(18 days)
No
The document describes a mechanical embolic protection system and does not mention any AI or ML components.
Yes
The device is described as an "Embolic Protection System" intended to protect the distal coronary vasculature by trapping and extracting debris during percutaneous coronary intervention (PCI). Its function is to directly mitigate a medical condition (embolism during PCI) and prevent adverse outcomes, which falls under the definition of a therapeutic device.
No
Explanation: The device is described as an embolic protection system intended to trap and extract debris during percutaneous coronary intervention. Its purpose is therapeutic (protection), not diagnostic (identifying or characterizing a condition).
No
The device description clearly lists multiple hardware components, including a guidewire, inflator, catheter, and flow control system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during a medical procedure (percutaneous coronary intervention) to physically protect the patient's vasculature by trapping and extracting debris. This is a therapeutic and procedural device, not a diagnostic one.
- Device Description: The description details components like a balloon guidewire, inflator, and catheter, all designed for mechanical intervention within the body. IVD devices typically involve reagents, analyzers, or other components used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the TriActiv FX® Embolic Protection System is a medical device used for a therapeutic and protective purpose during a surgical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TriActiv FX® Embolic Protection System is indicated for use in conjunction with percutaneous coronary intervention (PCI), using a 7F guide catheter (without side holes), of diseased saphenous vein coronary bypass grafts ranging from 3.0mm to 5.0m in diameter. The TriActiv FX® Embolic Protection System is intended to protect the distal coronary vasculature by trapping and extracting thrombotic and atheromatous debris liberated during PCI.
The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid, or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction.
Product codes
NFA
Device Description
The TriActiv FX® Embolic Protection System is a temporary balloon occlusion embolic protection device used during percutaneous coronary intervention of diseased saphenous vein grafts ranging from 3.0mm to 5.0mm in diameter. The device is comprised of four principal components: ShieldWire™ Balloon Guidewire ("balloon guidewire), ShieldWire™ Inflator ("inflator"), FX™ Catheter ("flush catheter"), and AutoStream™ Flow Control ("flow control"). There are also four subcomponents or accessories included in the TriActiv FX® Embolic Protection System: the Split Tube Introducer, Shieldwire™ Guidewire Plug and Installer, TriActiv® Flow Control Power Supply and TriActiv® Tuohy. All TriActiv FX® Embolic Protection System components are supplied sterile and for single use only with exception of the TriActiv® Flow Control Power Supply which is non-sterile and reusable.
The balloon guidewire is advanced through the hospital-supplied 7F guide catheter (without sideholes) prior to percutaneous coronary intervention of a saphenous vein graft (SVG) and positioned just past the target lesion. The balloon is inflated with a medical grade carbon dioxide gas blend, creating a protected space between the guide catheter and the balloon. Once the balloon is inflated and vessel occusion is confirmed, PTCA and/or stenting can be performed over the balloon guidolum is Immediately after intervention, the flush catheter is loaded on the end of the balloon guidewire and advanced into the graft. With the flush catheter positioned just proximal to the balloon, the flow control delivers saline through the flush cather to gently wash the vessel and remove any debris generated during the intervention through the guide catheter into a collection bag. The TriActiv FX® Embolic Protection System has been designed to extract at a greater rate than it infuses to prevent aortic embolization. Once the physician is satisfied with the amount of debris removed from the vessel, the protection balloon is deflated and the device is removed.
-
ShieldWire™ Balloon Guidewire: The ShieldWire™ Balloon Guidewire is a single-use 0.014" stainless steel hypo-tube guidewire containing a latex distal protection balloon, which is used to occude a 3.0mm to 5.0mm vessel. It is available in both standard (190cm) and exchange (300cm) lengths. The latex balloon is mounted over two inflation holes, which allow the balloon to be inflated with gas through the lumen of the hypotubes. The use of a gas as an inflation medium, allows for rapid inflation and deflation of the protection balloon. The balloon is inflated using the ShieldWire™ Inflator attached to the proximal end of the guidewire. The physician estimates the vessel size and sets the inflation volume accordingly to occlude vessels between 3.0mm and 5.0mm. The guidewire is coated to reduce surface friction and allow for easier delivery of interventional devices. A radiopaque tip stop is soldered to the distal segment just proximal to the balloon. The tip stop prevents the interventional catheter from contacting the balloon and provides visualization under fluoroscopy. The spilt tube introducer is an accessory used to protect the balloon and floppy tipe during introduction through the TriActiv® Tuohy valve. The proximal end of the guidewire is sealed with a removable guidewire plug to prevent debris or fluid from entacinii the lumen during catheter exchanges. Just prior to balloon inflation, the guidewire plug is removed from the proximal end of the guidewire. An additional guidewire plug is provided within a guidewire plug installer.
