(29 days)
The Elekta Medical Linear Accelerator is indicated to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumors), whilst sparing surrounding normal tissue and critical organs from excess radiation for treatment that includes but is not limited to, malignant and benign brain tumors, brain metastases, spine lesions treated using SRS, squamous cell carcinoma of the head and neck, lung, breast, pancreatic, hepatic malignancies treated using SBRT, prostate, and bone metastases.
The Elekta Medical Linear Accelerator 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 Medical Linear Accelerator System is currently available in the following model variants – Precise Treatment System, Elekta Synergy Platform, Elekta Infinity and Versa HD.
This document (K182138) is a 510(k) Premarket Notification for a Medical Linear Accelerator, which is a radiation therapy device. The document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria for a new AI/software component.
Therefore, many of the requested details, such as specific acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment methods for a new AI, or MRMC studies, are not applicable or not provided in this document. This submission appears to be about software updates (control software, Integrity™) to an existing device, which mostly focuses on safety and existing functionality, rather than introducing a new AI-powered diagnostic or therapeutic capability that would require such extensive AI performance validation.
However, I can extract the information that is present and explain why other information is missing.
Acceptance Criteria and Device Performance (Based on the provided document)
Since this submission is for software changes to an existing medical linear accelerator and focuses on substantial equivalence, the "acceptance criteria" discussed are primarily related to general device safety, performance, and adherence to regulatory standards, rather than specific diagnostic or therapeutic efficacy metrics that would be evaluated for a novel AI algorithm.
| Acceptance Criteria (Inferred/General) | Reported Device Performance |
|---|---|
| Conformance to FDA Quality System Regulation (21 CFR §820) | Met - "Testing in the form of module, integration and system level verification was conducted in accordance with FDA Quality System Regulation (21 CFR §820)" |
| Conformance to ISO 13485 Quality Management System standard | Met - "ISO 13485 Quality Management System standard" |
| Conformance to ISO 14971 Risk Management Standard | Met - "ISO 14971 Risk Management Standard" |
| Conformance to IEC 62304 Software life-cycle processes | Met - "IEC 62304 Software life-cycle processes" |
| Conformance to FDA recognised consensus standards (e.g., IEC 60601-1, etc.) | Met - "and the other FDA recognised consensus standards which includes but is not limited to IEC 60601-1, IEC 60601-2-1, IEC 60601-1-6, IEC 62366-1." |
| Software Verification Testing (for Major Level of Concern - Class C) | Met - "Software verification testing was conducted and documented in accordance with FDA's 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' for devices that pose a major level of concern (Class C per IEC 62304)." |
| Basic safety and essential performance | Met - "Basic safety and essential performance have been satisfied through conformance with device-specific recognised consensus standards, as well as applicable general and collateral safety and essential performance standards for medical devices." |
| Conformance to applicable technical design specifications | Met - "Results from verification and validation testing demonstrate that conformance to applicable technical design specifications have been met" |
| Safety & Effectiveness (overall) | Met - "...and safety & effectiveness has been achieved." and "The results of verification, validation and safety standard testing demonstrate that the Elekta Medical Linear Accelerator system is substantially equivalent to their predicate device." This refers to overall device safety and effectiveness as being substantially equivalent to the cleared predicate, not new performance for a novel AI. |
| Tighter error detection (for the new Integrity™ software) | Achieved - "Elekta has introduced changes to the control software, Integrity™, primarily to provide tighter error detection..." (This is a design goal for the software change, not a quantified acceptance criterion here). |
| Merged codebase to support current hardware platform (for Integrity™) | Achieved - "...and to merge the codebase to provide a single release that supports the current hardware platform." |
Detailed Study Information (Based on the Provided Document):
-
A table of acceptance criteria and the reported device performance:
- As detailed in the table above, the acceptance criteria are generally qualitative and refer to adherence to regulatory standards (e.g., QSR, ISO standards, IEC standards) and the successful completion of verification and validation testing. The "reported device performance" is a confirmation that these standards were met and testing was successfully completed, leading to a determination of substantial equivalence.
- Specific quantitative metrics for an AI algorithm's performance (e.g., AUC, sensitivity, specificity for a diagnostic task) are not present because the submission is for software updates to a linear accelerator, not a new AI diagnostic/therapeutic algorithm.
-
Sample sizes used for the test set and the data provenance:
- N/A. This document describes "module, integration and system level verification" and "validation of the integrated system under clinically representative conditions." This is typical for a software update to an existing medical device. It does not mention a "test set" in the context of an AI algorithm's performance evaluation on a separate dataset of patient cases.
- Data Provenance: Not specified as it's not a dataset-driven AI validation. The testing is described generally as "clinically representative conditions."
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth establishment for an AI test set is not applicable here as the submission is for control software updates, not AI performance validation.
- Validation was performed by "competent and professionally qualified personnel," but their specific number or qualifications are not provided for the purpose of "ground truth" establishment in an AI context.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not applicable for this type of submission.
