(29 days)
The IQM Integral Quality Monitor is a large-area ionization chamber intended to be used for quality assurance verification measurements and documentation of the treatment delivery accuracy (beam shape, position and dose) from medical linear accelerators used for intensity modulated radiation therapy.
The data acquired by IQM is used to compare and verify a treatment dose (delivered dose) to the expected dose and to compile treatment delivery radiation beam data over time as part of a quality assurance program.
The IQM System is designed for the verification of radiation therapy treatments delivered with a linear accelerator. The IQM consists of an electronic detector device and software used to control the device and to process and display the results. Comparisons may be made with expected / previously measured data, results reviewed and documented for quality assurance purposes, and deviations from the expected signal can be detected and reported. Where results can be presented on a segment by segment basis, the realtime reporting of results gives the user the opportunity to detect serious deviations still during treatment, potentially aiding radiation therapy professionals in increasing patient safety.
Here's an analysis of the provided text regarding the acceptance criteria and study for the IQM Integral Quality Monitor, structured according to your requested information:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the specific numerical acceptance criteria are limited, but the document repeatedly emphasizes performance relative to the predicate device and established standards.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Measurement Principle | Relative dosimetry using measured dose length product, correlating to the opening of an MLC leaf pair and the supplied dose (predicate). | Relative dosimetry using measured spatially-sensitive large area dose product, correlating to the opening of all MLC pairs (entire beam shape) and the supplied dose. Device has been validated as acquiring the entire beam shape and dose as required for verification. |
| Reproducibility | ≤ 1% or better | Demonstrated in performance data. |
| Non-linearity | ≤ 1% or better | Demonstrated in performance data. |
| Safety (Electrical & Mechanical) | Compliance with IEC 60601-1 and IEC 60601-1-2 (EMC). | Certified as in compliance with IEC 60601-1 (ed. 3.1, AAMI/ANSI ES 60601-1:2005+A2012) and IEC 60601-1-2 (2014, ed. 4). |
| Battery Safety | (Implicit: Safe operation of power source) | Rechargeable lithium ion battery tested for safety to IEC 62133 by an independent accredited laboratory. |
| Software Verification & Validation | As recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Performed per IEC 62304 and validated in conformance with ISO 13485, GMP and the FDA Guidance for Software Validation. | Detailed documentation provided. Software design, development and verification are performed per IEC 62304 and validated in conformance with ISO 13485, GMP and the FDA Guidance for Software Validation. |
| Usability/Human Factors | (Implicit: Device is easily removed/attached; recognized by accessory code recognition system of linac) | Validated in system and usability testing, by test users at 17 sites. |
| Functional Performance | Detect deviations and lack of deviations in beam intensity, shape, and position. | Evaluated in bench tests, demonstrating fulfillment of design specifications and that the device performs the intended use and meets users' needs. |
| Equivalence to Predicate | Safe and effective as the predicate device. | Demonstrates that the IQM is as safe and effective as the predicate device and performs as well or better for its application. Technological differences do not raise new or different questions of safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document mentions that "Test users at 17 sites participated in various tests." This refers to the number of sites where the device was tested, not necessarily the number of treatments or data points collected. The specific number of test cases or data points within these sites is not provided.
- Data Provenance: The testing was conducted "in multiple hospital environments where the IQM was installed and tested in the clinical workflow." While specific countries are not mentioned, the submitter's address is Koblenz, Germany, and the FDA review is for the US market, suggesting international and potentially US sites. The tests were performed "under clinically representative conditions with Elekta and Varian brand linear accelerators, commissioned and used clinically at the respective hospitals," indicating prospective data collection in real-world clinical settings, though not on patients.
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)
The concept of "ground truth" for the IQM device relates to the expected dose and beam characteristics from the linear accelerator.
- Number of Experts: This is not explicitly stated as a number of experts, but "qualified personnel, through iRT staff and hospital medical physicists and radiation therapists at the respective hospital locations" were involved in performing the tests.
