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.

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 the Split Tube Introducer, Shieldwire™ Guidewire Plug and Installer, System: 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 araft (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 quide catheter and the balloon. Once the balloon is inflated and vessel occlusion is confirmed, PTCA and/or stenting can be performed over the balloon guidewire. Immediately after intervention, the flush catheter is loaded on 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 catheter 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the TriActiv FX® Embolic Protection System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the TriActiv FX® Embolic Protection System were primarily established through a non-inferiority comparison to existing predicate devices (Medtronic Guardwire® or Boston Scientific Filterwire EX™). The key performance metrics are related to Major Adverse Cardiac Events (MACE) and other clinical outcomes.

Metric (Acceptance Criteria)	Reported Device Performance (TriActiv FX® - ASPIRE Study)	Reference Device Performance (Guardwire® / Filterwire EX™ - PRIDE Study)	Adjusted P-Value	Unadjusted Difference (95% CI)
MACE to 30 days (Non-inferiority to predicate)	3.2% (3/93)	10.1% (32/318)	0.013	-6.8% (-2.7%)
Myocardial Infarction (MI) (Lower rate desired)	2.2% (2/93)	8.8% (28/318)	0.021	-6.7% (-3.1%)
Device Success⁴	95.7% (89/93)	94.5% (293/310)	0.79	1.2% (-2.9%)
Procedure Success/Patient⁵ (Criteria for successful procedure)	97.8% (90/92)	90.5% (286/316)	0.013	7.3% (3.6%)
Lesion Success/Lesion⁶ (Criteria for successful lesion treatment)	100% (103/103)	99.4% (319/321)	-	0.6% (-0.1%)
Final TIMI Flow 0	0% (0/97)	0.6% (2/306)	0.98	-
Final TIMI Flow 1	0% (0/97)	0.6% (2/306)	-	-
Final TIMI Flow 2	4.1% (4/97)	0.9% (3/306)	-	-

⁴ Device success is defined as attainment of all of the following: the device was successfully delivered to the target location, the device operated as intended, the device was successfully retrieved.
⁵ Final stenosis < 50% by QCA for all lesions and no in-hospital MACE.
⁶ Final stenosis < 50% by QCA.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Test Set):
- TriActiv FX® (ASPIRE Study): 93 patients in the Enrollment Phase (113 total patients enrolled, 20 were "roll-in" patients for training).
- Control (PRIDE Study Active Control): 318 patients.
Data Provenance:
- Country of Origin: The ASPIRE Study was conducted at 17 U.S. and 3 German investigational sites. The PRIDE Study data is referred to as "historical control data" and is implied to be from a similar multi-center, potentially international, context given the device manufacturers.
- Retrospective or Prospective:
  - ASPIRE Study: Prospective, multi-center, non-randomized.
  - PRIDE Study Active Control: Retrospective (used as historical control data). The PRIDE study itself was likely prospective, but the data was utilized retrospectively for comparison in this 510(k).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not specify the number of experts used to establish ground truth or their qualifications. The outcomes (e.g., MACE, MI) are clinical endpoints based on patient diagnosis and objective measurements, likely adjudicated by physicians involved in the studies, but specific details on an adjudication committee or expert panel for ground truth are not provided in this summary.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the test set (e.g., 2+1, 3+1). Clinical events like MACE and MI are typically adjudicated by an independent clinical events committee in large trials, but this specific detail is not present in the summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an embolic protection system, a physical medical device, not an AI or imaging diagnostic tool that would typically involve "human readers" or "AI assistance." The study evaluates the device's clinical performance in preventing adverse events during a procedure.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical medical device, not a software algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used

The ground truth for evaluating the device's performance was based on clinical outcomes data. Specifically, it included:

Major Adverse Cardiac Events (MACE)
Death (Cardiac, Non-Cardiac)
Myocardial Infarction (MI) (Q wave, Non-Q wave)
Target Vessel Revascularization (TVR)
Stroke
Hemorrhagic/vascular complications
Transfusion
Device Success (defined by successful delivery, operation, and retrieval)
Procedure Success/Patient (defined by final stenosis < 50% by QCA and no in-hospital MACE)
Lesion Success/Lesion (defined by final stenosis < 50% by QCA)
Final TIMI Flow

These are direct clinical endpoints and objective measurements taken during and after the intervention.

8. The Sample Size for the Training Set

The document refers to "roll-in" patients for training purposes within the ASPIRE study:

Training Set Size: 20 patients (out of 113 total enrolled in ASPIRE). These were for "training purposes" for the investigators, not for training a machine learning model.

9. How the Ground Truth for the Training Set Was Established

For the 20 "roll-in" patients, the ground truth was established through standard clinical evaluation and reporting of outcomes, similar to the main study patients. However, their data was likely not included in the primary efficacy analysis for statistical rigor, as their purpose was for investigator training/familiarization with the device. This "training" refers to human operators learning to use the device, not a machine learning model.

