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 single lumen, 20 and 22 gauge configurations with usable lengths of 6 cm (2.36'') and 8 cm (3.15").

AI/ML Overview

The provided text is a 510(k) Summary for the Arrow™ Endurance™ Extended Dwell Peripheral Catheter System, detailing its substantial equivalence to a predicate device. This document focuses on the physical and functional aspects of a medical device (intravascular catheter) and its comparison to a similar existing device. It does not contain information related to an AI/ML powered medical device, a multi-reader multi-case (MRMC) comparative effectiveness study, or details about ground truth establishment for a diagnostic algorithm.

Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria and studies for an AI/ML device performance, as this information is not present in the provided document. The nonclinical testing listed relates to the physical performance and safety of the catheter itself, not to the diagnostic accuracy of an AI.

To elaborate on why the requested information cannot be found:

Acceptance Criteria & Reported Device Performance (Table): The document provides a comparison of features, materials, and functional aspects of the subject device against a predicate device. It indicates "Same" or "Different" for many features and then lists various nonclinical bench tests in Section 8. However, it does not present quantitative acceptance criteria or reported performance for an AI/ML output. For example, it doesn't state "AI sensitivity > X%" or "AI accuracy > Y%" with corresponding actual performance.
Sample Size (Test Set) & Data Provenance: This would be relevant for an AI study involving patient data. The document describes bench testing of a physical catheter, which does not typically involve a "test set" of patient data in the context of AI.
Number of Experts, Qualifications & Adjudication Method: These points are critical for establishing ground truth in AI studies. Since this device is a physical catheter, there is no AI algorithm generating diagnostic outputs that would require expert adjudication for a ground truth.
MRMC Comparative Effectiveness Study: This type of study assesses how AI affects human reader performance. As the device is not an AI, this study type is not applicable.
Standalone Performance: This refers to the AI algorithm's performance without human intervention. Again, not applicable to a physical catheter.
Type of Ground Truth: For an AI device, ground truth might be pathology, long-term outcomes, or expert consensus. For this physical catheter, "ground truth" is established through engineering specifications, material properties, and physical performance benchmarks.
Sample Size for Training Set & How Ground Truth for Training Set was Established: These are fundamental elements of AI model development. Since this is not an AI device, there is no "training set" or corresponding ground truth establishment process in the context of machine learning.

In summary, the provided document describes the regulatory clearance for a physical medical device (intravascular catheter) through a substantial equivalence pathway, not an AI/ML-powered diagnostic or assistive device. Therefore, the information requested in your prompt is not available within this text.

Summary

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

December 20, 2024

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

Re: K242281

Trade/Device Name: Arrow™ Endurance™ Extended Dwell Peripheral Catheter System Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: November 22, 2024 Received: November 22, 2024

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" (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).

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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 QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 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 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-advicecomprehensive-regulatory-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-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and 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-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).

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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

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Indications for Use

510(k) Number (if known) K242281

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)

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510(k) SUMMARY- K242281

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:	December 20, 2024

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 single lumen, 20 and 22 gauge configurations with usable lengths of 6 cm (2.36'') and 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.

