iSchemaView's RAPID is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing and analysis of brain images. Data and images are acquired through DICOM compliant imaging devices.

iSchemaView's RAPID provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast enhanced imaging data for MRI and CT).

The DWI Module is used to visualize local water diffusion properties from the analysis of diffusionweighted MRI data.

The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume.

Device Description

RAPID is a software package that provides for the visualization and study of changes of tissue perfusion and diffusion in digital images captured by CT (Computed Tomography) and MRI (Magnetic Image Resonance). RAPID can be installed on a customer PC or it can be accessed online as virtual system. It provides viewing, quantification, analysis and reporting capabilities.

RAPID works with the following types of (DICOM compliant) medical image data:

· CT (Computed Tomography)
· MRI (Magnetic Image Resonance)

RAPID acquires (DICOM compliant) medical image data from the following sources:

· DICOM file
· DICOM CD-R
· Network using DICOM protocol

RAPID provides tools for performing the following types of analysis:

· volumetry of threshold maps
· time intensity plots for dynamic time courses
measurement of mismatch between labeled volumes on co-registered image volumes

RAPID is a software-only device consisting of one or more RAPID Servers (dedicated or virtual and an iSchemaView Server). The RAPID Server is an image processing engine that connects to a hospital LAN, inside the Hospital Firewall. It can be a dedicated RAPID Server or a vmRAPID appliance, which is a virtualized RAPID Server that runs on a dedicated hospital server. Where available, the RAPID Server is placed logically in the demilitarized zone (DMZ) of the hospital's network to facilitate bidirectional secure connection between the (local) RAPID Server and the centralized iSchemaView Server.

The RAPID Server is configured to connect to applicable DICOM devices (PACS, Imaging Modalities, Research Workstations) via the hospital LAN and to receive diffusion and perfusion (DICOM) data directly and automatically from imaging modalities as they become available. It processes acquired data and delivers postprocessed images directly back to imaging modalities, local PACS and/or workstations, again using DICOM communication. It also transmits data to the iSchemaView Server for storage, retrieval and viewing.

The iSchemaView Server is a dedicated server that provides a central repository for RAPID data. All iSchemaView Server data is stored on encrypted hard disks. It also provides a user interface for accessing RAPID data. It connects to a firewalled Data Center Network and has its own firewall for additional data security. The iSchemaView Server connects to one or more RAPID Servers via WAN. Available types of connection include VPN (Virtual Private Network - RFC2401 and RFC4301 Standards) Tunnel and SSH (Secure Shell).

AI/ML Overview

The provided 510(k) summary for iSchemaView, Inc.'s RAPID does not include specific acceptance criteria or an explicit study proving performance against them. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Olea Sphere) through a comparison of technological characteristics and a general statement about performance validation testing.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria or specific reported device performance metrics against such criteria. The closest information is a comparison of technological characteristics between RAPID and its predicate device, Olea Sphere, to demonstrate substantial equivalence.

Parameter	RAPID	Olea Sphere (Predicate Device)
Primary Claim	Substantial Equivalence to Olea Sphere	N/A (Legally marketed predicate)
Product Code	LLZ	LLZ
Regulation	21 CFR §892.2050	21 CFR §892.2050
Intended Use/ Indications for use	Image processing software for viewing, processing, and analysis of brain images from CT Perfusion and MRI (DWI and Dynamic Analysis Modules for dynamic contrast-enhanced imaging data). Visualizes local water diffusion properties and calculates parameters related to tissue flow (perfusion) and tissue blood volume.	Image processing software for viewing, processing, and analysis of medical images from MRI or other relevant modalities (DWI/Fiber Tracking Module and Dynamic Analysis Module for dynamic contrast-enhanced imaging data). Visualizes local water diffusion properties (and fiber tracking) and calculates parameters related to tissue flow (perfusion), tissue blood volume, and permeability.
PACS Functionality	View, process, and analyze medical images. Performs standard PACS functions with respect to querying and listing.	Same
Computer Platform	Standard "off-the-shelf" PC workstation (also virtual platform like VMware)	Same
DICOM Compliance	(Not explicitly stated in table, but mentioned in body)	Yes
Functional Overview	Visualization and study of changes of tissue perfusion and diffusion in digital images captured by CT and MRI. Provides viewing and quantification.	Same
Data Acquisition	Acquires medical image data from DICOM compliant imaging devices and modalities	Same
Data/Image Types	Computed Tomography (CT), Magnetic Image Resonance (MRI)	Same
Acquisition and Modalities Features	MRI: Diffusion Weighted Image (DWI), Perfusion Weighted Image (PWI). CT: CT Perfusion (CTP).	MRI: Yes. CT: Yes.
Computed Parameter Maps (DWI)	Isotropic DWI (isoDWI), Exponential apparent diffusion coefficient (eADC), ADC, Trace of diffusion tensor (Trace), Fractional Anisotropy (FA) and color FA, Eigenvector, Eigenvalue	Yes (for all listed DWI parameters)
Computed Parameter Maps (Perfusion)	Cerebral blood flow (CBF), Cerebral blood volume (CBV), Mean transit time (MTT), Tissue residue function time to peak (Tmax)	Yes (for all listed perfusion parameters), plus Permeability Module parameters.
Measurements/Tools	Arterial input function (AIF)/Venous output function (VOF), Time-course, Brain mask, Region of interest (ROI) and Volumetry, Volumetric comparison between 2 ROIs, Motion correction, Export perfusion and diffusion files to PACS and DICOM, Acquire, transmit, process, and store medical images	Yes (for all listed tools)

