The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System permits access to the patient's peripheral vascular system for short-term venous use (less than 30 days) to sample blood, administer fluids, and perform high pressure contrast injections at a maximum of 325 psi.

The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System permits access to the patient's peripheral vascular system for short-term use (less than 30 days) to facilitate arterial blood pressure measurement and blood sampling.

The safety feature is intended to minimize the risk of sharps injuries.

The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used for any patient population with consideration given to adequacy of anatomy and appropriateness of the procedure.

The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used in hospitals, clinics, and other advanced clinical facilities.

Device Description

The subject device, Arrow™ Endurance™ Extended Dwell Peripheral Catheter System, is a sterile, single use peripheral intravascular device designed to permit access to the peripheral vascular system. The Endurance catheter is intended to permit access to the patient's peripheral vascular system for short-term venous use to sample blood, administer fluids and for high pressure contrast injections at a maximum of 325 psi. The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System permits access to the patient's peripheral vascular system for short-term arterial use to monitor arterial blood pressure and blood sampling. The safety feature is intended to minimize the risk of sharps injuries.

The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System is available in a single lumen, 18 gauge configuration with usable length of 8 cm (3.15").

AI/ML Overview

This document is a 510(k) summary for the Arrow™ Endurance™ Extended Dwell Peripheral Catheter System, seeking substantial equivalence to a predicate device. As such, it focuses on demonstrating equivalence through comparison of technological characteristics and nonclinical bench testing. It does not describe acceptance criteria and a study that proves the device meets those criteria in the context of an AI-powered medical device.

The information provided confirms that the device is a physical intravascular catheter, not an AI/software device. Therefore, the specific requirements listed in the prompt (e.g., sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone algorithm performance) are not applicable to the content of this document.

The document highlights:

Acceptance Criteria (Implied by equivalence): The "acceptance criteria" here are implicitly that the new device performs equivalently to the predicate device in relevant physical and functional characteristics, and that any differences do not raise new questions of safety or effectiveness.
Reported Device Performance: This is demonstrated through a detailed comparison table (Section 7) and a list of "Nonclinical Testing" (Section 8).

Here's a breakdown of what is available and what is not relevant from your prompt:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table with numerical targets as would be seen for an AI device. Instead, it presents a comparison to a predicate device. The "acceptance" is based on demonstrating that the subject device is "substantially equivalent" to the predicate, meaning it performs similarly and does not introduce new safety or effectiveness concerns.

