(29 days)
No
The 510(k) summary describes a mechanical guidewire and its accessories. There is no mention of AI, ML, or any software-driven decision-making or analysis. The device's function is based on its physical properties and the skill of the physician.
No
Explanation: The device is a guidewire used to facilitate the introduction and positioning of other interventional devices, rather than directly providing a therapeutic effect itself.
Yes
The device description explicitly states that the guidewire is used to "gain intravascular access to and facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for peripheral, neuro diagnostic and interventional procedures." This indicates that it can be used for diagnostic purposes.
No
The device description clearly outlines a physical guidewire made of materials like Nitinol, with specific dimensions, coatings, and a marker coil. It also mentions accompanying physical accessories (torque device and introducer). This is a hardware medical device, not software-only.
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, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The description clearly states that this device is a guidewire intended for "general intravascular use," specifically for "selectively introduce and position catheters and other interventional devices within the peripheral & neurovasculature." This means it is used inside the body during medical procedures.
- No Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its purpose is mechanical – to guide other devices within the blood vessels.
Therefore, based on the provided information, this device is an invasive medical device used for interventional procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PVS 1300 Synchro® 0.014" & PVS 1600 Synchro® 0.010" Neuro Guidewire series of products are intended for general intravascular use, which includes peripheral and neurovascular use. The device can be used to selectively introduce and position catheters and other interventional devices within the peripheral & neurovasculature. The 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
products having a 0.014" & 0.010" outside diameter respectively, being sterile, single use/disposable products, with 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, 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 products are 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 25cm - 65cm range, with 35-45cm being nominal. 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 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
general intravascular use, which includes peripheral and neurovascular use. The device can be used to selectively introduce and position catheters and other interventional devices within the peripheral & neurovasculature.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
used only by 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 1300 Synchro® 0.014" & PVS 1600 Synchro® 0.010" guidewires 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, guide 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. The results of these tests, in conjunction with the substantial equivalence claims as outlined in the premarket notification, effectively demonstrate the PVS 1300 Synchro® 0.014" & PVS 1600 Synchro® 0.010" 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.
K002907, K023700, K964611, K001033, K001454, 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
AUG 1 2 2003
510K SUMMARY
K 032146
Summary of Safety and Effectiveness
| Prepared July 11, 2003 | ||||
|---|---|---|---|---|
| General | ||||
| Provisions | 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 | ||||
| Contact Person: | Rick Gaykowski | |||
| Vice President, Regulatory/Clinical Affairs | ||||
| & Quality Systems | ||||
| Device Trade Name: | PVS 1300 Synchro® 0.014" & PVS 1600 Synchro® | |||
| 0.010" Guidewires | ||||
| Device Generic Name: | Guide Wire | |||
| The predicate devices are listed in the table below. | ||||
| Device | Manufacturer | 510(k) Number, | ||
| Concurrence Date | Product | |||
| Code | ||||
| Predicate | ||||
| Devices | Synchro™ .014" | Precision Vascular | K002907, 08 Mar 2001 | DQX |
| Synchro™ .010" | Precision Vascular | K023700, 04 Dec 2002 | DQX | |
| Transend-14 | Target Therapeutics | K964611, 28 Jan 1997 | DQX | |
| Agility-14 | Cordis | K001033, 14 Apr 2000 | DQX | |
| MTI Silverspeed | Micro Therapeutics | K001454, 07 Jun 2000 | 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 1300 Synchro® 0.014" & 1600 Synchro® 0.010" Neuro Guidewire series of | |||
| products are intended for general intravascular use, which includes peripheral and | ||||
| neurovascular use. The device can be used to selectively introduce and position | ||||
| catheters and other interventional devices within the peripheral & neurovasculature. | ||||
| The device should be used only by physicians trained in percutaneous, intravascular | ||||
| techniques and procedures. |
Description products having a 0.014" & 0.010" outside diameter respectively, being sterile, single use/disposable products, with shapeable tip which is used to gain intravascular access
1
to and facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for peripheral, 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 products are 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 25cm - 65cm range, with 35-45cm being nominal. 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 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 Characteristics
Technological similarities between the PVS 1300 Synchro® 0.014" & PVS 1600 Synchro® 0.010" guidewires and the cited Synchro™ predicates remain identical. This is also true for competitive predicate device 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" & PVS 1600 Synchro®0.010" guidewires.
Biocompatibility of the PVS 1300 Synchro® 0.014" 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 (