The High-Flo Silver Polyethylene Catheter is intended for the delivery of contrast media and therapeutic agents to the peripheral, carotid, and coronary vasculature, not including the neurovasculature.

Device Description

The High-Flo Silver Polyethylene Catheter, subject of this submission, is a sterile, single use device designed for use in angiographic procedures. The High-Flo Silver Polyethylene Catheter is available in a 5.5 French size and is manufactured in lengths of 65 to 100 centimeters. Each configuration includes a luer lock adapter, connecting cap, and a single lumen braided shaft.

AI/ML Overview

The acceptance criteria and device performance for the High-Flo Silver Polyethylene Catheter are detailed in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Biocompatibility Testing	Conformance with applicable sections of ANSI AAMI ISO 10993-1:2009(R)2013, predetermined acceptance criteria met.	Device is biocompatible for the intended use, demonstrated by testing for cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogenicity, hemocompatibility, complement activation, in vivo thrombogenicity, and partial thromboplastin time. The predetermined acceptance criteria were met.
Tensile Testing of Hub-to-Shaft Bond	Peak load value of the hub-to-shaft connection in accordance with BS EN ISO 10555-1:2013, Annex B.	The predetermined acceptance criterion was met, verifying the peak load value of the hub-to-shaft connection under proper clinical use.
Tensile Testing of Tip-to-Shaft Bond	Peak load value of the tip-to-shaft connection in accordance with BS EN ISO 10555-1:2013, Annex B.	The predetermined acceptance criterion was met, verifying the peak load value of the tip-to-shaft connection under proper clinical use.
Liquid Leakage Testing	No liquid leakage when tested in accordance with BS EN ISO 10555-1:2013, Annex C.	The predetermined acceptance criterion was met, verifying no liquid leakage under proper clinical use.
Air Leakage Testing	No air leakage when tested in accordance with BS EN ISO 10555-1:2013, Annex D.	The predetermined acceptance criterion was met, verifying no air leakage under proper clinical use.
Static Burst Testing	Characterization of the catastrophic failure pressure for the catheter in accordance with BS EN ISO 10555-1:2013, Annex F.	Testing successfully characterized the catastrophic failure pressure for the catheter. The reported detail is that it was "successfully characterized," implying it met the objective of the test.
Dimensional Verification Testing	Dimensional requirements of the subject device are within a specified tolerance.	The predetermined acceptance criteria were met.
Hub Pressure Testing	Hub pressure, when tested at maximum flow rate, does not exceed the static burst pressure.	Testing successfully characterized the hub pressure and verified that it does not exceed the static burst pressure. The reported detail is that it was "successfully characterized" and "verified," implying it met the objective of the test.

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

The document does not explicitly state the specific sample sizes used for each of the performance tests (e.g., number of catheters tested for tensile strength, burst pressure, etc.). It generally refers to "applicable testing" and that "the predetermined acceptance criteria were met."

The provenance of the data is internal to Cook Incorporated, as these are engineering and biocompatibility tests conducted directly on the device. It is not patient data, so concepts like "country of origin" or "retrospective/prospective" do not apply in the typical clinical study sense. These are laboratory-based, pre-market validation tests.

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

This information is not applicable to the reported tests. The ground truth for these tests is established by objective, standardized engineering and biocompatibility test methods (e.g., ISO standards) and measurable physical properties and biological responses, rather than expert consensus on a clinical diagnosis or image interpretation.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation by multiple readers to establish a ground truth for diagnostic accuracy. The tests described are objective, quantitative laboratory tests.

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:

No MRMC comparative effectiveness study was mentioned or performed. This device is a physical medical instrument (catheter), not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance does not apply to this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. As mentioned, this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth for these performance tests is based on objective, measurable criteria defined by international standards (e.g., BS EN ISO 10555-1:2013, ANSI AAMI ISO 10993-1:2009(R)2013) and the inherent physical and chemical properties of the device materials and design. It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI algorithm and therefore does not have a "training set" in the machine learning context. The product development process involves design iterations and engineering testing, but not machine learning training.

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

Not applicable, as there is no "training set" for this physical device.

