(99 days)
Not Found
No
The document describes image post-processing and generation of different image contrasts from existing MR data. There is no mention of AI, ML, or related terms, nor any description of training or test sets typically associated with AI/ML development.
No.
The document states that STAGE is a software medical device for visualizing the brain and aiding in diagnosis, not for providing therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section states, "When interpreted by a trained physician, STAGE images may provide information useful in determining diagnosis." This indicates its role in aiding the diagnostic process.
No
The device description explicitly states that the STAGE system consists of a "dedicated medical grade computer (STAGE Module)" which is a hardware component.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes medical images: The STAGE device processes data from MR imaging systems (medical images) of the brain. It does not interact with or analyze biological samples.
- The intended use is image post-processing and visualization: The primary function described is to enhance and generate different types of images from existing MR data for visualization and interpretation by a physician.
Therefore, based on the definition of an IVD, STAGE does not fit that category. It is a medical device that performs image processing and analysis.
N/A
Intended Use / 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 ) 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).
Product codes (comma separated list FDA assigned to the subject device)
LNH, LLZ
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.
STAGE uses two or more 3D spoiled gradient echo scans collected with different flip angles.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR imaging systems, MRI
Anatomical Site
brain, head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician, Qualified Radiologist
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)
A reader study was conducted to demonstrate acceptable diagnostic image 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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)
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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 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.
-
- 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 | N/A | SWI | N/A |
| Hardware | Minimum 16GB RAM
and i7-6700TE 2.4Ghz
CPU | Minimum 4GB RAM and
1.6Ghz CPU | N/A | Minimum 8GB RAM
and i7 4790k CPU | N/A |
| Operating
System | 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 Supplied
PC / Console | No | User Supplied
PC / Console | No |
| Thermal Safety | N/A | N/A | N/A | N/A | N/A |
| Energy
Used/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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"One tissue NMR paranelers are quantified in the mast, this infornation on be used o simulae will olie. Syllet intersionecovery data dhe inversionered spoiled gradient-echo data.
7
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.