(25 days)
Definium Pace Select (K231892)
No
The summary describes a standard digital radiography system with motorized components and image processing capabilities, but there is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is intended for generating diagnostic radiographic images, not for treating conditions or diseases.
Yes
Explanation: The "Intended Use / Indications for Use" section states the device is intended to "generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages," and the "Device Description" mentions that the system "generates diagnostic radiographic images." Imaging to generate diagnostic images is a core function of a diagnostic device.
No
The device description explicitly lists multiple hardware components including a tube stand, wall stand, X-ray generator, wireless access point, wireless detectors, and an acquisition workstation. This is not a software-only device.
Based on the provided information, the Definium Pace Select ET is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for generating digital radiographic images of various body parts in patients. This is an in-vivo imaging procedure, meaning it's performed on a living organism (the patient).
- Device Description: The description details an X-ray system with components like a tube stand, wall stand, generator, and detectors. These are all components of an imaging system used to capture images of the inside of the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any interaction with biological specimens.
Therefore, the Definium Pace Select ET is a medical imaging device, specifically a digital radiography system, and not an IVD.
N/A
Intended Use / Indications for Use
The Definium Pace Select ET is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and the system is intended for use in all routine radiography exams. Optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. This device is not intended for mammographic applications.
Product codes
KPR, MQB
Device Description
The Definium Pace Select ET Radiography X-ray System is designed as a modular system with components that include a 2-axis motorized tube stand with tube and auto collimator assembled on an elevating table, a motorized wall stand, a cabinet with X-ray high voltage generator, a wireless access point, wireless detectors, an acquisition workstation including a monitor and control box with hand-switch. The system generates diagnostic radiographic images which can be reviewed or managed locally and sent through a DICOM network for reviewing, storage and printing.
By leveraging platform components / design, Definium Pace Select ET is similar to the predicate Definium Pace Select (K231892) and the reference Discovery XR656 HD (K191699) with regards to the user interface layout, patient worklist refresh and selection, protocol selection, image acquisition, and image processing based on the raw image. This product introduces motorized tube stand (vertical and tube angulation) instead of manual tube stand of the predicate. The high voltage generator is new and is backwards compatible to the predicates high voltage generator. This product also introduced Image Pasting on Table and Wall Stand Mode, Auto tracking for Wall Stand, Auto Angulation, Camera Workflow, DAP software calculation, Siemens LED collimator and LCD touch screen console. The other minor changes include updates to components due to obsolescence.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
skull, spinal column, chest, abdomen, extremities, and other body parts
Indicated Patient Age Range
All ages
Intended User / Care Setting
Professional Use Only
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)
Summary of Non-Clinical Tests:
The following quality assurance measures were applied to the development of Definium Pace Select ET system:
-
- Risk Analysis
-
- Requirements Reviews
-
- Design Reviews
-
- Testing on unit level (Module verification)
-
- Integration testing (System verification)
-
- Performance testing (Verification)
-
- Safety testing (Verification)
-
- Simulated use testing (Validation)
Definium Pace Select ET verification and validation testing was performed to confirm that the safety and effectiveness of the device has not been affected. The test plans and results have been executed with acceptable results.
Summary of Clinical testing:
The Definium Pace Select ET does not contain clinical testing data.
Conclusion:
The results of the testing described above demonstrate that the Definium Pace Select ET is as safe and effective as the predicate device and supports a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Definium Pace Select (K231892)
Reference Device(s)
Discovery XR656 HD with VolumeRad (K191699)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 1, 2024
GE Hualun Medical Systems Co., Ltd % Kenny Ma Manager, Regulatory Affairs - WHXR No.1, Yong Chang North Road, Beijing Economic Technological Development Zone Beijing, 100176 CHINA
Re: K242678
Trade/Device Name: Definium Pace Select ET Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB Dated: September 3, 2024 Received: September 6, 2024
Dear Kenny Ma:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Definium Pace Select ET
Indications for Use (Describe)
The Definium Pace Select ET is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and the system is intended for use in all routine radiography exams. Optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. This device is not intended for mammographic applications.
