The Concentric Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices.

Device Description

Like the predicate device, the Modified Balloon Guide Catheter is a coaxial-lumen, braid-reinforced, variable stiffness catheter designed for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. A radiopaque marker is included on the distal end for angiographic visualization. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. A bifurcated luer hub on the proximal end allows attachments for flushing, inflation and aspiration. Balloon Guide Catheter dimensions and maximum recommended balloon inflation volume are indicated on product label.

AI/ML Overview

This document describes a 510(k) submission for a Modified Balloon Guide Catheter (K122581) which claims substantial equivalence to a predicate device (K112404). This is a medical device submission, not an AI/ML product. Therefore, many of the requested criteria related to AI/ML device evaluation frameworks (e.g., sample size for test set, data provenance, ground truth establishment, MRMC studies, standalone algorithm performance, training set details) are not applicable to this submission.

The evaluation of this catheter focuses on its mechanical, functional, and biocompatibility performance to ensure it is as safe and effective as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Specific Test	Acceptance Criteria	Reported Device Performance
Functional/Performance	Simulated Use Testing	Device and accessories can be used per procedural instructions in a neurovascular model.	Successfully evaluated.
	Balloon Symmetry and Compliance	Balloon demonstrates appropriate symmetry and compliance.	Successfully evaluated.
	Balloon Inflation and Deflation	Balloon inflates and deflates effectively.	Successfully evaluated.
	Balloon Fatigue Strength	Balloon withstands specified fatigue without failure.	Successfully evaluated.
	Constrained Balloon Burst and Leakage	Balloon resists bursting and leakage under constrained conditions.	Successfully evaluated.
	Tensile Testing	Device maintains mechanical integrity under specified tensile loads.	Successfully evaluated.
	Tip Deflection Force Testing	Distal tip deflects within specified force parameters.	Successfully evaluated.
	Torque Transmission Testing	Torque transmission ratio is within acceptable limits.	Successfully evaluated.
	Leak Testing	Device resists leaking during use.	Successfully evaluated.
	Kink Resistance	Device shaft resists kinking under specified conditions.	Successfully evaluated.
	Dilator Shape Retention	Dilator tip retains its shape.	Successfully evaluated.
	Peel Strength (for Peel-Away Sheath)	Force required to peel the Peel-Away Sheath is within acceptable limits.	Successfully evaluated.
Biocompatibility	Sensitization/Maximization	No significant sensitization or allergic reactions.	Results met pre-determined acceptance criteria.
	Cytotoxicity	No significant cytotoxic effects on cells.	Results met pre-determined acceptance criteria.
	Intracutaneous Reactivity	No significant intracutaneous reactions.	Results met pre-determined acceptance criteria.
	Systemic Toxicity/Systemic Injection Test	No significant systemic toxicity from injected extracts.	Results met pre-determined acceptance criteria.
	Systemic Toxicity/Rabbit Pyrogen Test	No significant pyrogenic response in rabbits.	Results met pre-determined acceptance criteria.
	Hemocompatibility/Hemolysis	No significant hemolysis (red blood cell destruction).	Results met pre-determined acceptance criteria.
	Hemocompatibility/Complement Activation	No significant complement activation.	Results met pre-determined acceptance criteria.
	Hemocompatibility/in vivo Thrombogenicity	No significant thrombogenic response in vivo.	Results met pre-determined acceptance criteria.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is a series of verification and validation (V&V) tests performed on the Modified Balloon Guide Catheter and its accessories. These tests were conducted by Concentric Medical, Inc. (the submitter). The summary states that "The results of verification and validation conducted on the Modified Balloon Guide Catheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: This information is not provided in the given text. For medical device V&V testing, sample sizes are typically determined based on statistical rationale for each specific test (e.g., number of units tested for tensile strength, number of balloons for burst pressure). The general statement "successfully evaluated" implies that sufficient units were tested to meet the predetermined acceptance criteria.
Data Provenance: The data originates from internal testing conducted by Concentric Medical, Inc., for their 510(k) submission to the FDA. The nature of these tests (e.g., mechanical, functional, biocompatibility) implies they are prospective in relation to the submission, as they were specifically carried out to support the device's clearance. Country of origin of data is implicitly the USA, where the company is based, although the specific test labs are not detailed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable as there is no "ground truth" in the context of expert review for diagnostic imaging or similar AI/ML applications. The "truth" for this physical device is established by objective, measurable engineering and biological test standards and protocols. For example, for tensile testing, the "ground truth" is a certain force in Newtons, not a diagnostic interpretation by an expert.

