(97 days)
The TMS Brachytherapy Module, Version 3.0, is a 3D Radiotherapy Treatment Planning (RTP) system for radiation dose planning of patients undergoing interstitial or intracavitary treatment in the Oncology clinic. The system software is designed to function as an integrated part of the TMS (Treatment Management System) radiotherapy treatment planning system (K953391). The TMS Brachytherapy Module is used for planning the treatment only, not for performing the treatment.
TMS Brachytherapy is an integrated work module for treatment modelling of interstitial and intracavity Brachytherapy treatment techniques. The work module is designed to assist in treatment planning in accordance with the broad range of clinical routines and therapy techniques. The TMS Brachytherapy work module provides support in treatment design by supplying tools for source channel definition, source positioning, manual optimisation of source weights, presentation of dose distributions, and point dose values in arbitrary sections and evaluation of treatment tactics. The structure of the work module parallels that of the external beam module in the design of the user interface.
This document does not contain the information required to populate the requested table and study details. This document is a 510(k) summary for a brachytherapy treatment planning system. It describes the device, its intended use, and states that its technological characteristics and performance are equivalent to a predicate device.
Specifically, the document lacks:
- A defined set of acceptance criteria (e.g., specific accuracy metrics, thresholds).
- Any reported device performance values against such criteria.
- Details about a specific study involving a test set, including sample size, data provenance, number/qualifications of experts, or adjudication methods.
- Information on Multi-Reader Multi-Case (MRMC) studies or standalone algorithm performance.
- Details about the type of ground truth used or how it was established for either testing or training.
- Information regarding a training set's sample size or ground truth establishment.
The "Performance Evaluation" section merely states that "the TMS Brachytherapy system consistently performed within its system requirements specifications and equivalently to the predicate device," without providing specific data or a study design to support this claim in the context of the requested details.
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OCT 2 9 1996
Summary of Safety and Effectiveness 81 92 1962892
| 1. Submittor's Information: | Dated: July 19, 1996 | |
|---|---|---|
| Siemens Medical Systems | ||
| Oncology Care Systems Group | ||
| 4040 Nelson Avenue | ||
| Concord, CA 94520 | ||
| Contact Person: | Kenneth R. Michael, Pharm.D.Vice President Regulatory Affairs and Quality Assurance | |
| 2. Common or Usual Name: | Brachytherapy Treatment Planning | |
| Proprietary Name: | Helax TMS Brachy Version 3.0 | |
| Classification Names: | Class: II, Product Code: 90 LHN | |
| 3. Predicate Device: | PLATO Radiotherapy Treatment Planning System,NUCLETRON Corporation, Columbia MD (USA)K915622 |
4. Description of Device:
TMS Brachytherapy is an integrated work module for treatment modelling of interstitial and intracavity Brachytherapy treatment techniques. The work module is designed to assist in treatment planning in accordance with the broad range of clinical routines and therapy techniques. The TMS Brachytherapy work module provides support in treatment design by supplying tools for source channel definition, source positioning, manual optimisation of source weights, presentation of dose distributions, and point dose values in arbitrary sections and evaluation of treatment tactics. The structure of the work module parallels that of the external beam module in the design of the user interface.
5. Statement of Intended Use:
The TMS Brachytherapy Module, Version 3.0, is a 3D Radiotherapy Treatment Planning (RTP) system for radiation dose planning of patients undergoing interstitial or intracavitary treatment in the Oncology clinic. The system software is designed to function as an integrated part of the TMS (Treatment Management System) radiotherapy treatment planning system (K953391). The TMS Brachytherapy Module is used for planning the treatment only, not for performing the treatment.
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The intended use is the same as the predicate device.
14962892 P 2012 - 1
6. Technological Characteristics
The predicate device is presently in commercial distribution in the United States. The TMS Brachytherapy system has the same technological characteristics and is similar in design, function, and application to the predicate device.
The Technological Characteristics are the same as the predicate device.
7. Differences:
There are no differences between the technology of the predicate device and the Helax TMS Brachy Version 3.0 system. Minor differences in configuration and specifications as noted in the predicate device comparison chart do not alter the intended use or affect the safety and effectiveness of the TMS Brachytherapy system when used as labeled.
8. Performance Evaluation:
The test results summarized in the Summary Test Report and in the Safety and Effectiveness Test Report indicate that the TMS Brachytherapy system consistently performed within its system requirements specifications and equivalently to the predicate device.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.