PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054

K090752 · Penumbra, Inc. · NRY · Sep 21, 2009 · Cardiovascular

Device Facts

• Record ID: K090752
• Device Name: PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054
• Applicant: Penumbra, Inc.
• Product Code: NRY · Cardiovascular
• Decision Date: Sep 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (in the internal carotid, middle cerebral, and vertebral arteries) within 8 hours of symptom onset.

Device Story

Penumbra System consists of Penumbra Reperfusion Catheter 054, Penumbra Separator 054, and aspiration tubing; used with Penumbra Aspiration Pump. System designed for mechanical removal of thrombus in intracranial large vessel occlusive disease. Operated by physicians in clinical settings. Catheter inserted into vasculature to reach occlusion; separator used to assist in thrombus removal; aspiration pump provides vacuum to extract clot. Output is physical removal of thrombus; restores blood flow in ischemic stroke patients. Benefits include revascularization within 8-hour symptom onset window.

Clinical Evidence

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

Technological Characteristics

Medical grade materials; biocompatible. Percutaneous catheter design. System includes aspiration pump, tubing, reperfusion catheter, and separator. Standalone mechanical system.

Indications for Use

Indicated for patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (internal carotid, middle cerebral M1/M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.

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 System™ (K090752)
• Neuron™ Intracranial Access System (K090752)

Submission Summary (Full Text)

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SEP 2 1 2009

# Penumbra

#### 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

K090752

March 19, 2009

Date Summary Prepared

Trade Name 054

Common Name

Classification Name

Submitted By

Contact

Percutaneous Catheter

Percutaneous Catheter (21 CFR Part 870, 1250; Product Code NRY)

Penumbra Reperfusion Catheter 054 and Penumbra

Separator

Penumbra, Inc. 1351 Harbor Bay Parkway Alameda, CA 94502

Louise Musante Regulatory Specialist Tel: [phone] [e-mail]

(Alternate Contact)

Theresa Brandner-Allen VP of Regulatory Tel: [phone] Fax: [phone] [e-mail]

#### Predicate Devices

Penumbra System™ and Neuron™ Intracranial Access System, manufactured by Penumbra, Inc.

Device Description

Dovice Doceription
The Penumbra System™ consists of three devices that work as a system to remove thrombus including the Penumbra Reperfusion Catheter, Penumbra Separator and Aspiration Tubing. The Penumbra System is used with the Penumbra Aspiration Pump.

Materials used in the Penumbra 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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#### Intended Use

The Penumbra System is intended for use in the revascularization of patients with acute ischemic 1116 I chumora Dyoren is moial large vessel occlusive disease (in the internal carotid, middle stroke secondary to miractural large ar, and vertebral arteries) within 8 hours of symptom onset.

#### Substantial Equivalence

Substantial Equivations
The intended use, methods of operation, methods of construction, and materials used are either identical or substantially equivalent to the existing, legally marketed, predicate devices. IChical of Substantially equires that the Penumbra Reperfusion Catheter 054 and Penumbra Separator 054 are substantially equivalent to the predicate devices.

#### Testing

I esting, in vitro testing, and in vivo testing have been performed on the device materials, Denen resting, in Thi b teenig af tinal assemblies. The devices tested acceptably met the specifications.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes on its wing, representing the three levels of government: federal, state, and local. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

SEP 2 1 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Penumbra, Inc. c/o Seth Schulman Director, Regulatory Affairs 1351 Harbor Bay Parkway Alameda, CA 94502

Re: K090752

· Trade/Device Name: Penumbra Reperfusion Catheter 054, Penumbra Separator 054 Regulation Number: 21 CFR 870.1250

Regulation Name: Percutaneous Catheter

Regulatory Class: II

Product Code: NRY

Dated: September 1, 2009

Received: September 2, 2009

Dear Mr. Schulman:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 vours.

Emile Thormer Jr.

Malvina B. Eydelman, M.L Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

#### 510(k) Number (if known): K090752

Device Name:

Indications for Use:

Penumbra Reperfusion Catheter 054, Penumbra Separator 054

The Penumbra System™ is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral -- M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.

Prescription Use _ X (Per 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)
Kristen Bowsher

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

K090752 510(k) Number_