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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510K Summary Definium Pace Select ET
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510(k) Summary:
In accordance with 21 CFR 807.92 the following summary information is provided:
| Date: | September 6, 2024 |
|---|---|
| Owner/Submitter: | |
| 21 CFR 807.92(a)(1) | GE Hualun Medical Systems Co., Ltd. |
| No.1, Yong Chang North Road, Beijing Economic Technological Development Zone, 100176 Beijing P.R. China | |
| Primary Contact | |
| Person: | Kenny Ma |
| Manager, Regulatory Affairs, WHXR | |
| GE Hualun Medical Systems Co., Ltd. | |
| Email: Kenny.Ma@gehealthcare.com | |
| Contact Phone Number: +86 (181) 01130591 | |
| Secondary Contact | |
| Person: | Christopher Paulik |
| Senior Regulatory Affairs Manager | |
| GE HealthCare (GE Medical Systems, LLC) | |
| Email: Christopher.A.Paulik@gehealthcare.com | |
| Contact Phone Number: +1 (262) 8945415 | |
| Device Trade Name: | |
| 21 CFR 801.92(a)(2) | Definium Pace Select ET |
| Common/Usual | |
| Name: | Digital Radiographic System |
| Regulation Name: | Stationary X-Ray System |
| Regulation: | 21 CFR 892.1680 |
| Classification: | Class II |
| Product Code: | KPR |
| Subsequent Product | |
| Code(s): | MQB |
| Predicate Device: | |
| 21 CFR 807.92(a)(3) | Definium Pace Select (K231892) |
| 21CFR 892.1680 (KPR, MQB) | |
| Class 2 | |
| Predicate Device | |
| Manufacturer | GE Hualun Medical Systems Co., Ltd. |
| No.1, Yong Chang North Road, Beijing Economic Technological Development Zone, | |
| 100176 Beijing P.R. China | |
| Reference Device: | Discovery XR656 HD with VolumeRad (K191699) |
| 21CFR 892.1680 (KPR, MQB) | |
| Class 2 | |
| Reference Device | |
| Manufacturer: | GE Hualun Medical Systems Co., Ltd. |
| No.1, Yong Chang North Road, Beijing Economic Technological Development Zone, | |
| 100176 Beijing P.R. China | |
| Device Description: | |
| 21 CFR 807.92(a)(4) | The Definium Pace Select ET Radiography X-ray System is designed as a modular |
| system with components that include a 2-axis motorized tube stand with tube and | |
| auto collimator assembled on an elevating table, a motorized wall stand, a cabinet | |
| with X-ray high voltage generator, a wireless access point, wireless detectors, an | |
| acquisition workstation including a monitor and control box with hand-switch. The | |
| system generates diagnostic radiographic images which can be reviewed or | |
| managed locally and sent through a DICOM network for reviewing, storage and | |
| printing. |
By leveraging platform components / design, Definium Pace Select ET is similar to
the predicate Definium Pace Select (K231892) and the reference Discovery XR656
HD (K191699) with regards to the user interface layout, patient worklist refresh and
selection, protocol selection, image acquisition, and image processing based on the
raw image. This product introduces motorized tube stand (vertical and tube
angulation) instead of manual tube stand of the predicate. The high voltage
generator is new and is backwards compatible to the predicates high voltage
generator. This product also introduced Image Pasting on Table and Wall Stand
Mode, Auto tracking for Wall Stand, Auto Angulation, Camera Workflow, DAP
software calculation, Siemens LED collimator and LCD touch screen console. The
other minor changes include updates to components due to obsolescence. |
| Indications for Use:
21 CFR 807.92(a)(5) | The Definium Pace Select ET is intended to generate digital radiographic images
of the skull, spinal column, chest, abdomen, extremities, and other body parts in
patients of all ages. Applications can be performed with the patient sitting,
standing, or lying in the prone or supine position and the system is intended for
use in all routine radiography exams. Optional image pasting function enables the
operator to stitch sequentially acquired radiographs into a single image. |
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Image /page/6/Picture/2 description: The image shows the GE HealthCare logo. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is purple and features a stylized "GE" monogram. The text "GE HealthCare" is also purple and is written in a clean, sans-serif font.
are
This device is not intended for mammographic applications.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE: 21CFR807.92(a)(6)
A comparison of the indications for use and technological features of the subject and predicate device is provided in Table 1 below.