Feature / Characteristic	Subject Device Performance (Reference to K243599)	Predicate Device Performance (Reference to K163513)	Assessment of Device Differences / Meeting "Acceptance"
Classification Name	Catheter, intravascular, therapeutic, short-term less than 30 days	Catheter, intravascular, therapeutic, short-term less than 30 days	Same
Product Code	FOZ	FOZ	Same
Regulation Number	880.5200	880.5200	Same
Class	II	II	Same
Intended Use	Access to patient's peripheral vascular system for short-term venous or short-term arterial use.	Access to patient's peripheral vascular system for short-term venous or short-term arterial use.	Same
Indications for Use	Detailed venous (blood sample, fluids, high pressure contrast @ 325 psi) and arterial (BP measurement, blood sampling) use. Patient population/usage environment specified.	Less granular: sample blood, monitor blood pressure, administer fluids, high pressure injection.	Different granularity; deemed similar, no new safety/effectiveness questions.
Single Use	Yes	Yes	Same
Duration of Use	Less than 30 days	Less than 30 days	Same
Insertion Technique	Guidewire, catheter advance, remove needle/guidewire, deploy safety.	Guidewire, catheter advance, remove needle/guidewire, deploy safety.	Same
Principle of Operation	Closed fluid path system catheter.	Closed fluid path system catheter.	Same
Shelf Life	6 months	2 years	Different, justified by business needs and bench testing.
MR Safety	MR Safe (catheter)	MR Safe (catheter)	Same
Device Components	Guard, Handle, Advancer, Slider, Needle Supports, Needle Safety, Extension Line Clamp, Needle, Guide Wire, Juncture Hub, Catheter with Extension Line.	Same components.	Same
Device Materials (Key Differences Highlighted)	Catheter Body: Polyurethane with Silicone Coating (Quadraflex Polyurethane).	Catheter Body: Polyurethane (Tecoflex Polyurethane).	Different; biocompatibility and bench testing support no new safety/effectiveness concerns.
Catheter Design	Ergonomically designed handle, echogenic needle, passive needle safety, needle support, guidewire with slider.	Same description.	Same
Catheter Body OD	18 Ga	18 Ga, 20 Ga, 22 Ga	Same (for 18 Ga), excluding 20 & 22 Ga.
Catheter Body ID	0.039" (18 Ga)	0.039" (18 Ga), 0.032" (20 Ga), 0.027" (22 Ga)	Same (for 18 Ga), excluding 20 & 22 Ga.
Catheter Usable Length	8 cm (3.15")	6 cm (2.36") (20 Ga, 22 Ga), 8 cm (3.15") (18 Ga, 20 Ga, 22Ga)	Same (for 8cm), excluding 6cm.
Needle Safety Feature	Yes	Yes	Same
Blood Safety Feature	Bloodless (seal and extension lines)	Bloodless (seal and extension lines)	Same
Pressure Injection Limits	325 psi	325 psi	Same
Sidearm Clamp	Pinch	Slide	Different; bench testing supports no new safety/effectiveness concerns.
Juncture Hub Advancer	Half Circle Suture Wing Posts, Removed Hub Nose Clips.	Round Suture Wing Posts, Hub Nose Clips.	Different; bench testing supports no new safety/effectiveness concerns.
Handle	Lower needle support, No Catheter Release Tab.	No Lower Needle Support, Catheter Release Tab.	Different; bench testing supports no new safety/effectiveness concerns.
Sterile	Yes	Yes	Same
Sterilization Method	Ethylene Oxide	Ethylene Oxide	Same
Biocompatibility	Biocompatible (per ISO 10993-1), Prolonged Contact: Circulating Blood.	Biocompatible (per ISO 10993-1), Prolonged Contact: Circulating Blood.	Same

2. Sample sized used for the test set and the data provenance:

This is not an AI/software device, so there isn't a "test set" in the sense of a dataset for algorithm evaluation.
The performance is evaluated through bench testing (listed in Section 8). Details on the specific sample sizes for these physical and material tests are not provided in this summary.
Data provenance: Not applicable as it's not clinical data. The tests are laboratory-based, performed on manufactured devices.

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

Not applicable. This is not an AI/software device requiring expert labeling of data.
The "ground truth" for a physical device is established through engineering specifications, material science, and performance standards.

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

Not applicable. This concept is for resolving disagreements in expert annotations for AI datasets, not for physical device testing.

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. This device is a catheter, not an AI software intended to assist human readers.

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

Not applicable. This is not an AI algorithm. Its performance is inherent in its physical properties and design.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For physical devices like this, the "ground truth" for validating performance is typically derived from:
- Engineering specifications and design requirements: Does it meet the intended physical dimensions, material properties, and functional outputs (e.g., flow rate, pressure limits)?
- Recognized consensus standards: Compliance with ISO standards related to biocompatibility, sterilization, and general medical device safety.
- Bench testing results: Data from rigorous laboratory tests simulating various use conditions.

8. The sample size for the training set:

Not applicable. This is not a machine learning model.

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

Not applicable. This is not a machine learning model.

In summary, this 510(k) pertains to a physical medical device (catheter), not an AI/software product. Therefore, most of the requested information regarding AI device evaluation (test/training sets, expert ground truth, MRMC studies) is not relevant to this document. The "study" proving the device meets acceptance criteria is the comprehensive nonclinical bench testing outlined in Section 8, which demonstrates that the device performs functionally and safely, and is substantially equivalent to its predicate.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 13, 2025

Arrow International, LLC (A Subsidiary of Teleflex, Inc.) Kim Pennington Senior Regulatory Affairs Specialist 3015 Carrington Mill Blvd Morrisville, North Carolina 27560

Re: K243599

Trade/Device Name: Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: February 10, 2025 Received: February 10, 2025

Dear Kim Pennington:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

{1}------------------------------------------------

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advice-comprehensiveregulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

{2}------------------------------------------------

Sincerely,

Porsche Bennett

Porsche Bennett For David Wolloscheck, Ph.D. Assistant 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 Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K243599

Device Name

Arrow™ Endurance™ Extended Dwell Peripheral Catheter System

Indications for Use (Describe)

The safety feature is intended to minimize the risk of sharps injuries.

