(125 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the description focuses on the hardware and software for image-guided radiation therapy.
Yes
The device is described as a "multifunctional digital linear accelerator" used for "radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body," indicating its role in treating medical conditions.
No
The device is primarily a radiation therapy treatment system (linear accelerator) that uses MRI for therapy planning, patient positioning, and treatment delivery, rather than for diagnosing diseases.
No
The device description clearly states that Elekta Unity consists of hardware components including a linear accelerator, MRI sub-system, and patient positioning sub-system, in addition to software.
Based on the provided information, the Elekta Unity is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Elekta Unity's Function: The Elekta Unity is a radiation therapy system that uses MRI for imaging within the body to guide and deliver radiation treatment. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body." The MRI component is used for imaging before, during and after treatment to assist with planning, positioning, and delivery.
Therefore, the Elekta Unity falls under the category of a therapeutic device that utilizes imaging for guidance, rather than an IVD device used for analyzing biological samples.
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 maging system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during, and after the radiotherapy treatment. Images provide information that may assist therapy planning, patient positioning and treatment delivery related to radiation oncology.
Product codes (comma separated list FDA assigned to the subject device)
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). Elekta Unity consists of a gantry-mounted 7MV linear accelerator sub-system which rotates around a 1.5T Magnetic Resonance Imaging (MRI) sub-system and a Patient Positioning Sub-system (PPS). It is controlled by dedicated system software, which incorporates patient positioning, imaging, and treatment delivery functions, and it is designed for use in conjunction with approved compatible Oncology Information and Treatment Planning systems. 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.
Mentions image processing
Not Found
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
Not Found
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 FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System standard, ISO 14971 Risk Management Standard, IEC 62304 Software life-cycle processes, and the other FDA recognised consensus standards presented below. 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 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 applicable general and collateral safety and essential performance standards for medical devices.
Validation and usability testing of the integrated system was performed in accordance with FDA guidance on human factors and usability engineering under clinically representative conditions by competent and professionally qualified personnel. The results from verification testing demonstrate device conformance to stated design specifications and standards.
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.
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
§ 892.5050 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
Elekta Limited % Mr. Nicholas Power RA Manager Fleming Way CRAWLEY, WEST SUSSEX, RH10 9RR GREAT BRITAIN
Re: K182076
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 Dated: October 29, 2018 Received: November 2, 2018
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.
December 4, 2018
1
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) 182076
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 maging system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during, and after the radiotherapy treatment. Images provide information that 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (7/17)
3
K182076
510(k) SUMMARY
as required by 21 CFR 807.92
| Date of preparation: | July 26, 2018 |
|---|---|
| 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: | ViewRay (MRIdian) Linac System, K170751 |
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). Elekta Unity consists of a gantry-mounted 7MV linear accelerator sub-system which rotates around a 1.5T Magnetic Resonance Imaging (MRI) sub-system and a Patient Positioning Sub-system (PPS). It is controlled by dedicated system software, which incorporates patient positioning, imaging, and treatment delivery functions, and it is designed for use in conjunction with approved compatible Oncology Information and Treatment Planning systems. 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.
Intended 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 compatible Treatment Planning and Oncology Information Systems.
4
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. Images provide information that may assist the therapy planning, patient positioning and treatment delivery related to radiation oncology.
Substantial Equivalence:
Elekta Unity is substantially equivalent (SE) to the predicate device, the ViewRay (MRIdian) Linac System (K170751) in intended use and indications for use, principles of operation, technological characteristics and labeling. The differences between the two devices have been addressed by non-clinical testing in conformance with predetermined performance criteria and recognised consensus standards.
Summary of Technological Characteristics:
Both devices are designed specifically to facilitate IGRT; they rely on established medical linear accelerator (linac) technology to deliver comparable photon energies and dose rates for targeted external beam radiation therapy, using established magnetic resonance imaging (MRI) technology for image guidance, and specifically designed software systems for treatment planning and delivery. Both devices incorporate a split magnet design to create an area of reduced X-ray attenuation for the treatment beam. Elekta Unity incorporates a 1.5T MRI sub-system as compared to the predicate's 0.345T MRI sub-system.
