PERFSCAPE V2.0

K111161 · Olea Medical · LLZ · Nov 4, 2011 · Radiology

Device Facts

• Record ID: K111161
• Device Name: PERFSCAPE V2.0
• Applicant: Olea Medical
• Product Code: LLZ · Radiology
• Decision Date: Nov 4, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

PERFSCAPE V2.0 is a PACS system that allows the display, analysis and post-processing of dynamically acquired Magnetic Resonance (MRI) and Computed Tomography (CT) datasets to evaluate image intensity variations over time. PERFSCAPE V2.0 retrieves and accepts data from existing MRI and CT systems. Based on these data, PERFSCAPE V2.0 performs quality control checks, displays Diffusion Weighted Images (MRI only) and generates parametric maps such as Relative Blood Volume, Relative Blood Flow, Relative Mean Transit Time, Time to Peak, Impulse Response Time to Peak, permeability and leakage between intravascular and extracellular space (MRI only), and temporal Maximum Intensity Projection (CT only). PERFSCAPE V2.0 also generates Diffusion Weighted Images and/or Diffusion Tensor Images (MRI only). These images, when interpreted by a trained physician, may vield clinically useful information. PERFSCAPE V2.0 is compliant with the DICOM standard allowing the system to visualize medical images. The system is a multiplatform software running on Windows, Mac and Linux operating systems. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.

Device Story

PERFSCAPE V2.0 is a software-based PACS application for analyzing dynamic MRI and CT datasets. It ingests DICOM-compliant image data from existing scanners. The software performs quality control, motion correction, and organ mask generation. It utilizes established algorithms to compute parametric maps (e.g., Relative Blood Volume, Blood Flow, Mean Transit Time, Time to Peak, permeability/leakage, temporal MIP) and generates Diffusion Weighted/Tensor Images (DWI/DTI). Features include automated or interactive Arterial Input Function (AIF) and Venous Output Function (VOF) selection. Used in clinical settings by physicians, the software displays results in real-time, allowing export to PACS or local files. It integrates with NEUROSCAPE (K083491) for further study. By providing quantitative perfusion and diffusion maps, the device assists physicians in interpreting image intensity variations, potentially aiding clinical decision-making and patient diagnosis.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

PACS software for Windows, Mac, and Linux. DICOM compliant. Features: automated/interactive AIF/VOF selection, motion correction, organ mask generation, and parametric map computation (perfusion/diffusion). Software-based; no hardware components. Connectivity via standard DICOM networking.

Indications for Use

Indicated for use by trained physicians to display, analyze, and post-process dynamically acquired MRI and CT datasets to evaluate image intensity variations over time. Not for primary interpretation of lossy compressed mammographic or digitized film screen images.

Regulatory Classification

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

• Nordic Image Control and Evaluation (nICE) Software (K090546)

Reference Devices

• NEUROSCAPE (K083491)

Submission Summary (Full Text)

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K111161
NOV - 4 2011 P 1/5

# 510(k) Summary

(in accordance with 21 CFR 807.92)

510(k) Number K

#### I. Applicant Information

| Applicant: | |
|------------|--|
|------------|--|

OLEA MEDICAL

| 93 avenue des Sorbiers, Zone Athelia IV |
|-----------------------------------------|
| La Ciotat 13600 |
| France |

Contact Person: Caroline Lene . Quality Manager Tel: [phone] Fax: [phone] e-mail: [e-mail]

Application Correspondent:

EMERGO GROUP INC. 611 West 5th Street, Third Floor Austin, TX 78701 U.S.A.

Contact Person: Kristi Gusman Project Manager Tel: [phone] Fax: [phone] e-mail: [e-mail]

Date Prepared: April 15, 2011

#### II. Device Name and Classification

| Proprietary Name: | PERFSCAPE V2.0 |
|-----------------------|-----------------------------------------|
| Common/Usual Name: | PACS |
| Classification Name: | Picture Archiving Communications System |
| Regulation Number: | 892.2050 |
| Product Codes: | LLZ |
| Classification: | Class II |
| Classification Panel: | Radiology Devices |

510(k) - PERFSCAPE V2.0

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Image /page/1/Picture/0 description: The image shows the logo for Olea Medical. The logo consists of a cube with a human figure on one side and a pattern of dots on the other. To the right of the cube is the text "Olea" in a bold, sans-serif font, with the word "medical" in a smaller font below it.

K111161

P²/₄

#### III. Predicate Device

The PERFSCAPE V2.0 device is substantially equivalent to the following FDA cleared predicate device with regard to indications for use, performance and technological characteristics:

| 510(k) Number: | K090546 |
|----------------------|--------------------------------------------------------|
| Trade Name: | Nordic Image Control and Evaluation (nICE)<br>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

PERFSCAPE V2.0 is a software application designed to analyze dynamically acquired datasets. The software provides a wide range of basic image processing and manipulation functions applied to MRI or CT datasets.

Using well-established algorithms, parametric maps can be generated such as Relative Blood Volume, Relative Blood Flow. Relative Mean Transit Time. Time to Peak, impulse response time to peak, permeability and leakage between intravascular and extracellular space (MRI only), temporal Maximum Intensity Projection (CT only). PERFSCAPE V2.0 also generates Diffusion Weighted Images and/or Diffusion Tensor Images (DWI and DTI, MRI only).

