Continuous or intermittent drug infusions
Central venous blood pressure monitoring (CVP)
Acute hyperalimentation
Blood sampling
Delivery of whole blood or blood products
Simultaneous, separate infusion of drugs for multi-lumen catheters only
The device is a short-term use catheter, intended for less than 30 days.
The Cook dilator is used for dilating puncture sites or catheter tracts.
The Cook Unimpregnated Central Venous Catheter (Non-Power Injectable) is intended for adult and pediatric populations.

The Cook Unimpregnated Central Venous Catheter with power injection is used for:

Continuous or intermittent drug infusions
Central venous blood pressure monitoring (CVP)
Acute hyperalimentation
Blood sampling
Delivery of whole blood or blood products
Simultaneous, separate infusion of drugs for multi-lumen catheters only
Power injection of contrast media*
*The flow rate may not exceed 3 mL/sec for 4.0 and 5.0 French catheters and 10 mL/sec for 7.0, 8.0, 9.0, and 10.0 French catheters. Verify prior to use that the maximum safety cut-off pressure limit is set at or below 250 psi for 4.0 and 5.0 French catheters and 325 psi for 7.0, 8.0, 9.0, and 10.0 French catheters.
The device is a short-term use catheter, intended for less than 30 days.
The 9.0 and 10.0 French catheters include an inner catheter to facilitate insertion of the main catheter.
The Cook dilator is used for dilating puncture sites or catheter tracts.
The Cook Unimpregnated Central Venous Catheter with power injection is intended for adult and pediatric populations.

Device Description

AI/ML Overview

The provided text describes the acceptance criteria and the results of various performance tests for the Cook Unimpregnated Central Venous Catheter. It is a submission for a 510(k) premarket notification to demonstrate substantial equivalence to a predicate device, not an AI or algorithm-driven device. Therefore, many of the requested categories (such as sample size for test set, data provenance, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance) are not applicable to this document.

Here's the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria	Reported Device Performance
Catheter Shaft Tensile (Aged)	Peak tensile load for the shaft section of the catheter shall be: - ≥ 5 N for 2.5 and 3 Fr catheters - ≥ 10 N for 4 and 5 Fr catheters - ≥ 15 N for catheters > 5 Fr (In accordance with BS EN ISO 10555-1:2013)	The acceptance criteria were met.
Catheter Sideport Tensile (Aged)	Peak tensile load for the sideport section of the catheter shall be: - ≥ 10 N for 4 and 5 Fr catheters - ≥ 15 N for catheters > 5 Fr (In accordance with BS EN ISO 10555-1:2013)	The acceptance criteria were met.
Catheter Shaft-to-Hub Tensile (Aged)	Peak tensile load for the shaft-to-hub section of the catheter shall be: - ≥ 5 N for 2.5 and 3 Fr catheters - ≥ 10 N for 4 and 5 Fr catheters - ≥ 15 N for catheters > 5 Fr (In accordance with BS EN ISO 10555-1:2013)	The acceptance criteria were met.
Catheter Shaft-to-Manifold Tensile (Aged)	Peak tensile load for the shaft-to-manifold section of the catheter shall be: - ≥ 10 N for 4 and 5 Fr catheters - ≥ 15 N for catheters > 5 Fr (In accordance with BS EN ISO 10555-1:2013)	The acceptance criteria were met.
Catheter Manifold-to-Extension Tube Tensile (Aged)	Peak tensile load for the manifold-to-extension tube section of the catheter shall be: - ≥ 10 N for 4 and 5 Fr catheters - ≥ 15 N for catheters > 5 Fr (In accordance with BS EN ISO 10555-1:2013)	The acceptance criteria were met.
Catheter Extension Tube-to-Hub Tensile (Aged)	Peak tensile load for the extension tube-to-hub section of the catheter shall be: - ≥ 10 N for 4 and 5 Fr catheters - ≥ 15 N for catheters > 5 Fr (In accordance with BS EN ISO 10555-1:2013)	The acceptance criteria were 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 Radius (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 of the test articles will be characterized when tested in accordance with Annex E of BS EN ISO 10555-1.	The acceptance criterion was met.
Catheter Static Burst (Aged)	The catheter failure pressure during static burst was characterized for the test articles when tested in accordance with Annex F of BS EN ISO 10555-1.	The acceptance criterion was met.
Catheter Hub Pressure (Power Injection) (Aged)	The peak hub pressure of the power injectable lumen for each specimen type for the test articles when tested in accordance with Annex G of BS EN ISO 10555-1.	The acceptance criterion was met.
Inner Catheter Shaft Tensile (Time-Zero)	Peak tensile load for the shaft section of the inner catheter shall be: - ≥ 5 N for 3 Fr catheters - ≥ 10 N for 4 Fr catheters (In accordance with BS EN ISO 10555-1:2013)	The acceptance criteria were met.
Inner Catheter Hub-to-Shaft Tensile (Time-Zero)	Peak tensile load for the hub-to-shaft section of the inner catheter shall be: - ≥ 5 N for 3 Fr catheters - ≥ 10 N for 4 Fr catheters (In accordance with BS EN ISO 10555-1:2013)	The acceptance criteria were met.
Dilator Hub-to-Shaft Tensile (Aged)	Peak tensile load for the hub-to-shaft section of the dilator shall be: - ≥ 5 N for 3.0 Fr dilators - ≥ 10 N for 3.5, 4.0, 5.0, and 5.5 Fr dilators - ≥ 15 N for dilators > 5.5 Fr (In accordance with BS EN ISO 11070)	The acceptance criterion was met.
Dilator and Wire Guide Compatibility Analysis	Each unique dilator French size shall be compatible with the correlating wire guide.	The acceptance criteria were met (implied by "The acceptance criterion was met").
Catheter Hub Luer Compatibility Analysis	Tested in accordance with the test methods specified in ISO 594-1:1986 and ISO 594-2:1998.	The acceptance criterion was met (implied by "The acceptance criterion was met").
Packaging: Dye penetration testing	Per ASTM F1929-15.	Performed (stated "Performed to assure design and performance").
Packaging: Seal strength testing	Per ASTM F88/F88M-15.	Performed (stated "Performed to assure design and performance").
Sterilization validation testing	Per ISO 11135-1:2014.	Performed (stated "Performed to assure design and performance").
Biocompatibility Testing	Testing for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, genotoxicity, implantation, and hemocompatibility were performed per ISO 10993-1 and FDA guidance.	Performed (stated "Performed to ensure the biocompatibility of the subject device set").