Summary

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April 3, 2018

Cook Incorporated Jessica Swafford Regulatory Affairs Specialist 750 Daniels Wav Bloomington, Indiana 47402

Re: K172635

Trade/Device Name: High-Flo Silver Polyethylene Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: March 5, 2018 Received: March 6, 2018

Dear Jessica Swafford:

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 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 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.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kenneth J. Cavanaugh -S

for

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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Indications for Use

510(k) Number (if known)

K172635

Device Name High-Flo Silver Polyethylene Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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COOK INCORPORATED OOMINGTON. IN 47404 USA N.COOKME

510(k) Summary -- K172635

High-Flo Silver Polyethylene Catheter Traditional 510(k) Summary 21 CFR §807.92

Submitter Information

Applicant:	Cook Incorporated
Address:	750 Daniels WayBloomington, IN 47404
Contact:	Jessica P. Swafford
Email:	RegSubmissions@cookmedical.com
Contact Phone Number:	812-335-3575 ext. 104260
Contact Fax Number:	812-332-0281
Date Prepared:	05 March 2018
Device Information
Trade Name:	High-Flo Silver Polyethylene Catheter
Common Name:	Angiographic Catheters

Predicate Device

Classification Name:

The predicate device of the subject High-Flo Silver Polyethylene Catheter is the Slip-Cath® Beacon® Tip Catheter cleared under 510(k) number K122937. The predicate Slip-Cath® Beacon® Tip Catheter is visually identified by a distal radiopaque tip bonded onto a stainless steel braided catheter shaft. The predicate device is manufactured in lengths of 60 to 150 centimeters and in sizes of 4.0 to 6.5 French. The shaft of these catheters have an inner lumen that tapers to a 0.035 or 0.038 inch endhole diameter and are manufactured in a variety of distal tip configurations.

Catheter, Intravascular, Diagnostic

DQO (21 CFR §870.1200)

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Comparison to Predicate(s)

It has been demonstrated that the subject High-Flo Silver Polyethylene Catheter and the predicate device are substantially equivalent in terms of intended use, duration of use, principles of operation, fundamental technological characteristics, and insertion method. The design, dimensions, manufacture, and materials of the subject device are either similar to the materials of the predicate device(s) or have been used in other cleared devices. The differences between the subject device and the predicate device(s) do not raise new questions of safety and effectiveness as demonstrated by performance and biocompatibility testing.

Device Description

Intended Use

Test Data

The High-Flo Silver Polyethylene Catheter, subject of this submission, was subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests were conducted to ensure reliable design and performance:

. Biocompatibility testing - Testing (i.e., cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogenicity, hemocompatibility, complement activation, in vivo thrombogenicity, and partial thromboplastin time) demonstrated that the device is biocompatible for the intended use. In conformance with the applicable sections of ANSI AAMI ISO 10993-1:2009(R)2013, the predetermined acceptance criteria were met.

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. Tensile Testing of the Hub-to-Shaft Bond - Testing verified that under proper clinical use of the catheter, the peak load value of the hub-to-shaft connection is in accordance with the methods of BS EN ISO 10555-1:2013. Annex B. The predetermined acceptance criterion was met.
Tensile Testing of the Tip-to-Shaft Bond Testing verified that under proper . clinical use of the catheter, the peak load value of the tip-to-shaft connection is in accordance with the methods of BS EN ISO 10555-1:2013, Annex B. The predetermined acceptance criterion was met.
Liquid Leakage Testing Testing verified that under proper clinical use of the . catheter, there will be no liquid leakage when tested in accordance with BS EN ISO 10555-1:2013, Annex C. The predetermined acceptance criterion was met.
Air Leakage Testing Testing verified that under proper clinical use of the . catheter. there will be no air leakage when tested in accordance with BS EN ISO 10555-1:2013, Annex D. The predetermined acceptance criterion was met.
Static Burst Testing Testing successfully characterized the catastrophic failure . pressure for the catheter is accordance with BS EN ISO 10555-1:2013. Annex F.
. Dimensional Verification Testing - Testing verified that the dimensional requirements of the subject device are within a specified tolerance. The predetermined acceptance criteria were met.
Hub Pressure Testing Testing successfully characterized the hub pressure, when . tested at maximum flow rate, and to verify that it does not exceed the static burst pressure.

In conclusion, the results of these tests support a determination of substantial equivalence.

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).