(94 days)
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.
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).
The provided document is a 510(k) Pre-market Notification for the OmniPro I'mRT System, dated August 29, 2003. It's a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, the RIT113 Film Analysis System (K935928).
Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of quantitative acceptance criteria with reported performance values in the way one might see for a diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implied by the demonstration of substantive equivalence to the predicate device in terms of intended use, technological characteristics, and performance. The performance is assessed through a qualitative comparison, not a quantitative one against predefined metrics.
However, we can infer "performance" in the context of this submission as the ability of the OmniPro I'mRT system to perform the same functions as the predicate device (RIT113) effectively and safely.
| Acceptance Criteria (Implied by Equivalence) | Reported Device Performance (OmniPro I'mRT) |
|---|---|
| Intended Use Equivalence | Meets Intended Use: The OmniPro I'mRT system's intended use is identical to or encompasses the predicate: to verify treatment plans and delivered dose of intensity modulated or static beams prior to treatment, verify intensity maps during IMRT delivery prior to treatment, and verify absolute dose in given points for IMRT fields. This is explicitly stated as being fulfilled. |
| Technological Equivalence | Substantially Equivalent Technologies: Both systems are described as analyzing and measuring software supporting hardware (film scanners, detector arrays). The document details minor differences but concludes "There are no principal differences between the systems, neither regarding support of measured data, import of data or tools for comparing or analysing of data." |
| Performance Equivalence | Equivalent Performance: The document argues that performance differences are minor and do not limit intended use. For example: - Data Import: OmniPro I'mRT supports DICOM/RTOG; RIT113 supports more vendor-specific formats, but standards are gaining traction. - Film Scanners: OmniPro I'mRT supports additional scanners (Vidar VXR-16, Lumisys) not supported by RIT113, with similar specifications. - Calibration: OmniPro I'mRT uses a two-step (signal to OD, OD to dose) calibration, providing an advantage in independent checking, but achieving the same goal. - Body Phantom Support: Both support almost all market phantoms; OmniPro I'mRT does not support the Gammex 469, but this "does not limitate the intended use." - Detector Array Support: RIT113 supports import from portal imaging systems; OmniPro I'mRT supports the "whole measurement process" of a dedicated detector array (I'mRT QA). Both achieve the goal of comparing intensity maps. - Single Detector Support: OmniPro I'mRT supports single detector measurements (e.g., Dose 1) to verify absolute dose, which is one of its stated intended uses. - Analyzing Tools: OmniPro I'mRT includes all tools of RIT113 (film alignment, subtraction, isodose comparison) and adds multiplication and the gamma method, offering enhanced analysis capabilities. |
| Safety and Electrical Standards | Meets Safety Standards: The device adheres to recognized industry practices. All electrical devices conform to national and international standards (e.g., IEC 61010, CSA 22.2-601.1, EN 60-601, EN 55022, FCC Class B). Quality assurance system is certified to DIN EN ISO 9001 and DIN EN 46001. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "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, it also states: "However, the device was tested in clinical environment by medical physicists to evaluate the overal performance (indication for use) of the system."
This indicates that a formal "test set" with a defined sample size, data provenance, and retrospective/prospective design in the sense of a clinical trial for diagnostic or therapeutic devices, was not conducted or reported. The evaluation in a "clinical environment" by medical physicists seems to be more of a usability and general performance assessment rather than a structured quantitative study with a specific test set. No specific sample size for this hands-on evaluation is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Given that no formal clinical "test set" and ground truth establishment study was described, this information is not provided. The assessment appears to rely on the expertise of "medical physicists" in the general clinical environment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since no formal test set and ground truth establishment study was described, there is no adjudication method reported.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done or reported. The device is a "Dosimetry System for Quality Assurance" and not an AI-assisted diagnostic tool that would typically undergo such a study. The comparison is between the new device (OmniPro I'mRT) and a predicate device (RIT113), not between human readers with and without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the OmniPro I'mRT as a "system" consisting of "software (herafter called OmniPro I'mRT)" and "hardware supported by OmniPro I'mRT". The workflow clearly indicates "human-in-the-loop" involvement (e.g., physicists placing films, developing films, importing data, analyzing data, comparing data). As a quality assurance system for radiotherapy, it inherently requires human input and interpretation.
