(86 days)
No
The document describes standard image processing techniques (automatic generation of ADC/eADC maps) and does not mention AI, ML, or related terms. The performance studies focus on image quality assessment by radiologists and conformance to established standards, not on the performance of an AI/ML algorithm.
Yes
The device is described as a "multifunctional digital linear accelerator designed to assist licensed medical practitioners in the delivery of ionizing radiation to defined volumes (e.g. malignant and benign tumors)" for "radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases." This directly indicates its use in treating diseases, which is a therapeutic function.
No
The device is primarily indicated for radiation therapy treatments. While it can produce images that "yield information that can be useful in diagnosis," this is a secondary function to its primary role in treatment delivery. The device's main purpose is therapeutic, not diagnostic.
No
The device description clearly states that Elekta Unity is a multifunctional digital linear accelerator and includes a 1.5T MRI scanner sub-system, indicating significant hardware components. While it includes software for image processing and control, it is not solely software.
Based on the provided text, the Elekta Unity device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The primary intended use is for radiation therapy treatments and stereotactic radiation treatments. While the MRI component is used for imaging before, during, and after treatment to assist with diagnosis, therapy planning, patient positioning, and treatment delivery, this is in the context of guiding and monitoring radiation therapy, not for performing diagnostic tests on samples taken from the body.
- Device Description: The device is described as a "multifunctional digital linear accelerator" designed to deliver ionizing radiation. The MRI is a "sub-system" for imaging the internal structure of the body.
- Nature of Testing: The performance studies focus on image quality for diagnostic purposes in the context of radiation oncology, not on analyzing biological samples.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Elekta Unity operates by imaging the body directly using magnetic resonance, which is not the function of an IVD.
N/A
Intended Use / Indications for Use
Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan.
Elekta Unity is intended for use with the compatible Treatment Planning and Oncology Information Systems.
The Elekta Unity 1.5T MR scanner is a magnetic resonance imaging system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during, and after the radiotherapy treatment. When interpreted by a trained physician magnetic resonance images acquired before, during, and after the radiotherapy treatment yield information that can be useful in diagnosis and may assist therapy planning, patient positioning and treatment delivery related to radiation oncology.
Product codes
IYE, LNH
Device Description
Elekta Unity is a multifunctional digital linear accelerator designed to assist licensed medical practitioners in the delivery of ionizing radiation to defined volumes (e.g. malignant and benign tumors). Elekta Unity is capable of both intensity modulated radiation therapy (IMRT) and image guided radiation therapy (IGRT).
The Elekta Unity 1.5T MRI scanner is a magnetic resonance imaging sub-system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during, and after the radiotherapy treatment.
When interpreted by a trained physician the images acquired before, during, and after the radiotherapy treatment yield information that can be useful in diagnosis and may assist therapy planning, patient positioning and treatment delivery related to radiation oncology.
In addition to the MRI sequences cleared with the predicate device, the current Elekta Unity configuration has the ability to generate images using following techniques, before, during or after treatment for Off-line review:
- Single-shot EPI diffusion imaging (DWI) with 3 diffusion directions and up to 16 b-values.
- . Diffusion imaging processing with automatic generation of the ADC and/or eADC maps.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
anywhere in the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed medical practitioner
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
Anonymized images, obtained on Elekta Unity were reviewed by US Board Certificated Diagnostic Radiologists to asses image quality for diagnostic purposes.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification and performance testing were carried out in accordance with design controls of FDA's Quality System Regulation (21 CFR Section 820.30), applicable ISO 13485 Quality Management System requirements, ISO 14971 risk management requirements, IEC 62304 requirements for software life-cycle processes, and FDA guidance for the "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices," November 2016. Non-clinical testing was performed to evaluate device performance and functionality against design and risk management requirements at sub-system, integration and system levels. Software verification testing was conducted and documented in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, " May 2005, for devices that pose a major level of concern (Class C per IEC 62304). Basic safety and essential performance have been satisfied through conformance with device-specific recognised consensus standards, as well as the general and collateral safety and essential performance standards for medical devices listed below.
Validation and usability testing of the integrated system were performed in accordance on human factors and usability engineering under clinically representative conditions by competent and professionally qualified personnel.
Image validation was performed in accordance with FDA Guidance for Magnetic Resonance Diagnostic Devices, whereby anonymized images, obtained on Elekta Unity were reviewed by US Board Certificated Diagnostic Radiologists to asses image quality for diagnostic purposes. There was consensus among the expert reviewers that imaging with Elekta Unity met the clinical criteria for diagnostic MRI.
The results from verification and validation testing demonstrate device conformance to stated design specifications and recognized consensus safety and performance standards.
