SPIN-SWI

K173224 · Spintech, Inc. · LNH · Feb 23, 2018 · Radiology

Device Facts

• Record ID: K173224
• Device Name: SPIN-SWI
• Applicant: Spintech, Inc.
• Product Code: LNH · Radiology
• Decision Date: Feb 23, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The SpinTech, Inc. SPIN-SWI application is intended for use in the post-acquisition image enhancement of MRI acquired 3D gradient-echo images of the brain. When used in combination with other clinical information, the SPIN-SWI application may aid the qualified radiologist with diagnosis by providing enhanced visualization of structures containing venous blood such as cerebral venous vasculature.

Device Story

SPIN-SWI is a software application for post-processing 3D gradient-echo (GRE) MRI brain images. It operates on a PC workstation in conjunction with an FDA-cleared third-party DICOM viewer (ORIS Visual). The software processes magnitude and phase information from MRI scans to enhance contrast in tissues with varying magnetic susceptibility, specifically targeting iron-containing molecules like deoxyhemoglobin, ferritin, and hemosiderin. The device eliminates unwanted background fields and applies high-pass filtering to reconstruct enhanced images. These outputs are displayed to a qualified radiologist to assist in the visualization of cerebral venous vasculature and support clinical diagnosis. The device is intended for use by radiologists and technologists in clinical settings.

Clinical Evidence

No clinical studies were required. Evidence consists of non-clinical verification and validation, including risk analysis, requirements review, unit/integration testing, and simulated use testing. Performance testing confirmed the software meets predefined acceptance criteria across various imaging parameters and field strengths. Clinical validation testing focused on clinical user needs and image quality, confirming the device meets clinical requirements.

Technological Characteristics

Software-based image post-processing application. Operates on PC workstations. Compatible with 1.5T and 3.0T MRI systems (Siemens). Features include filtered phase maps, minimum intensity projection, and automatic high-pass filtering. Software is classified as Moderate Level of Concern. No hardware, energy delivery, or biocompatibility requirements.

Indications for Use

Indicated for use in post-acquisition enhancement of 3D gradient-echo MRI brain images to aid radiologists in visualizing venous blood structures and cerebral venous vasculature.

Regulatory Classification

Identification

A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

Special Controls

*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Philips' SWIp application device (K131241)

Reference Devices

• ORIS Visual (K100335)

Submission Summary (Full Text)

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February 23, 2018

SpinTech, Inc. % Kay Fuller, RAC Regulatory Affairs Consultant 30200 Telegraph Road, Suite 140 BINGHAM FARMS MI 48025

Re: K173224

Trade/Device Name: SPIN-SWI Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, LLZ Dated: January 12, 2018 Received: January 17, 2018

Dear Ms. Fuller:

We have reviewed vour 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 (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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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 mediation-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,

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) K173224

Device Name SPIN-SWI

Indications for Use (Describe)

The SpinTech, Inc. SPIN-SWI application is intended for use in the post-acquisition image enhancement of MRI acquired 3D gradient-echo images of the brain. When used in combination with other clinical information, the SPIN-SWI application may aid the qualified radiologist with diagnosis by providing enhanced visualization of structures containing venous blood such as cerebral venous vasculature.

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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# 15. 510(k) SUMMARY

# SpinTech, Inc.

# SPIN-SWI Application Software

## February 14, 2018

The following summary is provided pursuant to Section 513 (I) (3) (A) of the Federal Food Drug and Cosmetic Act:

#### 1. GENERAL INFORMATION

| Submitter Information: | SpinTech, Inc.<br>30200 Telegraph Road<br>Suite 140<br>Bingham Farms, MI 48025 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Kay Fuller, RAC<br>Principal Regulatory & Clinical Research Consultant<br>Medical Device Regulatory Solutions, LLC<br>734-846-7852 |
| 2. DEVICE INFORMATION | |
| Device Name: | SPIN-SWI application software |
| Proprietary Name: | SPIN-SWI |
| Common Name: | System, Imaging Processing, Radiological |
| Classification Name: | Magnetic resonance diagnostic device |
| Classification Code: | LNH, LLZ |
| Regulation Number: | 21 CFR § 892.1000 |

## 3. PREDICATE DEVICE

The SpinTech, Inc. SPIN-SWI application device is substantially equivalent to the predicate device, Philips' SWIp application device, cleared for US commercialization via K131241 on 8/30/2013.

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## 4. DEVICE DESCRIPTION

The SPIN-SWI device includes a post-processing algorithm that enhances the contrast of tissues with different susceptibilities from 3D gradient-echo MRI images. The susceptibility of a biological tissue relates to the concentration of iron within it. which can be present in the form of deoxyhemoglobin, ferritin, hemosiderin, or other molecules.

An MRI scan results in both magnitude and phase images. While magnitude is most commonly used clinically, the phase information can also be useful as it relates directly to the magnetic field. When tissues or objects of differing magnetic susceptibility are present, they perturb the field around them. This effect can be seen directly from phase images. While this perturbation already leads to signal loss in magnitude images, thus creating contrast, the phase information can still be used to enhance this contrast for local susceptibility changes.

Enhancing this contrast allows us to visualize structures containing venous blood such as cerebral venous vasculature that may have not been visible prior to enhancement. Some technical challenges of SWI include eliminating the effects of unwanted background fields and choosing parameters to create optimal contrast.