Therefore, a standalone (algorithm only) performance assessment was not performed or is not applicable in the context of this device's intended use and design.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
As this is a quality assurance device, the "ground truth" for the system's function is the accurate measurement and comparison of planned vs. delivered radiation dose/intensity distributions. The system itself produces data that is then compared. The accuracy of these measurements is relative to the physical reality of the radiation field, not a clinical diagnosis. The "testing in clinical environment by medical physicists" likely involved verifying that the system accurately processed input data and produced expected output comparisons, consistent with established physics principles and clinical practice standards for radiation dosimetry. This is implicitly the "ground truth" for a QA device.
8. The sample size for the training set
No training set is mentioned or applicable in the context of this 2003 submission for a dosimetry QA system. The device does not appear to employ machine learning or AI that would require a distinct training set. Its functionality is based on algorithms that process acquired physical data according to known physical laws and calibration curves.
9. How the ground truth for the training set was established
Since no training set is indicated, the method of establishing ground truth for a training set is not applicable.
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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 GmbHBahnhofsstraße 5,D-90592 SchwarzenbruckGermanyScanditronix 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 therapysystem, §892,5750; X-ray radiation therapysystem, §892,5900; and Medical charged-particleradiation therapy system, §892.5050. | |
| (3) | Identification of predicatemarketed device: | RIT113 Film Analysis System FDA K93592812/13/1993 |
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:
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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:
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Section 4 p3 Jul
| Area | RIT113 | OmniPro I'mRT |
|---|---|---|
| Indication for use | Verifying delivered dose or intensity maps and comparing it with treatment plans especially inintensity modulated radiotherapy (IMRT) treatments | |
| Used by | Physicists and dosimetryexperts in radiotherapydepartments | Physicists, dosimetryexperts in radiotherapydepartments |
| Design | Analysing- andmeasuring-softwaresupporting devices likefilm scanners | Analysing- andmeasuring-softwaresupporting devices likefilm scanners |
| Energy used | Vidar: 95-130 or 190-260VAC, <75W | Vidar 95-130 or 190-260VAC, <75WLumisys: 100-120V,50/60Hz, 1.5AmpsOr 200-240V, 50/60Hz,1.0Amps,BIS: 100-240V, 50/60Hz.0.75-0.35ADose 1: 100-240VAC,max 40W, typical 15W |
| Energy deliveredElectrical safety | No energy delivered.UL1950 (Vidar Dos. Pro) | No energy deliveredEN 60-601, IEC 61010(Dose 1), CSA C22.2-601(Dose 1), UL1950 (VidarDos. Pro) |
| Performance | RIT113 | OmniPro I'mRT |
| Dose/Fluence Mapimport format | DicomRTOGBMPTIFFBINARYVendor specific:- ADAC Pinnacle- CadPlan- additonally differentother vendors | DicomRTOG+ vendor specific:- ADAC Pinnacle- CadPlan (Varian) |
| Film digitizers Support? | Yes.Vidar (VXR-12, -12plus, -16 Dosimetry Pro) | Yes.Vidar (VXR-12, -16, 16Dosimetry Pro)Lumisys |
| Calibration | Signal to dose | Signal to OD, OD to Dose |
| Body Phantom support | Yes (in principal allavailable phantoms) | Yes. All phantoms thatallow filmpositioningperpendicular to roomcoordinate system. |
| Support of data fromDetector Arraymeasurements | Yes.Import of data from anumber of Digital Portalimagers- Varian a500- Varian Portalvision- Elekta- Kodak CR | Yes.Controlling the Beamimaging system (I'mRTQA). |
| Support of data fromsingle detectormeasurements | ? | Yes |
| Difference | Yes | Yes |
| Sum | Yes | Yes |
| Multiplication | No (?) | Yes |
| Profile Comparison | Yes | Yes |
| Isodose comparison | Yes | Yes |
| Gammamethod | No (?) | Yes |
| Plan-plan intercomparison | Available for most operations | All operations |
| Plan –film intercomparison | All operations | All operations |
| Film-film intercomparison | Available for most operations | All operations |
2003-05-23/TM
{3}------------------------------------------------
K$\phi$31634
Section 4
PY 11
Comment to the above comparison list:
There are no principal differences between the systems, neither regarding support of measured data, import of data or tools for comparing or analysing of data.
