(29 days)
No reference devices were used in this submission.
No
The summary describes a hardware device (ionization chamber) and software for processing and displaying measurement data for quality assurance. There is no mention of AI, ML, or related concepts like training/test sets, image processing, or complex algorithms beyond comparison and deviation detection.
No
This device is for quality assurance and verification of radiation therapy treatments, not for directly treating a disease or condition.
No.
The device is used for quality assurance verification measurements of treatment delivery accuracy from medical linear accelerators, not for diagnosing patient conditions. It verifies a delivered dose against an expected dose and reports deviations, primarily for a hospital's quality assurance program.
No
The device description explicitly states that the IQM System consists of an "electronic detector device and software," indicating the presence of hardware components in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for quality assurance verification measurements of medical linear accelerators used for radiation therapy. It measures the delivered radiation beam to verify treatment delivery accuracy.
- Device Description: The device is an ionization chamber and software used to measure and analyze radiation beams from a linear accelerator.
- No mention of biological samples: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue). This device interacts with the radiation beam from a medical device, not a biological sample.
The device is clearly designed for quality control and verification of a medical treatment delivery system, not for diagnosing or monitoring a patient's health status through the analysis of biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes
IYE
Device Description
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.
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
At the linear accelerator in the the treatment room with protective bunker in a radiation therapy department. User handling the device is a radiation oncology specialized professional
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
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 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
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 guidance. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design featuring three profiles that resemble human faces, stacked on top of each other and connected by a flowing line.
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.
1
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
2
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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3
§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 |
4
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 |
5
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, validation
reference |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Use Environment & User | | |
| At the linear accelerator
in the the treatment room
with protective bunker in
a radiation therapy
department. User
handling the device is a
radiation oncology
specialized professional | Same | No difference for safety
and effectiveness |
| Supported linear
accelerator treatment
modality | | |
| Intended for verification of
photon beam therapy | Same | No difference for safety
and effectiveness |
| Not intended for
verification of electron
beam therapy. Detector is
removed if electron
beams are to be used | Same | No difference for safety
and effectiveness |
| Detector construction | | |
| Construction & materials:
flat, vented ion chamber,
for photon energy beams,
multiple filaments (wires)
electrodes between
PMMA | Flat, vented ion
chamber, for photon
energy beams, angled
metal electrode plates in
PMMA frame | No safety issue,
effectiveness
demonstrated with
performance data:
subject device delivers
appropriate 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 |
6
| §5 510(k) Summary | |
|---|---|
| ------------------- | -- |
il RT
Systems GmbH
IQM Integral Quality Monitor
| Radiological
characteristics: Beam
attenuation caused by
detector must be
considered in TPS | Same | No difference for safety
and effectiveness.
Handling of beam
attenuation is
demonstrated in
performance data |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical and mechanical
safety characteristics:
compliance with IEC
60601-1 and IEC 60601-1-2
(EMC) | Same | No difference for safety
and effectiveness.
Subject device has been
tested to newest editions
of the Medical Electrical
Equipment safety (IEC
60601-1) and MEE EMC
(IEC 60601-1-2) standards |
| Detector Dimensions &
weight:
Varies dependent on
model, including linac
specific holder:
451mm-498 mm x
243mm-372mm x
49 mm-99mm
approx. 3.5kg-4.9kg | Similar:
One detector model,
overall dimensions &
weight vary with linac
vendor specific holder:
450mm-476mm x
449mm-462 mm x
35mm
approx. 6.8kg | No difference for safety
and effectiveness |
| Availability of the light
field:
Light field is available (at
least 70% translucent) | Light field is made
available by removing
detector (detector is
opaque) | No difference for safety
and effectiveness.
Detector holder to attach
subject device to a linear
accelerator is
constructed for easy
removal and attachment
and is automatically
recognized by accessory
code recognition system
of linac, as validated in
system and usability
testing. |
| Fixation of detector to
treatment machine: | Similar | No difference for 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 5.1-4 of 8 |
7
| | §5 510(k) Summary | Traditional 510(k)
Submission |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | IQM Integral Quality Monitor | Date: 2016-06-24 |
| Mechanical fixation &
optical-mechanical
coding plugs on the
device holder, per the
specification /
implementation of the
respective linac
manufacturer | | Detector holder to attach
subject device to a linear
accelerator is
constructed for easy
removal and attachment
and is automatically
recognized by accessory
code recognition system
of linac, as validated in
system and usability
testing. |
| Energy Source | | |
| Detector powered with
rechargeable NiMH
battery pack | Detector powered with
rechargeable Lithium ion
battery pack | No difference for safety
and effectiveness;
Battery and battery
implementation in subject
device have been tested
to newest MEE (IEC
60601-1) and
rechargeable battery
(IEC 62133) standards |
| Transceiver power via
power supply connected
to mains | Same | No difference for safety
and effectiveness. |
| Energy delivered | | |
| No energy is delivered to
patient or to another
system | Same | No difference for safety
and effectiveness |
| Communication: | | |
| Wireless transmission of
signal between detector
and transceiver via
Bluetooth | Same | No difference for safety
and effectiveness |
| Physical cable
connection between
transceiver and computer
in control room through | Same | No difference for safety
and 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 |
8
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 using | ||
| measured dose length | ||
| product, correlating to the | ||
| opening of an MLC leaf | ||
| pair and the supplied | ||
| dose | 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 | No difference for safety | |
| and effectiveness. | ||
| Subject device IQM has | ||
| been validated as | ||
| acquiring the entire | ||
| beam shape and dose as | ||
| required for verification, | ||
| demonstrated in the | ||
| performance data | ||
| Specification of | ||
| reproducibility of = 1%iRT | ||
| Systems 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 |