(60 days)
No
The summary describes post-processing and visualization software for PET images, focusing on pharmacokinetic modeling and parametric image generation. There is no mention of AI, ML, or related concepts like training or test sets for algorithmic development.
No
Explanation: The device is described as a post-processing and visualization software for PET images, providing adjunct information for diagnosis, staging, treatment planning, and monitoring. It does not directly provide therapy or affect the body's structure or function to treat a disease, but rather aids in the evaluation process.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the output of DynamicIQ is "intended to be used by appropriately trained healthcare professionals as adjunct information for the review, analysis, and communication of PET static images for diagnosis, staging, treatment planning and monitoring." The inclusion of "diagnosis" clearly indicates its role as a diagnostic device.
Yes
The device description explicitly states "DynamiclQ is a post processing and visualization for visualizing and quantifying dynamic and static PET DICOM series. The software provides FDG tracer pharmacokinetics...". It processes existing image data and provides visualizations and calculations, without mentioning any hardware components included with the device itself.
Based on the provided information, DynamicIQ is NOT an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: An IVD device is defined as a medical device that is used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or treatment.
- DynamicIQ's Function: DynamicIQ processes and visualizes images (PET, CT, MR) and calculates parameters based on the tracer distribution within the body as seen in those images. It does not perform tests on biological samples taken from the body.
- Intended Use: The intended use clearly states that DynamicIQ provides "adjunct information for the review, analysis, and communication of PET static images for diagnosis, staging, treatment planning and monitoring." This is based on image analysis, not laboratory testing of biological samples.
- Device Description: The description focuses on "post processing and visualization for visualizing and quantifying dynamic and static PET DICOM series" and generating "parametric images." This reinforces its role in image analysis.
While DynamicIQ provides information that can be used in the diagnostic process, it does so by analyzing images of the body, not by performing tests on biological samples. Therefore, it falls under the category of medical imaging software or a medical image analysis device, not an IVD.
N/A
Intended Use / Indications for Use
DynamicIQ enables visualization and quantification of PET tracer pharmacokinetics based on whole body dynamic PET images. PET tracer pharmacokinetics include the physiological parameters of tracer uptake rate (Ki), metabolic rate of the tracer and total blood distribution volume (Vd) that allow for analyzing and visualizing the tracer accumulation over time, providing additional information that may help in the evaluation of SUV measurements on PET static images. The output of DynamicIQ is intended to be used by appropriately trained healthcare professionals as adjunct information for the review, analysis, and communication of PET static images for diagnosis, staging, treatment planning and monitoring. The parametric images should always be considered in addition to the conventional static PET images, which are the primary source to assist with diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
KPS, LLZ
Device Description
DynamiclQ is a post processing and visualization for visualizing and quantifying dynamic and static PET DICOM series. The software provides FDG tracer pharmacokinetics by generation of parametric images based on dynamic PET scans. The parametric images include physiological parameters of tracer uptake rate (Ki), metabolic rate of FDG and total blood distribution volume (Vd). In addition to the FDG Tracer pharmacokinetics, the software also performs the conventional review, analysis and communication of conventional PET static images, CT and MR images.
DynamicIQ assists with the clinical workflow by providing adjunct information of FDG tracer pharmacokinetics along with conventional PET static images for cross reference. The adjunct information of FDG tracer pharmacokinetics also help with analyzing the images that could have variability of quantitative measurements due to differences in uptake time, patient body size and blood glucose levels, leading to better characterization of tracer uptake compared to SUV alone.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET, CT, MR
Anatomical Site
whole body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
appropriately trained healthcare professionals
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)
DynamicIQ has successfully completed the design control testing per GE's quality system. It was designed and will be manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485. No additional hazards were identified, and no unexpected test results were observed. The proposed DynamicIQ has been successfully verified on the AW VolumeShare workstation and AW Server platforms.
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.
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
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.
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November 22, 2022
GE Medical Systems SCS % Tong Zhao Regulatory Affairs Leader 283, rue de la Miniere Buc, 78530 FRANCE
Re: K222895
Trade/Device Name: DynamicIQ Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS, LLZ Dated: September 21, 2022 Received: September 23, 2022
Dear Tong Zhao:
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 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
1
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.