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each performance test. It mentions "each specimen type" for some tests, implying multiple samples were tested for each variation. Data provenance is not explicitly stated in terms of country of origin or whether it was retrospective/prospective, but these are laboratory-based performance tests, not clinical studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This document describes laboratory performance testing of a physical medical device, not a diagnostic or AI-driven system that requires expert ground truth.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, this is about the mechanical and material performance of a central venous catheter, not a diagnostic or AI system.

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

Not applicable, as this is not an algorithm or AI device.

7. The type of ground truth used

For the performance tests, the "ground truth" is defined by the objective physical and chemical standards and test methods specified by the referenced international standards (e.g., BS EN ISO 10555-1, BS EN 13868, ISO 594-1, ISO 594-2, ASTM F1929-15, ASTM F88/F88M-15, ISO 11135-1, ISO 10993-1). These standards outline the methods to objectively measure and verify the device's characteristics.

8. The sample size for the training set

Not applicable, as this is not an AI or algorithm-driven device that requires a training set.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

May 17, 2019

Cook Incorporated Chelsea Woods Regulatory Affairs Specialist 750 Daniels Way P.Box 489 Bloomington, Indiana 47404

Re: K182252

Trade/Device Name: Cook Unimpregnated Central Venous Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular catheter Regulatory Class: Class II Product Code: FOZ, DRE Dated: April 15, 2019 Received: April 16, 2019

Dear Chelsea Woods:

We have reviewed vour 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/cfpmp/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

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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.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Tina Kiang, Ph.D Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182252

Device Name

Cook Unimpregnated Central Venous Catheter

Indications for Use (Describe)

The Cook Unimpregnated Central Venous Catheter (Non-Power Injectable) is used for:
1. Continuous or intermittent drug infusions
1. Central venous blood pressure monitoring (CVP)
1. Acute hyperalimentation
1. Blood sampling
1. Delivery of whole blood or blood products
1. Simultaneous, separate infusion of drugs for multi-lumen catheters only

The device is a short-term use catheter, intended for less than 30 days.