- Qualifications of Experts: The experts involved were "hospital medical physicists and radiation therapists." While years of experience are not specified, their roles imply expertise in radiation therapy and linear accelerator operation/calibration.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe an adjudication method with multiple independent reviewers determining ground truth for the test set. The "ground truth" seems to be derived from the expected dose and previously measured data generated by the linear accelerators themselves, which are calibrated and operated by the medical physicists. The IQM's output is then compared against these established expected values.
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
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
- Effect Size of AI Improvement: Since no MRMC study was performed involving human readers and AI assistance (as the IQM is a quality assurance device, not an AI diagnostic tool), there is no reported effect size for human reader improvement. The device's purpose is to automatically verify treatment delivery, not to assist humans in interpreting images or making diagnoses.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies described are essentially standalone performance evaluations of the device (IQM). The IQM itself acts as an automated "integral quality monitor" to verify radiation therapy treatments. It "detects deviations and lack of deviations in beam intensity, shape, and position" and compares delivered doses to expected doses. While "test users" were observed for usability, the core function of the device's measurement and comparison is an algorithm-driven process without continuous human interpretation for each result.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for evaluating the IQM appears to be based on:
- Expected Dose/Beam Characteristics: The "expected dose" or "previously measured data" from the linear accelerators, established through standard calibration and treatment planning processes performed by qualified medical physicists.
- Design Specifications: The device's performance was evaluated against its own design specifications (
device performance and functionality fulfill the design specifications).
8. The sample size for the training set
The document does not report a sample size for a training set. This is because the IQM Integral Quality Monitor is described as "a large-area ionization chamber intended to be used for quality assurance verification measurements." It's a measurement device, not a machine learning or AI-based diagnostic tool that typically requires a large training dataset for pattern recognition or prediction. Its operation is based on physical principles of radiation detection and comparison against established reference data, rather than learning from a training set.
9. How the ground truth for the training set was established
As there is no mention of a training set for a machine learning algorithm, there is no information provided on how ground truth for a training set was established.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 20, 2016
iRT Systems GmbH % Mr. Dave Yungvirt CEO Third Party Review Group, LLC The Old Station House 24 Lackawanna Place MILLBURN NJ 07041
Re: K162629
Trade/Device Name: IQM Integral Quality Monitor Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 19, 2016 Received: September 21, 2016
Dear Mr. Yungvirt:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D.'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K162629
Device Name IQM Integral Quality Monitor
Indications for Use (Describe)
The IQM Integral Quality Monitor is a large-area ionization chamber intended to be used for quality assurance verification measurements and documentation of the treatment delivery accuracy (beam shape, position and dose) from medical linear accelerators used for intensity modulated radiation therapy.
The data acquired by IQM is used to compare and verify a treatment dose (delivered dose) to the expected dose and to compile treatment delivery radiation beam data over time as part of a quality assurance program.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ---------------------------------------------------------------------------------------------------- |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|
| ----------------------------------------------------------------- |
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§5 510(k) Summary IQM Integral Quality Monitor
The following information is provided following the format of 21 CFR 807.92
1 SUBMITTER/HOLDER
iRT Systems GmbH Schlosstrasse 1 56068 Koblenz, Germany
Phone: +49 (261) 91545-0 Fax: +49 (261) 91545-99
Contact Person: Juergen Oellig
Date Prepared: June 24, 2016
2 DEVICE
Name of Device: IQM Integral Quality Monitor (also "IQM" or the "IQM System)
Common or Usual Name: Linear Accelerator. The subject device is a Verification System for Radiation Therapy, an accessory or ancillary device for a Linear Accelerator.
Classification Name: "Medical charged-particle radiation therapy system" and accessory devices (21 CFR 892.5050) (IQM is an accessory device)
Regulatory Class: II
Product Code: IYE
3 PREDICATE DEVICE
PTW DAVID, 510(k)# K062817
This predicate device has not been subject to a design-related recall1.
