(196 days)
Yes
The device description explicitly states it is a "deep learning based reconstruction technique" and mentions the use of "neural networks".
No.
The device is a software feature for MR systems that enhances image quality and reduces scan time by removing noise and artifacts from MR images. It does not directly provide therapy or treatment to patients.
No
The device is described as a deep learning-based reconstruction technique that reduces noise and artifacts in MR images to improve image quality and potentially reduce scan time. It processes existing MR images and does not independently identify diseases or conditions.
No
The device is described as a software feature integrated into GE Healthcare MR systems, which are hardware medical devices. While the device itself is software, it is not a standalone software-only medical device; it functions as a component of a larger hardware system.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
-
IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
-
Device Function: AIR Recon DL is a software feature that processes MR images acquired directly from the patient's body. It improves the quality of these images by reducing noise and artifacts. It does not analyze biological specimens (like blood, urine, or tissue) in vitro.
-
Intended Use: The intended use is to improve the quality of MR images for diagnostic purposes, which is a function of the imaging system itself, not an in vitro analysis of a specimen.
In summary, AIR Recon DL is a medical device that enhances the output of an imaging modality (MRI), but it does not perform in vitro diagnostic testing on biological samples.
No
The letter does not state that the FDA has reviewed and cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
AIR Recon DL is a deep learning based reconstruction technique that is available for use on GE Healthcare 1.5T, 3.0T, and 7.0T MR systems. AIR Recon DL reduces noise and ringing (truncation artifacts) in MR images, which can be used to reduce scan time and improve image quality. AIR Recon DL is intended for use with all anatomies, and for patients of all ages. Depending on the anatomy of interest being imaged, contrast agents may be used.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
AIR Recon DL is a software feature intended for use with GE Healthcare MR systems. It is a deep learning based reconstruction technique that removes noise and ringing (truncation) artifacts from MR images. AIR Recon DL is an optional feature that is integrated into the MR system software and activated through a purchasable software option kev. This 510(k) submission has been triggered by a modification to AIR Recon DL to expand its compatible pulse sequences to include PROPELLER and 3D Cartesian acquisitions.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
MR
Anatomical Site
all anatomies
Indicated Patient Age Range
all ages
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Both the proposed AIR Recon DL and the predicate device use neural networks that have similar architecture, and were trained using similar methods and data.
Description of the test set, sample size, data source, and annotation protocol
A reader evaluation study was performed on images acquired across a variety of pulse sequences and anatomies. The study involved 133 cases as summarized below:
Source of data:
129 patient cases from 10 different clinical sites
4 cases from healthy subjects obtained at a GE Healthcare facility
Equipment used:
GE Healthcare 1.5T MR systems: 51 cases
GE Healthcare 3.0T MR systems: 82 cases
Protocols used:
3D acquisitions: 92 cases
PROPELLER acquisitions: 41 cases
Anatomical coverage:
Body (breast, abdomen, and pelvis): 42 cases
Cardiac: 10 cases
Neuro (head, neck, and spine): 57 cases
Musculoskeletal (shoulder, wrist, hip, knee, and ankle): 24 cases
Use of exogenous contrast:
With Contrast: 31 cases
Without Contrast: 102 cases
Presence of pathology:
With pathology: 124 cases
Without pathology: 9 cases
Readers were asked to compare the AIR Recon DL images to conventional images (without AIR Recon DL) reconstructed from the same acquired raw data. Each image pair was evaluated independently by three radiologists.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Testing: AIR Recon DL has undergone phantom testing to evaluate the feature and its impact on image quality, including SNR, sharpness, and low contrast detectability. For PROPELLER acquisitions, analysis was also performed to compare Apparent Diffusion Coefficient (ADC) maps calculated from images using AIR Recon DL to those calculated from conventional images. The nonclinical testing demonstrated that AIR Recon DL does improve SNR and image sharpness while maintaining low contrast detectability. AIR Recon DL was also able to maintain image SNR and did not sacrifice sharpness for images acquired with a reduced scan time. ADC maps were not adversely impacted by the use of AIR Recon DL. The nonclinical testing passed the defined acceptance criteria and did not identify any adverse impacts to image quality or other concerns related to safety and performance.
