← Product Code [LLZ](/productcode/LLZ) · K233908 # cNeuro cDAT (K233908) _Combinostics OY · LLZ · Jul 1, 2024 · Radiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K233908 ## Device Facts - **Applicant:** Combinostics OY - **Product Code:** [LLZ](/productcode/LLZ.md) - **Decision Date:** Jul 1, 2024 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Software as a Medical Device, Real-World Evidence ## Real-World Evidence | Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags | | --- | --- | --- | --- | --- | --- | | K233908 · Jul 1, 2024 | cNeuro cDAT | Combinostics OY | Retrospective clinical imaging data from third-party clinical investigations (NCT01952678, NCT01141023) | Retrospective patient imaging data was used to compare the subject device's z-value outputs against the predicate device's outputs to demonstrate substantial equivalence. | Retrospective clinical data; Comparative analysis; Substantial equivalence | ### Clinical Evidence | Study Design | Population | Comparator | Key Endpoints | | --- | --- | --- | --- | | Comparative performance analysis using third-party clinical investigation data; Retrospective comparative analysis | Patients from third-party clinical investigations (NCT01952678, NCT01141023); Sample Size: 370 patients (322 included in final analysis after exclusions) | Xeleris V Processing and Review Systems (DaTQUANT Application) | Comparison of paired z-value outputs between subject and predicate devices | ## Indications for Use cNeuro™ cDAT is intended for use by Nuclear Medicine or Radiology practitioners and referring physicians for display, processing, and reporting of Nuclear Medicine Imaging data. cNeuro™ cDAT enables visual evaluation and quantification of ioflupane I 123 (DaTscan™) images. The software enables automated quantification of tracer uptake and comparison with the corresponding tracer uptake in healthy subjects as provided by normal population databases of ioflupane I 123 (DaTscan™) images. cNeuro™ cDAT assists in detection of loss of functional dopaminergic neuron terminals in the striatum, which is correlated with Parkinson disease or Dementia with Lewy Bodies (DLB). cNeuro™ cDAT has not been demonstrated to improve ioflupane I 123 reader performance for distinguishing positive from negative patients. This device should not be used to deviate from ioflupane I 123 dosing and administration instructions. Refer also to ioflupane I 123 prescribing information for instructions. ## Device Story cNeuro™ cDAT is a fully automated SaMD for analyzing ioflupane I 123 (DaTscan™) SPECT images. Input: reconstructed DaTscan™ SPECT images. Operation: registers images to a template space; defines volumes of interest (VOIs) for caudate and putamen; calculates Striatal Binding Ratios (SBRs) by subtracting background uptake and normalizing; compares results against a normative reference database to compute z-scores. Output: PDF report containing SBRs, z-scores, and asymmetry metrics; browser-based viewer for interactive image review. Used in clinical settings by radiologists/nuclear medicine physicians. The software automates registration and quantification, providing objective data to assist clinicians in evaluating dopaminergic terminal loss. It does not replace clinical judgment or improve reader performance in distinguishing positive/negative patients. ## Clinical Evidence Bench testing only. Retrospective analysis of 370 patient images from third-party clinical investigations (NCT01952678, NCT01141023). 48 images excluded due to processing failure on predicate. Paired z-value outputs compared between subject and predicate devices. Results showed 92.4% to 94.6% of patients had z-value differences ≤0.5 (95% CI upper bound for >0.5 difference ranged from 5.4% to 7.6%). ## Technological Characteristics Software-only medical device (SaMD). Operates on reconstructed SPECT images. Quantification via VOI template registration. Normalization using OLS linear regression and quadratic Bezier curves for age-segmented normative data. Connectivity: exports PDF reports to PACS. Complies with NEMA PS 3.1-3.20 (DICOM). ## Regulatory 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. ## Special Controls *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). ## Predicate Devices - Xeleris V Processing and Review Systems (DaTQUANT Application) ([K201103](/device/K201103.