Performance Statement:
The document states: "iSchemaView conducted extensive performance validation testing and software verification and validation testing of the RAPID system. This performance validation testing demonstrated that the RAPID system provides accurate representation of key diffusion and perfusion processing parameters under a range of clinically relevant parameters and perturbations associated with the intended use of the software. Software validation and verification testing demonstrated that the RAPID system met all design requirements and specifications."

This is a general statement about the existence of testing, but it does not detail specific acceptance criteria (e.g., "accuracy must be > 95% for parameter X against ground truth Y") nor does it provide quantitative results.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for any test set or the provenance (e.g., country of origin, retrospective/prospective) of the data used for performance validation.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document does not mention using experts to establish ground truth for a test set, nor does it specify the number or qualifications of any such experts.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor does it mention any effect size of how much human readers improve with AI vs. without AI assistance. The focus is on the device's standalone processing capabilities, not its impact on human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the implied performance validation is focused on the standalone algorithm. The statement "This performance validation testing demonstrated that the RAPID system provides accurate representation of key diffusion and perfusion processing parameters" suggests algorithmic accuracy and reliability, rather than human-in-the-loop performance. However, specific details of this standalone performance (e.g., accuracy metrics, specific parameters tested) are not provided in this 510(k) summary.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for any validation. It broadly refers to showing "accurate representation of key diffusion and perfusion processing parameters," which implies comparison against some reference standard, but doesn't specify if this was expert consensus, pathology, outcomes data, a phantom, or another method.

8. The Sample Size for the Training Set

The document does not mention any training set or its sample size. This 510(k) summary is for a software package that processes images based on established physiological models for diffusion and perfusion, rather than a machine learning or AI model that typically requires a discrete training set.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned (see point 8), there is no information on how its ground truth would have been established.

In summary: The provided 510(k) summary focuses almost exclusively on demonstrating substantial equivalence to a predicate device by comparing technical specifications and intended use. It describes the device's functionality and its role in processing medical images based on established scientific principles. It states that performance validation testing was conducted and that the system met design requirements, but it does not provide any specific quantitative acceptance criteria, details of the study design (e.g., sample size, data provenance), ground truth methodology, or reader study results. This type of summary for software performing calculations based on known physical models often relies on verification and validation against those models, rather than clinical efficacy studies with ground truth derived from pathology or expert consensus.

Summary

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510(k) SUMMARY iSchemaView, Inc.'s RAPID

Applicant's name:	iSchemaView, Inc.323 Olmsted RoadStanford, CA 94305
Contact Person:	John J. Smith, M.D., J.D.PartnerHogan Lovells US LLP555 Thirteenth Street, NWWashington, DC 20004

OCT 04 2013

Date Prepared: September 13, 2013

Name of Device: RAPID

PACS - Picture Archiving Communications System Common or Usual Name:

Classification: Product Code: LLZ Regulation No: 21 C.F.R. §892.2050 Class: Il Classification Panel: Radiology Devices

Tel. (202) 637-3638 Fax (202) 637-5910

Predicate Devices

OLEA MEDICAL's Olea Sphere (K120196)

Device Description

RAPID works with the following types of (DICOM compliant) medical image data:

· CT (Computed Tomography)
· MRI (Magnetic Image Resonance)

RAPID acquires (DICOM compliant) medical image data from the following sources:

· DICOM file
· DICOM CD-R
· Network using DICOM protocol

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RAPID provides tools for performing the following types of analysis:

· volumetry of threshold maps
· time intensity plots for dynamic time courses
measurement of mismatch between labeled volumes on co-registered image volumes

Intended Use / Indications for Use

The DWI Module is used to visualize local water diffusion properties from the analysis of diffusionweighted MRI data.

