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 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.

AI/ML Overview

This is a 510(k) summary for a medical device (Penumbra Balloon Guide Catheter), not a study analyzing AI/ML device performance. Therefore, most of the requested information (acceptance criteria, study design, expert involvement, etc.) typical for AI/ML device evaluations is not present in this document.

The document states that the Penumbra Balloon Guide Catheter is substantially equivalent to a predicate device (Concentric Balloon Guide Catheter, K021899). Substantial equivalence is the primary acceptance criterion in these types of submissions, rather than specific performance metrics against a defined dataset.

Here's what can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion	Reported Device Performance
Substantial Equivalence to Predicate Device (Concentric Balloon Guide Catheter K021899)	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.
Bench Testing	Devices tested acceptably met the specifications.
In vitro Testing	Devices tested acceptably met the specifications.
In vivo Testing	Devices tested acceptably met the specifications.
Biocompatibility	Materials are commonly used, similar or identical to predicate device, and historically demonstrated to be biocompatible and suitable for this use.

2. Sample size used for the test set and the data provenance:

Not applicable. This document describes a traditional medical device (catheter) submission, not an AI/ML device requiring a test set for performance evaluation against a dataset. The "testing" mentioned refers to engineering and preclinical validation of the physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth establishment by experts for an AI/ML test set is not part of this device submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. The "ground truth" for this type of device is its physical and functional performance according to established engineering and medical device standards, and its equivalence to a predicate device.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/ML device.

Summary of the Study/Testing that Proves the Device Meets Acceptance Criteria:

The document states that "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."

The primary "study" for this submission is implicitly the demonstration of substantial equivalence to the predicate Concentric Balloon Guide Catheter (K021899). This means that Penumbra presented data (likely from the aforementioned bench, in vitro, and in vivo tests) to show that their device is as safe and effective as the predicate device for its intended use. The FDA's letter confirms that they have reviewed the submission and determined that the device is substantially equivalent.

Without the specific test reports from the bench, in vitro, and in vivo testing, the detailed methodology and results of these tests cannot be described further. However, the FDA's clearance indicates that these tests were deemed sufficient to support the claim of substantial equivalence.

Summary

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K053491

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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(21 CFR Part 870.1250, 21CFR 878.4200; ProductCode DQY)
Submitted By	Penumbra, Inc.2401 Merced Street, Suite 200San Leandro, CA 94577
Contact	Theresa Brander-AllenVP of Regulatory and QualityTel: 510-618-3223Fax: 510-352-1766tballen@penumbrainc.com

Predicate Device Concentric Balloon Guide Catheter (K021899) Manufactured by Concentric Medical, Inc.

Device Description

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K053491

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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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined strands and a bird-like figure at the top. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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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Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).