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 1, 2024 Combinostics OY % Erin Gontang Senior Consultant Ram+ 2790 Mosside Boulevard, #800 Monroeville, PA 15146 Re: K233908 Trade/Device Name: cNeuro™ cDAT Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: May 30, 2024 Received: May 30, 2024 Dear Erin Gontang: 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. 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). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) 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. 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, D.G.K. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K233908 Device Name cNeuro™ cDAT #### Indications for Use (Describe) cNeuro™ cDAT is intended for use by Nuclear Medicine or Radiology practitioners and referring physicians for display, processing, and reporting of Nuclear Medicine Imaging data. cNeuro™ cDAT enables visual evaluation and quantification of ioflupane I 123 (DaTscan™) images. The software enables automated quantification of tracer uptake and comparison with the corresponding tracer uptake in healthy subjects as provided by normal population databases of ioflupane I 123 (DaTscan™) images. cNeuro™ cDAT assists in detection of loss of functional dopaminergic neuron terminals in the striatum, which is correlated with Parkinson disease or Dementia with Lewy Bodies (DLB). cNeuro™ cDAT has not been demonstrated to improve ioflupane I 123 reader performance for distinguishing positive from negative patients. This device should not be used to deviate from ioflupane I 123 dosing and administration instructions. Refer also to ioflupane I 123 prescribing information for instructions. | 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}------------------------------------------------ # 510(k) Summary K233908 ## DATE PREPARED July 3, 2024 ## MANUFACTURER AND 510(k) OWNER Combinostics OY Hatanpään valtatie 24 FI 33100 Tampere, Finland Telephone: Official Contact: Lennart Thurfjell, CEO ## REPRESENTATIVE/CONSULTANT Erin A. Gontang, Ph.D. Allison C. Komiyama, Ph.D., RAC RQM+ 2790 Mosside Boulevard, #800 Monroeville, PA 15146, United States Telephone: +1 (877) 652-0830 Email: egontang@rqmplus.com akomiyama@rqmplus.com ### DEVICE INFORMATION | Proprietary Name/Trade Name: | cNeuro™ cDAT | |------------------------------|----------------------------------------| | Common Name: | System, Image Processing, Radiological | | Regulation Number: | 21 CFR §892.2050 | | Class: | Class II | | Product Code: | LLZ | | Premarket Review Panel: | Radiology | ### PREDICATE DEVICE IDENTIFICATION The cNeuro™ cDAT is substantially equivalent to the following predicate: | 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate | |---------------|----------------------------------------------------------------------------------------------|-------------------| | K201103 | Xeleris V Processing and Review Systems
(DaTQUANT Application) / GE Medical Systems, LLC. | ✓ | The predicate device have not been subject to a design related recall. {4}------------------------------------------------ ## DEVICE DESCRIPTION cNeuro™ cDAT is Software as a Medical Device (SaMD) intended to aid physicians in the evaluation of the loss of functional dopaminergic neuron terminals in the striatum through the quantification of ioflupane I 123 (DaTscan™) images. cNeuro™ cDAT is a fully automated image analysis software tool that provides tools for viewing DaTscan™ images and quantification of tracer uptake in the striatum with comparison to reference data from healthy controls. The results are summarized in a PDF-report. cNeuro™ cDAT quantifies DaTscan™ brain images and computes Striatal Binding Ratios (SBRs) for different volumes of interest (VOIs). SBRs are computed by subtracting the uptake in a background VOI from the tracer uptake in the target VOI and then dividing this value with uptake in a background VOI. Results are compared with normative values in a reference database and z-scores are presented. cNeuro™ cDAT quantifies the data by registering the images to a template where VOIs are defined. Quantification results are summarized in PDF-reports that are sent to the organization's PACS. cNeuro™ cDAT also offers interactive review of the DaTscan™ images and the quantification results in a browser-based viewer. ## INDICATIONS FOR USE cNeuro™ cDAT is intended for use by Nuclear Medicine or Radiology practitioners and referring physicians for display, processing, and reporting of Nuclear Medicine Imaging data. cNeuro™ cDAT enables visual evaluation and quantification of ioflupane l 123 (DaTscan™) images. The software enables automated