Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes image post-processing and a white noise filtering algorithm (CROWN), but does not mention AI, ML, or related terms like deep learning or neural networks.

Therapeutic

No
The device is a post-processing software that visualizes the brain and provides information useful in determining diagnosis; it does not directly treat or manage a disease or condition.

Diagnostic

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 that the device aids in the diagnostic process.

SaMD (Software as a Medical Device)

Yes

The device is explicitly described as a "post-processing software medical device" and its function is solely to process existing MR imaging data. While it requires a dedicated computer, this computer is described as "client supplied" and the software operates within a virtual machine, indicating the submission is focused on the software itself, not the hardware.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
Device Function: The description clearly states that STAGE is a post-processing software medical device that analyzes MR imaging data from the brain. It does not involve the analysis of biological samples taken from the body.
Intended Use: The intended use is for the visualization of the brain and providing information useful in determining diagnosis based on the processed MR images.

Therefore, STAGE falls under the category of medical imaging software, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 Tl 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 TI, 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 client supplied dedicated computer with an ethernet connection to the client's existing local network. The STAGE software will operate within a virtual machine environment (virtual STAGE module) on this dedicated computer. 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. STAGE has been modified from the predicate to include CROWN, a white noise filtering algorithm intended to improve specific STAGE outputs.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

MR imaging systems
MRI

Anatomical Site

brain

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)

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) .

All predefined acceptance criteria for the performance testing were met. The results from the performance testing executed on STAGE produced results consistently according to its intended use.

Clinical Testing Summary:
Clinical testing was not necessary to demonstrate substantial equivalence of STAGE to the predicate device.

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.

K210843

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

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 28, 2022

SpinTech, Inc. % Rana Hachem Management Representative / Business Operations Manager 30200 Telegraph Road Suite 140 BINGHAM FARMS MI 48025

Re: K223079

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: September 28, 2022 Received: September 30, 2022

Dear Rana Hachem:

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

1

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 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 medical devices and radiation-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,

Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

K223079

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 Tl 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 TI, 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).

X 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

Image /page/3/Picture/0 description: The image shows the logo for SpinTech MRI. The logo features a stylized atom graphic on the left, followed by the text "SpinTechMRI" in a sans-serif font. Below the company name is the tagline "from image to insight" in a smaller font size.

K223079

510(k) Summary

Date Prepared:	September 28, 2022
Submitter:	SpinTech, Inc.
30200 Telegraph Road, Suite 140
Bingham Farms, MI 48025
Contact:	Rana El Hachem
Management Representative / Business Operations Manager
SpinTech, Inc.
(248) 712-6789
rana@ spintechmri.com
Proprietary Name:	STAGE
Common Name:	System, Imaging Processing, Radiological
Classification Name:	Magnetic resonance diagnostic device
Regulation Number:	21 CFR Section 892.1000
Classification Code:	LNH / LLZ
Review Panel:	Radiology
Substantially
Equivalent Devices:	K210843 - SpinTech, Inc. STAGE

Device Description:

STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a client supplied dedicated computer with an ethernet connection to the client's existing local network. The STAGE software will operate within a virtual machine environment (virtual STAGE module) on this dedicated computer. 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. STAGE has been modified from the predicate to include

4

Image /page/4/Picture/0 description: The image is the logo for SpinTech MRI. The logo consists of a blue atom-like graphic on the left, followed by the words "SpinTechMRI" in blue. Below the company name is the tagline "from image to insight" in a smaller font, also in blue. The logo is clean and modern, with a focus on the company's name and its mission.