The differences regarding performance are the following
- 1- Import of data: The RIT113 system supports more vendor specific dataformats than OmniPro I'mRT. OmniPro I'mRT supports rather data formats according to standards (DICOM, RTOG), since more and more vendors support either of the standards.
- 2- Film scanners: RIT113 does not support the VXR-16 scanner and Lymisys scanners. The use and the specifications of those scanners however are very similar to the VXR-12 and VXR-16 Dosimetry Pro scanners, parameters like geometric resolution, data deepth (12 or 16 bits) may vary slightly.
- 3- Calibration: The RIT113 performs the calibration in one step from signal to dose, in OmniPro I'mRT the calibration is performed in two steps: First from signal to optical density and then from optical density to dose. The two step method has the adventage that the calibration curves for the scanner and the film can be checked independently from each other.
- 4- Bodyphantom support: Both systems support almost all phantoms on the market (mounting of film in planes parallel or perpendicular to the room coordinate system). This way of mounting films is seen as the standard and all parameters that can be checked with film can be checked using this standard set up.
There is the Gammex 469 phantoms where the film is mounted in a a helix inside a cylinders. This phantom is not supported by OmniPro I'mRT. However this does not limitate the intended use in any way, since with films using the standard set up all parameters to be checked with film can be measured.
- 5- Support of data from Detector Array measurements: RIT113 supports the import of data measured with a detector array (portal imaging systems), OmniPro I'mRT supports the whole measurement process of the detector array (I'mRT QA). The detector arrays supported by RIT113 are optmized for optimal imaging quality. The I'mRT QA has been developed for dosimetric purpose.
The principal of use is very similar: Both systems give a signal that is proportional to the intensity map. The signal can be imported to the main application and than be compared with a planned intensity, fluence- or dose distribution.
2003-05-23/TM
{4}------------------------------------------------
Kd3/63Y
Section 4
ρJΛ6
Both systems are gantry mounted, the I'mRT QA can additionally be placed onto the treatment couch.
-
6- Support of data from single detector measurements: There are two important tasks in verifying IMRT plans: Verifying the relative dose or intensity map (done with film or detector array), verifying the absolute dose in one single point. Therefore OmniPro I'mRT supports measurements done with a single detector. The Dose 1 (510(k) K000209) or other absolute dosimetry
measurement systems can be used. -
Analysing tools: The tools for IMRT field verification are almost 7 identical: Three of the most important tools/operations Film alignment. Subtraction and isodose comparison are available in both systems. In OmniPro I'mRT even multiplication and the gammamethod (see Daniel A. Low et al: A technique for the quantitative evaluation of dose distribution, Med Phys 25 (5) May 1998) are available, allowing the comparison of two datadistributions in one single step instead of using two different methods (subtraction and isodose comparison) in two steps.
Non-Clinical tests: (6b) (1)
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.
The quality assurance system at Scanditronix Wellhöfer GmbH is certified since 1995 according to DIN EN ISO 9001 and DIN EN 46001.
- Clinical tests: (2)
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K$\phi$3/63y
Section 4
P (
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.
- (3) 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.
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows a circular seal with an eagle-like bird in the center. The bird is stylized with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle, following its curvature. The seal appears to be a logo or emblem, possibly representing a government agency related to health and human services in the United States.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 9 2003
Scanditronix Wellhöfer GmbH % Mr. Thomas Matzen Official Correspondent Scanditronix Wellhöfer AB Stålgatan 14, 75450 Uppsala SWEDEN
Re: K031634
Trade/Device Name: OmniPro I'mRT System Regulation Number; 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: May 5, 2003 Received: June 3, 2003
Dear Mr. Matzen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
{7}------------------------------------------------
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 3
Ver/ 3 - 4/24/96
| Applicant: | Scanditronix Wellhöfer GmbH |
|---|---|
| 510(k) Number (if known): | K431634 |
| Device Name: | OmniPro I'mRT |
| Indications For Use: |
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109) (Optional Format 1-2-96)
David G. Seggern
(Division Sign Division of Re and Radiologic 510(k) Num
3-1 (1)
Indication for Use 2003-04-28/TM
Prescription Use ✓
§ 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.