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 consists of a single lumen, braided, variable stiffness shaft with a radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use.

AI/ML Overview

The provided text, K091961, is a 510(k) summary for a medical device called the "Modified Concentric Microcatheter." This document is a premarket notification to the FDA for a modified version of an already cleared device.

Crucially, this type of 510(k) submission (specifically a "Special 510(k): Device Modification") and the information provided within it are primarily focused on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria, ground truth, or human reader studies typically associated with AI/ML device evaluations.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes for test/training sets, expert involvement, and ground truth types is not applicable or present in this document. The document specifically states: "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." This indicates that the "study" conducted was a series of engineering verification and validation tests, not a clinical performance study with human subjects or experts establishing ground truth in the way described in your request.

Here's a breakdown of what can be extracted from the provided text, and where information is missing or not applicable:

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

Not explicitly stated in the provided text. The document states that "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."
For a medical device like a microcatheter, acceptance criteria would typically relate to physical and mechanical properties (e.g., burst pressure, tensile strength, lubricity, steerability, trackability, radiopacity, dimensions) and biocompatibility. The document implies these tests were performed and met success criteria but does not detail them.

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

Not applicable/Not provided. This device is a physical medical instrument, not an AI/ML algorithm that processes data. The "test set" would refer to the number of microcatheters or components tested in engineering verification and validation, which is not specified.
"Data provenance" in the context of clinical data for AI is not relevant here.

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/Not provided. As this is a physical device, ground truth for its performance would be established through engineering measurements and established medical device testing standards, not by human experts adjudicating clinical cases.

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

Not applicable/Not provided. Adjudication methods are relevant for subjective interpretations (like medical images) where expert consensus establishes ground truth. For objective physical device performance, this is not applicable.

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

Not applicable/No evidence. This is a physical medical device, not an AI/ML diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant to this submission.

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

Not applicable/No evidence. This is a physical medical device. There is no algorithm involved in its direct function.

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

Not explicitly stated, but implied to be engineering and performance specifications. Given the nature of a microcatheter, ground truth would be based on:
- Engineering specifications: Conformance to dimensional tolerances, material properties.
- Pre-defined performance criteria: E.g., ability to navigate a tortuous path, resistance to kinking, lubricity, burst pressure, tensile strength.
- Biocompatibility testing results: Adherence to ISO standards for material safety.

8. The sample size for the training set

Not applicable/Not provided. This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" for its development in the context of this 510(k).

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

Not applicable/Not provided. As there is no training set for an AI/ML model, this question is not relevant.

In summary, the K091961 document details a 510(k) submission for a modification to a physical medical device (microcatheter). The "study" mentioned refers to engineering verification and validation tests to ensure the modified device meets its design specifications and remains substantially equivalent to a predicate device. It does not involve AI/ML performance evaluation, expert ground truth establishment for clinical data, or human reader studies. Therefore, most of the specific questions asked, which are highly relevant to AI/ML device submissions, are not applicable to this particular document.

Summary

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K091961

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

IJUL 30 2009

General Information

Trade Name	Concentric Microcatheter
Common Name	Diagnostic Intravascular Catheter
Classification	Diagnostic Intravascular Catheter, 21CFR 870.1200 - Class II
Submitter	Concentric® Medical, Inc.
	301 E. Evelyn Avenue
	Mountain View, CA 94041
	Tel 650-938-2100
	Fax 650-237-5230
Contact	Kirsten Valley
	Senior Vice President, Technology & Regulatory Affairs

Intended Use

Predicate Device

Concentric Microcatheter, K003086

Device Description

Materials

All materials used in the manufacture of the Modified Concentric Microcatheter are suitable for the intended use of the device and have been used in numerous previously cleared products.

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.

Summary of Substantial Equivalence

The Modified Concentric Microcatheter is substantially equivalent to the predicate device with regard to device design, intended use, patient population and anatomical site. Any differences in technological characteristics between the Moditied Concentric Microcatheter and the predicate device do not raise any new issues of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 30 2009

Concentric Medical % Ms. Kirsten Valley 301 East Evelyn Avenue Mountain View. California 94041

Re: K091961

Trade/Device Name: Modified Concentric Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: June 29, 2009 Received: July 1, 2009

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.

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

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Page 2-Ms. Kirsten Valley

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/ResourcesforYou/Industry/default.htm.

Singerely yours,

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

Enclosure

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Concentric Medical, Inc. Special 510(k): Device Modification Concentric Microcatheter

INDICATIONS FOR USE

510(k) Number (if known):

This application - K091961

Modified Concentric Microcatheter

Device Name:

Indications for Use:

Prescription Use X (Per 21 CFR 801.109) AND/OR

Over-The-Counter Use (Optional Format 1-2-96)

(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_Kog

I d

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).