(109 days)
Not Found
No
The summary describes a standard medical linear accelerator for radiation therapy. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the physical components, imaging capabilities, and standard safety and performance testing.
Yes
The device is intended for external beam radiation therapy (EBRT) treatments for benign and malignant tumors and functional disorders, indicating a direct therapeutic purpose.
No
Explanation: The device description clearly states that the Elekta Medical Linear Accelerator (EMLA) is an "image guided Radiation Therapy device" intended for "delivery of ionizing radiation to a defined target volume." Its purpose is to deliver treatment, not to diagnose diseases or conditions. The imaging capabilities mentioned (MV portal imaging, kV imaging) are for guiding the treatment delivery, not for diagnostic purposes.
No
The device description clearly outlines hardware components such as the accelerator, beam shaping, imaging systems (MV portal imaging, kV imaging), a treatment table with linear and rotational movements, and user interfaces located in both the treatment and control rooms. While software is mentioned as being developed and verified according to IEC 62304, the device is fundamentally a physical system for delivering radiation therapy, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "external beam radiation therapy (EBRT) treatments" and to "assist a licensed medical practitioner in the defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation." This describes a therapeutic device that delivers radiation to a patient's body.
- Device Description: The description details a "Medical Linear Accelerator (EMLA) system" that delivers "ionizing radiation" and includes components like "beam shaping," "imaging," and "accessories for patient positioning." This aligns with a radiation therapy device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with patient specimens.
The device is a therapeutic medical device used for treating patients with radiation, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licensed medical practitioner.
It is intended to assist a licensed medical practitioner in the delivery of EBRT to defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation.
- Elekta Synergy and Elekta Harmony are the default entry-level configurations. It is intended to be used for single or multiple fractions using standard dose fractionation, hyperfractionation, and hypofractionation in all areas of the body where such treatment is indicated.
- Elekta Infinity is the default mid-level configurations. It is intended to be used for single or multiple fractions using standard dose fractionation, hyperfractionation, hypofractionation and stereotactic delivery (stereotactic body radiation therapy -SBRT; stereotactic ablative radiotherapy – SABR) in all areas of the body where such treatment is indicated.
- Versa HD is the default high-level configuration. It is intended to be used for single or multiple fractions using standard fractionation, hyperfractionation, hypofractionation and stereotactic delivery (stereotactic body radiation therapy - SBRT; stereotactic ablative radiotherapy – SABR; stereotactic radio surgery - SRS) in all areas of the body where such treatment is indicated and for the treatment of functional disorders, such as trigeminal neuralgia.
The EMLA is indicated for the delivery of curative and palliative intent EBRT to Adult and Pediatric patients with primary benign and malignant tumor and metastasis (or secondaries) anywhere in the body.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
The Elekta Medical Linear Accelerator (EMLA) system is an image guided Radiation Therapy device to assist a licensed practitioner in the delivery of ionizing radiation to a defined target volume. The system consists of components of the accelerator, such as, beam shaping, with imaging and accessories for patient positioning and set-up to deliver therapeutic treatments. The Elekta Harmony being introduced with this premarket notification submission.
The EMLA offers multiple treatment modalities including photon energies in the range of 4 – 25 MV and electron energies in the range of 4 – 22 MeV. Un-flattened and flattened photon energies are available. A treatment table, located in the treatment room, allows the patient to be accurately positioned to receive the prescribed radiotherapy and supports the patient during treatment. The table is capable of linear and rotational movements. The EMLA is equipped with a MV portal imaging subsystem, i.e. iViewGT, and an optional kV imaging sub-system, i.e. XVI. The user interface controlling devices are located partly in the treatment room and partly in the control room.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MV portal imaging, kV imaging
Anatomical Site
all areas of the body
Indicated Patient Age Range
Adult and Pediatric
Intended User / Care Setting
licensed medical practitioner / Not Found
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)
Development, verification and validation activities for the modified system were carried out in accordance with design controls as required by FDA's Quality System Regulation (21 CFR §820.30), applicable ISO 13485 Quality Management System requirements, ISO 14971 Risk Management requirements, and IEC 62304 requirements for software life-cycle processes. Non-clinical testing was performed to evaluate device performance and functionality in accordance with design and risk management requirements at subsystem, integration and system levels including interoperability. This includes the essential performance defined by Elekta. Basic safety and essential performance of the individual subsystems and the integrated EMLA system have been satisfied through conformance with the applicable general, particular and collateral safety and essential performance standards for medical devices.