No reference devices were used in this submission.
1 Most recent database search from Dec. 21, 2015
| File Name | 5-1_510(k) Summary Statement per 21 CFR 807 92.docx | FM_7.3-1-2v01.00 |
|---|---|---|
| Author | Thesi Roestel | Page 5.1-1 of 8 |
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DEVICE DESCRIPTION র্ব
The IQM System is designed for the verification of radiation therapy treatments delivered with a linear accelerator. The IQM consists of an electronic detector device and software used to control the device and to process and display the results. Comparisons may be made with expected / previously measured data, results reviewed and documented for quality assurance purposes, and deviations from the expected signal can be detected and reported. Where results can be presented on a segment by segment basis, the realtime reporting of results gives the user the opportunity to detect serious deviations still during treatment, potentially aiding radiation therapy professionals in increasing patient safety.
5 INTENDED USE & INDICATIONS FOR USE
Intended Use Statement
The IQM Integral Quality Monitor is a large-area ionization chamber intended to be used for quality assurance verification measurements and documentation of the treatment delivery accuracy (beam shape, position and dose) from medical linear accelerators used for intensity modulated radiation therapy.
The data acquired by IQM is used to compare and verify a treatment dose (delivered dose) to the expected dose and to compile treatment delivery radiation beam data over time as part of a quality assurance program.
Comparison of Statements between Predicate and Subject Devices
The Intended Use statement for the subject device, IQM, is not identical to the predicate device DAVID Intended Use statement (see below); however, the statements are very comparable despite small differences in phrasing or word choice. The differences do not describe a substantial difference in use or in the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices are intended for use in verification of the radiation beam delivered by a linear accelerator. Both systems acquire data during the treatment, and compare these to data acquired before the treatment, and compare these to verify the treatment dose delivered to the dose expected. Both devices allow the compilation of treatment delivery data for quality assurance purposes, such as monitoring for the consistency and accuracy of the treatment delivered.
| File Name | 5-1_510(k) Summary Statement per 21 CFR 807 92.docx | FM_7.3-1-2v01.00 |
|---|---|---|
| Author | Thesi Roestel | Page 5.1-2 of 8 |
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A detailed comparison of the use statements for the subject and predicate devices is made in chapter 12 of this submission, Discussion of Substantial Equivalence, in section 3 Intended Use.
COMPARISON OF TECHNOLOGICAL 6 CHARACTERISTICS With THE PREDICATE DEVICE
| Predicate Device | Subject Device IQM | Conclusion, validationreference |
|---|---|---|
| Use Environment & User | ||
| At the linear acceleratorin the the treatment roomwith protective bunker ina radiation therapydepartment. Userhandling the device is aradiation oncologyspecialized professional | Same | No difference for safetyand effectiveness |
| Supported linearaccelerator treatmentmodality | ||
| Intended for verification ofphoton beam therapy | Same | No difference for safetyand effectiveness |
| Not intended forverification of electronbeam therapy. Detector isremoved if electronbeams are to be used | Same | No difference for safetyand effectiveness |
| Detector construction | ||
| Construction & materials:flat, vented ion chamber,for photon energy beams,multiple filaments (wires)electrodes betweenPMMA | Flat, vented ionchamber, for photonenergy beams, angledmetal electrode plates inPMMA frame | No safety issue,effectivenessdemonstrated withperformance data:subject device deliversappropriate linearity,sensitivity & reproducibility |