The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used for any patient population with consideration given to adequacy of anatomy and appropriateness of the procedure.

The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used in hospitals, clinics, and other advanced clinical facilities.

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.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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."

{4}------------------------------------------------

510(k) SUMMARY - K243599

1. Submitter Information

Name:	Arrow International, LLC (a subsidiary of Teleflex Inc.)
Address:	3015 Carrington Mill BlvdMorrisville, NC 27560
Telephone Number:	(610) 451-3095
Contact Person:	Kim PenningtonSr. Regulatory Affairs Specialist
Email:	kim.pennington@teleflex.com
Date Prepared:	March 13, 2025

2. Device Name

Device Trade Name: Arrow™ Endurance™ Extended Dwell Peripheral Catheter System Common Name: Intravascular Catheter Classification Name: Catheter, intravascular, therapeutic, short-term less than 30 days (Class II, FOZ, 21 CFR 880.5200)

3. Predicate Device

K163513: Arrow™ Endurance™ Extended Dwell Peripheral Catheter System Common Name: Intravascular Catheter Classification Name: Catheter, intravascular, therapeutic, short-term less than 30 days (Class II, FOZ, 21 CFR 880.5200)

4. Device Description

The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System is available in a single lumen, 18 gauge configuration with usable length of 8 cm (3.15").

5. Intended Use

The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System is intended to access to the patient's peripheral vascular system for short-term venous or short-term arterial use.

{5}------------------------------------------------

6. Indications for Use

The safety feature is intended to minimize the risk of sharps injuries.

The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used for any patient population with consideration given to adequacy of anatomy and appropriateness of the procedure.

The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used in hospitals, clinics, and other advanced clinical facilities.

7. Technological Characteristics

The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System is substantially equivalent to the predicate Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (K163513) in terms of indications for use, intended use, design, functional performance and materials of construction.