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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 Device Differences
	Arrow™ Endurance™ ExtendedDwell Peripheral Catheter System	Arrow™ Endurance™ ExtendedDwell Peripheral Catheter System(K163513)
Intended Use	The Arrow™ Endurance™Extended Dwell Peripheral CatheterSystem is intended to access to thepatient's peripheral vascular systemfor short-term venous or short-termarterial use.	The Arrow™ Endurance™ ExtendedDwell Peripheral Catheter System isintended to access to the patient'speripheral vascular system for short-term venous or short-term arterial use.	Same
Indication forUse	The Arrow™ Endurance™Extended Dwell Peripheral CatheterSystem permits access to thepatient's peripheral vascular system for short-	The ARROW Endurance cathetersystem permits access to the patient'speripheral vascular system for short-	DifferentThe subject device IFU separates
Features	Subject Device:	Predicate Device	Assessment of Device Differences
	Arrow™ Endurance™ ExtendedDwell Peripheral Catheter System	Arrow™ Endurance™ ExtendedDwell Peripheral Catheter System(K163513)
	patient's peripheral vascular systemfor short-term venous use (less than30 days) to sample blood,administer fluids, administer bloodand blood products, and for highpressure contrast injections at amaximum of 325 psi.The Arrow™ Endurance™Extended Dwell Peripheral CatheterSystem permits access to thepatient's peripheral vascular systemfor short-term use (less than 30days) to facilitate arterial bloodpressure measurement and bloodsampling.The safety feature is intended tominimize the risk of sharps injuries.The Arrow™ Endurance™Extended Dwell Peripheral Cathetermay be used for any patientpopulation with consideration givento adequacy of anatomy andappropriateness of the procedure.The Arrow™ Endurance™Extended Dwell Peripheral Cathetermay be used in hospitals, clinics,and other advanced clinicalfacilities.	term use (less than 30 days) to sampleblood, monitor blood pressure, oradminister fluids. The catheter maybe used for high pressure injection.The safety feature is intended tominimize the risk of sharps injuries.	peripheral vascular system intoVascular and Arterial usage andadded the patient population andusage environment. While there is adifference in granularity, the intendeduse and indications for use of thesubject device is similar. Thedifference does not raise new ordifferent questions of safety andeffectiveness.
Single Use	Yes	Yes	Same
Duration of Use	Less than 30 days	Less than 30 days	Same
Insertion	Gain vascular access with needle,	Gain vascular access with needle,	Same
Features	Subject Device:	Predicate Device	Assessment of Device Differences
	Arrow™ Endurance™ ExtendedDwell Peripheral Catheter System	Arrow™ Endurance™ ExtendedDwell Peripheral Catheter System(K163513)
Technique	advance guide wire, advancecatheter, remove needle andguidewire, deploy needle safety	advance guide wire, advance catheter,remove needle and guidewire, deployneedle safety
Principle ofOperation	The catheter is a closed fluid pathsystem that consists of an insertionplatform and a catheter.	The catheter is a closed fluid pathsystem that consists of an insertionplatform and a catheter.	Same
Shelf Life	6 months	2 years	DifferentBased on business needs and does notaffect substantial equivalence. Benchtesting and labeling support that thereare no new safety or effectivenessconcerns. See Nonclinical Testing.
MR Safety	MR Safe (catheter)	MR Safe (catheter)	Same
Device Design Feature
DeviceComponents	Includes Guard, Handle, Advancer,Slider, Needle Supports, NeedleSafety, Extension Line Clamp,Needle, Guide Wire, Juncture Hub,Catheter with Extension Line	Includes Guard, Handle, Advancer,Slider, Needle Supports, NeedleSafety, Extension Line Clamp,Needle, Guide Wire, Juncture Hub,Catheter with Extension Line	Same
Device Materials	Guard - PolypropyleneHandle - PolycarbonateAdvancer – PolycarbonateSlider -ABSNeedle Supports - PolycarbonateNeedle Safety - Stainless SteelExtension Line Clamp - Acetal	Guard - PolypropyleneHandle - PolycarbonateAdvancer – PolycarbonateSlider -ABSNeedle Supports - PolycarbonateNeedle Safety - Stainless SteelExtension Line Clamp - Acetal	DifferentThe catheter body and coating andExtension Line Clamp materials aredifferent. Biocompatibility and benchtop testing demonstrate the differencedoes not raise new or differentquestions of safety and effectiveness.
