(143 days)
No
The description focuses on a post-processing algorithm based on magnetic susceptibility principles and does not mention AI or ML.
No.
The device is described as an image post-processing application intended to enhance MRI images for diagnosis, not to treat or cure a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device "may aid the qualified radiologist with diagnosis".
Yes
The device is described as a "post-processing algorithm" and "software application" that works in conjunction with an FDA cleared third-party DICOM viewer on a PC workstation. There is no mention of any hardware component being part of the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The description clearly states that the SPIN-SWI application processes MRI images of the brain. It does not analyze blood, tissue samples, or any other biological specimens taken from the body.
- The intended use is post-acquisition image enhancement. The device works with existing MRI data to improve visualization, not to perform a test on a biological sample.
The device is a medical image processing software intended to aid in diagnosis by enhancing existing imaging data. This falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes
LNH, LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI acquired 3D gradient-echo images
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified Radiologist and Technologist
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing, including design control, risk management, and quality assurance methodologies (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 was included. All performance testing acceptance criteria were met across different imaging parameters, field strength, and different subjects. The results demonstrate that the SPIN-SWI application produces results consistently according to its intended use.
Clinical testing: No clinical studies were required to support substantial equivalence. Predefined acceptance criteria for clinical validation testing, including clinical user needs testing, as part of performance validation were met across all test cases. The results demonstrated acceptable image quality and that all clinical user needs are met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
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).(b)
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.
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Food and Drug Administration (FDA) and the Department of Health & Human Services. The FDA logo features the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. To the left of the FDA logo is the symbol of the Department of Health & Human Services, which consists of a stylized human figure.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.
30200 Telegraph Road
Suite 140
Bingham Farms, MI 48025 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Kay Fuller, RAC
Principal Regulatory & Clinical Research Consultant
Medical Device Regulatory Solutions, LLC
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
SPIN-SWI K173224 | Predicate Device
K131241 | Subject
Device SE
to K131241? |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| 21 CFR Reg #, Product Code & | 21 CFR §892.1000 | 21 CFR §892.1000 | Yes |
| Classification | LNH, LLZ
Class II | LNH
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
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. | SWIp is a software option intended for use on Achieva and Ingenia
1.5T & 3.0T MR Systems. It's indicated for magnetic resonance
imaging of the Brain. SWIp is a technique using phase information to
enhance contrast between tissues presenting susceptibility
differences, such as deoxygenated blood or some mineral deposits
(e.g. calcium deposits). Due to this contrast enhancement, SWIp
images are sensitive for structures containing venous blood such as
cerebral venous vascularture. When used in combination with other
clinical information, SWIp may help the expert radiologist in the
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
Supports 3.0T Images
(Siemens MRI Systems Only) | Yes
1.5T &3.0T
(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.