RFA-300, LDA UTILITY

K961400 · Scanditronix Medical AB · IYE · Jan 3, 1997 · Radiology

Device Facts

• Record ID: K961400
• Device Name: RFA-300, LDA UTILITY
• Applicant: Scanditronix Medical AB
• Product Code: IYE · Radiology
• Decision Date: Jan 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The Scanditronix Medical RFA-300, LDA Utility is used to more effectively perform radiation therapy beam measurements including acceptance testing, trimming information, routine beam checks and quality assurance measurements and on-line data analyses using personal computer (PC) monitor.

Device Story

The Scanditronix Medical RFA-300, LDA Utility is an accessory system for radiation therapy beam analysis. It utilizes a Linear Detector Array (LDA-11 or LDA-25) to capture radiation beam intensity data. These signals are processed by multichannel electrometers (EMX or DPD-510) and transmitted to a PC. The PC-based software controls the system, performs data analysis, and provides visualization, storage, and transfer of measurements. Used by medical physicists or technicians in clinical settings to verify radiation therapy equipment performance. The output allows clinicians to perform acceptance testing, routine beam checks, and quality assurance, ensuring accurate dose delivery and therapy planning. The device benefits patients by ensuring the precision and safety of radiation therapy equipment.

Clinical Evidence

No clinical data. Bench testing only. Operational parameters and performance were verified against established industry standards (IEC 601-1, IEC 601-1-2, CSA, UL) and compared to predicate device performance.

Technological Characteristics

System consists of Linear Detector Arrays (LDA-11/LDA-25), multichannel electrometers (EMX/DPD-510), and PC-based control software. Operates via solid-state radiation detection. Designed for compliance with IEC 601-1 (electrical safety), IEC 601-1-2 (EMC), and IEC-601C (accelerator performance).

Indications for Use

Indicated for use by medical physicists or technicians for radiation therapy beam measurements, including acceptance testing, trimming, routine beam checks, and quality assurance in clinical radiation therapy environments.

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

• RFA-300 (Scanditronix Medical AB, K934303)
• Wellhöfer WP600 (K882770)
• Wellhöfer MDA

Submission Summary (Full Text)

{0}

510(k) Notification for Scanditronix Medical RFA-300, LDA Utility, Appendix VI.

# 510(k) Summary

$k961400$

$Jan 3, 1997$

This summary is submitted in compliance with the FDA interim rule as published 28 April 1992 in 21 CFR 807.92:

(a) (1) Submitted by:
Scanditronix Medical AB
Stålgatan 14,
S-754 50 Uppsala
Sweden

Contact Persons:
Lars Göran Larsson
[phone]
or
Görgen Nilsson
[phone]

Date of preparation:
28 Mar 1996

(2) Trade name of device:
Scanditronix Medical RFA-300, LDA Utility

Common name:
Radiation field analyzer, LDA

Classification name:
(Accessory to)Radionuclide radiation therapy system, §892,5750; and X-ray radiation therapy system, §892,5900.

(3) Identification of predicate marketed device:
RFA-300 (Scanditronix Medical AB, or legally K934303 / S1), Wellhöfer WP600 (Medical Physics instrumentation, K882770) and Wellhöfer MDA (Medical Physics instrumentation).

(4) Description of the devise:
The Scanditronix Medical RFA-300, LDA Utility is an extension to the RFA-300 system used to measure radiation therapy beam intensity. For use, a complete RFA-300 system is needed extended with the following equipment:
1. Multichannel electrometers (EMX) which provides 12 independent electrometer channels each or a DPD-510 which provides 10 independent electrometer channels.
2. Linear Detector Array LDA-11 (11 detectors) or LDA-25 (25 detectors).
3. PC-based software providing control, display, calibration and save functions.

(5) Intended uses:
The Scanditronix Medical RFA-300, LDA Utility is used to more effectively perform radiation therapy beam measurements including acceptance testing, trimming information, routine beam checks and

96-03-28 LGL

365

{1}

510(k) Notification for Scanditronix Medical RFA-300, LDA Utility, Appendix VI.

quality assurance measurements and on-line data analyses using personal computer (PC) monitor.

These uses are similar to those of the predicate identified in section (3) of this Summary.

(6) Technological comparison:

The Scanditronix Medical RFA-300, LDA Utility, is similar to the predicate marketed device in that radiation beam measurements are made using solid state, single or multi, detectors connected to electrometers which converts data into formats suitable for tabulation, display, or transfer to therapy planning systems. Control of the system is based on the software in a PC which also provides for display, storage, or transfer of data.

(b) (1) Non-Clinical tests:

Comparison of operational characteristics for the Scanditronix Medical RFA-300, LDA Utility and the predicate product show similar results that are suitable for their intended purpose. To minimize potential electrical hazards, Scanditronix Medical adheres to recognized and established industry practice, and all devices are subject to final performance testing. The Scanditronix Medical RFA-300, LDA Utility is designed for conformance with IEC 601-1 standards for electrical isolation, and meets electrical performance standards for CSA and UL certifications. In addition, IEC-601C standards for accelerator performance are used as minimum criteria of measurement and data processing capabilities of the Scanditronix Medical RFA-300, LDA. The Scanditronix Medical RFA-300, LDA Utility has been tested and found to fulfil the requirements concerning electromagnetic compatibility according to the standard IEC 601-1-2 (see appendix XVIII).

(2) Clinical tests:

Due to the fact that the system is not directly involved with patients, no clinical testing was performed.

(3) Test conclusions:

Testing of operational parameters for the Scanditronix Medical RFA-300, LDA Utility, indicate that the device is safe, that it provides appropriate verification and dose measurements of radiation beams, and that it performs as well as or better than the legally marketed predicate device identified in section (3) of this summary.

96-03-28 LGL

304 2(2)