(88 days)
Not Found
Not Found
No
The description mentions "image processing capabilities" but does not explicitly mention AI, ML, or related terms like deep learning or neural networks. The focus is on displaying, archiving, and processing images, which can be achieved with traditional algorithms.
No
The device is described as an accessory to x-radiation therapy systems for displaying and processing images. It does not deliver therapy itself.
No
The device is described as an electronic portal imaging device (EPID) for use as an accessory to existing x-radiation therapy systems, displaying images and providing archiving and image processing capabilities. Its function is to provide images for treatment verification rather than to diagnose a medical condition.
No
The device description explicitly states it is a "digital camera based electronic portal imaging device (EPID)" and an "accessory to existing x-radiation therapy systems," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The PORTpro is described as an "electronic portal imaging device (EPID)" used as an accessory to "x-radiation therapy systems". It captures and displays images generated by external radiation, not from samples taken from the body.
- Intended Use/Indications for Use: While not explicitly stated, the description clearly indicates its use in the context of radiation therapy, which is a treatment modality, not a diagnostic test performed on bodily samples.
Therefore, the PORTpro falls under the category of a medical device used in radiation therapy, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
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).
Mentions image processing
image processing capabilities
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-radiation therapy systems operating in the megavoltage range (1 - 15 MeV)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
treating physicians and therapy technicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
SUMMARY OF SAFETY AND EFFECTIVENE
i his 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: +972.4.842.1541 Fax: +972.2.841.1129
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).
| 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" |
Comparison of Technological Characteristics:
The differences between the systems raise no new issues of safety or effectiveness.
Date
Mr. Reuven Levinson, President