(188 days)
Not Found
Yes
The device description explicitly states that Sonic DL is a "Deep Learning based image reconstruction technique" and consists of a "deep learning based reconstruction algorithm." Deep learning is a subset of machine learning and artificial intelligence.
No.
The device is an image reconstruction technique for MR systems, intended to improve image quality and accelerate acquisition, not to directly treat or diagnose a disease.
No
Explanation: Sonic DL is described as an image reconstruction technique that processes MR data to create images, enabling accelerated acquisitions. Its intended use is to "reconstructs MR images," and not to directly diagnose or provide diagnostic information to the user.
No
The device is described as a "new software feature intended for use with GE Healthcare MR systems" and is "integrated into the MR system software". While it is software, it is explicitly tied to and integrated within specific hardware (GE Healthcare 1.5T and 3.0T MR systems) and is not a standalone software application.
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 used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Sonic DL's Function: Sonic DL is a software feature for MR systems that processes imaging data acquired directly from the patient's body (in vivo). It reconstructs MR images from this data.
- No Sample Analysis: The description clearly states that Sonic DL works with MR images and data acquired from the patient. There is no mention of analyzing biological samples taken from the patient.
Therefore, Sonic DL falls under the category of medical imaging software, not an In Vitro Diagnostic device.
No
The letter does not mention that the FDA has reviewed, approved, or cleared a PCCP for this specific device.
Intended Use / Indications for Use
Sonic DL is a Deep Learning based image reconstruction technique that is available for use on GE Healthcare 1.5T and 3.0T MR systems. Sonic DL reconstructs MR images from highly under-sampled data, and thereby enables highly accelerated acquisitions. Sonic DL is intended for cardiac imaging, and for patients of all ages.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
Sonic DL is a new software feature intended for use with GE Healthcare MR systems. It consists of a deep learning based reconstruction algorithm that is applied to data from MR cardiac cine exams obtained using a highly accelerated acquisition technique.
Sonic DL is an optional feature that is integrated into the MR system software and activated through a purchasable software option key.
Mentions image processing
Sonic DL is a Deep Learning based image reconstruction technique that is available for use on GE Healthcare 1.5T and 3.0T MR systems. Sonic DL reconstructs MR images from highly under-sampled data, and thereby enables highly accelerated acquisitions.
Mentions AI, DNN, or ML
Sonic DL is a Deep Learning based image reconstruction technique
Sonic DL is a new software feature intended for use with GE Healthcare MR systems. It consists of a deep learning based reconstruction algorithm
Input Imaging Modality
MR
Anatomical Site
cardiac
Indicated Patient Age Range
patients of all ages.
12 weeks to 82 years old
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
Summary of Clinical Testing:
Two reader evaluation studies were performed using Sonic DL images acquired from clinical sites and from healthy volunteers at GE Healthcare facilities. In one study, three radiologists were asked to determine various quantitative measurements such as left ventricular volumes, ejection fraction, and cardiac output using both conventional Cine and Sonic DL image sets as summarized below:
Number of image series evaluated: 107
Number of unique subjects: 57
Patients: 46
Healthy volunteers: 11
Sites contributing data: 7
GE Healthcare facilities: 2
External collaborators (clinical sites): 5
Gender of subjects: Male: 35, Female: 22
Age range of subjects: 12 weeks to 82 years old
Pathology: Subjects from clinical sites included examples of various cardiac pathology, including structural heart disease, ischemic cardiomyopathy, and non-ischemic cardiomyopathy.
Equipment Used: GE HealthCare 1.5T and 3.0T MR Systems
Acquisition Parameters:
Field of View: 28 - 46 cm
In-plane resolution: 1.3 – 2.2 mm (both x and y directions)
Acquired Temporal Resolution (frame rate) 23.7 – 70.2 ms
In a second study, three radiologists were asked to perform blinded image quality assessments of both conventional 2D FIESTA Cine images with ASSET acceleration, and Sonic DL images obtained with different number of R-R intervals and different acceleration factors. This study involved 127 image sets which included a subset of the subjects described above, and included different cardiac views such as short axis, long axis, and aortic valve images.