The results of verification and validation and safety standards testing demonstrate that Elekta Unity fulfills the established safety and performance criteria and it is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Elekta Unity, K182076
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, 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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December 5, 2019
Image /page/0/Picture/1 description: The image shows 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 the FDA logo, which 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.
Elekta Limited % Mr. Nicholas Power RA Director Linac House Fleming Way Crawley, West Sussex RH10 9RR UNITED KINGDOM
Re: K192482
Trade/Device Name: Elekta Unity Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE, LNH Dated: September 11, 2019 Received: September 13, 2019
Dear Mr. Power:
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
1
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 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
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192482
Device Name Elekta Unity
Indications for Use (Describe)
Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan.
Elekta Unity is intended for use with the compatible Treatment Planning and Oncology Information Systems.
The Elekta Unity 1.5T MR scanner is a magnetic resonance imaging system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during, and after the radiotherapy treatment. When interpreted by a trained physician magnetic resonance images acquired before, during, and after the radiotherapy treatment yield information that can be useful in diagnosis and may assist therapy planning, patient positioning and treatment delivery related to radiation oncology.
| 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
510(k) SUMMARY
as required by 21 CFR 807.92
| Date of preparation: | August 28, 2019 |
|---|---|
| Submitted by: | Elekta Limited |
| Linac House, Fleming Way, Crawley, West Sussex | |
| RH10 9RR, United Kingdom | |
| Telephone: +44 (0)1293 544422 | |
| Fax: +44 (0)1293 654321 | |
| Contact name: | Nicholas Power |
| Name of Device: | Elekta MR-Linac |
| Trade / Proprietary Name: | Elekta Unity |
| Common or Usual Name: | Image-Guided Radiation Therapy System |
| Classification Name: | Medical charged-particle radiation therapy system, 21CFR 892.5050 |
| Product Code: | IYE, LNH |
| Device classification name: | Accelerator, Linear, Medical |
| Predicate Device: | Elekta Unity, K182076 |
Product Description:
Elekta Unity is a multifunctional digital linear accelerator designed to assist licensed medical practitioners in the delivery of ionizing radiation to defined volumes (e.g. malignant and benign tumors). Elekta Unity is capable of both intensity modulated radiation therapy (IMRT) and image guided radiation therapy (IGRT).
The Elekta Unity 1.5T MRI scanner is a magnetic resonance imaging sub-system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during, and after the radiotherapy treatment.
When interpreted by a trained physician the images acquired before, during, and after the radiotherapy treatment yield information that can be useful in diagnosis and may assist therapy planning, patient positioning and treatment delivery related to radiation oncology.
In addition to the MRI sequences cleared with the predicate device, the current Elekta Unity configuration has the ability to generate images using following techniques, before, during or after treatment for Off-line review:
- Single-shot EPI diffusion imaging (DWI) with 3 diffusion directions and up to 16 b-values.
- . Diffusion imaging processing with automatic generation of the ADC and/or eADC maps.
4
Intended Use:
Elekta Unity using information from Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.
Indications for Use Statement:
Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.
The Elekta Unity 1.5T MRI scanner is a magnetic resonance imaging system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during and after the radiotherapy treatment.
When interpreted by a trained physician magnetic resonance images acquired before, during, and after the radiotherapy treatment yield information that can be useful in diagnosis and may assist therapy planning, patient positioning and treatment delivery related to radiation oncology.
Substantial Equivalence:
Elekta Unity is substantially equivalent (SE) to the predicate device, Elekta Unity (K182076), in intended use and indications for use, principles of operation, technological characteristics and labeling. The differences in imaging functionality between the two devices do not affect the fundamental scientific technology. The device safety and performance have been addressed by non-clinical testing in conformance with predetermined performance criteria, FDA guidance, and recognised consensus standards.
Summary of Technological Characteristics:
Elekta Unity is designed specifically to facilitate IGRT. Both, current and predicate device configurations use the same medical linear accelerator (linac) to deliver photon energies and dose rates for targeted external beam radiation therapy using established magnetic resonance imaging technology for image guidance. Both devices rely on the same split magnet design to create an area of reduced X-ray attenuation for the treatment beam. Both devices use the same specifically designed software systems for treatment planning and delivery.
