The Arterial Pressure Monitoring Set/Tray is comprised of a pressure monitoring catheter, wire guide, entry access needle, and syringe. Certain sets are also available with a dilator and/or other convenience components. The catheter is manufactured from polyurethane, ethylene-vinyl acetate, or polyethylene tubing and is designed with a pre-molded winged hub. Catheters are manufactured 2.5, 3.0, and 4.0 French in size with endhole diameters of 0.015, 0.018, and 0.021 inches, respectively. The wire guide is manufactured from stainless steel coils, a safety wire, a mandril wire, and All-State solder. The access needle is manufactured from stainless steel. The dilator is manufactured from polyethylene and has a pre-molded proximal hub. Other convenience accessories include syringes, lidocaine solution, PVP ointment, antiseptic, Monoject needles, a scalpel, gauze, drapes, and needle holders. The Arterial Pressure Monitoring Set/Tray is sterilized by ethylene oxide and intended for one-time use.

AI/ML Overview

This document describes the performance testing of the Arterial Pressure Monitoring Set/Tray to demonstrate its substantial equivalence to a predicate device. It does not describe a study involving an AI/algorithmic device or human readers. Therefore, several of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) are not applicable or cannot be extracted from the provided text.

1. Table of acceptance criteria and the reported device performance

Test	Acceptance Criteria	Reported Device Performance
Catheter Shaft Tensile (Time Zero and Aged)	Peak tensile load for shaft section: ≥ 5 N for 2.5 and 3.0 Fr catheters; ≥ 10 N for 4.0 and 5.0 Fr catheters (in accordance with BS EN ISO 10555-1:2013).	Acceptance criteria were met.
Catheter Hub-to-Shaft Tensile (Time Zero and Aged)	Peak tensile load for hub-to-shaft section: ≥ 5 N for 2.5 and 3.0 Fr catheters; ≥ 10 N for 4.0 and 5.0 Fr catheters (in accordance with BS EN ISO 10555-1:2013).	Acceptance criteria were met.
Catheter Liquid Leakage (Time Zero and Aged)	No part of the catheter shall leak liquid (in accordance with Annex C of BS EN ISO 10555-1).	Acceptance criterion was met.
Catheter Air Leakage (Time Zero and Aged)	No air shall enter the hub (in accordance with Annex D of BS EN ISO 10555-1).	Acceptance criterion was met.
Catheter Kink Length (Time Zero and Aged)	The catheter shall not kink (flowrate reduced by 50%) at a specified kink (circumferential) length (in accordance with Annex B of BS EN 13868).	Acceptance criterion was met.
Catheter Flow Rate (Time-Zero)	Minimum of 90% of the flow rate stated by the manufacturer (in accordance with Annex E of BS EN ISO 10555-1).	Acceptance criterion was met.
Visual Inspection, Dimensional Verification, Compatibility (Time-Zero, Aged)	Catheter dimensions are within specified tolerances, and the catheter and wire guide are compatible.	Test was conducted.
Wire Guide Corrosion (Time-Zero)	No evidence of corrosion that could affect functional performance (in accordance with Annex B of BS EN ISO 11070:2014).	Acceptance criterion was met.
Wire Guide Fracture (Time-Zero)	The wire guide shall not fracture when wound around an appropriate former (in accordance with Annex F of BS EN ISO 11070).	Acceptance criterion was met.
Wire Guide Flex (Time-Zero)	No signs of defects or damage, including flaking or material loss (in accordance with Annex G of BS EN ISO 11070).	Acceptance criterion was met.
Wire Guide Tensile (Time-Zero)	Peak tensile load to failure: ≥ 5 N for O.D. ≥ 0.55 mm and < 0.75 mm; ≥ 10 N for O.D. ≥ 0.75 mm (in accordance with Annex H of BS EN ISO 11070).	Acceptance criterion was met.
Dilator Hub-to-Shaft Tensile (Time Zero and Aged)	Peak tensile load for hub-to-shaft section: ≥ 5 N for 3.0 Fr dilators; ≥ 10 N for 3.5, 4.0, 5.0, and 5.5 Fr dilators (in accordance with BS EN ISO 11070).	Acceptance criterion was met.
Biocompatibility	Cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, genotoxicity, implantation, and hemocompatibility testing performed per ISO 10993-1 and FDA guidance.	Testing was performed.
Sterilization Testing (EO/ECH Residuals)	Residual levels of ethylene oxide (EO) and ethylene chlorohydrin (ECH) no greater than maximum limits specified in ANSI/AAMI/ISO 10993-7:2008(R)2012.	Evaluated and verified.
Packaging Visual Inspection (simulated distribution)	No package shall display damage that will compromise sterility of its contents.	Acceptance criterion was met.
Packaging Destructive Inspection (simulated distribution)	Components inside the package shall show no signs of damage that would interfere with the performance of the product.	Acceptance criterion was met.
Packaging Bubble Test (simulated distribution)	No signs of pin holes or imperfect seals indicated by bubbles created from pressurized air leaking into the surrounding solution.	Acceptance criterion was met.
Packaging Seal Strength Test	Seal strength shall not be less than 1.2 N per 15 mm (0.46 lbf/in). Mean seal force - 3σ shall meet or exceed 0.50 lbf/in (per EN 868-5:1999).	Acceptance criterion was met.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This is a testing report for a medical device and does not involve AI or algorithmic analysis of a test set with data provenance. The tests are bench tests performed on physical device samples.

