NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F

K070970 · Penumbra, Inc. · DQY · Aug 17, 2007 · Cardiovascular

Device Facts

• Record ID: K070970
• Device Name: NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F
• Applicant: Penumbra, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Neuron Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Device Story

Neuron Intracranial Access System consists of Neuron Delivery Catheter (outer, 6F proximal/5F distal) and Neuron Select Catheter (inner, 3.5F). Used by physicians in clinical settings to facilitate introduction of interventional devices into peripheral, coronary, and neuro vasculature. Delivery catheter functions with guidewire or inner select catheter. System provides access pathway for interventional procedures; aids in navigation to target vasculature. Benefits include improved access to complex vascular anatomy.

Clinical Evidence

Bench, in vitro, and in vivo testing performed on materials, components, subassemblies, and final assemblies. Devices met all specifications. No clinical trial data provided.

Technological Characteristics

Percutaneous catheter system. Materials are medical grade, biocompatible, and industry-standard. System includes outer delivery catheter (6F/5F) and inner select catheter (3.5F).

Indications for Use

Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. No specific patient population, age, or contraindications provided.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Penumbra Balloon Guide Catheter (K053491)
• Guider Softip Guiding Catheter XF 5F (K010853)

Submission Summary (Full Text)

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K070970 p 1 of 2

Image /page/0/Picture/1 description: The image shows the logo for Penumbra, Inc., a company that specializes in stroke intervention. The logo features the company name in a simple, sans-serif font, with a curved line above the name. The words "stroke intervention" are written in a smaller font below the company name. The logo is simple and modern, and it effectively communicates the company's focus on stroke intervention.

AUG 17 2007

## 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c)

### 510(k) Number

| Date Summary Prepared | April 4, 2007 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Neuron™ Intracranial Access System |
| Common Name | Percutaneous Catheter |
| Classification Name | Percutaneous Catheter<br>(21 CFR Part 870.1250; Product Code DQY) |
| Submitted By | Penumbra, Inc.<br>2401 Merced Street, Suite 200<br>San Leandro, CA 94577 |
| Contact | Theresa Brander-Allen<br>VP of Regulatory and Quality<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |

#### Predicate Devices

- Penumbra Balloon Guide Catheter (K053491), manufactured by Penumbra, Inc.

- Guider Softip Guiding Catheter XF 5F (K010853), manufactured by Boston Scientific Corporation

### Device Description

The Neuron Intracranial Access System has a Neuron Delivery Catheter (outer catheter), which is available with a diameter of 6F proximal and 5F distal, and a Neuron Select Catheter (inner catheter), which measures 3.5F and has multiple tip configurations. The Neuron Delivery Cather may be used with a guidewire or with the Neuron Select Catheters.

Materials used in the Neuron Intracranial Access System devices are manufactured from medical grade materials that are commonly used in the industry, are similar or identical to the predicate devices, and have historically been demonstrated to be both biocompatible and suitable for this use.

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Image /page/1/Picture/1 description: The image shows the logo for Penumbra, a stroke intervention company. The logo features the word "Penumbra" in a bold, sans-serif font, with the words "stroke intervention" in a smaller font below it. Above the word "Penumbra" is a curved line. The logo is simple and modern, and it effectively communicates the company's focus on stroke intervention.

#### Intended Use

The Neuron Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. The indication statement of the Neuron Intracranial Access System is substantially equivalent to the legally marketed predicate devices.

#### Substantial Equivalence

The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to the existing, legally marketed, predicate devices. Therefore, Penumbra believes the Neuron Intracranial Access System is substantially equivalent to the predicate devices.

#### Testing

Bench testing, in vitro testing, and in vivo testing have been performed on the device materials, components, subassemblies, and final assemblies. The devices tested acceptably met the specifications.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 7 2007

Penumbra, Inc. c\o Ms. Theresa Brandner-Allen VP of Regulatory and Quality 2401 Merced St, Suite 200 San Leandro, CA 94577

Re: K070970

Trade/Device Name: Neuron™ Intracranial Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: August 10, 2007 Received: August 13, 2007

Dear Ms. Brandner-Allen:

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 such 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 (OS) 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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Page 2 - Ms. Brandner-Allen

This letter will allow you to begin marketing your device as described in your Section 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.
QML

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for Penumbra, a stroke intervention company. The logo features the word "Penumbra" in a bold, sans-serif font, with the words "stroke intervention" in a smaller font underneath. Above the word "Penumbra" is a curved line. The logo is simple and modern, and it effectively communicates the company's focus on stroke intervention.

# Indications for Use

| 510(k) Number (if known): | K 070970 |
|---------------------------|----------|
|---------------------------|----------|

Device Name:

Neuron™ Intracranial Access System

Indications for Use:

The Neuron™ Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Prescription Use _X (Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

QQ Mall

sion Silah-Off ision of Cardiovascular Devices

Page of

K070970 510(k) Number

Neuron™ Intracranial Access System Traditional 510(k) 04Aprr07

CONFIDENTIAL