PERFSCAPE allows the post-processing and display of dynamically acquired Magnetic Resonance datasets to evaluate image intensity variations over time. PERFSCAPE retrieves and accepts data from existing MRI systems. Based on these data, PERFSCAPE performs quality control checks, displays Diffusion Weighted Images and generates parametric perfusion maps such as Relative Cerebral Blood Volume (rCBV), Relative Cerebral Blood Flow (rCBF), Relative Mean Transit Time (rMTT), Time to Peak (TTP) and Impulse Response Time to Peak (TMAX). These images when interpreted by a trained physician may yield information useful in clinical applications.

Device Description

PERFSCAPE is a software application designed to analyze dynamically acquired datasets. Using well-established algorithms, parametric perfusion maps can be generated such as Relative Cerebral Blood Volume (rCBV), Relative Cerebral Blood Flow (CBF), Relative Mean Transit Time (MTT), Time to Peak (TTP) and impulse response time to peak (TMAX). The system includes critical features such as:

Enables rapid creation of a complete array of critical perfusion . parameter maps of rCBV, rCBF, rMTT, TTP, TMAX;
Automated brain mask generation: .
View dynamic signal time course on a per-voxel basis; .
. Interactive Arterial Input Function (AIF) selection:
Export computed perfusion map to the NEUROSCAPE PACS system. .

PERFSCAPE also allows the user to view the computed perfusion maps using the NEUROSCAPE software. NEUROSCAPE displays the original study series for FLAIR, ADC, B0 and B1000 and PERFSCAPE computed series for TTP, CBV, CBF, MTT and TMAX.

AI/ML Overview

The PERFSCAPE device is a software application intended for the post-processing and display of dynamically acquired Magnetic Resonance datasets to evaluate image intensity variations over time. It retrieves data from existing MRI systems to perform quality control checks, display Diffusion Weighted Images, and generate parametric perfusion maps (rCBV, rCBF, rMTT, TTP, TMAX). These images, when interpreted by a trained physician, are intended to provide information useful in clinical applications.

The provided document does not explicitly state specific quantitative acceptance criteria for the device's performance in terms of accuracy, sensitivity, or specificity for a particular clinical task. Instead, the focus of the 510(k) submission and the "Testing" section is on demonstrating substantial equivalence to a predicate device and confirming the software's functionality and reliability.

However, based on the provided text, we can infer the primary "acceptance criterion" as functional equivalence and reliability with the predicate device for its intended use as a post-processing and display tool for MR perfusion images.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

As no explicit quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are stated in the document, this table will reflect the inferred criteria of functional equivalence and software reliability.

Acceptance Criterion (Inferred from submission)	Reported Device Performance
Functional Equivalence to Predicate Device (IB Neuro™ 1.0, K080762)	"Based on the comparison of intended use and technological characteristics, the PERFSCAPE system is substantially equivalent to the IB Neuro™ 1.0 device manufactured by Imaging Biometrics, LLC (K080762)."
Reliable Post-processing and Display of MR perfusion images	"OLEA Medical has conducted extensive validation testing of the PERFSCAPE system, as a software that is capable of providing reliable postprocessing and display of magnetic resonance perfusion images for instantaneous multi-parametric analysis."
Generation of specified parametric perfusion maps (rCBV, rCBF, rMTT, TTP, TMAX)	"Enables rapid creation of a complete array of critical perfusion parameter maps of rCBV, rCBF, rMTT, TTP, TMAX." "PERFSCAPE analyzes dynamically acquired MR datasets and generates parametric maps of the brain."
Automated brain mask generation	"Automated brain mask generation." "It also allows generating, manually or automatically, a brain mask to remove non-brain voxels."
Interactive Arterial Input Function (AIF) selection and filtering	"Interactive Arterial Input Function (AIF) selection." "PERFSCAPE allows 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 before the beginning of the signal of interest and after the beginning of the recirculation."
Viewing dynamic signal time course	"View dynamic signal time course on a per-voxel basis."
Export computed perfusion maps to NEUROSCAPE PACS system	"Export computed perfusion map to the NEUROSCAPE PACS system." "PERFSCAPE allows creating a NEUROSCAPE study with computed perfusion maps and with imported diffusion map."
Compatibility with DICOM standard and multi-platform OS	"PERFSCAPE is compliant with the DICOM standard allowing the system to visualize medical images. The system is a multi-platform software running on any Windows, Mac and Linux operating systems."
Safety and Effectiveness (no new issues)	"The PERFSCAPE device raises no new safety or effectiveness issues."
Quality Control Checks and Display of Diffusion Weighted Images	"PERFSCAPE performs quality control checks, displays Diffusion Weighted Images..."
Stress testing of components	"All of the different components of the PERFSCAPE software have been stress tested to ensure that the system as a whole provides all the capabilities necessary to operate safely and effectively."

2. Sample size used for the test set and the data provenance

The document states, "OLEA Medical has conducted extensive validation testing of the PERFSCAPE system..." but does not specify the sample size of the test set (number of cases/patients) or the data provenance (e.g., country of origin, retrospective or prospective). The testing is described as focused on the software's functional capabilities and reliability rather than a diagnostic performance study on a patient cohort.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention the use of experts to establish ground truth for a test set, nor does it describe any such ground truth establishment process. The testing appears to be centered on software validation rather than clinical diagnostic accuracy against a ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

As there's no mention of a test set with ground truth established by experts, there is no adjudication method described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study is mentioned in the provided text. The device is a post-processing tool, and its submission focuses on substantial equivalence based on technical characteristics and intended use, not on reader performance improvement in a clinical setting.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The document describes the device as performing post-processing and displaying parametric maps, which are then "interpreted by a trained physician." This implies it is an algorithm-only (standalone) component that assists human interpretation rather than a system that provides a final diagnostic output. The validation described is of the software's ability to generate these maps and its functionality, which is a standalone performance aspect. However, it's not a standalone diagnostic performance in the sense of providing a definitive diagnosis without human oversight.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

No specific type of ground truth is mentioned for the validation of the PERFSCAPE system, as the testing described focuses on software functionality, reliability, and substantial equivalence, not the diagnostic accuracy of the generated maps against external clinical truth. The "ground truth" for the software's performance seems to be its ability to correctly generate the specified parametric maps based on established algorithms and display them reliably.