The Cook dilator is used for dilating puncture sites or catheter tracts.

The Cook Unimpregnated Central Venous Catheter (Non-Power Injectable) is intended for adult and pediatric populations.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Indications for Use

510(k) Number (if known) K182252

Device Name

Cook Unimpregnated Central Venous Catheter

Indications for Use (Describe)

The Cook Unimpregnated Central Venous Catheter with power injection is used for:
1. Continuous or intermittent drug infusions
1. Central venous blood pressure monitoring (CVP)
1. Acute hyperalimentation
1. Blood sampling
1. Delivery of whole blood or blood products
1. Simultaneous, separate infusion of drugs for multi-lumen catheters only
1. Power injection of contrast media*

*The flow rate may not exceed 3 mL/sec for 4.0 and 5.0 French catheters and 10 mL/sec for 7.0. 8.0. 9.0. and 10.0 French catheters. Verify prior to use that the maximum safety cut-off pressure limit is set at or below 250 psi for 4.0 and 5.0 French catheters and 325 psi for 7.0, 8.0, 9.0, and 10.0 French catheters.

The device is a short-term use catheter, intended for less than 30 days.

The 9.0 and 10.0 French catheters include an inner catheter to facilitate insertion of the main catheter.

The Cook dilator is used for dilating puncture sites or catheter tracts.

The Cook Unimpregnated Central Venous Catheter with power injection is intended for adult and pediatric populations.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/4/Picture/0 description: The image shows the Cook Medical logo. The logo is white text on a red background. The word "COOK" is in large, bold letters, and the word "MEDICAL" is in smaller letters below it.

510(k) SUMMARY

K182252 Cook Unimpregnated Central Venous Catheter 21 CFR §807.92 Date Prepared: May 16, 2019

Submission:	Traditional 510(k) Premarket Notification
Applicant:	Cook Incorporated
Applicant Address:	Cook Incorporated
	750 Daniels Way
	Bloomington, IN 47404
Primary Contact:	Chelsea Woods
Secondary Contact:	Ram Iyer, Ph.D. RAC
Email:	regsubmissions@cookmedical.com
Contact Phone Number:	(812) 335-3575 x104707
Contact Fax Number:	(812) 332-0281

Device Information:

Trade Name:	Cook Unimpregnated Central Venous Catheter
Common Name:	Catheter, Intravascular, Therapeutic, Short-Term Less Than30 Days
Classification Name:	Intravascular catheter
Regulation:	21 CFR §880.5200
Product Code:	FOZ; DRE
Device Class:	II
Classification Panel:	General Hospital

Predicate Device:

The Cook Unimpregnated Central Venous Catheter is substantially equivalent to the following devices:

Cook Central Venous Catheters with or without Heparin (K081113, Cook -Incorporated) cleared on July 30, 2008

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Cook Incorporated - Traditional 510(k) Cook Unimpregnated Central Venous Catheter May 16, 2019

Device Description:

The Cook Unimpregnated Central Venous Catheter is a single use sterile intravascular catheter designed to be inserted into a patient's vascular system. The CVC is inserted into the vasculature using the Seldinger technique. The tip of the catheter is then advanced until it is above the superior vena cava-right atrium (SVC-RA) junction. The CVC configurations include a single, dual, triple, or five-lumen shaft manufactured from polyethylene, ethylene-vinyl acetate, or polyurethane tubing. The CVC is manufactured with an outside diameter between 2.5 and 10 French and has a length between 5 and 40 centimeters dependent on the configuration. Single lumen CVCs are designed with a premolded winged hub on the proximal end. Dual, triple, and five-lumen CVCs are designed with a manifold assembly, which is comprised of a winged manifold connected to extension tubes. Each extension tube has a slide clamp and is manufactured with a proximal winged hub. Certain CVC configurations are power injectable. The CVC may be packaged as a convenience kit with various other components which may include a dilator, inner catheter, wire guide, access needle, injection caps, clamps, catheter securement device, connecting tube, and other convenience accessories. The subject device inner catheter, supplied with the 9 and 10 French subject device catheters, is used to assist advancement of the main catheter over the wire guide. The inner catheter, manufactured from nylon, is designed to lock with the hub of the polyurethane catheter. The subject device dilator, used to dilate the access site during the procedure, is designed with a radiopaque extruded polyethylene shaft and a pre-molded polyethylene proximal hub. It is manufactured with an outside diameter ranging from 3.5 to 12.0 French and has a length between 6 and 11 centimeters. For non-power injectable catheters, the 2.5 French, 3.0 French and 4.0 French catheters are recommended for patients from birth and older (or weighing at least 2.4 kilograms), the 5.0 French catheters are recommended for patients aged 2 years and older (or weighing at least 10 kilograms), the 6.0 French and 6.3 French catheters are recommended for patients aged 4 years and older (or weighing at least 13 kilograms), and the 7.5 French catheters are recommended for patients aged 10 years and older (or weighing at least 50 kilograms). For power injectable catheters, the 4.0 French catheters are recommended for patients from birth and older (or weighing at least 2.4 kilograms), the 5.0 French catheters are recommended for patients aged 2 years and older (or weighing at least 10 kilograms), the 7.0 French and 8.0 French catheters are recommended for patients aged 10 years and older (or weighing at least 50 kilograms),

