(353 days)
No
The summary describes a mechanical system for embolic protection and aspiration, with no mention of AI or ML components in the device description, intended use, or performance studies.
Yes.
The device's indication to "subselectively infuse/deliver diagnostic or therapeutic agents" implies it can be used to administer substances for treatment, which is a therapeutic function. Additionally, its primary role in containing and aspirating embolic material during procedures is a direct intervention aimed at improving patient outcomes.
No
The device is primarily indicated for containing and aspirating embolic material and for subselectively infusing/delivering diagnostic or therapeutic agents, not for diagnosing conditions itself. While it can deliver diagnostic agents, its core function is interventional support rather than diagnosis.
No
The device description explicitly lists multiple hardware components: GuardWire Temporary Occlusion Catheter, MicroSeal Adapter, EZ Flator Inflation Device, and Export Aspiration Catheter.
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 to provide information for diagnosis, monitoring, or screening.
- Device Function: The description of the PercuSurge GuardWire Plus Temporary Occlusion & Aspiration System clearly indicates it is a medical device used for interventional procedures within the coronary vasculature. It physically interacts with the patient's body to contain and aspirate embolic material and deliver agents.
- Lack of In Vitro Testing: There is no mention of this device being used to test samples outside of the body. Its function is entirely focused on procedures performed directly on the patient.
Therefore, the PercuSurge GuardWire Plus Temporary Occlusion & Aspiration System is a therapeutic or interventional medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The PercuSurge GuardWire Plus Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts (2.5-5.0mm) to:
- Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures.
- To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
- The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.
- The safety and effectiveness of the device as an embolic protection system has not been established in treating patients with acute myocardial infarction.
- The safety and effectiveness of the device as an embolic protection system has not been established in treating native coronaries.
Product codes
NFA
Device Description
The PercuSurge GuardWire Plus Temporary Occlusion & Aspiration System provides temporary vascular occlusion during diagnostic and interventional procedures in the coronary vasculature, specifically-diseased coronary bypass grafts. It is comprised of four principal components: the GuardWire Temporary Occlusion Catheter, the MicroSeal Adapter, the EZ Flator Inflation Device and the Export Aspiration Catheter.
The GuardWire Plus System is a sterile, single-use disposable device, packaged in a protective polyethylene tray covered by a polyethylene/Tyvek pouch. The pouch is then placed into a chipboard carton for protection during shipment. Both the pouch and the carton are labeled for easy product recognition.
The GuardWire Plus System is available in the following configurations:
Wire Diameter: 0.014"
Wire Length: 200cm, 300cm
Balloon Range: 2.5 - 5.0mm
The GuardWire Plus Temporary Occlusion Catheter is a 0.014" diameter guidewire. The shaft is coated to limit the frictional forces encountered when passing therapy devices over the wire. The distal end of the GuardWire contains an inflatable elastomeric balloon designed to occlude the target vessel during emboli-causing procedures such as stenting or angioplasty. The balloon is fully compliant and exerts less than two atmospheres of pressure on the target vessel during occlusion. The distal tip of the wire is a shapeable radiopaque coil similar to other standard guidewires.
The GuardWire is used in conjunction with a removable adapter that assists in the inflation and deflation of the distal occlusion balloon. The MicroSeal Adapter provides a means for opening and closing the internal MicroSeal of the GuardWire which is a small valve internal to the GuardWire Plus Temporary Occlusion Catheter. When the MicroSeal Adapter is in the "OPEN" position, the GuardWire internal seal is opened. This establishes fluid access to the occlusion balloon through the hollow GuardWire shaft. When the MicroSeal Adapter is in the "CLOSE MICROSEAL" position, the MicroSeal of the GuardWire closes. This discontinues fluid access to the occlusion balloon. This allows the occlusion balloon of the GuardWire to remain inflated in the absence of direct communication with an inflation device. The proximal end of the GuardWire Plus catheter is able to control the flow of contrast fluid when used in conjunction with the MicroSeal Adapter. This is achieved by means of a micro-seal plug located on the proximal end of the GuardWire Plus catheter. The MicroSeal plug consists of a wire that is formed to provide friction in the hypo-tube with a sealing member on the distal end. The plug is pushed in and out, hence the sealing member moves distal and proximal to the inflation port, via the MicroSeal Adapter pads that grip the wire plug and are moved in conjunction with the Adapter knob. An inflation port is positioned on the hypotube to line up with the inflation port on the Adapter to provide a continuous fluid path to inflate the occlusion balloon.
The EZ Flator Inflation Device is a controlled volume syringe system contained in a single housing that enables the exact amount of diluted contrast to fill the occlusion balloon to the appropriate size. The fluid is pushed through the extension tubing via a steel plunger pin that is controlled by the inflation dial. The deflation syringe barrel is used for prepping the hypo-tube and deflating the occlusion balloon.
The Export Aspiration catheter is a dual lumen catheter. The smaller of the lumens is the wire lumen used to run over the GuardWire. The larger sized lumen is the aspiration lumen. Via the 20cc syringe and one-way stopcock attached to the proximal end of the Export, blood and debris is evacuated from the graft and into the syringe.