The PERFSCAPE V2.0 device includes critical features such as:

- Enables the computation of DWI and DTI maps from co-registered . Bxxx images (eg B0 B500 B1000);
- . Enables rapid creation of a complete array of critical parameter maps;
- Automated organ mask generation; .
- . View dynamic signal time course on a per-voxel basis;
- Integrated motion correction ; .
- Automatic and Interactive Arterial Input Function (AIF) selection; ●
- Automatic and Interactive Venous Output Function (VOF) selection; .

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Image /page/2/Picture/1 description: The image shows the logo for Olea Medical. The logo consists of a cube with a human figure on one side and a pattern of circles on another side. To the right of the cube is the text "Olea" in a larger font, with the word "MEDICAL" underneath in a smaller font.

- Export computed perfusion map to PACS or to DICOM files in . filesystem.
PERFSCAPE V2.0 also allows the user to view the computed maps using the NEUROSCAPE software (K083491).

Based on these common functionalities, Perfscape is divided into three modules named:

- MRI module, ●
- . CT module, and
- MRI-LC module. .

Each module is designed to address useful subsets of images.

#### V. Intended Use

PERFSCAPE V2.0 is a PACS system that allows the display, analysis and post-processing of dynamically acquired Magnetic Resonance (MRI) and Computed Tomography (CT) datasets to evaluate image intensity variations over time.

PERFSCAPE V2.0 retrieves and accepts data from existing MRI and CT systems. Based on these data, PERFSCAPE V2.0 performs quality control checks, displays Diffusion Weighted Images (MRI only) and generates parametric maps such as Relative Blood Volume, Relative Blood Flow, Relative Mean Transit Time, Time to Peak, Impulse Response Time to Peak, permeability and leakage between intravascular and extracellular space (MRI only), and temporal Maximum Intensity Projection (CT only). PERFSCAPE V2.0 also generates Diffusion Weighted Images and/or Diffusion Tensor Images (MRI only).

These images, when interpreted by a trained physician, may vield clinically useful information.

PERFSCAPE V2.0 is compliant with the DICOM standard allowing the system to visualize medical images. The system is a multiplatform software running on Windows, Mac and Linux operating systems.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.

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Image /page/3/Picture/1 description: The image shows the logo for Olea Medical. The logo consists of a cube with a human figure on one side and a pattern of dots on the other. To the right of the cube is the text "olea" in a bold, sans-serif font, with the word "MEDICAL" in a smaller font below it.

#### VI. Summary of the Technical Characteristics

PERFSCAPE V2.0 is a PACS software designed to access series of CT or MRI images in DICOM format. PERFSCAPE V2.0 analyzes dynamically acquired CT or MR datasets and generates parametric maps.

Used in combination with MRI datasets, PERFSCAPE V2.0 allows automatic or interactive and multiple selections of arterial input functions and displays map results of the selected slice in real time. The selected AIF can be manually filtered. It also allows generating, manually or automatically, an organ mask to remove non-organ voxels. PERFSCAPE V2.0 also allows computing DWI and DTI maps from Bxxx coregistered images.

Used in combination with CT datasets, PERFSCAPE V2.0 allows automatic or interactive and multiple selections of arterial input functions, venous output functions and displays map results of the selected slice in real time. The selected AIF can be manually filtered. It also allows generating, manually or automatically, an organ mask to remove non-organ voxels.

PERFSCAPE V2.0 allows creating a NEUROSCAPE (K083491) study with computed and/or imported maps. It also allows exporting the results as a DICOM study to the PACS or the file system.

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's name in bold, uppercase letters. To the left of the text is a symbol that includes an eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Olea Medical % Ms. Kristi Gusman Project Manager Emergo Group, Inc. 611 West 5th Street, Third Floor AUSTIN TX 78701

NOV - 4 2011

Re: K11161

Trade/Device Name: PERFSCAPE V2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 6, 2011 Received: October 7, 2011

Dear Ms. Gusman:

We have reviewed vour 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. 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 5.10(k) premarket notification. The FDA finding of 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Pastel

Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## 4. Indication for Use Statement

510(k) Number (if known): __|<\1\1 \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \

Device Name:

PERFSCAPE V2.0

### Indications for Use:

PERFSCAPE V2.0 is a PACS system that allows the display, analysis and postprocessing of dynamically acquired Magnetic Resonance (MRI) and Computed Tomography (CT) datasets to evaluate image intensity variations over time.

PERFSCAPE V2.0 retrieves and accepts data from existing MRI and CT systems. Based on these data, PERFSCAPE V2.0 performs quality control checks, displays Diffusion Weighted Images (MRI only) and generates parametric maps such as Relative Blood Volume, Relative Blood Flow, Relative Mean Transit Time, Time to Peak, Impulse Response Time to Peak, permeability and leakage between intravascular and extracellular space (MRI only), and temporal Maximum Intensity Projection (CT only). PERFSCAPE V2.0 also generates Diffusion Weighted Images and/or Diffusion Tensor Images (MRI only).

These images, when interpreted by a trained physician, may yield clinically useful information.

PERFSCAPE V2.0 is compliant with the DICOM standard allowing the system to visualize medical images. The system is a multiplatform software running on Windows, Mac and 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)

510K

AND/OR '

Over-The-Counter Use (21 CFR 801 Subpart C)

Diagnostic

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (QDE).

Mury S. Patal
(Division Sign Off)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

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