(99 days)
STAGE is a post-processing software medical device intended for use in the visualization of the brain. STAGE analyzes input data from MR imaging systems. STAGE utilizes magnitude and phase data acquired with specific parameters to generate enhanced T1 weighted images, susceptibility weighted imaging (SWI) images, susceptibility weighted image map (SWIM) images, pseudo-SWIM (pSWIM) images, modified pSWIM ) images, true SWI (tSWI) images, MR angiography (MRA) images, simulated dual-inversion recovery (DIR) images, and maps of T1, R2*, and proton density (PD).
When interpreted by a trained physician, STAGE images may provide information useful in determining diagnosis.
STAGE is indicated for brain imaging only and should always be used in combination with at least one other conventional MR acquisition (e.g., T2 FLAIR).
STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a dedicated medical grade computer (STAGE Module) connected to the user's local area network. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e., the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to the PACS server. The data transfer is initiated by the user's current DICOM viewing software.
Here's a breakdown of the acceptance criteria and study information for the STAGE device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list specific quantitative acceptance criteria in a table format, nor does it provide a numerical "reported device performance" against those criteria. Instead, it makes general statements about meeting predefined acceptance criteria for image quality and clinical user needs.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Diagnostic Image Quality | Acceptable diagnostic image quality demonstrated in reader study. |
| Equivalent Radiologic Findings | Equivalent radiologic finding classes compared to the predicate device demonstrated in reader study. |
| Clinical User Needs | All predefined acceptance criteria for clinical user needs testing were met across all test cases. |
| Engineering (Pre-clinical) Performance | All predefined acceptance criteria for engineering (pre-clinical) performance testing were met. Results consistently according to intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "A reader study was conducted to demonstrate acceptable diagnostic image quality and equivalent radiologic finding classes compared to the predicate device."
- Test Set Sample Size: The exact number of cases or images in the test set for the reader study is not specified in the provided text.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used to establish ground truth or their qualifications. It mentions that "When interpreted by a trained physician, STAGE images may provide information useful in determining diagnosis." but this does not directly address the ground truth establishment for the reader study.
4. Adjudication Method for the Test Set
The document does not specify the adjudication method used for the test set in the reader study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document states: "A reader study was conducted to demonstrate acceptable diagnostic image quality and equivalent radiologic finding classes compared to the predicate device." This suggests a comparative study was performed, but it does not explicitly mention whether it was an MRMC study in the standard sense (comparing human readers with and without AI assistance).
- Effect Size of Human Readers with vs. without AI: This information is not provided in the document. The study aimed to show "equivalent radiologic finding classes compared to the predicate device," which implies a comparison between STAGE outputs and outputs from a predicate device, rather than a direct comparison of human reader performance with and without STAGE assistance on the same case.
6. Standalone (Algorithm Only) Performance Study
The document describes STAGE as "post-processing software medical device intended for use in the visualization of the brain" and states that "When interpreted by a trained physician, STAGE images may provide information useful in determining diagnosis." It clarifies that "STAGE is indicated for brain imaging only and should always be used in combination with at least one other conventional MR acquisition."
This suggests that STAGE is intended as a tool for a physician and not for standalone diagnostic use by the algorithm itself. Therefore, a standalone (algorithm-only) performance study, in the sense of the algorithm making a diagnosis without human input, was likely not performed or reported as part of this submission, given its described role as a "post-processing software."
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for the test set (e.g., expert consensus, pathology, outcome data). It only mentions demonstrating "acceptable diagnostic image quality and equivalent radiologic finding classes compared to the predicate device," implying comparison against established clinical understanding or predicate device outputs.
8. Sample Size for the Training Set
The document does not specify the sample size used for the training set. It only mentions the "Methodology" of STAGE and its use of input data.
9. How the Ground Truth for the Training Set was Established
The document does not specify how ground truth for the training set was established. It only describes the technical process of STAGE, stating it "analyzes input data from MR imaging systems" and uses "magnitude and phase data acquired with specific parameters to generate" various images and maps. This implies that the algorithms learn from MR imaging parameters and derived data, but the explicit method for establishing ground truth for training data is not detailed.
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June 29, 2021
Image /page/0/Picture/1 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.
SpinTech, Inc. % Mr. Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k SAINT PAUL MN 55114
Re: K210843
Trade/Device Name: STAGE Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LLZ Dated: June 21, 2021 Received: June 22, 2021
Dear Mr. Bom:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
K210843
Device Name STAGE
Indications for Use (Describe)
STAGE is a post-processing software medical device intended for use in the visualization of the brain. STAGE analyzes input data from MR imaging systems. STAGE utilizes magnitude and phase data acquired with specific parameters to generate enhanced T1 weighted images, susceptibility weighted imaging (SWI) images, susceptibility weighted image map (SWIM) images, pseudo-SWIM (pSWIM) images, modified pSWIM ) images, true SWI (tSWI) images, MR angiography (MRA) images, simulated dual-inversion recovery (DIR) images, and maps of T1, R2*, and proton density (PD).
