(110 days)
No
The summary describes a physical medical device (guidewire) and its mechanical properties and intended use. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a guidewire used to introduce and position other interventional devices, not to provide therapy itself.
No
This device is a guidewire primarily used to introduce and position other interventional devices for both diagnostic and interventional procedures, not to perform diagnostics itself.
No
The device description clearly describes a physical guidewire, a hardware component, and mentions performance testing related to physical properties like fatigue, tensile strength, and flexibility.
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 for "general intravascular use, including the neuro and peripheral vasculature" to "selectively introduce and position catheters and other interventional devices." This describes a device used within the body for procedural purposes, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details a physical guidewire designed for navigation and positioning within blood vessels. It mentions features like a shapeable tip, lubricious coating, and a marker coil for visualization under fluoroscopy. These are characteristics of an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis. The device's function is purely mechanical and procedural.
In summary, the PV 2000 Synchro®2 Guidewire is an interventional medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PV 2000 Synchro®2 Guidewire series of products is intended for peripheral and neurovascular use. The device can be used to selectively introduce and position catheters and other interventional devices within the peripheral and 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 PV 2000 is a member of the Synchro® Guidewire family of products having a 0.014" 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 peripheral and neuro diagnostic and interventional procedures. The guidewire can be torqued to facilitate navigation through the vasculature. A torque device, (Merit Medical (K936032)) is supplied with the wire to facilitate deployment & positioning. A guidewire introducer/shaping mandrel (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 nor the torque device are intended to enter the body. The product is projected to be provided in a 100cm - 300cm length range, with 200cm being nominal. The Nitinol tip length is projected to be presented in a 35cm length. A traditional range of flexibility profiles shall also be provided, ranging from support (stiff) to flex (soft). The device is coated on the outer diameter with a lubricious coating over the distal portion 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
Peripheral and 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 PV 2000 Synchro®2 Guidewire was conducted in accordance with ISO 11070:1998, Sterile, Single-Use Intravascular Catheter Introducers. Ventication testing for the subject device included dimensional inspection, fatique assessment, tip flexibility, tip shaping, tensile strength, guidewire compatibility testing and performance under simulated conditions. Subject product testing has yielded acceptable safety & performance outcomes.
In addition, torsional strength, torqueability, and EO sterilization adoption tests also yielded acceptable results. The results of these tests, in conjunction with the substantial equivalence claims as outlined in the premarket notification, effectively demonstrate the PV 2000 Synchro®2 Guidewires' substantial equivalence to the cited predicate devices.
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
§ 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
Image /page/0/Picture/0 description: The image shows a date and a number. The date at the top of the image is July 7, 2026. Below the date is the number 1053268. The text is black against a white background.
page 1 of 2
Summary of Safety and Effectiveness
| Prepared November 22, 2005
| Revised March 2, 2006 | |||||
|---|---|---|---|---|---|
| General | |||||
| Provisions | Submitter of 510(k) | ||||
| Premarket Notification: | Boston Scientific - Precision Vascular | ||||
| 2405 West Orton Circle | |||||
| West Valley City, UT 84119 | |||||
| Phone: 801.974.1700 | |||||
| Fax: 801.974.1740 | |||||
| Contact Person: | Rick Gaykowski | ||||
| VP, Regulatory/Clinical Affairs | |||||
| Quality Systems & Operations | |||||
| Device Trade Name: | |||||
| Device Generic Name: | PV 2000 Synchro®2 Guidewire | ||||
| Guidewire | |||||
| The predicate devices are listed in the table below. | |||||
| Predicate | |||||
| Devices | Device | Manufacturer | 510(k) Number/Date | Pro Code | |
| Synchro™ .014" | Precision Vascular | K032146, 12 August 2003 | DQX | ||
| Synchro™ .010" | |||||
| Synchro™ .016" | |||||
| Transend | Precision Vascular | ||||
| Precision Vascular | |||||
| Target Therapeutics | K032146, 12 August 2003 | ||||
| K050964, 13 June 2005 | |||||
| K971254, 01 July 1997* | DQX | ||||
| DQX | |||||
| DQX | |||||
| * This information is assumed based upon our best 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 PV 2000 Synchro®2 Guidewire series of products is intended for peripheral and | ||||
| neurovascular use. The device can be used to selectively introduce and position | |||||
| catheters and other interventional devices within the peripheral and neurovasculature. | |||||
| This device should be used only by physicians trained in percutaneous, intravascular | |||||
| techniques and procedures. | |||||
| Device | |||||
| Description | The PV 2000 is a member of the Synchro® Guidewire family of products having a | ||||
| 0.014" 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 | |||||
| peripheral and neuro diagnostic and interventional procedures. The guidewire can be | |||||
| torqued to facilitate navigation through the vasculature. A torque device, (Merit Medical | |||||
| (K936032)) is supplied with the wire to facilitate deployment & positioning. A guidewire |
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page 2042
introducer/shaping mandrel (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 nor the torque device are intended to enter the body. The product is projected to be provided in a 100cm - 300cm length range, with 200cm being nominal. The Nitinol tip length is projected to be presented in a 35cm length. A traditional range of flexibility profiles shall also be provided, ranging from support (stiff) to flex (soft). The device is coated on the outer diameter with a lubricious coating over the distal portion 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 Characteristics Technological similarities between the subject PV 2000 Synchro®2 Guidewire and the PVS 1300 Synchro™ predicate remain identical. This is also true for competitive predicate device features including the basal design and dimensions, generic materials & construction, and hydrophilic coating. There are no new questions raised regarding safety or efficacy of the PVS 1300 Synchro® 0.014" Guidewire.
Biocompatibility of the PV 2000 Synchro®2 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 (