quantification of tracer uptake and comparison with the corresponding tracer uptake in healthy subjects as provided by normal population databases of ioflupane I 123 (DaTscan™) images. cNeuro™ cDAT assists in detection of loss of functional dopaminergic neuron terminals in the striatum, which is correlated with Parkinson disease or Dementia with Lewy Bodies (DLB). cNeuro™ cDAT has not been demonstrated to improve ioflupane | 123 reader performance for distinguishing positive from negative patients. This device should not be used to deviate from ioflupane I 123 dosing and administrations. Refer also to ioflupane I 123 prescribing information for instructions. ## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS Combinostics believes that the cNeuro™ cDAT is substantially equivalent to the predicate device based on the information summarized here: The subject device and predicate device are software for the automated quantification, visualization, and reporting of ioflupane I 123 (DaTscan™) images. Both devices compute Striatal Binding Ratios (SBRs) where the uptake in a background region is subtracted from the uptake in a target region or voxel and then the difference is divided with the value in a background region. In addition to SBRs, both devices compute asymmetry between striatal {5}------------------------------------------------ regions as well as putamen/caudate ratios. Both devices compute z-scores by comparing extracted features with corresponding values in reference data from healthy controls. The subject device and predicate device achieve their intended use based on the identical principle, which is the quantification system relies on registering the SPECT data to a template space where a volume of interest template is defined. | | Subject Device | Predicate Device | Product
Code(s) | LLZ - System, Image Processing,
Radiological | LLZ - System, Image Processing,
Radiological | |-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | | Combinostics OY
cNeuro™ cDAT | GE Healthcare
Xeleris V Processing and Review Systems
(DaTQUANT Application) | Regulation | 21 CFR 892.2050 / Medical image | 21 CFR 892.2050 / Medical image | | | K233908 | K201103 | Number/
Description | management and processing system | management and processing system | | Indications
for Use | cNeuro™ cDAT is intended for use by
Nuclear Medicine or Radiology
practitioners and referring physicians for
display, processing, and reporting of
Nuclear Medicine Imaging data.

cNeuro™ cDAT enables visual evaluation
and quantification of ioflupane I 123
(DaTscan™) images. The software
enables automated quantification of
tracer uptake and comparison with the
corresponding tracer uptake in healthy
subjects as provided by normal
population databases of ioflupane I 123
(DaTscan™) images. cNeuro™ cDAT
assists in detection of loss of functional
dopaminergic neuron terminals in the
striatum, which is correlated with
Parkinson disease or Dementia with
Lewy Bodies (DLB). | The system is intended for use by
Nuclear Medicine (NM) or Radiology
practitioners and referring physicians for
display, processing, archiving, printing,
reporting and networking of NMI data,
including planar scans (Static, Whole
Body, Dynamic, Multi-Gated) and
tomographic scans (SPECT, Gated SPECT,
dedicated PET or Camera-Based-PET)
acquired by gamma cameras or PET
scanners. The system can run on
dedicated workstation or in a server-
client configuration. The NM or PET data
can be coupled with registered and/or
fused CT or MR scans, and with
physiological signals in order to depict,
localize, and/or quantify the distribution
of radionuclide tracers and anatomical
structures in scanned body tissue for
clinical diagnostic purposes. | Import of
SPECT
Images | Can only take reconstructed DaTscan™
SPECT images as input. | Can take both raw and reconstructed
DaTscan™ SPECT images as input. If raw
images are provided, there is a
reconstruction pre-processing step. | | | cNeuro™ cDAT has not been
demonstrated to improve ioflupane I
123 reader performance for
distinguishing positive from negative
patients. This device should not be used
to deviate from ioflupane I 123 dosing
and administration instructions. Refer
also to ioflupane I 123 prescribing
information for instructions. | The DaTQUANT optional application
enables visual evaluation and
quantification of 123I-ioflupane
(DaTscan™) images. DaTQUANT Normal
Database option enables quantification
relative to normal population databases
of 123 I ioflupane (DaTscan™) images.
