Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD

K182138 · Eleckta Limited · IYE · Sep 5, 2018 · Radiology

Device Facts

• Record ID: K182138
• Device Name: Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD
• Applicant: Eleckta Limited
• Product Code: IYE · Radiology
• Decision Date: Sep 5, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Medical linear accelerator system for image-guided radiation therapy; delivers ionizing radiation to defined target volumes (lesions, tumors, malformations) while sparing surrounding healthy tissue. Used in clinical settings by licensed practitioners (radiation oncologists/therapists). System includes beam shaping components, imaging, and patient positioning accessories. Device transforms treatment plans into precise radiation delivery. Output assists clinicians in targeting malignancies; enables SRS and SBRT procedures. Benefits include localized tumor control with reduced collateral damage to critical organs. Subject of this notification is an update to the Integrity control software to improve error detection and unify the codebase across hardware platforms.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation included module, integration, and system-level testing per FDA Quality System Regulation (21 CFR 820), ISO 13485, ISO 14971, and IEC 62304. Conformance to consensus standards (IEC 60601-1, IEC 60601-2-1, IEC 60601-1-6, IEC 62366-1) confirmed basic safety and essential performance.

Technological Characteristics

Medical linear accelerator with beam shaping and imaging. Software: Integrity control software. Standards: ISO 13485, ISO 14971, IEC 62304, IEC 60601-1, IEC 60601-2-1, IEC 60601-1-6, IEC 62366-1. No changes to hardware technological characteristics.

Indications for Use

Indicated for patients requiring radiation therapy for malignant and benign tumors, including brain tumors, brain metastases, spine lesions (SRS), head and neck squamous cell carcinoma, lung, breast, pancreatic, hepatic malignancies (SBRT), prostate cancer, and bone metastases.

Regulatory Classification

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.

Predicate Devices

• Agility (K123808)
• Elekta Synergy (K051932)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

K182138

#### 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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 Limited<br>Linac House, Fleming Way, Crawley, West Sussex<br>RH10 9RR, United Kingdom<br>Telephone: [phone] |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------|
| | Fax: [phone] |
| Contact name: | Andrew Hedges |
| Trade name: | Precise Treatment System™, Elekta Synergy® Platform,<br>Elekta Synergy®, Elekta Infinity ™ and Versa HD™ |
| Common Name: | Medical Linear Accelerator System |
| Classification Name: | Medical Charged-Particle Radiation Therapy System<br>Accelerator, 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.