(230 days)
Not Found
No
The document describes a "fit algorithm" for data processing, but does not explicitly mention or describe the use of AI or ML technologies. The focus is on standard spectroscopic analysis and data presentation.
No
The device is a software application that analyzes and evaluates MR spectroscopy data to support the diagnostic process; it does not directly treat or prevent medical conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the software "provides evaluation of MR Single Voxel Spectroscopy (SVS) data and MR Chemical Shift Imaging (CSI) data to support the diagnostic process" and that "When interpreted by a trained physician, these results provide information that may assist in diagnosis." This directly indicates its role as a diagnostic tool.
Yes
The device is described as "BrainSpec Core™ software" and its function is post-processing and analysis of existing MR spectroscopy data. It is accessed via a web browser and processes data in the cloud, indicating it is purely a software application that operates on data acquired by separate hardware (MRI scanners).
Based on the provided information, BrainSpec Core™ software is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- BrainSpec Core™ Function: BrainSpec Core™ software analyzes MR spectroscopy data, which is acquired directly from the patient's brain using an MRI scanner. It processes and interprets this imaging data, not biological specimens.
- Intended Use: The intended use clearly states it's a "post-processing application to analyze and evaluate MR (magnetic resonance) spectroscopy data" to "support the diagnostic process." This aligns with medical image analysis software, not IVD.
Therefore, BrainSpec Core™ software falls under the category of medical image processing or analysis software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BrainSpec Core™ software is a post-processing application to analyze and evaluate MR (magnetic resonance) spectroscopy data. It provides evaluation of MR Single Voxel Spectroscopy (SVS) data and MR Chemical Shift Imaging (CSI) data to support the diagnostic process. BrainSpec Core™ software includes the possibility of an integrated reading of MR images and spectroscopy data for spectroscopy exams and focuses on ease-of-use by reducing complexity.
A fit algorithm reduces the need for manual data processing and offers the user reproducible evaluation results. When interpreted by a trained physician, these results provide information that may assist in diagnosis.
The post-processing fits and displays spectra and provides intuitive representations of the metabolic profile. The calculation and display of pre-defined results such as spectral maps, and metabolite images is provided. Interactive reading of spectroscopy exams is supported by side-by-side display of MR images and spectroscopy results, and synchronized display.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, LNI
Device Description
The BrainSpec Core™ Software provides analysis of magnetic resonance spectroscopy (MRS) data. MRS is a technology available on standard MRI scanners that detects the presence of various chemical compounds in a volume of tissue. The software provides these analyses:
- Estimation of the concentrations of various metabolites present in the acquired . data, presented to the user as ratios concentrations (when water reference files is available). These metabolites include N-acetylaspartate (NAA). choline (Cho), creatine (Cr), myoinositol (mlns), and glutamine/glutamate (Glx), DL-lactic acid (Lac), and 2-hydroxygluturate (2HG-ng) expressed as a ratio.
- Spatial registration of the acquired volume with anatomical MR images, such that . the spectroscopy volume is overlaid on an anatomical image in the same plane.
- Visual display of the data's spectrum (a representation of the data in which peaks correspond to specific compounds)
- Ratio measurements of each metabolite may be compared to reference percentile data if a reference interval has been established.
BrainSpec Core™ Software supports 3.0 Tesla scanners manufactured by Philips, Siemens, and GE with predefined pulse sequences: PRESS short echo (TE=25-45ms), PRESS (long echo (TE=135-144) and PRESS optimized for 2HG (TE=97).
The software provides a user interface over the web. The user must access the software via the Google Chrome web browser on any operating system, provided the computer has a reliable internet connection. The uploaded data are processed with several applications. Both the web application and the data processing software read and write files and data in Google Cloud Platform resources.