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices 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) K222895
Device Name
DynamicIQ
Indications for Use (Describe)
DynamicIQ enables visualization and quantification of PET tracer pharmacokinetics based on whole body dynamic PET images. PET tracer pharmacokinetics include the physiological parameters of tracer uptake rate of the tracer and total blood distribution volume (Vd) that allow for analyzing the tracer accumulation over time, providing additional information that may help in the evaluation of SUV measurements on PET static images. The output of DynamicIQ is intended to be used by appropriately trained healthcare professionals as adjunct information for the review, analysis, and communication of PET static images for diagnosis, staging, treatment planning and monitoring. The parametric images should always be considered in addition to the conventional static PET images, which are the primary source to assist with diagnosis.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/4/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. There are decorative swirls around the circle, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, and is widely associated with the multinational conglomerate.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | September 21, 2022 |
|---|---|
| Submitter: | GE Medical Systems SCS |
| Establishment Registration Number - 9611343 | |
| 283 rue de la Miniere | |
| 78530 Buc, France | |
| Primary Contact Person: | Tong Zhao |
| Regulatory Affairs Leader | |
| GE Healthcare | |
| (+86) 15142077290 | |
| Email: Tong.Zhao2@ge.com | |
| Secondary Contact Person: | Elizabeth Mathew |
| Senior Regulatory Affairs Manager | |
| GE Healthcare | |
| Tel:(262)424-7774 | |
| Email: Elizabeth.Mathew@ge.com | |
| Device Trade Name: | DynamicIQ |
| Common/Usual Name: | DynamicIQ |
| Primary Regulation Number: | Emission computed tomography system (21 CFR 892.1200) |
| Primary Product Code: | KPS |
| Secondary Product Code: | LLZ |
| Classification: | Class II |
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Image /page/5/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. There are also some white swirls around the letters, adding a dynamic element to the design. The logo is simple, recognizable, and has been used by GE for many years.
| Predicate Device | |
|---|---|
| Device name: | Biograph Horizon PET/CT |
| Manufacturer: | Siemens Medical Solutions USA, Inc. |
| 510(k) number: | K193178 |
| Regulation Number: | 21 CFR 892.1200 Emission computed tomography system |
| 21 CFR 892.1750 Computed Tomography X-Ray System | |
| Product Code: | KPS, JAK |
| Classification: | Class II |
| Reference Devices | |
| Device name: | PET VCAR |
| Manufacturer: | GE Medical Systems SCS |
| 510(k) number: | K211247 |
| Regulation Number: | 21 CFR 892.1200 Emission computed tomography system |
| 21 CFR 892.2050 Medical image management and processing system | |
| Product Code: | KPS, LLZ |
| Classification: | Class II |
Device Description:
DynamiclQ is a post processing and visualization for visualizing and quantifying dynamic and static PET DICOM series. The software provides FDG tracer pharmacokinetics by generation of parametric images based on dynamic PET scans. The parametric images include physiological parameters of tracer uptake rate (Ki), metabolic rate of FDG and total blood distribution volume (Vd). In addition to the FDG Tracer pharmacokinetics, the software also performs the conventional review, analysis and communication of conventional PET static images, CT and MR images.
DynamicIQ assists with the clinical workflow by providing adjunct information of FDG tracer pharmacokinetics along with conventional PET static images for cross reference. The adjunct information of FDG tracer pharmacokinetics also help with analyzing the images that could have variability of quantitative measurements due to differences in uptake time, patient body size and blood glucose levels, leading to better characterization of tracer uptake compared to SUV alone.
6
Image /page/6/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. There are decorative swirls or flourishes around the circle, adding a touch of elegance to the design. The logo is simple, recognizable, and has been used by GE for many years.
Intended Use:
DynamiclQ enables visualization and quantification of PET tracer pharmacokinetics based on whole body dynamic PET images. The output of DynamiclQ is intended to be used by appropriately trained healthcare professionals as adjunct information for the review, analysis, and communication of conventional static PET images for diagnosis, staging, treatment planning and monitoring.