Clinical Testing: A reader evaluation study was performed on images acquired across a variety of pulse sequences and anatomies. The study involved 133 cases. Readers were asked to compare the AIR Recon DL images to conventional images (without AIR Recon DL) reconstructed from the same acquired raw data. Each image pair was evaluated independently by three radiologists. The results confirmed that the AIR Recon DL feature provides images with equivalent or better image quality in terms of apparent signal to noise ratio (133 out of 133 cases), sharpness (133 out of 133 cases), and lesion conspicuity (123 out of 124 cases with pathology). The radiologists reading the images also indicated a preference for the AIR Recon DL images over conventional images in 99% of the evaluations. Evaluations were also made of AIR Recon DL images from shorter scan time acquisitions and images without AIR Recon DL taken with longer scan times. Despite the shorter scan times, the AIR Recon DL images were rated as better or equivalent image quality for all 22 image pairs. Sample images involving the presence of motion and other common artifacts were evaluated both with and without the AIR Recon DL feature. The sample images show that AIR Recon DL does not significantly change the appearance of motion artifacts. Additionally, images were evaluated to confirm that the use of AIR Recon DL does not adversely affect the accuracy of quantitative measurements such as contrast pharmacokinetics, lesion sizes, and brain volumetry results. The analysis showed strong agreement between measurements made using conventional and AIR Recon DL images.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
apparent signal to noise ratio (133 out of 133 cases), sharpness (133 out of 133 cases), and lesion conspicuity (123 out of 124 cases with pathology). Radiologist preference in 99% of evaluations.
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
§ 892.1000 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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 8, 2022
GE Medical Systems, LLC % Glen Sabin Regulatory Affairs Director 3200 N Grandview Blvd. Waukesha, Wisconsin 53188
Re: K213717
Trade/Device Name: AIR Recon DL Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: Mav 9, 2022 Received: May 10, 2022
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
1
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,
for
Michael D. O'Hara, Ph.D. Deputy Director DHT 8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of In Vitro Diagnostics and 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) K213717
Device Name
AIR Recon DL
Indications for Use (Describe)
AIR Recon DL is a deep learning based reconstruction technique that is available for use on GE Healthcare 1.5T, 3.0T, and 7.0T MR systems. AIR Recon DL reduces noise and ringing (truncation artifacts) in MR images, which can be used to reduce scan time and improve image quality. AIR Recon DL is intended for use with all anatomies, and for patients of all ages. Depending on the anatomy of interest being imaged, contrast agents may be used.
| 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 logo for General Electric (GE). The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. The circle has a decorative border that resembles water droplets or stylized leaves. The logo is simple, clean, and recognizable, representing the brand identity of General Electric.
K213717
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | 6 June 2022 |
|---|---|
| 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: | Andrew Menden |
| Senior Regulatory Affairs Manager | |
| Phone: 262 308-5719 | |
| Email: Andrew.Menden@GE.com | |
| Device Trade Name: | AIR Recon DL |
| Common / Usual Name: | MR System |
| Classification Name: | |
| Regulation Number: | |
| Primary Product Code: | Magnetic Resonance Diagnostic Device |
| 21 CFR 892.1000 | |
| LNH | |
| Predicate Device: | |
| 510(k) Number: | |
| Device Name: | |
| Manufacturer: | K193282 |
| SIGNA Premier | |
| GE Medical Systems, LLC | |
| Reference Devices: | |
| 510(k) Number: | |
| Device Name: | |
| Manufacturer: | K202238 |
| SIGNA Artist | |
| GE Medical Systems, LLC |
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Image /page/4/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script in the center. There are white teardrop shapes around the perimeter of the circle. The logo is simple and recognizable, and it is associated with a well-known company.
Device Description:
AIR Recon DL is a software feature intended for use with GE Healthcare MR systems. It is a deep learning based reconstruction technique that removes noise and ringing (truncation) artifacts from MR images. AIR Recon DL is an optional feature that is integrated into the MR system software and activated through a purchasable software option kev.
This 510(k) submission has been triggered by a modification to AIR Recon DL to expand its compatible pulse sequences to include PROPELLER and 3D Cartesian acquisitions.
Indications for Use:
The Indications for Use statement for the proposed device is provided below:
AIR™ Recon DL is a deep learning based reconstruction technique that is available for use on GE Healthcare 1.5T, 3.0T, and 7.0T MR systems. AIR Recon DL reduces noise and ringing (truncation artifacts) in MR images, which can be used to reduce scan time and improve image quality. AIR Recon DL is intended for use with all anatomies, and for patients of all ages. Depending on the anatomy of interest beinq imaged, contrast agents may be used.