CROWN, a white noise filtering algorithm intended to improve specific STAGE outputs. The following table provide a summary of the methodology for each output with an example image and technical comparison to the predicate.

| STAGE
Quantitative
Output | Output Methodology | Technical Characteristics
Comparison |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| T1 Map
Image: T1 Map | STAGE uses a least squares fitting over
variable flip angles to quantify T1.
Expected Contrast: WM, GM, CSF
contrast will appear similar to a
conventional T2W scan.
Comparable Conventional Scan
Contrast: T1W (inverted) | Methodology Unchanged |
| R2* Map
Image: R2* Map
CROWN
enabled R2*
Map | STAGE uses a least squares fitting over
variable echo times to quantify $R2*/T2*$ .
The optional CROWN filter is compatible
with R2* Map.
Expected Contrast: Veins and midbrain
GM structures and cortical GM should
be bright relative to surrounding tissues.
Diamagnetic tissue (major WM tracts,
calcifications) should also appear bright.
Comparable Conventional Scan
Contrast: SWI /SWAN (inverted) | Methodology Unchanged
CROWN functionality available for
alternate R2* Map output. |
| T2* Map
Image: T2* Map | STAGE calculates T2* by simply taking
the inverse from the quantified R2*
result.
The optional CROWN filter is compatible
with T2Map. | Methodology Unchanged
CROWN functionality available for
alternate T2 Map output. |
| CROWN
enabled T2*
Map
Image: Brain scan
*different
patient scans | GM structures and cortical GM should
be dark relative to surrounding tissues.
Diamagnetic tissue (major WM tracts,
calcifications) should also appear dark.
Comparable Conventional Scan
Contrast: SWI/SWAN | |
| PD Map
Image: Brain scan | PD maps are quantified from the same
variable flip angle calculation as T1
maps, using the intercept rather than the
slope of the least squares fit.
The optional CROWN filter is compatible
with PD Map. | Methodology Unchanged
CROWN functionality available for
alternate PD Map output. |
| CROWN
enabled PD
Map
Image: Brain scan | Expected Contrast: WM, GM, CSF
contrast will appear similar to a
conventional T2W scan. However veins
and midbrain GM structures and cortical
GM should be slightly darker relative to
surrounding tissues.
Comparable Conventional Scan
Contrast: PDW | |
| Susceptibility
weighted image
mapping
(SWIM)
Image: Brain scan
SWIM | The SWIM output, also known as QSM
in the field, has been widely used and
tested in research. The STAGE version
uses a weighted average iterative TKD
(Threshold-based K-space Domain)
approach. The phase data from each
echo is unwrapped and then the
background fields are removed. As a
first pass, the inverse dipole kernel (the
fundamental kernel used to reconstruct
SWIM images) is defined using a
threshold of 0.1 to estimate the ill-posed
values. The veins are then thresholded
out of this first pass result and their
geometry is used to improve the
estimation ill-posed values. This process
is iterated 4 times to get a SWIM result
for each echo. Last a weighted average | Methodology Unchanged |
| | echoes to the final SWIM output.
Expected Contrast: Veins and midbrain GM structures and cortical GM should be bright relative to surrounding tissues. Diamagnetic tissue (major WM tracts, calcifications) should appear dark.
Comparable Conventional Scan Contrast: SWI /SWAN (inverted) | |
| STAGE
Qualitative
Output | | |
| T1 Weighted
Enhanced
(T1WE)
Image: T1WE brain scan

CROWN
enabled T1
Weighted
Enhanced
(T1WE)
Image: CROWN enabled T1WE brain scan
*different
patient scans | To create enhanced T1W data, STAGE subtracts the PDW input data with negative WM/GM contrast from the T1W input data with positive WM/GM contrast. This is not a synthetic image calculated from the quantitative maps.

The optional CROWN filter is compatible with T1WE.

Expected Contrast: This output should appear like a conventional T1 weighted anatomical scan.

Comparable Conventional Scan: MPRAGE | Methodology Unchanged
CROWN functionality available for alternate T1WE output. |
| Susceptibility
weighted
imaging (SWI) | The SWI from STAGE uses the same general process: high-pass filtering the phase data, creating a mask, and applying it to the magnitude data.

The optional CROWN filter is compatible with SWI. | Methodology Unchanged
CROWN functionality available for alternate SWI output. |
| Image: SWI
CROWN
enabled
Susceptibility
weighted
imaging (SWI)

Simulated SWI
*different
patient scans | Expected Contrast: Veins and midbrain
structures should appear dark relative to
surrounding tissues. Diamagnetic tissue
(major WM tracts, calcifications) should
also appear dark.

