NEUROEDGE INFUSION CATHETER

K011646 · Neuro Vasx, Inc. · KRA · Aug 27, 2001 · Cardiovascular

Device Facts

• Record ID: K011646
• Device Name: NEUROEDGE INFUSION CATHETER
• Applicant: Neuro Vasx, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Aug 27, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NeuroEdge™ Infusion Catheter is intended for the infusion of various diagnostic, embolic and therapeutic agents into the neurovasculature.

Device Story

NeuroEdge™ Infusion Catheter is a 1.4 Fr single-use device designed for use within a standard microcatheter. It features an internal nitinol mandrel for axial stability during navigation. The device is used by clinicians to infuse liquid agents (contrast media, embolic glues) into the neurovasculature for diagnosis and treatment of AVMs, AVFs, lesions, or embolisms. It can also penetrate soft thrombi to assess distal circulation. The device is supplied sterile via gamma radiation in a Tyvek/polyester pouch.

Clinical Evidence

Bench testing only. Performance testing was conducted to verify design specifications for the open-ended modification and to support compatibility for the delivery of embolic and therapeutic agents. No clinical data was provided.

Technological Characteristics

1.4 Fr infusion catheter; nitinol mandrel for stability; end-hole design for agent infusion; single-use; gamma radiation sterilization.

Indications for Use

Indicated for infusion of diagnostic, embolic, and therapeutic agents into the neurovasculature for diagnosis, visualization, and treatment of arterio-venous malformations/fistulas (AVM/AVF's), lesions, or embolisms; also indicated for penetration of soft thrombus to assess distal circulation.

Regulatory Classification

Identification

A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

Predicate Devices

• NeuroVasx Sub-MicroInfusion Catheter (K984258)
• Prowler™-10 Infusion Catheter (K003925)
• LTD Torque Device (K964352)

Submission Summary (Full Text)

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011646 1/2

# AUG 2 7 2001

## Section 2 - 510(k) Summary and Certification

[As required by 21 CFR 807.92(c)]

# 1. Submitter's Name / Contact Person

| Jack Slovick | Tel: [phone] |
|------------------------------------------|---------------------|
| Director, Quality and Regulatory Affairs | Fax: [phone] |

NeuroVasx, Inc. 7351 Kirkwood Lane, Suite 112 Maple Grove, MN 55369

## 2. General Information

| Trade Name: | NeuroEdge™ Infusion Catheter |
|----------------------|-------------------------------------------------------------------------------------------------------|
| Classification Name: | Continuous Flush Catheter |
| Classification: | This device is classified by the Circulatory Systems Device<br>Panel into Class II, (21 CFR 870.1210) |

## 3. Device Description

The NeuroEdge™ Infusion Catheter is a single use, 1.4 Fr device designed to fit within a standard microcatheter for advancement to, and navigation of a lesion site. A nitinol mandrel within the NeuroEdge™ Infusion Catheter lumen facilitates axial movement and stability during navigation. The catheter is designed to infuse liquid agents (such as contrast media and liquid embolic glues) through the end hole at select sites in the neurovasculature for the diagnosis, visualization, and treatment of arterio-venous malformations/fistulas (AVM/AVF's), lesions, or embolisms. The catheter is also designed to penetrate an embolism if it is determined to be a soft thrombus and navigate through the thrombus to assess the circulation distal to the thrombus.

The NeuroEdge™ Infusion Catheter is contained in a plastic hoop assembly and sealed in a Tyvek / polyester pouch. The sealed pouch assembly is labeled and placed in a shelf carton along with the instructions for use, and then sterilized via gamma radiation sterilization process. (See Attachment B for device drawings.)

#### 4. Intended Use

The NeuroEdge™ Infusion Catheter is intended for the infusion of various diagnostic, embolic and therapeutic agents into the neurovasculature.

CONFIDENTIAL

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## 5. Substantial Equivalence Comparison

The NeuroEdge Infusion Catheter is substantially equivalent to the following devices with respect to intended use, design, materials and construction:

- NeuroVasx Sub-MicroInfusion Catheter, NeuroVasx Inc. (K984258) o
- Prowler™-10 Infusion Catheter, Cordis Endovascular Systems Inc. (K003925) o
- LTD Torque Device, B. Braun Medical, (K964352) o

## 6. Summary of Studies

Performance testing was completed to verify the design specifications necessary for the open-ended modification and to support the compatibility of the catheter to deliver embolic / therapeutic agents. Test results support the safety and performance of the NeuroEdge™ Infusion Catheter for its intended use.

## 7. Conclusion (statement of equivalence)

The data and information provided in this submission supports a substantial equivalence determination, and, therefore, 510(k) premarket notification clearance of the NeuroEdge™ Infusion Catheter.

## CONFIDENTIAL

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AUG 2 7 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jack Slovick Director, Regulatory Affairs/Quality Assurance NeuroVasx, Inc. 7351 Kirkwood Lane, Suite 112 Maple Grove, Minnesota 55369

Re: K011646

R011040
Trade/Device Name: NeuroEdge™ Infusion Catheter Regulation Number: 870.1210 Regulatory Class: II Product Code: KRA Dated: May 25, 2001 Received: May 29, 2001

Dear Mr. Slovick:

We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your becaon - I oxil iteminally equivalent (for the indications for use above and we nave determined the actives is eadicate devices marketed in interstate commerce stated in the encrosule) to legally manated problem Amendments, or to devices that provision in accordance with the provisions of the Federal Food, Drug, and flave been reclassified in accordance thre device, subject to the general controls Cosment Act (Act). Tou may, morelors, marcols, marcoisions of the Act include requirements for annual provisions of the Act. "The general oversions practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 children rippt vary, it the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspotions, the Food and may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Juan Carlos Rivera

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 607110 for questions on the promotion and advertising of your device, [phone]. Practicenary), and [phone]. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21CFR 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 11allanderal or attitutionet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Mark N. Milkins

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K011646

## Indications for Use Statement

Page 1 of 1

The NeuroEdge™ Infusion Catheter is intended for the infusion of various diagnostic, embolic and therapeutic agents into the neurovasculature.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

SR

(Division Sign -Off) Division of General, Restorative and Neurological Devices

510(k) Number K011646

MAY 25, 2001