4. Adjudication Method for the Test Set

This question is not applicable as there is no need for expert adjudication in the context of physical medical device performance testing as described. The tests have objective pass/fail criteria.

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

This question is not applicable. This is a physical medical device (catheter), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant.

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

This question is not applicable. This is a physical medical device, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for this medical device is established by:

Engineering Specifications: Predetermined performance targets and specifications (e.g., maximum deflection force, torque transmission ratio, peel strength values).
Established Test Standards: Compliance with recognized international or national standards for medical device testing (e.g., ISO standards for biocompatibility).
Predicate Device Performance: Performance data from the legally marketed predicate device (K112404) often serves as a benchmark for substantial equivalence, implying that the modified device must perform at least as well as the predicate for critical characteristics.
Biological/Chemical Standards: For biocompatibility, established thresholds for toxicity, sensitization, hemolysis, etc. are the "ground truth."

8. The Sample Size for the Training Set

This question is not applicable. This is a physical medical device; there is no "training set" in the context of AI/ML model development.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as above.

Summary

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K122581.

510(k) Summary

Trade Name:	Modified Balloon Guide Catheter			NOV 21 2012
Common Name:	Percutaneous Catheter
Classification Name:	Percutaneous Catheter, 21CFR 870.1250 Class II
Submitter:	Concentric Medical, Inc.301 E. Evelyn AvenueMountain View, CA 94041Tel 650-938-2100Fax 650-237-5230Facility Registration #2954917
Contact:	Christina RoweManager, Regulatory Affairs
Date Prepared:	November 16, 2012
Predicate Device:	Concentric Balloon Guide Catheter (K112404)

Device Description

Indications for Use

The Indications for Use are the identical to that of the predicate device and are as follows:

The Modified Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.

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Technological Characteristics

The Modified Balloon Guide Catheters have the same technological characteristics as the predicate device. Minor modifications have been made to the device materials and design which were successfully evaluated during verification and validation testing.

Testing Summary

The results of verification and validation conducted on the Modified Balloon Guide Catheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device. Specifically, the following tests were performed on the proposed device and accessories:

Simulated Use Testing: the ability of the device and accessories to be used per procedural . instructions outlined in the Instructions for Use in a neurovascular model was successfully evaluated.
Balloon Testing: the symmetry and compliance of the distal balloon; balloon inflation and . deflation; balloon fatigue strength; constrained balloon burst and leakage were successfully evaluated.
Tensile Testing: the mechanical integrity of the device under tensile loads was successfully . evaluated.
Tip Deflection Force Testing: the force to deflect the distal tip of the device was successfully . evaluated.
Torque Transmission Testing: the torque transmission ratio was successfully evaluated. .
Leak Testing: the device resistance to leaking during use was successfully evaluated. .
Kink Resistance: the ability of the device shaft to resist kinking was successfully evaluated. A .
Dilator Shape Retention: the shape retention of the dilator tip was successfully evaluated. .
Peel Strength: the force to peel the Peel-Away Sheath was successfully evaluated. .

The following biocompatibility tests were performed on the device including the dilator; results for all tests met the pre-determined acceptance criteria.

Sensitization/Maximization ●
Cytotoxicity .
Intracutaenous Reactivity .
Systemic Toxicity/Systemic Injection Test .
. Systemic Toxicity/Rabbit Pyrogen Test
Hemocompatibility/Hemolysis .
Hemocompatibility/Complement Activation .
Hemocompatibility/in vivo Thrombogenicity

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Summary of Substantial Equivalence

The Modified Balloon Guide Catheter is substantially equivalent to the predicate device with regard to device design, intended use, and patient population. The conclusions drawn from the verification and validation testing conducted using the Modified Balloon Guide Catheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the legally marketed device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings or feathers. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the top and left side of the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 21, 2012

Concentric Medical, Inc. c/o Ms. Kirsten Valley Manager of Regulatory Affairs 301 East Evelyn Ave. Mountain View, CA 94041

Re: K122581

Trade/Device Name: Concentric Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: October 9, 2012 Received: October 10, 2012

Dear Ms. Valley:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, 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 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.

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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.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Joyce M. Whang

for

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K122581

Device Name: Concentric Balloon Guide Catheter

Indications For Use:

Prescription Use XX : (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joyce M. Whang

(Division Sign Off)

Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number K122581

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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).