The Concentric 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.

Device Description

The Concentric Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters 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. If indicated on product label, a dilator is provided.

AI/ML Overview

The provided document describes a 510(k) submission for the Concentric Balloon Guide Catheter, focusing on its substantial equivalence to a predicate device and a minor modification to its indications for use. As such, the document does NOT contain information about a study proving device performance against acceptance criteria in the context of AI/ML or diagnostic accuracy, but rather verification testing for the physical device.

Therefore, many of the requested fields cannot be populated from the provided text.

Here's the information that can be extracted or deduced from the document regarding the device's acceptance criteria and the verification testing performed:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Test Performed)	Reported Device Performance
Tensile Testing	Meets predetermined specifications (remains applicable from predicate device)
Leak Testing	Meets predetermined specifications (remains applicable from predicate device)
Dimensional Testing	Meets predetermined specifications (remains applicable from predicate device)
Torque Testing	Meets predetermined specifications (remains applicable from predicate device)
Kink Resistance	Meets predetermined specifications (remains applicable from predicate device)
Simulated Use	Meets predetermined specifications (remains applicable from predicate device)
Biocompatibility Testing	Meets predetermined specifications (remains applicable from predicate device). Additionally, for new colorant: - Hemolysis, Direct Contact Method: Successfully performed - Hemolysis, Extract Method: Successfully performed - Cytotoxicity - ISO MEM Elution: Successfully performed
Balloon Fatigue	Meets predetermined specifications (remains applicable from predicate device)
Inflation/Deflation Testing	Meets predetermined specifications (remains applicable from predicate device)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for these verification tests.
The data provenance is not specified beyond being part of a 510(k) submission to the FDA (USA). The tests are verification tests for a physical device, not a study involving human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a study involving diagnostic accuracy or human interpretation. The "ground truth" for the physical device tests would be established by engineering specifications and objective measurements.

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

Not applicable. This concept is relevant for studies involving human interpretation and consensus establishment, not for objective physical device testing.

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

No. This is a 510(k) submission for a physical medical device (catheter) and does not involve AI or human readers for diagnostic interpretation.

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

No. This is not an AI/ML algorithm or software device.

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

For the physical tests, the "ground truth" is based on predetermined engineering specifications and objective measurements for mechanical and biological properties (e.g., tensile strength, leak rates, dimensional tolerances, biocompatibility standards).

8. The sample size for the training set

Not applicable. This is not a machine learning model.

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

Not applicable. This is not a machine learning model.

Summary

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KJ2404

510(K) Summary

General Information

Trade NameCommon NameClassification	Concentric Balloon Guide CatheterPercutaneous CatheterPercutaneous Catheter, 21CFR 870.1250 - Class II
Owner	Concentric® Medical, Inc.301 E. Evelyn AvenueMountain View, CA 94041Tel 650-938-2100Fax 650-938-2700
Contact	Kirsten ValleySenior Vice President, Technology and Regulatory Affairs
Date Prepared	August 4, 2011

Predicate Device

Concentric Balloon Guide Catheters (K102657)

Device Description

Indications for Use

The modified Indications for Use are as follows:

The modification to the indications does not impact the intended therapeutic use of the device. As a result, the safety and effectiveness of the device are not impacted when used as indicated.

Technological Characteristics

The Concentric Balloon Guide Catheter has the same technological characteristics as the predicate device. A colorant has been added to the dilator. Apart from this minor modification, the device design, materials used, function, physical properties and composition have not been changed.

Testing Summary

The same performance standards and specifications as those previously submitted in the predicate device 510(k) submission are applicable. No additional verification testing was required for

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the change to the indications statement requested in this submission. The results of verification and validation conducted on the predicate device remain applicable. Specifically, the device meets the predetermined specifications for the following tests:

Tensile Testing .
. Leak Testing
. Dimensional Testing
. Torque Testing
Kink Resistance
. Simulated Use
. Biocompatibility Testing
. Balloon Fatique
. Inflation/Deflation Testing

To confirm the biocompatibility of the new colorant, the following testing was successfully performed:

Hemolysis, Direct Contact Method ●
Hemolysis, Extract Method ●
. Cytotoxicity - ISO MEM Elution

Based on conformance with these test requirements, the Concentric Balloon Guide Catheter is as safe and effective as the legally marketed predicate device.

Summary of Substantial Equivalence

The Concentric Balloon Guide Catheters are substantially equivalent to the predicate device with regard to device design, intended use, and patient population.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three parallel lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.

Public Health Service

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

Concentric Medical, Inc. c/o Regulatory Technology Services, LLC Mr. Mark Job Responsible Third Party Official 1394 25th Street NW Buffalo, MN 55313

Re: K112404

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: February 28, 2012 Received: February 29, 2012

Dear Mr. Job:

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.

MAR 1 5 2012

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Page 2 - Mr. Mark Job

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 (OS) 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Malvina B. Eydelman, M.D. 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: STATEMENT

INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

Indications for Use:

K112404

Concentric Balloon Guide Catheter

Prescription Use _ X_ (Per 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)

Quyñ Hoang

(Division Sign-Off)

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

510(k) Number K112404

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).