Supporting clinical diagnoses about the flow velocity and volume flow through the vascular system.
Supporting subsequent clinical decision making purposes.
Supporting clinical post-operation and follow-up evaluation about the flow velocity and volume flow throughout the vascular system.
Supporting the use in the treatment planning using computer modeling of the vascular system.

Device Description

N-VAS-D is a software tool used to non-invasively measure blood flow in the vascular system. N-VAS-D works on the images acquired from an MRI. It uses Time-of-Flight MRI images obtained via digital network to generate a 3D image. N-VAS-D allows fast scan acquisition time, fast post processing, and accurate flow measurement. N-VAS-D provides accurate vessel identification y using stereo visualization. N-VAS-D gives velocity and volume flow as a function of time, and other derived data such as mean velocity and volumetric flow rate. N-VAS-D generates a web browser compatible flow report that shows both flow results and images.

The N-VAS-D 2.0 includes three modules: 3DP, 3DFLOW and AUTOREPORT. N-VAS-D works on the images acquired from an MRI. It uses Time-of-Flight MRI images obtained via digital network to generate a 3D image. N-VAS-D allows fast scan acquisition time, fast post processing, and accurate flow measurement. N-VAS-D provides accurate vessel identification by using stereo visualization. N-VAS-D gives velocity and volume flow as a function of time, and other derived data such as mean velocity and volumetric flow rate. N-VAS-D generates a web browser compatible flow report that shows both flow results and images.

AI/ML Overview

The provided text describes a software device (N-VAS-D 2.0) intended for neuro-vascular analysis. However, it does not include detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the format requested.

The document primarily focuses on regulatory information, including:

The device's name, classification, and intended use.
A list of predicate devices for substantial equivalence.
A general statement about testing conducted ("Software Verification and Validation including...") and that the "Proposed device has successfully met the requirements of the above."
The FDA's letter of substantial equivalence determination.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and study methodologies cannot be extracted from the provided text.

Here's an attempt to answer based on the available information, with significant caveats where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from "Testing conducted")	Reported Device Performance
Software Installation	Successfully met requirements
Image Extraction and Transfer Test	Successfully met requirements
Product Validation	Successfully met requirements
Flow Velocity (Accuracy/Precision)	Successfully met requirements
Flow Rate (Accuracy/Precision)	Successfully met requirements
Perpendicularity of Vessel Cut	Successfully met requirements
ROI Repeatability	Successfully met requirements
Image Orientation	Successfully met requirements
Data Integrity	Successfully met requirements
Function Testing	Successfully met requirements

Note: The document states, "Proposed device has successfully met the requirements of the above." However, it does not specify what those requirements/acceptance criteria were (e.g., "flow velocity within X% of ground truth," "ROI repeatability to within Y pixels"). It only lists high-level categories of testing.

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

Information Not Provided. The document does not specify any sample sizes for test sets, nor does it mention data provenance (country of origin, retrospective/prospective).

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

Information Not Provided. The document does not describe the establishment of a "ground truth" for a test set or the involvement of experts in that process.

4. Adjudication method for the test set

Information Not Provided. No adjudication method is mentioned.

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

Information Not Provided. The document does not mention any MRMC study or comparative effectiveness study involving human readers with or without AI assistance. The device is described as a "supporting tool," but no studies on its impact on human performance are detailed.

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

Partially Addressed, but Lacking Detail: The listed "Testing conducted" (e.g., flow velocity, flow rate, ROI repeatability) implies standalone performance testing of the algorithm's capabilities. However, the specific metrics, methodologies, and results beyond "successfully met requirements" are not provided.

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

Information Not Provided. The document does not specify the type of ground truth used for any of the performance assessments mentioned.

8. The sample size for the training set

Information Not Provided. The document does not mention a training set or its size.

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

Information Not Provided. As no training set is mentioned, the method for establishing its ground truth is also not provided.

Summary

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Ko 1 40 11

FEB 0 5 2002

SAFETY & EFFECTIVENESS DATA SUMMARY

Submitters Name, Address & Phone Number:

VasSol. Inc. 2201 Campbell Park Drive Suite 2260 Chicago, IL 60612

Submission Correspondent:

Lyle Howard Corporation 203 Main Street, PMB 166 Flemington, NJ 08822 Attention: Lynette Howard

Classification Name: Common / Usual Name: Proprietary Name:

Magnetic Resonance Diagnostic Device Accessory Neuro-Vascular Analysis Software for Diagnosis CANVAS N-VAS-D 2.0

Establishment Registration Number: Pending

Classification:

Class II, Reg. # 21 CFR 892.1000

Performance Standards: No performance standards have been developed for this device.

Devices to which we claim Substantial Equivalence:

GE Advantage Windows (K923077A) & GE "Magnetic Resonance Diagnostic Accessory" (K924605).

The intended use of the device to which we claim substantial equivalence:

The General Electric Flow Analysis Option (K924605) in intended to quantitatively measure flow from a vessel using the principles of NMR. The GE Medical Systems 3D option (K923077A) is intended to create images of the anatomy in three dimensions from a set of CT or MRI images. The Dentascan option is intended to create a cross-referenced set of correlated axial, panorex and oblique planar images of the mandible and maxilla from CT scans of the jaw.

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SAFETY & EFFECTIVENESS DATA SUMMARY

Testing conducted to assure safety and effectiveness include but is not limited to:

Software Verification and Validation including: Software Installation Image Extraction and Transfer Test Product Validation Flow Velocity Flow Rate Perpendicularity of Vessel Cut ROI Repeatibility Image Orientation Data Integrity Function Testing

Proposed device has successfully met the requirements of the above.

Description of the new device:

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SAFETY & EFFECTIVENESS DATA SUMMARY

Intended Use:

N-VAS-D is designed and intended for use as a supporting tool to non-invasive assessment of the vascular system. Intended purposes are:

. Supporting clinical diagnoses about the flow velocity and volume flow through the vascular system.
Supporting subsequent clinical decision making purposes. .
· Supporting clinical post-operation and follow-up evaluation about the flow velocity and volume flow throughout the vascular system.
. Supporting the use in the treatment planning using computer modeling of the vascular system.

Caution: Federal Law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it, topped with a pair of wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 5 2002

VasSol, Inc. % Ms. Lynette Howard Submission Correspondent Lyle Howard Corporation 203 Main Street, PMB 166 FLEMINGTON NJ 08822 Re: K014011

Trade/Device Name: CANVAS N-VAS-D 2.0 (Neuro-Vascular Analysis Software for Diagnosis) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: December 3, 2001 Received: December 5, 2001

Dear Ms. Howard:

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); 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.

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This letter will allow you to begin marketing your device as described in your 510(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 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:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Snogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATION FOR USE

510(k) Number:

CANVAS N-VAS-D 2.0 Device Name:

Indications for Use:

N-VAS-D is designed and intended for use as a supporting tool to non-invasive assessment of the vascular system. Intended purposes are:

Supporting clinical diagnoses about the flow velocity and volume flow through . the vascular system.
Supporting subsequent clinical decision making purposes. .
Supporting clinical post-operation and follow-up evaluation about the flow . velocity and volume flow throughout the vascular system.
Supporting the use in the treatment planning using computer modeling of the . vascular system.

Concurrence of CDRH, Office of Device Evaluation (ODE)

David C. Syverson

Prescription Use

(Division Sign-Om
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K14011

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.