SIMVIEW 3000 CT OPTION

K953233 · Siemens Medical Solutions USA, Inc. · KPQ · Nov 29, 1996 · Radiology

Device Facts

• Record ID: K953233
• Device Name: SIMVIEW 3000 CT OPTION
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: KPQ · Radiology
• Decision Date: Nov 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5840
• Device Class: Class 2

Indications for Use

The SIMPLI C.T. Option for the SIMVIEW™ 3000 radiation therapy is used for the following: 1. To obtain CT images in the same position as the treatment. 2. To provide CT images to determine the contour of the patient. 3. To provide CT images to determine the size and location of internal structures. 4. To provide CT images to be used by the dosimetrist to determine the location of isocenter. 5. To provide tissue density information via Hounsfield numbers, which allows for more accurate calculations of the dose by accounting for variations in tissue densities. The intended use is the same as the predicate devices.

Device Story

SIMPLI C.T. is an add-on option for the SIMVIEW™ 3000 radiation therapy simulation system. It utilizes a rotating gantry and microprocessor-controlled solid-state electronics to acquire CT images of patients in their treatment position. The system generates CT images providing patient contours, internal structure size/location, and Hounsfield unit-based tissue density data. These outputs are used by dosimetrists and medical practitioners to determine the treatment isocenter and perform accurate radiation dose calculations. The device is intended for use in clinical radiation therapy environments by trained medical professionals.

Clinical Evidence

Bench testing only. Performance tests were conducted to verify that the system meets design parameters and performs equivalently to predicate devices. No clinical data provided.

Technological Characteristics

Microprocessor-controlled solid-state electronics, rotating gantry, and patient support couch. Complies with IEC 601-1 (General safety), IEC 601-1.1 (Medical electrical systems), IEC 601-2-29 (Radiotherapy simulators), IEC 1168 (Functional performance), and IEC 878 (Graphical symbols).

Indications for Use

Indicated for patients undergoing radiation therapy requiring CT imaging for treatment planning, including patient contouring, internal structure localization, isocenter determination, and tissue density assessment for dose calculation.

Regulatory Classification

Identification

A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. 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

• SIMULIX-MC-CT-EXTENSION Oldelft Corporation of America Treatment Planning Simulator (K912466)
• XIMATRON /CT, Varian Associates Treatment Planning Simulator (K853349, 82K0274)

Submission Summary (Full Text)

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STEMENS
SIMPLI C.T. Option for the SIMVIEW™ 3000 · 510(k) Notification

NOV 29 1996

11953233

## ATTACHMENT E

## SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 based on the format in the interim rule for 21 CFR § 807.92 as published in the Federal Register, April 28, 1992.

ATTACHMENT E

{1}

SIEMENS
SIMPLI C.T. Option for the SIMVIEW™ 3000 510(k) Notification

# SUMMARY OF SAFETY AND EFFECTIVENESS

1. **Submitter's Information:**
Dated: June 22, 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:**
CT Option for Radiation Therapy Simulation System

**Proprietary Name:**
SIMPLI C.T.

**Classification Names:**
Radiation Therapy Simulation System - 21 CFR § 892.5840
Class II, Product Code: RA 90 KPQ

3. **Predicate Devices:**
- SIMULIX-MC-CT-EXTENSION Oldelft Corporation of America
Treatment Planning Simulator, K912466
- XIMATRON /CT, Varian Associates
Treatment Planning Simulator, K 853349, 82K0274

4. **Description of Device:**
The SIMPLI C.T. Option for the SIMVIEW™ 3000 provides therapeutic quality CT images at simulation for use by the trained medical practitioner. It is similar in design to other such radiation therapy CT imaging simulation devices. The SIMVIEW™ 3000 has microprocessor controlled solid state electronics, rotating gantry, patient support couch and accessories.

5. **Statement of intended use:**
The SIMPLI C.T. Option for the SIMVIEW™ 3000 radiation therapy is used for the following:
1. To obtain CT images in the same position as the treatment.
2. To provide CT images to determine the contour of the patient.
3. To provide CT images to determine the size and location of internal structures.
4. To provide CT images to be used by the dosimetrist to determine the location of isocenter.
5. To provide tissue density information via Hounsfield numbers, which allows for more accurate calculations of the dose by accounting for variations in tissue densities. The intended use is the same as the predicate devices.

6. **Statement of technological characteristics:**
The SIMPLI C.T. for the SIMVIEW™ 3000 radiation therapy simulation system has no significant change in design, materials, energy source or other technological characteristics compared to the predicate devices.

The intended use and the technological characteristics are the same as the predicate devices and therefore we believe it is substantially equivalent to them.

7. **Differences:**
The minor configuration differences between the SIMPLI C.T. for the SIMVIEW™ 3000 and the predicate devices do not alter the intended use or affect the safety and effectiveness of the SIMPLI C.T. when used as labeled.

ATTACHMENT E

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SIEMENS
SIMPLI C.T. Option for the SIMVIEW™ 3000 510(k) Notification

## Special Controls:

Although there are no performance standards established by the FDA for these devices, the SIMPLI C.T. Option for the SIMVIEW™ 3000 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 601-2-29: Particular requirements for the safety of radiotherapy simulators
- IEC 1168: Radiotherapy simulators - Functional performance characteristics
- IEC 878: Graphical symbols for electrical equipment in medical practice

Performance tests were conducted and the results indicated that the system consistently performed within the design parameters and equivalently to the predicate devices.

ATTACHMENT E