When interpreted by a trained physician, STAGE images may provide information useful in determining diagnosis.
STAGE is indicated for brain imaging only and should always be used in combination with at least one other conventional MR acquisition (e.g., T2 FLAIR).
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 (K210843)
SpinTech, Inc. STAGE
510(k) Summary Preparation Date: June 28, 2021
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 RoadSuite 140Bingham Farms, MI 48025 |
|---|---|
| Contact Information: | Kay Fuller, RACPrincipal Regulatory & Clinical Research ConsultantMedical Device Regulatory Solutions, LLC734-846-7852 |
2. DEVICE INFORMATION
| Device Name: | STAGE |
|---|---|
| Proprietary Name: | STAGE |
| Common Name: | System, Imaging Processing, Radiological |
| Classification Name: | Magnetic Resonance Diagnostic Device |
| Classification Code: | LNH / LLZ |
| Regulation Number: | 21 CFR §892.1000 |
- The SpinTech, Inc. STAGE software medical device is substantially similar to 3. PREDICATE DEVICE(S) SyMRI software medical device cleared for US commercialization via K181093 on 6/12/2018 and the SPIN-SWI software application device cleared for US commercialization via K173224 on 2/23/2018.
-
- DEVICE DESCRIPTION STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a dedicated medical grade computer (STAGE Module) connected to the user's local area network. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e., the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to the PACS server. The data transfer is initiated by the user's current DICOM viewing software. The following table provide a summary of the methodology for each output with an example image and technical comparison to the predicate.
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Methodology
STAGE uses two or more 3D spoiled gradient echo scans collected with different flip angles.
Image /page/4/Picture/1 description: The image shows a black and white MRI scan of a brain. The scan is taken in the axial plane, showing a cross-sectional view of the brain. The white matter appears bright, while the gray matter appears darker. The ventricles, which are fluid-filled spaces in the brain, are also visible as dark areas.
STAGE
Quantitative
Output Pulse
Sequence
STAGF
Qualitative Output
Any simulated data (e.g., DIR) are created through a forward simulation process using the T1 and PD maps as input.
SyMRI forward simulates DIR data the exact same way, using the quantitative maps of T1 and PD.
generating intensity
generating intensity
Technical Characteristics Comparison
SyMRI uses a custom spin-echo based sequence
(SyMRI), collected multiple times with different
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5. INDICATIONS FOR USE STAGE is a post-processing software medical device intended for use in the visualization of the brain. STAGE analyzes input data from MR imaging systems. STAGE utilizes magnitude and phase data acquired with specific parameters to generate enhanced T1 weighted images, susceptibility weighted imaging (SWI) images, susceptibility weighted image map (SWIM) images, pseudo-SWIM (pSWIM) images, modified pSWIM (mpSWIM) images, true SWI (tSWI) images, MR angiography (MRA) images, simulated dualinversion recovery (DIR) images, and maps of T1, R2*, and proton density (PD). When interpreted by a trained physician, STAGE images may provide information useful in determining diagnosis. STAGE is indicated for brain imaging only and should always be used in combination with at least one other conventional MR acquisition (e.g., T2 FLAIR).
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The STAGE fundamental technological characteristics are similar to those of the predicate devices as described herein, and as noted in the following table.
| FeatureComparisonCriteria | Subject DeviceSTAGEK210843 | Predicate Device AK181093SyMRI | Subject DeviceSimilar toK181093? | Predicate Device BK173224SPIN-SWI | Subject DeviceSimilar toK173224? |
|---|---|---|---|---|---|
| 21 CFR Reg #,Product Code &Classification | 21 CFR §892.1000LNH / LLZClass II | 21 CFR §892.1000LNHClass II | Yes | 21 CFR §892.1000LNH / LLZClass II | Yes |
| Regulation Name | Magnetic resonancediagnostic device | Magnetic resonance diagnosticdevice | Yes | Magnetic resonancediagnostic device | Yes |
| PrescriptionDevice -Rx Only | Yes | Yes | Yes | Yes | Yes |