The reference intervals specific for adults indicating how user-uploaded data compares to a range of typical values for a given metabolite ratio are aggregated from decades of data from adult reference subjects with no known history of neurological or major psychiatric disorders. The reference intervals are specific to the acquisition parameters and indicated adult brain region of the uploaded data, and were determined from research studies employing those matching parameters and brain regions. Reference intervals are only displayed when the relevant acquisition parameters are matched.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR (magnetic resonance) spectroscopy
Anatomical Site
brain region
Indicated Patient Age Range
adults
Intended User / Care Setting
trained physician
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)
- Valid clinical association
- Risk Management activities
- Software testing, including unit testing, and verification testing
- Off-the-Shelf software analysis
- Cybersecurity assessment
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image shows 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.
November 14, 2023
BrainSpec, Inc % Carolyn Guthrie Principal Helix Medical, LLC 711 SE 5th Ave Pompano Beach, Florida 33060
Re: K230856
Trade/Device Name: BrainSpec Core™ Software Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ, LNI Dated: October 23, 2023 Received: October 24, 2023
Dear Carolyn Guthrie:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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,
D. Ray Kenned
Daniel M. Krainak, Ph.D. Assistant Director 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
3
Indications for Use
510(k) Number (if known) K230856
Device Name BrainSpec Core™ Software
Indications for Use (Describe)
BrainSpec Core™ software is a post-processing application to analyze and evaluate MR (magnetic resonance) spectroscopy data. It provides evaluation of MR Single Voxel Spectroscopy (SVS) data and MR Chemical Shift Imaging (CSI) data to support the diagnostic process. BrainSpec Core™ software includes the possibility of an integrated reading of MR images and spectroscopy data for spectroscopy exams and focuses on ease-of-use by reducing complexity.
A fit algorithm reduces the need for manual data processing and offers the user reproducible evaluation results. When interpreted by a trained physician, these results provide information that may assist in diagnosis.
The post-processing fits and displays spectra and provides intuitive representations of the metabolic profile. The calculation and display of pre-defined results such as spectral maps, and metabolite images is provided. Interactive reading of spectroscopy exams is supported by side-by-side display of MR images and spectroscopy results. and synchronized display.
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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4
Image /page/4/Picture/0 description: The image is a logo for Brainspec. The logo features a blue brain outline with a magnifying glass over it, inside the magnifying glass is a white line graph. To the right of the brain is the word "BRAINSPEC" in blue, and below that is the text "MAKING THE VIRTUAL BIOPSY A REALITY" in a smaller font.
510(k) Summary - K230856
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR 807.92, the following summary of information is provided.
Date of Preparation:
November 9, 2023
Applicant
BrainSpec, Inc 111 Speen St, Framingham, MA 01701
Official Correspondent
Carolyn Guthrie Email: cguthrie@helixmedical.us Helix Medical LLC 704-737-2866
Device Name
Trade Name: BrainSpec Core™ Software Common Name: Picture archiving and communications system Regulation Description: System, Image Processing, Radiological Regulation Number: 21 CFR 892.2050 Product Code: LLZ, LNI Classification: Class II Panel: Radiology
5
Image /page/5/Picture/0 description: The image is a logo for Brainspec. The logo features a blue brain icon with a magnifying glass over it. The magnifying glass is focused on a waveform. Next to the icon is the word "BRAINSPEC" in blue, block letters, and below that is the tagline "MAKING THE VIRTUAL BIOPSY A REALITY" in a smaller, lighter font.
Predicate Devices
BrainSpec Core™ Software is substantially equivalent to the predicate device shown in Table 1.
| Trade Name | Clearance | Claim of Equivalence for: | 510(k) holder |
|---|---|---|---|
| Siemens Syngo | K120315 | Primary Predicate | Siemens |
| Table 1: Predicate devices |
Indications for Use:
BrainSpec Core™ software is a post-processing application to analyze and evaluate MR (magnetic resonance) spectroscopy data. It provides evaluation of MR Single Voxel Spectroscopy (SVS) data and MR Chemical Shift Imaging (CSI) data to support the diagnostic process. BrainSpec Core™ software includes the possibility of an integrated reading of MR images and spectroscopy data for spectroscopy exams and focuses on ease-of-use by reducing complexity.