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and the 9.0 French and 10.0 French catheters are recommended for patients aged 21 years and older (adults only).

The Cook Unimpregnated Central Venous Catheter is a short-term device, sterilized by ethylene oxide, and intended for single use.

Indications for Use (Non-Power Injectable):

The Cook Unimpregnated Central Venous Catheter (Non-Power Injectable) is used for:

1. Continuous or intermittent drug infusions
1. Central venous blood pressure monitoring (CVP)
1. Acute hyperalimentation
1. Blood sampling
1. Delivery of whole blood or blood products
1. Simultaneous, separate infusion of drugs for multi-lumen catheters only

The device is a short-term use catheter, intended for less than 30 days.

The Cook dilator is used for dilating puncture sites or catheter tracts.

The Cook unimpregnated Central Venous Catheter (Non-Power Injectable) is intended for adult and pediatric populations.

Indications for Use (Power Injectable):

The Cook Unimpregnated Central Venous Catheter with power injection is used for:

1. Continuous or intermittent drug infusions
1. Central venous blood pressure monitoring (CVP)
1. Acute hyperalimentation
1. Blood sampling
1. Delivery of whole blood or blood products
1. Simultaneous, separate infusion of drugs for multi-lumen catheters only
1. Power injection of contrast media*

*The flow rate may not exceed 3 mL/sec 4.0Fr and 5.0Fr catheters and 10 mL/sec for 7.0, 8.0, 9.0, and 10.0Fr catheters. Verify prior to use that the maximum safety cut-off pressure limit is set at or below 250 psi for 4.0 and 5.0 French catheters and 325 psi for 7.0, 8.0, 9.0, and 10.0 French catheters.

The device is a short-term use catheter, intended for less than 30 days.

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The 9.0 and 10.0 French catheters include an inner catheter to facilitate insertion of the main catheter.

The Cook dilator is used for dilating puncture sites or catheter tracts.

The Cook Unimpregnated Central Venous Catheter with power injection is intended for adult and pediatric populations.

Comparison to Predicate Device:

The Cook Unimpregnated Central Venous Catheter is substantially equivalent to the predicate device, Cook Central Venous Catheters with or without Heparin (K081113, Cook Incorporated), cleared on July 30, 2008. The subject device is identical to the predicate device in intended use, principle of operation, and fundamental technologies. The differences between the subject device and the predicate device (K081113), including pediatric indication, materials, lumen number, and dimensions do not raise any different questions of safety and/or effectiveness. The substantial equivalence comparison of the subject device to the predicate devices is provided in the table below. To further support the safety and effectiveness of the subject device dilators, Dilator Sets cleared under K183036 are provided as a reference device.