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.

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

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for this device's performance is based on established engineering standards (e.g., ISO, EN standards) for material properties (tensile strength, leakage, kink resistance, corrosion, fracture, flex, etc.) and direct physical testing against those standards.

8. The sample size for the training set
Not applicable. This is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established
Not applicable.

Summary

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December 19, 2018

Cook Incorporated Johnathan Liu Regulatory Affairs Specialist 750 Daniels Wav Bloomington, Indiana 47404

Re: K180846

Trade/Device Name: Arterial Pressure Monitoring Set/Tray Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: DQO Dated: November 26, 2018 Received: November 27, 2018

Dear Johnathan Liu:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. However, you are responsible to determine that the medical devices you use as components in the tray have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls 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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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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,

Stephen C. Browning -S5

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K180846

Device Name Arterial Pressure Monitoring Set/Tray

Indications for Use (Describe)

The Arterial Pressure Monitoring Set/Tray is intended for arterial blood pressure monitoring in adult and pediatric patients.

2.5 French catheters are intended for patients from birth and older
3.0 and 4.0 French catheters are intended for patients 1 year and older

Type of Use (Select one or both, as applicable)	☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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and review the collection of information. Send comments regarding this burden estimate or any other aspect
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COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. HONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM

K180846 Page 1 of 6

2.0 510(k) SUMMARY

K180846 Arterial Pressure Monitoring Set/Tray 21 CFR §807.92 Date Prepared: December 17, 2018

Submitted By:

Submission:	Traditional 510(k) Premarket Notification
Applicant:	Cook Incorporated
Applicant Address:	Cook Incorporated750 Daniels WayBloomington, IN 47404
Primary Contact:	Johnathan Liu
Secondary Contact:	Chelsea Woods
Email:	regsubmissions@cookmedical.com
Contact Phone Number:	(812) 335-3575 x104509
Contact Fax Number:	(812) 332-0281

Device Information:

Trade Name:	Arterial Pressure Monitoring Set/Tray
Common Name:	Catheter, Intravascular, Diagnostic
Classification Name:	Diagnostic intravascular catheter
Regulation:	21 CFR §870.1200
Product Code:	DQO
Device Class:	II
Classification Panel:	Cardiovascular

Predicate Device:

The Arterial Pressure Monitoring Set/Tray is substantially equivalent to the following device: Cook Pressure Monitoring Catheter (K002254, Cook Incorporated) cleared on March 16, 2001.

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Cook Incorporated - Traditional 510(k) Arterial Pressure Monitoring Set/Tray December 17, 2018

Device Description:

Indications for Use:

The Arterial Pressure Monitoring Set/Tray is intended for arterial blood pressure monitoring and blood sampling in adult and pediatric patients.

