(129 days)
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.
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.
The provided text is a 510(k) summary for the Elekta Unity MR Linac and describes updates to an existing device rather than a new standalone AI/ML device with a clinical performance study. Therefore, a direct answer to all points regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML algorithm's clinical performance cannot be fully provided from this document.
Specifically, the document states: "No animal or clinical tests were performed to establish substantial equivalence with the predicate device." This indicates that a human-in-the-loop (MRMC) or standalone (algorithm only) clinical performance study as typically understood for AI/ML diagnostic or treatment planning algorithms was not conducted for this 510(k) submission. The clearance is based on substantial equivalence by demonstrating that the new motion management strategies do not change the fundamental scientific technology or raise different questions of safety or effectiveness.
However, I can extract the information relevant to the device's technical specifications and the non-clinical testing performed to establish substantial equivalence.
Here's a breakdown of the available information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present "acceptance criteria" in the traditional sense of a clinical performance study against a ground truth. Instead, it provides a comparison of "Technological Characteristics" between the subject device (Elekta Unity with new features) and its predicate device (Elekta Unity K212114). The "acceptance" here relates to demonstrating that the new features do not negatively impact the established performance and safety characteristics, or that they meet expected performance defined by engineering specifications.
| Technological Characteristic | Acceptance Criteria (Predicate Performance - Implied) | Reported Device Performance (Subject Device) |
|---|---|---|
| Radiation Source / Beam | 7MV Bremsstrahlung X-Rays | ✓ (Same) |
| Method of IMRT | MLC based cone-beam delivery | ✓ (Same) |
| Collimation | Field shaping, Multi Leaf Collimator (MLC) | ✓ (Same) |
| MLC material | Tungsten Alloy | ✓ (Same) |
| Number of leaves | 80 leaf pairs | ✓ (Same) |
| Range of MLC collimated beam size | 0.5cm x 0.5cm to 57.4cm x 22cm | ✓ (Same) |
| Gantry | Ring Gantry, collision with patient not possible | ✓ (Same) |
| Radiation Head Shielding | Lead, Tungsten Alloy, and Steel shielding | ✓ (Same) |
| Source control mechanism | Dual channel dose monitoring system | ✓ (Same) |
| Radiation Transmission through head | 0.2% of the primary beam | ✓ (Same) |
| Isocenter distance | 143.5 cm | ✓ (Same) |
| Isocenter accuracy (Radius) | 0.5 mm | ✓ (Same) |
| Max Dose Rate | Clinical use: 450 cG/min at isocentre | ✓ (Same) |
| Static Dose Accuracy | >95% points passing 3%/3mm (high dose); >95% passing 5mm/5% (low dose); 1% agreement for output factors | ✓ (Same) |
| Motion Management Strategies | Motion monitoring with manual interrupt | ✓ (Same + APM with manual interrupt, APM with ATC, Adaptive Therapy with optional BLS Recovery) |
| End-to-End Gating Latency | Not applicable to previous predicate; new feature | [-200 to +200 ms] (radiation off) and [-200 to +280 ms] (radiation on) for ATC |
| Patient table degrees of freedom | 2 (vertical & longitudinal) | ✓ (Same) |
| Integrated imaging | Magnetic resonance imaging system | ✓ (Same) |
| MR Physical Characteristics (Bore Diameter) | 700 mm | ✓ (Same) |
| MRI Frequency | 64 MHz | ✓ (Same) |
| Field Strength | 1.5T | ✓ (Same) |
| Field of View | Up to 500 mm Sequence dependent | ✓ (Same) |
| Field Homogeneity | < 2 ppm over 50 cm x 50 cm x 45 cm volume | ✓ (Same) |
| Field Stability | ≤ 0.1 ppm/hour | ✓ (Same) |
| 3D Imaging Volumes (cm) | 0.5 x 0.5 x 0.8 (min) / 56 x 56 x 40 (max) | ✓ (Same) |
| 3D Imaging Resolution (cm) | 0.01 x 0.01 x 0.1 (min) / 0.875 x 0.875 x 1 (max) | ✓ (Same) |
| 2D Imaging Planes (cm) | AP x HF: 0.5 x 0.5 (min) / 56 x 56 (max) | ✓ (Same) |
| 2D Imaging Resolution (mm) | Selectable: 0.011 x 0.011 mm (min) / 8.75 x 8.75 mm (max); Slice thickness: 0.01 mm (min) / 705 mm (max); ≤1 mm over 20 cm FOV | ✓ (Same) |
| Geometric Accuracy | ≤ 2 mm over 34 cm FOV (Guaranteed); ≤ 2 mm over 42 cm FOV (Typical) | ✓ (Same) |
| Signal to Noise | 120 | ✓ (Same) |
| Diffusion Weighted Imaging (DWI) | DWI can be imported for Off-line review | ✓ (Same) |
| Treatment Planning and Delivery System | GPU-based Monte Carlo dose calculation algorithm (GPUMCD) using Elekta Monaco | ✓ (Same) |
| Dose Output Modelling | Dose output modelled with monitor units | ✓ (Same) |
| Dose Display | Display of Linac delivery parameters | ✓ (Same) |
The specific performance of the new motion management strategies (APM with manual interrupt, APM with ATC, Adaptive Therapy with optional BLS Recovery) is demonstrated through consistency with existing features and the quantitative specification for End-to-End Gating Latency.