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	PREDICATE DEVICE	SUBJECT DEVICE
	Cook Central Venous Catheters with orwithout Heparin(K081113)	Cook Unimpregnated Central VenousCatheter
Regulation	21 CFR §880.5200	IDENTICAL TO PREDICATE
Product Code	FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	IDENTICAL TO PREDICATE
Classification	II	IDENTICAL TO PREDICATE
Indications forUse	The Cook Central Venous Catheter is usedfor:- Continuous or intermittent druginfusions- Central venous blood pressuremonitoring (CVP)- Acute hyperalimentation- Blood sampling- Delivery of whole blood or bloodproducts- Power injection of contrast mediaThe device is a short-term use catheter.The flow rate of the Cook Central VenousCatheters may not exceed 10 mL/sec.	The Cook Unimpregnated Central VenousCatheter (Non-Power Injectable) is used for:1. Continuous or intermittent drug infusions2. Central venous blood pressure monitoring(CVP)3. Acute hyperalimentation4. Blood sampling5. Delivery of whole blood or bloodproducts6. Simultaneous, separate infusion of drugsfor multi-lumen catheters onlyThe device is a short-term use catheter,intended for less than 30 days.The Cook dilator is used for dilating puncturesites or catheter tracts.The Cook unimpregnated Central VenousCatheter (Non-Power Injectable) is intendedfor adult and pediatric populations
		The Cook Unimpregnated Central Venous
		Catheter with power injection is used for:
		1. Continuous or intermittent drug infusions
		2. Central venous blood pressure monitoring
		(CVP)
		3. Acute hyperalimentation
		4. Blood sampling
		5. Delivery of whole blood or blood
		products
		6. Simultaneous, separate infusion of drugsfor multi-lumen catheters only
		7. Power injection of contrast media*
		*The flow rate may not exceed 3 mL/sec for
		4.0 and 5.0 French catheters and 10 mL/sec
		for 7.0, 8.0, 9.0, and 10.0 French catheters
		Verify prior to use that the maximum safety
		cut-off pressure limit is set at or below 250 psi
		for 4.0 and 5.0 French catheters and 325 psi
		for 7.0, 8.0, 9.0, and 10.0 French catheters.
		The device is a short-term use catheter,
		intended for less than 30 days.
		The 9.0 and 10.0 French catheters include an
		inner catheter to facilitate insertion of the
		main catheter.
		The Cook dilator is used for dilating puncture
		sites or catheter tracts.
		The Cook Unimpregnated Central Venous
		Catheter with power injection is intended for
		adult and pediatric populations.
		Catheter Size	Recommended MinimumAge / Weight
Patient Population	Not specified	2.5Fr	Birth / < 2.4 kg
		3.0Fr	Birth / 2.4 kg
		4.0Fr
		5.0Fr	2 yrs / 10 kg
		6.3Fr	4 yrs / 13 kg
		7.0Fr
		7.5Fr	10 yrs / 50 kg
		8.0Fr
		9.0Fr	21 yrs (adult only)
		10.0Fr
Device is for One-Time Use	Yes	IDENTICAL TO PREDICATE
CatheterPlacement Method	Percutaneous via Seldinger technique	IDENTICAL TO PREDICATE
Catheter TipTarget Anatomy	SVC-RA junction	IDENTICAL TO PREDICATE
Catheter TipLocationConfirmationMethod
Catheter DistalEnd Configuration	Straight and tapered	IDENTICAL TO PREDICATE
Catheter InkMarkings	Yes	IDENTICAL TO PREDICATE
Power InjectableCatheterConfigurations(7-10 Fr)	Dual Lumen: 8 FrTriple Lumen: 7, 9 FrFive-Lumen: 10 Fr	IDENTICAL TO PREDICATE
Upper PressureLimit for PowerInjection (7-10 Fr)	325 psi	IDENTICAL TO PREDICATE
Power InjectableCatheterConfigurations(4-5 Fr)	Not applicable	Dual Lumen: 4, 5 FrTriple Lumen: 5 Fr
Upper PressureLimit for PowerInjection (4-5 Fr)	Not applicable	250 psi
Catheter ShaftMaterial	Polyurethane	PolyethyleneEthylene-Vinyl AcetatePolyurethane
Catheter LumenNumber	2, 3, 5	1, 2, 3, 5
Lumen Shape	Round, Crescent	Round, D-shaped
Catheter OuterDiameter (Fr.)	Dual – 8 FrTriple - 7, 9 FrFive - 10 Fr	Single - 2.5, 3, 4, 5, 6, 6.3 FrDual - 4, 5, 7.5, 8 FrTriple - 5, 7, 9 FrFive – 10 Fr
Catheter Length	15 to 25 cm	5 to 26.5 cm
Inner CatheterMaterial	Nylon	IDENTICAL TO PREDICATE
Inner CatheterOuter Diameter	4.3 French	4.0 French
Dilator Size(French)	3.0-12.0	3.5-12.0
Dilator Tip OD(inch)	0.038-0.157	0.046-0.157
Dilator Tip ID(inch)	0.025-0.043	IDENTICAL TO PREDICATE
Dilator Material	Polyethylene	IDENTICAL TO PREDICATE
Dilator Length(centimeters)	4.0-11.0	IDENTICAL TO PREDICATE
Dilator EndholeDiameter (inch)	0.018, 0.021, 0.025, or 0.035	IDENTICAL TO PREDICATE
Main AccessoryComponents	Wire GuideIntroducer NeedleDilatorSyringeInjection Caps	Wire GuideIntroducer NeedleDilatorSyringeInjection CapsInner CatheterClampsMoveable Suture Wing
Packaging	PETG Tray with Tyvek Lidstock	IDENTICAL TO PREDICATE
SterilizationMethod	EtO	IDENTICAL TO PREDICATE
SterilityAssurance Level	$10^{-6}$	IDENTICAL TO PREDICATE