Features	Subject Device:	Predicate Device	Assessment of Device Differences
	Arrow™ Endurance™ ExtendedDwell Peripheral Catheter System	Arrow™ Endurance™ ExtendedDwell Peripheral Catheter System(K163513)
	Needle – Stainless SteelGuide Wire - NitinolJuncture Hub – PolyurethaneExtension Line - PolyurethaneLuer Hub - PolyurethaneCatheter Body– QuadraflexPolyurethane with Silicone Coating	Needle - Stainless SteelGuide Wire - NitinolJuncture Hub – PolyurethaneExtension Line - PolyurethaneLuer Hub - PolyurethaneCatheter Body - TecoflexPolyurethane
Catheter DesignConfiguration	The insertion platform consists ofan ergonomically designedpolycarbonate handle, an integralechogenic needle with openings toenhance flashback visibility toconfirm placement in the vessel, apassive needle safety mechanism, aneedle support to aid in insertion,and a guide wire with a slideradvancer.	The insertion platform consists of anergonomically designed polycarbonatehandle, an integral echogenic needlewith openings to enhance flashbackvisibility to confirm placement in thevessel, a passive needle safetymechanism, a needle support to aid ininsertion, and a guide wire with aslider advancer.	Same
Catheter BodyOD	20 Ga, 22 Ga	18 Ga, 20 Ga, 22 Ga	DifferentThe subject device does not include18Ga
Catheter Body ID	0.032" (20 Ga)0.027" (22 Ga)	0.039" (18 Ga)0.032" (20 Ga)0.027" (22 Ga)	DifferentThe subject device does not include18Ga
Catheter UsableLength	6 cm (2.36")8 cm (3.15")	6 cm (2.36")8 cm (3.15")	Same
Needle SafetyFeature	Yes	Yes	Same
Features	Subject Device:	Predicate Device	Assessment of Device Differences
	Arrow™ Endurance™ ExtendedDwell Peripheral Catheter System	Arrow™ Endurance™ ExtendedDwell Peripheral Catheter System(K163513)
Blood SafetyFeature	Bloodless (seal and extension lines)	Bloodless (seal and extension lines)	Same
PressureInjection Limits	325 psi	325 psi	Same
Sidearm Clamp	Pinch	Slide	DifferentA different clamp has no impact onsubstantial equivalence. Benchtesting supports that there are no newsafety or effectiveness concerns. SeeNonclinical Testing.
Juncture HubAdvancer	Half Circle Suture Wing PostsRemoved Hub Nose Clips	Round Suture Wing PostsHub Nose Clips	DifferentJuncture hub advancer designchanges have no impact onsubstantial equivalence. Benchtesting supports that there are no newsafety or effectiveness concerns. SeeNonclinical Testing.
Handle	Lower needle supportNo Catheter Release Tab	No Lower Needle SupportCatheter Release Tab	DifferentHandle design changes have noimpact on substantial equivalence.Bench testing supports that there areno new safety or effectivenessconcerns. See Nonclinical Testing.
Catheter BodyMaterial	Quadraflex Polyurethane	Tecoflex Polyurethane	DifferentThe difference in the catheter bodymaterial has no impact on the use orfunctionality of the subjectEndurance™ Catheter per itsintended use as demonstrated bybench and biocompatibility testing,supporting that there are no newsafety or effectiveness concerns. SeeNonclinical Testing.
Coating	MDX Silicone	None	Different
Features	Subject Device:	Predicate Device	Assessment of Device Differences
	Arrow™ Endurance™ ExtendedDwell Peripheral Catheter System	Arrow™ Endurance™ ExtendedDwell Peripheral Catheter System(K163513)	The addition of a coating has no impact on the use or functionality of the subject Endurance™ Catheter per its intended per its intended use as demonstrated by bench and biocompatibility testing, supporting that there are no new safety or effectiveness concerns. See Nonclinical Testing.
Sterilization
Sterile	Yes	Yes	Same
SterilizationMethod	Ethylene Oxide	Ethylene Oxide	Same
Biocompatibility
Biocompatibility	Biocompatible materials used(per ISO 10993-1)Contact Type: ExternallyCommunicating, Circulating BloodDuration: Prolonged (>24 hrs. and <30 days)	Biocompatible materials used(per ISO 10993-1)Contact Type: ExternallyCommunicating, Circulating BloodDuration: Prolonged (>24 hrs. and <30 days)	Same

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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 ●

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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 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 or different questions 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).