Finally, clinical testing has been performed to demonstrate that Sonic DL is capable of achieving a 12 times acceleration factor and obtaining free-breathing images in a single heartbeat (1 R-R). Functional measurements using Sonic DL 1 R-R free breathing images from 10 subjects were compared to functional measurements using the conventional ASSET Cine breath hold images, and showed close agreement. Additionally, the image quality of 13 Sonic DL 1 R-R free breathing cases was evaluated by a U.S. board certified radiologist, and scored higher than the corresponding conventional free breathing Cine images from the same subjects.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Nonclinical Testing:
The performance of the Sonic DL reconstruction algorithm has been evaluated using simulated data generated from an MRXCAT phantom, and a digital phantom. Model accuracy metrics such as Peak-Signal-to-Noise (PSNR), Root-Mean-Square Error (RMSE), Structural Similarity Index Measure (SSIM), and Mean Absolute Error (MAE) were used to compare simulated Sonic DL images with different levels of acceleration and numbers of phases to the fully sampled images. Additionally, line profiles across the heart at different phases were used to evaluate both inplane and temporal sharpness.
The nonclinical testing demonstrated that Sonic DL is capable of reconstructing Cine images from highly under sampled data that are similar to the fully sampled Cine images in terms of image quality and temporal sharpness.
Summary of Clinical Testing:
Two reader evaluation studies were performed.
Study 1: 107 image series evaluated from 57 unique subjects (46 patients, 11 healthy volunteers). Three radiologists performed quantitative measurements (left ventricular volumes, ejection fraction, cardiac output) using conventional Cine and Sonic DL images.
Results: The inter-method variability (coefficient of variability comparing functional measurements taken with Sonic DL images versus measurements using the conventional ASSET Cine images) was smaller than the inter-observer intra-method variability for the conventional ASSET Cine images for all parameters, indicating that Sonic DL is suitable for performing functional cardiac measurements.
Study 2: 127 image sets were evaluated. Three radiologists performed blinded image quality assessments of conventional 2D FIESTA Cine images with ASSET acceleration and Sonic DL images (with different R-R intervals and acceleration factors).
Results: On average the Sonic DL images were rated as being of diagnostic quality while providing a significant reduction in scan time compared to the conventional ASSET Cine images.
Additional Clinical Testing:
Model accuracy and temporal sharpness evaluations using in vivo cardiac cine images obtained from 19 healthy volunteers.
Comparison of Sonic DL 1 R-R free breathing images (10 subjects) with conventional ASSET Cine breath hold images for functional measurements.
Results: Close agreement.
Image quality evaluation of 13 Sonic DL 1 R-R free breathing cases by a U.S. board certified radiologist compared to corresponding conventional free breathing Cine images.
Results: Scored higher than the corresponding conventional free breathing Cine images from the same subjects.
Conclusions Drawn from Performance Testing:
The nonclinical and clinical testing demonstrated that Sonic DL satisfies the product claims of reducing scan times while preserving image quality, enabling single heartbeat functional imaging, and enabling rapid free-breathing functional imaging.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Model accuracy metrics such as Peak-Signal-to-Noise (PSNR), Root-Mean-Square Error (RMSE), Structural Similarity Index Measure (SSIM), and Mean Absolute Error (MAE) were used to compare simulated Sonic DL images with different levels of acceleration and numbers of phases to the fully sampled images.
inter-method variability (coefficient of variability comparing functional measurements taken with Sonic DL images versus measurements using the conventional ASSET Cine images)
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
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device 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.
May 30, 2023
GE Medical Systems,LLC (GE Healthcare) % Glen Sabin Regulatory Affairs Director 3200 N Grandview Blvd. WAUKESHA WI 53188
Re: K223523
Trade/Device Name: Sonic DL Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: April 28, 2023 Received: April 28, 2023
Dear Glen Sabin:
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
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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 (OS) 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 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-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,
D.R.X.
