(86 days)
NEUROSCAPE is a PACS image management software intended for use with general purpose computing hardware to acquire and process images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. The system is used in hospitals, imaging centers and radiologist practices by medically trained professionals.
NEUROSCAPE accepts data from existing MRI systems, allows the selection of regions of interest as defined by a trained professional and provides a measurement of the areas or volumes associated with such selected regions. These measurements are normally used by the practitioner as an aid in the assessment of ischemic cerebral stroke patients.
NEUROSCAPE is fully integrated with most existing medical image visualization applications. The system is a multi-platform software running on any Windows or Linux operating systems.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
NEUROSCAPE is a medical software which helps in making informed decisions about the choice of treatment following an Ischemic Cerebral Stroke.
NEUROSCAPE enables an optimized visualization of images created by Magnetic Resonance Imaging (MRI). The device is capable of making instantaneous multi-parametric image analyses for displaying critical information such as the extent and the significance of the cerebral lesions. By providing an estimate of the lesion volume in the brain, informed decisions about whether a patient may be an appropriate candidate for thrombolytic treatment can be made.
Additionally, the display of high-definition diffusion and perfusion images and of their size change by bilinear interpolation provides the operator with an overall view of all the images, which can be efficiently and instantaneously compared. NEUROSCAPE generates a medical report, which incorporates all performed images data calculations.
The system includes the following features:
- Image Loading; .
- Image Saving:
- Image Viewing;
- Image Manipulation;
- Image Analysis; and .
- Image Processing.
The provided 510(k) summary for NEUROSCAPE does not contain specific acceptance criteria or a detailed study that proves the device meets such criteria in the way a modern regulatory submission for AI/ML-driven medical devices typically would.
NEUROSCAPE is described as a PACS image management software that aids in visualizing and analyzing MRI images for ischemic cerebral stroke. Its primary functionalities involve image loading, viewing, manipulation, processing, and analysis (specifically for lesion volume estimation) and generating medical reports.
Here's an analysis based on the provided text, highlighting the absence of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the provided document. The submission focuses on substantial equivalence to a predicate device (Nordic Image Control and Evaluation (nICE) Software) rather than defining specific performance metrics and demonstrating their achievement. There are no quantitative measures of accuracy, sensitivity, specificity, or volume measurement deviation.
2. Sample Size Used for the Test Set and Data Provenance
This information is not present. The document mentions "extensive validation testing" but does not provide details on the test set's size, characteristics, or provenance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not present. There is no mention of ground truth establishment for a test set, nor the involvement of experts in that process.
4. Adjudication Method
This information is not present. There is no mention of any adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not present. The document does not describe any MRMC study comparing human readers with and without AI assistance. The device is presented as an aid to professionals rather than a standalone diagnostic tool or a tool for improving human reader performance in a controlled study.
6. Standalone (Algorithm Only) Performance Study
This information is not present. While the device performs "multi-parametric image analyses for displaying critical information such as the extent and the significance of the cerebral lesions" and provides "an estimate of the lesion volume," the document does not include a standalone performance study report for these analytical capabilities, independent of a human operator. The focus is on its function as a PACS system providing tools for assessment by a "trained professional."
7. Type of Ground Truth Used
This information is not present. Since no specific performance study with a test set is detailed, the type of ground truth used to validate any measurements or analyses is not mentioned.
8. Sample Size for the Training Set
This information is not present. As an image analysis and PACS software, it's not explicitly stated that NEUROSCAPE uses machine learning in the modern sense that would typically involve a "training set." The functionality described sounds more like rule-based image processing and measurement tools.
9. How the Ground Truth for the Training Set Was Established
This information is not present for the same reasons as point 8.
Summary of what is present:
- Predicate Device: Nordic Image Control and Evaluation (nICE) Software (K063539).
- Intended Use: PACS image management software to acquire and process images/data, specifically aiding in the assessment of ischemic cerebral stroke patients by providing measurements of areas/volumes associated with selected regions on MRI images.
