(267 days)
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No
The summary describes a system for measuring radiation therapy beam intensity using electrometers and detector arrays controlled by PC software. There is no mention of AI, ML, image processing, or any characteristics typically associated with AI/ML algorithms. The performance study focuses on comparing operational characteristics to a predicate device, not on the performance metrics common for AI/ML systems.
No
The device is used to measure radiation therapy beam intensity and perform quality assurance measurements for radiation therapy equipment, not to deliver therapy to a patient.
No.
The device is used to measure radiation therapy beam intensity for quality assurance and acceptance testing, not to diagnose a medical condition in a patient.
No
The device description explicitly states that the software is an "extension to the RFA-300 system" and requires additional hardware components (Multichannel electrometers and Linear Detector Array) for its intended use. Therefore, it is not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "perform radiation therapy beam measurements." This is a measurement of the radiation beam itself, not a test performed on a biological sample (like blood, urine, or tissue) to diagnose a disease or condition.
- Device Description: The description details components used to measure radiation intensity (electrometers, detector arrays). There is no mention of reagents, samples, or procedures related to analyzing biological specimens.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples
- Diagnosis, monitoring, or screening of diseases
- Use in a laboratory setting for patient testing
The device is used for quality assurance and measurement of a medical device (a radiation therapy machine), which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for 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.
Product codes
Not Found
Device Description
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:
- Multichannel electrometers emX which provides 12 independent 1. electrometer channels each or a DPD-510 which provides 10 independent electrometer channels.
-
- Linear Detector Array LDA-11 (11 detectors) or LDA-25 (25 detectors).
-
- PC-based software providing control, display, calibration and save functions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
RFA-300 (Scanditronix Medical AB, or legally K934303 / S1) , Wellhöfer WP600 (Medical Physics instrumentation, K882770) and Wellhöfer MDA ( Medical Physics instrumentation).
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
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
510(k) Summary
961400 Jan 3, 199-
This summery 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
+46 18 18 08 52
or
Görgen Nilsson
+46 18 18 08 94 |
| | | 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: -
Multichannel electrometers emX which provides 12 independent 1. electrometer channels each or a DPD-510 which provides 10 independent electrometer channels.
-
- Linear Detector Array LDA-11 (11 detectors) or LDA-25 (25 detectors).
-
- 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
1(2)
1
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.
-
Technological comparison: (6)
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. -
Non-Clinical tests: (b) (1)
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 XVII). -
Clinical tests: (2)
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.
304
2(2)