(90 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a guidewire, with no mention of AI or ML capabilities.
No.
The device is a guidewire intended to facilitate the placement of other devices within the circulatory system, not to directly treat a medical condition.
Yes
The device is described as facilitating "the placement of central circulatory system or peripheral vasculature devices for diagnostic and interventional procedures." While it is not a diagnostic device itself, it is explicitly stated to aid in diagnostic procedures by guiding other devices.
No
The device description clearly states it is a physical guidewire made of nitinol, a coil wire, and a solid core wire, and includes performance studies related to physical properties like tensile strength, torque strength, and kink resistance. This indicates it is a hardware device, not software only.
Based on the provided information, the Arrow® Nitinol Wires are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "facilitate the placement of central circulatory system or peripheral vasculature devices for diagnostic and interventional procedures." This describes a device used within the body to guide other devices, not a device used to test samples outside the body.
- Device Description: The description details a physical wire designed to be inserted into blood vessels to guide catheters. This is a surgical/interventional tool, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Arrow® Nitinol Wires do not fit this definition.
N/A
Intended Use / Indications for Use
The Arrow® Nitinol Wires are intended to facilitate the placement of central circulatory system or peripheral vasculature devices for diagnostic and interventional procedures.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The Arrow® Nitinol Wires are composed of a coil wire wrapped around a solid core wire, designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel to ensure proper tip placement of the catheter. The clinical benefit of the Arrow® Nitinol Wire is allow the clinician the ability to guide and control the advancing movement of the catheter body through the vessel gaining access to the vascular system through a single puncture site. The guidewires in Arrow / Teleflex Vascular finished goods are typically provided as Spring Wire Guide assemblies including additional components (straightener, Arrow Advancer, tubing clamps, snubber) for easier handling.
Core Material: Nitinol
Coil Material: Stainless Steel
Coil length: Full length
Joining Agent: Weld
Tip Type: Straight or J-shaped
Overall Lengths: 30cm to 68cm
Overall Diameters: 0.018" to 0.035"
Sterilization Method: Ethylene Oxide
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central circulatory system or peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Environment of use: The device is to be used in a hospital and sub-acute facility environment as directed by a physician.
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)
Non-clinical performance testing has been conducted in order to support that the proposed device performs as intended and the product conforms to user needs.
Test: Dimensional Verification
Acceptance Criteria: All dimensions shall be statistically inside tolerance limits according to the drawing with assurance of 95%.
Result: Pass
Test: Title: Visual Inspection / Surface
Acceptance Criteria: When examined by normal or corrected-to-normal vision with minimum 2.5x magnification, the external surface of the effective length of the device shall appear free from extraneous matter.
Result: Pass
Test: Tensile Strength / Peak Tensile Force
Acceptance Criteria: When tested in accordance with the method given in BS EN ISO 11070, Annex H, the minimum peak tensile force of the guidewire and any critical junctions shall be 2 N for diameters
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 18, 2024
Teleflex Medical Madison Snyder Regulatory Affairs Specialist 3015 Carrington Mill Blvd Morrisville, North Carolina 27560
Re: K241784
Trade/Device Name: Arrow® Nitinol Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: May 25, 2024 Received: June 20, 2024
Dear Madison Snyder:
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 820.30 and 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 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-devices/device-advicecomprehensive-regulatory-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-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and 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-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,
Lydia S. Digitally signed
Lydia S. Lydia S. Glaw -S Digitally signed by Glaw 7 2 Date: 2024.09.18
Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular 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) K241784
Device Name Arrow® Nitinol Wire
Indications for Use (Describe)
The Arrow® Nitinol Wires are intended to facilitate the placement of central circulatory system or peripheral vasculature devices for diagnostic and interventional procedures.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY Arrow® Nitinol Wire K241784
Name, Address, Phone and Fax Number of Applicant
Arrow International LLC Subsidiary of Teleflex Incorporated 3015 Carrington Mill Blvd Morrisville, NC 27560 USA Phone: 919.433.4932 Fax: 919.433.4996
Contact Person
Madison Snyder madison.snyder@teleflex.com Regulatory Affairs Specialist
Date Prepared
June 13, 2024
Device Name
Device Trade Name: Arrow® Nitinol Wire Device Common Name: Catheter Guide Wire Device Classification Name: Wire, Guide, Catheter FDA Classification Regulation: 21 CFR 870.1330 FDA Classification: Class II FDA Product Code: DQX Classification Panel: Cardiovascular FDA Panel Number: 74
Predicate Device
Predicate™ III Guidewire (Lake Region Medical)
Device Description
The Arrow® Nitinol Wires are composed of a coil wire wrapped around a solid core wire, designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel to ensure proper tip placement of the catheter. The clinical benefit of the Arrow® Nitinol Wire is allow the clinician the ability to guide and control the advancing movement of the catheter body through the vessel gaining access to the
Teleflex Medical, Inc.
5
vascular system through a single puncture site. The guidewires in Arrow / Teleflex Vascular finished goods are typically provided as Spring Wire Guide assemblies including additional components (straightener, Arrow Advancer, tubing clamps, snubber) for easier handling.
| Core Material | Nitinol |
|---|---|
| Coil Material | Stainless Steel |
| Coil length | Full length |
| Joining Agent | Weld |
| Tip Type | Straight or J-shaped |
| Overall Lengths | 30cm to 68cm |
| Overall Diameters | 0.018" to 0.035" |
| Sterilization Method | Ethylene Oxide |
The guidewire family is bound by the following parameters:
Intended Use Statement
The Arrow Nitinol Wires are intended to facilitate the placement of central circulatory system or peripheral vasculature devices for diagnostic and interventional procedures.
