(74 days)
Not Found
No
The summary describes a pressure guide wire and associated systems for measuring blood pressure, with no mention of AI or ML technologies.
No
The device is indicated for measuring pressure in blood vessels to provide diagnostic information, not for directly treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use to measure pressure in blood vessels...during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease." This directly points to a diagnostic function.
No
The device description explicitly states it is a "steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: The PrimeWire PRESTIGE® Plus Pressure Guide Wire is used inside the body to measure pressure directly within blood vessels. It is an invasive device used during diagnostic and interventional procedures.
- Intended Use: The intended use clearly states it's for measuring pressure in blood vessels during procedures, not for analyzing samples taken from the body.
Therefore, this device falls under the category of an in vivo diagnostic or therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PrimeWire PRESTIGE® Plus Pressure Guide Wire Device is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.
Product codes
DQX
Device Description
The PrimeWire PRESTIGE® Plus pressure guide wire is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The PrimeWire PRESTIGE® Plus guide wire measures pressure when used with the SmartMap®, s5™ Family, and ComboMap® systems. The PrimeWire PRESTIGE® Plus guide wire has a diameter of 0.014" (0.36 mm) and is available in lengths of 185 cm or 300 cm, and also in straight or pre-shaped tips. The PrimeWire PRESTIGE® Plus guide wire is packaged preconnected to the connector with a torque device to facilitate navigation through the vasculature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels including both coronary and peripheral vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Applicable testing was performed in accordance with the Design Verification Plan including a Risk Analysis addressing the impact of enhancements to the device and components. The test results indicate the PrimeWire PRESTIGE® Plus Pressure Guide Wire is comparable to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Volcano Corporation July 25, 2011
PrimeWire PRESTIGE®Plus Pressure Guide Wire Special 510(k)
510 (K) Summary
AUG - 1 2011
PrimeWire PRESTIGE® Plus Pressure Guide Wire
| Date Prepared: | July 7, 2011 | |
|---|---|---|
| Submitted by: | Volcano Corporation | |
| 3661 Valley Centre Dr. | ||
| Suite 200 | ||
| San Diego, CA 92130 | ||
| Contact person: | Marilyn Pourazar | |
| Senior Director of Regulatory Affairs | ||
| Phone number: | (858) 720-4116 | |
| Facsimile number: | (858) 720-0612 | |
| Device Name: | PrimeWire PRESTIGE® Plus Pressure Guide Wire | |
| Classification name: | > 870.1330 Catheter guide wire | Class |
| II | ||
| > 870.2870 Catheter tip pressure transducer | II |
Predicate Device:
The Volcano PrimeWire PRESTIGE® Plus Pressure Guide Wire is substantially equivalent to the following:
| 510(k) Number | Product Name | Clearance Date |
|---|---|---|
| K100930 | PrimeWire PRESTIGE® Pressure Guide Wire | April 30, 2010 |
Device Description:
The PrimeWire PRESTIGE® Plus pressure guide wire is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The PrimeWire PRESTIGE® Plus guide wire measures pressure when used with the SmartMap®, s5™ Family, and ComboMap® systems. The PrimeWire PRESTIGE® Plus guide wire has a diameter of 0.014" (0.36 mm) and is available in lengths of 185 cm or 300 cm, and also in straight or pre-shaped tips. The PrimeWire PRESTIGE® Plus guide wire is packaged preconnected to the connector with a torque device to facilitate navigation through the vasculature.
l
1
Intended Use:
The PrimeWire PRESTIGE® Plus Pressure Guide Wire Device is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.
Device Technological Characteristics and Comparison to Predicate Device:
The Volcano Corporation PrimeWire PRESTIGE® Plus Pressure Guide Wire Device is substantially equivalent to the predicate device, PrimeWire PRESTIGE® Pressure Guide Wire.
The PrimeWire PRESTIGE® Plus Pressure Guide Wire Device uses the same fundamental scientific technology and has the same intended use as that of the predicate device.
Performance Data:
Applicable testing was performed in accordance with the Design Verification Plan including a Risk Analysis addressing the impact of enhancements to the device and components. The test results indicate the PrimeWire PRESTIGE® Plus Pressure Guide Wire is comparable to the predicate device.
| Design Input Description | Design Change | Required Testing,
Leveraged or
Justification |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Working Length - product shall come
in 185cm and 300 cm lengths | No change from predicate device. | Testing |
| Flexible Distal Length - length of
flexible section shall be ~ 30 cm in
length | No change from predicate device. | Testing |
| Distal Radiopaque Length - length
of distal tip shall be 3.0 cm | No change from predicate device. | Testing |
| Design Input Description | Design Change | Required Testing,
Leveraged or
Justification |
| Maximum outer diameter of .0145" | No change from predicate device. | Justification –
100% verified in
manufacturing |
| The distal 1.0 cm of the wire shall be
equivalent stiffness to the predicate
device tip. | No change from predicate device. | Testing |
| Better torqueability than predicate
device in distal or tortuous anatomy. | Replaced silicon-based coating with
hydrophilic coating | Testing |
| Maintain lubricity within the body
throughout procedure (approx. 60
minutes). | Replaced silicon-based coating with
hydrophilic coating | Testing |
| Particulate generation in simulated use
shall meet USP 788: Maximum of 3000
particles $\ge$ 10 microns; maximum of
300 particles $\ge$ 25 microns. | Replaced silicon-based coating with
hydrophilic coating | Testing |
| Sensor Housing to Core Tensile shall
be $\ge$ 1.0 pounds. | No change from predicate device. | Testing |
| Tip Tensile $\ge$ 1.0 pounds. | No change from predicate device. | Testing |
| Turns to Failure $\ge$ 10 turns | No change from predicate device. | Testing |
| Wire connector must withstand 10
insertions in connector. | No change from predicate device. | Testing |
| Sensor shall have same accuracy as
predicate device | No change from predicate device. | Leveraged from
previously cleared
predicate device |
| Sensor drift shall not exceed 5 mmHG
in 10 minutes | No change from predicate device. | Leveraged from
previously cleared
predicate device and
100% verified in
manufacturing |
| Subjecting PLUS to clinically relevant
tortuosity shall not cause erratic output | No change from predicate device. | |
| 3 year shelf life | Replaced silicon-based coating with
hydrophilic coating | Testing |
| Biocompatibility | Replaced silicon-based coating with
hydrophilic coating | Testing |
| Packaging | No change from predicate device. | Leveraged from
previously cleared
predicate device |
| Sterilization | No change from predicate device. | Leveraged from
previously cleared
predicate device |
Summary of Performance Characteristics
K111395 2
2
3
Biocompatibility Studies:
The biocompatibility of the PrimeWire PRESTIGE® Plus was verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices and FDA Memorandum # G95-1. Test results confirmed biocompatibility of the pressure wire was tested as an external communicating, circulating blood contact, limited exposure (