(86 days)
No
The summary describes advanced imaging techniques and image-guided radiation therapy but does not mention AI or ML in the device description, intended use, or performance studies. The focus is on hardware capabilities and established imaging methods.
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." Radiation therapy is a therapeutic treatment.
Yes
The device description states, "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." This indicates a diagnostic capability.
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 beyond just software.
Based on the provided text, the Elekta Unity device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Elekta Unity's Function: The description clearly states that Elekta Unity is a radiation therapy system that uses Magnetic Resonance Imaging (MRI) to guide and deliver radiation treatment. It produces images of the internal structure of the body.
- No Sample Analysis: The device does not analyze biological samples taken from the patient. Its function is based on imaging the patient's body directly.
Therefore, the Elekta Unity falls under the category of a medical device used for treatment and image guidance, not an in vitro diagnostic device.
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 compatible Treatment Planning and Oncology Information Systems. The Elekta Unity 1.5T MR scanner is a magnetic resonance imaging system that produces cross-sectional imaqes 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 subject device Elekta Unity configuration has the ability to generate images using following techniques, before, during or after treatment:
Introduce 3D Vane
3D Vane XD is a free breathing acquisition method that can be used to compensate for respiratory motion and peristalsis in 3D/FFE and 3D/TFE body imaging.
Introduce CS-Sense - compressed images
Compressed SENSE is an acceleration technique that is less sensitive to noise allowing increased resolution and/or coverage without a scan time penalty.
Introduce Breath Hold (BH) .
Breath-hold is a technique where an image is acquired when a patient holds their breath in a defined phase of the breathing cycle.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
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)
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 guidance for devices that pose a major level of concern (Class C per IEC 62304).
No animal or clinical tests were performed to establish substantial equivalence with the predicate device. The performance data demonstrate that Elekta Unity is as safe and effective and performs as well as the predicate device Elekta Unity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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October 1, 2021
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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
Elekta Solutions AB % Ms. Melinda Smith Director, Regulatory Affairs & Quality - Americas Elekta, Inc. 400 Perimeter Center Ter. NE Suite 50 ATLANTA GA 30346
Re: K212114
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: June 30, 2021 Received: July 7, 2021
Dear Ms. Melinda Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
2
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
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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 compatible Treatment Planning and Oncology Information Systems. The Elekta Unity 1.5T MR scanner is a magnetic resonance imaging system that produces cross-sectional imaqes 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) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: | |
| Department of Health and Human Services | |
| Food and Drug Administration | |
| Office of Chief Information Officer | |
| Paperwork Reduction Act (PRA) Staff | |
| PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
| FORM FDA 3881 (6/20) | Page 1 of 1 |
| PSC Publishing Services (301) 443-67 |
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Image /page/3/Picture/0 description: The image shows the logo for Elekta, a company that specializes in precision radiation medicine. The logo consists of a circular graphic with three smaller circles inside, followed by the company name "Elekta" in a bold, sans-serif font. The logo is teal in color and is set against a white background.
TRADITIONAL 510(K) SUMMARY (21 CFR § 807.92)
| I. | SUBMITTER | Elekta Solutions AB
Kungstensgatan 18 Box 7593
Stockholm, SE SE10393 |
|-----|-------------------------------|----------------------------------------------------------------------------|
| | Contact: | Melinda Smith, MS, RAC, CBA
Melinda.Smith@elekta.com |
| | Establishment Registration #: | 3015232217 |
| | 510(k) Number: | K212114 |
| | Date Prepared: | 30 June 2021 |
| II. | DEVICE | |
| | Trade Name: | Elekta Unity |
| | Product Classification: | Class II |
| | Common Name: | Radiation charged-particle radiation system |
| | Regulation Number: | 21 CFR § 892.5050 |
| | Regulation Description: | Medical charged-particle radiation therapy system |
| | Product Code: | IYE, LNH |
PREDICATE DEVICE lll.
Predicate Device: Elekta Unity (K192482) Reference Devices: Philips Ingenia (K193215) and Elekta EMLA (K192242)
DEVICE DESCRIPTION IV.
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 subject device Elekta Unity configuration has the ability to generate images using following techniques, before, during or after treatment:
4
Introduce 3D Vane ●
3D Vane XD is a free breathing acquisition method that can be used to compensate for respiratory motion and peristalsis in 3D/FFE and 3D/TFE body imaging.
● Introduce CS-Sense - compressed images
Compressed SENSE is an acceleration technique that is less sensitive to noise allowing increased resolution and/or coverage without a scan time penalty.
Introduce Breath Hold (BH) .
Breath-hold is a technique where an image is acquired when a patient holds their breath in a defined phase of the breathing cycle.
V. INTENDED USE
Elekta Unity is intended for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body under MRI quidance as determined by a licensed medical practitioner in accordance with a defined treatment plan. The Indications for Use statement defines the disease or condition to be treated (or diagnosed for MR functions).
VI. 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 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, durinq, 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.