The similarities and differences in key device characteristics and performance specifications of the current and predicate Elekta Unity device configuration are noted in the table below:
| Device
Characteristic | Elekta Unity
(Predicate Device, K182076) | Elekta Unity
(Current Device) | Comparison |
|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Radiation Source /
Beam | 7MV Bremsstrahlung X- Rays
Produced by Linear Accelerator | 7MV Bremsstrahlung X- Rays
Produced by Linear Accelerator | Same |
| Method of IMRT | MLC based cone-beam delivery | MLC based cone-beam delivery | Same |
| Collimation | Field shaping, Multi Leaf
Collimator (MLC) | Field shaping, Multi Leaf
Collimator (MLC) | Same |
| MLC material | Tungsten Alloy | Tungsten Alloy | Same |
| Device
Characteristic | Elekta Unity
(Predicate Device, K182076) | Elekta Unity
(Current Device) | Comparison |
| Number of leaves | 80 leaf pairs | 80 leaf pairs | Same |
| Range of MLC
collimated beam
size @ isocenter | 0.5 cm x 0.5 cm to
57.4 cm x 22 cm | 0.5 cm x 0.5 cm to
57.4 cm x 22 cm | Same |
| Gantry | Ring Gantry, collision with
patient not possible | Ring Gantry, collision with patient
not possible | Same |
| Radiation Head
Shielding | Lead, Tungsten Alloy, and Steel
shielding | Lead, Tungsten Alloy, and Steel
shielding | Same |
| Source control
mechanism | Dual channel dose monitoring
system | Dual channel dose monitoring
system | Same |
| Radiation
Transmission
through head | 0.2% of the primary beam | 0.2% of the primary beam | Same |
| Isocenter distance | 143.5 cm | 143.5 cm | Same |
| Isocenter accuracy
(Radius) | 0.5mm | 0.5mm | Same |
| Max Dose Rate | Clinical use: 450 cG/min at
isocentre at Dmax for a 10 cm x
10 cm field
(500 MU/min @ isocentre
measured at Dmax) | Clinical use: 450 cG/min at
isocentre at Dmax for a 10 cm x
10 cm field
(500 MU/min @ isocentre
measured at Dmax) | Same |
| Static Dose
Accuracy | >95% of points passing 3%/3mm
in the high dose, low gradient
region.
95% passing 5mm/5% for low
dose, high gradient points. | >95% of points passing 3%/3mm
in the high dose, low gradient
region.
95% passing 5mm/5% for low
dose, high gradient points.
1% agreement for output factors. | Same |
| Motion
synchronized
treatment | No - Manual interrupt only | No - Manual interrupt only | Same |
| Patient table
degrees of
freedom | 2 (vertical & longitudinal) –
positional corrections are made
using the online adaptive
planning interface of the
treatment planning system | 2 (vertical & longitudinal) –
positional corrections are made
using the online adaptive
planning interface of the
treatment planning system | Same |
| Integrated imaging
for planning,
positioning, gating | Magnetic resonance imaging
system - for planning, positioning
and motion monitoring during
treatment | Magnetic resonance imaging
system - for planning, positioning
and motion monitoring during
treatment | Same |
| MR Physical
Characteristics | | | Same |
| Device
Characteristic | Elekta Unity
(Predicate Device, K182076) | Elekta Unity
(Current Device) | Comparison |
| Bore Diameter | 700 mm | 700 mm | |
| Diameter Spherical
Volume | 500mm x 500mm x 450mm | 500mm x 500mm x 450mm | |
| MRI Frequency | 64 MHz | 64 MHz | Same |
| Field Strength | 1.5T | 1.5T | |
| Field of View | Up to 500 mm Sequence
dependent | Up to 500 mm Sequence
dependent | |
| Field Homogeneity | ≤ 2 ppm measured over 50 cm x
50 cm x 45 cm volume | ≤ 2 ppm measured over 50 cm x
50 cm x 45 cm volume | |
| Field Stability | ≤ 0.1 ppm/hr | ≤ 0.1 ppm/hr | |
| 3D Imaging
Volumes (cm) | RL x AP x HF
Min 0.5 x 0.5 x 0.8
Max 56 x 56 x 40 (Anterior coil
dependent) | RL x AP x HF
Min 0.5 x 0.5 x 0.8
Max 56 x 56 x 40 (Anterior coil
dependent) | Same |
| 3D Imaging
Resolution (cm) | Min 0.01 x 0.01 x 0.1
Max 0.875 x 0.875 x 1 | Min 0.01 x 0.01 x 0.1
Max 0.875 x 0.875 x 1 | |
| 2D Imaging Planes
(cm) | AP x HF
Min 0.5 x 0.5
Max 56 x 56 | AP x HF
Min 0.5 x 0.5
Max 56 x 56 | |
| 2D Imaging
Resolution (mm) | Resolution selectable:
0.011 x 0.011 mm (min)
8.75 x 8.75 mm (max) | Resolution selectable:
0.011 x 0.011 mm (min)
8.75 x 8.75 mm (max) | |
| | Slice thickness selectable:
0.01 mm (min); 705 mm (max) | Slice thickness selectable:
0.01 mm (min); 705 mm (max) | |
| Geometric
Accuracy |