PICA CATHETER

K093970 · Penumbra, Inc. · LIT · Jan 15, 2010 · Cardiovascular

Device Facts

• Record ID: K093970
• Device Name: PICA CATHETER
• Applicant: Penumbra, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Jan 15, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The PICA™ Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

Device Story

PICA Catheter is a variable stiffness, intravascular catheter; 0.056in outer diameter; 0.041in inner diameter. Features stainless steel coil-reinforced shaft; PTFE-lined lumen; hydrophilic coating; radiopaque distal markerband. Inserted via guide catheter or vascular sheath; provides access to target site; serves as reinforcing conduit for other intravascular devices. Used in clinical settings by physicians. Includes rotating hemostasis valve and tip shaping mandrel. Benefits patient by facilitating delivery of interventional devices to peripheral and neuro vasculature.

Clinical Evidence

Bench testing only. Biocompatibility testing conducted per ISO-10993-1 for external communicating devices contacting circulating blood. Physical, mechanical, and performance testing demonstrate safety and effectiveness.

Technological Characteristics

Variable stiffness catheter; stainless steel coil-reinforced shaft; PTFE-lined lumen; hydrophilic coating; radiopaque distal markerband. Dimensions: 0.056in OD, 0.041in ID. Provided sterile. Includes rotating hemostasis valve and tip shaping mandrel.

Indications for Use

Indicated for patients requiring the introduction of interventional devices into the peripheral and neuro vasculature.

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 Reperfusion Catheter (K072718 & K090752)
• Neuron™ Intracranial Access System (K070970, K082290 & K083125)

Submission Summary (Full Text)

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JAN 1 5 2010

PICA™ Catheter

### 10 510(K) SUMMARY

(as required by 21 CFR 807.92)

Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Penumbra Inc. is providing the summary of Substantial Equivalence for the PICA Catheter.

### 10.1 Sponsor/Applicant Name and Address

Penumbra Inc. 1351 Harbor Bay Parkway Alameda, CA 94502

### 10.2 Sponsor Contact Information

Seth A. Schulman Director, Regulatory Affairs Phone: [phone] FAX: [phone] email: [e-mail]

### . 10.3 Date of Preparation of 510(k) Summary

December 22, 2009

#### 10.4 Device Trade or Proprietary Name

PICA™ Catheter

### 10.5 Device Common/Usual or Classification Name

Catheter, Percutaneous (Product Code: DQY)

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Image /page/1/Picture/1 description: The image contains the word "Penumbra" in a bold, sans-serif font. Below the word "Penumbra" is the phrase "the path is clear" in a smaller, less bold font. To the right of the word "Penumbra" is a circular logo with a stylized letter "P" inside.

## 10.6 Identification of the Legally Marketed Devices to which Equivalence is Being Claimed:

| Name of Predicate Device | Name of Manufacturer<br>(Town, State) | 510(k) Number |
|-----------------------------------------|---------------------------------------|----------------------------------|
| Penumbra System Reperfusion<br>Catheter | Penumbra, Inc<br>Alameda, CA | K072718 &<br>K090752 |
| Neuron™ Intracranial Access<br>System | Penumbra, Inc<br>Alameda, CA | K070970,<br>K082290 &<br>K083125 |

### 10.7 Device Description:

The PICA Catheter is a variable stiffness catheter with an outer diameter of 0.056in, has a catheter shaft reinforced with a stainless steel coil, and has a radiopaque markerband on the distal end. It is available with an inner diameter of 0.041 in and in various lengths. The PICA Catheter has a PTFE-lined lumen, which is coil re-enforced, flexible, and hydrophilically coated. The PICA Catheter is inserted through a guide catheter or vascular sheath, provides access to the target site and once in place, provides a reinforcing conduit for other intravascular devices. The device is provided sterile and includes a rotating hemostasis valve and tip shaping mandrel. The PICA Catheter will be available in various configurations to allow physician ease of device tracking to the target site

### 10.8 Intended Use:

The PICA™ Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

### 10.9 Summary of Non-clinical Data:

Biocompatibility tests conducted for the PICA Catheter were selected in accordance with ISO-10993 -1 guidelines (Biological Evaluation of Medical Devices) for external communicating devices contacting circulating blood. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices.

Non-clinical testing found the PICA Catheter to be biocompatible and non-pyrogenic. The physical, mechanical and performance testing of the subject PICA Catheter demonstrate that the product is safe and effective for its labeled indications and is Substantially Equivalent to the currently marketed predicate devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

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

'JAN 1 5 2010

Re: K093970

Trade/Device Name: PICA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (2) Product Code: LIT, DQY Dated: December 22, 2009 Received: December 23, 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 I ou may , dierelevy manns of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability addition. Teasonote: US/122 as , that device labeling must be truthful and not misleading.

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 may of subject to additions, 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 or any I cochar battle and seeguirements, including, but not limited to: registration and listing (21

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Page 2 - Mr. Seth A. Schulman

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.

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/CDRH/CDRHOffices/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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Dma R. Vilmer

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. The word "Penumbra" is written in a bold, sans-serif font. Below the word "Penumbra" is the phrase "the path is clear" in a smaller, lighter font. To the right of the word "Penumbra" is a circular logo with a stylized "P" in the center.

PICA™ Catheter

# STATEMENT OF INDICATION FOR USE

Indications for Use.

510(k) Number (if known): Not Yet Assigned - K 0 9 3 9 7 0

Device Name: PICA™ Catheter

Indications for Use:

2

The PICA™ Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over The Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Vihner

(Division Sign-Off) Division of Cardiovascular Devices

EiO(k) Number_ K093970

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