Documentation of software development and verification testing activities for each subsystem of the EMLA system is maintained in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," May 2005, for devices that pose a major level of concern (Class C per IEC 62304).
Formal validation of the clinical workflows has been performed on a clinically representative production equivalent system by competent and professionally qualified personnel.
The verification and validation non-clinical test results demonstrate compliance with the applicable consensus standards and that the functional and performance requirements defined by Elekta are met. We therefore conclude that the device is as safe, as effective, and performs as well as or better than the legally marketed device.
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
June 11, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Elekta Limited % Mr. Lorenzo Muratori Regulatory Affairs and Compliance Engineer Linac House, Fleming Way Crawley, West Sussex RH10 9RR UNITED KINGDOM
Re: K210500
Trade/Device Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE, Dated: February 18, 2021 Received: February 22, 2021
Dear Mr. Muratori:
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
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
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Indications for Use
510(k) Number (if known) K210500
Device Name Elekta Medical Linear Accelerator
Indications for Use (Describe)
The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licensed medical practitioner.
It is intended to assist a licensed medical practitioner in the defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation.
-Elekta Synergy and Elekta Harmony are the default entry-level configurations. They are intended to be used for single or multiple fractions using standard dose fractionation, and hypofractionation in all areas of the body where such treatment is indicated.
-Elekta Infinity is the default mid-level configuration. It is intended to be used for single or multiple fractions using standard dose fractionation, hypofractionation and stereotactic delivery (stereotactic body radiation therapy - SBRT; stereotactic ablative radiotherapy - SABR) in all areas of the body where such treatment is indicated.
-Versa HD is the default high-level configuration. It is intended to be used for single or multiple fractions using standard fractionation, hyperfractionation and stereotactic delivery (stereotactic body radiation therapy - SBRT; stereotactic ablative radiotherapy – SABR; stereotactic radio surgery - SRS) in all areas of the body where such treatment is indicated and for the treatment of functional disorders, such as trigeminal neuralgia.
The EMLA is indicated for the delivery of curative and palliative intent EBRT to Adult and Pediatic with primary benign and malignant tumor and metastasis (or secondaries) anywhere in the body.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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TRADITIONAL 510(k) SUMMARY K210500
The following information follows the format of 21 CFR 807.92
| I. | SUBMITTER | |
|---|---|---|
| Date of preparation: | 18 February 2021 | |
| Submitted by: | Elekta Limited | |
| Linac House, Fleming Way, Crawley, West Sussex | ||
| RH10 9RR, United Kingdom | ||
| Telephone: +44 (0)1293 654836 | ||
| Contact name: | Lorenzo Muratori | |
| II. | DEVICE | |
| Trade Name: | Elekta Synergy ®, Elekta Harmony™, Elekta Infinity™, | |
| Versa HD™ | ||
| Common Name: | Elekta Medical Linear Accelerator (ELMA) | |
| Classification Name: | Medical Charged-Particle Radiation Therapy System | |
| Accelerator, Linear, Medical, 21CFR 892.5050 | ||
| Product Code: | IYE | |
| III. | PREDICATE DEVICE | K192242 |
IV. DEVICE DESCRIPTION
The Elekta Medical Linear Accelerator (EMLA) system is an image guided Radiation Therapy device to assist a licensed practitioner in the delivery of ionizing radiation to a defined target volume. The system consists of components of the accelerator, such as, beam shaping, with imaging and accessories for patient positioning and set-up to deliver therapeutic treatments. The Elekta Harmony being introduced with this premarket notification submission.
