(87 days)
Not Found
No
The description focuses on mechanical scanning and data presentation, with no mention of AI/ML terms or functionalities.
No.
The device is used for quality control and data collection for linear accelerators, not for directly treating patients. It functions as an accessory for analyzing radiation fields, which is a measurement and data collection task, not a therapeutic intervention.
No
The device is used for quality control, acceptance testing, and data collection for linear accelerators, which are therapeutic devices, not for diagnosing medical conditions in patients.
No
The device description explicitly states it consists of hardware components including a water tank, linear scanning guides, and electronic controls, in addition to software.
Based on the provided information, the RPS-50 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the RPS-50 is used as an accessory to a linear accelerator for tasks related to the accelerator's performance and data collection for treatment planning. This involves measuring radiation fields, not analyzing biological samples from the human body.
- Device Description: The device description details a system for scanning radiation fields in a water tank using a detector. This is a physical measurement process, not a diagnostic test performed on biological specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on analysis of biological samples.
The RPS-50 is a device used in the field of radiation therapy physics for quality control and data acquisition related to the radiation delivery equipment. It is not used to diagnose or test a patient directly using biological samples.
N/A
Intended Use / Indications for Use
The RPS-50 is intended to be used as an accessory to a linear accelerator under the direct control of a qualified individual (usually a therapeutic radiation physicist.) The scanner may be used for acceptance testing of new accelerators, quality control of existing accelerators, or for the collection of data necessary for the operation of a computerized treatment planning system.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The RPS-50 scanner consists of a water tank, linear scanning guides, electronic control of movement, chamber bias, and system gain control. A software program controls all movements and necessary electronic signals. The scanner moves a radiation detector through a field of high radiation and presents the collected data as a plot on a computer screen, as a table of data or on a floppy disk suitable for use in a treatment planning system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified individual (usually a therapeutic radiation physicist.)
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)
Not Found
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.
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.
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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
TAB 12. 13 23
PREMARKET NOTIFICATION [510(k)] SUMMARY
Trade Name: RPS-50 Beam Scanner
Common Name: Beam scanner for clinical linear accelerator
Classification Name and Number: None given
Class: Class II, accessory to a linear accelerator
Predicate: A.R.M. beam scanner: control number K933558
Description: The RPS-50 scanner consists of a water tank, linear scanning guides, electronic control of movement, chamber bias, and system gain control. A software program controls all movements and necessary electronic signals. The scanner moves a radiation detector through a field of high radiation and presents the collected data as a plot on a computer screen, as a table of data or on a floppy disk suitable for use in a treatment planning system.
Intended Use: The RPS-50 is intended to be used as an accessory to a linear accelerator under the direct control of a qualified individual (usually a therapeutic radiation physicist.) The scanner may be used for acceptance testing of new accelerators, quality control of existing accelerators, or for the collection of data necessary for the operation of a computerized treatment planning system.
Technological Characteristics: The technological characteristics of the RPS-50 scanner and the predicate device are the same in that both are meant to collect beam data descriptive of the accelerator scanned. The data for both devices is evaluated by a clinical physicist for completeness and accuracy.
Prepared by: Jack C. Sofield, President Sofield Science Services, Inc. Seymour, TN 37865-5017 Tel. 423 573 1795; Fax. 423 577 8713 Date: Mav 21, 1996