Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)

K243599 · Arrow International, LLC (A subsidiary of Teleflex, Inc.) · FOZ · Mar 14, 2025 · General Hospital

Device Facts

• Record ID: K243599
• Device Name: Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)
• Applicant: Arrow International, LLC (A subsidiary of Teleflex, Inc.)
• Product Code: FOZ · General Hospital
• Decision Date: Mar 14, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

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.

Device Story

The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System is a sterile, single-use peripheral intravascular catheter. It facilitates vascular access for venous fluid/contrast administration or arterial pressure monitoring. The system includes an insertion platform with an ergonomic polycarbonate handle, echogenic needle for flashback visualization, passive needle safety mechanism, and a nitinol guidewire. The catheter body is made of Quadraflex polyurethane with an MDX silicone coating. It is operated by clinicians in hospitals or clinics. The device provides a closed fluid path. The safety feature minimizes sharps injury risk during insertion. The device is designed for short-term use (less than 30 days).

Clinical Evidence

Bench testing only. No clinical data provided. Testing included surface integrity, tensile force, kink resistance, flow rates, pressure injection limits (325 psi), leakage, and biocompatibility per ISO 10993-1.

Technological Characteristics

Single-lumen, 18 Ga, 8 cm length. Materials: Polyurethane (catheter body/juncture hub/extension line), Polycarbonate (handle/advancer/needle supports), Stainless Steel (needle/needle safety), Nitinol (guidewire), ABS (slider), Polypropylene (guard), Acetal (clamp). Coating: MDX Silicone. Sterilization: Ethylene Oxide. MR Safe. Passive needle safety mechanism.

Indications for Use

Indicated for patients requiring peripheral vascular access for short-term venous use (<30 days) for blood sampling, fluid administration, and high-pressure contrast injections (max 325 psi), or short-term arterial use (<30 days) for blood pressure monitoring and blood sampling. Includes a safety feature to minimize sharps injury risk. Suitable for any patient population based on anatomy and procedure appropriateness. Used in hospitals, clinics, and advanced clinical facilities.

Regulatory Classification

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.

Predicate Devices

• Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (K163513)

Submission Summary (Full Text)

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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"

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(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 ([e-mail]) or phone [phone] 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) K243599

Device Name

Arrow™ Endurance™ Extended Dwell Peripheral Catheter System

#### Indications for Use (Describe)

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.

| 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 - K243599

#### 1. Submitter Information

| Name: | Arrow International, LLC (a subsidiary of Teleflex Inc.) |
|-------------------|----------------------------------------------------------|
| Address: | 3015 Carrington Mill Blvd<br>Morrisville, NC 27560 |
| Telephone Number: | [phone] |
| Contact Person: | Kim Pennington<br>Sr. Regulatory Affairs Specialist |
| Email: | [e-mail] |
| 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 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").

