K Number
K123808
Device Name
AGILITY
Manufacturer
Date Cleared
2013-04-04

(114 days)

Product Code
Regulation Number
892.5050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed. The associated Integrity R3.1 software is the interface and control software for the Elekta medical digital linear accelerator and is intended 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. Both High Dose Rate mode and flattened beams are intended to be used for single or multiple fractions, delivered as static and/or dynamic, in gated or un-gated deliveries, in all areas of the body where such treatment is indicated. The use of the Agility multileaf collimator in conjunction with an Elekta digital linear accelerator may be helpful in the delivery of 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 Description
This Traditional 510(k) describes changes to the Elekta range of medical linear accelerators when fitted with the Agility multileaf collimator and associated Integrity linac control system. Items added are; High Dose Rate mode x-rays, specific clinical indications for use, and the Response™ gating interface that enables the linac treatment beam to be automatically turned on and off by signals from an external gating device. High Dose Rate mode x-rays are provided by changes to the filtering arrangement to reduce wasteful attenuation of the beam.
More Information

K121328, 983629, K111106

Not Found

No
The summary describes a linear accelerator system with a multileaf collimator and control software, focusing on hardware and software modifications for radiation delivery and gating. There is no mention of AI or ML in the device description, intended use, or performance studies.

Yes
The device is intended to assist in the delivery of radiation for treatment of various medical conditions, including malignant and benign tumors, which constitutes therapeutic use.

No

Explanation: The device is described as a multileaf collimator and software for a linear accelerator, intended for delivering radiation therapy to defined target volumes while sparing normal tissue. This is a therapeutic function, not a diagnostic one.

No

The device description explicitly states it describes changes to "medical linear accelerators when fitted with the Agility multileaf collimator and associated Integrity linac control system," indicating it includes significant hardware components (linear accelerator, multileaf collimator). While software is mentioned as an interface and control system, it is part of a larger hardware system.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes the device as being used for delivering radiation to defined target volumes within the body for therapeutic purposes (treating tumors, lesions, etc.). This is a therapeutic application, not a diagnostic one.
  • Device Description: The device description focuses on the components and functionalities related to shaping and delivering a radiation beam for treatment.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening.

The device is a medical linear accelerator with a multileaf collimator, which is a therapeutic device used in radiation oncology.

N/A

Intended Use / Indications for Use

The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.

The associated Integrity R3.1 software is the interface and control software for the Elekta medical digital linear accelerator and is intended 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.

Both High Dose Rate mode and flattened beams are intended to be used for single or multiple fractions, delivered as static and/or dynamic, in gated or un-gated deliveries. in all areas of the body where such treatment is indicated.

The use of the Agility multileaf collimator in conjunction with an Elekta digital linear accelerator may be helpful in the delivery of 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.

Product codes (comma separated list FDA assigned to the subject device)

IYE

Device Description

This Traditional 510(k) describes changes to the Elekta range of medical linear accelerators when fitted with the Agility multileaf collimator and associated Integrity linac control system. Items added are; High Dose Rate mode x-rays, specific clinical indications for use, and the Response™ gating interface that enables the linac treatment beam to be automatically turned on and off by signals from an external gating device.

High Dose Rate mode x-rays are provided by changes to the filtering arrangement to reduce wasteful attenuation of the beam.
The Elekta range of medical linear accelerators when fitted with the Agility multileaf collimator beam limiting device and its associated linear accelerator control software, Integrity R3.1, and the addition of High Dose Rate mode x-rays and a gating interface do not introduce any novel forms of technology.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

all areas of the body, brain, spine, head and neck, lung, breast, pancreatic, hepatic, prostate, bone

Indicated Patient Age Range

Not Found

Intended User / Care Setting

licensed practitioner

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)

Testing in the form of module, integration and system level verification was performed to evaluate the performance and functionality of the new and existing features against the requirement specification.

Regression testing has been performed successfully to verify the integrity of any changes.

Validation of the 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 assured safety & effectiveness as been achieved.

Testing has been undertaken on production equivalent systems both at Elekta and at hospital sites.

The system is subject to compliance testing to voluntary consensus safety standards. Details of the standards employed in the design are specified in the Standard Data Report in section 9 which includes but is not limited to, IEC 60601-1, IEC 60601-2-1, IEC 62366 and ISO 14971.

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.

Agility (K121328), Varian RPM (983629), Varian TrueBeam Linear Accelerator (K111106)

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

K 123808

510(k) SUMMARY

APR 0 4 2013

Date of preparation of summary: 14th February 2013

Submitted by:

Elekta Limited Linac House, Fleming Way, Crawley, West Sussex RH10 9RR, United Kingdom Telephone: +44 (0)1293 654165 Fax: +44 (0)1293 658445

Contact name: Patrick Hull

Trade Name:AgilityTM
Common Name:Multileaf Collimator
Classification Name:Medical Linear Accelerator Accessory, 21CFR 892.5050
Product Code:IYE
Predicate Devices:Agility™ (K121328), Varian RPM (983629), Varian TrueBeam Linear Accelerator (K111106)

Product Description:

This Traditional 510(k) describes changes to the Elekta range of medical linear accelerators when fitted with the Agility multileaf collimator and associated Integrity linac control system. Items added are; High Dose Rate mode x-rays, specific clinical indications for use, and the Response™ gating interface that enables the linac treatment beam to be automatically turned on and off by signals from an external gating device.

High Dose Rate mode x-rays are provided by changes to the filtering arrangement to reduce wasteful attenuation of the beam.

Indications for Use and Intended Use Statement:

The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.

The associated Integrity R3.1 software is the interface and control software for the Elekta medical digital linear accelerator and is intended 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.

Both High Dose Rate Mode and flattened beams are intended to be used for single or multiple fractions, delivered as static and/or dynamic, in gated or un-gated deliveries, in all areas of the body where such treatment is indicated.

The use of the Aglity multileaf collimator in conjunction with an Elekta digital linear accelerator may be helpful in the delivery of 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:

The Elekta range of medical linear accelerators when fitted with the Agility multileaf collimator beam limiting device and its associated linear accelerator control software, Integrity R3.1, and the addition of High Dose Rate mode x-rays and a gating interface do not introduce any novel forms of technology.

Substantial Equivalence

The functionality of the Elekta medical linear accelerator with Agility™ and High Dose Rate mode is substantially equivalent to that of its predicate device, Agility (K1211328), in safety and effectiveness. The intended use, principles of operation, technological characteristics and labeling are substantially equivalent except for the addition of a number of specific indications for use.

1

Substantial Equivalence Table for High Dose Rate Mode

The primary functional differences between the predicate device and the new device are the changes made to the linac control software and beam filtration to allow the user the option to select unflattened x-ray beams in High Dose Rate mode and the option to fit a gating interface upgrade kit to permit external gating devices to temporarily suspend beam delivery.

| Attributes | Elekta linac with Agility, FFF &
Integrity R3.1 (this submission) | Varian TrueBeam Linear
Accelerator (K111106) |
|-----------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------|
| Physics Performance | | |
| Average transmission through leaf
bank | K123808 510(k)

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