(71 days)
Not Found
No
The document describes a physical medical device (catheter system) and its mechanical features. There is no mention of software, algorithms, data processing, or any terms related to AI or ML. The performance studies focus on bench testing of physical properties.
No
The device is described as a system for accessing the peripheral vascular system to sample blood, monitor blood pressure, or administer fluids, particularly for short-term use and infusion therapies. It does not actively treat a disease or condition.
No.
The device is used to access the peripheral vascular system for sampling blood, monitoring blood pressure, or administering fluids, but it does not perform any diagnostic function itself.
No
The device description clearly outlines a physical catheter system with various hardware components (handle, needle, guide wire, catheter body, etc.) and describes bench testing related to these physical components. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states that the Arrow Endurance catheter system is used to access the patient's peripheral vascular system for purposes like sampling blood, monitoring blood pressure, or administering fluids. This is a device that is inserted into the body (in vivo) for direct interaction with the patient's circulatory system.
- Lack of Diagnostic Testing: The device facilitates the collection of blood samples, but it does not perform any diagnostic testing on those samples. The diagnostic testing would be performed separately using other IVD devices or laboratory procedures.
Therefore, based on the intended use and device description, the Arrow Endurance catheter system is a medical device used for accessing the vascular system, not for performing in vitro diagnostic tests.
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 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
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 a handle with an integral needle, a passivelyactivated needle protection mechanism, guide wire with slider advancer, catheter release tab, and single-lumen catheter. The catheter is advanced over the needle and threaded over a guide wire into a peripheral vessel. The catheter system consists of a catheter body, juncture hub, integrated extension tubing with Luer hub, vent plug to prevent blood leakage during insertion, and a clamp.
The catheter is intended for short-term use 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 ga. 20 ga. and 22 ga. configurations with usable lengths of 6 cm (2.36") and 8 cm (3.15").
The overall device description of the subject and predicate Arrow Endurance Extended Dwell Peripheral Catheter Systems are the same.
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 conducted as a result of the device modifications:
- Biocompatibility in accordance with ISO 10993-1
- Applicable requirements from ISO 11070 including:
- Surface: Extraneous Matter and Defects
- Surface: Lubricant
- Guide wire Radio Detectability
- Guide wire Fracture
- Guide wire Flexure
- Guide wire Tensile
- Guide wire Stiffness
- Simulated Use Testing
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 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 24. 2017
Arrow International, Inc. (subsidiary of Teleflex Inc.) % Fallon Young Associate Regulatory Affairs Specialist 2400 Bernville Road Reading, Pennsylvania 19605
Re: K163513
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: January 26, 2017 Received: January 27, 2017
Dear Ms. Fallon Young:
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.
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
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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 devicerelated 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Susan Runno DDS, MA
For Tina Kiang, Ph.D. Acting 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) K163513
Device Name
Arrow Endurance™ Extended Dwell Peripheral Catheter System
Indications for Use (Describe)
The ARROW Endurance catheter system permits access to the patient's peripheral vascular system for short-term use 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.
| 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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K163513
510(K) SUMMARY
(as required by the Safe Medical Devices Act of 1990 and in accordance with 21 CFR $807.92(a))
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 Peron: | Fallon Young |
| Associate Regulatory Affairs Specialist | |
| Telephone Number: | (610) 984-7188 |
| Fax Number: | (610) 374-5360 |
| Email: | fallon.young@teleflex.com |
| Date Prepared: | February 23, 2017 |
2. Device Name
| Device Trade Name: | Arrow® Endurance™ Extended Dwell Peripheral Catheter System |
|---|---|
| Common Name: | Peripheral Intravascular Catheter |
| Classification Name: | Catheter, intravascular, therapeutic |
| (Class II, FOZ, 21 CFR 880.5200) |
3. Predicate Devices
- K152272: Arrow® Endurance™ Extended Dwell Peripheral Catheter System
- K151513: Arrow® Endurance™ Extended Dwell Peripheral Catheter System
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 a handle with an integral needle, a passivelyactivated needle protection mechanism, guide wire with slider advancer, catheter release tab, and single-lumen catheter. The catheter is advanced over the needle and threaded over a guide wire into a peripheral vessel. The catheter system consists of a catheter body, juncture hub, integrated extension tubing with Luer hub, vent plug to prevent blood leakage during insertion, and a clamp.
4
The catheter is intended for short-term use 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 ga. 20 ga. and 22 ga. configurations with usable lengths of 6 cm (2.36") and 8 cm (3.15").
The overall device description of the subject and predicate Arrow Endurance Extended Dwell Peripheral Catheter Systems are the same.
