboard (Qty. 1)
Footswitch (3- or 2- pedal) (Qty. 1)
Printer (optional) (Qty. 1)
G-Arm Major Component:
Image intensifier assembly (Qty. 2)
X-Ray tube assembly (Qty. 2)
Laser light indicator (Qty. 2)
The G-Arm system offers a group of motor-driven positioning features, including:
Image Intensifier Adjustment: 300 mm±10mm
G-Arm Height Adjustment: 300 mm±10mm
G-Arm Orbital Rotation: +35°+2°
G-Arm Radial Rotation: ±45°±2°
The B6 can be operated in two different modes: Continuous fluoroscopy and Pulse fluoroscopy. Each of these two modes can be operated either manually or automatically.
So, the fluoroscopy mode can be categorized by the X-ray emitting pattern or by the control method of the imaging process, which consequently divides a fluoroscopy mode into the following four major types: Automatic Continuous Fluoroscopy, Automatic Pulse Fluoroscopy, Manual Pulse Fluoroscopy, Manual Continuous Fluoroscopy.
Besides the above four fundamental fluoroscopy modes, the G-Arm system offers two other features: ER Fluoroscopy and Half Dose Fluoroscopy (modifies only Automatic Pulse Fluoroscopy and Automatic Continuous Fluoroscopy modes)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray fluoroscopic image
Anatomical Site
spinal column, chest, abdomen, extremities, and other body parts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified doctor or technologist / trauma surgery, orthopedics, spine surgery, and chest surgery
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed to demonstrate compliance with safety and performance standards:
- AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009(R)2012 And A2:2010/(R)2012 (34 testing items listed, all passed)
- IEC 60601-1-2 Edition 3:2007-03 (8 testing items listed, all passed)
- IEC 60601-1-3 Edition 2.1:2013-04 (4 testing items listed, all passed)
- IEC 60601-2-54 Edition 1.1: 2015-04 (4 testing items listed, all passed)
The device also meets the provisions of Digital Imaging communications in Medicine (DICOM).
Software testing (18 items listed, all passed) was performed, including: Function of Main Control Panel Software, Function of main interface, Function of patient list, Function of image process, Function of save as, Function of print, Function of system settings, Function of on-line processing settings, Function of DICOM settings, Function of DICOM server, Others function, Long Time Exposure, High Dose Exposure, Pulse Exposure, CAN bus communication, Laser Aimer Control Test, Function of Movement control Panel Software, Function of G-ARM Control Panel Software.
Results indicate conformance to all applicable standards recognized by FDA and that the proposed device B6 is as safe and effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
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.(b)
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 4, 2017
Beijing East Whale Imaging Technology Co., Ltd. % Ms. Sharon Fan Regulatory Affairs Manager Unit 701, Building 1, Yongchang Industrial Park No. 3 Yongchang North Rd., BDA Beijing, 100176 CHINA
Re: K163429 Trade/Device Name: B6 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OXO, JAA Dated: November 22, 2016 Received: December 7, 2016
Dear Ms. 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.
1
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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D'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
2
Indications for Use
510(k) Number (if known) K163429
Device Name B6
Indications for Use (Describe)
The B6 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 B6 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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013_510(k) Summary of Safety and Effectiveness
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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)]
Nov 22th, 2016
2. Submitter's Information [21 CFR807.92 (a) (1)]
| Name of Sponsor: | Beijing East Whale Imaging Technology Co., Ltd. |
|---|---|
| Address: | Unit 701, Building 1, Yongchang Industrial Park, No. 3 Yongchang North Rd., BDA, |
| 100176, Beijing, China. | |
| Contact Name: | Sharon Fan |
| Telephone No.: | + 86 (10) 67896701- 8058 |
| Fax No.: | + 86 (10) 67082218 |
| Email Address: | fanxiaoyan@whaleimaging.com |
3. Trade Name, Common Name, Classification [21 CFR807.92(a)(2)]
| Trade Name: | B6 |
|---|---|
| Common Name: | MultiScan G-Arm System |
| Classification: | Image-intensified fluoroscopic X-ray system |
| Product code: | OXO&JAA |
| Regulation Number: | 21 CFR 892.1650 |
| Classification Panel: | Radiology |
| Device Class: | II |
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[
Table 1- Predicate Devices
| 510(k) Number | K160984 |
|---|---|
| Applicant | Beijing East Whale Imaging Technology Co., Ltd. |
| Device Name | MultiScan G-Arm System |
5
5. Description of the Device [21 CFR 807.92(a)(4)]
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 B6 is comprised of control unit and G-Arm, the control unit and G-Arm include below primary components.