-
ShieldWire™ Inflator: The ShieldWire™ Inflator is a modified "syringe" that is pre-filled with a sterile, medical grade CO2 gas blend and used to inflate the balloon. It contains a ormaily closed valve to lock onto the guidewire, a plunger with volume control that allows for incremental increases in gas and a mechanism to seal the end of the guidewire, which allows for protected catheter exchanges. The ShieldWire™ Inflator is pre-filled with enough gas to occlude a 3.0mm to 5.0mm vessel.
-
AutoStream™ Flow Control: The AutoStream™ Flow Control is a single use AC powered fluid flow control system with integrated tubing. The flow control incorporates mechanical pumps for fluid infusion and extraction as well as the tubing used to connect the flow control to the FX™ Catheter (infusion) and the TriActiv® Tuohy (extraction). The sterile flow control is powered by a reusable non-sterile power supply that is kept out of the sterile field. The flow control user interface incorporates 3 buttons and a digital numeric readout. A simple electronic circuit with a pre-programmed microprocessor controls all the functions of the unit. The TriActiv® Flow Control Power Supply is a non-sterile, reusable power cord used to provide power from an electrical putlet to the flow control. The TriActiv® Tuohy is a multiple port Tuohy-Borst valvo that is attached to the guide catheter by a rotating luer and allows interventional access. It also provides an angiographic interface and port for extraction of debris.
-
FX™ Catheter: The FX™ Catheter is a catheter used to infuse saline and gently wash debris in the target vessel. The FX™ Catheter is a dual lumen catheter with a "rapid exchange" section. The FX Catheter is loaded on to the ShieldWire™ Balloon Guidowire to flush the target vessel after intervention. The distal end of the catheter incorporates an atraumatic tip with a radiopaque band to aid in placement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
diseased saphenous vein coronary bypass grafts, distal coronary vasculature
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
Clinical evaluation of the TriActiv® FX™ Embolic Protection System was conducted in the prospective, multi-center, non-randomized ASPIRE (Angioplasty in SVGs with Post Intervention Removal of Embolic Debris) Study. The purpose of the ASPIRE Study was to establish the safety and performance of the Tripctiv® FR™ System during percutaneous coronary intervention (PCI) of diseased saphenous vein grafts (SVGs). The data from the ASPIRE Study was compared to historical control data; patients in the Active Control group from the PRIDE Study. The Active Control group consisted of patients that were randomized to control and were to receive either the Guardwire® Plus System or the FilterWire® EX System. A total of 113 patients were enrolled in the study at 17 U.S. and 3 German investigational sites, between March 2005 and November 2005. Investigators in the study were allowed up to 3 "mli-in" patients, for training purposes, which accounted for 20 of the 113 patients.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical verification and validation of the TriActiv FX® Embolic Protection System has been performed through extensive in vitro bench testing, biocompatibility testing, software validation, electrical safety testing, package integrity testing, shell life testing, and in vivo animal studies. Results of this testing indicate that the TriActiv FX® Embolic Protection System design meets all specifications and intended use.
Clinical evaluation: prospective, multi-center, non-randomized ASPIRE (Angioplasty in SVGs with Post Intervention Removal of Embolic Debris) Study. Versus historical control data from the PRIDE Study (Active Control group: Guardwire® Plus System or FilterWire® EX System).
Sample size: ASPIRE Study: 113 patients enrolled (93 in enrollment phase, 20 initial "roll-in" patients for training). PRIDE Active Control group: 318 patients.
Key results:
The primary endpoint analysis was adjusted based on subclassifications from a propensity score analysis. All baseline variables from patients in ASPIRE and in the Active Control group from PRIDE were combined and analyzed by a stepwise logistic regression with patient cohort as the outcome variable. These probabilities were then sorted and patients were grouped to form five patient strata of equal size. These resulting strata were then used as a stratification variable in all analyses that compared the two patient groups. The primary endpoint results were tested to determine non-inferiority.
The patient populations in the ASPIRE Trial and the Active Control Arm of the PRIDE Trial were generally similar. Patients in the Enrollment Phase of the ASPIRE Trial had an observed 30-day MACE rate of 3.2% (3/93). This was compared to the 30day MACE rate observed in the Active Control Arm (the Medtronic Guardwire® or the Boston Scientific Filterwire EXTM) of the PRIDE Trial, 10.1% (32/318) [Difference of -6.8% (upper 95% C.I. -2.7%)]. Following the propensity score analysis, these data demonstrated that the TriActiv® FX™ System is not inferior to the Active Control Arm from PRIDE (p
§ 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
510(k) Summary
510(k) Number: K06)772
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR§807.92.
