TREATMENT MANAGEMENT SYSTEM

K953391 · Siemens Medical Solutions USA, Inc. · LHN · Mar 7, 1996 · Radiology

Device Facts

• Record ID: K953391
• Device Name: TREATMENT MANAGEMENT SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LHN · Radiology
• Decision Date: Mar 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

TMS 1/2.10 is a 3D radiotherapy treatment planning system used in oncology clinics by clinicians to plan external beam radiation. Input data includes patient anatomy and beam parameters. The system utilizes a convolution/superposition pencil beam algorithm for photons and a generalized Gaussian pencil beam model for electrons to calculate radiation dose distributions. Output includes treatment plans, beam data, and control information for block-cutting devices and compensating filter milling machines. The system guides users through a logical planning workflow to optimize treatment approaches, including multi-leaf collimators, dynamic wedges, and customized blocking. It facilitates clinical decision-making by providing precise dose calculations, potentially improving treatment accuracy and patient outcomes.

Clinical Evidence

Bench testing only. System performance verified against design parameters and compared to predicate device. Compliance with IEC 601-1, IEC 601-1.1, and IEC 878 standards, and FDA Reviewer Guidance for Computer Controlled Medical Devices (1991).

Technological Characteristics

3D radiotherapy treatment planning software. Complies with IEC 601-1, IEC 601-1.1, and IEC 878. Features export capabilities for block-cutting and milling machines. Dose calculation algorithms: convolution/superposition pencil beam (photons) and generalized Gaussian pencil beam (electrons).

Indications for Use

Indicated for patients undergoing external beam radiation therapy requiring 3D treatment planning for x-ray energies 4-50MV, Cobalt-60, or electron energies 4-50 MeV.

Regulatory Classification

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.

Predicate Devices

• SCANDIPLAN 3-Dimensional Radiation Therapy Treatment Planning System (K914926)

Submission Summary (Full Text)

{0}

SIEMENS TMS 510(K) Notification
SIEMENS TREATMENT PLANNING SYSTEM
K953391

# SUMMARY OF SAFETY AND EFFECTIVENESS

MAR - 7 1996

1. 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 Regulatory Affairs and Quality Assurance

2. Common or Usual Name: TREATMENT PLANNING SYSTEM (TMS)
Proprietary Name: TMS 1/2.10
Classification Name:
Medical Charged-Particle Radiation Therapy System
21 CFR 892.5050
Class II, Product Code: RA 90 LHN

3. 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.

Page 6

{1}

STEMENS TMS 510(K) Notification

Export capabilities exist as part of TMS to verify 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
IEC 878 Graphical symbols for electrical equipment in medical practice

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.

ATTACHMENT H
Page 7