NEURON SELECT CATHETER SIZE 070

K083125 · Penumbra, Inc. · DQY · Nov 21, 2008 · Cardiovascular

Device Facts

• Record ID: K083125
• Device Name: NEURON SELECT CATHETER SIZE 070
• Applicant: Penumbra, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Nov 21, 2008
• Decision: SESE
• Submission Type: Special
• 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 Select Catheter is a percutaneous catheter used for intracranial access. It facilitates the introduction of interventional devices into peripheral, coronary, and neuro vasculature. The system includes various catheter sizes (053 and 070) and delivery catheters with multiple tip configurations. It is used by clinicians in a clinical setting to navigate the vasculature for interventional procedures. The device is a mechanical tool; it does not involve electronic processing, software, or automated decision-making. It functions as a conduit for other interventional equipment.

Clinical Evidence

Bench testing, in vitro testing, and in vivo testing were performed on device materials, components, subassemblies, and final assemblies. All tests met specifications.

Technological Characteristics

Percutaneous catheter; medical grade materials; multiple tip configurations; sizes include 053 (3.5F) and 070 (5F); delivery catheters taper from 6F to 5F or are 6F. No electronic components, software, or energy sources.

Indications for Use

Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. Prescription use only.

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

• Neuron Intracranial Access System (K070970)

Submission Summary (Full Text)

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### 510(k) Summary

NOV 2 ] 2008

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 | K083125 pg. 1of2 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Date Summary Prepared | October 21, 2008 |
| Trade Name | Neuron™ Select Catheter |
| Common Name | Percutaneous Catheter |
| Classification Name | Percutaneous Catheter<br>(21 CFR Part 870.1250; Product Code DQY) |
| Submitted By | Penumbra, Inc.<br>1351 Harbor Bay Parkway<br>Alameda, CA 94502 |
| Contact | Theresa Brander-Allen<br>VP of Regulatory and Quality<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |

#### Predicate Devices

Neuron Intracranial Access System (K070970), manufactured by Penumbra, Inc.

### Device Description

The Neuron Intracranial Access System has a Neuron Select Catheter 053 (predicate device), which is 3.5F and has multiple tip configurations, and a Neuron Select Catheter 070 (modified device) which is 5F and has multiple tip configurations. The Neuron Intracranial Access System also has a Neuron Delivery Catheter size 053, which tapers from 6F to 5F, and a Neuron Delivery Catheter 070, which is 6F.

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.

### 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

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pg. 2 of 2 K083125

# Penumbra

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 Select Catheter size 070 is substantially equivalent to the predicate device.

## Testing

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 2 1 2008

Penumbra, Inc. c/o Ms. Theresa Brandner-Allen, M.S., B.S.M.E. Vice President of Regulatory and Quality 1351 Harbor Bay Parkway Alameda, CA 94502

Re: K083125

> Trade/Device Name: Neuron™ Select Catheter Common Name: Catheter, Percutaneous Regulation Number: 21 CFR 870.1250 Regulatory Class: II Product Code: DQY Dated: October 21, 2008 Received: October 22, 2008

Dcar 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 (sce 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

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Page 2 - Ms. Brandner-Allen

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. 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's) 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,

Dana R. Lahner

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

Enclosure

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# Indications for Use

K083125

510(k) Number (if known):

Device Name:

Neuron™ Select Catheter, size 070

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)

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Duina R. la lmes

Division Sign-Off) Division of Cardiovascular Devices

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510(k) Number_1 083125

Neuron Select Catheter size 070 Special 510(k) 210ct08: Device Modification Page 9 of 54