These applications may assist in
detection of loss of functional
dopaminergic neuron terminals in the
striatum, which is correlated with
Parkinson disease. | Supported
Tracers | DaTscan™ only | DaTscan™ only | | Method for
Quantification | A VOI template outlining caudate,
anterior putamen, posterior putamen
and a background region is defined in
template space. The patient's SPECT
image is registered to the template and
the regions are applied to the data and
counts within each region. | A VOI template outlining caudate,
anterior putamen, posterior putamen
and a background region is defined in
template space. The patient's SPECT
image is registered to the template and
the regions are applied to the data and
counts within each region. | | | | | Quality
Check of
Registration | There is an automated check of the
registration parameters and if they are
outside the expected range, the image is
automatically repositioned, and a new
registration is started. This is repeated 5
times. There is also a check if the
occipital reference region is outside the
brain.
If registration was not successful, no
quantification results are presented.
If registration is successfully completed,
the user is provided with images to
review the quality of the image
registration and fitting of the VOIs, but
there is no explicit "I have approved"
button. | The user needs visually check
registration and click "Passed" before
quantification results are shown. If
registration was not successful, the user
has the ability to manually reposition the
images and rerun the image registration. | | | | | Ability for
User to
Move
Regions | User does not have the ability to
interactively move regions. | User has the ability to interactively move
regions. | | | | | Normal
Database | Data from DaTscan™ studies of healthy
controls is used to define a reference
normal database. | Data from DaTscan™ studies of healthy
controls is used to define a reference
normal database. | | | | A comparison of the subject device and predicate device is provided below. {6}------------------------------------------------ {7}------------------------------------------------ | Formula for
Normal
Values | By default, a line is fitted to the mean
of values in the normal database. From
the user interface, it is possible to enable
visualization of z-scores for normative
data at ±1.0, ±1.5, ±1.7, and ±2.0. The
lines are fitted using the
ordinary least squares (OLS) method, i.e.,
linear regression, and was performed
separately for two age segments ([31,
55] and [68, 84]). Additionally, quadratic
Bezier curves are fitted to connect the
two linear segments.
The mean and standard deviation for a
certain age are defined from these
fitted curves. | By default, a line is fitted to the mean
of values in the normal database. From
the user interface, it is possible to
enable visualization of z-scores for
normative data at ±1.0, ±1.5, ±1.7, and
±2.0. The lines are fitted using the
ordinary least squares (OLS) method, i.e.,
linear regression, and was performed
separately for two age segments ([31,
55] and [68, 84]). Additionally, quadratic
Bezier curves are fitted to connect the
two linear segments.
The mean and standard deviation for a
certain age are defined from these
fitted curves. | |------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | User Created
Normal
Database | User does not have the ability to create
their own database. | User has the ability to create their own
database. | | Output from
Quantification | Striatal Binding Ratios (SBRs) are
computed for Caudate, anterior
Putamen, posterior Putamen, Putamen
as a whole, and Striatum as a whole. In
addition, asymmetry is computed for the
Striatum as a whole, for the Caudate and
for the Putamen.
Z-scores are computed for each feature
by comparing the value with the
corresponding mean and standard
deviation in the normal database. | Striatal Binding Ratios (SBRs) are
computed for Caudate, anterior
Putamen, posterior Putamen, Putamen
as a whole, and Striatum as a whole. In
addition, asymmetry is computed for the
Striatum as a whole, for the Caudate and
for the Putamen.
