NEURON DELIVERY CATHETER 070

K082290 · Penumbra, Inc. · DQY · Oct 31, 2008 · Cardiovascular

Device Facts

• Record ID: K082290
• Device Name: NEURON DELIVERY CATHETER 070
• Applicant: Penumbra, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Oct 31, 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

The Neuron Delivery Catheter is a percutaneous catheter used to facilitate the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. The device is a modification of the existing Neuron Intracranial Access System, specifically increasing the inner diameter from 0.053in to 0.070in. It is used by clinicians in a clinical setting to provide access for other interventional tools. The device is constructed from medical-grade materials similar to those used in the predicate device, ensuring biocompatibility and suitability for its intended vascular access function.

Clinical Evidence

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

Technological Characteristics

Percutaneous catheter; inner diameter 0.070in; medical-grade materials consistent with industry standards and predicate devices; biocompatible.

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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# OCT 3 1 2008

### 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 | K082290 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Date Summary Prepared | August 07, 2008 |
| Trade Name | Neuron™ Delivery 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 Delivery Catheter size 053 (predicate device), which is available with an inner diameter of 0.053in, and a Neuron Delivery Catheter 070 (modified device), which is available with an inner diameter of 0.070in. The Neuron Intracranial Access System also has a Neuron Select Catheter (used with predicate device), which measures 3.5F and has multiple tip configurations.

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

#### 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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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 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: K082290

> Trade/Device Name: Neuron™ Delivery Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: II Product Code: DQY Dated: September 25, 2008 Received: September 30, 2008

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

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#### Page 2 – Ms. Theresa 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 CDRI's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding 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,

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

Enclosure

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## Indications for Use

510(k) Number (if known): KOB229C

| Device Name: | NeuronTM Delivery Catheter, size 070 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The NeuronTM Intracranial Access System is indicated<br>for the introduction of interventional devices into the<br>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)

| Division Sign-Off | |
|------------------------------------|---------|
| Division of Cardiovascular Devices | |
| 510(k) Number | k082250 |

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