Features	Subject Device:	Predicate Device	Assessment of DeviceDifferences
	Arrow™ Endurance™ Extended Dwell	Arrow™ Endurance™ Extended Dwell
	Peripheral Catheter System	Peripheral Catheter System (K163513)
Classification Name	Catheter, intravascular, therapeutic, short-	Catheter, intravascular, therapeutic, short-	Same
	term less than 30 days	term less than 30 days
Product Code	FOZ	FOZ	Same
Regulation Number	880.5200	880.5200	Same
Class	II	II	Same
Intended Use		The Arrow™ Endurance™ Extended Dwell The Arrow™ Endurance™ Extended Dwell	Same
		Peripheral Catheter System is intended to Peripheral Catheter System is intended to
	access to the patient's peripheral vascular	access to the patient's peripheral vascular
	system for short-term venous or short-	system for short-term venous or short-
	term arterial use.	term arterial use.
Features	Subject Device:	Predicate Device	Assessment of DeviceDifferences
	Arrow™ Endurance™ Extended DwellPeripheral Catheter System	Arrow™ Endurance™ Extended DwellPeripheral Catheter System (K163513)
Indication for Use	The Arrow™ Endurance™ Extendedsystem for short-term venous use (lessthan 30 days) to sample blood, administerfluids, administer blood and bloodproducts, and for high pressure contrastinjections at a maximum of 325 psi.The Arrow™ Endurance™ ExtendedDwell Peripheral Catheter System permitsaccess to the patient's peripheral vascularsystem for short-term use (less than 30days) to facilitate arterial blood pressuremeasurement and blood sampling.The safety feature is intended to minimizethe risk of sharps injuries.The Arrow™ Endurance™ ExtendedDwell Peripheral Catheter may be usedfor any patient population withconsideration given to adequacy ofanatomy and appropriateness of theprocedure.The Arrow™ Endurance™ ExtendedDwell Peripheral Catheter may be used inhospitals, clinics, and other advanced	The Arrow™ Endurance™ Extended DwellDwell Peripheral Catheter System permits Peripheral Catheter System permits accessaccess to the patient's peripheral vascular to the patient's peripheral vascular systemfor short-term use (less than 30 days) tosample blood, monitor blood pressure, oradminister fluids. The catheter may beused for high pressure injection. Thesafety feature is intended to minimize therisk of sharps injuries.	DifferentThe subject device IFUseparates peripheral vascularsystem into Vascular andArterial usage and added thepatient population and usageenvironment. While there is adifference in granularity, theintended use and indicationsfor use of the subject device issimilar. The difference doesnot raise new or differentquestions of safety andeffectiveness.
	clinical facilities.
Single Use	Yes	Yes	Same
Duration of Use	Less than 30 days	Less than 30 days	Same
Insertion Technique	guide wire, advance catheter, removeneedle and guidewire, deploy needlesafety	Gain vascular access with needle, advanceGain vascular access with needle, advanceguide wire, advance catheter, removeneedle and guidewire, deploy needlesafety	Same
Principle of Operation	The catheter is a closed fluid path systemcatheter.	The catheter is a closed fluid path systemthat consists of an insertion platform and athat consists of an insertion platform and acatheter.	Same
Features	Subject Device:Arrow™ Endurance™ Extended DwellPeripheral Catheter System	Predicate DeviceArrow™ Endurance™ Extended DwellPeripheral Catheter System (K163513)	Assessment of DeviceDifferences
Shelf Life	6 months	2 years	DifferentBased on business needs anddoes not affect substantialequivalence. Bench testing anlabeling support that there areno new safety or effectivenessconcerns. See NonclinicalTesting.
MR Safety	MR Safe (catheter)	MR Safe (catheter)	Same
Features	Subject Device:Arrow™ Endurance™ Extended DwellPeripheral Catheter System	Predicate DeviceArrow™ Endurance™ Extended DwellPeripheral Catheter System (K163513)	Assessment of DeviceDifferences
Device Components	Includes Guard, Handle, Advancer, Slider,Needle Supports, Needle Safety,Extension Line Clamp, Needle, GuideWire, Juncture Hub, Catheter withExtension Line	Includes Guard, Handle, Advancer, Slider,Needle Supports, Needle Safety,Extension Line Clamp, Needle, GuideWire, Juncture Hub, Catheter withExtension Line	Same
Device Materials	Guard - PolypropyleneHandle - PolycarbonateAdvancer – PolycarbonateSlider -ABSNeedle Supports - PolycarbonateNeedle Safety - Stainless SteelExtension Line Clamp - AcetalNeedle - Stainless SteelGuide Wire - NitinolJuncture Hub – Polyurethane	Guard - PolypropyleneHandle - PolycarbonateAdvancer – PolycarbonateSlider -ABSNeedle Supports - PolycarbonateNeedle Safety - Stainless SteelExtension Line Clamp - AcetalNeedle - Stainless SteelGuide Wire - NitinolJuncture Hub – Polyurethane	SameThe catheter body and coatingand Extension Line Clampmaterials are different.Biocompatibility and bench totesting demonstrate thedifference does not raise newor different questions of safetyand effectiveness.
Features	Subject Device:	Predicate Device	Assessment of DeviceDifferences
	Arrow™ Endurance™ Extended DwellPeripheral Catheter System	Arrow™ Endurance™ Extended DwellPeripheral Catheter System (K163513)
	Extension Line - Polyurethane	Extension Line - Polyurethane
	Luer Hub - Polyurethane	Luer Hub - Polyurethane
	Catheter Body- Polyurethane withSilicone Coating	Catheter Body – Polyurethane
Catheter DesignConfiguration	The insertion platform consists of anergonomically designed polycarbonatehandle, an integral echogenic needle withopenings to enhance flashback visibilityto confirm placement in the vessel, apassive needle safety mechanism, a needle safety mechanism, a needlesupport to aid in insertion, and a guidewire with a slider advancer.	The insertion platform consists of anergonomically designed polycarbonatehandle, an integral echogenic needle withopenings to enhance flashback visibilityto confirm placement in the vessel, asupport to aid in insertion, and a guidewire with a slider advancer.	Same
Catheter Body OD	18 Ga	18 Ga, 20 Ga, 22 Ga	Same
			Excluding 20 Ga and 22 Ga
Catheter Body ID	0.039" (18 Ga)	0.039" (18 Ga)	Same
		0.032" (20 Ga)	Excluding 20 Ga and 22 Ga
		0.027" (22 Ga)
Catheter Usable Length	8 cm (3.15")	6 cm (2.36") (20 Ga and 22 Ga)	Same
		8 cm (3.15") (18 Ga, 20 Ga, and 22Ga)	Excluding 6 cm
Needle Safety Feature	Yes	Yes	Same
Blood Safety Feature	Bloodless (seal and extension lines)	Bloodless (seal and extension lines)	Same
Pressure Injection Limits	325 psi	325 psi	Same
Sidearm Clamp	Pinch	Slide	DifferentA different clamp has noimpact on substantialequivalence. Bench testingsupports that there are no newsafety or effectivenessconcerns. See NonclinicalTesting.
Juncture Hub Advancer	Half Circle Suture Wing Posts	Round Suture Wing Posts	Different
Features	Subject Device:	Predicate Device	Assessment of DeviceDifferences
	Arrow™ Endurance™ Extended DwellPeripheral Catheter System	Arrow™ Endurance™ Extended DwellPeripheral Catheter System (K163513)
	Removed Hub Nose Clips	Hub Nose Clips	Juncture hub advancer designchanges have no impact onsubstantial equivalence.Bench testing supports thatthere are no new safety oreffectiveness concerns. SeeNonclinical Testing.
Handle	Lower needle support	No Lower Needle Support	Different
	No Catheter Release Tab	Catheter Release Tab	Handle design changes have noimpact on substantialequivalence. Bench testingsupports that there are no newsafety or effectivenessconcerns. See NonclinicalTesting.
Catheter Body Material	Quadraflex Polyurethane	Tecoflex Polyurethane	Different
			The difference in the catheterbody material has no impact onthe use or functionality of thesubject Endurance™ Catheterper its intended use asdemonstrated by bench testingsupporting that there are nonew safety or effectivenessconcerns. See NonclinicalTesting.
Coating	MDX Silicone	None	DifferentThe addition of a coating hasno impact on the use orfunctionality of the subjectEndurance™ Catheter per itsintended per its intended use asdemonstrated by bench testingsupporting that there are nonew safety or effectivenessconcerns. See NonclinicalTesting.
Features	Subject Device:	Predicate Device	Assessment of Device Differences
	Arrow™ Endurance™ Extended DwellPeripheral Catheter System	Arrow™ Endurance™ Extended DwellPeripheral Catheter System (K163513)
Sterilization
Sterile	Yes	Yes	Same
Sterilization Method	Ethylene Oxide	Ethylene Oxide	Same
Biocompatibility
Biocompatibility	Biocompatible materials used(per ISO 10993-1)	Biocompatible materials used(per ISO 10993-1)	SameContact: Circulating BloodDuration: Prolonged