- Testing Mentioned: "Extensive validation testing" of the NEUROSCAPE system as a PACS system capable of reliable post-processing and display of MRI images. It states "all of the different components... have been stress tested to ensure that the system as a whole provides all the capabilities necessary to operate safely and effectively."
- Safety & Effectiveness Conclusion: Based on the comparison of intended use and technological characteristics, it is substantially equivalent to the predicate and "raises no new safety or effectiveness issues."
Conclusion:
The provided 510(k) summary is a traditional submission focused on substantial equivalence to a predicate PACS device. It describes the device's functions and intended use, but it lacks the detailed performance study information, acceptance criteria, and ground truth establishment methods typically found in submissions for AI/ML-driven devices, especially those making quantitative claims about accuracy or aiding in diagnosis. The "testing" mentioned is high-level and refers to stress testing for system functionality rather than clinical performance metrics.
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Image /page/0/Picture/0 description: The image shows a logo for a medical company. The logo features a cube with two figures on it, one is a stick figure made of spheres and the other is a solid stick figure. To the right of the cube is the word "medical" in a sans-serif font, and above the word is a symbol that looks like a stylized "O".
FEB 1 9 2009
510(k) Summary (in accordance with 21 CFR 807.92)
510(k) Number KO8349/
Applicant Information I.
Applicant:
OLEA MEDICAL 6 cours Forbin 13120, Gardanne France
Contact Person:
Application Correspondent:
Fayçal Djeridane President Tel: (011) 33 6 61 34 26 82 Fax: (011) 33 4 88 56 53 39 e-mail: faycal.djeridane@olea-medical.com
EMERGO GROUP INC. 1705 S. Capital of Texas Hwy., Suite 500 Austin, TX 78746 U.S.A.
Contact Person:
Neal Kolber Project Manager Tel: (512) 327-9997 Fax: (512) 327-9998 e-mail: neal@emergogroup.com
Date Prepared:
October 31, 2008
CONFIDENTIAL
II. Device Name and Classification
Proprietary Name: Common/Usual Name: Classification Name: Regulation Number: Product Codes: Classification: Classification Panel:
NEUROSCAPE PACS Picture Archiving Communications System 892.2050 LLZ Class II Radiology Devices
Traditional 510(k) – NEUROSCAPE
Page 5-1
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Image /page/1/Picture/0 description: The image shows the logo for OLC Medical. The logo consists of a cube-like shape on the left side, with a cluster of spheres on one face and a silhouette of a person on another face. To the right of the cube is the text "OLC" in a larger font, with the word "medical" underneath in a smaller font.
III. Predicate Device
The NEUROSCAPE device is substantially equivalent to the following FDA cleared predicate device with regard to indications for use, performance and technological characteristics:
| 510(k) Number: | K063539 |
|---|---|
| Trade Name: | Nordic Image Control and Evaluation (nICE)Software |
| Manufacturer: | NordicIceMedical AS |
| Classification Name: | Picture Archiving Communications System |
| Common/Usual Name: | PACS |
| Regulation Number: | 892.2050 |
| Product Codes: | LLZ |
| Classification: | Class II |
IV. Device Description
NEUROSCAPE is a medical software which helps in making informed decisions about the choice of treatment following an Ischemic Cerebral Stroke.
NEUROSCAPE enables an optimized visualization of images created by Magnetic Resonance Imaging (MRI). The device is capable of making instantaneous multi-parametric image analyses for displaying critical information such as the extent and the significance of the cerebral lesions. By providing an estimate of the lesion volume in the brain, informed decisions about whether a patient may be an appropriate candidate for thrombolytic treatment can be made.
Additionally, the display of high-definition diffusion and perfusion images and of their size change by bilinear interpolation provides the operator with an overall view of all the images, which can be efficiently and instantaneously compared. NEUROSCAPE generates a medical report, which incorporates all performed images data calculations.
The system includes the following features:
- Image Loading; .