| Submitter Information: | Kensey Nash Corporation
735 Pennsylvania Drive
Exton, PA 19341 USA
Robin M. Fatzinger, RAC
V.P. of Clinical & Regulatory Affairs
Tel: (484) 713-2100
e-mail: Robin.Fatzinger@kenseynash.com |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | TriActiv FX® Embolic Protection System |
| Common Name: | Distal Occlusion Balloon Catheter |
| Classification Name: | Device, Coronary Saphenous Vein Bypass Graft,
Temporary For Embolization Protection
(per 21 CFR Section 870.1250) |
| Regulatory Class: | Class II |
| Device Product Code: | NFA |
| Predicate Device: | Kensey Nash Corporation's TriActiv® System
(K042040) |
| Date Prepared: | June 22, 2006 |
Description of Device
The TriActiv FX® Embolic Protection System is a temporary balloon occlusion embolic protection device used during percutaneous coronary intervention of diseased saphenous vein grafts ranging from 3.0mm to 5.0mm in diameter. The device is comprised of four principal components: ShieldWire™ Balloon Guidewire ("balloon guidewire), ShieldWire™ Inflator ("inflator"), FX™ Catheter ("flush catheter"), and AutoStream™ Flow Control ("flow control"). There are also four subcomponents or accessories included in the TriActiv FX® Embolic Protection System: the Split Tube Introducer, Shieldwire™ Guidewire Plug and Installer, TriActiv® Flow Control Power Supply and TriActiv® Tuohy. All TriActiv FX® Embolic Protection System components are supplied sterile and for single use only with exception of the TriActiv® Flow Control Power Supply which is non-sterile and reusable.
1
The balloon guidewire is advanced through the hospital-supplied 7F guide catheter (without sideholes) prior to percutaneous coronary intervention of a saphenous vein graft (SVG) and positioned just past the target lesion. The balloon is inflated with a medical grade carbon dioxide gas blend, creating a protected space between the guide catheter and the balloon. Once the balloon is inflated and vessel occusion is confirmed, PTCA and/or stenting can be performed over the balloon guidolum is Immediately after intervention, the flush catheter is loaded on the end of the balloon guidewire and advanced into the graft. With the flush catheter positioned just proximal to the balloon, the flow control delivers saline through the flush cather to gently wash the vessel and remove any debris generated during the intervention through the guide catheter into a collection bag. The TriActiv FX® Embolic Protection System has been designed to extract at a greater rate than it infuses to prevent aortic embolization. Once the physician is satisfied with the amount of debris removed from the vessel, the protection balloon is deflated and the device is removed.
1. ShieldWire™ Balloon Guidewire
The ShieldWire™ Balloon Guidewire is a single-use 0.014" stainless steel hypo-tube guidewire containing a latex distal protection balloon, which is used to occude a 3.0mm to 5.0mm vessel. It is available in both standard (190cm) and exchange (300cm) lengths. The latex balloon is mounted over two inflation holes, which allow the balloon to be inflated with gas through the lumen of the hypotubes. The use of a gas as an inflation medium, allows for rapid inflation and deflation of the protection balloon. The balloon is inflated using the ShieldWire™ Inflator attached to the proximal end of the guidewire. The physician estimates the vessel size and sets the inflation volume accordingly to occlude vessels between 3.0mm and 5.0mm. The guidewire is coated to reduce surface friction and allow for easier delivery of interventional devices. A radiopaque tip stop is soldered to the distal segment just proximal to the balloon. The tip stop prevents the interventional catheter from contacting the balloon and provides visualization under fluoroscopy. The spilt tube introducer is an accessory used to protect the balloon and floppy tipe during introduction through the TriActiv® Tuohy valve. The proximal end of the guidewire is sealed with a removable guidewire plug to prevent debris or fluid from entacinii the lumen during catheter exchanges. Just prior to balloon inflation, the guidewire plug is removed from the proximal end of the guidewire. An additional guidewire plug is provided within a guidewire plug installer.
2. ShieldWire™ Inflator
The ShieldWire™ Inflator is a modified "syringe" that is pre-filled with a sterile, medical grade CO2 gas blend and used to inflate the balloon. It contains a ormaily closed valve to lock onto the guidewire, a plunger with volume control that allows for incremental increases in gas and a mechanism to seal the end of the guidewire, which allows for protected catheter exchanges. The ShieldWire™ Inflator is pre-filled with enough gas to occlude a 3.0mm to 5.0mm vessel.
