(104 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe features or components typically associated with AI/ML processing of medical images. The description focuses on the hardware components and basic functionality of a mobile digital X-ray system.
No
The device is described as a "mobile digital X-ray diagnostic system" intended to generate X-ray fluoroscopic images for diagnostic purposes, not for treating or curing a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The B5 S is a mobile digital X-ray diagnostic system" and that its application "permits a qualified doctor or technologist to take a range of diagnostic exposures."
No
The device description clearly outlines multiple hardware components including X-ray tube assemblies, Image Intensifiers, a control unit with monitors, keyboard, footswitch, and a G-Arm. This is a physical medical device that utilizes software for control and image generation, but it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The B5 S is an X-ray diagnostic system that generates images directly from the patient's body using X-rays. It does not analyze samples in vitro.
- Intended Use: The intended use is for generating X-ray fluoroscopic images for real-time positioning and monitoring during surgical procedures and for taking diagnostic exposures of various body parts. This is a form of in vivo imaging, not in vitro testing.
Therefore, the B5 S falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The B5 S is a mobile digital X-ray diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning 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.
Product codes
OXO, JAA
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).
Mentions image processing
Not Found
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
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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)
Device Name MultiScan G-Arm System
Indications for Use (Describe)
The B5 S is a mobile digital X-ray diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning operations in trauma surgery, orthopedics, spine surgery, and chest surgery. It is not intended to be used in interventional procedures.
The B5 S permits a qualified doctor or technologist to take a range of diagnostic exposures of spinal column, chest, abdomen, extremities, and other body parts on the patients .
Type of Use (Select one or both, as applicable):
| ❌ 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 small, stylized logo. The logo is a white square with a blue outline, and inside the square are two green rectangles stacked on top of each other.
510(k) Summary of Safety and Effectiveness
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
May 17th 2016
2. Submitter's Information [21 CFR807.92 (a) (1)]
Name of Sponsor: Beijing East Whale Imaging Technology Co., Ltd.
Address: B2-2 New City Industrial Park, No.9 KeChuang 2nd St.,
YiZhuang, 100023, Beijing, China.
Contact Name: Sharon Fan
- 86 (10) 67892355- 8866 Telephone No.:
Fax No.: + 86 (10) 67082218
Email Address: 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 a mobile digital X-ray diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning and monitoring operations in trauma surgery, orthopedics, spine surgery, and chest surgery. It is not intended to be used in interventional procedures.
There are two sets of X-ray tube assemblies and Image Intensifiers which are perpendicularly distributed on the G-Arm, acting as two sets of vertical X-ray source and receptor systems and providing fluoroscopy image of the patient. The two sets of X-ray tube assemblies and Image Intensifiers can operate simultaneously and separately.
The B5 S is comprised of control unit and G-Arm, the control unit and G-Arm 510(k) Summary of Safety and Effectiveness 004-2
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Image /page/5/Picture/1 description: The image contains the word "WHALE" in large, bold, blue letters. To the right of the word is a stylized graphic that appears to be a lowercase "e" in blue, with a white square behind it. Inside the white square are two green rectangles.
include below primary components.
Table 2-1 control unit Primary components list
| Control Unit Major Component | Qty. |
|---|---|
| Viewing monitor | 2 |
| Exposure lamp | 2 |
| Control monitor | 1 |
| Keyboard | 1 |
| Footswitch subassembly | 1 |
| Printer(optional) | 1 |
Table 2-2 G-Arm Primary components list
| G-Arm Major Component | Qty. |
|---|---|
| Image intensifier assembly | 2 |
| X-Ray tube assembly | 2 |
| Laser light indicator(optional) | 2 |
| Steering unit (optional) | 1 |
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6. Intended Use [21 CFR 807.92(a)(5)]
The B5 S is a mobile digital X-ray diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning and monitoring operations in trauma surgery,
orthopedics, spine surgery, and chest surgery. It is not intended to be used in
interventional procedures.
The B5 S permits a qualified doctor or technologist to take a range of diagnostic exposures of spinal column, chest, abdomen, extremities, and other body parts on the patients.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
| Item | Predicate Device | Subject Device (B5 S) | Remark |
|---|---|---|---|
| Applicable | |||
| 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 |
| 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 |
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 blue, block letters. To the right of the word is a white square with a thin gray border. Inside the square are two green rectangles stacked on top of each other. The "E" in "WHALE" extends into the white square.
| Mobile or
| stationary | Mobile | Mobile | Same | ||
|---|---|---|---|---|---|
| Entrance | |||||
| Field Size of | |||||
| image | |||||
| intensifier | 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 kV | |||||
| Range of X-ray tube current: | |||||
| 0.1–15mA | |||||
| Manual Pulse Fluoroscopy | |||||
| kV: 40–120, step: 1kV | |||||
| mA: 0.1–15.0, step: 0.1 mA | Range of x-ray tube voltage: | ||||
| 40–120 kV | |||||
| Range of x-ray tube current: | |||||
| 0.1-8.0ma | |||||
| Manual Pulse Fluoroscopy | |||||
| kV: 40–120, step: 1kV | |||||
| mA: 0.1-8.0, step: 0.1 mA | SE | ||||
| Automatic Pulse Fluoroscopy | |||||
| kV:40–120, step: 1kV | |||||
| mA : fixed at 8.0mA(AP |