K Number
K031634
Device Name
OMNIPRO I'MRT
Date Cleared
2003-08-29

(94 days)

Product Code
Regulation Number
892.5050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the OmniPro I'mRT system is to: • verify the treatment plan and delivered dose of intensity modulated or static beams prior to treatment • verify the intensity maps during IMRT delivery prior to treatment • verify the absolute dose in given points for IMRT fields.
Device Description
The Scanditronix & Wellhöfer OmniPro I'mRT system is a system similar to Radiological Imaging Technology: RIT113 Film Analysis System FDA K935928 12/13/1993 The OmniPro I'mRT system and the marketed predicated product are radiotherapy quality assurance systems designed to measure dose, doseor intensity-distributions, to analyse these data and to compare the measurement data with calculated dose- or intensity-distributions, especially in the field of Intensity Modulated Radiotherapy. The OmniPro I'mRT system can consist of - software (herafter called OmniPro I'mRT) . - hardware supported by OmniPro I'mRT (like detector arrays, . filmscanning devices, single detectors, bodyphantoms for positioning and pacing of film and/or detectors or detector arrays).
More Information

No
The document describes a radiotherapy quality assurance system that measures and analyzes dose distributions, comparing them to calculated distributions. There is no mention of AI or ML in the intended use, device description, or performance studies. The system appears to rely on established measurement and comparison techniques rather than learning algorithms.

No

The device description explicitly states: "The OmniPro I'mRT system can consist of - software (herafter called OmniPro I'mRT) . - hardware supported by OmniPro I'mRT (like detector arrays, . filmscanning devices, single detectors, bodyphantoms for positioning and pacing of film and/or detectors or detector arrays)." This indicates that the system includes both software and hardware components. The performance studies also mention "The OmniPro I'mRT system consists of software and hardware."

No

The summary explicitly states that the OmniPro I'mRT system "can consist of software... and hardware supported by OmniPro I'mRT (like detector arrays, filmscanning devices, single detectors, bodyphantoms for positioning and pacing of film and/or detectors or detector arrays)." This indicates that the device is a system that includes both software and hardware components, making it more than just software-only.

No

The device description explicitly states that the system "can consist of - software... - hardware supported by OmniPro I'mRT". This indicates that while software is a component, the system is not solely software and includes hardware elements.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is clearly described as verifying treatment plans and delivered doses in radiotherapy, specifically for intensity modulated or static beams. This is a quality assurance function for a medical treatment, not a diagnostic test performed on biological samples.
  • Device Description: The device is described as a radiotherapy quality assurance system designed to measure and analyze dose and intensity distributions. It uses hardware like detector arrays and film scanning devices to collect data related to radiation delivery.
  • Lack of Biological Sample Analysis: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) to diagnose a disease or condition. IVDs are specifically designed for this purpose.
  • Target User and Setting: The intended users are physicists and dosimetry experts in radiotherapy departments, and the setting is a radiotherapy department. This aligns with a quality assurance role in radiation therapy, not a diagnostic laboratory setting.

In summary, the OmniPro I'mRT system is a quality assurance tool for radiotherapy equipment and treatment plans, not a device used to perform diagnostic tests on biological samples. Therefore, it does not fit the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The intended use of the OmniPro I'mRT system is to:
• verify the treatment plan and delivered dose of intensity modulated or static beams prior to treatment
• verify the intensity maps during IMRT delivery prior to treatment
• verify the absolute dose in given points for IMRT fields.

Product codes (comma separated list FDA assigned to the subject device)

90 IYE

Device Description

The Scanditronix & Wellhöfer OmniPro I'mRT system is a system similar to Radiological Imaging Technology: RIT113 Film Analysis System FDA K935928 12/13/1993

The OmniPro I'mRT system and the marketed predicated product are radiotherapy quality assurance systems designed to measure dose, doseor intensity-distributions, to analyse these data and to compare the measurement data with calculated dose- or intensity-distributions, especially in the field of Intensity Modulated Radiotherapy.

The OmniPro I'mRT system can consist of

  • software (herafter called OmniPro I'mRT).
  • hardware supported by OmniPro I'mRT (like detector arrays, . filmscanning devices, single detectors, bodyphantoms for positioning and pacing of film and/or detectors or detector arrays).

A typical workflow could looks like this:

  1. A treatment planning system (not part of the OmniPro I'mRT system) calculates the dose distribution inside the I'mRT Phantom for a specific IMRT plan.
  2. Films are placed in the I'mRT Phantom.
  3. The I'mRT Phantom (and the films) is irradiated according to the above IMRT plan. (Radiation device not part of the OmniPro I'mRT system).
  4. The films are developed (development machine not part of the OmniPro I'mRT system) and scanned using a film scanner supported by OmniPro I'mRT (e.g. Vidar VXR-12).
  5. Exposure is translated into dose, data are visualised in OmniPro I'mRT where data can be analysed.
  6. The dose plan (point 1-) is imported to OmniPro I'mRT.
  7. Measured dose and planned dose are compared.
  8. The data and/or the result of the comparison are saved and exported (e.g. printed out).