Comparable Conventional Scan: SWI
/SWAN | |
| True
Susceptibility
weighted
imaging (tSWI)

tSWI
| True SWI works the same way except
using iSWIM data to create a mask,
helping eliminate the geometry
dependence of the phase data.

The optional CROWN filter is compatible
with tSWI.

Expected Contrast: Veins and midbrain
structures should appear dark relative to
surrounding tissues. Diamagnetic tissue
(major WM tracts, calcifications) should
also appear dark.

Comparable Conventional Scan
Contrast: SWI /SWAN | Methodology Unchanged
CROWN functionality available for
alternate tSWI output. |
| Image: CROWN
enabled True
Susceptibility
weighted
imaging (tSWI)

Simulated tSWI | | |
| *different
patient scans | | |
| Pseudo SWIM
(pSWIM)
Image: pSWIM | Pseudo-susceptibility map (pSWIM) is
created from an intensity projection of
the filtered phase data. The results are
not quantitative but provide similar
contrast to SWIM.

Expected Contrast: Veins and midbrain
GM structures and cortical GM should
be bright relative to surrounding tissues.

Comparable Conventional Scan
Contrast: SWI /SWAN MIP (inverted) | Methodology Unchanged |
| Modified
pSWIM
(mpSWIM)
Image: mpSWIM | Modified pseudo-susceptibility map
(mpSWIM) are created from an intensity
projection of the filtered phase data. The
results are not quantitative but provide
similar contrast to SWIM.

Expected Contrast: Veins and midbrain
GM structures and cortical GM should
be bright relative to surrounding tissues.
Highly diamagnetic tissue (calcifications)
should appear dark.

Comparable Conventional Scan
Contrast: SWI /SWAN MIP (inverted) | Methodology Unchanged |
| Magnetic
resonance
angiography
(MRA)
Image: MRA | The STAGE MRA output uses a
maximum intensity projection of the T1W
input data to exploit the time of flight
effect of the arterial blood.

Expected Contrast: Arterial blood flowing
into the imaging slab should be bright.
Other tissues should show little to no
contrast.

Comparable Conventional Scan
Contrast: TOF MRA | Methodology Unchanged |
| Simulated
Synthetic dual
inversion
recovery (DIR) | Any simulated data (e.g., DIR) are
created through a forward simulation
process using the T1 and PD maps as
input.

The optional CROWN filter is compatible | Methodology Unchanged |
| Image: Brain scan | with simulated DIR.
Expected Contrast: For the three DIR
outputs, either GM, WM, or CSF alone
will be bright and the rest will be dark.
Comparable Conventional Scan
Contrast: Dual Inversion Recovery | |
| Simulated T1W
Image: Brain scan | Any simulated data are created through
a forward simulation process using the
T1 and PD maps as input.
Expected Contrast: For the three DIR
outputs, either GM, WM, or CSF alone
will be bright and the rest will be dark.
Comparable Conventional Scan
Contrast: Dual Inversion Recovery | Methodology Unchanged
CROWN functionality available for
alternate simulated T1W output. |
| Simulated PDW
Image: Brain scan | Any simulated data are created through
a forward simulation process using the
T1 and PD maps as input.
Expected Contrast: For the three DIR
outputs, either GM, WM, or CSF alone
will be bright and the rest will be dark.
Comparable Conventional Scan
Contrast: Dual Inversion Recovery | Methodology Unchanged
CROWN functionality available for
alternate simulated PDW output. |

5

Image /page/5/Picture/0 description: The image shows the logo for SpinTech MRI. The logo consists of a blue circular graphic with three orbiting lines on the left, followed by the text "SpinTechMRI" in blue. Below the company name is the tagline "from image to insight" in a smaller font size and also in blue.