A fit algorithm reduces the need for manual data processing and offers the user reproducible evaluation results. When interpreted by a trained physician, these results provide information that may assist in diagnosis.
The post-processing fits and displays spectra and provides intuitive representations of the metabolic profile. The calculation and display of pre-defined results such as spectral maps, and metabolite images is provided. Interactive reading of spectroscopy exams is supported by side-by-side display of MR images and spectroscopy results, and synchronized display.
Device Description
The BrainSpec Core™ Software provides analysis of magnetic resonance spectroscopy (MRS) data. MRS is a technology available on standard MRI scanners that detects the presence of various chemical compounds in a volume of tissue. The software provides these analyses:
- Estimation of the concentrations of various metabolites present in the acquired . data, presented to the user as ratios concentrations (when water reference files is available). These metabolites include N-acetylaspartate (NAA). choline (Cho), creatine (Cr), myoinositol (mlns), and glutamine/glutamate (Glx), DL-lactic acid (Lac), and 2-hydroxygluturate (2HG-ng) expressed as a ratio.
- Spatial registration of the acquired volume with anatomical MR images, such that . the spectroscopy volume is overlaid on an anatomical image in the same plane.
6
Image /page/6/Picture/1 description: The image is a logo for Brainspec. The logo features a blue brain with a magnifying glass over it, and the word "BRAINSPEC" in blue letters. Below the word "BRAINSPEC" is the phrase "MAKING THE VIRTUAL BIOPSY A REALITY" in smaller, gray letters. The logo is simple and modern, and it conveys the idea of using technology to improve brain health.
- . Visual display of the data's spectrum (a representation of the data in which peaks correspond to specific compounds)
- . Ratio measurements of each metabolite may be compared to reference percentile data if a reference interval has been established.
BrainSpec Core™ Software supports 3.0 Tesla scanners manufactured by Philips, Siemens, and GE with predefined pulse sequences: PRESS short echo (TE=25-45ms), PRESS (long echo (TE=135-144) and PRESS optimized for 2HG (TE=97).
The software provides a user interface over the web. The user must access the software via the Google Chrome web browser on any operating system, provided the computer has a reliable internet connection. The uploaded data are processed with several applications. Both the web application and the data processing software read and write files and data in Google Cloud Platform resources.
The reference intervals specific for adults indicating how user-uploaded data compares to a range of typical values for a given metabolite ratio are aggregated from decades of data from adult reference subjects with no known history of neurological or major psychiatric disorders. The reference intervals are specific to the acquisition parameters and indicated adult brain region of the uploaded data, and were determined from research studies employing those matching parameters and brain regions. Reference intervals are only displayed when the relevant acquisition parameters are matched.
Substantial Equivalence
1.1 Comparison of Intended Use
The intended use of BrainSpec Core™ Software is identical to the predicate device.
| Features | BrainSpec Core™ Software | syngo.MR Spectroscopy |
|---|---|---|
| Subject Device | Predicate Device | |
| Quantification | ||
| of spectra (i.e., | ||
| determination | ||
| of the intensity | ||
| of metabolite | ||
| signals) | Results are based on a sequence | |
| of post-processing steps; the main | ||
| step is a fit of a metabolite model to | ||
| the measured data | Results are based on a | |
| sequence of post-processing | ||
| steps; the main step is a fit of a | ||
| metabolite model to the | ||
| measured data | ||
| Baseline and phase correction | ||