Key device characteristics and performance specifications of the Elekta Unity and the predicate device are noted in the table below:
| Device
Characteristic | Cleared Device
(K170751) | Elekta Unity | Comparison |
|------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Radiation Source
/ Beam | 6 MV Bremsstrahlung X- Rays
Produced by Linear Accelerator | 7MV Bremsstrahlung X- Rays
Produced by Linear Accelerator | Substantially
equivalent (SE)
energy source and
output |
| 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) | SE MLC specifications,
IEC 60601-2-1
compliant |
| MLC material | Tungsten Alloy | Tungsten Alloy | |
| Number of leaves | 34 leaf pairs upper stack, 35 leaf
pairs lower stack | 80 leaf pairs | |
| Range of MLC
collimated beam
size @ isocenter | 0.415 cm x 0.2 cm to
27.4 cm x 24.1 cm | 0.5 cm x 0.5 cm to
57.4 cm x 22 cm | |
| Gantry | Ring Gantry, collision with
patient not possible | Ring Gantry, collision with
patient not possible | Same |
| Device
Characteristic | Cleared Device
(K170751) | Elekta Unity | Comparison |
| Radiation Head
Shielding | Lead, Tungsten Alloy, and Steel
shielding | Lead, Tungsten Alloy, and Steel
shielding | Same |
| Source control
mechanism | Redundant ion chambers and
dose monitoring cards | Dual channel dose monitoring
system | SE mechanisms;
IEC 60601-2-1
compliant |
| Radiation
Transmission
through head | Less than 0.1% of the primary
beam | 0.2% of the primary beam | SE specification;
IEC 60601-2-1
compliant |
| Isocenter
distance | 90 cm | 143.5 cm | SE; no impact on dose
accuracy |
| Isocenter
accuracy (Radius) | 0.5mm | 0.5mm | Same |
| Max Dose Rate | 600 cGy/min
at Dmax at a 90 cm isocenter for
a 10 cm x 10 cm field | Clinical use: 450 cG/min at
isocentre at Dmax for a 10 cm x
10 cm field
(500 MU/min @ isocentre
measured at Dmax) | SE dose rate at
isocenter |
| Static Dose
Accuracy | 90% of the points evaluated in a
treatment volume pass a relative
gamma criteria of 3%/3mm and a
high dose, low gradient absolute
point measurement is within 5%
of the planned dose (per AAPM
TG 119 based on the
recommendations of Palta et al.). | >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. | SE dose accuracy
specification |
| Motion
synchronized
treatment | Yes | No - Manual interrupt only | No automatic gating
function in Unity |
| Patient table
degrees of
freedom | 3 translational | 2 (vertical & longitudinal) -
positional corrections are made
using the online adaptive
planning interface of the
treatment planning system | SE; Position accuracy
is compliant with IEC
60601-2-1 |
| Integrated
imaging for
planning,
positioning,
gating | Magnetic resonance imaging
system | Magnetic resonance imaging
system - for planning,
positioning and motion
monitoring during treatment | SE; No automatic
gating function in
Unity |
| MR Physical
Characteristics | | | SE physical
specifications |
| Bore Diameter | 700 mm | 700 mm | |
| Spherical Volume | 500 mm | 500mm x 500mm x 450mm | |
| Device
Characteristic | Cleared Device
(K170751) | Elekta Unity | Comparison |
| MRI Frequency | 14.7 MHz | 64 MHz | SE MRI system;
IEC 60601-2-33
compliant |
| Field Strength | 0.345 T | 1.5T | compliant |
| Field of View | 500 mm | Up to 500 mm Sequence
dependent | The effects of 1.5T
magnetic field on
dose distribution are |
| Field
Homogeneity |