(76 days)
No
The document describes a standard digital radiographic system and does not mention AI, ML, or related terms. The "image processing with same algorithm" likely refers to conventional image processing techniques.
No
This device is an X-ray imaging system intended to generate diagnostic images, not to treat or alleviate a medical condition.
Yes
The device is intended to generate digital radiographic images to assist in medical diagnosis, which is a core function of a diagnostic device. The "Intended Use / Indications for Use" section explicitly states its purpose is to generate images of various body parts for "routine radiography exams," and the "Device Description" mentions it generates "diagnostic radiographic images."
No
The device description explicitly lists multiple hardware components (fixed table, tube-stand, wallstand, digital detector, X-ray tube, collimator, generator, acquisition workstation) that are part of the system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the product is for generating digital radiographic images of various body parts in patients. This is a diagnostic imaging device, not a device used to examine specimens derived from the human body (which is the definition of an IVD).
- Device Description: The description details a radiographic system with components like an X-ray tube, detector, and workstation. This aligns with the description of an imaging system, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This product is intended to generate digital radiographic images of the skull, spinal column, 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. This device is not intended for mammographic applications.
Product codes
KPR, MOB
Device Description
The Definium Pace Select is a Digital Radiographic System designed as a modular system with components that includes fixed table with tube-stand, wallstand, cleared wireless digital detector, X-ray tube, collimator, high kV generator and acquisition workstation in control room. The system generates diagnostic radiographic images which can be sent through a DICOM network for applications including printing, viewing, and storage. The components may be grouped into different configurations to meet specific customer needs.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital Radiographic
Anatomical Site
skull, spinal column, extremities, and other body parts
Indicated Patient Age Range
all ages
Intended User / Care Setting
Not Found
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
The subject of this premarket submission, Definium Pace Select, does not require clinical studies to support substantial equivalence for the introduction of the floor mounted positioners and updates to the image chain.
Design verification and validation testing was performed to confirm the safety and effectiveness of the device. The test plans and results have been executed with acceptable results.
Key Metrics
Not Found
Predicate Device(s)
Discovery XR656 HD clearance (K172869)
Reference Device(s)
Mars1717X Wireless Digital Flat Panel Detector (cleared in K210314)
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 12, 2023
GE Hualun Medical Systems Co. Ltd. % Miny Liu Regulatory Affairs Leader No. 1 Yong Chang North Road, Beijing Economic Technological Development Zone Beijing, Beijing 100176 CHINA
Re: K231892
Trade/Device Name: Definium Pace Select Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MOB Dated: June 5, 2023 Received: June 29, 2023
Dear Miny Liu:
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. 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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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-regulatoryassistance/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 Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231892
Device Name Definium Pace Select
Indications for Use (Describe)
This product is intended to generate digital radiographic images of the skull, spinal column, 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. 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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3
GE HealthCare
510(k) Premarket Notification Submission
Image /page/3/Picture/3 description: The image shows the logo for GE HealthCare. The logo consists of a circular emblem with a stylized "GE" monogram on the left, and the text "GE HealthCare" on the right. The emblem and text are both in a purple color. The logo is simple and modern, and it is likely used to represent the company's brand.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | Jun. 26, 2023 |
|---|---|
| Submitter: | 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: | Miny Liu |
| Regulatory Affairs Leader | |
| GE Hualun Medical Systems Co., Ltd. | |
| Contact Phone Number: +86 (173) 10313927 | |
| Email: liuminy@ge.com | |
| Secondary Contact Person: | Christopher Paulik |
| Senior Regulatory Affairs Manager | |
| GE HealthCare (GE Medical Systems, LLC) | |
| Contact Phone Number: +1 (262) 8945415 | |
| Email: christopher.a.paulik@ge.com | |
| Device Trade Name: | Definium Pace Select |
| Common/Usual Name: | Digital Radiographic System |
| Regulation, Classification Names: | |
| Product Code: | Regulation: 21CFR 892.1680 |
| Classification: Class II | |
| Regulation Name: Stationary X-Ray System | |
| Product Codes: KPR, MQB |
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Image /page/4/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of the GE monogram on the left and the words "GE HealthCare" on the right. The monogram and the words are both in purple.
| Predicate Device(s): | Discovery XR656 HD clearance (K172869). |
|---|---|
| Regulation: | 21CFR 892.1680 |
| Classification: | Class II |
| Regulation Name: | Stationary X-Ray System |
| Product Codes: | KPR, MQB |
| Legal Manufacturer Name: | GE Hualun Medical Systems Co., Ltd. |
| Device Description: | The Definium Pace Select is a Digital Radiographic System designed as a modular system with components that includes fixed table with tube-stand, wallstand, cleared wireless digital detector, X-ray tube, collimator, high kV generator and acquisition workstation in control room. The system generates diagnostic radiographic images which can be sent through a DICOM network for applications including printing, viewing, and storage. The components may be grouped into different configurations to meet specific customer needs. |
| Intended Use: | General Purpose Digital Radiographic Imaging System |
| Indication for Use: | This product 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. |
| This device is not intended for mammographic applications. |
| Technology: | The Definium Pace Select employs the same fundamental
scientific technology as its predicate device Discovery XR656 HD.
