(30 days)
No
The description focuses on the physical properties and mechanical function of a guidewire, with no mention of AI or ML.
No.
The device is a guidewire designed to facilitate the introduction and positioning of other interventional devices, rather than directly providing therapy.
No
The device is a guidewire used to introduce and position other interventional devices within the neurovasculature, not to diagnose a condition. While it facilitates procedures that might include diagnostic steps, the guidewire itself is an interventional tool.
No
The device description clearly details a physical guidewire made of materials like Nitinol and platinum, intended for insertion into the neurovasculature. It also mentions associated physical accessories (torque device, introducer). This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "selectively introduce and position catheters and other interventional devices within the neurovasculature." This describes a device used within the body for a medical procedure, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description details a physical guidewire designed for navigation within blood vessels. This aligns with an interventional medical device, not an IVD.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.) or to provide diagnostic information about a patient's condition.
- Input Imaging Modality: The mention of Fluoroscopy indicates the device is used in conjunction with imaging techniques to guide its placement within the body, which is typical for interventional devices.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The PVS 1600 Synchro® 0.010" Neuro Guidewire series of products is intended for neurovascular use. It can be used to selectively introduce and position catheters and other interventional devices within the neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The PVS 1600 is a member of the Synchro® Neuro Guidewire family of products having a 0.010" outside diameter, being a sterile, single use/disposable product, with a shapeable tip which is used to gain intravascular access to and facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for neuro diagnostic and interventional procedures. The guidewire can be torqued to facilitate navigation through the vasculature. A torque device, (Merit Medical Systems (K936032)) is supplied with the wire to facilitate deployment & positioning. A guidewire introducer (B. Braun (K760389)) is also supplied and may be used to aid introduction of the guidewire into the catheter hub and/or hemostasis valve and to gently shape the guidewire's distal flexible tip, if desired, according to standard practice. Neither the guidewire introducer or the torque device are intended to enter the body. The product is projected to be provided in a 180cm - 300cm length range, with 200cm being nominal. The Nitinol tip length is projected to be presented in a 35cm - 65cm range, with 55cm being nominal. A traditional range of flexibility profiles shall also be provided, ranging from standard (stiff) to flex (soft). The device is coated on the outer diameter with a lubricious coating over the distal segment of the device. The marker coil is platinum wire at the distal tip of the device to aid visualization under fluoroscopy. The subject device has the ability to access distal, tortuous vasculature, with steerability and torque transmission properties.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Neurovasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians trained in percutaneous, intravascular techniques and procedures
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)
Performance testing of materials comprising the PVS 1600 Synchro® 0.010" Neuro Guidewire was conducted in accordance with ISO 11070:1998, Sterile, Single-Use Intravascular Catheter Introducers. Verification testing for the subject device included dimensional inspection, fatigue assessment, tip flexibility, tip shaping, tensile strength, quide wire compatibility testing and performance under simulated conditions. Subject product testing has yielded acceptable safety & performance outcomes. In addition, torsional strength, torqueability, and corrosion resistance tests also yielded acceptable results.
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.
K002907, K964611, K991646, K002212
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.
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
§ 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.
0
DEC 0 4 2002
K023700
page 1 of 2
Summary of Safety and Effectiveness
| | Submitter of 510(k)
Premarket Notification: | | Precision Vascular
2405 West Orton Circle
West Valley City, UT 84119
Phone: 801.974.1700
Fax: 801.974.1740 | | |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----------------|
| General
Provisions | Contact Person: | | Rick Gaykowski
Vice President, Regulatory/Clinical Affairs
& Quality Systems | | |
| | Device Trade Name:
Device Generic Name: | | PVS 1600 Synchro® 0.010" NGW
Guide Wire | | |
| | The predicate devices are listed in the table below. | | | | |
| Predicate
Devices | Device | Manufacturer | | 510(k) Number,
Concurrence Date | Product
Code |
| | Synchro™ .014" | Precision Vascular | | K002907, 08 March 2001 | DQX |
| | Transend-10 | Target Therapeutics | | K964611, 02 May 1996* | DQX |
| | Agility-10 | Cordis | | K991646, 20 Jul 2000 | DQX |
| | Mirage .008" | Micro Therapeutics | | K002212, 03 Aug 2000 | DQX |
| | * This information is assumed based on our best, current knowledge. | | | | |
| Classification | Class II, 21 CFR 870.1330, Wire, Guide, Catheter 74DQX | | | | |
| Performance
Standards | Performance standards have not been established by FDA under section 514 of the
Federal Food, Drug and Cosmetic Act. | | | | |
| Intended Use | The PVS 1600 Synchro® 0.010" Neuro Guidewire series of products is intended for
neurovascular use. It can be used to selectively introduce and position catheters and
other interventional devices within the neurovasculature. This device should be used
only by physicians trained in percutaneous, intravascular techniques and procedures. | | | | |
| Device
Description | The PVS 1600 is a member of the Synchro® Neuro Guidewire family of products
having a 0.010" outside diameter, being a sterile, single use/disposable product, with a
shapeable tip which is used to gain intravascular access to and facilitate the positioning
and exchange of interventional devices in small diameter, tortuous vasculature for
neuro diagnostic and interventional procedures. The guidewire can be torqued to
facilitate navigation through the vasculature. A torque device, (Merit Medical Systems
(K936032)) is supplied with the wire to facilitate deployment & positioning. A guidewire
introducer (B. Braun (K760389)) is also supplied and may be used to aid introduction of
the guidewire into the catheter hub and/or hemostasis valve and to gently shape the
guidewire's distal flexible tip, if desired, according to standard practice. Neither the
guidewire introducer or the torque device are intended to enter the body. The product | | | | |
Prepared November 1, 2002
1
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is projected to be provided in a 180cm - 300cm length range, with 200cm being nominal. The Nitinol tip length is projected to be presented in a 35cm - 65cm range, with 55cm being nominal. A traditional range of flexibility profiles shall also be provided, ranging from standard (stiff) to flex (soft). The device is coated on the outer diameter with a lubricious coating over the distal segment of the device. The marker coil is platinum wire at the distal tip of the device to aid visualization under fluoroscopy. The subject device has the ability to access distal, tortuous vasculature, with steerability and torque transmission properties.
Technological similarities between the PVS 1600 Synchro® 0.010" Neuro Guidewire and the PVS 1300 Synchro™ predicate remain identical. This is also comparatively true for competitive predicate device features including the basal design and dimensions, generic materials & construction, and hydrophilic coating. In instances where the technological characteristics may differ, it has been demonstrated that there are no new questions raised regarding safety or efficacy of the PVS 1600 Synchro® 0.010" Neuro Guidewire.
Biocompatibility of the PVS 1600 Synchro® 0.010" Neuro Guidewire materials have been verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices - Part 1. Materials test results confirmed biocompatibility of the subject device when tested as an external communicating, blood contact, short duration (