| Indications forUse | STAGE is a post-processingsoftware medical device intendedfor use in the visualization of thebrain.STAGE analyzes input datafrom MR imaging systems.STAGE utilizes magnitude andphase data acquired withspecific parameters to generateenhanced T1 weighted images,susceptibility weighted imaging(SWI) images, susceptibilityweighted image map (SWIM)images, pseudo-SWIM (pSWIM)images, modified pSWIM(mpSWIM) images, true SWI(tSWI) images, MR angiography(MRA) images, simulated dual-inversion recovery (DIR)images, and maps of T1, R2*,and proton density (PD).When interpreted by a trainedphysician, STAGE images mayprovide information useful indetermining diagnosis.STAGE is indicated for brainimaging only and should alwaysbe used in combination with atleast one other conventional MRacquisition (e.g., T2-FLAIR). | SyMRI is a post-processingsoftware medical device intendedfor use in visualization of the brain.SyMRI analyzes input data from MRimaging systems. SyMRI utilizesdata from a multi-delay, multi-echoacquisition (MDME) to generateparametric maps of R1, R2,relaxation rates, and proton density(PD). SyMRI can generate multipleimage contrasts from the parametricmaps. SyMRI enables post-acquisition image contrastadjustment. SyMRI is indicated forhead imaging.SyMRI is also indicated forautomatic labeling, visualization,and volumetric quantification ofsegmetable brain tissues from a setof MR images. Brain tissue volumesare determined based on modelingof parametric maps from MDME.When interpreted by a trainedphysician, SyMRI images canprovide information useful indetermining diagnosis. SyMRIshould always be used incombination with at least one otherMR acquisition (e.g., T2-FLAIR). | Yes | The SpinTech, Inc.application is intended foruse in the post-acquisitionimage enhancement of MRIacquired 3D gradient-echoimages of the brain. Whenused in combination withother clinical information, theSPIN-SWI application mayaid the qualified radiologistwith diagnosis by providingenhanced visualization ofstructures containing venousblood such as cerebralvenous vasculature. | Yes |
| Intended Users | Qualified Radiologist | Qualified Radiologist | Yes | Qualified Radiologist | Yes |
| Type of ImagingScans | MRI | MRI | Yes | MRI | Yes |
| FeatureComparisonCriteria | Subject DeviceSTAGEK Number TBD | Predicate Device AK181093SyMRI | Subject DeviceSimilar toK181093? | Predicate Device BK173224SPIN-SWI | Subject DeviceSimilar toK173224? |
| TargetOrgan/System | MR Brain | MR Brain | Yes | MR Brain | Yes |
| Loading MultipleStudies | Yes | Yes | Yes | Yes | Yes |
| TechnologicalFeatures | Supports 1.5T ImagesSupports 3.0T Images | Yes1.5T & 3.0T | Yes | Yes1.5T & 3.0T | Yes |
| Filtered Phase Maps | No | Yes | Yes | Yes | |
| Intensity Projection | No | Yes | Yes | Yes | |
| Automatic High-PassFiltering | No | Yes | Yes | Yes | |
| B1 correction | Yes | Yes | No | No | |
| Enhanced T1 weightedimages | Yes | Yes | No | No | |
| SWI | No | Yes | Yes | Yes | |
| Output | SWIM | No | No | No | No |
| pSWIM | No | Yes | Yes | Yes | |
| mpSWIM | No | Yes | Yes | Yes | |
| tSWI (SWI algorithm) | No | Yes | Yes | Yes | |
| MRA (intensityprojection) | No | Yes | Yes | Yes | |
| Simulated data (DIR,T1W, PDW) | Yes | Yes | No | No | |
| T1 map | Yes | Yes | No | No | |
| R2* map (T2=1R2*) | Yes (R2, same method) | Yes | No | No | |
| PD map | Yes | Yes | No | No | |
| Pulse Sequence | 3D Spoiled GRE (w/phase data) | SyMRI | N/A | SWI | N/A |
| Hardware | Minimum 16GB RAMand i7-6700TE 2.4GhzCPU | Minimum 4GB RAM and1.6Ghz CPU | N/A | Minimum 8GB RAMand i7 4790k CPU | N/A |
| OperatingSystem | Windows 10 | Windows 10, macOS | Yes | Windows 10 | Yes |
| Sterility | N/A | N/A | N/A | N/A | N/A |
| Biocompatibility | N/A | N/A | N/A | N/A | N/A |
| Electrical Safety | UL ANSI/AAMI ES 60601-1:2012 (v3.1)(STAGE Module) | User SuppliedPC / Console | No | User SuppliedPC / Console | No |
| Thermal Safety | N/A | N/A | N/A | N/A | N/A |
| EnergyUsed/Delivered | N/A | N/A | N/A | N/A | N/A |
| Chemical Safety | N/A | N/A | N/A | N/A | N/A |
| Radiation Safety | N/A | N/A | 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 STAGE:
- 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. STAGE was tested in accordance with SpinTech's verification and validation procedures.
All predefined acceptance criteria for the engineering (pre-clinical) performance testing were met. The results from the pre-clinical testing performed on STAGE produced results consistently according to its intended use.
-
- CLINICAL TESTING A reader study was conducted to demonstrate acceptable diagnostic image SUMMARY quality and equivalent radiologic finding classes compared to the predicate device. All predefined acceptance criteria for clinical validation testing included clinical user needs testing, as a part of the STAGE performance validation testing efforts were met across all test cases. The results of the clinical validation related testing performed on STAGE demonstrated acceptable image quality and that all clinical user needs were met.
9. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS
The subject device and the predicate devices 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 devices (K181093 and K17324) noted herein.
10. CONCLUSION The non-clinical and clinical testing contained herein, demonstrates that STAGE performs according to its intended use. The SpinTech, Inc. considers the STAGE (subject device) to be substantially equivalent to the legally marketed predicate devices noted herein.
§ 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.