2. Sample size used for the test set and data provenance
Not applicable, as no clinical performance study was conducted. The assessment was based on non-clinical (engineering and software) verification and validation testing, and comparison of technological characteristics to a predicate device.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts
Not applicable, as no clinical performance study requiring expert adjudication for ground truth was conducted. Ground truth for the MR images themselves is implicitly the physical reality captured by the scanner, with interpretation by "trained physician" for diagnosis, therapy planning, patient positioning, and treatment delivery.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical performance study was conducted.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was done, stated as "No animal or clinical tests were performed to establish substantial equivalence with the predicate device."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone clinical performance study was done for the purpose of this 510(k) clearance, as explicitly stated that no animal or clinical tests were performed. The "algorithm" here refers to the system's control and motion tracking, which is part of the integrated device functionality, not a separate AI diagnostic or treatment planning algorithm being evaluated for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing, the "ground truth" would be engineering specifications, physical measurements, and adherence to recognized standards (e.g., IEC 60601 series for safety and essential performance). For the imaging component, the imaging system produces cross-sectional images for interpretation by a "trained physician," where the intended ground truth for diagnostic or guidance purposes is the patient's anatomy and pathology as determined by clinical practice.
8. The sample size for the training set
Not applicable. This document describes a medical device with updated motion management software, not a de novo AI/ML algorithm requiring a training set in the typical sense for machine learning model development. The software capabilities are validated through engineering and functional testing.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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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
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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
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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) |
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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 ABKungstensgatan 18 Box 7593Stockholm, SE SE10393 |
|---|---|
| Contact: | Melinda Smith, MS, RAC, CBAMelinda.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.
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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.
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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 points1% 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 mmDiameter Spherical Volume: 500 mm x 500 mm x 450 mm | ✓ | ✓ |
| MRI Frequency | 64 MHz | ✓ | |
| Field Strength | 1.5T | ||
| Field of ViewField Homogeneity | Up to 500 mm Sequence dependent< 2 ppm measured over 50 cm x 50 cm x 45 cm volume | ||
| Technological Characteristics Comparison | Unity(Subject Device) | Unity(K212114) | |
| Field Stability | ≤ 0.1 ppm/hour | ||
| 3D Imaging Volumes (cm) | RL x AP x HF: 0.5 x 0.5 x 0.8 (min) / 56 x 56 x 40 (max) (Anterior coil dependent) | ✓ | ✓ |
| 3D Imaging Resolution (cm) | 0.01 x 0.01 x 0.1 (min) / 0.875 x 0.875 x 1 (max) | ✓ | |
| 2D Imaging Planes (cm) | AP x HF: 0.5 x 0.5 (min) / 56 x 56 (max) | ||
| 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)≤1 mm over 20 cm FOV (Guaranteed) | ✓ | ✓ |
| Geometric Accuracy | ≤ 2 mm over 34 cm FOV (Guaranteed)≤ 2 mm over 42 cm FOV (Typical) | ✓ | ✓ |
| Signal to Noise | 120 | ✓ | ✓ |
| Diffusion Weighted Imaging (DWI) | Diffusion Weighted Images can be imported from an alternative magneticresonance imaging device for Off-line review. | ✓ | ✓ |
| Treatment Planning and DeliverySystem | GPU-based Monte Carlo dose calculation algorithm (GPUMCD) using thecompatible Elekta Monaco treatment planning system | ✓ | ✓ |
| Dose Output Modelling Dose Display | Dose output modelled with monitor units Display of Linac delivery parameters |
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ெElekta
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Image /page/7/Picture/0 description: The image shows the logo for Elekta, a company that specializes in precision radiation medicine. The logo features a stylized atom symbol to the left of the company name. The atom symbol is a circle with three smaller circles inside, and the company name is written in a sans-serif font. The color of the logo is a teal blue.
SUMMARY OF PERFORMACE TESTING (NON-CLINICAL) VIII.
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.
| Standard No. | Standard Title |
|---|---|
| ISO 14971 | Medical Devices - Application of risk management to medicaldevices |
| IEC 60601-1 | Medical electrical equipment - Part 1: Generalrequirements for basic safety andessentialperformance |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: Generalrequirements for basic safety andessential performance -Collateral Standard: Electromagnetic |
| IEC 60601-1-6 | Medical electrical equipment - Part 1-6: Generalrequirements for basic safety andessential performance -Collateral standard: Usability |
| IEC 60601-2-1 | Medical electrical equipment - Part 2-1: Particular requirementsfor the safety of electronaccelerators in the range of 1 MeV to50 MeV |
| IEC 60601-2-33 | Medical electrical equipment - Part 2-33: Particularrequirements for the safety ofmagnetic resonanceequipment for medical diagnosis |
| IEC 61217 | Radiotherapy equipment - Coordinates, movements and scales |
| IEC 60976 | Medical electrical equipment. Medical electronaccelerators. Functional performancecharacteristics |
| IEC 62304 | Medical device software - Software life-cycle processes |
| IEC 62366-1 | Medical devices - Application of usability engineering to medicaldevices |
| ISO 10993-1 | Biological evaluation of medical devices - Part 1:Evaluation and testing within a riskmanagement 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.
Submission of Premarket Notfications for Magnetic Resonance Diagnostic 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
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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.
§ 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.