| File Name | 5-1_510(k) Summary Statement per 21 CFR 807 92.docx | FM_7.3-1-2v01.00 |
|---|---|---|
| Author | Thesi Roestel | Page 5.1-3 of 8 |
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| §5 510(k) Summary | |
|---|---|
| ------------------- | -- |
il RT
Systems GmbH
IQM Integral Quality Monitor
| Radiologicalcharacteristics: Beamattenuation caused bydetector must beconsidered in TPS | Same | No difference for safetyand effectiveness.Handling of beamattenuation isdemonstrated inperformance data |
|---|---|---|
| Electrical and mechanicalsafety characteristics:compliance with IEC60601-1 and IEC 60601-1-2(EMC) | Same | No difference for safetyand effectiveness.Subject device has beentested to newest editionsof the Medical ElectricalEquipment safety (IEC60601-1) and MEE EMC(IEC 60601-1-2) standards |
| Detector Dimensions &weight:Varies dependent onmodel, including linacspecific holder:451mm-498 mm x243mm-372mm x49 mm-99mmapprox. 3.5kg-4.9kg | Similar:One detector model,overall dimensions &weight vary with linacvendor specific holder:450mm-476mm x449mm-462 mm x35mmapprox. 6.8kg | No difference for safetyand effectiveness |
| Availability of the lightfield:Light field is available (atleast 70% translucent) | Light field is madeavailable by removingdetector (detector isopaque) | No difference for safetyand effectiveness.Detector holder to attachsubject device to a linearaccelerator isconstructed for easyremoval and attachmentand is automaticallyrecognized by accessorycode recognition systemof linac, as validated insystem and usabilitytesting. |
| Fixation of detector totreatment machine: | Similar | No difference for safetyand effectiveness. |
| File Name | 5-1_510(k) Summary Statement per 21 CFR 807 92.docx | FM_7.3-1-2v01.00 |
|---|---|---|
| Author | Thesi Roestel | Page 5.1-4 of 8 |
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| §5 510(k) Summary | Traditional 510(k)Submission | |
|---|---|---|
| IQM Integral Quality Monitor | Date: 2016-06-24 | |
| Mechanical fixation &optical-mechanicalcoding plugs on thedevice holder, per thespecification /implementation of therespective linacmanufacturer | Detector holder to attachsubject device to a linearaccelerator isconstructed for easyremoval and attachmentand is automaticallyrecognized by accessorycode recognition systemof linac, as validated insystem and usabilitytesting. | |
| Energy Source | ||
| Detector powered withrechargeable NiMHbattery pack | Detector powered withrechargeable Lithium ionbattery pack | No difference for safetyand effectiveness;Battery and batteryimplementation in subjectdevice have been testedto newest MEE (IEC60601-1) andrechargeable battery(IEC 62133) standards |
| Transceiver power viapower supply connectedto mains | Same | No difference for safetyand effectiveness. |
| Energy delivered | ||
| No energy is delivered topatient or to anothersystem | Same | No difference for safetyand effectiveness |
| Communication: | ||
| Wireless transmission ofsignal between detectorand transceiver viaBluetooth | Same | No difference for safetyand effectiveness |
| Physical cableconnection betweentransceiver and computerin control room through | Same | No difference for safetyand effectiveness |
§5 510(k) Summary
Traditional 510(k)
| File Name | 5-1_510(k) Summary Statement per 21 CFR 807 92.docx | FM_7.3-1-2v01.00 |
|---|---|---|
| Author | Thesi Roestel | Page 5.1-5 of 8 |
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Image /page/8/Picture/0 description: The image contains the logo for iRT System. The logo features the letters "iRT" in a bold, sans-serif font, with the "i" and "R" in white and the "T" in a lighter shade of blue. The letters are set against a dark blue circle, which is surrounded by concentric rings of green and light blue. To the right of the circular logo, the words "iRT System" are written in a smaller, sans-serif font, with "iRT" in the same dark blue as the circle and "System" in a lighter gray.
