(56 days)
No
The description focuses on the physical characteristics and mechanical performance of a guidewire, with no mention of AI or ML capabilities.
No
The device is a guidewire used to introduce and position other interventional devices within the vasculature, rather than directly treating a condition itself.
Yes
The Device Description explicitly states that the device is used for "peripheral and neuro diagnostic and interventional procedures." This indicates its role in diagnostic processes.
No
The device description clearly details a physical guidewire made of materials like Nitinol and platinum, intended for insertion into the body. It also mentions physical components like a torque device and 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 peripheral and neurovasculature." This describes a device used within the body for interventional procedures, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description details a guidewire designed for navigation within blood vessels, with features like a shapeable tip, lubricious coating, and marker coil for visualization under fluoroscopy. These are characteristics of an invasive medical device used for procedures, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological specimens (blood, urine, tissue, etc.) or to provide diagnostic information based on such testing.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens and provide information for the diagnosis, treatment, or prevention of disease. This device is clearly intended for in vivo (within the body) use.
N/A
Intended Use / Indications for Use
The PV 1900 Synchro® 0.016" Neuro Guidewire series of products is intended for peripheral and neurovascular use. It 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 1900 is a member of the Synchro® Guidewire family of products having a 0.016" 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, (Boston Scientific (K903606)) 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 nor the torque device are intended to enter the body. The product is projected to be provided in a 100cm - 300cm length range with 140-180cm being nominal. The Nitinol tip length is projected to be presented in a 25cm - 35cm range. 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
Not Found
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 1900 Synchro® 0.016" 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, guide wire compatibility testing and performance under simulated conditions. Subject product testing has yielded acceptable safety & performance outcomes.
In addition, torsional strength, torqueability, and EO sterilization 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 1900 Synchro® 0.016" 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.
K032146, K971254, K010511, K913074
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.
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Summary of Safety and Effectiveness
| Amended May 23, 2005 | ||||
|---|---|---|---|---|
| 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 1900 Synchro® 0.016" Guidewire | |||
| Guide Wire | ||||
| The predicate devices are listed in the table below. | ||||
| Device | Manufacturer | 510(k) Number/Date | Pro Code | |
| Predicate | ||||
| Devices | Synchro™ .014" | |||
| Synchro™ .010" | ||||
| Transend | ||||
| Agility-16 | ||||
| 0.016" Guidewire |
-
| Precision Vascular
Precision Vascular
Target Therapeutics
Cordis
Terumo
This information is assumed based upon our best knowledge. | K032146, 12 Aug 2003
K032146, 12 Aug 2003
K971254, 01 Jul 1997*
K010511, 01 Mar 2001*
K913074, 05 Nov 1991* | DQX
DQX
DQX
DQX
DQX |
| 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 1900 Synchro® 0.016" Neuro Guidewire series of products is intended for
peripheral and neurovascular use. It 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 1900 is a member of the Synchro® Guidewire family of products having a
0.016" 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, (Boston
Scientific (K903606)) 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 | | | |
1
| 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 140-180cm being nominal. The Nitinol tip length is projected to be presented in a 25cm - 35cm range. 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 PV 1900 Synchro® 0.016" 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 1900 Synchro® 0.016" 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 ( |