ZOOM

K172768 · Zetta Medical Technologies, LLC · LLZ · Apr 24, 2018 · Radiology

Device Facts

• Record ID: K172768
• Device Name: ZOOM
• Applicant: Zetta Medical Technologies, LLC
• Product Code: LLZ · Radiology
• Decision Date: Apr 24, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

ZOOM Image Enhancement System is an image processing software that can be used for image enhancement in MRI images. Enhanced images will be sent to PACS server and exist in conjunction to the original images.

Device Story

ZOOM is an image processing software for MRI enhancement; operates on a remote computer. Inputs: DICOM images from MRI host computer. Processing: noise reduction via wavelet decomposition, soft thresholding of wavelet sub-bands, and inverse wavelet transform reconstruction. Outputs: enhanced DICOM images sent to PACS server. Workflow: automated processing of received images; enhanced images stored alongside originals. Benefits: improves signal-to-noise ratio (SNR) by at least 10% without degrading contrast resolution, aiding clinical image quality.

Clinical Evidence

Bench testing only. Validation performed using 64 data sets acquired via ACR MRI phantom on GE 1.5T Excite, Siemens Avanto 1.5T, Philips Intera 1.5T, and Toshiba Titan 1.5T systems. Sequences included spin echo, fast spin echo, and gradient echo. Primary endpoint: SNR improvement of at least 10% in slice 7 of ACR phantom data without degrading high-contrast (slice 1) or low-contrast (slice 11) resolution. All tests passed.

Technological Characteristics

Software-based image enhancement. Operates on PC/PC-compatible hardware (Intel i3, 4GB RAM, 500GB HDD). OS: Windows 7. Input/Output: DICOM. Algorithm: Wavelet-based noise reduction with image-guided filtering. Connectivity: Networked (receives from MRI host, sends to PACS).

Indications for Use

Indicated for image enhancement of MRI images. No specific patient population, age, or gender restrictions are defined.

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

• Context Vision Sharp View Image Enhancement System (K024028)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Zetta Medical Technologies, LLC. Main Ghazal President 1313 Ensell Road LAKE ZURICH IL 60047

April 24, 2018

Re: K172768

Trade/Device Name: ZOOM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: LLZ Dated: March 14, 2018 Received: March 23, 2018

Dear Main Ghazal:

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 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 (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.

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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 CDRHs Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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

Michael D. O'Hara For

Robert A. 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) K172768

Device Name ZOOM

Indications for Use (Describe)

ZOOM Image Enhancement System is an image processing software that can be used for image enhancement in MRI images. Enhanced images will be sent to PACS server and exist in conjunction to the original images.

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

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

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# 510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirement of Titles 21 CFR §807.87 and 807.92.

- 1. Applicant & Submitted By: Zetta Medical Technologies, LLC. 1313 Ensell Road, Lake Zurich, IL 60047 Phone: [phone] Fax: [phone] Contact Person: Main M. Ghazal, President Date Prepared: March 14th 2018
#### 2. Identification of the Device:

Trade Name: ZOOM Common Name: Image Enhancement System Classification Name: Image Processing System, Radiological (21 CFR, 892.2050, LLZ) Regulatory Description: Picture Archiving and Communications System

### 3. Predicate Device:

Context Vision Sharp View Image Enhancement System, K024028

### 4. Indications for Use:

ZOOM Image Enhancement System is an image processing software that can be used for image enhancement in MRI images. Enhanced images will be sent to PACS server and exist in conjunction to the original images.

### 5. Device Description:

ZOOM Image Enhancement System is an image processing software that can be used for image enhancement in MRI images. ZOOM image enhancement software implements a noise reduction algorithm using wavelets and image guided filtering. Original images are decomposed into different wavelet sub bands and noise in each band is soft threshold. De-noised images are reconstructed from softthresholded images using inverse wavelet transform. The software, which is installed on a remote computer, receives DICOM images from MRI host computer, automatically processes the received images and sends the enhanced images to a PACS server. Enhanced images exist in conjunction to the original images.