| Control Unit Major Component | Qty. |
|---|---|
| Viewing monitor | 2 |
| Control monitor | 1 |
| Keyboard | 1 |
| Footswitch (3- or 2- pedal) | 1 |
| Printer(optional) | 1 |
Table 2-1 control unit Primary components list
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 | 2 |
The G-Arm system offers a group of motor-driven positioning features, including:
- lmage Intensifier Adjustment: 300 mm±10mm
- G-Arm Height Adjustment: 300 mm±10mm
G-Arm Orbital Rotation: +35°+2°
- G-Arm Radial Rotation: ±45°±2°
- 510(k) Summary of Safety and Effectiveness
6
The B6 can be operated in two different modes: Continuous fluoroscopy and Pulse fluoroscopy. Each of these two modes can be operated either manually or automatically.
So, the fluoroscopy mode can be categorized by the X-ray emitting pattern or by the control method of the imaging process, which consequently divides a fluoroscopy mode into the following four major types: Automatic Continuous Fluoroscopy, Automatic Pulse Fluoroscopy, Manual Pulse Fluoroscopy, Manual Continuous Fluoroscopy.
Besides the above four fundamental fluoroscopy modes, the G-Arm system offers two other features: ER Fluoroscopy and Half Dose Fluoroscopy (modifies only Automatic Pulse Fluoroscopy and Automatic Continuous Fluoroscopy modes)
6. Intended Use [21 CFR 807.92(a)(5)]
The B6 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 B6 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
B5 S | Subject Device
B6 | SE
Remark |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| K# | K160984 | In process | --- |
| Applicable
Standard | AAMI / ANSI ES60601-1
IEC60601-1-2
IEC60601-1-3
IEC60601-2-54 | AAMI / ANSI ES60601-1
IEC60601-1-2
IEC60601-1-3
IEC60601-2-54 | Same |
| Power apply | 110/120VAC±10%, 50/60Hz | 110/120VAC±10%, 50/60Hz | Same |
| Energy
delivered | X-Ray and laser | X-Ray and laser | same |
| Primary
components | Image gantry + X-ray tube + image
intensifier +view monitor + control
monitor + footswitch | Image gantry + X-ray tube + image
intensifier +view monitor + control
monitor + footswitch | Same |
| Mobile or
stationary | Mobile | Mobile | Same |
| Fluoroscopy
Mode | Manual Continuous Fluoroscopy
Automatic Continuous Fluoroscopy
Manual Pulse Fluoroscopy
Automatic Pulse Fluoroscopy
ER Fluoroscopy (ER)
Half Dose Fluoroscopy | Manual Continuous Fluoroscopy
Automatic
Continuous
Fluoroscopy
Manual Pulse Fluoroscopy
Automatic Pulse Fluoroscopy
ER Fluoroscopy (ER)
Half Dose Fluoroscopy | Same |
| Design | | | |
| Appearance
design | Appearance of B5 S see the figure 1
of "012_ Substantial Equivalence
Device Comparison.pdf" | Appearance of B6 see figure 2
of "012_ Substantial Equivalence
Device Comparison.pdf" | Note 1 |
| Electrical
structure | The circuits regarding to Inverter,
switch power supply, a part of PCB in
the control unit side.
The control panel only in the control
unit side . | The circuits regarding to Inverter,
switch power supply, a part of PCB
in the G-Arm side.