2
3. AutoStream™ Flow Control
The AutoStream™ Flow Control is a single use AC powered fluid flow control system with integrated tubing. The flow control incorporates mechanical pumps for fluid infusion and extraction as well as the tubing used to connect the flow control to the FX™ Catheter (infusion) and the TriActiv® Tuohy (extraction). The sterile flow control is powered by a reusable non-sterile power supply that is kept out of the sterile field. The flow control user interface incorporates 3 buttons and a digital numeric readout. A simple electronic circuit with a pre-programmed microprocessor controls all the functions of the unit. The TriActiv® Flow Control Power Supply is a non-sterile, reusable power cord used to provide power from an electrical putlet to the flow control. The TriActiv® Tuohy is a multiple port Tuohy-Borst valvo that is attached to the guide catheter by a rotating luer and allows interventional access. It also provides an angiographic interface and port for extraction of debris.
4. FX™ Catheter
The FX™ Catheter is a catheter used to infuse saline and gently wash debris in the target vessel. The FX™ Catheter is a dual lumen catheter with a "rapid exchange" section. The FX Catheter is loaded on to the ShieldWire™ Balloon Guidowire to flush the target vessel after intervention. The distal end of the catheter incorporates an atraumatic tip with a radiopaque band to aid in placement.
Indication and Intended Use of Device
The TriActiv FX® Embolic Protection System is indicated for use in conjunction with percutaneous coronary intervention (PCI), using a 7F guide catheter (without side holes), of diseased saphenous vein coronary bypass grafts ranging from 3.0m on o 5.0m in diameter. The TriActiv® FX™ Embolic Protection System is intended to protect the distal coronary vasculature by trapping and extracting thrombritie and atheromatous debris liberated during PCI. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid, or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction.
Technological Characteristics
The TriActiv FX® Embolic Protection System is the "next generation" of the TriActiv® The technological characteristics are substantially equivalent to the System. "previous generation" with the following differences:
- The balloon guidewire and inflation components ("ShieldWire™ Temporary Occlusion Balloon Guidewire" and "Balloon Inflation Syringe" respectively) of the TriActiv® System were modified to allow for multiple device exchanges over the balloon guidewire during ballow occlusion. The TriActiv FX® Embolic Protection System design incorporates a mechanism into the inflation component ("ShieldWire") Inflator") to seal the proximal end of the guidewire ("ShieldWire™ Balloon Guidewire") upon user deployment.
3
- The TriActiv® System's flush catheter ("FlushCath™ Catheter") was redesigned from a "side-attachable" catheter to a "rapid exchange" type catheter ("FX™ Catheter") which physicians are more accustomed to using. The original "sideattachable" version also requires an Attachment Tool, which is no longer necessary since the FXTM Catheter simply is loaded onto the end of the balloon quidewire.
Non-Clinical and Clinical Summary
Non-clinical verification and validation of the TriActiv FX® Embolic Protection System has been performed through extensive in vitro bench testing, biocompatibility testing, software validation, electrical safety testing, package integrity testing, shell life testing, and in vivo animal studies. Results of this testing indicate that the TriActiv FX® Embolic Protection System design meets all specifications and intended use.
Clinical evaluation of the TriActiv® FX™ Embolic Protection System was conducted in the prospective, multi-center, non-randomized ASPIRE (Angioplasty in $SVGs with Post Intervention Removal of Embolic Debris) Study. The purpose of the ASPIRE Study was to establish the safety and performance of the Tripctiv® FR™ System during percutaneous coronary intervention (PCI) of diseased saphenous vein grafts (SVGs). The data from the ASPIRE Study was compared to historical control data; patients in the Active Control group from the PRIDE Study. The Active Control group consisted of patients that were randomized to control and were to receive either the Guardwire® Plus System or the FilterWire® EX System. A total of 113 patients were enrolled in the study, at 17 U.S. and 3 German investigational sites, between March 2005 and November 2005. Investigators in the study were allowed up to 3 "mli-in" patients, for training purposes, which accounted for 20 of the 113 patients.
The primary endpoint analysis was adjusted based on subclassifications from a propensity score analysis. All baseline variables from patients in ASPIRE and in the Active Control group from PRIDE were combined and analyzed by a stepwise logistic regression with patient cohort as the outcome variable. These probabilities were then sorted and patients were grouped to form five patient strata of equal size. These resulting strata were then used as a stratification variable in all analyses that compared the two patient groups. The primary endpoint results were tested to determine non-inferiority.
The patient populations in the ASPIRE Trial and the Active Control Arm of the PRIDE Trial were generally similar. Patients in the Enrollment Phase of the ASPIRE Trial had an observed 30-day MACE rate of 3.2% (3/93). This was compared to the 30day MACE rate observed in the Active Control Arm (the Medtronic Guardwire® or the Boston Scientific Filterwire EXTM) of the PRIDE Trial, 10.1% (32/318) [Difference of -6.8% (upper 95% C.I. -2.7%)]. Following the propensity score analysis, these data demonstrated that the TriActiv® FX™ System is not inferior to the Active Control Arm from PRIDE (p