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# 6. Substantial Equivalence Table

The subject device ZOOM is substantially equivalent to the predicate device, Sharp View Image Enhancement System. The main difference is that Sharp View Enhancement Image transfer/storage/enhancement system where as ZOOM (as of 7/27/2017) is strictly an MRI image enhancement software. Detailed differences between ZOOM and Sharp view systems are listed in Table-1.

| Characteristics | ZOOM | Sharp View Image<br>Enhancement System |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | ZOOM Image<br>Enhancement System is<br>an image processing<br>software that can be used<br>for image enhancement<br>in MRI images.<br>Enhanced images will be<br>sent to PACS server and<br>exist in conjunction to<br>the original images. | The Image Enhancement<br>System is intended for use by<br>a qualified/trained<br>technologist for transfer,<br>storage, enhancement and<br>viewing of multi-modality<br>images. |
| Computer | PC or PC Compatible | PC compatible |
| Operating<br>System | Windows 7 | Windows 98, NT 4.0, 2000 and<br>XP |
| Storage | Is not a primary image<br>storage system.<br>However, processed<br>images are archived on<br>local hard drive | Hard disk or any compatible<br>PC method: Optical, CDROM,<br>Tape |
| Image Processing<br>Hardware | Intel i3 processor, 4GB<br>RAM, 500GB Hard drive | Javelin (PCI-bus) or Similar |
| Software core | ZOOM Image<br>Enhancement Software<br>(Zetta's own trademark) | GOP® Enhancement software<br>(The GOP trademark is the<br>property of Context Vision) |
| Image Input | DICOM | DICOM |
| Image output | DICOM | DICOM |

Table -1: ZOOM vs Sharp View Image Enhancement System

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## 7. Performance Testing:

ZOOM has been designed, verified and validated in compliance with FDA 21 CFR Part 820 requirements. The device has been validated through the use of ACR MRI PHANTOM. A total of 64 data sets were acquired using spin echo, fast spin echo and gradient echo based sequences from the following systems: GE 1.5T Excite, Siemens Avanto 1.5T, Philips Intera 1.5T and Toshiba Titan 1.5T. Parameters (slice thickness, field of view, matrix dimensions and number of averages) that effect the signal to noise ratio (SNR) were varied while acquiring the 64 data sets. These data sets were processed using ZOOM software for image enhancement and results are compared between original and processed images. Performance test results indicate that the ZOOM software improves SNR by at least 10% without degrading high and low contrast resolutions.

| Requirement specification | Verified on systems | Result |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|--------|
| For spin echo large phantom protocol in<br>ACR quality control 2015, the software<br>shall increase SNR by at-least 10% in slice<br>7 ACR data without compromising high<br>contrast resolution in slice 1 and low<br>contrast resolution in slice 11 | GE 1.5T Excite Siemens Avanto 1.5T Philips Intera 1.5T Toshiba Titan 1.5T | Pass |
| For fast spin echo sequences with slice<br>thickness in the range 2-5mm and in-<br>plane resolution in the range 0.6-1.4 mm,<br>the software shall increase SNR by at-least<br>10% in slice 7 ACR data without<br>compromising high contrast resolution in<br>slice 1 and low contrast resolution in slice<br>11 | GE 1.5T Excite Siemens Avanto 1.5T Philips Intera 1.5T Toshiba Titan 1.5T | Pass |
| For gradient echo sequences with slice<br>thickness in the range 2-5mm and in-<br>plane resolution in the range 0.6-1.4 mm,<br>the software shall increase SNR by at-least<br>10% in slice 7 ACR data without<br>compromising high contrast resolution in<br>slice 1 and low contrast resolution in slice<br>11 | GE 1.5T Excite Siemens Avanto 1.5T Philips Intera 1.5T Toshiba Titan 1.5T | Pass |
| For spin echo small phantom protocol in<br>ACR quality control 2015, the software<br>shall increase SNR by at-least 10% in slice<br>7 ACR data without compromising high | GE 1.5T Excite Siemens Avanto 1.5T Philips Intera 1.5T Toshiba Titan 1.5T | Pass |

Table - 2: High level performance test results

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| contrast resolution in slice 1 and low |
|----------------------------------------|
| contrast resolution in slice 11 |

#### 8. Safety and Effectiveness:

Based on the ZOOM software performance test results and incorporated risk minimization methods in design, Zetta Medical Technologies concludes that this device is substantially equivalent to the predicate device.

#### 9. Conclusion:

ZOOM is an image enhancement software which has similar indications for use as predicate device. The main difference is that the predicate device is a multimodality image transfer/storage/enhancement system where as ZOOM (as of 7/27/2017) is strictly an MRI image enhancement system. Performance test results and incorporated risk minimization methods demonstrate that ZOOM is as safe and effective as predicate device.