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
2
Indications for Use
510(k) Number (if known) K223523
Device Name Sonic DL
Indications for Use (Describe)
Sonic DL is a Deep Learning based image reconstruction technique that is available for use on GE Healthcare 1.5T and 3.0T MR systems. Sonic DL reconstructs MR images from highly under-sampled data, and thereby enables highly accelerated acquisitions. Sonic DL is intended for cardiac imaging, and for patients of all ages.
| 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/0 description: The image shows the GE HealthCare logo. On the left is the GE monogram in purple. To the right of the monogram is the text "GE HealthCare" in purple.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | 24 May 2023 |
|---|---|
| Submitter: | GE Medical Systems, LLC |
| 3200 N. Grandview Blvd. | |
| Waukesha, WI 53188 | |
| Primary Contact: | Glen Sabin |
| Regulatory Affairs Director | |
| Phone: 262 894-4968 | |
| Email: Glen.Sabin@GE.com | |
| Secondary Contact: | Sandra Westphal |
| Senior Regulatory Affairs Leader | |
| Phone: 262 720-8872 | |
| Email: Sandra.Westphal@GE.com | |
| Device Trade Name: | Sonic DL |
| Common / Usual Name: | MR System |
| Classification Name: | Magnetic Resonance Diagnostic Device |
| Regulation Number: | 21 CFR 892.1000 |
| Primary Product Code: | LNH |
| Predicate Device: | |
| 510(k) Number: | K213668 |
| Device Name: | SIGNA Hero |
| Manufacturer: | GE Medical Systems, LLC |
Device Description:
Sonic DL is a new software feature intended for use with GE Healthcare MR systems. It consists of a deep learning based reconstruction algorithm that is applied to data from MR cardiac cine exams obtained using a highly accelerated acquisition technique.
Sonic DL is an optional feature that is integrated into the MR system software and activated through a purchasable software option key.
4
Image /page/4/Picture/0 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 design. The text is also purple and is written in a sans-serif font.
Indications for Use:
The Indications for Use statement for the proposed device is provided below:
Sonic DL is a Deep Learning based image reconstruction technique that is available for use on GE Healthcare 1.5T and 3.0T MR systems. Sonic DL reconstructs MR images from highly under-sampled data, and thereby enables highly accelerated acquisitions. Sonic DL is intended for cardiac imaging, and for patients of all ages.
Comparison of Technological Characteristics:
The proposed Sonic DL software feature that is the subject of this 510(k) is similar to the 2D FIESTA Cine feature with ASSET acceleration that is included in the predicate SIGNA Hero. K213668. The predicate device uses breath holds and a conventional parallel imaging acceleration technique (ASSET) that typically achieves acceleration factors between 2 and 4, and acquires each slice in 6 to 10 heartbeats. Sonic DL can achieve acceleration factors as high as 12, and enables single heartbeat (1 R-R) imaging with either breath holds or free breathing.
Summary of Nonclinical Testing:
The performance of the Sonic DL reconstruction algorithm has been evaluated using simulated data generated from an MRXCAT phantom, and a digital phantom. Model accuracy metrics such as Peak-Signal-to-Noise (PSNR), Root-Mean-Square Error (RMSE), Structural Similarity Index Measure (SSIM), and Mean Absolute Error (MAE) were used to compare simulated Sonic DL images with different levels of acceleration and numbers of phases to the fully sampled images. Additionally, line profiles across the heart at different phases were used to evaluate both inplane and temporal sharpness.
The nonclinical testing demonstrated that Sonic DL is capable of reconstructing Cine images from highly under sampled data that are similar to the fully sampled Cine images in terms of image quality and temporal sharpness.