| Specification | Predicate Device
Definium Pace Select | Subject Device
Definium Pace Select ET | Discussion of
Differences |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | General Purpose Digital
Radiographic Imaging System | General Purpose Digital
Radiographic Imaging System | Identical |
| Indications for
Use | The Definium Pace Select is
intended to generate digital
radiographic images of the
skull, spinal column, chest,
abdomen, extremities, and
other body parts in patients of
all ages. Applications can be | The Definium Pace Select ET is
intended to generate digital
radiographic images of the
skull, spinal column, chest,
abdomen, extremities, and
other body parts in patients of
all ages. Applications can be | Equivalent
The optional image
pasting function has
been cleared in the
reference product
Discovery XR656 HD
under K191699. |
| Specification | Predicate Device
Definium Pace Select | Subject Device
Definium Pace Select ET | Discussion of
Differences |
| | performed with the patient
sitting, standing, or lying in the
prone or supine position and
the system is intended for use
in all routine radiography
exams.
The device is not intended for
mammographic applications. | performed with the patient
sitting, standing, or lying in the
prone or supine position and
the system is intended for use
in all routine radiography
exams. Optional image pasting
function enables the operator
to stitch sequentially acquired
radiographs into a single
image.
The device is not intended for
mammographic applications. | |
| Contraindications | None . | None . | Identical |
| User group | Professional Use Only | Professional Use Only | Identical |
| Patient
Population | All ages | All ages | Identical |
| System Software
Architecture | Distributed software
architecture (Atlas) | Distributed software
architecture (Atlas) | Identical |
| Operator I/F | One-LCD monitor, Keyboard,
Mouse, Barcode reader | One-LCD monitor, Keyboard,
Mouse, Barcode reader | Identical |
| X-Ray Tube | Kailong 300kHU Tube: KL
H1080Y | Kailong 300kHU Tube: KL
H1080Y | Identical |
| Tube head
console | LED screen display | LCD touch screen console | Changed
Besides the previous
angle display. This
console provides
more positioner
information and
exposure parameter
display and
adjustment approach
from the exam room. |
| Collimator and
Auto FOV | Manual collimator
Manual FOV change and light
on/off | Siemens AL01CIIeL LED lamp
Manual and automatic FOV
change and light on/off | Changed
The device now
provides additional
automatic
collimation (Auto
FOV). |
| DAP | Physical DAP meter | DAP software calculation
based on FOV and SID
measured by Encoder after
Dose calibration | Changed
The system now
automatically
calculates the DAP
instead of providing a
physical
measurement. |
| Specification | Predicate Device
Definium Pace Select | Subject Device
Definium Pace Select ET | Discussion of
Differences |
| Camera Workflow | None | The depth camera provides
workflow improvement:
- Live video on main UI
- Patient size suggestion
based on camera depth
measurement; - Detector and ion chamber
outline on video; - FOV adjustable from video | New
This new feature
provides additional
observation for
patient positioning. |
| High Voltage
Generator | - Jedi 80 RD 1T
- 50KW or 65KW or 80kW | - PSG-HR80S5
- 50KW or 65KW or 80kW | Equivalent
Same function,
different supplier |
| DICOM | DICOM 3.0 | DICOM 3.0 | Identical |
| OS | Linux OS - SUSE | Linux OS - SUSE | Identical |
| Detector | IRAY
17x17 detector US (K210314) | IRAY
17x17 detector US (K210314) | Identical |
| Detector Wireless
Connectivity | YES – 802.11 wireless (Personal
Area Network) | YES – 802.11 wireless (Personal
Area Network) | Identical |
| Detector size/
resolution | One detector Size supported at
100 um resolutions:
17 x 17 inch | One detector Size supported at
100 um resolutions:
17 x 17 inch | Identical |
| Detector loading | 300kg (distributed loading)
150kg (point loading) | 300kg (distributed loading)
150kg (point loading) | Identical |
| Patient Table | Fixed table height 66cm
220 kg static non-elevating
table
Longitudinal travel 900mm
Transversal travel 220mm | Elevating range 59 – 90 cm
Maximum Loading 305kg
(672lbs)
Elevation speed