The ARROW Endurance catheter system permits access to the patient's peripheral vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids. The catheter may be used for high pressure injection. The safety feature is intended to minimize the risk of sharps injuries.

Device Description

The 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 insertion device consists of an ergonomically designed handle with an integral echogenic needle with a passively-activated needle protection mechanism, guide wire with slider advancer, catheter release tab, and single-lumen catheter is advanced over the needle and threaded over a guidewire into a peripheral vessel. Throughout catheter insertion. blood is contained within the device to aid in prevention of blood exposure. The catheter system consists of a translucent radiopaque polyurethane catheter, a needle with openings to enhance flashback visibility, a seal in the catheter hub designed to reduce blood exposure, a stabilization with a strain relief nose designed to reduce kinking at the hub of the catheter, integrated extension tubing with Luer hub, vent plug to prevent blood from leaking out during insertion, and a clamp to eliminate blood exposure when the vent plug is removed and replaced with a mating Luer component such as an infusion set or Luer access device.

The catheter is intended for short-term use (less than 30 days) to permit delivery of infusion therapies, infusion of blood and blood products, pressure monitoring, high pressure injection at a maximum of 325 psi, and withdrawal of blood.

The Arrow Endurance™ Extended Dwell Peripheral Catheter System is available in single lumen, 18, 20 and 22 gauge configurations with usable lengths of 6 cm (2.36") and 8 cm (3.15").

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Arrow Endurance™ Extended Dwell Peripheral Catheter System, based on the provided document:

This document describes a 510(k) submission for a product line extension of an already cleared device, not an entirely new device with a standalone performance study in the traditional sense of evaluating an AI or diagnostic algorithm. Therefore, many of the typical questions for AI/algorithm performance (like sample sizes for test sets, ground truth establishment for training sets, MRMC studies, etc.) are not applicable in this context. The core of this submission is demonstrating substantial equivalence to a previously cleared predicate device.

Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on meeting established international standards and demonstrating functional equivalence to the predicate device. The "reported device performance" is essentially the successful completion of these tests.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria / Standard	Demonstrated Performance / Status
Biocompatibility	ISO 10993-1, -3, -4, -5, -6, -7, -10, -11, -12	Testing completed / Device is biocompatible.
Physical and Functional Performance (ISO 10555 & 11070 Requirements)	Radio-Detectability	Testing completed / Device is radio-detectable.
	Surface	Testing completed / Meets surface requirements.
	Corrosion Resistance	Testing completed / Device is corrosion-resistant.
	Freedom from leakage (Air and Liquid)	Testing completed / Device is free from leakage.
	Flow rate	Testing completed / Meets flow rate specifications.
	Pressure Injection	Testing completed / Withstands 325 psi.
	Tensile Testing	Testing completed / Meets tensile strength requirements.
	Blood Containment	Testing completed / Effectively contains blood.
Luer Testing	BS EN 20594-1 (ISO 594-1) & BS EN 1707	Testing completed / Meets Luer connection standards.
Simulated Use	Not specified standard, but indicated as a test	Testing completed / Performs as intended in simulated use.
Penetration/Insertion Force	Not specified standard, but indicated as a test	Testing completed / Meets penetration/insertion force requirements.
Sharps Safety Feature	CDRH Sharps Guidance and ISO 23908	Testing completed / Safety feature performs as intended.
Catheter Kink Resistance	BS EN 13868	Testing completed / Device is kink-resistant.

Study Details (as applicable to a 510(k) of this nature)

Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in the context of an algorithm's performance with a specific number of patient cases. Instead, it refers to bench testing performed on physical samples of the new catheter configurations (18 gauge and 22 gauge, 6cm and 8cm lengths).
- Data Provenance: The testing was conducted by Arrow International, Inc.
- The nature of the testing is retrospective in the sense that physical samples were manufactured and then subjected to various engineering and biological tests. It is not patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not a study involving human interpretation of data where ground truth is established by experts (e.g., radiologists). The "ground truth" for these tests is defined by engineering specifications, international standards (ISO, EN), and regulatory guidance (CDRH).
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. As there are no human interpretations or disagreements to resolve, no adjudication method is used.
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 peripheral catheter system, a physical medical device, not an AI or diagnostic tool. Therefore, no MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance of the catheter is based on engineering specifications, established international standards (ISO, EN), and regulatory guidance (CDRH Sharps Guidance). For example, passing particular flow rate tests, achieving specific tensile strength, or demonstrating a certain level of biocompatibility according to defined protocols and limits.
The sample size for the training set:
- Not Applicable. There is no "training set" in the context of machine learning for this physical device.
How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an algorithm, this question is not relevant.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 23, 2015