#### 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 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.

## 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<br>Differences |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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 Device<br>Differences |
| | Arrow™ Endurance™ Extended Dwell<br>Peripheral Catheter System | Arrow™ Endurance™ Extended Dwell<br>Peripheral Catheter System (K163513) | |
| Indication for Use | The Arrow™ Endurance™ Extended<br>system for short-term venous use (less<br>than 30 days) to sample blood, administer<br>fluids, administer blood and blood<br>products, and for high pressure contrast<br>injections at a maximum of 325 psi.<br>The Arrow™ Endurance™ Extended<br>Dwell Peripheral Catheter System permits<br>access to the patient's peripheral vascular<br>system for short-term use (less than 30<br>days) to facilitate arterial blood pressure<br>measurement and blood sampling.<br>The safety feature is intended to minimize<br>the risk of sharps injuries.<br>The Arrow™ Endurance™ Extended<br>Dwell Peripheral Catheter may be used<br>for any patient population with<br>consideration given to adequacy of<br>anatomy and appropriateness of the<br>procedure.<br>The Arrow™ Endurance™ Extended<br>Dwell Peripheral Catheter may be used in<br>hospitals, clinics, and other advanced | The Arrow™ Endurance™ Extended Dwell<br>Dwell Peripheral Catheter System permits Peripheral Catheter System permits access<br>access to the patient's peripheral vascular to the patient's peripheral vascular system<br>for short-term use (less than 30 days) to<br>sample blood, monitor blood pressure, or<br>administer fluids. The catheter may be<br>used for high pressure injection. The<br>safety feature is intended to minimize the<br>risk of sharps injuries. | Different<br>The subject device IFU<br>separates peripheral vascular<br>system into Vascular and<br>Arterial usage and added the<br>patient population and usage<br>environment. While there is a<br>difference in granularity, the<br>intended use and indications<br>for use of the subject device is<br>similar. The difference does<br>not raise new or different<br>questions of safety and<br>effectiveness. |
| | 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, remove<br>needle and guidewire, deploy needle<br>safety | Gain vascular access with needle, advanceGain vascular access with needle, advance<br>guide wire, advance catheter, remove<br>needle and guidewire, deploy needle<br>safety | Same |
| Principle of Operation | The catheter is a closed fluid path system<br>catheter. | The catheter is a closed fluid path system<br>that consists of an insertion platform and athat consists of an insertion platform and a<br>catheter. | Same |
| Features | Subject Device:<br>Arrow™ Endurance™ Extended Dwell<br>Peripheral Catheter System | Predicate Device<br>Arrow™ Endurance™ Extended Dwell<br>Peripheral Catheter System (K163513) | Assessment of Device<br>Differences |
| Shelf Life | 6 months | 2 years | Different<br>Based on business needs and<br>does not affect substantial<br>equivalence. Bench testing an<br>labeling support that there are<br>no new safety or effectiveness<br>concerns. See Nonclinical<br>Testing. |
| MR Safety | MR Safe (catheter) | MR Safe (catheter) | Same |
| Features | Subject Device:<br>Arrow™ Endurance™ Extended Dwell<br>Peripheral Catheter System | Predicate Device<br>Arrow™ Endurance™ Extended Dwell<br>Peripheral Catheter System (K163513) | Assessment of Device<br>Differences |
| Device Components | Includes Guard, Handle, Advancer, Slider,<br>Needle Supports, Needle Safety,<br>Extension Line Clamp, Needle, Guide<br>Wire, Juncture Hub, Catheter with<br>Extension Line | Includes Guard, Handle, Advancer, Slider,<br>Needle Supports, Needle Safety,<br>Extension Line Clamp, Needle, Guide<br>Wire, Juncture Hub, Catheter with<br>Extension Line | Same |
| Device Materials | Guard - Polypropylene<br>Handle - Polycarbonate<br>Advancer – Polycarbonate<br>Slider -ABS<br>Needle Supports - Polycarbonate<br>Needle Safety - Stainless Steel<br>Extension Line Clamp - Acetal<br>Needle - Stainless Steel<br>Guide Wire - Nitinol<br>Juncture Hub – Polyurethane | Guard - Polypropylene<br>Handle - Polycarbonate<br>Advancer – Polycarbonate<br>Slider -ABS<br>Needle Supports - Polycarbonate<br>Needle Safety - Stainless Steel<br>Extension Line Clamp - Acetal<br>Needle - Stainless Steel<br>Guide Wire - Nitinol<br>Juncture Hub – Polyurethane | Same<br>The catheter body and coating<br>and Extension Line Clamp<br>materials are different.<br>Biocompatibility and bench to<br>testing demonstrate the<br>difference does not raise new<br>or different questions of safety<br>and effectiveness. |
| Features | Subject Device: | Predicate Device | Assessment of Device<br>Differences |
| | Arrow™ Endurance™ Extended Dwell<br>Peripheral Catheter System | Arrow™ Endurance™ Extended Dwell<br>Peripheral Catheter System (K163513) | |
| | Extension Line - Polyurethane | Extension Line - Polyurethane | |
| | Luer Hub - Polyurethane | Luer Hub - Polyurethane | |
| | Catheter Body- Polyurethane with<br>Silicone Coating | Catheter Body – Polyurethane | |
| Catheter Design<br>Configuration | The insertion platform consists of an<br>ergonomically designed polycarbonate<br>handle, an integral echogenic needle with<br>openings to enhance flashback visibility<br>to confirm placement in the vessel, a<br>passive needle safety mechanism, a needle safety mechanism, a needle<br>support to aid in insertion, and a guide<br>wire with a slider advancer. | The insertion platform consists of an<br>ergonomically designed polycarbonate<br>handle, an integral echogenic needle with<br>openings to enhance flashback visibility<br>to confirm placement in the vessel, a<br>support to aid in insertion, and a guide<br>wire 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 |
| |…