(113 days)
Not Found
No
The 510(k) summary describes a physical medical device (a catheter system) and its intended use and performance characteristics. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as permitting access for blood sampling, fluid administration, contrast injections, and blood pressure measurements, which are diagnostic and procedural support functions, not therapeutic treatments.
No
Explanation: The device is used to access the peripheral vascular system for purposes like sampling blood, administering fluids, performing high pressure contrast injections, and monitoring arterial blood pressure. While these activities can be part of diagnostic processes, the device itself is a tool for accessing the body and delivering/collecting substances, not for interpreting data to provide a diagnosis. The device's function is purely interventional/sampling, not diagnostic.
No
The device description clearly states it is a "peripheral intravascular device" and describes physical components like a catheter, needle, and wire guide, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System is a device used to access the patient's peripheral vascular system for procedures like administering fluids, sampling blood, and monitoring blood pressure. It is a tool used on the patient, not a test performed on a sample from the patient.
- Intended Use: The intended use clearly describes procedures performed directly on the patient's vascular system.
Therefore, the device falls under the category of a medical device used for direct patient care, not an in vitro diagnostic.
N/A
Intended Use / 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.
Product codes
FOZ
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").
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral vascular system
Indicated Patient Age Range
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.
Intended User / Care Setting
The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used in hospitals, clinics, and other advanced clinical facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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).
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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
3
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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4
510(k) SUMMARY - K243599
1. Submitter Information
| Name: | Arrow International, LLC (a subsidiary of Teleflex Inc.) |
|---|---|
| Address: | 3015 Carrington Mill Blvd |
| Morrisville, NC 27560 | |
| Telephone Number: | (610) 451-3095 |
| Contact Person: | Kim Pennington |
| Sr. 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 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.
5
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
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
Differences |
| | Arrow™ Endurance™ Extended Dwell
Peripheral Catheter System | Arrow™ Endurance™ Extended Dwell
Peripheral Catheter System (K163513) | |
| Indication for Use | The Arrow™ Endurance™ Extended
system for short-term venous use (less
than 30 days) to sample blood, administer
fluids, administer blood and blood
products, 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 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 | The Arrow™ Endurance™ Extended Dwell
Dwell Peripheral Catheter System permits Peripheral Catheter System permits access
access to the patient's peripheral vascular 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. | Different
The subject device IFU
separates peripheral vascular
system into Vascular and
Arterial usage and added the
patient population and usage
environment. While there is a
difference in granularity, the
intended use and indications
for use of the subject device is
similar. The difference does
not raise new or different
questions of safety and
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
needle and guidewire, deploy needle
safety | Gain vascular access with needle, advanceGain vascular access with needle, advance
guide wire, advance catheter, remove
needle and guidewire, deploy needle
safety | Same |
| Principle of Operation | The catheter is a closed fluid path system
catheter. | The catheter is a closed fluid path system
that consists of an insertion platform and athat consists of an insertion platform and a
catheter. | Same |
| Features | Subject Device:
Arrow™ Endurance™ Extended Dwell
Peripheral Catheter System | Predicate Device
Arrow™ Endurance™ Extended Dwell
Peripheral Catheter System (K163513) | Assessment of Device
Differences |
| Shelf Life | 6 months | 2 years | Different
Based on business needs and
does not affect substantial
equivalence. Bench testing an
labeling support that there are
no new safety or effectiveness
concerns. See Nonclinical
Testing. |
| MR Safety | MR Safe (catheter) | MR Safe (catheter) | Same |
| Features | Subject Device:
Arrow™ Endurance™ Extended Dwell
Peripheral Catheter System | Predicate Device
Arrow™ Endurance™ Extended Dwell
Peripheral Catheter System (K163513) | Assessment of Device
Differences |
| Device Components | Includes Guard, Handle, Advancer, Slider,
Needle Supports, Needle Safety,
Extension Line Clamp, Needle, Guide
Wire, Juncture Hub, Catheter with
Extension Line | Includes Guard, Handle, Advancer, Slider,
Needle Supports, Needle Safety,
Extension Line Clamp, Needle, Guide
Wire, Juncture Hub, Catheter with
Extension Line | Same |
| Device Materials | Guard - Polypropylene
Handle - Polycarbonate
Advancer – Polycarbonate
Slider -ABS
Needle Supports - Polycarbonate
Needle Safety - Stainless Steel
Extension Line Clamp - Acetal
Needle - Stainless Steel
Guide Wire - Nitinol
Juncture Hub – Polyurethane | Guard - Polypropylene
Handle - Polycarbonate
Advancer – Polycarbonate
Slider -ABS
Needle Supports - Polycarbonate
Needle Safety - Stainless Steel
Extension Line Clamp - Acetal
Needle - Stainless Steel
Guide Wire - Nitinol
Juncture Hub – Polyurethane | Same
The catheter body and coating
and Extension Line Clamp
materials are different.