Z-scores are computed for each feature
by comparing the value with the
corresponding mean and standard
deviation in the normal database | | Database
selection
and
warnings | The recommended reconstruction
method is OSEM, 2 iterations, 10
subsets, Butterworth 3D post-filtering
with power factor = 10, cut off = 0.6.
The default normal database is
configured in the organizations settings.
The reconstruction method used is
displayed in the UI and in the report and
if the user selects a different database, a
warning is shown in the UI and in the
report. | The recommended reconstruction
method is OSEM, 2 iterations, 10
subsets, Butterworth 3D post-filtering
with power factor = 10, cut off = 0.6.
If data is reconstructed within the
device, i.e., reconstruction methods is
known, the system will select the correct
database. If already reconstructed
images are imported, the user will have
to enter information so a database can
be selected unless the necessary
information can be derived from DICOM
tags.
The reconstruction method used is
displayed in the UI and in the report and if
the user selects a different database, a
warning is shown in the UI and in the
report. | | Graphical User
Interface
(GUI) | The GUI allows the user to scroll images,
view images with and without regions
outlined, change color scale and window
levels, view regional results and plots
with comparison to the normal
database. | The GUI allows the user to scroll images,
view images with and without regions
outlined, change color scale and window
levels, view regional results and plots
with comparison to the normal
database. | | Report | A PDF report is generated. The report
format is fixed. | A PDF report can be generated. The user
has some flexibility in the tailoring of the
report. | {8}------------------------------------------------ ## SUMMARY OF PERFORMANCE TESTING The cNeuro™ cDAT software complies with NEMA PS 3.1 - 3.20 (2021) Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard. cNeuro™ cDAT employs the same fundamental scientific technology as its predicate device, Xeleris/DaTQUANT. cNeuro™ cDAT uses the equivalent DICOM image data input requirements. It has equivalent display, formatting, archiving and visualization technologies compared to the predicate device. cNeuro™ cDAT utilizes the same methodology to quantify and assess uptake in ioflupane I 123 (DaTscan™) images. The information is presented using volumes of interest. Thorough testing of these capabilities has not raised any safety or effectiveness issues. The following quality assurance measures were applied to the development of the system: - Risk Analysis - Requirements Reviews - Design Reviews - Integration testing (System verification) - Performance testing (Bench testing, verification) - Safety testing (Verification) Combinostics believes that a failure or latent flaw of the cNeuro™ cDAT software function, such as inadequate quality of displayed images, would not present a hazardous situation with a probable risk of death or serious injury to either a patient, user of the device, or others in the environment of use, prior to the implementation of risk control measures. Based on the implementation of the Documentation Level risk-based approach, Combinostics has provided Basic Documentation in support of the cNeuro™ cDAT premarket notification. Combinostics has conducted testing on the cNeuro™ cDAT software. For performance testing, imaging of 370 patients was available to Combinostics following third-party clinical investigations (NCT01952678, NCT01141023). A subset of 48 images could not be processed with the predicate device and were excluded from further testing. Combinostics used the imaging from each included patient as input to both the subject and predicate devices so that paired z-value outputs from each device could be compared. The upper bound of the 95% confidence interval for the percentage of patients with paired z-value outputs differing by >0.5 was tested. This patient percentage ranged from 5.4% to 7.6% for the left and right putamen, caudate, anterior putamen, and posterior putamen, suggesting 92.4% to 94.6% of patients representative of the studied population have equivalent-to-predicate (±0.5) z-value outputs. {9}------------------------------------------------ The software passed all performance requirements and met specifications. ## CONCLUSION The subject device does not raise different issues of safety or effectiveness compared to the predicate device. The similar indications for use, technological characteristics, and performance characteristics for the proposed cNeuro™ cDAT are assessed to be substantially equivalent to the predicate device. --- **Source:** [https://fda-staging.innolitics.com/device/K233908](https://fda-staging.innolitics.com/device/K233908) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com