| automatically applied during | ||
| metabolite quantification | No extra step for baseline and | |
| phase correction needed | ||
| Features | BrainSpec Core™ Software | syngo.MR Spectroscopy |
| Subject Device | Predicate Device | |
| Usage of extended prior knowledge | ||
| for the metabolite model | ||
| (metabolites are represented by | ||
| their model signals, i.e., their | ||
| complete spectral pattern) | Usage of extended prior | |
| knowledge for the metabolite | ||
| model (metabolites are | ||
| represented by their model | ||
| signals, i.e., their complete | ||
| spectral pattern) | ||
| Spectral quality check performed, | ||
| with additional metrics for data | ||
| quality and metabolite fits | Spectral quality check | |
| performed | ||
| Handling of | ||
| spectroscopy | ||
| results | Support of spectra, result tables, | |
| metabolite images, spectral maps, | ||
| and image co-registration | Support of spectra, result tables, | |
| metabolite images, spectral | ||
| maps, and reference images | ||
| Interactive modification of display | ||
| characteristics of spectro results | ||
| (e.g., toggle fit and baseline | ||
| display, add or remove metabolite | ||
| ratios, and transparency for a | ||
| metabolite image) | Interactive modification of | |
| display characteristics of spectro | ||
| results (e.g., adjusting the range | ||
| and scale for a spectrum, | ||
| adjusting the range and | ||
| transparency for a metabolite | ||
| image) | ||
| Interactive voxel selection on | ||
| metabolite map and co-registration | ||
| images with automatic update of | ||
| spectrum display | Interactive voxel selection on | |
| metabolite- and reference | ||
| images with automatic update of | ||
| spectrum display | ||
| Interactive voxel selection on | ||
| metabolite map and co-registration | ||
| images with automatic update of | ||
| spectrum display | Synchronized scrolling through | |
| reference and metabolite | ||
| images with automatic update of | ||
| spectrum display | ||
| Display of measurement | ||
| parameters | Display of measurement | |
| parameters | ||
| Display of measurement | ||
| parameters as image test | Display of measurement | |
| parameters as image test | ||
| Features | BrainSpec Core™ Software | syngo.MR Spectroscopy |
| Subject Device | Predicate Device | |
| Saving of spectro results in a PDF report for off-line viewing | Saving of spectro results as screenshots and their usage for printing | |
| Image co-registration available | Usage of reference images of arbitrary orientations with respect to the CSI slab possible (MPR creation for reference images) | |
| Visualization of default spectra | Visualization of default spectra | |
| Usage of post processing protocols for spectroscopy | All relevant parameters for post-processing and display contained | All relevant parameters for post-processing and display contained |
| Dedicated protocols for typical measurement scenarios | Dedicated protocols for typical measurement scenarios | |
| Automatic protocol selection | Automatic protocol selection | |
| Usage of standardized enhanced DICOM format “MR spectroscopy object” for spectro raw data | Yes | Yes |
| Hardware prerequisites | Software only device | Software only device |
1.2 Comparison of Operating Principle
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Image /page/7/Picture/1 description: The image is a logo for Brainspec. The logo features a blue brain icon with a magnifying glass over it on the left side. To the right of the icon, the word "BRAINSPEC" is written in blue, block letters. Below the company name is the phrase "MAKING THE VIRTUAL BIOPSY A REALITY".
8
Image /page/8/Picture/1 description: The image is a logo for Brainspec. The logo features a blue brain outline with a magnifying glass over it, and the word "BRAINSPEC" in blue, block letters. Below the word "BRAINSPEC" is the tagline "MAKING THE VIRTUAL BIOPSY A REALITY" in a smaller, lighter font.