Indication for Use:
DynamiclQ enables visualization and quantification of PET tracer pharmacokinetics based on whole body dynamic PET images. PET tracer pharmacokinetics include the physiological parameters of tracer uptake rate (Ki), metabolic rate of the tracer and total blood distribution volume (Vd) that allow for analyzing and visualizing the tracer accumulation over time, providing additional information that may help in the evaluation of SUV measurements on PET static images. The output of DynamicIQ is intended to be used by appropriately trained healthcare professionals as adjunct information for the review, analysis, and communication of PET static images for diagnosis, staging, treatment planning and monitoring. The parametric images should always be considered in addition to the conventional static PET images, which are the primary source to assist with diagnosis.
Technology:
The proposed device DynamiclQ employs the same fundamental scientific technology as its predicate device and reference devices.
Comparison:
The table below summarizes the key feature/technological differences and similarities between the predicate device and the proposed device:
Note: Proposed device DynamicIQ compares with "FlowMotion Multi - Parametric PET Al" which is a feature of Siemens Biograph Horizon PET/CT system (K193178). Other features of the predicate device are outside of the scope of the comparison.
| Specification | Predicate Device:
Biograph Horizon
PET/CT (K193178) | Proposed Device:
DynamicIQ | Comparison |
|---------------------------------------------------------|-----------------------------------------------------------|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Location of
Processing | During scanning | Post-processing | Substantially Equivalent |
| Estimation of input
function from
blood pool scan | Yes | Yes | Substantially Equivalent
Both predicate and proposed device generate
tracer Time Activity Curve (TAC) from blood
pool scan |
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Image /page/7/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script inside a blue circle. There are decorative white swirls around the circle.
| Estimation of input
function without
blood pool scan | Yes | Yes | Substantially Equivalent
Predicate and proposed device manage missing
input function case in different manners:
Predicate uses manually inputted values while
proposed device uses Relative Patlak Analysis. |
|------------------------------------------------------------|----------------|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Output (Absolute
Patlak Analysis) | Yes | Yes | Identical.
Generation of parametric images using Patlak
model (Ki, Vd, Metabolic rate of FDG). |
| Output (Relative
Patlak analysis) | Not applicable | Yes | Substantially Equivalent
Proposed device has Relative Patlak analysis
mode to deliver Relative tracer uptake rate Ki
which has been shown to lead to visually
identical images to the Absolute Patlak analysis.
Quantitative values are not available and Vd is
not available. |
| Result Review | Yes | Yes | Substantially Equivalent
Both applications can display static and
dynamic PET images, CT and MR images (if
available). Both applications include an
interactive toolset to delineate findings and
extract measurements from the static and
dynamic PET images. |
DynamicIQ is substantially equivalent to FlowMotion Multiparametric PET Al of Biograph Horizon PET/CT. The main differences between the proposed device and predicate device are:
- -The proposed device is a standalone image post-processing software while the predicate is embedded into the Biograph Horizon PET/CT system.
- -The proposed device performs a Relative Patlak analysis when a blood pool scan is not available as input, while the predicate requires a manual radiation titration to be entered to conduct the Patlak Analysis. The Relative Patlak analysis has been shown to lead to visually identical images to the Absolute Patlak analysis.
These differences do not raise new type of safety and effectiveness questions.
Determination of Substantial Equivalence:
Summary of Non-Clinical, Design Control Testing
DynamicIQ has successfully completed the design control testing per GE's quality system. It was designed and will be manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485. No additional hazards were identified, and no unexpected test results were observed. The following quality assurance measures were applied to the development of the device:
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Image /page/8/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. There are decorative swirls around the circle, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, and is widely associated with the multinational conglomerate.
- Requirements Definition
- Risk Analysis ●
- Technical Design Reviews
- Formal Design Reviews
- Software Development Lifecycle ●
- Performance testing (Verification, Validation)
- Safety Testing (Verification)
The proposed DynamicIQ has been successfully verified on the AW VolumeShare workstation and AW Server platforms. Software documentation is for a MODERATE level of concern.
Conclusion:
DynamicIQ has substantial equivalent technological characteristics as its predicate device.
Based on development under GE Healthcare's quality system, successful design verification, software documentation for a "Moderate" level of concern, along with the engineering bench testing, GE Healthcare believes that the proposed DynamicIQ is substantially equivalent to, and hence as safe and as effective for its Intended Use as the legally marketed predicate device.