The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data. showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume.

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Technological Characteristics

RAPID performs the following functions:

processes DICOM images from multiple sources to provide visualization of changes of . tissue perfusion and diffusion
receives DICOM images from external DICOM image providers (modalities (CT/MRI . Scanners), PACS and Workstations) and sends DICOM images to external image consumers
processes requests, statuses and results, and references therein, which are stored in a . queryable database
processing status is available through a web browser using HTTP, HTML and PHP. .
can send summary results to the user over email. For this, RAPID generally connects to the . infrastructure of the medical partner (e.g., the hospital). In particular, RAPID uses a SMTP protocol with security extensions to provide secure emailing.

RAPID is available in the following configurations:

Standard RAPID, which is installed directly on a customer's Linux-based PC and integrated . with medical image processing software such as commercial PACS.
. Virtual RAPID, wherein the user accesses RAPID online and uses it to process DICOM images otherwise available on his/her computer.

RAPID is a DICOM-compliant PACS software that provides comprehensive functionality to transfer, process, and display diffusion-weighted MRI (DWI) and dynamically acquired CT and MR imaging data (following the administration of a bolus of contrast media). RAPID runs on standard "off-theshelf" computer and networking hardware. RAPID is entirely independent from CT, MRI, or PACS platforms. It supports secure VPN (Virtual Private Network) networking or encapsulated Secure Shell (SSH), and seamlessly integrates into an existing radiological data network.

The primary users of RAPID PACS software are medical imaging professionals who analyze diffusion MRI and/or dynamic CT or MRI images. The images generated by RAPID provide additional diagnostic information, which is derived from the temporal/diffusion features of the native CT or MRI images.

Performance Data

RAPID complies with DICOM (Digital Imaging and Communications in Medicine) - Developed by the American College of Radiology and the National Electrical Manufacturers Association. NEMA PS 3.1 - 3.20 (2011).

Additionally. iSchemaView conducted extensive performance validation testing and software verification and validation testing of the RAPID system. This performance validation testing demonstrated that the RAPID system provides accurate representation of key diffusion and perfusion processing parameters under a range of clinically relevant parameters and perturbations associated with the intended use of the software. Software validation and verification testing demonstrated that the RAPID system met all design requirements and specifications.

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Substantial Equivalence

RAPID is as safe and effective as the Olea Sphere. RAPID has the same intended use and similar indications, technological characteristics and principles of operation as its predicate device. The minor technological differences between the RAPID and its predicate raise no new issues of safety or effectiveness as demonstrated by the testing conducted with RAPID that confirms that the software reliably processes CT diffusion and MRI diffusion and perfusion medical images. Thus, the RAPID software is substantially equivalent.

