Who is the manufacturer of STAGE?

Spintech, Inc. filed the 510(k) submission for STAGE (K210843).

What is the FDA product code for STAGE?

LNH. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for STAGE?

510(k) clearance (submission type: Traditional).

What are the predicate devices for STAGE?

SyMRI (K181093); SPIN-SWI (K173224).

Who can help prepare an FDA 510(k) submission like STAGE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

STAGE

K210843 · Spintech, Inc. · LNH · Jun 29, 2021 · Radiology

Device Facts

Record ID	K210843
Device Name	STAGE
Applicant	Spintech, Inc.
Product Code	LNH · Radiology
Decision Date	Jun 29, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2
Attributes	3rd-Party Reviewed

Intended 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 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).

Device Story

STAGE is a post-processing software medical device for brain MRI. It takes DICOM data from 3D spoiled gradient echo (GRE) MRI scans as input. The system uses magnitude and phase data to generate various enhanced images (SWI, SWIM, pSWIM, mpSWIM, tSWI, MRA) and quantitative maps (T1, R2*, proton density). Simulated data like DIR are created via forward simulation using T1 and PD maps. The device runs on a dedicated medical-grade computer (STAGE Module) connected to a local area network; it receives data initiated by the user's existing DICOM viewing software and outputs processed datasets to a PACS server. Used by radiologists in clinical settings to aid diagnosis by providing enhanced visualization of brain structures. It benefits patients by providing additional diagnostic information from standard MRI acquisitions.

Clinical Evidence

A reader study was conducted to evaluate diagnostic image quality and radiologic finding classes. Results demonstrated acceptable image quality and confirmed that all clinical user needs were met. No specific sensitivity/specificity metrics were reported.

Technological Characteristics

Software-based post-processing system. Operates on a dedicated medical-grade computer (minimum 16GB RAM, i7-6700TE 2.4Ghz CPU) running Windows 10. Complies with UL ANSI/AAMI ES 60601-1:2012 (v3.1). Processes 3D spoiled GRE MRI data (1.5T and 3.0T). Features include B1 correction, high-pass filtering, and intensity projection. Software is classified as Moderate Level of Concern.

Indications for Use

Indicated for brain imaging in patients requiring visualization of brain structures via MRI. Must be used by a qualified radiologist in combination with at least one other conventional MR acquisition (e.g., T2 FLAIR).

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

SyMRI (K181093)
SPIN-SWI (K173224)

Related Devices

K223079 — Stage · Spintech, Inc. · Oct 28, 2022
K173558 — SyMRI · Syntheticmr AB · Jan 26, 2018
K181093 — SyMRI · Syntheticmr AB · Jun 12, 2018
K233733 — SyMRI · Syntheticmr AB (Publ.) · Mar 26, 2024
K173224 — SPIN-SWI · Spintech, Inc. · Feb 23, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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 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: | 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. - 4. 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. {4}------------------------------------------------ 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 {5}------------------------------------------------ #### 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. | Feature Comparison Criteria | Subject Device STAGE K210843 | Predicate Device A K181093 SyMRI | Subject Device Similar to K181093? | Predicate Device B K173224 SPIN-SWI | Subject Device Similar to K173224? | |---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------| | 21 CFR Reg #, Product Code & Classification | 21 CFR §892.1000 LNH / LLZ Class II | 21 CFR §892.1000 LNH Class II | Yes | 21 CFR §892.1000 LNH / LLZ Class II | Yes | | Regulation Name | Magnetic resonance diagnostic device | Magnetic resonance diagnostic device | Yes | Magnetic resonance diagnostic device | Yes | | Prescription Device - Rx Only | Yes | Yes | Yes | Yes | Yes | | 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 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). | SyMRI is a post-processing software medical device intended for use in visualization of the brain. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from a multi-delay, multi-echo acquisition (MDME) to generate parametric maps of R1, R2, relaxation rates, and proton density (PD). SyMRI can generate multiple image contrasts from the parametric maps. SyMRI enables post- acquisition image contrast adjustment. SyMRI is indicated for head imaging. SyMRI is also indicated for automatic labeling, visualization, and volumetric quantification of segmetable brain tissues from a set of MR images. Brain tissue volumes are determined based on modeling of parametric maps from MDME. When interpreted by a trained physician, SyMRI images can provide information useful in determining diagnosis. SyMRI should always be used in combination with at least one other MR acquisition (e.g., T2-FLAIR). | Yes | The SpinTech, Inc. 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. | Yes | | Intended Users | Qualified Radiologist | Qualified Radiologist | Yes | Qualified Radiologist | Yes | | Type of Imaging Scans | MRI | MRI | Yes | MRI | Yes | | Feature Comparison Criteria | Subject Device STAGE K Number TBD | Predicate Device A K181093 SyMRI | Subject Device Similar to K181093? | Predicate Device B K173224 SPIN-SWI | Subject Device Similar to K173224? | | Target Organ/System | MR Brain | MR Brain | Yes | MR Brain | Yes | | Loading Multiple Studies | Yes | Yes | Yes | Yes | Yes | | Technological Features | Supports 1.5T Images Supports 3.0T Images | Yes 1.5T & 3.0T | Yes | Yes 1.5T & 3.0T | Yes | | | Filtered Phase Maps | No | Yes | Yes | Yes | | | Intensity Projection | No | Yes | Yes | Yes | | | Automatic High-Pass Filtering | No | Yes | Yes | Yes | | | B1 correction | Yes | Yes | No | No | | | Enhanced T1 weighted images | 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 (intensity projection) | 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…