HELAX TMS BRACHYTHERAPY, VERSION 3.0

K962892 · Siemens Medical Solutions USA, Inc. · LNH · Oct 29, 1996 · Radiology

Device Facts

• Record ID: K962892
• Device Name: HELAX TMS BRACHYTHERAPY, VERSION 3.0
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Oct 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

TMS Brachytherapy Version 3.0; integrated work module for 3D radiotherapy treatment planning; interstitial/intracavitary techniques. Inputs: clinical data for source channel definition, source positioning. Processing: manual optimization of source weights; calculation of dose distributions and point dose values in arbitrary sections; evaluation of treatment tactics. Output: radiation dose plans for clinical review. Used in oncology clinics by clinicians. Assists in treatment design; does not perform treatment. Benefits: facilitates precise radiation dose planning.

Clinical Evidence

Bench testing only. System performance verified against system requirements specifications and compared to predicate device; results indicate equivalent performance.

Technological Characteristics

3D Radiotherapy Treatment Planning (RTP) software module. Integrated with TMS radiotherapy treatment planning system. Functionality includes source channel definition, source positioning, manual source weight optimization, and dose distribution calculation.

Indications for Use

Indicated for patients undergoing interstitial or intracavitary radiation therapy requiring 3D treatment planning in an oncology clinic setting.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• PLATO Radiotherapy Treatment Planning System (K915622)

Reference Devices

• TMS (Treatment Management System) radiotherapy treatment planning system (K953391)

Submission Summary (Full Text)

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OCT 29 1996

Summary of Safety and Effectiveness P192
K96 2892

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.

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## 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.