(97 days)
No
The description focuses on traditional treatment planning tools and does not mention AI or ML.
No.
This device is a treatment planning system for radiotherapy, not a device that directly performs therapeutic action on a patient. It assists in planning the treatment but does not perform it.
No
Explanation: The device is described as a "3D Radiotherapy Treatment Planning (RTP) system" for "radiation dose planning of patients undergoing interstitial or intracavitary treatment." Its purpose is "planning the treatment only, not for performing the treatment." This indicates it's used for treatment planning, not for diagnosing a disease or condition.
Yes
The device description explicitly states it is a "work module" and "system software" designed to assist in treatment planning, providing tools for data manipulation and visualization. There is no mention of any associated hardware components being part of this specific device submission.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "3D Radiotherapy Treatment Planning (RTP) system for radiation dose planning of patients undergoing interstitial or intracavitary treatment in the Oncology clinic." This describes a system used for planning medical treatment based on imaging and patient data, not for testing samples taken from the human body.
- Device Description: The description focuses on tools for "treatment modelling," "source channel definition," "source positioning," "manual optimisation of source weights," and "presentation of dose distributions." These are all related to planning the delivery of radiation therapy, not performing diagnostic tests on biological samples.
- 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 diagnosis, monitoring, or screening based on laboratory tests.
The device is a radiotherapy treatment planning system, which falls under the category of medical devices used for planning and managing patient treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
90 LHN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
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
§ 892.1000 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.
0
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.
1
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.