The Arterial Pressure Monitoring Set/Tray consists of a pressure monitoring catheter, wire guide, access needle, and syringe. The catheter is inserted into the vasculature using the Seldinger technique. The subject device is sterilized by ethylene oxide and intended for one-time use.

The subject device catheter is a single lumen intravascular catheter manufactured from nylon tubing and is designed with a pre-molded proximal winged hub. The catheter is 5.0 French with a length of 15 centimeters and has an endhole diameter of 0.035 inches. Additionally, the catheter is manufactured with one-centimeter incremental ink markings along the shaft. The wire guide is manufactured from stainless steel, has an outer diameter of 0.035 inches, and a length of 50 centimeters. The access needle is manufactured from stainless steel. Additional set configurations may contain convenience accessories, including lidocaine, PVP ointment, silk suture, Monoject needles, thumb scalpel, gauze, drapes, a filter straw, and ChloraPrep antiseptic.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (Arterial Pressure Monitoring Set/Tray). It focuses on demonstrating substantial equivalence to a predicate device through comparison of features and performance testing.

Crucially, this document does NOT describe the acceptance criteria or studies for an AI/ML-driven device. The device in question is a physical catheter set, not a software algorithm. Therefore, the questions related to AI/ML device performance (like expert readers, MRMC studies, ground truth establishment for training/test sets, etc.) are not applicable to this submission.

The document discusses physical performance testing for the catheter. I will extract the details that are relevant to physical device testing rather than AI/ML performance, as per the document's content.

Here's the breakdown based on the provided text, addressing the applicable points:

Acceptance Criteria and Study for Arterial Pressure Monitoring Set/Tray (Physical Device)

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Triteria	Reported Device Performance
Catheter Shaft Tensile (Aged)	Peak tensile load for shaft section ≥ 10 N (in accordance with BS EN ISO 10555-1:2013)	The acceptance criterion was met.
Catheter Hub-to-Shaft Tensile (Aged)	Peak tensile load for hub-to-shaft section ≥ 10 N (in accordance with BS EN ISO 10555-1:2013)	The acceptance criterion was met.
Catheter Liquid Leakage (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 (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 (Aged)	Catheter shall not kink (flowrate reduced by 50%) at a specified kink (circumferential) length (in accordance with Annex B of BS EN 13868)	The acceptance criterion was met.
Catheter Gravity Flow Rate (Time-Zero)	Flow rate shall be a minimum of 90% of the flow rate stated by the manufacturer (in accordance with Annex E of BS EN ISO 10555-1)	The acceptance criterion was met.
Visual Inspection & Dimensional Analysis	Catheter dimensions are within specified tolerances and catheter and wire guide are compatible.	Test was conducted to demonstrate criteria met.

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

Sample Size: The document does not specify the exact number of units/samples used for each performance test (e.g., how many catheters were subjected to tensile testing). It only states that the device "was subjected to applicable testing."
Data Provenance: Not specified in terms of country of origin. The tests are described as "Performance Testing" and "Biocompatibility Testing" conducted by the manufacturer, Cook Incorporated. The context suggests these are internal validation tests. The tests are prospective in the sense that they were designed and performed to validate the new device design.

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

Not Applicable. This is a physical medical device, not an AI/ML algorithm. There is no concept of "ground truth" established by human experts in the context of the physical performance tests described (e.g., tensile strength, leakage, flow rate). These are objective engineering measurements.

4. Adjudication Method for the Test Set

Not Applicable. As this is a physical device subject to objective engineering tests, there is no need for adjudication by multiple experts. The success or failure of a test is based on measurable criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is relevant to imaging diagnostics or AI-assisted interpretation, which is not the nature of this device.

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

Not Applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

Objective Measurement/Standard Compliance: For the performance tests, the "ground truth" is adherence to predefined engineering specifications and compliance with relevant ISO/BS EN standards. For biocompatibility, the "ground truth" is demonstration of non-toxicity as per ISO 10993-1 and FDA guidance.

8. The Sample Size for the Training Set

Not Applicable. This is a physical device, not a machine learning model. There is no "training set."

9. How the Ground Truth for the Training Set was Established

Not Applicable. As no training set exists for this type of device.

Summary

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November 30, 2018

Cook Incorporated Johnathan Liu Regulatory Affairs Team Lead 750 Daniels Way Bloomington, Indiana 47404

Re: K180792

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: October 19, 2018 Received: October 22, 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. 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

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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 mediation-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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Indications for Use

510(k) Number (if known) K180792

Device Name

Arterial Pressure Monitoring Set/Tray

Indications for Use (Describe)

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

5.0 French catheters are intended for patients aged 12 years 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)

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2.0 510(k) SUMMARY

K180792 Arterial Pressure Monitoring Set/Tray 21 CFR §807.92 Date Prepared: October 19, 2018

Submitted By:

Submission:	Traditional 510(k) Premarket Notification
Applicant:	Cook Incorporated
Applicant Address:	Cook Incorporated750 Daniels WayBloomington, IN 47404
Contact:	Johnathan LiuChelsea Woods
Secondary Contact:	Andrew Breidenbach, PhD, RAC
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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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.

-5.0 French catheters are intended for patients aged 12 years and older

Comparison to Predicate Device:

The Arterial Pressure Monitoring Set/Tray is substantially equivalent to the predicate device, Cook Pressure Monitoring Catheter (K002254), in that these devices are identical in intended use, principle of operation, catheter design (single lumen, straight tip), and packaging. The differences between the subject device and the predicate device, including pediatric indication, materials, and dimensions, do not raise different questions of safety and/or effectiveness when compared to the predicate. 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 for Use		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/Trayis intended for arterial blood pressuremonitoring and blood sampling in adult andpediatric patients.5.0 French catheters are intended forpatients aged 12 years and older.
Device is for One-time use		Yes	IDENTICAL TO PREDICATE
Catheter PlacementMethod		Percutaneously via Seldinger technique	IDENTICAL TO PREDICATE
	ShaftMaterial	Polyurethane	Nylon
	HubMaterial	Polyurethane	Nylon
	OuterDiameter	3.0 French	5.0 French
Catheter	Length	2.5, 5.0, 7.5, 8.0, 12.0, 22.0 cm	15 cm
	Number ofLumens	Single Lumen	IDENTICAL TO PREDICATE
	Distal TipDesign	Straight Tip	IDENTICAL TO PREDICATE
	InkMarkings	Yes	IDENTICAL TO PREDICATE
Packaging		Tray w/ Tyvek lidstock	IDENTICAL TO PREDICATE
SterilizationMethod		EtO	IDENTICAL TO PREDICATE
Sterility AssuranceLevel		10-6	IDENTICAL TO PREDICATE

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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 (Aged) – The peak tensile load for the shaft section of the catheter shall be greater than or equal to 10 N in accordance with BS EN ISO 10555-1:2013. The acceptance criterion was met.
Catheter Hub-to-Shaft Tensile (Aged) The peak tensile load for the hub-to-shaft . section of the catheter shall be greater than or equal to 10 N in accordance with BS EN ISO 10555-1:2013. The acceptance criterion was met.
Catheter Liguid Leakage (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 (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 (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 Gravity 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 Analysis (Aged) Test was conducted to . demonstrate that the catheter dimensions are within the specified tolerances and the catheter and wire guide are compatible.

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.

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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).