5. Intended Use
The Arrow Endurance Extended Dwell Peripheral Catheter System is intended for short- term use to permit delivery of infusion therapies, infusion of blood and blood products, pressure monitoring, high pressure injection and withdrawal of blood.
The subject Arrow Endurance Extended Dwell Peripheral Catheter System intended use statement is the same as the predicate Arrow Endurance Extended Dwell Peripheral Catheter System intended use statement.
6. Indications for Use
The ARROW Endurance catheter system permits access to the patient's peripheral vascular system for short-term use 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 (K152272 & K151513) in terms of indications for use, intended use, and functional performance.
The only changes made to the subject device Arrow Endurance Extended Dwell Peripheral Catheter System are the guide wire design change and the catheter release colorant change. The modifications to the device's guide wire are shortening the flexible distal portion of the wire and the removal of the stainless steel coil/spring on the distal end of the guide wire. The overall length of the guide wire and the core nitinol wire material are the same as the predicate Endurance device. The modification to the device's catheter release is the addition of one (1) colorant. The base resin will remain the same. Testing on the subject guide wire and catheter release verified that the changes presented no different questions of safety or efficacy.
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Below is a comparison table to highlight the similarities and differences in the subject and predicate Arrow Endurance Extended Dwell Peripheral Catheter Systems.
| Design Feature | Predicate Device:
Arrow Endurance
Extended Dwell
Peripheral Catheter
System K151513 | Predicate Device:
Arrow Endurance
Extended Dwell
Peripheral Catheter
System K152272 | Subject Device:
Arrow Endurance
Extended Dwell
Peripheral Catheter
System |
|-----------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Catheter Body OD | 20 Ga | 18 Ga and 22 Ga | SAME: 18 Ga, 22 Ga, 20 Ga |
| Catheter Body ID | 0.032" (20 Ga) | 0.039 " (18 Ga)
0.027" (22 Ga) | SAME: 0.039 " (18 Ga)
0.027" (22 Ga)
0.032" (20 Ga) |
| Catheter Body Material | Polyurethane | Polyurethane | SAME: Polyurethane |
| Catheter Usable Length | 6 cm (2.36")
8 cm (3.15") | 6 cm (2.36")
8 cm (3.15") | SAME: 6 cm (2.36")
8 cm (3.15") |
| Cather Body Radiopacifier | 20% Barium Sulfate | 20% Barium Sulfate | SAME: 20% Barium Sulfate |
| Needle Safety Feature | Yes | Yes | SAME: Yes |
| Blood Safety Feature | Bloodless (seal and
extension lines) | Bloodless (seal and
extension lines) | SAME: Bloodless (seal and
extension lines) |
| Pressure Injection Limits | 325 psi | 325 psi | SAME: 325 psi |
| Sterilization Method | EO | EO | SAME: EO |
| Flashback Visualization | Yes | Yes | SAME: Yes |
| Guide Wire Comparison | | | |
| Integrated Guide Wire | Yes | Yes | SAME: Yes |
| Guide Wire Coating | None | None | SAME: None |
| Guide Wire Overall Size | 0.010" | 0.010" | SAME: 0.010" |
| Effective Guide Wire Length | 4 cm | 4 cm | SAME: 4 cm |
| Atraumatic Tip | Yes | Yes | SAME: Yes |
| Guide Wire Material | Nitinol | Nitinol | SAME: Nitinol |
| Guide Wire Coil Material | Stainless Steel | Stainless Steel | N/A – No Coil |
| Catheter Release Material | | | |
| Base Material | Blue Polycarbonate | Blue Polycarbonate | SAME: Blue Polycarbonate |
Predicate(s) and Subject Device Comparison
With exception of the changes to the guide wire and the catheter release, no other changes have been made to the subject Arrow Endurance Extended Dwell Peripheral Catheter System in comparison to Arrow International's legally marketed predicate devices, the Arrow Endurance Extended Dwell Peripheral Catheter System (K152272 & K151513).
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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 conducted as a result of the device modifications:
- . Biocompatibility in accordance with ISO 10993-1
- Applicable requirements from ISO 11070 including: ●
- o Surface: Extraneous Matter and Defects
- o Surface: Lubricant
- Guide wire Radio Detectability O
- Guide wire Fracture O
- Guide wire Flexure O
- Guide wire Tensile o
- Guide wire Stiffness ●
- Simulated Use Testing ●
9. Conclusions
The predicate and subject Arrow Endurance Extended Dwell Peripheral Catheter System devices have the same indications for use, intended use, method of application and mechanism of release and are manufactured using the same processes, conditions, and aids. The results of the risk assessment and resultant testing performed have demonstrated that the proposed guide wire design and catheter release colorant change present no different questions of safety or effectiveness and therefore the subject device is considered substantially equivalent to the cited predicate devices.