Patient Population
The guidewires are intended for use in patients undergoing central or peripheral vascular access procedures where use of a guidewire to aid insertion is indicated. There are no restrictions on the target patient population. Guidewire choice is per clinician expertise and consideration of guidewire size and patient habitus.
Environment of use
The device is to be used in a hospital and sub-acute facility environment as directed by a physician.
Contraindications
There are no known contraindications for this device.
Substantial Equivalence
The proposed device is substantially equivalent to the predicate device:
| Predicate Device | Manufacturer | 510(k)
Number | Date Cleared |
|-------------------------|------------------------|------------------|-------------------|
| PREDICATE III GUIDEWIRE | Lake Region
Medical | K142393 | November 25, 2014 |
Comparison to Predicate Device
The proposed device has the same or equivalent indications for use, operating principles, classification, sterilization and general design as the predicate device. The subject and predicate devices are both intended to introduce and place vascular devices. In this
Teleflex Medical, Inc.
6
application, the words "coronary vasculature" used for the predicate device means the same as "central circulatory system" used for the subject device. The guidewire is designed for peripheral applications and does not navigate beyond the superior vena cava into further coronary vasculature. Biocompatibility testing and performance testing has been performed on the proposed device in order to establish substantial equivalence to the predicate device. The proposed changes below do not impact the safety or effectiveness of the Arrow Nitinol Wire. The subject device is therefore substantially equivalent to the predicate device identified within this submission.
| | Predicate Device
K142393
Predicate III Guidewire | Proposed
Arrow Nitinol Wire | Equivalence |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Classification
Name | wire, guide, catheter | wire, guide, catheter | Identical |
| Common Name | CATHETER GUIDEWIRE | CATHETER GUIDEWIRE | Identical |
| Product Code | DQX | DQX | Identical |
| Classification | Class II | Class II | Identical |
| Regulation
Number | 870.1330 | 870.1330 | Identical |
| Indications for Use | PREDICATE III GUIDEWIRE are
indicated to facilitate the
placement of devices in
angiographic procedures | The Arrow Nitinol Wires are
indicated to facilitate the
placement of devices for diagnostic
and interventional procedures. | EQUIVALENT |
| Intended Use | The guidewires are intended for
use in angiographic procedures to
introduce and position catheters
and interventional devices within
the coronary and peripheral
vasculature | The guidewires are intended to
facilitate the placement of central
circulatory system or peripheral
vascular devices for diagnostic and
interventional procedures. | EQUIVALENT |
| Device Use | Single Use | Single Use | Identical |
| Prescription | Yes | Yes | Identical |
| Contraindications | There are no known
contraindications for this device | There are no known
contraindications for this device | Identical |
| Shelf Life | 36 months from date of
manufacture | 60 months from date of
manufacture | Similar* |
| Design | A solid nitinol core wire welded at
both ends to SS coil. | A solid nitinol core wire welded
at both ends to SS coil | Identical |
| Tip Type | J-end, straight | J-end, straight | Identical |
| Coating | None | None | Identical |
| Core Material | NiTinol | NiTinol | Identical |
| Coil Material | Stainless steel | Stainless steel | Identical |
| Diameter | 0.018" to 0.038" | 0.018" - 0.035" (0.46 - 0.89 mm) | EQUIVALENT |
| Length | 30cm to 500cm | 17-3/4" - 23-5/8" (45 – 68 cm) | EQUIVALENT |
| Biocompatibility | Biocompatible materials used
(per ISO 10993-1) | Biocompatible materials used
(per ISO 10993-1) | Identical |
| Sterilization
Method | EO | EO | Identical |
Teleflex Medical, Inc.
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*Shelf life was established via performance testing of accelerated-aged products.
Materials
All patient contacting materials, including those with indirect patient contact, are in compliance with ISO 10993-1. Biocompatibility testing has been performed on the proposed device and meets the acceptance criteria.
| Test | Acceptance Criteria | Result |
|---|---|---|
| Cytotoxicity - L 929 Proliferation | The test article will meet the requirements of the test if it obtains a Grade of 0,1,or 2 (not more than 50% of the cells are round, devoid of intracytoplasmic granules, and no extensive cell lysis) | Acceptable |
| Sensitization - Kligman | ||
| Maximization Assay | The test article will be considered a non-irritant if the difference between the test article mean score and the vehicle control mean score is 1.0 or less. | Acceptable |
| Intracutaneous Reactivity Test | ||
| (Polar and Non- Polar (ISO) | The test article will meet the requirements of the test if it receives a Grade of 1, 0 or less using the Kligman scoring system. | Acceptable |
| Acute Systemic Toxicity |
- Systemic Injection Test | The test article will meet the requirements of the test if it does not induce a significantly greater biological reaction than the control. | Acceptable |
| Acute Systemic Toxicity -
Material Mediated Test | The test article will meet the requirements of the test if no rabbit shows an individual rise in temperature of 0.50C or more above the baseline temperature. | Acceptable |
8
| Hemocompatibility – Rabbit
Blood Hemolysis (Complete)
ASTM Test | The test article will meet the requirements of
the test and is not considered to have
hemolytic activity potential, if the hemolytic
index above the negative control article and
negative control article extract is