IQM Integral Quality Monitor (also IQM)

K162629 · Irt Systems · IYE · Oct 20, 2016 · Radiology

Device Facts

• Record ID: K162629
• Device Name: IQM Integral Quality Monitor (also IQM)
• Applicant: Irt Systems
• Product Code: IYE · Radiology
• Decision Date: Oct 20, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended 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.

Device Story

IQM is a large-area ionization chamber accessory for medical linear accelerators (linacs). It captures radiation beam data (shape, position, dose) during IMRT delivery. The device consists of a detector unit and control software. The detector, mounted on the linac, transmits signals via Bluetooth to a transceiver, which connects to a control room computer. Software compares real-time delivery data against expected/reference values to verify accuracy. Used by radiation oncology professionals in clinical settings; provides real-time reporting of deviations to aid patient safety. Benefits include automated quality assurance documentation and potential detection of delivery errors during treatment.

Clinical Evidence

Bench testing only. No clinical data required as device workflow is identical regardless of patient presence. Performance evaluated at 17 hospital sites using Elekta and Varian linacs. Testing confirmed device detection of beam intensity, shape, and position deviations, as well as reproducibility. Human factors/usability testing conducted with clinical staff.

Technological Characteristics

Large-area, flat, vented ionization chamber. Materials: PMMA frame, metal electrode plates. Energy source: Rechargeable Lithium-ion battery (detector), mains-powered transceiver. Connectivity: Bluetooth (detector to transceiver), wired (transceiver to PC). Dimensions: 450-476mm x 449-462mm x 35mm. Weight: ~6.8kg. Compliance: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 62133 (battery).

Indications for Use

Indicated for quality assurance verification of radiation therapy treatment delivery (beam shape, position, and dose) from medical linear accelerators used for intensity modulated radiation therapy (IMRT). Not indicated for electron beam therapy.

Regulatory Classification

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.

Predicate Devices

• PTW DAVID (K062817)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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)

| <div> <span style="font-size:14px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
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| <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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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: [phone] Fax: [phone]

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, validation<br>reference |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Use Environment & User | | |
| At the linear accelerator<br>in the the treatment room<br>with protective bunker in<br>a radiation therapy<br>department. User<br>handling the device is a<br>radiation oncology<br>specialized professional | Same | No difference for safety<br>and effectiveness |
| Supported linear<br>accelerator treatment<br>modality | | |
| Intended for verification of<br>photon beam therapy | Same | No difference for safety<br>and effectiveness |
| Not intended for<br>verification of electron<br>beam therapy. Detector is<br>removed if electron<br>beams are to be used | Same | No difference for safety<br>and effectiveness |
| Detector construction | | |
| Construction & materials:<br>flat, vented ion chamber,<br>for photon energy beams,<br>multiple filaments (wires)<br>electrodes between<br>PMMA | Flat, vented ion<br>chamber, for photon<br>energy beams, angled<br>metal electrode plates in<br>PMMA frame | No safety issue,<br>effectiveness<br>demonstrated with<br>performance data:<br>subject device delivers<br>appropriate linearity,<br>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

| Radiological<br>characteristics: Beam<br>attenuation caused by<br>detector must be<br>considered in TPS | Same | No difference for safety<br>and effectiveness.<br>Handling of beam<br>attenuation is<br>demonstrated in<br>performance data |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical and mechanical<br>safety characteristics:<br>compliance with IEC<br>60601-1 and IEC 60601-1-2<br>(EMC) | Same | No difference for safety<br>and effectiveness.<br>Subject device has been<br>tested to newest editions<br>of the Medical Electrical<br>Equipment safety (IEC<br>60601-1) and MEE EMC<br>(IEC 60601-1-2) standards |
| Detector Dimensions &<br>weight:<br>Varies dependent on<br>model, including linac<br>specific holder:<br>451mm-498 mm x<br>243mm-372mm x<br>49 mm-99mm<br>approx. 3.5kg-4.9kg | Similar:<br>One detector model,<br>overall dimensions &<br>weight vary with linac<br>vendor specific holder:<br>450mm-476mm x<br>449mm-462 mm x<br>35mm<br>approx. 6.8kg | No difference for safety<br>and effectiveness |
| Availability of the light<br>field:<br>Light field is available (at<br>least 70% translucent) | Light field is made<br>available by removing<br>detector (detector is<br>opaque) | No difference for safety<br>and effectiveness.<br>Detector holder to attach<br>subject device to a linear<br>accelerator is<br>constructed for easy<br>removal and attachment<br>and is automatically<br>recognized by accessory<br>code recognition system<br>of linac, as validated in<br>system and usability<br>testing. |
| Fixation of detector to<br>treatment machine: | Similar | No difference for safety<br>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 |

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| | §5 510(k) Summary | Traditional 510(k)<br>Submission |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | IQM Integral Quality Monitor | Date: 2016-06-24 |
| Mechanical fixation &<br>optical-mechanical<br>coding plugs on the<br>device holder, per the<br>specification /<br>implementation of the<br>respective linac<br>manufacturer | | Detector holder to attach<br>subject device to a linear<br>accelerator is<br>constructed for easy<br>removal and attachment<br>and is automatically<br>recognized by accessory<br>code recognition system<br>of linac, as validated in<br>system and usability<br>testing. |
| Energy Source | | |
| Detector powered with<br>rechargeable NiMH<br>battery pack | Detector powered with<br>rechargeable Lithium ion<br>battery pack | No difference for safety<br>and effectiveness;<br>Battery and battery<br>implementation in subject<br>device have been tested<br>to newest MEE (IEC<br>60601-1) and<br>rechargeable battery<br>(IEC 62133) standards |
| Transceiver power via<br>power supply connected<br>to mains | Same | No difference for safety<br>and effectiveness. |
| Energy delivered | | |
| No energy is delivered to<br>patient or to another<br>system | Same | No difference for safety<br>and effectiveness |
| Communication: | | |
| Wireless transmission of<br>signal between detector<br>and transceiver via<br>Bluetooth | Same | No difference for safety<br>and effectiveness |
| Physical cable<br>connection between<br>transceiver and computer<br>in control room through | Same | No difference for safety<br>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 |

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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 using<br>measured dose length<br>product, correlating to the<br>opening of an MLC leaf<br>pair and the supplied<br>dose | Relative dosimetry using<br>measured spatially-<br>sensitive large area dose<br>product, correlating to<br>the opening of all MLC<br>pairs (entire beam<br>shape) and the supplied<br>dose | No difference for safety<br>and effectiveness.<br>Subject device IQM has<br>been validated as<br>acquiring the entire<br>beam shape and dose as<br>required for verification,<br>demonstrated in the<br>performance data |
| Specification of<br>reproducibility of = 1%<br or better; non-linearity<br>=1% or better</td SameNo difference for safety<br>and effectiveness. IQM<br>performance (sensitivity,<br>reproducibility, linearity) is<br>demonstrated in the<br>performance data. | | |
| Software functionalities<br>provided | | |
| Extent of software<br>provided:<br>Software provided to<br>control data acquisition<br>(measurement), derive/<br>save the expected /<br>reference values against<br>which each session is<br>compared, to compare<br>data, to display and save<br>results, retrieve data for<br>reports | Same | No difference for safety<br>and effectiveness.<br>Software design,<br>development and<br>verification are<br>performed per IEC 62304<br>and validated in<br>conformance with ISO<br>13485, GMP and the FDA<br>Guidance for Software<br>Validation |

#### 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 logo<br><b>iRT</b><br>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 |