PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F

K053491 · Penumbra, Inc. · DQY · Apr 27, 2006 · Cardiovascular

Device Facts

• Record ID: K053491
• Device Name: PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F
• Applicant: Penumbra, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Apr 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Penumbra Balloon Guide Catheter is indicated for temporary occlusion of blood flow and to serve as a conduit for devices used in the neurovasculature.

Device Story

Coaxial-lumen, braid-reinforced, variable stiffness catheter; features distal semi-compliant balloon and radiopaque markerband; proximal bifurcated Luer hub. Used in neurovasculature to temporarily occlude blood flow and provide conduit for vascular devices. Operated by physicians in clinical settings. Balloon inflation allows flow control; catheter lumen facilitates device passage. Benefits include improved access and flow management during neurovascular procedures.

Clinical Evidence

Bench testing, in vitro testing, and in vivo testing performed on materials, components, subassemblies, and final assemblies. Devices met all specifications.

Technological Characteristics

Coaxial-lumen, braid-reinforced catheter; variable stiffness; semi-compliant distal balloon; radiopaque markerband; bifurcated Luer hub. Medical grade materials consistent with industry standards for biocompatibility.

Indications for Use

Indicated for temporary occlusion of blood flow and as a conduit for neurovascular devices in patients requiring neurovascular intervention.

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

• Concentric Balloon Guide Catheter (K021899)

Submission Summary (Full Text)

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Penumbra

## 510(k) Summary

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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 | K053491 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------|
| Date Summary Prepared | April 20, 2006 |
| Trade Name | Penumbra Balloon Guide Catheter |
| Common Name | Balloon Guide Catheter |
| Classification Name | Percutaneous Catheter, Balloon Type Catheter<br>(21 CFR Part 870.1250, 21CFR 878.4200; Product<br>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 Device Concentric Balloon Guide Catheter (K021899) Manufactured by Concentric Medical, Inc.

#### Device Description

The Penumbra Balloon Guide Catheter is a coaxial-lumen, braid-reinforced, variable stiffness catheter with a radiopaque markerband on the distal end and bifurcated Luer hub on the proximal end. A semi-compliant balloon is flush mounted on the distal end. During use, the balloon may be inflated to temporarily occlude blood flow, and the catheter lumen may be used to provide a conduit for passage of vascular devices. The design combines the features of a guide catheter with the features of a semi-compliant balloon catheter.

Materials used in the Penumbra Balloon Guide Catheter are manufactured from medical grade materials that are commonly used in the industry, are similar or identical to the predicate device, and have historically been demonstrated to be both biocompatible and suitable for this use.

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#### Intended Use

The Penumbra Balloon Guide Cathcter is indicated for temporary occlusion of blood flow and to serve as a conduit for devices used in the neurovasculature. The indication statement of the Penumbra Balloon Guide Catheter is substantially equivalent to the legally marketed predicate device.

## 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 device. Therefore, Penumbra believes the Penumbra Balloon Guide Catheter 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Penumbra, Inc. c/o Ms. Theresa Brandner-Allen VP of Regulatory and Quality 2401 Merced Street - Suite 200 San Leandro, California 94577

Re: K053491

Trade/Device Name: Penumbra Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: DOY Dated: March 29, 2006 Received: March 30, 2006

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 r, 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,
Mark H. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K053491

Device Name:

Penumbra Balloon Guide Catheter

Indications for Use:

The Penumbra Balloon Guide Catheter is indicated for temporary occlusion of blood flow and to serve as a conduit for devices used in the neurovasculature.

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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