(34 days)
Not Found
No
The provided text describes a mechanical catheter system with a safety feature and does not mention any computational or data-driven components indicative of AI/ML.
Yes
The device is used to administer fluids and therapies, which are intended to treat or manage a patient's condition, making it a therapeutic device.
No
The device is a catheter system used to access the peripheral vascular system for administering fluids, monitoring blood pressure, sampling blood, and high-pressure injection, none of which primarily involve diagnosing a medical condition. While it allows for blood sampling and pressure monitoring, these are functions that support patient management rather than active diagnosis by the device itself.
No
The device description clearly outlines a physical catheter system with various hardware components (needle, guide wire, catheter, tubing, etc.) and describes bench testing related to physical properties and performance. There is no mention of software as a component or the primary function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Device Function: The description clearly states the device is a catheter system used for accessing the patient's peripheral vascular system for purposes like sampling blood, monitoring blood pressure, or administering fluids directly into the body.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze or test a specimen in vitro. The blood sampling mentioned is for collection, not for analysis by the device itself.
The device is an invasive medical device used for accessing the circulatory system.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
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 guide wire 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 platform 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 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, 20 gauge configurations with usable lengths of 6 cm (2.36") and 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
Not Found
Intended User / Care Setting
Not Found
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 device. The following testing has been completed for the subject device:
- Biocompatibility in accordance with ISO 10993-1
- Requirements from ISO 10555 and ISO 11070 including:
- Radio-Detectability
- Surface
- Corrosion Resistance
- Freedom from leakage (Air and Liquid)
- Flow rate
- Pressure Injection
- Tensile Testing
- Blood Containment
- Luer testing in accordance with BS EN 20594-1(ISO 594-1) & BS EN 1707
- Simulated Use testing
- Penetration/Insertion force
- Sharps Safety Feature performance in accordance to CDRH Sharps Guidance and ISO 23908
- Catheter Kink resistance in accordance to BS EN 13868
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three faces in profile, stacked on top of each other, forming a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 8, 2015
Arrow International c/o Mr. Dave Yungvirt Third Party Review Group, LLC 45 Rockefeller Plaza. Suite 2000 New York, NY 1011
Re: K151513
Trade/Device Name: Arrow Endurance™ Extended Dwell Peripheral Catheter System Regulation Number: 21 CFR 880.5200 Regulation Name: Regulatory Class: II Product Code: FOZ Dated: June 21, 2015 Received: June 23, 2015
Dear Mr. Yungvirt:
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.
1
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 -S
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
2
Indications for Use
510(k) Number (if known): _ K151513
Device Name: Arrow Endurance™ Extended Dwell Peripheral Catheter System
Indications for Use:
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.
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 §807.92(a))
FOR
THE ARROW ENDURANCE™ EXTENDED DWELL PERIPHERAL CATHETER SYSTEM (K1515)
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: March 16, 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
- K032843: Nexiva Closed IV Catheter System
- K021120: Radial Artery Catheterization Set with Integral Needle Protection ●
4. 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 guide wire 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 platform 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 products, pressure monitoring, high pressure injection at a maximum of 325 psi, and withdrawal of blood.
4
The Arrow Endurance™ Extended Dwell Peripheral Catheter System is available in single lumen, 20 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 shortterm 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 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 Nexiva Closed IV Catheter System (K032843) and the predicate Arrow Radial Artery Catheterization Set with Integral Needle Protection (K021120) in terms of indications for use, intended use, general design, functional performance and materials of construction.
| Design Feature | Subject device:
Arrow
Endurance™
Extended Dwell
Peripheral
Catheter System | Predicate device:
Nexiva Closed IV
Catheter System
(K032843) | Predicate devices:
Radial Artery Cath. Set
with Integral Needle
Protection (K021120) |
|-----------------------------|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Catheter body OD | 20 Ga | 18, 20, 22, 24 Ga | 20 Ga |
| Catheter body ID | 0.032" (20 Ga) | 0.039", 0.033" (20ga),
0.026", 0.021" | 0.0325"(20 Ga) |
| Catheter body material | Polyurethane | Polyurethane | Polyurethane |
| Catheter usable length | 6 cm(2.36")
8 cm(3.15") | 1.42cm(0.56")
1.91cm(0.75")
2.54cm(1.0")
3.18cm(1.25")
4.45cm(1.75") | 4.45 cm(1.75") |
| Catheter body Radiopacifier | 20% Barium Sulfate | Unknown | 20% Barium Sulfate |
| Integrated Guide wire | Yes | No | Yes |
| Guide wire material/size | Stainless Steel and
Nitinol/0.010" | N/A | Stainless Steel /0.018" |
| Needle safety feature | Yes | Yes | Yes |
| Blood safety feature | Bloodless (seal and
extension line) | Bloodless (seal and
extension line) | None |
| Pressure Injection Limits | 325 psi | 300 psi | N/A |
| Sterilization Method | EO | EO | EO |
| Flashback visualization | Yes | Yes | Yes |
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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 device. The following testing has been completed for the subject device:
- Biocompatibility in accordance with ISO 10993-1 o
- Requirements from ISO 10555 and ISO 11070 including: o
- l Radio-Detectability
- 트 Surface
- Corrosion Resistance
- 트 Freedom from leakage (Air and Liquid)
- 트 Flow rate
- 트 Pressure Injection
- 트 Tensile Testing
- I 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 ISO O 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 devices demonstrated that the subject device, Arrow Endurance™ Extended Dwell Peripheral Catheter System, is substantially equivalent to the legally marketed predicate devices, Nexiva Closed IV Catheter System (K032843) and Radial Artery Catheterization Set with Integral Needle Protection (K021120). Any differences between the subject device and predicate devices do not raise new issues of safety and effectiveness.