(95 days)
Entry-level EMLA (Synergy Platform/Synergy)
• The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licenced medical practitioner.
• It is intended to assist a licenced medical practitioner in the delivery of EBRT to defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation. It is 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.
• 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.
Mid-level EMLA (Infinity)
• The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licenced medical practitioner.
• It is intended to assist a licenced medical practitioner in the delivery of EBRT to defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation. 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.
• 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.
High-level EMLA (Versa HD)
• The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licenced medical practitioner.
• It is intended to assist a licenced practitioner in the delivery of EBRT to defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions using standard fractionation, 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.
• 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 and for the treatment of functional disorders, such as trigeminal neuralgia.
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 Synergy, Elekta Infinity and Versa HD.
This document, K192242, is an FDA 510(k) premarket notification for an Elekta Medical Linear Accelerator system. It outlines the device's indications for use and asserts its substantial equivalence to a predicate device (EMLA K182138).
Crucially, this document does not describe a study that proves the device meets specific acceptance criteria based on performance metrics (e.g., accuracy, sensitivity, specificity) for an AI/ML component. Instead, the notification primarily concerns restructuring and clarifying the Indications for Use statements for different models of the linear accelerator.
The "Summary of performance testing (non-clinical)" section explicitly states: "Since no changes to the hardware or software was made in this submission, no additional non-clinical testing has been conducted." Similarly, for "Summary of performance testing (clinical)", it mentions, "The only change in this submission concern Indications for Use. An extensive literature search was conducted to collect and analyze available clinical evidence in order to support new Indications for Use."
Therefore, based on the provided text, it is not possible to complete the requested information about acceptance criteria and a study demonstrating device performance for an AI/ML component. The document does not contain such a study or performance metrics.
However, if we were to infer the types of information that would be present in such a study, and filling in with "N/A" or "Not provided" for elements not found in the text, here's how the table and subsequent points would be structured:
Acceptance Criteria and Device Performance Study Information (Based on the supplied document, which does not contain this data):
As the provided FDA 510(k) notification (K192242) for the Elekta Medical Linear Accelerator focuses on clarifying Indications for Use and asserts substantial equivalence without new performance testing, the specific details regarding acceptance criteria and a study proving an AI/ML device meets these criteria are not available in the document. The document explicitly states no changes were made to hardware or software and no additional non-clinical testing was conducted for this submission.
Therefore, the following table and subsequent points will indicate "Not Provided" or "N/A" for the requested information, as it is not present in the given text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric | Acceptance Threshold | Reported Device Performance |
|---|---|---|---|
| Device Performance | N/A | N/A | N/A |
| Safety | N/A | N/A | N/A |
| Effectiveness | N/A | N/A | N/A |
| Clinical Efficacy | N/A | N/A | N/A |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not provided. The submission states that no new non-clinical testing was conducted, and for clinical "performance," an extensive literature search was performed, not a new clinical study with a defined test set.
- Data Provenance: The document refers to "extensive literature search" for clinical evidence, but does not detail the origin (e.g., country of origin, retrospective/prospective nature) of data within that literature.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable as no specific test set requiring expert-established ground truth for an AI/ML component's performance is described in this submission. The "ground truth" for the current submission is based on existing clinical literature supporting the general use of linear accelerators for radiation therapy.
4. Adjudication Method for the Test Set
- Not applicable as no specific test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The document does not describe any MRMC study.
- Effect size of human reader improvement with AI vs. without AI assistance: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? No. The document refers to the Elekta Medical Linear Accelerator system as a whole, not a specific standalone AI algorithm, and states no new non-clinical testing was performed.
7. Type of Ground Truth Used for the Test Set
- Not applicable for a performance study of an AI/ML component. The current submission's "ground truth" for its claims relates to the well-established clinical indications for external beam radiation therapy, supported by existing literature.
8. Sample Size for the Training Set
- Not applicable as no AI/ML training set is described in this submission, which focuses on device indications and substantial equivalence rather than a new AI component's development or validation.
9. How Ground Truth for the Training Set Was Established
- Not applicable.
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November 22, 2019
Elekta Limited % Ms. Irina Proutski Senior Regulatory Affairs Consultant Linac House, Fleming Way Crawley, West Sussex RH10 9RR UNITED KINGDOM
Re: K192242
Trade/Device Name: Precise Treatment System™, Elekta Synergy® Platform, Elekta Synergy® Elekta Infinity™ and Versa HD™ Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: August 6, 2019 Received: August 22, 2019
Dear Ms. Proutski:
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.
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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 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 medical devices and radiation-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.
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192242
Device Name
Precise Treatment System™, Elekta Synergy® Platform, Elekta Synergy®, Elekta InfinityTM and Versa HDTM
Indications for Use (Describe)
Entry-level EMLA (Synergy Platform/Synergy)
• The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licenced medical practitioner.
· It is intended to assist a licenced medical practitioner in the delivery of EBRT to defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation. It is 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.
• 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.
Mid-level EMLA (Infinity)
· The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licenced medical practitioner.