Summary of Clinical Testing:
Two reader evaluation studies were performed using Sonic DL images acquired from clinical sites and from healthy volunteers at GE Healthcare facilities. In one study, three radiologists were asked to determine various quantitative measurements such as left ventricular volumes, ejection fraction, and cardiac output using both conventional Cine and Sonic DL image sets as summarized below:
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Image /page/5/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem features a stylized, swirling design within a circle, and the text is in a clean, sans-serif font, all in a matching purple color.
| Number of image series evaluated: | 107 |
|---|---|
| Number of unique subjects: | 57 |
| Patients: | 46 |
| Healthy volunteers: | 11 |
| Sites contributing data: | 7 |
| GE Healthcare facilities: | 2 |
| External collaborators (clinical sites): | 5 |
| Gender of subjects: | |
| Male: | 35 |
| Female: | 22 |
| Age range of subjects: | 12 weeks to 82 years old |
| Pathology: | Subjects from clinical sites included examples of various cardiac pathology, including structural heart disease, ischemic cardiomyopathy, and non-ischemic cardiomyopathy. |
| Equipment Used: | GE HealthCare 1.5T and 3.0T MR Systems |
| Acquisition Parameters: | |
| Field of View: | 28 - 46 cm |
| In-plane resolution: | 1.3 – 2.2 mm |
| (both x and y directions) | |
| Acquired Temporal Resolution (frame rate) | 23.7 – 70.2 ms |
The results showed that the inter-method variability (coefficient of variability comparing functional measurements taken with Sonic DL images versus measurements using the conventional ASSET Cine images) was smaller than the inter-observer intra-method variability for the conventional ASSET Cine images for all parameters, indicating that Sonic DL is suitable for performing functional cardiac measurements.
In a second study, three radiologists were asked to perform blinded image quality assessments of both conventional 2D FIESTA Cine images with ASSET acceleration, and Sonic DL images obtained with different number of R-R intervals and different acceleration factors. This study involved 127 image sets which included a subset of the subjects described above, and included different cardiac views such as short axis, long axis, and aortic valve images. The results of this study showed that on average the Sonic DL images were rated as being of diagnostic quality while providing a significant reduction in scan time compared to the conventional ASSET Cine images.
6
Image /page/6/Picture/1 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 a stylized version of the letters "GE" inside a circle, and the text is in a sans-serif font.
In addition to the two reader studies described above, other tests were performed. Similar to the nonclinical testing using the digital phantom, model accuracy and temporal sharpness evaluations were conducted using in vivo cardiac cine images obtained from 19 health volunteers.
Finally, clinical testing has been performed to demonstrate that Sonic DL is capable of achieving a 12 times acceleration factor and obtaining free-breathing images in a single heartbeat (1 R-R). Functional measurements using Sonic DL 1 R-R free breathing images from 10 subjects were compared to functional measurements using the conventional ASSET Cine breath hold images, and showed close agreement. Additionally, the image quality of 13 Sonic DL 1 R-R free breathing cases was evaluated by a U.S. board certified radiologist, and scored higher than the corresponding conventional free breathing Cine images from the same subjects.
The results of the clinical testing confirmed that the Sonic DL feature provides images that are of diagnostic quality, and that allow functional measurements that are within typical inter reader variability to the same measurements taken with conventional images. Additionally, the Sonic DL feature provided significantly shorter scan times that the conventional Cine imaging.
Conclusions Drawn from Performance Testing:
The nonclinical and clinical testing demonstrated that Sonic DL satisfies the product claims of reducing scan times while preserving image quality, enabling single heartbeat functional imaging, and enabling rapid free-breathing functional imaging.
The proposed Sonic DL software feature has been developed under GE Healthcare's quality system and is at least as safe and effective as the 2D FIESTA Cine feature with ASSET acceleration that is used in the legally marketed predicate device. The performance testing did not identify any new hazards, adverse effects, safety concerns, or performance concerns that are significantly different from those associated with cardiac cine MR imaging in general.
Therefore, GE Healthcare believes that Sonic DL is substantially equivalent to the predicate device and is safe and effective for its intended use.