SPIN-SWI software works in conjunction with an FDA cleared third-party DICOM viewer as an image postprocessing solution in a PC workstation. The DICOM viewer (ORIS Visual) was FDA cleared on 4/29/2010 via K100335 and is used to transmit DICOM data and display the input and output images, the SPIN-SWI software application performs the SWI post-processing on 3D GRE input images to reconstruct the SWI output images.

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## 5. INDICATIONS FOR USE

The SpinTech, Inc. SPIN-SWI application is intended for use in the post-acquisition image enhancement of MRI acquired 3D gradient-echo images of the brain. When used in combination with other clinical information, the SPIN-SWI application may aid the qualified radiologist with diagnosis by providing enhanced visualization of structures containing venous blood such as cerebral venous vasculature.

#### 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The SPIN-SWI application's fundamental technological characteristics are similar to those of the predicate device as described in this submission, and in noted in the following table.

| Feature Comparison Criteria | Subject Device<br>SPIN-SWI K173224 | Predicate Device<br>K131241 | Subject<br>Device SE<br>to K131241? |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| 21 CFR Reg #, Product Code & | 21 CFR §892.1000 | 21 CFR §892.1000 | Yes |
| Classification | LNH, LLZ<br>Class II | LNH<br>Class II | |
| Requlation Name | Magnetic resonance diagnostic device | Magnetic resonance diagnostic device | Yes |
| Prescription Device - Rx Only | Yes | Yes | Yes |
| Indications for Use | The SpinTech, Inc. SPIN-SWI application is<br>intended for use in the post-acquisition image<br>enhancement of MRI acquired 3D gradient-echo<br>images of the brain. When used in combination with<br>other clinical information, the SPIN-SWI application<br>may aid the qualified radiologist with diagnosis by<br>providing enhanced visualization of structures<br>containing venous blood such as cerebral venous<br>vasculature. | SWIp is a software option intended for use on Achieva and Ingenia<br>1.5T & 3.0T MR Systems. It's indicated for magnetic resonance<br>imaging of the Brain. SWIp is a technique using phase information to<br>enhance contrast between tissues presenting susceptibility<br>differences, such as deoxygenated blood or some mineral deposits<br>(e.g. calcium deposits). Due to this contrast enhancement, SWIp<br>images are sensitive for structures containing venous blood such as<br>cerebral venous vascularture. When used in combination with other<br>clinical information, SWIp may help the expert radiologist in the<br>diagnosis of various neurological pathologies | Yes |
| Intended Users | Qualified Radiologist and Technologist | Qualified Radiologist and Technologist | Yes |
| Type of Imaging Scans | MRI | MRI | Yes |
| Target Organ/System | MR Brain | MR Brain | Yes |
| Loading Multiple Studies | Yes | Yes | Yes |
| Technological Features | Supports 1.5T Images<br>Supports 3.0T Images<br>(Siemens MRI Systems Only) | Yes<br>1.5T &3.0T<br>(Achieva & Ingenia Only) | Yes |
| | Filtered Phase Maps | Yes | Yes |
| | Minimum Intensity Projection | No | No |
| | Automatic High-Pass Filtering | Yes | Yes |
| Sterility | N/A | N/A | N/A |
| Biocompatibility | N/A | N/A | N/A |
| Electrical Safety | N/A | N/A | N/A |
| Thermal Safety | N/A | N/A | N/A |
| Energy Used/Delivered | N/A | N/A | N/A |
| Chemical Safety | N/A | N/A | N/A |
| Radiation Safety | N/A | N/A | N/A |

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## 7. NON-CLINICAL TESTING SUMMARY

The following design control, risk management and quality assurance methodologies were utilized to develop the SPIN-SWI application:

- Risk Analysis
- . Requirements Review
- Design Reviews ●
- Testing on Unit Level (Verification)
- Integration Testing (System Verification) ●
- Performance Testing (V&V) .
- Safety Testing (V&V) ●
- . Simulated Use Testing (Validation)

Software documentation for Moderate Level of Concern software per the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", issued on May 11, 2005, is also included in this premarket notification submission. The SpinTech SPIN-SWI application was tested in accordance with SpinTech's verification and validation procedures.

predefined acceptance criteria for the engineering All performance testing were met for all test cases across different imaging parameters, field strength and different subjects. The results from the pre-clinical testing performed on the SPIN-SWI application, demonstrate that the SPIN-SWI application produces results consistently according to its intended use.

#### 8. CLINICAL TESTING SUMMARY

The subject device of this premarket notification, SPIN-SWI application, did not require clinical studies to support substantial equivalence to the predicate device.

All predefined acceptance criteria for clinical validation testing, including clinical user needs testing, as a part of the SPIN-SWI performance validation testing efforts were met across all test cases. The results of the clinical validation related testing on the SPIN-SWI application demonstrates performed acceptable image quality and that all clinical user needs are met.

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# 9. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS

The subject device and the predicate device are substantially equivalent, with respect to intended use, instructions for use, design features, technological characteristics, manufacturing methods, performance criteria, special controls, and safety and effectiveness. The subject device is substantially equivalent to the predicate device (K131241) noted herein.

## 10. CONCLUSION

The non-clinical and clinical testing contained herein demonstrates the SPIN-SWI application performs according to its intended use. SpinTech, Inc. considers the SPIN-SWI application software (subject device) to be substantially equivalent to the legally marketed predicate device (K131241) noted herein, and is safe and effective for its labeled intended use.