CANVAS N-VAS-D 2.0

K014011 · Vassol, Inc. · LNH · Feb 5, 2002 · Radiology

Device Facts

• Record ID: K014011
• Device Name: CANVAS N-VAS-D 2.0
• Applicant: Vassol, Inc.
• Product Code: LNH · Radiology
• Decision Date: Feb 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Software as a Medical Device

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).

Device Story

N-VAS-D 2.0 is a software tool for non-invasive vascular blood flow measurement. Input: Time-of-Flight MRI images acquired via digital network. Operation: Software processes MRI data to generate 3D images; utilizes stereo visualization for vessel identification; calculates velocity and volume flow over time, mean velocity, and volumetric flow rate. Output: 3D images and web-browser compatible flow reports containing results and images. Used in clinical settings by physicians/licensed practitioners to support diagnosis, post-op evaluation, and treatment planning via computer modeling. Benefits: Provides fast post-processing and accurate flow quantification to assist clinical decision-making.

Clinical Evidence

Bench testing only. Verification and validation included software installation, image extraction/transfer, flow velocity and rate accuracy, perpendicularity of vessel cut, ROI repeatability, image orientation, data integrity, and function testing. No clinical data provided.

Technological Characteristics

Software-based medical device. Operates on Time-of-Flight MRI images. Features three modules: 3DP (3D processing), 3DFLOW (flow analysis), and AUTOREPORT (report generation). Utilizes stereo visualization for vessel identification. Connectivity via digital network. No specific hardware materials or energy sources defined as it is a software-only accessory.

Indications for Use

Indicated for non-invasive assessment of the vascular system, including clinical diagnosis, post-operative follow-up, and treatment planning involving flow velocity and volume flow measurements. No specific age or gender restrictions stated.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• GE Advantage Windows (K923077A)
• GE Magnetic Resonance Diagnostic Accessory (K924605)

Submission Summary (Full Text)

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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:

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.

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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

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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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