8. The sample size for the training set

The document does not provide any information regarding a training set sample size. This is common for devices of this nature (post-processing software using established algorithms), as explicit "training" in the context of machine learning (where training set sizes are critical) might not be applicable or explicitly called out if the algorithms are deterministic and well-established.

9. How the ground truth for the training set was established

Since no training set is described or implied in the context of machine learning, there is no information on how ground truth for a training set was established. The device "Using well-established algorithms" suggests that the underlying principles are known and validated, rather than learned from a labeled training set in a machine learning context.

Summary

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JUL 20 2009

K091444

510(k) Summary (in accordance with 21 CFR 807.92)

510(k) Number K

I. Applicant Information

Applicant:

OLEA MEDICAL 93 avenue du Sorbier 13600 La Ciotat France

Fayçal Djeridane

Tel: (011) 33 4 42 71 24 20 Fax: (011) 33 4 88 56 53 39

President

Contact Person:

Application Correspondent:

EMERGO GROUP INC. 1705 S. Capital of Texas Hwy., Suite 500 Austin, TX 78746 U.S.A.

e-mail: faycal.djeridane@olea-medical.com

Contact Person:

Neal Kolber Project Manager Tel: (512) 327-9997 Fax: (512) 327-9998 e-mail: neal@emergogroup.com

Date Prepared:

May 4, 2009

II. Device Name and Classification

Proprietary Name: Classification Name: Common/Usual Name: Regulation Number: Product Codes: Classification: Classification Panel:

PERFSCAPE Magnetic Resonance Diagnostic Device Picture Archiving Communications System (PACS) 892.1000 LNH . Class II Radiology Devices

Traditional 510(k) – PERFSCAPE

CONFIDENTIAL

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III. Predicate Device

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

510(k) Number:	K080762
Trade Name:	IB Neuro™ 1.0
Manufacturer:	Imaging Biometrics, LLC
Classification Name:	Magnetic Resonance Diagnostic Device
Common/Usual Name:	Picture Archiving Communications System (PACS)
Regulation Number:	892.1000
Product Codes:	LNH
Classification:	Class II

IV. Device Description

Enables rapid creation of a complete array of critical perfusion . parameter maps of rCBV, rCBF, rMTT, TTP, TMAX;
Automated brain mask generation: .
View dynamic signal time course on a per-voxel basis; .
. Interactive Arterial Input Function (AIF) selection:
Export computed perfusion map to the NEUROSCAPE PACS system. .

V. Intended Use

Traditional 510(k) - PERFSCAPE

CONFIDENTIAL

Page 5-2

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Weighted Images and generates parametric perfusion maps such as Relative Cerebral Blood Volume (rCBV), Relative Cerebral Blood Flow (rCBF), Relative Mean Transit Time (rMTT), Time to Peak (TTP) and Impulse Response Time to Peak (TMAX). These images when interpreted by a trained physician may yield information useful in clinical applications.

PERFSCAPE is compliant with the DICOM standard allowing the system to visualize medical images. The system is a multi-platform software running on any Windows, Mac and Linux operating systems.

VI. Summary of the Technical Characteristics

PERFSCAPE is a PACS software designed to access series of MRI perfusion and diffusion images in DICOM format. PERFSCAPE analyzes dynamically acquired MR datasets and generates parametric maps of the brain.

PERFSCAPE allows 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 before the beginning of the signal of interest and after the beginning of the recirculation. It also allows generating, manually or automatically, a brain mask to remove non-brain voxels. PERFSCAPE allows creating a NEUROSCAPE study with computed perfusion maps and with imported diffusion map.

VII. Testing

OLEA Medical has conducted extensive validation testing of the PERFSCAPE system, as a software that is capable of providing reliable postprocessing and display of magnetic resonance perfusion images for instantaneous multi-parametric analysis. All of the different components of the PERFSCAPE 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 PERFSCAPE system is substantially equivalent to the IB Neuro™ 1.0 device manufactured by Imaging Biometrics, LLC (K080762). The PERFSCAPE device raises no new safety or effectiveness issues.

CONFIDENTIAL

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 20 2009

Olea Medical % Mr. Neal Kolber Project Manager Emergo Group, Inc. 1705 S. Capital of Texas Hwy., Suite 500 AUSTIN TX 78746

Re: K091444

Trade/Device Name: PERFSCAPE Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 4, 2009 Received: May 21, 2009

Dear Mr. Kolber:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. 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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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 (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrl/mdr/ 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Janine 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

K0914444 510(k) Number (if known):

510(k) Number

Device Name:

PERFSCAPE

Indications for Use:

PERFSCAPE is compliant with the DICOM standard allowing the system to visualize medical images. The system is a multi-platform software running on any Windows, Mac and Linux operating systems.

Prescription Use _X (Part 21 CFR 801 Subpart D)	AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
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(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

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Regulation Number and Section

N/A