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

{10}------------------------------------------------

{11}------------------------------------------------

8. Nonclinical Testing

Bench testing performed on the Arrow™ Endurance™ Extended Dwell Peripheral Catheter System supports substantial equivalence of the subject devices. The following testing has been completed for the subject devices:

Surface (Extraneous Mater and Defects & Lubricant) ●
Wire Guide Advancement Length ●
Catheter MR Compatibility ●
Device Center of Gravity ●
Latex, DEHP, and BPA Content
Catheter Body Fluid Visualization
Inactivated Extension Line Clamp
Catheter Body Markings
Peak Removal Force
Catheter/ Needle Transition Insertion Force
Needle Support
Wire Guide Advancement Force
Blood Flash
Catheter Insertion tip damage
Catheter column strength
Catheter Tensile Force ●
. Catheter Tensile Elongation
Catheter Body Kink
Catheter Body to Juncture Hub Kink ●
Gravity Flow Rate
Repeat Pressure Injection (Flow Rate)
Static Burst pressure under pressure injection
Catheter Liquid Leakage
Catheter Air Leakage
Extension line Clamp Closure Efficacy
Blood Draw Rate ●
Pumped Flow Rate
Arterial Blood Pressure Monitoring
Catheter Body Softening
Catheter Body Drag Force
Particulate ●
Needle Support
Needle Strength of Union ●
Clamp Force ●

9. Conclusion

The described intended use, results of verification testing performed, comparison of design and fundamental technology and comparison testing to the predicate device demonstrate

{12}------------------------------------------------

that the subject device, Arrow™ Endurance™ Extended Dwell Peripheral Catheter System, is substantially equivalent to the legally marketed predicate device, Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (K163513). Any differences between the subject devices and predicate device do not raise new issues of safety and effectiveness.

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).