The control panel both in the
control unit and G-Arm, but the
control panel in the G-Arm side
cannot control exposure. | Note 2 |
| Constitute and structure | | | |
| Tracking
wheel system | Optional | Tracking wheels is integrated in
the base of G-Arm. | Note 3 |
| Function and performance | | | |
| Manual Continuous Fluoroscopy
kV: 40–120, step: 1kV
mA: 0.1–8.0, step: 0.1 mA | Manual Continuous Fluoroscopy
kV: 40–120, step: 1kV
mA: 0.2–8.0, step: 0.1 mA | | |
| Automatic Continuous Fluoroscopy
kV: 40–120, step: 1kV
mA: 7.0mA | Automatic Continuous
Fluoroscopy
kV: 40–120
mA: 0.2–7.0 | | |
| Manual Pulse Fluoroscopy
kV: 40–120, step: 1kV
mA: 0.1–8.0, step: 0.1 mA | Manual Pulse Fluoroscopy
kV: 40–120, step: 1kV
mA: 0.1–15.0 (1-plane
imaging)/8.0mA (2-plane
imaging), step: 0.1 mA | | |
| Ranges of
loading
factors | Automatic Pulse Fluoroscopy
kV: 40–120, step: 1kV
mA: 8.0mA | Automatic Pulse Fluoroscopy
kV: 40–120, step: 1kV
mA: 0.1–15.0 (1-plane
imaging)/8.0mA (2-plane imaging) | Note 4 |
| | ER Fluoroscopy
kV: min40, max120
mA : 8.0mA | ER Fluoroscopy
kV: min40, max120
mA : 8.0mA | |
| | Half automatic continuous
fluoroscopy:
kV: 40–120, step: 1kV
mA: 3.5mA | Half dose automatic continuous
fluoroscopy:
kV: 40-120, step: 1kV
mA: 0.2-3.5mA | |
| | Half automatic pulse fluoroscopy:
kV: 40–120, step: 1kV
mA: 7.5mA | Half dose automatic pulse
fluoroscopy:
kV: 40–120, step: 1kV
mA: 0.2–7.5mA | |
| | movement | G-Arm Orbital rotation | |
| | | G-Arm radial rotation | |
| | G-Arm lift distance | 300 mm±10 mm | 300 mm±10 mm |
| | I.I. unit travel distance | 300 mm±5mm | 300 mm±10mm |
| | Movement control | Control keys on the control panel in the control unit. | Control keys on the line control in the G-Arm. |
| | | | |
| | | The G-Arm's orbital rotation is driven by DC motor. | The G-Arm's orbital and radial rotation are driven by servo motor. |
| Physical Characteristics | | | |
| SID | 890-1190mm | 800-1100mm | |
| dimension | G-Arm:
2116(min L)/ 2324(max L) x 910 (W)
x1950(min H)/ 2550(max H) | G-Arm:
2520(min L)/ 2820(max L) x 910 (W) x 1876(min H)/ 2476(max H) | Note 6 |
| | | | |
| | Control unit:
864 (L) x 1110 (W) x 1873(H) | Control unit:
904(L) x 1010 (W) x 1760(H) | |
| | | | |
| Weight | G-arm: ≈365 kg (with tracking wheel system) | G-Arm: ≈ 520 kg | |
| | Control Unit≈ 235 kg | Control Unit: ≈ 150 kg | |
| | Whole Product Gross Weight: 600 kg(with tracking wheels) | Whole Product Gross Weight: ≈ 670 kg | |
| | | | |
Table 3- Major similarities and differences between subject and predicate devices
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9
510(k) Submission
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 white square with a blue outline. Inside the square are two horizontal green bars. The logo appears to be for a company or organization named "WHALE".
Note1 - Appearance design
B6's appearance is more elegant and suitable for the electrical structure. This difference will not affect safety and effectiveness.
Note 2 - Electrical structure
In B6's electrical structure, only the circuit layout is changed, while the essential principle and components are the same as the predicate device. Adding additional control panel to the G-Arm base helps in better observation of the exposure conditions during surgery and more convenient adjustment of the loading factors. The image-intensifier has not been modified.
10
The B6 has passed all the tests in accordance to AAMI/ ANSI ES60601-1, IEC60601-1-2, IEC60601-3 and IEC60601-2-54. Therefore, this difference does not raise different questions of safety and effectiveness and that the device is as safe and effective as the predicate device.
