iQMR

K173605 · Medic Vision - Imaging Solutions, Ltd. · LLZ · Mar 8, 2018 · Radiology

Device Facts

• Record ID: K173605
• Device Name: iQMR
• Applicant: Medic Vision - Imaging Solutions, Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Mar 8, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The iQMR is intended for networking, communication, processing and enhancement of MRI images in DICOM format. The device processing is not effective for lesion, mass, or abnormalities of sizes less than 1.5mm. This device is indicated for use by qualified trained medical professionals.

Device Story

iQMR is a software package for MRI image enhancement via noise reduction. It operates on an off-the-shelf PC server connected to a local area network (LAN). The device receives DICOM-formatted MRI images from workstations, processes them using proprietary algorithms, and transmits the enhanced images back to selected workstations. It is intended for use by qualified medical professionals in clinical environments. The output is used by healthcare providers to assist in viewing MRI data; the enhancement aims to improve image quality for diagnostic review. The device does not detect lesions or abnormalities smaller than 1.5mm.

Clinical Evidence

No formal clinical trials were conducted. Performance was validated using non-clinical bench testing with MRI standard phantoms and processing of clinical MRI images to ensure conformance to user needs and intended use under actual conditions.

Technological Characteristics

Software package running on off-the-shelf PC server with graphical boards. Operating system: Linux Ubuntu. Inputs/outputs: DICOM format MRI images. Connectivity: LAN. Risk management per ISO 14971.

Indications for Use

Indicated for qualified trained medical professionals requiring networking, communication, processing, and enhancement of MRI images in DICOM format. Not effective for lesions, masses, or abnormalities smaller than 1.5mm.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• SharpView (K993802)

Submission Summary (Full Text)

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Medic Vision - Imaging Solutions Ltd % Mr. Dan Laor Q&R Advisor 6 Sireni St. Haifa, 3297206 ISRAEL

Re: K173605

Trade/Device Name: iOMR Regulation Number: 21 CFR 892,2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 19, 2018 Received: February 27, 2018

Dear Mr. Laor:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

March 8, 2018

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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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,
Robert Sauer

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) K173605

Device Name iQMR

Indications for Use (Describe)

The iQMR is intended for networking, communication, processing and enhancement of MRI images in DICOM format. The device processing is not effective for lesion, mass, or abnormalities of sizes less than 1.5mm. This device is indicated for use by qualified trained medical professionals.

Type of Use (Select one or both, as applicable)

| <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------|
| <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary of Safety and Effectiveness

# Submitter details

Medic Vision Imaging Solutions Ltd. 3 Yozma St, Tirat Carmel 39032, Israel

Telephone [phone]

Submission Contact: Dan Laor Israel.

#### Details of the submitted Device

| Proprietary Name: | iQMR |
|-------------------|-----------|
| Regulation Number | 892.2050 |
| Product Code: | LLZ |
| Committee/Panel: | Radiology |
| Device Class: | 2 |

6 Sireni St., Haifa, 3297206,

# Type of 510(k) Submission:

Traditional

#### Identification of the Legally Marketed Predicate Device K993802 SharpView

### Device Description

iQMR is a software package that is aimed to process MRI images. The iQMR processing enhances MRI images by reduction of the image noise. The software runs on a PC server, which is connected to the Local Area Network (LAN). The device receives MRI images from different work stations over the network in DICOM format, processes the images and transmits them in DICOM format, to selected work stations.

#### Intended use and indications for Use

The iQMR is intended for networking, communication, processing and enhancement of MRI images in DICOM format. The device processing is not effective for lesion, mass, or abnormalities of sizes less than 1.5mm. This device is indicated for use by qualified trained medical professionals.

#### Technological Characteristics

The iQMR software package is installed in an off-the-shelf PC server, which include off-the -shelf graphical boards. The Operating System is Linux Ubuntu. The iQMR software package consists of three software modules: The User Interface, Algorithm, and Interface module. Data inputs and output are MRI images in DICOM format.

#### Performance Tests

#### Non-Clincal tests

The device software has been verified by testing the software following predefined software test plan.

The iQMR system has been verified by testing that it meets its specified performance, using MRI standard phantoms.

The iQMR performance has been validated by testing it performing its intended and indications for use, in end-user environment.

Vol_003 002_510K Summary

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The above testing methods adhered to state-of-art standards and procedures. The tests results demonstrate that the device output meet the design input and the intended use.

#### Clinical tests:

Clinical tests were not conducted. However, MRI clinical images were processed in order to ensure that the iQMR conforms to defined user needs and intended uses under actual conditions.

## Risk Management

The device risks were managed and controlled following the requirements of ISO 14971standard. The device hazards were identified, their risk levels were evaluated and mitigation measures were taken to reduce the risk levels. In Medic Vision opinion the benefits of providing the iQMR features, overweight the device residual risks.

### Substantial Equivalence

| Parameter | Predicate Device<br>SharpView (K993802) | Subject Device<br>iQMR |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Intended use | Intended for use by qualified<br>trained medical professionals for<br>enhancement of MRI images that<br>are transferred in the network in<br>DICOM format. | The same |
| 21CFR section | 892.2050 | The same |
| Product Code | LLZ | The same |
| <b>Technological<br/>Characteristics</b> | | |
| Device nature | SW package | The same |
| Operating System | Windows | Linux |
| Data input | MRI images in DICOM format | The same |
| Data output | MRI images in DICOM format | The same |
| Processing<br>Algorithms | GOP Enhancement Software | Medic Vision's<br>Algorithms |
| User Interface | Included | The same |

Comparison with the predicate device

# Substantial Equivalence conclusion

The iQMR has the same intended use as the legally marketed SharpView predicate device. The two devices have similar technological characteristics. Results of tests, which were adhered to state-of-art standards and procedures, demonstrate that differences in the technological characteristics do not raise new questions of safety or effectiveness. Based on this discussion, it is Medic Vision's opinion that iQMR is substantially equivalent in terms of safety and effectiveness to the SharpView (K993802) predicate device.