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE
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:
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| Technological Characteristics Comparison | | Unity
(Subject Device) | Unity
(K192482) |
|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|--------------------|
| Radiation Source / Beam | 7MV Bremsstrahlung X- Rays produced by
Linear Accelerator | ✓ | ✓ |
| Method of IMRT | MLC based cone-beam delivery | ✓ | ✓ |
| Collimation | Field shaping, Multi Leaf Collimator (MLC) | ✓ | ✓ |
| MLC material | Tungsten Alloy | ✓ | ✓ |
| Number of leaves | 80 leaf pairs | ✓ | ✓ |
| Range of MLC collimated
beam size @ isocenter | 0.5 cm x 0.5 cm to 57.4 cm x 22 cm | ✓ | ✓ |
| Gantry | Ring Gantry, collision with patient not possible | ✓ | ✓ |
| Radiation Head Shielding | Lead, Tungsten Alloy, and Steel shielding | ✓ | ✓ |
| Source control mechanism | Dual channel dose monitoring system | ✓ | ✓ |
| Radiation Transmission
through head | 0.2% of the primary beam | ✓ | ✓ |
| Isocenter distance | 143.5 cm | ✓ | ✓ |
| Isocenter accuracy (Radius) | 0.5mm | ✓ | ✓ |
| 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) | ü | ✓ |
| 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
1% agreement for output factors | ✓ | ✓ |
| Motion synchronized
treatment | No - Manual interrupt only | ✓ | ✓ |
| Patient table degrees of
freedom | 2 (vertical & longitudinal) - positional
corrections are made using the online
adaptive planning interface of the treatment
planning system | ✓ | ✓ |
| Integrated imaging for
planning, positioning, gating | Magnetic resonance imaging system - for
planning, positioning and motion monitoring
during treatment | ✓ | ✓ |
| MR Physical
Characteristics | Bore Diameter: 700 mm
Diameter Spherical Volume:
500 mm x 500 mm x 450 mm | ✓ | ✓ |
| MRI Frequency
Field Strength
Field of View
Field Homogeneity
Field Stability | 64 MHz
1.5T
Up to 500 mm Sequence dependent
≤ 2 ppm measured over 50 cm x 50 cm x 45
cm volume
≤ 0.1 ppm/hour | ✓ | ✓ |
| 3D Imaging Volumes (cm)
3D Imaging Resolution (cm) | RL x AP x HF
Min 0.5 x 0.5 x 0.8
Max 56 x 56 x 40 (Anterior coil dependent)
Min 0.01 x 0.01 x 0.1
Max 0.875 x 0.875 x 1 | ✓ | ✓ |
| Technological Characteristics Comparison | | Unity
(Subject Device) | Unity
(K192482) |
| 2D Imaging Planes (cm) | 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)
Slice thickness selectable:
0.01 mm (min); 705 mm (max) | ✓ | ✓ |
| Geometric Accuracy | 1 Submission of Premarket Notifications for Magnetic Devices – Guidance for Industry and Food and Drug Administration Staff, November 2016
2 Content of Premarket Submissions for Software Contained in Medical Devices – Guidance for Industry and Food and Drug Administration Staff, May 2005
7
Basic safety and essential performance have been satisfied through conformance with device-specific recognized consensus standards, as well as the general and collateral safety and essential performance standards for medical devices listed below.
| Standard No. | Standard Title |
|---|---|
| ISO 14971 | Medical Devices - Application of risk management to medical devices |
| IEC 60601-1 | Medical electrical equipment - Part 1: General requirements for basic safety and |
| essential performance | |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for basic safety and |
| essential performance - Collateral Standard: Electromagnetic | |
| IEC 60601-1-6 | Medical electrical equipment - Part 1-6: General requirements for basic safety and |
| essential performance - Collateral standard: Usability | |
| IEC 60601-2-1 | Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron |
| accelerators in the range of 1 MeV to 50 MeV | |
| IEC 60601-2-33 | Medical electrical equipment - Part 2-33: Particular requirements for the safety of |
| magnetic resonance equipment for medical diagnosis | |
| IEC 61217 | Radiotherapy equipment - Coordinates, movements and scales |
| IEC 60976 | Medical electrical equipment. Medical electron accelerators. Functional performance |
| characteristics | |
| IEC 62304 | Medical device software - Software life-cycle processes |
| IEC 62366-1 | Medical devices - Application of usability engineering to medical devices |
| ANSI IEEE | |
| C63.18 | Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating |
| Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) | |
| Emissions from RF Transmitters | |
| ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk |
| management process |
IX. SUMMARY OF PERFORMACE TESTING (CLINICAL)
No animal or clinical tests were performed to establish substantial equivalence with the predicate device. The performance data demonstrate that Elekta Unity is as safe and effective and performs as well as the predicate device Elekta Unity.
X. SUBSTANTIAL EQUIVALENCE CONCLUSION
Elekta Unity is substantially equivalent (SE) to the predicate device, Elekta Unity (K192482). The intended use and indications for use are identical to the predicate device and the principles of operation remain unchanged.
The technological characteristics are substantially equivalent to the predicate device; the differences in imaging functionality between the two devices do not affect the fundamental scientific technology or raise different questions of safety or effectiveness of the device. The device safety and performance have been addressed by non-clinical testing in conformance with predetermined performance criteria, FDA quidance, and recognized consensus standards.
The results of verification and validation as well as conformance to relevant safety standards demonstrate that Elekta Unity meets the established safety and performance criteria and is substantially equivalent to the predicate device.