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Intended Use

The predicate and subject devices are short-term use (less than 30 days) central venous catheters (CVC). They have the same intended use, which is inserted into the patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously.

Indications for Use

Function of catheter: Both the predicate and subject devices are indicated for continuous or intermittent drug infusions, central venous blood pressure monitoring (CVP), acute hyperalimentation, blood sampling, delivery of whole blood or blood products, and power injection of contrast media. The subject device is also indicated for simultaneous, separate infusion of drugs (for multilumen catheters only). Since a multi-lumen CVC allows simultaneous and separate infusion of drugs by utilizing individual lumens, this additional language in the indications for use statement does not raise different questions of safety and/or effectiveness when compared to the predicate device.
Power injection of contrast media: All French sizes of the predicate device catheter are indicated for power injection of contrast media, and the flow rate may not exceed 10 mL/sec. The subject device includes catheters that are indicated for power injection of contrast media and catheters that are not indicated for power injection of contrast media. For the power injectable catheters, the flow rate may not exceed 3.0 mL/sec for the 4.0 and 5.0 French catheters and 10 mL/sec for the 7.0, 8.0, 9.0, and 10.0 French catheters. These flow rate limits were established from performance testing using subject device catheters with power injector pressures set at the maximum safety cut-off pressure to ensure safe and effective use of the catheters. For the 4.0 and 5.0 French subject device catheters, the

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maximum flow rate (3.0 mL/sec) is within the range of a reference device, the Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) (K072625), which is available in 4.0 and 5.0 French with maximum flow rates ranging from 3 mL/sec to 7.0 mL/sec. For the 7.0, 8.0, 9.0, and 10.0 French subject device catheters, the maximum flow rate (10 mL/sec) is identical to the predicate. The 2.5, 3.0, 6.3, and 7.5 French subject device catheters are not indicated for power injection of contrast media. The non-power injectable subject device catheters, not having an indication for power injection of contrast media does not raise different questions of safety and/or effectiveness when comparing to the predicate. In addition, the subject device will include two Instructions for Use (IFU) booklets; one for the power injectable catheters and one for the non-power injectable catheters. For the non-power injectable catheters, the IFU states the following in the Warning Section: "Do not power inject contrast medium through catheter. Catheter rupture may result."

। Patient Population: The predicate device does not specify age / weight recommendation for patient use. The subject device is indicated for adult and pediatric patients. Central venous catheters are critical in establishing a vascular access to sample blood, monitor blood pressure, and administer fluids intravenously, and these functions apply to both adult and pediatric patients. It is common in clinical practice to use relatively small CVCs in pediatric patients because their blood vessels are generally smaller comparing to adult patients. When establishing the minimum age and weight of patients for each catheter French size, the approximate diameters of femoral veins from a wide range of pediatric patients (from preterm neonates to 19 years old) have been carefully considered to ensure each French size is appropriate for use in patients with the associated minimum age/weight.
Overall, the subject and predicate devices have the same intended use and similar indications for use.

