NEUROVASX SUB-MICROINFUSION CATHETER

K984258 · Neuro Vasx, Inc. · DQO · Feb 11, 1999 · Cardiovascular

Device Facts

• Record ID: K984258
• Device Name: NEUROVASX SUB-MICROINFUSION CATHETER
• Applicant: Neuro Vasx, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Feb 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The NeuroVasx Sub-Microinfusion Catheter is intended for the delivery of diagnostic agents into the neurovasculature.

Device Story

The NeuroVasx Sub-Microinfusion Catheter is a 1.4 Fr single-use device designed for navigation to neurovascular lesion sites. It fits within a standard microcatheter and utilizes an internal nitinol mandrel for axial stability during navigation. The catheter features side holes in the wall to facilitate radial infusion of liquid diagnostic agents, improving diffusion and mixing with blood flow. It is sterilized via gamma radiation and supplied in a Tyvek/polyester pouch. The device is intended for use by clinicians in a vascular setting to deliver diagnostic agents, aiding in the visualization of the neurovasculature.

Clinical Evidence

Bench testing only. Design verification testing confirmed the device met specifications and performance requirements. Biocompatibility testing was performed on all construction materials, with all materials passing.

Technological Characteristics

1.4 Fr single-use catheter; materials include high density polyethylene, nitinol wire, and polycarbonate hub. Features side holes for radial infusion. Sterilized via gamma radiation. No software or electronic components.

Indications for Use

Indicated for the delivery of diagnostic agents into the neurovasculature.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• In-Time™ Intravascular Infusion Catheter (K963988)
• Segue™ Infusion Catheter (K964154)
• Mach-16 Nitinol Guidewire (K862983)

Submission Summary (Full Text)

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2/11/99
**CONFIDENTIAL**

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

# [As required by 21 CFR 807.92(c)]

### 1. Submitter's Name / Contact Person

Jeffrey A. Lee President and CEO NeuroVasx. Inc. 2355 Polaris Lane No. Suite 116 Plymouth. MN 55447

Tel: [phone] [phone] Fax:

#### 2. General Information

| Trade Name | NeuroVasx Sub-Microinfusion Catheter |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name | Diagnostic Intravascular Catheter |
| Classification: | This device has been classified by the Circulatory Systems Device<br>Panel into Class II, (21 CFR 870.1200). |
| Identification of<br>Equivalent<br>Device | In-Time™ Intravascular Infusion Catheter; Boston Scientific<br>Corporation / SciMed Life Systems (K963988) Segue™ Infusion Catheter; Interventional Innovations<br>Corporation (K964154) Mach-16 Nitinol Guidewire; Target Therapeutics (K862983) |

#### 3. Device Description

The NeuroVasx Sub-Microinfusion 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 NeuroVasx catheter lumen facilitates axial movement and stability during navigation. The catheter is designed to infuse liquid diagnostic agents radially through side holes in the wall of the catheter to improve the diffusion and mixing of the infused agent with the blood flow.

The NeuroVasx 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 in a gamma radiation sterilization process.

### 4. Intended Use

The NeuroVasx Sub-Microinfusion Catheter is intended for the delivery of diagnostic agents into the neurovasculature.

#### 5. Technological Characteristic Comparisons

The NeuroVasx Sub-Microinfusion Catheter is substantially equivalent to the Boston Scientific Corporation / Target Therapeutics In-Time™ Intravascular

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Infusion Catheter (K963988), the Interventional Innovations Corporation Seque™ Infusion Catheter (K964154) and the Mach-16 Nitinol Guidewire: Target Therapeutics (K862983). Compared to these predicate devices, the NeuroVasx catheter has similar intended use (delivery of liquid agents into the vascular system) and is constructed of the same or substantially equivalent materials (high density polyethylene, nitinol wire, polycarbonate hub). The NeuroVasx catheter sizes are comparable as are the infusion pressures.

### 6. Summary of Studies

Design verification testing was performed to verify that the NeuroVasx catheter met the design specifications and performance requirements. The results of the comparative and design verification testing confirmed that the NeuroVasx catheter performs as well or better than the predicate devices tested and is suitable for use; no new questions of safety and effectiveness were raised. Confirmatory biocompatibility testing was performed on the materials used in the construction of the NeuroVasx catheter. All materials passed biocompatibility testing and are suitable for this application.

### 7. Substantial Equivalence Comparison

The NeuroVasx Sub-Microinfusion Catheter is substantially equivalent to the following products:

| In-Time™ Intravascular<br>Infusion Catheter | Segue™ Infusion<br>Catheter | Mach-16 Nitinol Guidewire |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Boston Scientific Corp /<br>SciMed Life Systems<br>6655 Wedgewood Road<br>Maple Grove, MN 55311 | Interventional<br>Innovations Corp.<br>2670 Patton Road<br>St. Paul, MN 55113 | Target Therapeutics<br>2100 South Sepulveda Blvd<br>Los Angeles, CA 90025 |
| Premarket Notification<br>Number: K963988 | Premarket Notification<br>Number: K964154 | Premarket Notification<br>Number: K862983 |

### 8. 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 NeuroVasx Sub-Microinfusion Catheter.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 1999

Mr. Jeffrey A. Lee President/Chief Executive Officer NeuroVasx, Inc. 2355 Polaris Lane North, Suite 116 Plymouth, Minnesota 55447

Re: K984258

> Trade Name: Neuro Vasx Sub-Microinfusion Catheter Regulatory Class: II Product Code: JCY Dated: November 25, 1998 Received: November 30, 1998

Dear Mr. Lee:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) 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 comply with the GMP regulation 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. Jeffrey A. Lee

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 [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Sincerely yours,

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

Enclosure

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CONFIDENTIAL

## Indications for Use

The NeuroVasx Sub-Microinfusion Catheter is intended for the delivery of diagnostic agents into the neurovasculature.

K98425

Pacollo

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**Prescription Use**
(Per 21 CFR 801.109)