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

The provided document describes a medical device called the "Modified Concentric Microcatheter" (K113260) and its substantial equivalence to a predicate device. The document does not contain information about software, AI, or diagnostic performance metrics typically associated with acceptance criteria for such systems. Therefore, most of the requested information regarding AI device performance, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance cannot be extracted from this text.

The acceptance criteria described in this document are primarily related to the physical performance and biocompatibility of the microcatheter.

Here's an analysis based on the provided text, addressing the relevant points and indicating where information is not available:

Acceptance Criteria and Device Performance (for physical and biocompatibility tests)

Acceptance Criteria (What was evaluated)	Reported Device Performance
Kink Resistance	"...successfully evaluated."
Leak Resistance (high pressure and vacuum)	"...successfully evaluated."
Flexibility Testing (navigating tight bends)	"...successfully evaluated."
Tensile Testing (mechanical integrity)	"...successfully evaluated."
Torque Testing (mechanical integrity)	"...successfully evaluated."
Coating Testing (durability and lubricity)	"...successfully evaluated."
Radiopacity (visibility under fluoroscopy)	"...successfully evaluated."
Particulate Testing (amount and size of particles)	"...successfully evaluated."
Biocompatibility: Sensitization/Maximization	"...results for all tests met the predetermined acceptance criteria."
Biocompatibility: Cytotoxicity	"...results for all tests met the predetermined acceptance criteria."
Biocompatibility: Intracutaneous Reactivity	"...results for all tests met the predetermined acceptance criteria."
Biocompatibility: Systemic Toxicity/Systemic Injection Test	"...results for all tests met the predetermined acceptance criteria."
Biocompatibility: Systemic Toxicity/Rabbit Pyrogen Test	"...results for all tests met the predetermined acceptance criteria."
Biocompatibility: Hemocompatibility/Hemolysis	"...results for all tests met the predetermined acceptance criteria."
Biocompatibility: Hemocompatibility/Complement Activation	"...results for all tests met the predetermined acceptance criteria."
Biocompatibility: Hemocompatibility/in vivo Thrombogenicity	"...results for all tests met the predetermined acceptance criteria."

Study Details (Based on available information)

Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in the context of data for an AI/diagnostic device. Instead, it refers to physical testing of components and biocompatibility testing. No sample sizes are provided for these tests.
- Data provenance (country of origin, retrospective/prospective) is not applicable as there is no data-driven diagnostic component described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" establishment by experts for a diagnostic performance test, as this is a physical medical device. The "ground truth" for the physical tests would be the established engineering standards and specifications.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to resolving discrepancies in expert labeling for diagnostic datasets, which is not present here.
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 physical microcatheter, not an AI or diagnostic imaging device. No MRMC study was conducted or relevant to this device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical microcatheter; there is no algorithm, AI, or standalone performance to evaluate.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the physical and biocompatibility tests, the "ground truth" would be the pre-defined engineering specifications, international standards (e.g., ISO, ASTM), and regulatory guidelines for medical device safety and performance. The document states that "results for all tests met the predetermined acceptance criteria."
The sample size for the training set:
- Not applicable. There is no AI algorithm or training set mentioned or relevant to this physical device.
How the ground truth for the training set was established:
- Not applicable. There is no training set for an AI algorithm.

Summary regarding AI/Diagnostic Performance:

The provided 510(k) summary for the "Modified Concentric Microcatheter" pertains to a physical medical device. The testing described focuses on its mechanical integrity, material properties, and biocompatibility, demonstrating substantial equivalence to a predicate device. There is no mention or indication of any AI component, diagnostic algorithm, or performance evaluation that would involve radiologists, image analysis, or typical AI acceptance criteria.

Summary

{0}------------------------------------------------

K113260

MAR - 9 2012

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
Submitter:	Concentric® Medical, Inc.301 E. Evelyn AvenueMountain View, CA 94041Tel 650-938-2100Fax 650-237-5230Facility Registration #2954917
	Contact: Kirsten Valley
Predicate Device:	Concentric Microcatheter (K111619)

Device Description

Intended Use

Technological Characteristics

The Modified Concentric Microcatheter has the same technological characteristics as the predicate device (K111619). Both have braided shafts with varying durometers of polymer along the length for optimal flexibility.

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 same test methods were applied as those previously submitted for the predicate Concentric Microcatheter. Specifically, the following tests were performed on the proposed device:

Kink Resistance the device's ability to withstand kinking when flexed was successfully evaluated.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image contains handwritten text. The text at the top reads "K113260". Below that, the text reads "p.2 of 2". The handwriting is in black ink.

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.
. Radiopacity - the visibility of the device under fluoroscopy was successfully evaluated.
Particulate Testing the amount and size of particles that are released from the device . during simulated clinical use were successfully evaluated.

The following biocompatibility tests were performed on the device; results for all tests met the predetermined acceptance criteria.

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

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.

{2}------------------------------------------------

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 with three lines forming its body and head, and two curved lines representing its legs. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the left side of the eagle.

Public Health Service

MAR - 9 2012

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

Concentric® Medical, Inc. c/o Ms. Kirsten Valley Vice President, Technology & Regulatory Affairs 301 East Evelyn Avenue Mountain View, CA 94041

Re: K113260

Trade/Device Name: Modified Concentric Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: DOO Dated: March 1, 2012 Received: March 5, 2012

Dear Ms. Valley:

We have reviewed vour 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 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

{3}------------------------------------------------

(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 (240) 276-3150 or at its Internet address

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

Sincerely yours,

M. A. Wilhelm

C / Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Statement of Indications for Use

	INDICATIONS FOR USE
510(k) Number (if known):	K113260
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_ (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)

Ms. Villeheni

(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices

16119260 510(k) Number_

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).