Note 3 - Tracking wheel system
B5 S and B6 use different connection types in their tracking wheel systems. The tracking wheels of B6 are mechanically integrated with the G-Arm base, i.e., it is a part of base. The tracking wheel system of B5 S is optional. But the control principle and control process between B5 S and B6 are the same. The B6 has passed all the tests in accordance to AAMI/ ANSI ES60601-1, IEC60601-1-2, IEC60601-3 and IEC60601-2-54. Therefore, this difference does not raise different questions of safety and effectiveness and that the device is as safe and effective as the predicate device.
Note 4 - Ranges of loading factors
Loading factors of the B6 are controlled by the software, the software system has been well tested and validated. The B6 has passed all the tests in accordance to AAMI/ ANSI ES60601-1, IEC60601-1-2, IEC 60601-3 and IEC60601-2-54. Therefore, this change does not raise different questions of safety and effectiveness and that the device is as safe and effective as the predicate device.
Note 5 - Movement
Comparing with the movements of the predicate device, the B6 introduces the radial rotation of the G-Arm and the angle of the orbital rotation movement is changed from ±13° (B5 S) to ±35°±2°.
The G-Arm's orbital and radial rotations are driven by servo motor, which meets the requirements of the associated clauses of AASI/AAMI 60601-1, making the rotation control more accurately.
The movements control keys of B5 S are incorporated into the control panel, which is located on the control unit, while the B6's movements control keys are located on a separate movement control board (line control) on the G-Arm base. The control principle and electrical circuits between B5 S and B6 are the same. No new technology is introduced.
11
The B6 has passed all the tests in accordance to AAMI/ ANSI ES60601-1, IEC60601-1-2, IEC 60601-3 and IEC60601-2-54. Therefore, this change does not raise different questions of safety and effectiveness and that the device is as safe and effective as the predicate device.
Note 6 - SID & Dimension & Weight
The primary mechanical structure between predicate device and proposed device is the same. The differences with regard to the SID & Dimensions & Weight are resulted from different mechanical characteristic settings. No new technology is introduced. The B6 has passed all the tests in accordance to AAMI/ ANSI ES60601-1, IEC60601-1-2, IEC 60601-3, and IEC60601-2-54. Therefore, this difference does not raise different questions of safety and effectiveness.
The software modifications of proposed device have been verified and validated, the following table include the major changed elements.
| No. | Modified elements | section | Note |
|---|---|---|---|
| 1 | Separated the G-Arm's | ||
| movement from Main control | |||
| panel software | 2.2.2&4.2.1&4.2.5&4.2.6 | ||
| &4.5&5.3.1&5.5&6.5&9. | |||
| 1&9.4 | Better control | ||
| 2 | Single exposure time limit | 33# of 3.2 | User need |
| 3 | Use CAN bus communication | 36# of | |
| 3.2&5.1&6.1&9.2.4 | More stable and accurate | ||
| communication | |||
| 4 | Increase a G-Arm control panel in | ||
| the G-Arm side. | 4.2.3&4.2.4&5.4&6.4&6. | ||
| 5&9.5 | help doctor to better see the | ||
| exposure conditions and | |||
| adjust the loading factors | |||
| more convenience | |||
| 5 | Update dose report icon and | ||
| BMP image save icon | 4.3.1.3&4.3.1.7&9.1.2 | Enhance user experience |
Table 4- Major modifications of software
12
The B6 have the same technological characteristics as the predicate device except items in table3-Major similarities and differences between subject and predicate devices. However, the B6 employs the same imaging concepts and fundamental scientific technology with the predicate device and has 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 B6 indicate conformance to all applicable standards recognized by FDA for this device.