Arrow International, Inc. (subsidiary Of Teleflex Inc.) Ms. Tracy Larish Regulatory Affairs Specialist 2400 Bernville Rd Reading, Pennsylvania 19605

Re: K152272

Trade/Device Name: Arrow Endurance™ Extended Dwell Peripheral Catheter System Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: October 23, 2015 Received: October 23, 2015

Dear Ms. Larish:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Tina Kiang -

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _ K152272

Device Name: Arrow Endurance™ Extended Dwell Peripheral Catheter System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) SUMMARY

(as required by the Safe Medical Devices Act of 1990 and in accordance with 21 CFR 8807.92(a))

FOR

THE ARROW ENDURANCE™ EXTENDED DWELL PERIPHERAL CATHETER SYSTEM

1. Submitter Information

Name:	Arrow International, Inc. (subsidiary of Teleflex Inc.)
Address:	2400 Bernville Road
	Reading, PA 19605-9607
Telephone Number:	(610) 378-0131
Contact Person:	Tracy Larish
	Regulatory Affairs Specialist
Telephone Number:	(610) 378-0131 Extension 603835
Fax Number:	(610) 374-5360
Email:	tracy.larish@teleflex.com
Date Prepared:	August 11, 2015

2. Device Name

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

3. Predicate Devices

K151513: Arrow® Endurance™ Extended Dwell Peripheral Catheter System .

4. Device Description

The purpose of this Traditional 510(k) submission is a product line extension to the Arrow Endurance™ Extended Dwell Peripheral Catheter System (K151513) to add 18 gauge and 22 gauge catheters in both 6 and 8 cm lengths. Arrow International's legally marketed predicate device, the Arrow Endurance™ Extended Dwell Peripheral Catheter System (K151513), was cleared with a 20 gauge catheter in lengths of 6 cm and 8 cm. The below device description has been modified to include the entire product offering.

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The Arrow Endurance™ Extended Dwell Peripheral Catheter System is available in single lumen, 18, 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 for short-term use (less than 30 days) to permit delivery of infusion therapies, infusion of blood and blood products, pressure monitoring, high pressure injection and withdrawal of blood.

6. Indications for Use

The indications for use for the subject device are identical to the predicate and are listed below:

The Arrow Endurance catheter system permits access to the patient's peripheral vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids. The catheter may be used for high pressure injection. The safety feature is intended to minimize the risk of sharps injuries.

7. Technological Characteristics

The Arrow Endurance™ Extended Dwell Peripheral Catheter System is substantially equivalent to the predicate Arrow Endurance™ Extended Dwell Peripheral Catheter System (K151513) in terms of indications for use, intended use, design, functional performance and materials of construction.

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Design Feature	Subject device:Arrow Endurance™ ExtendedDwell Peripheral Catheter System	Predicate device:Arrow Endurance™ Extended DwellPeripheral Catheter System (K151513)
Catheter body OD	18 Ga. and 22 Ga.	20 Ga.
Catheter body ID	0.039" (18 Ga.) and 0.027" (22 Ga.)	0.032" (20 Ga.)
Catheter body material	Polyurethane	Polyurethane
Catheter usable length	6 cm (2.36")8 cm (3.15")	6 cm (2.36")8 cm (3.15")
Catheter body Radiopacifier	20% Barium Sulfate	20% Barium Sulfate
Integrated Guide wire	Yes	Yes
Guide wire material/size	Stainless Steel and Nitinol/0.010"	Stainless Steel and Nitinol/0.010"
Needle safety feature	Yes	Yes
Blood safety feature	Bloodless (seal and extension line)	Bloodless (seal and extension line)
Pressure Injection Limits	325 psi	325 psi
Sterilization Method	EO	EO
Flashback visualization	Yes	Yes

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:

Biocompatibility in accordance with ISO 10993-1, 10999-3, 10993-4, 10993-5, o 10993-6, 10993-7, 10993-10, 10993-11 and 10993-12
Requirements from ISO 10555 and ISO 11070 including: O
- l Radio-Detectability
- l Surface
- l Corrosion Resistance
- I Freedom from leakage (Air and Liquid)
- I Flow rate
- Pressure Injection
- I Tensile Testing
- Blood Containment
Luer testing in accordance with BS EN 20594-1(ISO 594-1) & BS EN 1707 O
Simulated Use testing o
Penetration/Insertion force O
Sharps Safety Feature performance in accordance to CDRH Sharps Guidance and O ISO 23908
Catheter Kink resistance in accordance to BS EN 13868 o

9. Conclusions

The described intended use, results of verification testing performed, comparison of design and fundamental technology and comparison testing to the predicate device demonstrated that the subject 18 gauge and 22 gauge devices are substantially equivalent to the legally marketed predicate device, Arrow Endurance™ Extended Dwell Peripheral Catheter System (K151513).

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).