(40 days)
Not Found
No
The summary describes a hardware component (multileaf collimator) and its control software. While it mentions an optical and machine vision system for leaf tracking, there is no mention of AI or ML being used for decision-making, control, or analysis. The testing described is standard verification and validation, not performance studies typical of AI/ML devices.
Yes
The device is described as assisting a licensed practitioner in the delivery of radiation to defined target volumes (e.g., lesions, malignant and benign tumors), which is a therapeutic intervention.
No
Explanation: The device, the Agility multileaf collimator and its associated software, is described as a beam limiting device for a linear accelerator used in radiation delivery to treat conditions like tumors. Its purpose is to conform the radiation beam to the anatomy for treatment, not to diagnose medical conditions.
No
The device description clearly states that this 510(k) describes the addition of a new hardware component, the Agility multileaf collimator, to an existing linear accelerator, along with its associated control software. While software is involved, it is integral to the operation of the hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for delivering radiation to defined target volumes within the body for therapeutic purposes (treating lesions, tumors, etc.). This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a multileaf collimator and associated software for controlling a linear accelerator, which is a device used for radiation therapy.
- 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 treatment.
The device is a component of a medical linear accelerator used for radiation therapy, which falls under the category of therapeutic medical devices, not in vitro diagnostics.
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 R3.0 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. It is intended to be used for single or multiple fractions. delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
This Traditional 510(k) describes the addition of the new Agility multileaf collimator beam limiting device and its associated control software to the Elekta medical linear accelerator. The new device has 160 leaves of 5mm width at isocenter, a fast leaf speed of up to 65 mm/s, low leakage (
§ 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
JUN 1 2 2012
510(k) SUMMARY
Date of preparation of summary: 27th April 2012
Submitted by:
Elekta Limited Linac House, Fleming Way, Crawley, West Sussex RH10 9RR, United Kingdom Telephone: +44 (0)1293 654422 Fax: +44 (0)1293 654260
ontact name: Patrick Hull
Trade Name: | Agility ™ |
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Common Name: | Multileaf Collimator |
Classification Name: | Medical Linear Accelerator Accessory, 21CFR 892.5050 |
Product Code: | IYE |
Predicate Device: | MLCi2 (K082122) |
Product Description:
This Traditional 510(k) describes the addition of the new Agility multileaf collimator beam limiting device and its associated control software to the Elekta medical linear accelerator. The new device has 160 leaves of 5mm width at isocenter, a fast leaf speed of up to 65 mm/s, low leakage ( The associated Integrity R3.0 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. It is intended to be used for single or multiple fractions. delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign-Off)
Division of Radiologic Office of In Vitro Diagnostic Device Evaluati 510K
2012/04/14 | Agility ™ | Document 04 - 01 |
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© 2012 Elekta Limited, Crawley, UK. All rights reserved. | Page 1 of 1 |