Comparison of Technological Characteristics:
The proposed AIR Recon DL software feature that is the subject of this 510(k) is similar to the feature of the same name included in the predicate SIGNA Premier, K193282. The predicate device used deep learning convolutional networks to remove noise and ringing from certain 2D Cartesian acquisitions. The proposed AIR Recon DL has been modified to be compatible with PROPELLER and selected 3D Cartesian acquisitions. Both the proposed AIR Recon DL and the predicate device use neural networks that have similar architecture, and were trained using similar methods and data.
The proposed AIR Recon DL is intended for use on GE Healthcare 1.5T, 3.0T, and 7.0T MR systems. The AIR Recon DL feature included in the predicate device was intended for use with only GE Healthcare 3.0T systems. However, the same alqorithm described in the predicate device (K193282) is also cleared for use in GE Healthcare 1.5T systems (SIGNA Artist - K202238), and 7.0T systems (SIGNA 7.0T - K211118).
Summary of Nonclinical Testing:
AIR Recon DL has undergone phantom testing to evaluate the feature and its impact on image quality, including SNR, sharpness, and low contrast detectability. For PROPELLER acquisitions, analysis was also performed to compare Apparent
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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized monogram. The monogram is enclosed within a circular frame, and there are decorative swirls or flourishes around the outer edge of the circle. The logo is presented in a blue color scheme.
Diffusion Coefficient (ADC) maps calculated from images using AIR Recon DL to those calculated from conventional images.
The nonclinical testing demonstrated that AIR Recon DL does improve SNR and image sharpness while maintaining low contrast detectability. AIR Recon DL was also able to maintain image SNR and did not sacrifice sharpness for images acquired with a reduced scan time. ADC maps were not adversely impacted by the use of AIR Recon DL. The nonclinical testing passed the defined acceptance criteria and did not identify any adverse impacts to image quality or other concerns related to safety and performance.
Summary of Clinical Testing:
A reader evaluation study was performed on images acquired across a variety of pulse sequences and anatomies. The study involved 133 cases as summarized below:
Source of data:
129 patient cases from 10 different clinical sites
4 cases from healthy subjects obtained at a GE Healthcare facility
Equipment used:
GE Healthcare 1.5T MR systems: 51 cases
GE Healthcare 3.0T MR systems: 82 cases
Protocols used:
3D acquisitions: 92 cases
PROPELLER acquisitions: 41 cases
Anatomical coverage:
Body (breast, abdomen, and pelvis): 42 cases
Cardiac: 10 cases
Neuro (head, neck, and spine): 57 cases
Musculoskeletal (shoulder, wrist, hip, knee, and ankle): 24 cases
Use of exogenous contrast:
With Contrast: 31 cases
Without Contrast: 102 cases
Presence of pathology:
With pathology: 124 cases
Without pathology: 9 cases
6
Image /page/6/Picture/0 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 flourishes resembling water droplets or stylized leaves surrounding the circle, adding a touch of elegance to the design.
Readers were asked to compare the AIR Recon DL images to conventional images (without AIR Recon DL) reconstructed from the same acquired raw data. Each image pair was evaluated independently by three radiologists. The results confirmed that the AIR Recon DL feature provides images with equivalent or better image quality in terms of apparent signal to noise ratio (133 out of 133 cases), sharpness (133 out of 133 cases), and lesion conspicuity (123 out of 124 cases with pathology). The radiologists reading the images also indicated a preference for the AIR Recon DL images over conventional images in 99% of the evaluations.
Evaluations were also made of AIR Recon DL images from shorter scan time acquisitions and images without AIR Recon DL taken with longer scan times. Despite the shorter scan times, the AIR Recon DL images were rated as better or equivalent image quality for all 22 image pairs.
Sample images involving the presence of motion and other common artifacts were evaluated both with and without the AIR Recon DL feature. The sample images show that AIR Recon DL does not significantly change the appearance of motion artifacts.
Additionally, images were evaluated to confirm that the use of AIR Recon DL does not adversely affect the accuracy of quantitative measurements such as contrast pharmacokinetics, lesion sizes, and brain volumetry results. The analysis showed strong agreement between measurements made using conventional and AIR Recon DL images.
Conclusions Drawn from Performance Testing:
The nonclinical and clinical testing demonstrated that AIR Recon DL satisfies the product claims of improved SNR and image sharpness, and can enable shorter scan times while preserving SNR and image sharpness.
The proposed AIR Recon DL software feature has been developed under GE Healthcare's quality system and is at least as safe and effective as the earlier version of AIR Recon DL 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 MR imaging in general.
Therefore, GE Healthcare believes that AIR Recon DL is substantially equivalent to the predicate device and is safe and effective for its intended use.