6

Image /page/6/Picture/0 description: The image shows the logo for SpinTech MRI. The logo features a stylized atom symbol on the left, followed by the text "SpinTechMRI" in a blue sans-serif font. Below the company name is the tagline "from image to insight" in a smaller font size.

7

Image /page/7/Picture/0 description: The image is the logo for SpinTech MRI. The logo features a stylized atom graphic on the left, followed by the text "SpinTechMRI" in blue. Below the company name is the tagline "from image to insight" in a smaller font size.

8

Image /page/8/Picture/0 description: The image shows the SpinTech MRI logo. The logo features a stylized atom graphic on the left, followed by the text "SpinTechMRI" in blue. Below the company name is the tagline "from image to insight" in a smaller font.

9

Image /page/9/Picture/0 description: The image is the logo for SpinTech MRI. The logo features a stylized atom graphic to the left of the company name. The text "SpinTech" is in a dark blue, and "MRI" is in a lighter blue. Below the company name is the tagline "from image to insight" in a smaller font.

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 TI 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 TI, R2*, and proton density (PD).

10

Image /page/10/Picture/0 description: The image is a logo for SpinTech MRI. The logo features a blue atom-like graphic on the left, followed by the text "SpinTechMRI" in blue. Below the text, there is a tagline that reads "from image to insight" in a smaller font size.

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).

Comparison of Technological Characteristics:

The STAGE fundamental technological characteristics are similar to those of the predicate device as noted in the following table.

| Characteristic | Predicate Device
STAGE (v. 1.1)
SpinTech, Inc.
(K210843) | Proposed Device
STAGE (v 2.0 incl. CROWN)
SpinTech, Inc.
(TBD) | Similarities
and
Differences |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Classification | Class II | Class II | Identical |
| Regulation | 21 CFR 892.1000 | 21 CFR 892.1000 | Identical |
| Regulation
Name | Magnetic resonance diagnostic
device | Magnetic resonance diagnostic
device | Identical |
| Product Code | LNH
LLZ | LNH
LLZ | Identical |
| Prescription | Rx only | Rx only | Identical |
| 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 Tl 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 TI, R2*, and proton
density (PD).

When interpreted by a trained
physician, STAGE images may
provide information useful in
determining diagnosis. | 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 Tl 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 TI, R2*, and proton
density (PD).

11

Image /page/11/Picture/0 description: The image shows the SpinTech MRI logo. The logo features a stylized atom graphic on the left, followed by the text "SpinTechMRI" in blue. Below the company name is the tagline "from image to insight" in a smaller font.

12

Image /page/12/Picture/0 description: The image is the logo for SpinTech MRI. The logo consists of a blue atom-like graphic on the left, followed by the words "SpinTechMRI" in blue. Below the company name is the tagline "from image to insight" in a smaller font, also in blue. The logo is clean and modern, with a focus on the company's name and its mission.

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) .

13

Image /page/13/Picture/0 description: The image is the logo for SpinTech MRI. The logo features a blue atom-like graphic on the left, followed by the text "SpinTechMRI" in blue. Below the company name is the tagline "from image to insight" in a smaller font, also in blue. The logo is clean and professional, conveying a sense of innovation and expertise in the field of medical imaging.

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, was established and maintained for STAGE. STAGE was tested in accordance with SpinTech's verification and validation procedures.

All predefined acceptance criteria for the performance testing were met. The results from the performance testing executed on STAGE produced results consistently according to its intended use.

Clinical Testing Summary:

Clinical testing was not necessary to demonstrate substantial equivalence of STAGE to the predicate device.

Conclusions Drawn from Non-Clinical Tests:

The subject device and the predicate devices are substantially equivalent, with respect to intended use, instructions for use, design features, technological characteristics, performance criteria, and safety and effectiveness. The subject device is substantially equivalent to the predicate device, K210843.

Conclusion:

The non-clinical software testing performed on STAGE demonstrates that STAGE performs according to its intended use. SpinTech, Inc. considers STAGE (subject device) to be substantially equivalent to the legally marketed predicate device, K210843.