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Parameter	RAPID	Olea Sphere (K120196)
Product Code	LLZ	LLZ
Regulation	21 CFR §892.2050	21 CFR §892.2050
Intended Use/ Indications for use	iSchemaView's RAPID is an image processingsoftware package to be used by trainedprofessionals, including but not limited to physiciansand medical technicians. The software runs on astandard "off-the-shelf" computer or a virtualplatform, such as VMware, and can be used toperform image viewing, processing and analysis ofbrain images. Data and images are acquiredthrough DICOM compliant imaging devices.	Olea Sphere is an image processing software package to be used bytrained professionals including but not limited to physicians andmedical technicians. The software runs on a standard "off-the-shelf"workstation and can be used to perform image viewing, processingand analysis of medical images. Data and images are acquiredthrough DICOM compliant imaging devices and modalities.
	The iSchemaView RAPID provides both viewing andanalysis capabilities for functional and dynamicimaging datasets acquired with CT Perfusion andMRI including a Diffusion Weighted MRI (DWI)Module and a Dynamic Analysis Module (dynamiccontrast-enhanced imaging data for MRI and CT).	Olea Sphere provides both viewing and analysis capabilities offunctional and dynamic imaging datasets acquired with MRI or otherrelevant modalities, including a Diffusion Weighted MRI (DWI) / FiberTracking Module and a Dynamic Analysis Module (dynamic contrastenhanced imaging data for MRI and CT).
	The DWI Module is used to visualize local waterdiffusion properties from the analysis of diffusion-weighted MRI data.	The DWI Module is used to visualize local water diffusion propertiesfrom the analysis of diffusion-weighted MRI data. The Fiber Trackingfeature utilizes the directional dependency of the diffusion to displaythe white matter Structure in the brain or more generally the centralnervous system.
	The Dynamic Analysis Module is used forvisualization and analysis of dynamic imaging data,showing properties of changes in contrast over time.This functionality includes calculation of parametersrelated to tissue flow (perfusion) and tissue bloodvolume.	The Dynamic Analysis Module is used for visualization and analysisof dynamic imaging data, showing properties of changes in contrastover time where such techniques are useful or necessary. Thisfunctionality is referred to as:Perfusion Module - the calculation of parameters related totissue flow (perfusion) and tissue blood volume.Permeability Module - the calculation of parameters relatedto leakage of injected contrast material from intravascular toextracellular space.
PACS FunctionalityBasic PACS Functions	View, process and analyze medical images.Performs standard PACS functions with respect toquerying and listing.	Same
Computer Platform	Standard "off-the-shelf" PC workstation	Same
DICOM Compliance		Yes
Funcional Overview	RAPID is a software package that provides for thevisualization and study of changes of tissueperfusion and diffusion in digital images captured byCT and MRI. RAPID provides viewing andquantification.	Same
Data Acquisition	Acquires medical image data from DICOM compliantimaging devices and modalities	Same
Data/Image Types	Computed Tomography (CT)Magnetic Image Resonance (MRI)	Same
Acquisition and Modalities Features
MRI	Diffusion Weighted Image (DWI)Perfusion Weighted Image (PWI)	Yes
CT	CT Perfusion (CTP)	Yes
Computed Parameter Maps	Isotropic DWI (isoDWI)	Yes
	Exponential apparent diffusion coefficient (eADC)	Yes
	ADC	Yes
Diffusion MRI	Trace of diffusion tensor (Trace)	Yes
	Fractional Anisotropy (FA) and color FA	Yes
	Eigenvector	Yes
	Eigenvalue	Yes
Perfusion MRI and PerfusionCT	Cerebral blood flow (CBF)	Yes
	Cerebral blood volume (CBV)	Yes
	Mean transit time (MTT)	Yes
	Tissue residue function time to peak (Tmax)	Yes
Measurements/Tools	Arterial input function (AIF)/Venous output function(VOF)	Yes
	Time-course	Yes
	Brain mask	Yes
MRI and CT Tools	Region of interest (ROI) and Volumetry	Yes
	Volumetric comparison between 2 ROIs	Yes
	Motion correction	Yes
	Export perfusion and diffusion files to PACS andDICOM file systems	Yes
	Acquire, transmit, process, and store medicalimages	Yes

Substantial Equivalence

Note: RAPID also may be used with a virtual platform such as VMware

NDC - 038926/00001 - 4886242 v2

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NDC: 03892600001-4886242 V2

K121442
page 6 of 6
0137

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-0609 Silver Spring, MD 20993-0002

October 4, 2013

iSchemaView, Inc. % John J. Smith, M.D., J.D. Pariner Hogan Lovells US L.LP Columbia Square 555 Thirtcenth Street. NW WASHINGTON DC 20004

Re: K121447

Trade/Device Name: RAPID Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ. Dated: September 16, 2013 Received: September 16, 2013

Dear Dr. Smith:

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 for too May 28, 1976. the enactment date of the Medical Device Amendments, or 10 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). and Cosmetic North the device, subject to the general controls provisions of the Act. The rou may, merely provisions of the Act include requirements for annual registration. Ilisting 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.

ff your device is classified (see above) into cither 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 mat I DA has made a devel regulations administered by other Federal agencies. You must or any roothall 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2-Dr. Smith

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. 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/MedicalDevices/Safety/ReportalProblem/default.hum 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K121447

Device Name: iSchemaView's RAPID

Indications for Use:

iSchemaView's RAPID provides both viewing and analysis capabilities for functional and dynamic Imaging datasets acquired with CT Perfusion and MRI including a Diffusion Weighted MRI (DVM) Module and a Dynamic Analysis Module (dynamic contrast enhanced imaging data for MRI and CT).

The DWI Module is used to visualize local water diffusion properties from the analysis of diffusionweighted MRI data.

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 In Vitro Diagnostics and Radiological Health (OIR)

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(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

长121447 510(k)

Page 1 of 1

Regulation Number and Section

§ 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).