1.3 Comparison of Technological Characteristics with the Predicate Device
| Feature | Subject Device | syngo.MR Spectroscopy | Discussion of differences |
|---|---|---|---|
| Quantification | |||
| of spectra (i.e., | |||
| determination | |||
| of the intensity | Quantification of | ||
| the following | |||
| metabolites: | |||
| NAA, Ins, Cho, | Quantification of | ||
| the following | |||
| metabolites: | 2HG is a metabolite quantified | ||
| by the subject device but not by | |||
| the predicate. | |||
| Feature | Subject Device | syngo.MR | |
| Spectroscopy | Discussion of differences | ||
| of metabolite | |||
| signals) | Cr, Glx, Lac, | ||
| 2HG | NAA, Ins, Cho, | ||
| Cr, Glx, Lac | It is quantified in the same | ||
| manner (algorithm) as the other | |||
| metabolites but with different | |||
| acquisition parameters. | |||
| Values of | |||
| metabolite peaks | |||
| are calculated | |||
| based on a | |||
| linear | |||
| combination | Integral values of | ||
| metabolite peaks | |||
| are calculated | |||
| based on the fit | |||
| results | The linear combination model | ||
| approach to metabolite | |||
| quantification improves on peak | |||
| integration methods by | |||
| incorporating prior knowledge | |||
| of the metabolite peaks for a | |||
| given pulse sequence and echo | |||
| time. It allows for modeling of | |||
| baseline and macromolecule | |||
| contributions, which otherwise | |||
| create artifacts in the spectrum | |||
| that cannot be easily accounted | |||
| for using peak integration. Both | |||
| methods of quantification result | |||
| in metabolite values / ratios. | |||
| Handling of | |||
| spectroscopy | |||
| results | Display of | ||
| quantification | |||
| within a | |||
| reference | |||
| interval for a | |||
| metabolite within | |||
| a brain region, if | |||
| available | Comparison of | ||
| spectro results of | |||
| different | |||
| measurements of | |||
| one and more | |||
| patients | Use of reference intervals in | ||
| the BrainSpec Core™ software | |||
| does not alter the quantification | |||
| of the metabolite. The intervals | |||
| were established according to | |||
| CLSI guidelines and are | |||
| intended to provide further | |||
| support in the diagnostic | |||
| process. | |||
| Feature not | |||
| included | 3D scaling of | ||
| metabolite | |||
| images and | |||
| spectral maps | 3D scaling in the predicate | ||
| allows for an alternative view of | |||
| the imaging and spectra. This | |||
| does not alter the method for | |||
| quantification and therefore | |||
| does not impact the intended | |||
| use of the device. | |||
| Feature not | |||
| included | Real-time | ||
| spectrum update | |||
| (real time | |||
| updates of the | |||
| spectrum without | |||
| mouse clicking) | Data is processed in the | ||
| BrainSpec Core™ software | |||
| after spectra are acquired. Lack | |||
| of an "on the fly" update does | |||
| not introduce any questions of | |||
| safety or effectiveness. | |||
| Feature | Subject Device | syngo.MR Spectroscopy | Discussion of differences |
| Usage of post processing protocols for spectroscopy | Feature not included | ("on-the-fly" display) | |
| User-configurable protocols | Only preset acquisition protocols are supported to limit the conditions to the tested environment. | ||
| Software prerequisites | Google Chrome version v79 or higher | Windows XP or Windows Vista | Use of a cloud-based service introduces cybersecurity concerns vs a non-wired software. Cybersecurity controls are in place to reduce the risk associated with cybersecurity. |
| RIS Communication | Feature not included | Yes | Reporting output does not relate to safety or performance, and is therefore considered an acceptable difference |
9
Image /page/9/Picture/1 description: The image is a logo for Brainspec. The logo features a blue brain icon with a magnifying glass over it, and a waveform inside the magnifying glass. To the right of the icon is the word "BRAINSPEC" in blue, with the tagline "MAKING THE VIRTUAL BIOPSY A REALITY" in gray below it.
10
Image /page/10/Picture/0 description: The image is a logo for Brainspec. The logo features a blue brain silhouette with a magnifying glass over it, and a white line graph inside the magnifying glass. To the right of the brain is the word "BRAINSPEC" in blue, and below that is the phrase "MAKING THE VIRTUAL BIOPSY A REALITY" in a smaller font.
Performance Data
The following information is provided in support of substantial equivalence.
- . Valid clinical association
- Risk Management activities
- Software testing, including unit testing, and verification testing ●
- Off-the-Shelf software analysis
- Cybersecurity assessment ●
11 Conclusion
BrainSpec Core™ Software and the predicate device Siemens Syngo (K120315) have the same intended use and are available by prescription only. Any technical differences identified do not result in new questions of safety or effectiveness.
Through assessment of technological characteristics, intended use and performance data, it can be concluded that BrainSpec Core™ Software is substantially equivalent to the Siemens Syngo device.