· It is intended to assist a licenced medical practitioner in the delivery of EBRT to defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation. 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.
• 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.
High-level EMLA (Versa HD)
· The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licenced medical practitioner.
· It is intended to assist a licenced practitioner in the delivery of EBRT to defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions using standard fractionation, 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.
• 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 and for the treatment of functional disorders, such as trigeminal neuralgia.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) SUMMARY
The following information follows the format of 21 CFR 807.92
Date of preparation of summary: 25th October 2019
Submitted by:
| Elekta LimitedLinac House, Fleming Way, Crawley, West SussexRH10 9RR, United KingdomTelephone: +44 (0)1293 654201 | |
|---|---|
| Fax: +44 (0)1293 654321 | |
| Contact name: | Irina Proutski |
| Trade name: | Precise Treatment System™, Elekta Synergy®Platform, Elekta Synergy®, Elekta Infinity ™ and VersaHD ™ |
| Common Name: | Elekta Medical Linear Accelerator System |
| Classification Name: | Medical Charged-Particle Radiation Therapy SystemAccelerator, Linear, Medical, 21CFR 892.5050 |
| Product Code: | 90 IYE |
| Predicate Device: | EMLA K182138 |
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 Synergy, Elekta Infinity and Versa HD.
| Product | Proposed Indications for Use |
|---|---|
| Entry-level EMLA(Synergy1/SynergyPlatform) | The Elekta Medical Linear Accelerator (EMLA) is intended to beused for external beam radiation therapy (EBRT) treatments asdetermined by a licenced medical practitioner. It is intended to assist a licenced medical practitioner in thedelivery of EBRT to defined target volumes, while sparingsurrounding normal tissue and critical organs from excessradiation. It is intended to be used for single or multiple fractionsusing standard dose fractionation, hyperfractionation, andhypofractionation in all areas of the body where such treatment isindicated. The EMLA is indicated for the delivery of curative and palliativeintent EBRT to Adult and Pediatric patients with primary benignand malignant tumor and metastasis (or secondaries) anywherein the body. |
| Mid-level EMLA(Infinity2) | The Elekta Medical Linear Accelerator (EMLA) is intended to beused for external beam radiation therapy (EBRT) treatments asdetermined by a licenced medical practitioner. |
Intended Use / Indication For Use Statement:
1 Synergy and Synergy Platform ads the Trade Names and are used with the Entry-level EMLA
interchangeably
2 Infinity is a Trade Name and used with Mid-level EMLA interchangeably
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| Addition of KV imaging(XVI) | It is intended to assist a licenced medical practitioner in thedelivery of EBRT to defined target volumes, while sparingsurrounding normal tissue and critical organs from excessradiation. It is intended to be used for single or multiple fractionsusing standard dose fractionation, hyperfractionation,hypofractionation and stereotactic delivery (stereotactic bodyradiation therapy - SBRT: stereotactic ablative radiotherapy– SABR) in all areas of the body where such treatment isindicated. The EMLA is indicated for the delivery of curative and palliativeintent EBRT to Adult and Pediatric patients with primary benignand malignant tumor and metastasis (or secondaries) anywherein the body. |
|---|---|
| High-level EMLA(Versa HD3)Addition of High Dose RateMode (HDRM) | The Elekta Medical Linear Accelerator (EMLA) is intended to beused for external beam radiation therapy (EBRT) treatments asdetermined by a licenced medical practitioner. It is intended to assist a licenced practitioner in the delivery ofEBRT to defined target volumes, while sparing surroundingnormal tissue and critical organs from excess radiation. It isintended to be used for single or multiple fractions using standardfractionation, hyperfractionation, hypofractionation andstereotactic delivery (stereotactic body radiation therapy -SBRT: stereotactic ablative radiotherapy – SABR;stereotactic radio surgery - SRS) in all areas of the body wheresuch treatment is indicated. The EMLA is indicated for the delivery of curative and palliativeintent EBRT to Adult and Pediatric patients with primary benignand malignant tumor and metastasis (or secondaries) anywherein the body and for the treatment of functional disorders,such as trigeminal neuralgia. |
Whilst the Indications for Use statement is restructured into three statements, these updates do not represent significant changes and serve primarily to improve clarity on capabilities of each configuration.
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 (EMLA, K182138) or the software used in the device. 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 EMLA K182138 in safety and effectiveness. The principles of operation and technological characteristics are substantially equivalent.
Summary of performance testing (non-clinical)
Testing in the form of module, integration and system level verification was included in the previous submission K182138. Since no changes to the hardware or software was made in this submission, no additional non-clinical testing has been conducted. The bench testing provided in the previous submission still applies.
Summary of performance testing (clinical)
3 Versa HD is a Trade Name and used with High-level EMLA interchangeably
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The only change in this submission concern Indications for Use. An extensive literature search was conducted to collect and analyze available clinical evidence in order to support new Indications for Use.
Conclusion:
An analysis of scientific literature demonstrated that the proposed Indications for Use are supported by existing clinical evidence. The Elekta Medical Linear Accelerator system continues to be safe and effective and it 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.