(129 days)
Not Found
No
The document describes advanced motion management strategies and adaptive therapy features, but it does not explicitly mention the use of AI or ML algorithms in their implementation. The focus is on image-guided radiation therapy and anatomical position monitoring, which can be achieved through traditional image processing and tracking techniques.
Yes
The device is indicated for "radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body," indicating its use in treating diseases.
Yes
The device is described as a magnetic resonance imaging system that produces cross-sectional images for diagnosis and therapy planning, which are key functions of a diagnostic device.
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 it is a complex hardware system with integrated software, not a software-only device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The description of the Elekta Unity focuses on imaging the internal structure of the whole body using Magnetic Resonance Imaging (MRI). It does not mention the analysis of blood, urine, tissue samples, or any other biological specimens.
- The intended use is for radiation therapy treatments and stereotactic radiation treatments. While the MRI images can be useful in diagnosis and therapy planning, the primary function of the Elekta Unity is the delivery of radiation, not the diagnostic testing of biological samples.
- The device description details a linear accelerator and an MRI scanner. These are imaging and treatment delivery systems, not devices designed for in vitro analysis.
Therefore, the Elekta Unity, as described, falls under the category of a medical device used for imaging and radiation therapy, 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 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 vield 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 motion monitoring with manual interrupt previously cleared with predicate Unity devices, the subject device Elekta Unity has added the following motion management strategies:
- Anatomic Position Monitoring (APM) with Manual interrupt (also referred to as True Tracking as it 'tracks' in 3D and enables the system to gate using the 3D position of the anatomy's motion)
- APM with Anatomic Tolerance Check (ATC)
- Adaptive Therapy with optional Baseline Shift (BLS) Recovery.
These modifications are not contained solely within the Elekta Unity Device, as the full clinical benefit is achieved with interoperability of Unity, Monaco RTP, and MOSAIQ OIS.
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
trained physician
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 design controls of FDA's Quality System Requlation (21 CFR §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 1.
Non-clinical testing was performed to evaluate device performance and functionality against design and risk management requirements at sub-system, integration and systemlevels. Software verification testing was conducted and documented in accordance with FDA guidance2 for devices that pose a major level of concern (Class C per IEC 62304).
Basic safety and essential performance have been satisfied through conformance withdevice-specific recognized consensus standards, as well as the general and collateralsafety and essential performance standards for medical devices listed below.
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)
Elekta Unity (K212114)
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.
0
February 23, 2023
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the agency name in a sans-serif font.
Elekta Solutions AB % Melinda Smith Director, Regulatory Affairs & Quality - Americas Elekta, Inc. 400 Perimeter Center Terrace NE. Suite 50 ATLANTA GA 30346
Re: K223209
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: January 26, 2023 Received: January 26, 2023
Dear 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
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,
Image /page/1/Picture/5 description: The image shows a digital signature. The signature is from Lora D. Weidner -S. The date of the signature is 2023.02.23, and the time is 14:40:52 -05'00'.
Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
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 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) |
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."
3
Image /page/3/Picture/0 description: The image shows the logo for Elekta, a company that specializes in precision radiation therapy. The logo consists of a circular icon with three dots inside, followed by the word "Elekta" in a teal sans-serif font. The icon is a stylized representation of a circle with three dots of varying sizes inside, suggesting movement or progression. The overall design is clean and modern, conveying a sense of innovation and precision.
TRADITIONAL 510(K) SUMMARY (21 CFR § 807.92)
| 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: | K223209 |
| Date Prepared: | 13 October 2022 |
| DEVICE | |
| Trade Name: | Elekta Unity MR Linac |
| 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 |
lll. PREDICATE DEVICE
Predicate Device: Elekta Unity (K212114)
IV. 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 guidance 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).
V. 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 witha 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 imagingsystem 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 maqnetic 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.
4
Image /page/4/Picture/0 description: The image shows the logo for Elekta, a company that specializes in precision radiation therapy. The logo consists of a circular icon with three dots inside, followed by the word "Elekta" in a bold, sans-serif font. The icon and the text are both in a teal color. The logo is simple and modern, and it is likely used on the company's website, marketing materials, and products.
DEVICE DESCRIPTION VI.
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 vield 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 motion monitoring with manual interrupt previously cleared with predicate Unity devices, the subject device Elekta Unity has added the following motion management strategies:
- · Anatomic Position Monitoring (APM) with Manual interrupt (also referred to as True Tracking as it 'tracks' in 3D and enables the system to gate using the 3D position of the anatomy's motion)
- · APM with Anatomic Tolerance Check (ATC)
- Adaptive Therapy with optional Baseline Shift (BLS) Recovery.
These modifications are not contained solely within the Elekta Unity Device, as the full clinical benefit is achieved with interoperability of Unity, Monaco RTP, and MOSAIQ OIS.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VII. 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. Bothdevices 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.
5
Image /page/5/Picture/0 description: The image shows the logo for Elekta. The logo consists of a circular icon with three smaller circles inside, followed by the text "Elekta" in a sans-serif font. The icon and text are both in a teal color. The logo appears to be for a company or organization named Elekta.
| Technological Characteristics Comparison | | Unity
(Subject Device) | Unity
(K212114) |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|--------------------|
| 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 | 0.5cm x 0.5cm to 57.4cm x 22cm | ✓ | ✓ |
| 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) | 0.5 mm | ✓ | ✓ |
| 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) | ✓ | ✓ |
| 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 Management Strategies | Motion monitoring with manual interrupt | ✓ | ✓ |
| | Anatomical Position Monitoring (APM) with manual interrupt | ✓ | X |
| | APM with ATC (Anatomical Tolerance Check)
Adaptive Therapy with optional BLS (Baseline Shift) Recovery | ✓ | X |
| End-to-End Gating Latency | [-200 to +200 ms] (radiation off) and
[-200 to +280 ms] (radiation on) for ATC for free-breathing respiratory motion treatment techniques | ✓ | X |
| 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 | 64 MHz | ✓ |
| | Field Strength | 1.5T | |
| | Field of View
Field Homogeneity | Up to 500 mm Sequence dependent
2 Content of Premarket Submissions for Software Contained in Medical Devices – Guidance for Industry and Food and Drug Administration Staff, May 2005
8
Image /page/8/Picture/0 description: The image shows the logo for Elekta, a company that specializes in precision radiation therapy. The logo consists of a circular icon with three smaller circles inside, followed by the company name "Elekta" in a teal sans-serif font. The icon is positioned to the left of the company name, creating a visual balance.
SUBSTANTIAL EQUIVALENCE CONCLUSION X.
Elekta Unity is substantially equivalent (SE) to the predicate device, Elekta Unity (K212114). The intended use and indications for use are identical to the predicate deviceand the principles of operation remain unchanged.
The technological characteristics are substantially equivalent to the predicate device; the additional motion management strategies 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 pre-determined performance criteria, FDA guidance, 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 performancecriteria and is substantially equivalent to the predicate device.