PORTPRO ELECTRONIC PORTAL IMAGING SYSTEM

K964485 · Eliav , Ltd. · IYE · Feb 4, 1997 · Radiology

Device Facts

• Record ID: K964485
• Device Name: PORTPRO ELECTRONIC PORTAL IMAGING SYSTEM
• Applicant: Eliav , Ltd.
• Product Code: IYE · Radiology
• Decision Date: Feb 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The PORTpro is a free-standing, digital camera based electronic portal imaging device (EPID) for use as an accessory to existing x-radiation therapy systems operating in the megavoltage range (1 - 15 MeV). The PORTpro displays high quality portal images on a computer monitor in virtually real time and also provides archiving and image processing capabilities.

Device Story

Free-standing digital camera-based electronic portal imaging device (EPID); accessory to megavoltage (1-15 MeV) radiation therapy systems. Input: megavoltage x-ray radiation. Transformation: CCD-based digital image acquisition; real-time processing; archiving. Output: high-quality portal images on computer monitor. Used in radiation therapy clinics; operated by physicians and therapy technicians. Benefit: rapid position verification without film development; improved geometric accuracy of field placement; enables non-couch total body (TBI) and total lymphatic irradiation (TLI).

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

CCD-based digital camera; 746 x 582 acquisition matrix; 16-bit pixel resolution; 1.0 mm spatial resolution. Free-standing support system; 75-inch height; 136 lbs. Operates with megavoltage (1-15 MeV) x-ray systems. No high voltage components.

Indications for Use

Indicated for use as an accessory to megavoltage (1-15 MeV) x-radiation therapy systems to provide real-time portal imaging for patient position verification during radiation therapy.

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

• SRI 100 Radiotherapy Imaging System (Phillips Medical Systems)
• Huestis Flexi-Holder (Huestis Medical Products)

Submission Summary (Full Text)

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SUMMARY OF SAFETY AND EFFECTIVENESS
K964485

This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

FEB - 4 1997

## Submitter:

Eliav Ltd., POB 10403, Haifa 26115, Israel
Tel: [phone] Fax: [phone]

## Name of the Device:

PORTpro Electronic Portal Imaging System

## Predicate Devices:

The PORTpro is substantially equivalent to a combination of the SRI 100 Radiotherapy Imaging System manufactured by Phillips Medical Systems and the Huestis Flexi-Holder manufactured by Huestis Medical Products.

## Description of the Device:

The PORTpro is a free-standing, digital camera based electronic portal imaging device (EPID) for use as an accessory to existing x-radiation therapy systems operating in the megavoltage range (1 - 15 MeV). The PORTpro displays high quality portal images on a computer monitor in virtually real time and also provides archiving and image processing capabilities. The real time display of images is advantageous insofar as treating physicians and therapy technicians are able to quickly produce position verification images without time consuming set up and development of radiographic films. This is helpful in radiation therapy since frequent monitoring of patient positioning can reduce the frequency of discrepancies in (x-ray) field placement, and improve geometric accuracy of the treatments.

Because the PORTpro has a free-standing detector support system, it offers advantages over other EPID’s without this feature, i.e., easy positioning of the imaging system, adjustable and relatively large effective field of view, and the ability to do “non-couch” total body irradiation (TBI) and total lymphatic irradiation (TLI).

## Comparison of Technological Characteristics:

| Technological Characteristic | PORTpro | SRI 100 | Flexi-holder |
| --- | --- | --- | --- |
| Acquisition regime | Full field | Full field | NA |
| Acquisition matrix | 746 x 582 | 512 x 256 | NA |
| Spatial resolution | 1.0 mm | 2.0 mm | NA |
| Pixel resolution (bits) | 16 | 16 | NA |
| High Voltage | No | No | No |
| CCD/Video | CCD | CCD | NA |
| Height | 75” | NA | 75” |
| Weight | 136 lbs. | --- | 110 lbs. |
| Base | 14” x 30” | NA | 19” x 22” |

The differences between the systems raise no new issues of safety or effectiveness.

Date
Mr. Reuven Levinson, President

PORTpro 510(k) Application