-
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. This type of study is not mentioned as it's not relevant to the nature of this submission (software update for a linear accelerator control system, not an AI assisting human interpretation).
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. No specific AI algorithm performance in a standalone capacity is evaluated or described. The software changes are to the control system of a device that assists a licensed practitioner.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. The concept of "ground truth" in the context of an AI algorithm's performance is not discussed here. The validation described is against technical design specifications and safety/performance standards for a medical device's control system.
-
The sample size for the training set:
- N/A. No AI training set is mentioned or implied for this submission. The software changes are described as "tighter error detection" and codebase merging, which likely comes from software development and testing cycles rather than machine learning training.
-
How the ground truth for the training set was established:
- N/A. Not applicable as there is no mention of an AI training set. Grounds for validation are based on established engineering principles, regulatory standards, and clinical representativeness as opposed to a data-driven AI training methodology.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. Food & Drug Administration' in blue text.
September 5, 2018
ELEKTA LIMITED % Mr. Andrew Hedges Principal Engineer - RA and Compliance Linac House, Fleming Way Crawley, West Sussex RH10 9RR UNITED KINGDOM
Re: K182138
Trade/Device Name: Precise Treatment System™; Synergy® platform; Synergy®; Infinity TM; VersaHD TM Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: July 31, 2018 Received: August 7, 2018
Dear Mr. Hedges:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jeff Bollyer
for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
Precise Treatment System, Synergy Platform, Synergy, Infinity and Versa HD
Indications for Use (Describe)
The Elekta Medical Linear Accelerator is indicated to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g. lesions, arterio-venous malignant and benign tumors), whilst sparing surrounding normal tissue and critical organs from excess radiation for treatment that includes but is not limited to, malignant and benign brain tumors, brain metastases, spine lesions treated using SRS, squamous cell carcinoma of the head and neck, lung, breast, pancreatic, hepatic malignancies treated using SBRT, prostate, and bone metastases.
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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510(k) SUMMARY
The following information follows the format of 21 CFR 807.92
Date of preparation of summary: 31th July 2018
Submitted by:
| Elekta LimitedLinac House, Fleming Way, Crawley, West SussexRH10 9RR, United KingdomTelephone: +44 (0)1293 654201 | |
|---|---|
| Fax: +44 (0)1293 654321 | |
| Contact name: | Andrew Hedges |
| Trade name: | Precise Treatment System™, Elekta Synergy® Platform,Elekta Synergy®, Elekta Infinity ™ and Versa HD™ |
| Common Name: | Medical Linear Accelerator System |
| Classification Name: | Medical Charged-Particle Radiation Therapy SystemAccelerator, Linear, Medical, 21CFR 892.5050 |
| Product Code: | 90 IYE |
| Predicate Device: | Elekta Limited, K123808 Agility, K051932 Elekta Synergy |
Product Description:
The Elekta Medical Linear Accelerator 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 Medical Linear Accelerator System is currently available in the following model variants – Precise Treatment System, Elekta Synergy Platform, Elekta Infinity and Versa HD.
Intended Use / Indication For Use Statement:
The Elekta Medical Linear Accelerator is indicated to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumors), whilst sparing surrounding normal tissue and critical organs from excess radiation for treatment that includes but is not limited to, malignant and benign brain tumors, brain metastases, spine lesions treated using SRS, squamous cell carcinoma of the head and neck, lung, breast, pancreatic, hepatic malignancies treated using SBRT, prostate, and bone metastases.
Summary of Technological Characteristics:
This premarket notification is not related to any change in the technological characteristics of the medical linear accelerator system and these are unchanged from those of the previously cleared medical device. Elekta has introduced changes to the control software, Integrity™, primarily to provide tighter error detection and to merge the codebase to provide a single release that supports the current hardware platform. There are no novel forms of technology introduced in this premarket notification.
Substantial Equivalence
The functionality of the Elekta Medical Linear Accelerator system is substantially equivalent to that of its predicate device Agility K123808 and its associated linear accelerator, devices in safety and effectiveness. The intended use of the system, principles of operation, technological characteristics are substantially equivalent.
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Summary of performance testing (non clinical)
Testing in the form of module, integration and system level verification was conducted in accordance with FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System standard, ISO 14971 Risk Management Standard, IEC 62304 Software life-cycle processes, and the other FDA recognised consensus standards which includes but is not limited to IEC 60601-1, IEC 60601-2-1, IEC 60601-1-6, IEC 62366-1. Software verification testing was conducted and documented in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for devices that pose a major level of concern (Class C per IEC 62304). Basic safety and essential performance have been satisfied through conformance with device-specific recognised consensus standards, as well as applicable general and collateral safety and essential performance standards for medical devices.
Validation of the integrated system under clinically representative conditions has been performed by competent and professionally qualified personnel. Results from verification and validation testing demonstrate that conformance to applicable technical design specifications have been met and safety & effectiveness has been achieved.
Conclusion:
The results of verification, validation and safety standard testing demonstrate that the Elekta Medical Linear Accelerator system is substantially equivalent to their 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.