- Image Saving: �
- Image Viewing;
- Image Manipulation;
- Image Analysis; and .
Traditional 510(k) - NEUROSCAPE
CONFIDENTIAL
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Image /page/2/Picture/0 description: The image shows a logo for a medical company. The logo consists of a cube-like shape on the left side, with two figures depicted on its faces. To the right of the cube, the text "Olea medical" is displayed, with "Olea" in a larger font size than "medical". The overall design appears to be clean and professional, suggesting a company focused on healthcare or medical services.
- Image Processing.
V. Intended Use
NEUROSCAPE is a PACS image management software intended for use with general purpose computing hardware to acquire and process images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. The system is used in hospitals, imaging centers and radiologist practices by medically trained professionals.
NEUROSCAPE accepts data from existing MRI systems, allows the selection of regions of interest as defined by a trained professional and provides a measurement of the areas or volumes associated with such selected regions. These measurements are normally used by the practitioner as an aid in the assessment of ischemic cerebral stroke patients.
NEUROSCAPE is fully integrated with most existing medical image visualization applications. The system is a multi-platform software running on any Windows or Linux operating systems.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
VI. Summary of the Technical Characteristics
NEUROSCAPE is a PACS software designed to access series of MRI perfusion and diffusion images in DICOM format. The system utilizes the information contained in each image meta-data to compare images and to perform zoom, pan and crop functions.
NEUROSCAPE displays simultaneously all the images of selected series within a particular data set in tabular format where rows represent image series and columns represent cross-sectional levels. The system allows the calculation of surfaces and volumes over a set of unfiltered images by using "segmentation masks". This also allows the user to optimize selected images by customizing the segmentation masks based on user defined areas, and to export or save the results of this image optimization into analysis reports in PDF format.
CONFIDENTIAL
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Image /page/3/Picture/0 description: The image shows a logo for a medical company. The logo features a cube with a DNA strand on one side and a human figure on another. Next to the cube, the text "medical" is written in a simple, sans-serif font.
VII. Testing
OLEA Medical has conducted extensive validation testing of the NEUROSCAPE system, as a PACS system that is capable of providing reliable post-processing and display of magnetic resonance images for instantaneous multi-parametric analysis. All of the different components of the NEUROSCAPE software have been stress tested to ensure that the system as a whole provides all the capabilities necessary to operate safely and effectively.
VIII. Safety & Effectiveness Conclusions
Based on the comparison of intended use and technological characteristics, the NEUROSCAPE system is substantially equivalent to the Nordic Image Control and Evaluation (nICE) Software manufactured by NordicIceMedical AS (K063539). The NEUROSCAPE device raises no new safety or effectiveness issues.
CONFIDENTIAL
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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 2009
OLEA Medical c/o Mr. Ian Gordon Senior Vice President Emergo Group, Inc. 1705 S. Capital of Texas Highway, Suite 500 AUSTIN TX 78746
Re: K083491
Trade/Device Name: NEUROSCAPE Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 31, 2008 Received: December 2, 2008
Dear Mr. Gordon:
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, qubject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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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; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k). oremarket notification. The FDA finding os substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR. 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97), For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device) Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppor/index.html.
Sincerely yours,
Lamme B. Morris
anine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indication for Use Statement
510(k) Number (if known):
Device Name:
NEUROSCAPE
Indications for Use:
NEUROSCAPE is a PACS image management software intended for use with general purpose computing hardware to acquire and process images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. The system is used in hospitals, imaging centers and radiologist practices by medically trained professionals.
NEUROSCAPE accepts data from existing MRI systems, allows the selection of regions of interest as defined by a trained professional and provides a measurement of the areas or volumes associated with such selected regions. These measurements are normally used by the practitioner as an aid in the assessment of ischemic cerebral stroke patients.
NEUROSCAPE is fully integrated with most existing medical image visualization applications. The system is a multi-platform software running on any Windows or Linux operating systems.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
Prescription Use : X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K083491 |
Page 1 of 1
§ 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).