(232 days)
No
The summary describes a traditional 3D radiotherapy treatment planning system using established algorithms (convolution/superposition, generalized Gaussian pencil beam) and does not mention any AI or ML components.
No
The device is described as a "3D Radiotherapy Treatment Planning (RTP) system" used for planning radiation treatments, not for actually delivering the therapy itself.
No
The device is a 3D Radiotherapy Treatment Planning (RTP) system used to plan radiation treatments, not to diagnose medical conditions.
No
The device is described as a "3D Radiotherapy Treatment Planning (RTP) system" which implies it is a software system, but the description of performance tests and comparison to a predicate device (another treatment planning system) suggests it is a complete system, not solely software. The summary does not explicitly state it is software-only and the context of a treatment planning system typically involves hardware components for data input and output.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a "3D Radiotherapy Treatment Planning (RTP) system for radiation dose planning of patients undergoing external beam treatment." It uses imaging data (implied by "3D") to plan radiation therapy, which is a treatment, not a diagnostic test performed on a specimen.
- Intended Use: The intended use is to "plan radiation treatments," not to diagnose a condition based on a sample.
- Device Description: The description focuses on the software algorithms for dose calculations and the planning process, not on analyzing biological samples.
Therefore, based on the provided information, this device falls under the category of a treatment planning system for radiation therapy, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
TMS is used to plan radiation treatments with linear accelerators and other similar teletherapy devices with x-ray energies from 4 to 50MV, as well as Cobalt-60, and electron energies from 4 to 50 MeV. TMS will plan the 3D radiotherapy treatment approaches of combined modality plans, asymmetric and noncoplanar fields; total body irradiation (TBI); multi-leaf collimators (MLC); motorized and dynamic wedges; customized blocking; compensating filters (CF); and bolus, Export capabilities exist as part of TMS to venfy beam and patient data, dose planning results, and provide on-line information to block-cutting devices and (CF) milling machines. The intended use is the same as the predicate device.
Product codes
LHN
Device Description
The Siemens Medical Systems, Oncology Care Systems Group TMS is a 3D Radiotherapy Treatment Planning (RTP) system for radiation dose planning of patients undergoing external beam treatment in the Oncology clinic. TMS is a 3-D system, using modern algorithms for dose calculations. A convolution/superposition pencil beam algorithm is used for photons and a generalized Gaussian pencil beam model is used for electrons. The system software is designed to lead the user through a logical flow planning process.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Oncology clinic
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Performance tests were conducted and the results indicated that the system consistently performed within the design parameters and equivalently to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
7 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
- Submitter's Information: Dated: November 27, 1995 Siemens Medical Systems Oncology Care Systems Group 4040 Nelson Avenue Concord, CA 94520
Contact Person: Kenneth R. Michael, Pharm.D. Vice President Requlatory Affairs and Quality Assurance
TREATMENT PLANNING SYSTEM (TMS) デ 2. Common or Usual Name: V2.10 Proprietary Name: TMS Classification Name: Medical Charged-Particle Radiation Therapy System 21 CFR 892.5050 Class II, Product Code: RA 90 LHN
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- Predicate Device: SCANDIPLAN 3-Dimensional Radiation Therapy Treatment Planning System K914926 Scanditronix
4. Description of Device:
The Siemens Medical Systems, Oncology Care Systems Group TMS is a 3D Radiotherapy Treatment Planning (RTP) system for radiation dose planning of patients undergoing external beam treatment in the Oncology clinic. TMS is a 3-D system, using modern algorithms for dose calculations. A convolution/superposition pencil beam algorithm is used for photons and a generalized Gaussian pencil beam model is used for electrons. The system software is designed to lead the user through a logical flow planning process.
5. Statement of intended use:
TMS is used to plan radiation treatments with linear accelerators and other similar teletherapy devices with x-ray energies from 4 to 50MV, as well as Cobalt-60, and electron energies from 4 to 50 MeV. TMS will plan the 3D radiotherapy treatment approaches of combined modality plans, asymmetric and noncoplanar fields; total body irradiation (TBI); multi-leaf collimators (MLC); motorized and dynamic wedges; customized blocking; compensating filters (CF); and bolus,
1
ટાદ ભદ્રાદ TMS 510(K) Notification
Export capabilities exist as part of TMS to venfy beam and patient data, dose planning results, and provide on-line information to block-cutting devices and (CF) milling machines.
The intended use is the same as the predicate device.
6. Statement of technological characteristics:
The Treatment Management System has no significant change in design, materials, energy source or other technological characteristics compared to the predicate device.
The intended use and the technological characteristics are the same as the predicate device and therefore we believe it is substantially equivalent to it.
7. Differences:
The minor configuration differences between the Treatment Management System and the predicate device do not alter the intended use or affect the safety and effectiveness of the TMS when used as labeled.
Special Controls:
Although there are no performance standards established by the FDA for these devices, TMS has been designed, and manufactured to meet the following standards:
| IEC 601-1 | Medical electrical equipment - General requirements for safety |
|---|---|
| IEC 601-1.1 Safety requirements for medical electrical systems | |
| Company of the country of the country of the county of the county of the county of the county of the county of the county of the county of the county of the county of the cou | and the same of the same of the same of the same of the same of the same of the seat of the seat of the seat of the seat of the seat of the seat of the seat of the seat of th |
Graphical symbols for electrical equipment in medical practice IEC 878
The device and its development process also comply with the FDA, CDRH, ODE, August 29, 1991, Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review.
Performance tests were conducted and the results indicated that the system consistently performed within the design parameters and equivalently to the predicate device.