-2.5 French catheters are intended for patients from birth and older
-3.0 and 4.0 French catheters are intended for patients 1 year and older

Comparison to Predicate Device:

The Arterial Pressure Monitoring Set/Tray and the predicate device, Cook Pressure Monitoring Catheter (K002254), are substantially equivalent in that these devices are identical in intended use, principle of operation, and fundamental technologies. Additionally, the subject device has similar materials and dimensions as the predicate device. The differences between the subject device and the predicate device, including pediatric indication, materials, and other dimensions do not raise any new issues of safety and/or effectiveness. The substantial equivalence comparison of the subject device to the predicate is provided in the table below.

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	PREDICATE DEVICE	SUBJECT DEVICE
	Cook Pressure Monitoring Catheter(K002254)	Arterial Pressure Monitoring Set/Tray
Regulation	21 CFR §870.1200	IDENTICAL TO PREDICATE
Product Code	DQO - Catheter, Intravascular, Diagnostic	IDENTICAL TO PREDICATE
Classification	II	IDENTICAL TO PREDICATE
Indications forUse	The Cook Pressure Monitoring Catheter isused for arterial pressure monitoring andblood sampling. It is provided sterile inpeel-open packages and intended for one-time use.	The Arterial Pressure Monitoring Set/Tray isintended for arterial blood pressuremonitoring and blood sampling in adult andpediatric patients.- 2.5 French catheters are intended forpatients from birth and older- 3.0 and 4.0 French catheters areintended for patients 1 year and older
Device is forOne-time use	Yes	IDENTICAL TO PREDICATE
CatheterInsertion Method	Percutaneously via Seldinger technique	IDENTICAL TO PREDICATE
CatheterInsertion Site	Not specified	Radial, Brachial, Dorsalis Pedis, Femoral,Posterior Tibial Arteries
Catheter ShaftMaterial	Polyurethane	PolyethyleneEthylene-Vinyl AcetatePolyurethane
Catheter HubMaterial	Polyurethane	PolyethylenePolyurethane
Catheter OuterDiameter	2.5, 3.0, 4.0, 5.0 French	2.5, 3.0, 4.0 French
Catheter Length	2.5, 5.0, 7.5, 8.0, 12.0, 22.0 cm	2.5, 4.0, 5.0, 6.0, 8.0, 12.0 cm
Catheter LumenDesign	Single Lumen	IDENTICAL TO PREDICATE
Catheter DistalEnd	Straight Tip	IDENTICAL TO PREDICATE
Dilator ShaftMaterial	Polypropylene	Polyethylene
Wire GuideMaterial	Stainless Steel	Stainless SteelAll-State Solder
Wire GuideDiameter	0.015, 0.018, 0.021, 0.035 inch	IDENTICAL TO PREDICATE
Packaging	Tray w/ Tyvek Lidstock	IDENTICAL TO PREDICATE
Sterilization	EtO	IDENTICAL TO PREDICATE
SterilityAssurance Level	10-6	IDENTICAL TO PREDICATE

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Cook Incorporated - Traditional 510(k) Arterial Pressure Monitoring Set/Tray December 17, 2018

Technological Characteristics:

The subject device, Arterial Pressure Monitoring Set/Tray, was subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests have been conducted to ensure reliable design and performance under the specified testing parameters:

Performance Testing:

Catheter Shaft Tensile (Time Zero and Aged) The peak tensile load for the shaft . section of the catheter shall be greater than or equal to 5 N for 2.5 and 3.0 Fr catheters, and 10 N for 4.0 and 5.0 Fr catheters in accordance with BS EN ISO 10555-1:2013. The acceptance criteria were met.
. Catheter Hub-to-Shaft Tensile (Time Zero and Aged) - The peak tensile load for the hub-to-shaft section of the catheter shall be greater than or equal to 5 N for 2.5 and 3.0 Fr catheters, and 10 N for 4.0 and 5.0 Fr catheters in accordance with BS EN ISO 10555-1:2013. The acceptance criteria were met.
Catheter Liquid Leakage (Time Zero and Aged) No part of the catheter shall leak . liquid when tested in accordance with Annex C of BS EN ISO 10555-1. The acceptance criterion was met.
. Catheter Air Leakage (Time Zero and Aged) - No air shall enter the hub when tested in accordance with Annex D of BS EN ISO 10555-1. The acceptance criterion was met.
Catheter Kink Length (Time Zero and Aged) The catheter shall not kink (flowrate . reduced by 50%) at a specified kink (circumferential) length when tested in accordance with Annex B of BS EN 13868. The acceptance criterion was met.
Catheter Flow Rate (Time-Zero) The flow rate shall be a minimum of 90% of the . flow rate stated by the manufacturer when tested in accordance with Annex E of BS EN ISO 10555-1. The acceptance criterion was met.
Visual Inspection, Dimensional Verification, Compatibility (Time-Zero, Aged) Test . was conducted to demonstrate that the catheter dimensions are within the specified tolerances and the catheter and wire guide are compatible.
. Wire Guide Corrosion (Time-Zero) – The wire guide shall show no evidence of corrosion that could affect the functional performance when tested in accordance with Annex B of BS EN ISO 11070:2014. The acceptance criterion was met.

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· Wire Guide Fracture (Time-Zero) The wire guide shall not fracture when wound around an approximate former in accordance with Annex F of BS EN ISO 11070. The acceptance criterion was met.
. Wire Guide Flex (Time-Zero) – The wire guide shall show no signs of defects or damage, including flaking or material loss when tested in accordance with Annex G of BS EN ISO 11070. The acceptance criterion was met.
. Wire Guide Tensile (Time-Zero) – The peak tensile load to failure shall be greater than or equal to 5 N for wire guides with an outside diameter greater than or equal to 0.55 mm and less than 0.75 mm, and 10 N for wire guides with an outside diameter greater than or equal to 0.75 mm in accordance with Annex H of BS EN ISO 11070. The acceptance criterion was met.
. Dilator Hub-to-Shaft Tensile (Time Zero and Aged) – The peak tensile load for the hub-to-shaft section of the dilator shall be greater than or equal to 5 N for 3.0 Fr dilators and 10 N for 3.5, 4.0, 5.0, and 5.5 Fr dilators, in accordance with BS EN ISO 11070. The acceptance criterion was met.

Biocompatibility Testing:

Per ISO 10993-1 and FDA guidance, testing for cytotoxicity, sensitization, . intracutaneous irritation, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, genotoxicity, implantation, and hemocompatibility were performed to ensure the biocompatibility of the subject device set.
Sterilization Testing:
Per ISO 10993-1 Residual levels of ethylene oxide (EO) and ethylene chlorohydrin . (ECH) have been evaluated and verified to be no greater than the maximum limits as specified in ANSI/AAMI/ISO 10993-7:2008(R)2012: Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals.
Packaging Testing following simulated distribution:
. Visual Inspection - No package shall display damage that will compromise sterility of its contents. The acceptance criterion was met.
. Destructive Inspection – The components inside the package shall show no signs of damage that would interfere with the performance of the product. The acceptance criterion was met.
Bubble Test The package shall show no signs of pin holes or imperfect seals . indicated by bubbles created from the pressurized air leaking into the surrounding solution. The acceptance criterion was met.

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Cook Incorporated - Traditional 510(k) Arterial Pressure Monitoring Set/Tray December 17, 2018

Seal Strength Test Per EN 868-5:1999, the seal strength shall not be less than 1.2N ● per 15 mm (0.46 lbf/in). For additional confidence, the mean seal force - 3 σ shall meet or exceed 0.50 lbf/in. The acceptance criterion was met.

Conclusion:

The results of these tests confirm that the Arterial Pressure Monitoring Set/Tray meets the design input requirements based on the intended use and support the conclusion that this device does not raise different questions of safety and/or effectiveness and is substantially equivalent to the predicate device, the Cook Pressure Monitoring Catheter (K002254).

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).