By leveraging platform components/design, it delivers a floor
mounted DR system with incremental changes. Technically,
Definium Pace Select is similar as Discovery XR656 HD from user
operation, i.e., patient worklist access, image acquisition, image
processing with same algorithm and image management with
DICOM compliance. New image chain components are
introduced, including a cleared wireless detector, tube and
collimator. Traditional floor mounted positioner is used, that
includes fixed table with tube Stand and wallstand. Definium
Pace Select has equivalent feature from risk and safety level by
comparation with Discovery XR656HD but removing advanced |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Determination of
Substantial Equivalence: | application Image pasting. These change from XR656 HD involves:
A cleared detector Mars1717X Wireless Digital Flat Panel Detector (cleared in K210314) is used. It has the same detector size 17"X17", pixel size 100um and same 802.11 wireless technology as the predicate The tube support is changed. It uses traditional floor mounted tube support instead of Overhead Suspend tube support. The tube support and positioning is equivalent to the predicate. The patient table is changed. The Definium Pace Select uses a traditional fixed non-elevating table. The patient support function is equivalent to the predicate. A new X-ray tube is used. It has equivalent functionality with same kV range and slight differences in target angle and focal spot and HU capability A new manual collimator is used. It has equivalent functionality with the predicate collimator. Wall stand is changed. The manual Wall Stand function it provides is equivalent to the predicate. The indication for use is the equivalent with its predicate product. The only difference is the removal of the “image pasting option” (removing an optional feature). No functionalities are added, and the intended use and patient population remains unchanged. Summary of Non-Clinical Tests:
The Definium Pace Select and its applications comply with voluntary standards.
ES 60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 60601-1-2:2014[Including AMD 1:2021], Edition 4.1 |
| | Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance -
Collateral Standard: Electromagnetic disturbances -
Requirements and tests |
| ● | IEC 60601-1-3: 2021, Edition 2.2 |
| | Medical Electrical Equipment - Part 1-3: General
Requirements for Basic Safety and Essential Performance -
Collateral Standard: Radiation Protection in Diagnostic X-
Ray Equipment |
| ● | IEC 60601-1-6: 2020, Edition 3.2 |
| | Medical electrical equipment - Part 1-6: General
requirements for safety - Collateral Standard: Usability |
| ● | IEC 60601-2-54: 2018, Edition 1.2 |
| | Medical Electrical Equipment - Part 2-54: Particular
Requirements for The Basic Safety and Essential
Performance of X-Ray Equipment for Radiography and
Radioscopy |
| ● | IEC 62366: 2015 + AMD1:2020 |
| | Medical devices Part 1: Application of usability engineering
to medical devices, including Amendment 1 |
| ● | ISO 10993-1: 2018 |
| | Biological evaluation of medical devices - Part 1: Evaluation
and testing within a risk management process |
| ● | ISO 10993-5: 2009/(R)2014 |
| | Biological evaluation of medical devices - Part 5: Tests for in
vitro cytotoxicity |
| ● | ISO 10993-10: 2010/(R)2014 |
| | Biological evaluation of medical devices - Part 10: Tests for
irritation and skin sensitization |
| ● | ISO 10993-18 Second edition 2020-01 |
| Biological evaluation of medical devices - Part 18: Chemical
characterization of medical device materials within a risk
management process | |
| • PS 3.1 - 3.20: 2022d | |
| Digital Imaging and Communications in Medicine (DICOM)
set | |
| The following quality assurance measures were applied to the
development of the 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) | |
| The risks were evaluated for the newly introduced floor
mounted positioners and image chain. These risks were
reviewed and mitigated with design controls and labeling. The
mitigations were verified and validated as a part of the design
verification and validation testing that has been executed with
acceptable results. The testing/ documentation we provided for
the Definium Pace Select were according to the following FDA
guidance documents: | |
| Guidance for the Content of Premarket Submissions for
Software Contained in Medical Devices Content of Premarket Submissions for Management of
Cybersecurity in Medical Devices Pediatric Information for X-ray Imaging Premarket
Notifications | |
| Summary of Clinical Tests: | |
| The subject of this premarket submission, Definium Pace Select,
does not require clinical studies to support substantial
equivalence for the introduction of the floor mounted
positioners and updates to the image chain. | |
| Design verification and validation testing was performed to
confirm the safety and effectiveness of the device. The test
plans and results have been executed with acceptable results. | |
| Conclusion: | The Definium Pace Select use traditional floor mounted
positioners and equivalent or same image chain components
based on the predicate. This introduction of the Definium Pace
Select system does not result in any new potential safety risks, it
has the similar technological characteristics, and perform as well
as the devices currently on the market.
After analyzing design verification and validation testing on the
bench it is the conclusion of GE HealthCare that the Definium
Pace Select to be as safe, as effective, and performance is
substantially equivalent to the predicate device. |
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Image /page/5/Picture/1 description: The image contains 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 a stylized, circular design with swirling lines inside a purple circle, and the text is in a simple, sans-serif font, also in purple.
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Image /page/6/Picture/1 description: The image shows the logo for GE HealthCare. The logo consists of a circular emblem with a stylized "GE" inside, followed by the text "GE HealthCare". The emblem and text are both in a purple color.
7
Image /page/7/Picture/1 description: The image contains the GE HealthCare logo. The logo consists of a purple circular emblem with a stylized "GE" inside, followed by the text "GE HealthCare" in purple. The text is written in a clean, sans-serif font and is aligned horizontally with the emblem.
8
Image /page/8/Picture/1 description: The image shows the GE HealthCare logo. The logo consists of a purple circular emblem with a stylized "GE" inside. To the right of the emblem is the text "GE HealthCare" in purple. The text is in a sans-serif font and is aligned horizontally with the emblem.