The MicroSeal Adapter provides the mechanism to move the plug on the GuardWire catheter. Six grip pads are located on the Adapter, three on the upper half and three on the lower. Three wire clips are found on the lower half and are used for holding the wire firmly between the pads. The proximal pads are movable via the Adapter knob. The other four pads are immovable and are used to hold in place the GuardWire distal to the plug.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Coronary saphenous vein bypass grafts
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)
Clinical Performance Data (SAFER Study Data Results Summary)
The data below illustrate the vessel sizes treated in the SAFER study (IDE G980209, and cleared under 510(k) K003992). Table 1 demonstrates that out of 406 GuardWire patients (417 vessels and 442 lesions) 113 lesions treated were sized at 3.0mm or less. Table 2 further analyzes the data demonstrating the safety and efficacy results (MACE) for this patient population (n=111 patients).
Table 1: RVD in GuardWire Patients (N=406 Patients, N=442 Lesions)
Reference Vessel Diameter (RVD, in mm)
0 mm = 5.0 mm: 2.9% (12 /417)
All data are from OCA (QCA). Denominator = # of vessels (n=417)
Table 2: MACE Rate in Reference Vessel Diameters
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
KO13913
510(k) Summary
NOV 1 5 2002
| Submitter Information: | PercuSurge, Inc.
540 Oakmead Parkway
Sunnyvale, CA 94085
Matthew Moon, Regulatory Affairs Manager
Fax) 408.733.2489
Tel) 408.733.2423 |
| ------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
| Trade Name: | PercuSurge GuardWire Temporary Occlusion and
Aspiration System |
|----------------------|-------------------------------------------------------------------|
| Common Name: | Distal Occlusion Balloon Catheter |
| Classification Name: | Catheter, Intravascular Occluding, Temporary |
Premarket Notification Number: K013913
Predicate Device: 3-6 GuardWire Plus™ System
Date Prepared: October 31, 2002
1
| PercuSurge, Incorporated
Sunnyvale, California | PercuSurge GuardWire System for Use in
the Percutaneous Interventional Treatment
of Saphenous Vein Bypass Grafts |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Premarket Notification [510(k)]
Application | October 31, 2002 |
Description
The PercuSurge GuardWire Plus Temporary Occlusion & Aspiration System provides temporary vascular occlusion during diagnostic and interventional procedures in the coronary vasculature, specifically-diseased coronary bypass grafts. It is comprised of four principal components: the GuardWire Temporary Occlusion Catheter, the MicroSeal Adapter, the EZ Flator Inflation Device and the Export Aspiration Catheter.
The GuardWire Plus System is a sterile, single-use disposable device, packaged in a protective polyethylene tray covered by a polyethylene/Tyvek pouch. The pouch is then placed into a chipboard carton for protection during shipment. Both the pouch and the carton are labeled for easy product recognition.
The GuardWire Plus System is available in the following configurations:
| Catalog
Number | Wire
Diameter | Wire
Length | Balloon
Range |
|-------------------|------------------|----------------|------------------|
| G14-5-200US | 0.014" | 200cm | 2.5 - 5.0mm |
| G14-5-300US | 0.014" | 300cm | 2.5 - 5.0mm |
Table 1: GuardWire Plus Configurations
The GuardWire Plus Temporary Occlusion Catheter is a 0.014" diameter guidewire available in lengths of 200 and 300 centimeters. The industry standard 0.014" diameter of this device allows for the delivery of a wide range of diagnostic and interventional devices over its shaft. The shaft is coated to limit the frictional forces encountered when passing therapy devices over the wire. The distal end of the GuardWire contains an inflatable elastomeric balloon designed to occlude the target vessel during emboli-causing procedures such as stenting or angioplasty. The balloon is fully compliant and exerts less than two atmospheres of pressure on the target vessel during occlusion. The distal tip of the wire is a shapeable radiopaque coil similar to other standard guidewires.
The GuardWire is used in conjunction with a removable adapter that assists in the inflation and deflation of the distal occlusion balloon. The MicroSeal Adapter provides a means for opening and closing the internal MicroSeal of the GuardWire which is a small valve internal to the GuardWire Plus Temporary Occlusion Catheter. When the MicroSeal Adapter is in the "OPEN" position, the GuardWire internal seal is opened. This establishes fluid access to the occlusion balloon through the hollow GuardWire shaft. When the MicroSeal Adapter is in the "CLOSE MICROSEAL" position, the MicroSeal of the GuardWire closes. This discontinues fluid access to the occlusion balloon. This allows the occlusion balloon of the GuardWire to remain inflated in the absence of direct communication with an inflation device.