Note that this is just an example to illustrate the general workflow: Steps in the workflow may be left out, others may be altered or some may be added for example if using other detectors than film. In addition to film detector arrays or single detectors are supported.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physicists, dosimetry experts in radiotherapy departments

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)

Non-Clinical tests:
The OmniPro I'mRT system consists of software and hardware. The hardware supported is mainly the same as supported by the RIT113. Also the data formats (and thereby the planning systems) supported for import are mainly the same.
Since the accuracy of the measured och planned data is limited by the technical specification of the measurement device or the raw planning data rather by the software reading these data we can conclude that a non-clinical comparison tests in a laboratory between the RIT113 and the OmniPro I'mRT system is not necessary to show equivalence.
To minimize potential electrical hazards, Scanditronix Wellhöfer adheres to recognized and established industry practice, and all devices are subject to final performance testing.
All electrical devices of the OmniPro I'mRT System are designed for conformance with national and international standards Dose 1:
Mechanical stability: IEC 61010
CSA 22.2-601.1, EN 60-601, IEC 61010 Electrical safety: EMC: EN 55022. FCC Class B BIS20 / I'mRT QA: IEC 601-1 standards for electrical isolation and leakage current, EN 60 601-1-2, Electromagnetic compatibility.

Clinical tests:
Due to the fact that the system is a quality assurance device in radiation treatment not directly involved in the delivery of the treatment radiation, no clinical testing was performed.
However, the device was tested in clinical environment by medical physicists to evaluate the overal performance (indication for use) of the system.

Conclusion:
Testing operational parameters indicates that the Scanditronix Wellhöfer OmniPro I'mRT System is save, that it fulfills the intended use.
The technological comparison with the predicate device RIT113 Film indicates that it is equivalent with the product RIT113.

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.

K935928

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.

K000209 (for Dose 1)

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

K∅3/63Y

Section 4 018/1

AUG 2 9 2003

(a)

510(k) Summary

This summery is submitted in compliance with 21 CFR 807.92

| (1) | Submitted by:
Trade name of the company: | Scanditronix Wellhöfer GmbH
Bahnhofsstraße 5,
D-90592 Schwarzenbruck
Germany
Scanditronix Wellhöfer |
|-----|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact persons: | Thomas Matzen
+46 18 18 07 00 |
| | Date of preparation: | 23 May -2003 |
| (2) | Trade name of device: | OmniPro I'mRT |
| | Common name: | Dosimetry System for Quality Assurance |
| | Classification name: | (Accessory to) Radionuclide radiation therapy
system, §892,5750; X-ray radiation therapy
system, §892,5900; and Medical charged-particle
radiation therapy system, §892.5050. |
| (3) | Identification of predicate
marketed device: | RIT113 Film Analysis System FDA K935928
12/13/1993 |

Description of the device: (4)

The Scanditronix & Wellhöfer OmniPro I'mRT system is a system similar to Radiological Imaging Technology: RIT113 Film Analysis System FDA K935928 12/13/1993

The OmniPro I'mRT system and the marketed predicated product are radiotherapy quality assurance systems designed to measure dose, doseor intensity-distributions, to analyse these data and to compare the measurement data with calculated dose- or intensity-distributions, especially in the field of Intensity Modulated Radiotherapy.

The OmniPro I'mRT system can consist of

  • software (herafter called OmniPro I'mRT) .
  • hardware supported by OmniPro I'mRT (like detector arrays, . filmscanning devices, single detectors, bodyphantoms for positioning and pacing of film and/or detectors or detector arrays).

A typical workflow could looks like this:

1

K$\phi$3/63Y

  • Section 4
  • 1 A treatment planning system (not part of the OmniPro I'mRT system) calculates the dose distribution inside the I'mRT Phantom for a specific IMRT plan.
  • 2- Films are placed in the I'mRT Phantom.
  • 3- The I'mRT Phantom (and the films) is irradiated according to the above IMRT plan. (Radiation device not part of the OmniPro I'mRT svstem)
  • 4- The films are developped (development machine not part of the OmniPro I'mRT system) and scanned using a film scanner supported by OmniPro I'mRT (e.g. Vidar VXR-12).
  • 5- Exposure is translated into dose, data are visualised in OmniPro I'mRT where data can be analysed
  • 6- The dose plan (point 1-) is imported to OmniPro I'mRT
  • 7- Measured dose and planned dose are compared.
  • 8- The data and/or the result of the comparison are saved and exported (e.g. printed out).

Note that this is just an example to illustrate the general workflow: Steps in the workflow may be left out, others may be altered or some may be added for example if using other detectors than film. In addition to film detector arrays or single detectors are supported.

  • (5) Intended use:
    The intended use of the OmniPro I'mRT system is to:

  • · verify the treatment plan and delivered dose of intensity modulated or static beams prior to treatment

  • · verify the intensity maps during IMRT delivery prior to treatment

  • · verify the absolute dose in given points for IMRT fields.

  • (6) Technological comparison:

The Scanditronix Wellhöfer OmniPro I'mRT is a Dosimetry System similar to

  • Radiological Imaging Technology: RIT113 Film Analysis System FDA K935928 12/13/1993.

Both systems consist of a software supporting hardware. Both allow 1 - import of planned data.

  • 2- import of measured data,
  • 3- comparison of measured or planned data with measured or planned data.

Overview over relevant parameters:

2

j3/63y

Section 4 p3 Jul

AreaRIT113OmniPro I'mRT
Indication for useVerifying delivered dose or intensity maps and comparing it with treatment plans especially in
intensity modulated radiotherapy (IMRT) treatments
Used byPhysicists and dosimetry
experts in radiotherapy
departmentsPhysicists, dosimetry
experts in radiotherapy
departments
DesignAnalysing- and
measuring-software
supporting devices like
film scannersAnalysing- and
measuring-software
supporting devices like
film scanners
Energy usedVidar: 95-130 or 190-
260VAC,