The Modified Concentric Microcatheter is indicated for use in the selective placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures.

Device Description

The Modified Concentric Microcatheter is a single lumen, braided, variable stiffness catheter designed for use in the selective placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures. A luer hub on the proximal end of the shaft enables connection to the rotating hemostasis valve included in the package. The radiopaque shaft and distal marker facilitate fluoroscopic visualization. The catheter shaft is coated with a hydrophilic coating to reduce friction during use.

AI/ML Overview

Here's an analysis of the provided text regarding the Modified Concentric Microcatheter, focusing on acceptance criteria and the study proving it:

Summary of Device and Regulatory Status:

The Modified Concentric Microcatheter is a Class II diagnostic intravascular catheter (21 CFR 870.1200) seeking 510(k) clearance. Its intended use is for selective placement of fluids, devices, or agents in peripheral, coronary, and neuro vasculature during diagnostic/therapeutic procedures. The submitter claims substantial equivalence to the Concentric Microcatheter (K091961) based on identical technological characteristics (design, materials, function, physical properties, composition).

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Functional Tests
Kink Resistance	Device should sufficiently resist kinking when flexed.	"the device's ability to withstand kinking when flexed was successfully evaluated."
Leak Resistance	Device should prevent leaks during high pressure and vacuum.	"the device's leak resistance when subjected to both high pressure and vacuum was successfully evaluated."
Flexibility Testing	Device should be able to navigate tight bends.	"the device's ability to navigate tight bends was successfully evaluated."
Flow Testing	Device should allow for adequate infusion of fluids.	"the device's ability to infuse fluids was successfully evaluated."
Tensile Testing	Device should maintain mechanical integrity under tensile loads.	"the device's mechanical integrity under tensile loads was successfully evaluated."
Torque Testing	Device should maintain mechanical integrity when subjected to torsion.	"the device's mechanical integrity when subjected to torsion was successfully evaluated."
Biocompatibility	Must meet established biocompatibility standards.	"the following biocompatibility tests were leveraged" (from predicate device): Hemocompatibility/Coagulation, Cytotoxicity, Systemic Toxicity, Hematocompatibility/Hematology, Sensitization, Irritation/Intracutaneous Reactivity, Pyrogen/Systemic Toxicity.

Note on Acceptance Criteria: The provided document does not explicitly state quantitative acceptance criteria (e.g., "kink resistance must exceed X Newtons" or "leakage must be less than Y mL/min"). Instead, it uses qualitative terms like "successfully evaluated" or "demonstrate that it performs as designed." This is common in 510(k) summaries where the focus is on demonstrating equivalence to a predicate device, implying that the acceptance criteria are met if the new device performs comparably to the predicate device, which has already established safety and efficacy.

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

Sample Size: The document does not explicitly state the sample size used for any of the tests (e.g., how many catheters were tested for kink resistance).
Data Provenance: The data provenance for the functional tests is implied to be from the manufacturer's internal testing ("results of verification and validation conducted on the Modified Concentric Microcatheter"). For biocompatibility, it states that tests were "leveraged" from the predicate device, meaning they relied on existing data for the same materials previously approved. The country of origin and whether the data is retrospective or prospective are not specified.

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

This information is not applicable (N/A) to this specific submission. This document describes a 510(k) submission for a medical device (catheter), not an AI/Software as a Medical Device (SaMD). The tests are physical and material-based, not diagnostic accuracy assessments relying on expert interpretations or ground truth.

4. Adjudication Method for the Test Set

This information is not applicable (N/A) for the same reasons as above. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data (e.g., images) by human readers where there might be disagreement, which is not the case for device performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable (N/A). This is a medical device (catheter) submission, not an AI/SaMD submission. No MRMC study was conducted, and there is no AI component or human reader assistance involved.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable (N/A). This is a medical device (catheter) submission. There is no algorithm or software being tested in a standalone capacity.

7. The Type of Ground Truth Used

The "ground truth" for the functional tests is the objective physical performance of the catheter according to engineering standards and specifications. For biocompatibility, the ground truth is established by validated biological test methods and accepted safety standards, leveraging previous test results for identical materials. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense applied to diagnostic or prognostic devices.

8. The Sample Size for the Training Set

This information is not applicable (N/A). This is a medical device (catheter) submission, not an AI/machine learning product. Therefore, there is no "training set" in the context of data used to train an algorithm.

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

This information is not applicable (N/A) for the same reasons as above. There is no training set or associated ground truth for an algorithm in this device submission.

Summary

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510(k) Summary

Trade Name:	Modified Concentric Microcatheter
Common Name:	Diagnostic Intravascular Catheter
Classification Name:	Diagnostic Intravascular Catheter, 21CFR 870.1200 – Class II
Submitter	Concentric® Medical, Inc.301 E. Evelyn AvenueMountain View, CA 94041Tel 650-938-2100Fax 650-237-5230Facility Registration #2954917Contact: Kirsten Valley, Senior Vice President, Technology and Regulatory Affairs
Predicate Device	Concentric Microcatheter (K091961)

Device Description

Intended Use

Technological Characteristics

The Modified Concentric Microcatheter has the same technological characteristics as the K091961 predicate device. The device design, materials used, function, physical properties and composition have not been changed.

Testing Summary

The results of verification and validation conducted on the Modified Concentric Microcatheter 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:

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. Kink Resistance - the device's ability to withstand kinking when flexed was successfully evaluated.
. Leak Resistance – the device's leak resistance when subjected to both high pressure and vacuum was successfully evaluated.
. Flexibility Testing - the device's ability to navigate tight bends was successfully evaluated.
. Flow Testing - the device's ability to infuse fluids was succesfully evaluated.
. Tensile Testing - the device's mechanical integrity under tensile loads was successfully evaluated.
. Torque Testing - the device's mechanical integrity when subjected to torsion was successfully evaluated.

The materials on the Modified Concentric Microcatheter are the same as the predicate device. As a result, the following biocompatibility tests were leveraged.

. Hemocompatibilty/Coagulation
. Cytotoxicity
Systemic Toxicity .
Hemocompatibility/Hematology .
. Sensitization
Irritation/Intracutaneous Reactivity .
. Pyrogen/Sytem.Toxicity

Summary of Substantial Equivalence

The Modified Concentric Microcatheter is substantially equivalent to the predicate device with regard to device design, intended use, and patient population. The results of verification and validation conducted on the Modified Concentric Microcatheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device.

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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 with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

Concentric Medical, Inc. c/o Ms. Kristen Valley Senior Vice President, Technology and Regulatory Affairs 301 E. Evelyn Avenue Mountain View, CA 94041

JUL - 6 2011

Re: KI11619

Trade/Device Name: Modified Concentric Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Catheter, Intravascular, Diagnostic Regulatory Class: Class II Product Code: DQO Dated: June 9, 2011 Received: June 10, 2011

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. Iisting 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.

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

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Page 2 – Ms. Kristen Valley

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/ReportalProblem/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 yours,

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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Statement of Indications for Use

INDICATIONS FOR USE

510(k) Number (if known):	This application K111619
Device Name:	Modified Concentric Microcatheter
Indications for Use:	The Modified Concentric Microcatheter isindicated for use in the selective placement offluids and/or other devices or agents into theperipheral, coronary and neuro vasculatureduring diagnostic and/or therapeuticprocedures.

Prescription Use __X (Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_X (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)
(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number_(SII) 61) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).