Biocompatibility and bench to
testing demonstrate the
difference does not raise new
or different questions of safety
and effectiveness. |
| Features | Subject Device: | Predicate Device | Assessment of Device
Differences |
| | Arrow™ Endurance™ Extended Dwell
Peripheral Catheter System | Arrow™ Endurance™ Extended Dwell
Peripheral Catheter System (K163513) | |
| | Extension Line - Polyurethane | Extension Line - Polyurethane | |
| | Luer Hub - Polyurethane | Luer Hub - Polyurethane | |
| | Catheter Body- Polyurethane with
Silicone Coating | Catheter Body – Polyurethane | |
| Catheter Design
Configuration | The insertion platform consists of an
ergonomically designed polycarbonate
handle, an integral echogenic needle with
openings to enhance flashback visibility
to confirm placement in the vessel, a
passive needle safety mechanism, a needle safety mechanism, a needle
support to aid in insertion, and a guide
wire with a slider advancer. | The insertion platform consists of an
ergonomically designed polycarbonate
handle, an integral echogenic needle with
openings to enhance flashback visibility
to confirm placement in the vessel, a
support to aid in insertion, and a guide
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 |
| | | 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 | Different
A different clamp has no
impact on substantial
equivalence. Bench testing
supports that there are no new
safety or effectiveness
concerns. See Nonclinical
Testing. |
| Juncture Hub Advancer | Half Circle Suture Wing Posts | Round Suture Wing Posts | Different |
| Features | Subject Device: | Predicate Device | Assessment of Device
Differences |
| | Arrow™ Endurance™ Extended Dwell
Peripheral Catheter System | Arrow™ Endurance™ Extended Dwell
Peripheral Catheter System (K163513) | |
| | Removed Hub Nose Clips | Hub Nose Clips | Juncture hub advancer design
changes have no impact on
substantial equivalence.
Bench testing supports that
there are no new safety or
effectiveness concerns. See
Nonclinical Testing. |
| Handle | Lower needle support | No Lower Needle Support | Different |
| | No Catheter Release Tab | Catheter Release Tab | Handle design changes have no
impact on substantial
equivalence. Bench testing
supports that there are no new
safety or effectiveness
concerns. See Nonclinical
Testing. |
| Catheter Body Material | Quadraflex Polyurethane | Tecoflex Polyurethane | Different |
| | | | The difference in the catheter
body material has no impact on
the use or functionality of the
subject Endurance™ Catheter
per its intended use as
demonstrated by bench testing
supporting that there are no
new safety or effectiveness
concerns. See Nonclinical
Testing. |
| Coating | MDX Silicone | None | Different
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 testing
supporting that there are no
new safety or effectiveness
concerns. See Nonclinical
Testing. |
| Features | Subject Device: | Predicate Device | Assessment of Device Differences |
| | Arrow™ Endurance™ Extended Dwell
Peripheral Catheter System | Arrow™ Endurance™ Extended Dwell
Peripheral 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) | Same
Contact: Circulating Blood
Duration: 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.