2
| PercuSurge, Incorporated
Sunnyvale, California | PercuSurge GuardWire System for Use in
the Percutaneous Interventional Treatment
of Saphenous Vein Bypass Grafts |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Premarket Notification [510(k)]
Application | October 31, 2002 |
GuardWire Plus catheter
The proximal end of the GuardWire Plus catheter is able to control the flow of contrast fluid when used in conjunction with the MicroSeal Adapter. This is achieved by means of a micro-seal plug located on the proximal end of the GuardWire Plus catheter. The MicroSeal plug consists of a wire that is formed to provide friction in the hypo-tube with a sealing member on the distal end. The plug is pushed in and out, hence the sealing member moves distal and proximal to the inflation port, via the MicroSeal Adapter pads that grip the wire plug and are moved in conjunction with the Adapter knob. An inflation port is positioned on the hypotube to line up with the inflation port on the Adapter to provide a continuous fluid path to inflate the occlusion balloon. Fluid is transferred from the EZ Flator to the Adapter through the hypo-tube to fill the occlusion balloon. Fluid. i.e., diluted contrast, passes through the distal end and into the elastomeric occlusion balloon via the laser coil.
EZ Flator Inflation Device
The EZ Flator is a controlled volume syringe system contained in a single housing that enables the exact amount of diluted contrast to fill the occlusion balloon to the appropriate size. The fluid is pushed through the extension tubing via a steel plunger pin that is controlled by the inflation dial. Once the hypo-tube is prepped and the pin is pushed past the distal o-ring, a seal is formed in the extension line. The volume of the plunger pin in the inflation syringe barrel distal to the distal o-ring equates to the volume of the balloon. Therefore, inflation of the balloon is achieved by turning the dial, which pushes the plunger pin forward, to the appropriate volume indicated on the dial pad.
The deflation syringe barrel is used for prepping the hypo-tube and deflating the occlusion balloon. A handle is attached to the plunger to provide a vacuum to the deflation syringe barrel. The deflation syringe barrel is used only when the inflation dial is in the "0" position, i.e., when the plunger pin is positioned proximal to the distal o-ring, as shown below, thereby opening the fluid path. In the drawing below the housing and plunger handle are not shown.
Export Aspiration catheter
The Export Aspiration catheter is a dual lumen catheter. The smaller of the lumens is the wire lumen used to run over the GuardWire. The size of the wire lumen is sized so that the Export catheter may run over the GuardWire smoothly. The larger sized lumen is the aspiration lumen. Via the 20cc syringe and one-way stopcock attached to the proximal end of the Export, blood and debris is evacuated from the graft and into the syringe.
3
| PercuSurge, Incorporated
| Sunnyvale, California |
|---|
| Premarket Notification [510(k)] |
| Application |
PercuSurge GuardWire System for Use in the Percutaneous Interventional Treatment of Saphenous Vein Bypass Grafts
October 31, 2002
MicroSeal Adapter
The MicroSeal Adapter provides the mechanism to move the plug on the GuardWire catheter. Six grip pads are located on the Adapter, three on the upper half and three on the lower. Three wire clips are found on the lower half and are used for holding the wire firmly between the pads. The proximal pads are movable via the Adapter knob. The other four pads are immovable and are used to hold in place the GuardWire distal to the plug. Once the wire is placed in the Adapter and the knob is moved to the open position, the proximal pads slide, opening the plug. Diluted contrast flows through the Adapter via the inflation port. This port is sealed when the Adapter is closed and is lined up with the inflation port on the GuardWire when placed in the Adapter.
Statement of Indications for Use
The PercuSurge GuardWire Plus Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts (2.5-5.0mm) to.
- · Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures.
- · To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
- · The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.
- · The safety and effectiveness of the device as an embolic protection system has not been established in treating patients with acute myocardial infarction.
- · The safety and effectiveness of the device as an embolic protection system has not been established in treating native coronaries.
Technological Characteristics
The technological characteristics of the GuardWire 2.5-5.0 Temporary Occlusion and Aspiration System are substantially equivalent in materials of construction and methods of manufacture as the predicate device the GuardWire 3-6 Temporary Occlusion and Aspiration System. The performance of both systems, the 2.5-5.0 and the 3-6, has been assessed using similar bench test methods and under in-vitro simulated use conditions and determined to be equivalent.
Clinical Performance Data (SAFER Study Data Results Summary)
The data below illustrate the vessel sizes treated in the SAFER study (IDE G980209, and cleared under 510(k) K003992). Table 1 demonstrates that out of 406 GuardWire patients. (417 vessels and 442 lesions) 113 lesions treated were sized at 3.0mm or
4
| PercuSurge, Incorporated
Sunnyvale, California
Premarket Notification [510(k)]
Application | PercuSurge GuardWire System for Use in
the Percutaneous Interventional Treatment
of Saphenous Vein Bypass Grafts
October 31, 2002 |
| --------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
less. Table 2 further analyzes the data demonstrating the safety and efficacy results (MACE) for this patient population (n=111 patients).
| Table 1: RVD in GuardWire™ Patients | ||||
|---|---|---|---|---|
| ------------------------------------- | -- | -- | -- | -- |
| Reference Vessel Diameter
(RVD, in mm) | GuardWire™
(N=406 Patients,
N=442 Lesions) |
|-------------------------------------------|--------------------------------------------------|
| 0 mm ≤ RVD