Testing result from non-clinical demonstrates that the proposed device B6 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
| No. | Testing items | Result |
|---|---|---|
| 1 | Power input | Pass |
| 2 | Humidity preconditioning treatment | Pass |
| 3 | Determination of applied parts and accessible parts | Pass |
| 4 | Legibility of markings | Pass |
| 5 | Durability of markings | Pass |
| 6 | ME equipment for connection to a power source by a plug | Pass |
| 7 | Internal capacitive circuits | Pass |
| 8 | Protective earth connection | Pass |
| 9 | Leakage currents | Pass |
| 10 | Dielectric strength | Pass |
| 11 | Ball pressure test | Pass |
| 12 | Measurement of creepage distance and air clearance | Pass |
| 13 | Cord anchorage | Pass |
| 14 | Gaps | Pass |
| 15 | Instability-overbalance in transport position | Pass |
| 16 | Instability-overbalance excluding transport position | Pass |
| 17 | Instability-overbalance from horizontal and vertical forces | Pass |
| 18 | Castors and wheels -force for propulsion | Pass |
| 19 | Castors and wheels -movement over a threshold | Pass |
| 20 | Instability from unwanted lateral movement in transport position | Pass |
| 21 | Instability from unwanted lateral movement excluding transport position | Pass |
| 22 | Audible acoustic energy | Pass |
| 23 | Support system | Pass |
| 24 | Maximum temperature during normal use | Pass |
| 25 | Spillage | Pass |
| 26 | Ingress of water or particulate matter | Pass |
| 27 | Cleaning | Pass |
| 28 | Interruption of the power supply/supply mains to ME equipment | Pass |
| 29 | Single fault conditions | Pass |
| 30 | Mechanical strength test | Pass |
| 31 | Transformer short circuit | Pass |
| 32 | Transformer overload test | Pass |
| 33 | Transformer dielectric strength test | Pass |
| 34 | ME system-leakage measurements | Pass |
Table 5-- Performed testing items of ANSI/AAMI ES60601-1
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Image /page/14/Picture/1 description: The image shows the word "WHALE" in large, bold, blue letters. To the right of the word is a small, white rectangle with rounded corners. Inside the rectangle are two horizontal green bars. The logo is simple and clean, with a focus on the company name.
- b) IEC 60601-1-2 Edition 3:2007-03
| No. | Testing items | Result |
|---|---|---|
| 1 | Mains terminal continuous disturbance voltage | Pass |
| 2 | Radiated emission | Pass |
| 3 | Electrostatic discharge | Pass |
| 4 | RF electromagnetic field immunity test | Pass |
| 5 | Fast transients on AC power line, signal line and interconnecting line | Pass |
| 6 | Injected current into AC power line, signal line and interconnecting line | Pass |
| 7 | Surges to AC power port, signal line and interconnecting line | Pass |
| 8 | Variations of power frequency | Pass |
c) IEC 60601-1-3 Edition 2.1:2013-04
Table 7--Performed testing items of IEC60601-1-3
| No. | Testing items | Result |
|---|---|---|
| 1 | Half-value layer | Pass |
| 2 | Focal spot to image receptor distance | Pass |
| 3 | Leakage radiation in the loading state | Pass |
| 4 | Leakage radiation when not in the loading state | Pass |
- d) IEC 60601-2-54 Edition 1.1: 2015-04
Table 8—Performed testing items of IEC 60601-2-54
| No. | Testing items | Result |
|---|---|---|
| 1 | Test for dosimetric information | Pass |
| 2 | Accuracy of X-ray tube voltage | Pass |
| 3 | Accuracy of X-ray tube current | Pass |
| 4 | Determining the attenuation of residual radiation | Pass |
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Also the proposed device meets the provisions of Digital Imaging communications in Medicine
(DICOM)
The proposed device has performed the following software testing to demonstrates that the proposed
device B6 is as safe and effective as the predicate devices
| No. | Testing items | Result |
|---|---|---|
| 1 | Function of Main Control Panel Software | Pass |
| 2 | Function of main interface | Pass |
| 3 | Function of patient list | Pass |
| 4 | Function of image process | Pass |
| 5 | Function of save as | Pass |
| 6 | Function of print | Pass |
| 7 | Function of system settings | Pass |
| 8 | Function of on-line processing settings | Pass |
| 9 | Function of DICOM settings | Pass |
| 10 | Function of DICOM server | Pass |
| 11 | Others function | Pass |
| 12 | Long Time Exposure | Pass |
| 13 | High Dose Exposure | Pass |
| 14 | Pulse Exposure | Pass |
| 15 | CAN bus communication | Pass |
| 16 | Laser Aimer Control Test | Pass |
| 17 | Function of Movement control Panel Software | Pass |
| 18 | Function of G-ARM Control Panel Software | Pass |
Table 9- software testing items
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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 B6
is substantially equivalent to predicate devices with regard to safety and effectiveness.