(175 days)
Not Found
No
The summary describes a standard X-ray fluoroscopic system and does not mention any AI or ML capabilities, image processing features, or performance metrics typically associated with AI/ML algorithms.
No
The device is a diagnostic imaging system (X-ray fluoroscopic image) used for real-time positioning and monitoring in surgical procedures, not for therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "diagnostic system" and that its purpose is to "take a range of diagnostic exposures."
No
The device description explicitly states it is a "mobile digital X-ray G-Arm diagnostic system" and details hardware components like "X-ray tube assemblies and Image Intensifiers." This indicates it is a hardware device that likely includes software for control and image processing, but it is not solely software.
Based on the provided information, the DigiArc 100AU is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The intended use and device description clearly state that the DigiArc 100AU is used to generate X-ray fluoroscopic images of a patient's body parts (spinal column, chest, abdomen, extremities, etc.). It directly interacts with the patient, not with samples taken from the patient.
- The device description focuses on imaging technology. The description details the X-ray tube assemblies, image intensifiers, and their function in generating images. This is characteristic of medical imaging devices, not IVD devices.
- The intended use is for diagnostic imaging and real-time monitoring during surgery. This aligns with the function of an X-ray system used in a clinical setting for visualizing internal structures, not for analyzing biological samples.
Therefore, the DigiArc 100AU is a medical imaging device, specifically a mobile digital X-ray G-Arm system, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OXO
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 component.
control unit
Main monitor
Control monitor
Control panel
G-Arm
Image intensifier assembly
X-ray tube assembly
Foot switch subassembly
Printer (optional)
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
at least eighteen
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)
Non-clinical testing: The subject device has been tested to compliance to the following safety and performance standards: IEC 60601-1: 2005, IEC 60601-1-2:2007, IEC 60601-1-3:2008, IEC 60601-2-28:2010, IEC 60601-2-54:2009. And also the subject device meets the provisions of Digital Imaging communications in Medicine (DICOM)
Clinical testing: Clinical images evaluation was performed for each X-Ray generator and image intensifier which was considered as a critical component of verification and validation.
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 & clinical demonstrates that the subject device DigiArc 100AU is as safe and effective as the predicate devices.
software validation and images assessment for simultaneous imaging have been done by the manufacturer, and the results demonstrate that the subject device meet the requirement of intended use and clinical use.
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.
0
K131423
page 1 of 6
WHALE:
510(k) Summary of Safety and Effectiveness
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
NOV
07 2013
September 30th 2013
2. Submitter's Information [21 CFR807.92 (a) (1)]
Name of Sponsor: Beijing East Whale Imaging Technology Co., Ltd.
Address: No.2 Workshop Building 2,No.9 KeChuang2 Street, Beijing
Economy Technology Exploitation Section
Beijing,China,100023, China
Contact Name: Better Li
Telephone No.: + 86 (10) 67892701- 838
- 86 (10) 67892580 Fax No.:
Email Address: jqli@whaleimaging.com
- Trade Name, Common Name, Classification [21 CFR807.92(a)(2)]
Trade Name: DigiArc 100AU
G-Arm MultiScan System Common Name:
Image-intensified fluoroscopic X-ray system Classification:
Product code: ОХО
Classification Panel: Radiology
510(k) Summary of Safety and Effectiveness
4-1
1
Device Class: ll
| 510(k)
| Number | K120613 | K911739 |
|---|---|---|
| Applicant | GE Healthcare Surgery | SEEMAC REISON AB |
| CO. | ||
| Device | ||
| Name | OEC 9900 Elite | SWEMAC REISON |
| BIPLANAR 300 |
-
- Identification of Predicate Device(s) [21 CFR 807.92(a)(3)}
5. Description of the Device [21 CFR 807.92(a)(4)]
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 component.
Table 1- Primary components list
510(k) Summary of Safety and Effectiveness
2
WHALE"
510(k) Submission
| Component | Quantity |
|---|---|
| Control unit | 1 |
| Main monitor | 2 |
| Control monitor | 1 |
| Control panel | 1 |
| G-Arm | 1 |
| Image intensifier assembly | 2 |
| X-ray tube assembly | 2 |
| Foot switch subassembly | 1 |
| Printer (optional) | 1 |
6. Intended Use [21 CFR 807.92(a)(5)]
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.
510(k) Summary of Safety and Effectiveness
4-3
3
7. Technological Characteristics [21 CFR 807.92(a)(6)]
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 subject device and predicate device
| Item | OEC 9900 Elite
(K120613) | SWEMAC REISON
BIPLANAR 300
(K911739) | DigiArc 100AU
( K131423 ) | Note |
|----------------------------------------------------|-----------------------------|--------------------------------------------|---------------------------------------------|--------|
| G-arm/C-arm | C arm | G arm | G arm | Note 1 |
| Operation of the
two sets of
imaging systems | -- | Operate separately
only | Operate
simultaneously
and separately | Note 2 |
510(k) Summary of Safety and Effectiveness
4
Note1: Image gantry of DigiArc 100AU is referred to as " G-Arm" because of its " G" shaped gantry, compare to the C-arm, there are some mechanical differences, but the differences do not impact the electrical safety and image performance of the device. And the G-arm has passed all the tests in according to IEC 60601-1:2005.
Note 2: There is no international standard special for the function of simultaneous imaging, however, the DigiArc 100AU employs the same imaging concepts and fundamental scientific technology with the predicate devices, standards (IEC 60601-1: 2005 & IEC 60601-1-2:2007 & IEC 60601-1-3:2008 & IEC 60601-2-28:2010 & IEC 60601-2-54:2009 ) that apply to predicate devices also apply to the DigiArc 100AU, the DigiArc 100AU has passed all the tests in according to those standards which ensure that there is no safety and performance issue rasied. Besides, software validation and images assessment for simultaneous imaging have been done by the manufacturer, and the results demonstrate that the subject device meet the requirement of intended use and clinical use.
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 & clinical demonstrates that the subject device
510(k) Summary of Safety and Effectiveness
4-5
5
510(k) Submission
K131423
Page 6 of 6
HALE
DigiArc 100AU is as safe and effective as the predicate devices.
Non-clinical testing
The subject device has been tested to compliance to the following safety and performance standards:
IEC 60601-1: 2005
IEC 60601-1-2:2007
IEC 60601-1-3:2008
IEC 60601-2-28:2010
IEC 60601-2-54:2009
And also the subject device meets the provisions of Digital Imaging communications in Medicine (DICOM)
Clinical testing:
Clinical images evaluation was performed for each X-Ray generator and image intensifier which was considered as a critical component of verification and validation.
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 & clinical testing 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.
510(k) Summary of Safety and Effectiveness
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 7, 2013
Beijing East Whale Imaging Technology Co., Ltd. % Better Li No. 2 Workshop Bldg 2, No. 9 KeChuang 2 Street Beijing Economy Technology Exploitation Section Beijing, 100023 CHINA
Re: K131423
Trade/Device Name: G-Arm MultiScan System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OXO Dated: October 14, 2013 Received: October 22, 2013
Dear Better 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
Image /page/6/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles an abstract human figure.
7
Page 2- Better Li
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.inm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (2) 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 Small Manufacturers, International and Consumer Assistance 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,
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
8
510(k) submission
WHALE
Indications for Use
510(k) Number (if known): theprocess K131423
Device Name: G-Arm MultiScan System
Indications for Use: 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
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)
fm.7)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K131423 210(k)
Page 1 of 1
Indications for Use
ર-1