STEREOTACTIC BODY FRAME

K960338 · Elekta Instrument AB · IYE · Apr 23, 1996 · Radiology

Device Facts

• Record ID: K960338
• Device Name: STEREOTACTIC BODY FRAME
• Applicant: Elekta Instrument AB
• Product Code: IYE · Radiology
• Decision Date: Apr 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The Stereotactic Body Frame is a device designed for stereotactic diagnostic localization and stereotactic radiotherapy of extracranial targets.

Device Story

Stereotactic Body Frame provides external reference system for reproducible localization of extracranial targets during diagnostic imaging and radiotherapy. Device utilizes copper or copper sulfate reference indicators to produce fiducials on CT/MR images for x, y, z coordinate determination. Includes vacuum pillow for patient fixation, diaphragm control for respiratory movement minimization, and adjustable base for horizontal positioning. Arc-ruler and chest/tibia markers facilitate patient alignment via skin marks and frame-mounted laser. Used in clinical radiotherapy settings by medical staff to ensure accurate patient positioning and refixation relative to linear accelerators. Benefits include enhanced precision in target localization and treatment delivery.

Clinical Evidence

Bench testing only. Study evaluated frame strength, deformation under normal use, material behavior under repeated radiation exposure, and radiation attenuation. Results demonstrated capability for safe and accurate patient repositioning relative to external reference system.

Technological Characteristics

Stereotactic frame with copper or copper sulfate reference indicators for CT/MR imaging. Features vacuum pillow, diaphragm control, adjustable base, arc-ruler, and laser-guided alignment system. Mechanical device; no software or electronic components.

Indications for Use

Indicated for patients requiring stereotactic diagnostic localization and stereotactic radiotherapy of extracranial targets.

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

• Gill-thomas-cosman (Gtc) Relocatable Head Holder S (K934523)
• Vac-lok Immobilization System (K935300)

Submission Summary (Full Text)

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K960338
K960338

# SECTION 19: SUMMARY OF SAFETY AND EFFECTIVENESS
APR 23 1996

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

## 19.1 SUBMITTER INFORMATION

a. Company Name: Elekta Instrument AB
b. Company Address: St. Larsgatan 8, S-582 Linkoping, Sweden
c. Company Phone: [phone] (011) 4613112312
d. Contact Person: Sverker Glans Vice President Quality and Regulatory Affairs Elekta Instrument AB
e. Date Summary Prepared: January 19, 1996

## 19.2. DEVICE IDENTIFICATION

a. Trade/Proprietary Name: Stereotactic Body Frame
b. Classification Name: Radiographic Head Holder

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## 19.3 IDENTIFICATION OF PREDICATE DEVICE

| Company | Device | 510(k) No. | Date Cleared |
| --- | --- | --- | --- |
| Radionics | Gill-thomas-cosman (Gtc)
Relocatable Head Holder S | K934523 | 2/8/95 |
| Med-Tec | Vac-lok Immobilization System | K935300 | 7/18/94 |

## 19.4 DEVICE DESCRIPTION

The Stereotactic Body Frame utilizes a reference system which is external to the patient's body. Using this stereotactic system, the coordinates of a target can be reproducibly localized during diagnostic examination and treatment. The Frame has built-in copper or copper sulfate solution reference indicators for CT or MR determination of target coordinates. These reference indicators, which produce fiducials on the CT or MR images, permit x, y and z coordinate determination for localization of the target. A diaphragm control attached to the Frame can be used to minimize respiratory movements. Horizontal positioning of the Frame, in the scanner or on the treatment couch, is achieved using an adjustable base on the Frame.

Marker devices are used for reproducible positioning, after fixation of the patient in a vacuum pillow. An arc-ruler is attached to the Frame and a chest marker device on the arc-ruler is used for alignment of the patient. This is based on two skin marks over the patient's sternum. Longitudinal alignment is controlled by skin marks over the tibia using a frame-mounted laser. The coordinates used for patient positioning can be easily read on the arc-ruler holding the sternum marker and on the longitudinal ruler, along which the arc-ruler can be moved.

## 19.5 SUBSTANTIAL EQUIVALENCE

The Elekta Stereotactic Body Frame is substantially equivalent to other stereotactic frames currently in commercial distribution by Radionics and immobilization systems in distribution by Med-Tec in terms of the intended use of achieving a safe and accurate fixation and refixation of a patient's body part for localization of targets for radiotherapy treatment with Linear accelerators.

The fundamental technical characteristics are similar to those of the predicate devices and are listed on the comparison chart provided in this 510(k) submission. Differences that exist between these systems relate to physical

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appearance and materials which do not affect the relative safety or effectiveness of the device.

## 19.6 INTENDED USE

The Stereotactic Body Frame is a device designed for stereotactic diagnostic localization and stereotactic radiotherapy of extracranial targets.

## 19.7 TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the predicate and legally marketed devices is provided in the following table.

## 19.8 PERFORMANCE DATA

A study was conducted to evaluate the strength and deformation of the Stereotactic Body Frame under normal use, the influence of radiation on the behavior of Frame material which has been subjected to repeated use and the radiation attenuation when irradiating different parts of the Frame was assessed. The results of this study demonstrated that the Stereotactic Body Frame is capable of safely and accurately repositioning the patient in relation to an external reference system.

## 19.9 510(K) CHECKLIST

This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer’s Checklist is provided in this submission.