| Measurement Principle | ||
|---|---|---|
| Relative dosimetry usingmeasured dose lengthproduct, correlating to theopening of an MLC leafpair and the supplieddose | Relative dosimetry usingmeasured spatially-sensitive large area doseproduct, correlating tothe opening of all MLCpairs (entire beamshape) and the supplieddose | No difference for safetyand effectiveness.Subject device IQM hasbeen validated asacquiring the entirebeam shape and dose asrequired for verification,demonstrated in theperformance data |
| Specification ofreproducibility of = 1%<br or better; non-linearity=1% or better</td SameNo difference for safetyand effectiveness. IQMperformance (sensitivity,reproducibility, linearity) isdemonstrated in theperformance data. | ||
| Software functionalitiesprovided | ||
| Extent of softwareprovided:Software provided tocontrol data acquisition(measurement), derive/save the expected /reference values againstwhich each session iscompared, to comparedata, to display and saveresults, retrieve data forreports | Same | No difference for safetyand effectiveness.Software design,development andverification areperformed per IEC 62304and validated inconformance with ISO13485, GMP and the FDAGuidance for SoftwareValidation |
Performance Data 7
The FDA has not established any performance standards for this product.
Bio-compatibility
Bio-compatibility is not a concern because there is no contact with the patient, including no indirect contact. The IQM hardware can be handled without reservation by all users.
| File Name | 5-1_510(k) Summary Statement per 21 CFR 807 92.docx | FM_7.3-1-2v01.00 |
|---|---|---|
| Author | Thesi Roestel | Page 5.1-6 of 8 |
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Electrical & mechanical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the IQM by an independent accredited (IEC 17025) laboratory and is certified as in compliance with the IEC 60601-1 (ed. 3.1, AAMI/ANSI ES 60601-1:2005+A2012) standard for safety and the IEC 60601-1-2 (2014, ed. 4) standard for EMC. IQM uses a rechargeable lithium ion battery which was tested for safety to IEC 63122 by an independent accredited (IEC 17025) laboratory.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, " Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
The IQM is an accessory to a medical linear accelerator, itself a device considered as a "major" level of concern. Detailed documentation concerning software verification and validation have therefore been provided in accordance with the quidance. As a device intended to verify and document the accuracy of the treatment delivery, but not to deliver, plan, simulate or control delivery, the IQM itself can be categorized as of "minor" level of concern, since a failure or latent flaw in the software cannot result in injury or death to the patient or operator.
Bench & Non-clinical Testing
Verification and validation testing demonstrated that the device performance and functionality fulfill the design specifications and that the device performs the intended use and meets users' needs.
The performance of IQM as a measurement device were evaluated in bench tests conducted by iRT as manufacturer in multiple hospital environments where the IQM was installed and tested in the clinical workflow, with each hospital's clinical equipment and network environment. Performance testing evaluated how the device detected deviations and lack of deviations in beam intensity, shape and position as well as the reproducibility of measurement results. Test users at 17 sites participated in various tests and were observed in their handling and interaction with the device as part of human factors / usability testing.
Testing with a patient present (clinical testing) was not required because all tasks in the IQM's clinical workflow and its measurement results are the same whether or not a patient is present. Testing was performed with production equivalent IQM units, under clinically representative conditions with Elekta and
| File Name | 5-1_510(k) Summary Statement per 21 CFR 807 92.docx | FM_7.3-1-2v01.00 |
|---|---|---|
| Author | Thesi Roestel | Page 5.1-7 of 8 |
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| Image: iRT logoiRTSystems GmbH | § 5 510(k) Summary | Traditional 510(k) Submission |
|---|---|---|
| IQM Integral Quality Monitor | Date: 2016-06-24 |
Varian brand linear accelerators, commissioned and used clinically at the respective hospitals. Testing was performed by qualified personnel, through iRT staff and hospital medical physicists and radiation therapists at the respective hospital locations.
CONCLUSIONS യ
The comparison of the indication for use, performance, safety and effectiveness of the predicate and subject devices demonstrates that the IQM is as safe and effective as the predicate device and performs as well or better for its application. The technological differences between the predicate device and IQM do not raise new or different questions of safety and effectiveness.
| File Name | 5-1_510(k) Summary Statement per 21 CFR 807 92.docx | FM_7.3-1-2v01.00 |
|---|---|---|
| Author | Thesi Roestel | Page 5.1-8 of 8 |
N/A