The EMLA offers multiple treatment modalities including photon energies in the range of 4 – 25 MV and electron energies in the range of 4 – 22 MeV. Un-flattened and flattened photon energies are available. A treatment table, located in the treatment room, allows the patient to be accurately positioned to receive the prescribed radiotherapy and supports the patient during treatment. The table is capable of linear and rotational movements. The EMLA is equipped with a MV portal imaging subsystem, i.e. iViewGT, and an optional kV imaging sub-system, i.e. XVI. The user interface controlling devices are located partly in the treatment room and partly in the control room.
4
V. INTENDED USE / INDICATION FOR USE STATEMENT
The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licensed medical practitioner.
It is intended to assist a licensed medical practitioner in the delivery of EBRT to defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation.
- Elekta Synergy and Elekta Harmony are the default entry-level configurations. It is intended to be used for single or multiple fractions using standard dose fractionation, hyperfractionation, and hypofractionation in all areas of the body where such treatment is indicated.
- Elekta Infinity is the default mid-level configurations. It is intended to be used for single or multiple fractions using standard dose fractionation, hyperfractionation, hypofractionation and stereotactic delivery (stereotactic body radiation therapy -SBRT; stereotactic ablative radiotherapy – SABR) in all areas of the body where such treatment is indicated.
- Versa HD is the default high-level configuration. It is intended to be used for single or multiple fractions using standard fractionation, hyperfractionation, hypofractionation and stereotactic delivery (stereotactic body radiation therapy - SBRT; stereotactic ablative radiotherapy – SABR; stereotactic radio surgery - SRS) in all areas of the body where such treatment is indicated and for the treatment of functional disorders, such as trigeminal neuralgia.
The EMLA is indicated for the delivery of curative and palliative intent EBRT to Adult and Pediatric patients with primary benign and malignant tumor and metastasis (or secondaries) anywhere in the body.
VI. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The vast majority of technological characteristics are the same, however, there are some changes. All the changes are to be considered minor in respect of the complexity of technology employed in the EMLA.
The Elekta Harmony variant features improved user interface controls in the treatment room, a patient support system capable of motorized linear movement along the longitudinal, lateral and vertical directions and manual movement around the column axis, but it does not support the motorized rotational movement around the isocentre axis as the predicate device does. The Elekta Harmony model can be installed in a bunker up to 500cm smaller than the other models of the EMLA family. The Elekta Harmony imaging device panels are permanently deployed, while those of the predicate device are foldable.
There are no novel forms of technology introduced in this premarket notification.
VII. SUMMARY OF PERFORMANCE TESTING (NON-CLINICAL)
Development, verification and validation activities for the modified system were carried out in accordance with design controls as required by FDA's Quality System Regulation (21 CFR §820.30), applicable ISO 13485 Quality Management System requirements, ISO 14971 Risk Management requirements, and IEC 62304 requirements for software life-cycle processes. Non-clinical testing was performed to
5
evaluate device performance and functionality in accordance with design and risk management requirements at subsystem, integration and system levels including interoperability. This includes the essential performance defined by Elekta. Basic safety and essential performance of the individual subsystems and the integrated EMLA system have been satisfied through conformance with the applicable general, particular and collateral safety and essential performance standards for medical devices.
Documentation of software development and verification testing activities for each subsystem of the EMLA system is maintained in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," May 2005, for devices that pose a major level of concern (Class C per IEC 62304).
Formal validation of the clinical workflows has been performed on a clinically representative production equivalent system by competent and professionally qualified personnel.
VIII. CONCLUSION DRAWN FROM TESTS
The verification and validation non-clinical test results demonstrate compliance with the applicable consensus standards and that the functional and performance requirements defined by Elekta are met. We therefore conclude that the device is as safe, as effective, and performs as well as or better than the legally marketed device.
IX. SUBSTANTIAL EQUIVALENCE
Elekta Harmony is substantially equivalent to the predicate devices cleared under K192242 in intended use and indications for use, principles of operation, technological characteristics, performance, and labelling.