Technological Characteristics:

The subject device Cook Unimpregnated Central Venous Catheter was subjected to applicable testing to assure design and performance under the testing parameters. The following tests have been conducted to ensure design and performance under the specified testing parameters:

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Performance:

Catheter Shaft Tensile (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 Fr catheters, 10 N for 4 and 5 Fr catheters, and 15 N for catheters larger than 5 Fr in accordance with BS EN ISO 10555-1:2013. The acceptance criteria were met.
Catheter Sideport Tensile (Aged) The peak tensile load for the sideport section of . the catheter shall be greater than or equal to 10 N for 4 and 5 Fr catheters, and 15 N for catheters larger than 5 Fr in accordance with BS EN ISO 10555-1:2013. The acceptance criteria were met.
Catheter Shaft-to-Hub Tensile (Aged) The peak tensile load for the shaft-to-hub . section of the catheter shall be greater than or equal to 5 N for 2.5 and 3 Fr catheters, 10 N for 4 and 5 Fr catheters, and 15 N for catheters larger than 5 Fr in accordance with BS EN ISO 10555-1:2013. The acceptance criteria were met.
Catheter Shaft-to-Manifold Tensile (Aged) The peak tensile load for the shaft-to-. manifold section of the catheter shall be greater than or equal to 10 N for 4 and 5 Fr catheters, and 15 N for catheters larger than 5 Fr in accordance with BS EN ISO 10555-1:2013. The acceptance criteria were met.
. Catheter Manifold-to-Extension Tube Tensile (Aged) – The peak tensile load for the manifold-to-extension tube section of the catheter shall be greater than or equal to 10 N for 4 and 5 Fr catheters, and 15 N for catheters larger than 5 Fr in accordance with BS EN ISO 10555-1:2013. The acceptance criteria were met.
Catheter Extension Tube-to-Hub Tensile (Aged) The peak tensile load for the . extension tube-to-hub section of the catheter shall be greater than or equal to 10 N for 4 and 5 Fr catheters, and 15 N for catheters larger than 5 Fr in accordance with BS EN ISO 10555-1:2013. The acceptance criteria were 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.

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Catheter Kink Radius (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 of the test articles will be . characterized when tested in accordance with Annex E of BS EN ISO 10555-1. The acceptance criterion was met.
Catheter Static Burst (Aged) The catheter failure pressure during static burst was . characterized for the test articles when tested in accordance with Annex F of BS EN ISO 10555-1. The acceptance criterion was met.
. Catheter Hub Pressure (Power Injection) (Aged) – The peak hub pressure of the power injectable lumen for each specimen type for the test articles when tested in accordance with Annex G of BS EN ISO 10555-1. The acceptance criterion was met.
Inner Catheter Shaft Tensile (Time-Zero) The peak tensile load for the shaft section . of the inner catheter shall be greater than or equal to 5 N for 3 Fr catheters and 10 N for 4 Fr catheters in accordance with BS EN ISO 10555-1:2013. The acceptance criteria were met.
Inner Catheter Hub-to-Shaft Tensile (Time-Zero) The peak tensile load for the hub-. to-shaft section of the inner catheter shall be greater than or equal to 5 N for 3 Fr catheters and 10 N for 4 Fr catheters in accordance with BS EN ISO 10555-1:2013. The acceptance criteria were met.
Dilator Hub-to-Shaft Tensile (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, 10 N for 3.5, 4.0, 5.0, and 5.5 Fr dilators, and 15 N for dilators larger than 5.5 Fr, in accordance with BS EN ISO 11070. The acceptance criterion was met.
. Dilator and Wire Guide Compatibility Analysis – Each unique dilator French size shall be compatible with the correlating wire guide.
. Catheter Hub Luer Compatibility Analysis - The catheter hub subject device was tested in accordance with the test methods specified in ISO 594-1:1986 and ISO 594-2:1998.

Packaging and Sterility Testing:

. Dye penetration testing per ASTM F1929-15
Seal strength testing per ASTM F88/F88M-15 .

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Cook Incorporated - Traditional 510(k) Cook Unimpregnated Central Venous Catheter May 16, 2019

. Sterilization validation testing per ISO 11135-1:2014

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.

Conclusion:

The results of these tests confirm that the Cook Unimpregnated Central Venous Catheter 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 as compared to the predicate device. The submitted information supports the determination that the subject device is substantially equivalent to the primary predicate device, Cook Central Venous Catheters with or without Heparin (K081113).

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).