The Cantata™ Microcatheter is designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use.

Device Description

The Cantata™ Microcatheter is an infusion catheter with a hydrophilic coating, designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures. The device is available in 2.5 and 2.8 French shafts and is available in 100, 110, 135, and 150 cm lengths. The device is supplied sterile and intended for one-time use.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the Cantata™ Microcatheter. It focuses on demonstrating substantial equivalence to predicate devices and does NOT describe an AI/ML powered medical device. Therefore, it does not contain information about acceptance criteria for an AI model, study design for AI, sample sizes for test and training sets, expert qualifications, or ground truth establishment relevant to AI/ML devices.

The document lists various physical and biological tests performed on the Cantata™ Microcatheter to assure its reliable design and performance, such as:

Tensile strength
Static burst pressure
Kink radius
Coating durability and lubricity
Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous, Systemic Toxicity, Hemolysis, Pyrogen, Complement Activation, ASTM Partial Thromboplastin Time)
Shelf life
Endotoxin/bioburden
Particulate Testing

However, it does not provide specific acceptance criteria values for these tests or the reported performance data in a comparative table format. It simply states that "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use."

To directly answer your request based on the provided text:

A table of acceptance criteria and the reported device performance
- The document lists the types of tests performed but does not provide a table with specific acceptance criteria values or the reported device performance for each test.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided as the tests are for a physical medical device, not an AI/ML algorithm.
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 information is not relevant or provided as the tests are for a physical medical device, not an AI/ML algorithm requiring expert-established ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not relevant or provided as the tests are for a physical medical device, not an AI/ML algorithm.
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 not an AI/ML device, so an MRMC study related to AI assistance was not conducted or mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is not an AI/ML device.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the context of AI/ML ground truth. The "ground truth" for this physical device would be the established engineering and biocompatibility standards and test protocols.
The sample size for the training set
- Not applicable as this is not an AI/ML device.
How the ground truth for the training set was established
- Not applicable as this is not an AI/ML device.

Summary

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Special 510(k) Premarket Notification CantataTM Microcatheter COOK INCORPORATED

510(k) Summary

K101450

DEC 300 2010 .

Submitted By:

Mironda Carpenter Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 812.339.2235

22 December 2010

Device:

Trade Name: Proposed Classification: Cantata™ Microcatheter Catheter, Continuous Flush KRA

Indications for Use:

The Cantata™ Microcatheter is designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use.

Predicate Devices:

The Cantata™ Microcatheter is identical in terms of intended use and technological characteristics and similar in terms of material with the predicate MiraFlex®18 Microcatheter cleared under 510(k) number K060224 and the MiraFlex® High Flow Microcatheter cleared under 510(k) number K080737. The change involves a conversion from the current hydrophilic coating to a differently formulated hydrophilic coating.

Device Description:

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Substantial Equivalence:

The Cantata™ Microcatheter is substantially equivalent to the predicate MiraFlex®18 Microcatheter cleared under 510(k) number K060224 and MiraFlex® High Flow Microcatheter cleared under 510(k) number K080737.

Test Data:

The Cantata™ Microcatheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were:

1. Tensile strength
1. Static burst pressure
1. Kink radius
1. Coating durability and lubricity
1. Biocompatibility
- a. Cytotoxicity
- b. Sensitization, Maximization
- c. Intracutaneous
- d. Systemic Toxicity
- e. Hemolysis
- f. Pyrogen
- g. Complement Activation
- h. ASTM Partial Thromboplastin Time
1. Shelf life
1. Endotoxin/bioburden
1. Particulate Testing

A rationale based upon the geometry, conditions of use and the materials that interact with the blood was submitted to support the omission of the in vivo thrombogenicity testing.

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle with three stripes forming its wing, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle.

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

Cook Incorporated c/o Ms. Mironda Carpenter Regulatory Affairs Specialist 750 Daniels Wav P.O. Box 489 Bloomington. IN 47402

DEC 3 0 2010

Re: K101450

Trade/Device Name: Cantata™ Microcatheter Common Name: Catheter, Continuous Flush Regulation Number: 21 CFR 870.1210 Regulatory Class: II Product Code: KRA Dated: December 17, 2010 Received: December 20, 2010

Dear Ms. Carpenter:

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.

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Page 2 - Ms. Mironda Carpenter

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/CDRH0ffices/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

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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Special 510(k) Premarket Notification Cantata™M Microcatheter COOK INCORPORATED 21-May-2010

Indications for Use

DEC 3 0 2010

510(k) Number (if known): _ Kl (0145D

Device Name: Cantata™ Microcatheter

The Cantata™ Microcatheter is designed for use in small vessel or Indications for Use: superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use.

Prescription Use X (Per 21 CFR 801 Subpart D) OR

Over-the-Counter Use (Per 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

diovascular Devices

510(k) Number : K101450

Regulation Number and Section

§ 870.1210 Continuous flush catheter.

(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).