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 line extension to the existing Concentric Microcatheter, cleared under K113260. Like the predicate device, the Modified Concentric Microcather is a single-lumen, braided shaft, 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. The Modified Concentric Microcatheter differs from its predicate in that it has smaller shaft diameters and a longer effective shaft length. Device dimensions and configuration are shown on the product label. A rotating hemostasis valve with side-arm adapter is provided with each microcatheter.

AI/ML Overview

The provided submission describes a medical device, the "Modified Concentric Microcatheter," which is a line extension to an existing product. The submission focuses on demonstrating substantial equivalence to the predicate device rather than presenting a de novo study with acceptance criteria for a new AI/software device. Therefore, many of the requested categories related to AI/software performance evaluation (e.g., effect size with human readers, standalone performance, ground truth establishment for training) are not applicable to this document.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study, tailored to the context of a medical device submission demonstrating substantial equivalence:

1. A table of acceptance criteria and the reported device performance

The submission does not explicitly list quantitative acceptance criteria in a tabular format with corresponding performance metrics for the Modified Concentric Microcatheter. Instead, it describes various tests and states that the device successfully met the evaluation for each. The acceptance criteria generally seem to be "successful evaluation" or "meets its intended use" for each test. The performance is reported qualitatively as "successfully evaluated."

Acceptance Criteria (Implied)	Reported Device Performance
Withstand kinking when flexed	Kink Resistance: successfully evaluated
Withstand leak when subjected to both high pressure and vacuum	Leak Resistance: successfully evaluated
Navigate tight bends	Flexibility Testing: successfully evaluated
Maintain mechanical integrity under tensile loads	Tensile Testing: successfully evaluated
Maintain mechanical integrity when subjected to torsion	Torque Testing: successfully evaluated
Durability and lubricity of the device coating	Coating Testing: successfully evaluated
Satisfactory dimensions (as verified)	Dimensional verification testing: performed
Visibility under fluoroscopy	Radiopacity Testing: successfully evaluated
Meets intended use (in a simulated environment)	Design Validation Simulated Use Testing: successfully evaluated
Biocompatibility (relying on predicate device data)	Biocompatibility: met pre-determined acceptance criteria
Sterilization (relying on predicate device data)	Sterilization: met pre-determined acceptance criteria

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 explicitly state the sample sizes (number of devices or tests performed) for each specific test. It simply mentions that tests were "performed" or "evaluated."

For the Design Validation Simulated Use Testing, it states "testing was performed in a porcine model." This indicates the use of an ex vivo or in vivo animal model. Data provenance is implied to be from internal testing by Concentric Medical, Inc. The timing of testing is prospective to the submission.

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)

This section is not applicable as the submission is for a medical device (microcatheter) and not an AI/software device requiring expert interpretation for ground truth. The "ground truth" for this device relates to its physical and functional performance, which is assessed through engineering and simulated-use testing.

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

This is not applicable as the testing described pertains to the physical and mechanical properties of a microcatheter, not to the interpretation of images or data that would necessitate an adjudication method among experts.

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 is not applicable. The device is an intravascular catheter, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader performance with AI assistance is irrelevant to this submission.

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

This is not applicable as the device is a physical medical instrument and does not involve an algorithm.

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

The "ground truth" for this device's performance is established through:

Engineering specifications and standards: For physical and mechanical properties (kink resistance, leak resistance, flexibility, tensile strength, torque, coating).
Dimensional measurements: For shaft diameters and length.
Fluoroscopic visibility standards: For radiopacity.
Functional assessment in a simulated environment: In the porcine model to confirm intended use.

There is no "expert consensus" or "pathology" in the diagnostic sense, nor is there "outcomes data" presented in this 510(k) summary, as it's a pre-market submission focused on substantial equivalence.

8. The sample size for the training set

This is not applicable as the device is a physical medical instrument and does not involve AI or machine learning algorithms that require a training set.

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

This is not applicable for the same reason as point 8.

Summary

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Concentric Medical, Inc. Traditional 510(k) Submission, K131437

5. 510(k) Summary

Trade Name:	Modified Concentric Microcatheter
Common Name:	Diagnostic Intravascular Catheter
Classification Name:	Diagnostic Intravascular Catheter, 21CFR 870.1200 - Class II
Product Code:	DQO, DQY and KRA
Submitter:	Concentric Medical, Inc.301 E. Evelyn AvenueMountain View, CA 94041Tel 650-938-2100Fax 650-237-5230Facility Registration #2954917	OCT 1 1 2013
Contact:	Christina RoweManager, Regulatory Affairs
Date Prepared:	September 6, 2013
Predicate Device:	Concentric Microcatheter (K113260)

Device Description

Indications for Use

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Concentric Medical, Inc. Traditional 510(k) Submission, K131437

Technological Characteristics

The Modified Concentric Microcatheter has the same technological characteristics as compared to the predicate device (K113260). The Modified Concentric Microcatheter differs from the predicate device in that its shaft diameters are smaller and its effective shaft length is longer. The device design, materials used, function, physical properties and composition have not been changed. A comparison of the subject device with predicate device is summarized in the table below.

Feature	Results
Indications for Use	Same
Device Description	Same except smaller shaft diameters and longereffective shaft length
Target Population	Same
Accessory Devices Provided	Same
Materials	Same
Labeled shaft outer diameter	Smaller (2.4F vs. 2.7F)
Labeled shaft inner diameter	Smaller (.017" vs. .021")
Overall Length	Longer (157 cm vs. 150 cm)
Packaging Materials andConfiguration	Same
Sterilization Method	Same
How Supplied	Same

Product Feature Comparison of Subject Device with Predicate Device

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. The test methods applied were similar to those previously submitted for the predicate Concentric Microcatheter.

Specifically, the following tests were performed on the proposed device:

Design verification testing:

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. .
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.
. Coating Testing - the durability and lubricity of the device coating was successfully evaluated.

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Concentric Medical, Inc. Traditional 510(k) Submission, K131437

In addition, dimensional verification testing was performed as part of design verification tests for the proposed device.

Design validation testing:

. Radiopacity Testing - the visibility of the device under fluoroscopy was successfully evaluated.
. Design Validation Simulated Use Testing – testing was performed in a porcine model to confirm that the proposed device meets its intended use.

The Modified Concentric Microcatheter uses the same materials and processes as the predicate device. Biocompatibility and sterilization tests were performed on the predicate device; results for all tests met the pre-determined acceptance criteria and apply to the Modified Concentric Microcatheter.

Summary of Substantial Equivalence

The Modified Concentric Microcatheter is substantially equivalent to the predicate device with regard to device design, materials, 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 as safe, as effective, and performs as well as or better than the legally marketed device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G6U9 Silver Spring, MD 20993-0002

October 11, 2013

Concentric Medical, Inc. c/o Ms. Christina Rowe Manager. Regulatory Affairs 301 E. Evelyn Ave. Mountain View, CA 94041

Rc: K131437

Trade/Device Name: Modified Concentric Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO, DQY and KRA Dated: September 9, 2013 Received: September 10, 2013

Dear Ms. Rowe:

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,

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 ar any Federal statutes and regulations administered by other Federal agencies. You must or any vith 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 form in radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract image of an eagle or bird with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird image.

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Page 2 – Ms. Christina Rowe

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Biometries/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.

Sincercly yours.

Joyce M. Whang -S

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): K131437

Device Name:

Modified Concentric Microcatheter

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Joyce M. Whang -S

Page 1 of 1

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).