Summary

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K062870

510(k) Summary

510(k) Number: K06___________________________________________________________________________________________________________________________________________________________

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR$807.92.

Submitter Information:	Kensey Nash Corporation735 Pennsylvania DriveExton, PA 19341 USARobin M. Fatzinger, RACV.P. of Clinical & Regulatory AffairsTel: (484) 713-2100e-mail: robin.fatzinger@kenseynash.comOCT 20 2006
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 FX® System(K061772)
Date Prepared:	September 21, 2006

Description of Device

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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 occlude 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 hypotube. 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 quidewire 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 split tube introducer is an accessory used to protect the balloon and floppy tip during introduction through the TriActiv® Tuohy valve. The proximal end of the guidewire is sealed with a removable quidewire plug to prevent debris or fluid from entering the lumen during catheter exchanges. Just prior to balloon inflation, the guidewire plug is removed from the proximal end of the quidewire. 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 normally 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.

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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 outlet to the flow control. The TriActiv® Tuchy is a multiple port Tuohy-Borst valve 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 hydrophilic coated, dual lumen catheter with a "rapid exchange" section. The FX Catheter is loaded on to the ShieldWire™ Balloon Guidewire 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 3.0mm 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 peribheral 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 balloon 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.

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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 FX™ Catheter simply is loaded onto the end of the balloon auidewire.

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, shelf 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 TriActiv® FX™ 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 "roll-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 EX™) 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<0.001). Patients in ASPIRE also had a lower rate of all myocardial infarctions than patients in the Active Control group from the PRIDE Study [2.2% vs. 8.8% respectively, (Difference of -6.7% (upper 95% C.I. -3.1%)].

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	ASPIREEnrollmentPhase(N=93)n (%)	PRIDEActive Control(N=318)n (%)	AdjustedP-Value¹	UnadjustedDifference(95% CB)²
MACE to 30 days	3 (3.2%)	32 (10.1%)	0.013	-6.8%(-2.7%)
Death	0 (0%)	2 (0.6%)	-	-0.6%(0.1%)
Cardiac	0 (0%)	2 (0.6%)	-	-0.6%(0.1%)
Non Cardiac³	0 (0%)	0 (0%)	-
MI	2 (2.2%)	28 (8.8%)	0.021	-6.7%(-3.1%)
Q wave	0 (0%)	1 (0.3%)	-	-0.3%(0.2%)
Non-Q wave	2 (2.2%)	27 (8.5%)	0.022	-6.3%(-2.8%)
TVR	1 (1.1%)	4 (1.3%)	0.41	-0.2%(1.9%)
MACE-in-hospital	2 (2.2%)	29 (9.1%)	0.015	-7.0%(-3.3%)
Stroke-in-hospital	1 (1.1%)	1 (0.3%)	0.70	0.8%(2.6%)
Stroke to 30 days	1 (1.1%)	1 (0.3%)	0.70	0.8%(2.6%)
Hemorrhagic/vascularcomplications to 30days	2 (2.2%)	21 (6.6%)	0.21	-4.5%(-1.8%)
Transfusion to 30 days	0 (0%)	13 (4.1%)	-	-4.1%(-2.3%)
Device Success⁴	89 (95.7%)	293/310 (94.5%)	0.79	1.2%(-2.9%)
ProcedureSuccess/Patient⁵	90/92⁷ (97.8%)	286/316 (90.5%)	0.013	7.3%(3.6%)
LesionSuccess/Lesion⁶	103/103⁷(100%)	319/321 (99.4%)	-	0.6%(-0.1%)
Final TIMI Flow
0	0 (0%)	2 (0.6%)	0.98
1	0 (0%)	2 (0.6%)
2	4 (4.1%)	3 (0.9%)

Table 1: ASPIRE Principle Results

Two-sided p-value companing ASPIRE Enrollment Phase and the PRIDE Active Control adjusted for propensity score groups

2 Difference in percentages between ASPIRE Enrollment Phase and the PRIDE Active Control (one-sided 95% upper confidence bound on the difference)

3 Non-cardiac death is not a MACE as defined in the protocol, but is shown for comparison to cardiac death, which is

a MACE as defined in the protocol

Device success is defined as attainment of all of the following: the device was successfully delivered to the target location, the device operated as intended, the device was successfully retrieved.

5 Final stenosis < 50% by QCA for all lesions and no in-hospital MACE.

8 Final stenosis < 50% by QCA

1 P C Concell - 2010 a J Q .
7 Pt 14-003 censored. TriActiv FX System used for IVUS lesion evaluation. No PCI. Medical treatment only.

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Image /page/5/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 0 2006

Kensey Nash Corporation c/o Ms. Robin M. Fatzinger V.P. of Clinical & Regulatory Affairs 735 Pennsylvania Drive Exton, PA 19341

K062870 TriActiv FX® Embolic Protection System Regulation Number: 21 CFR 870.1250 Regulation Name: Device, Coronary Saphenous Vein Bypass Graft, Temporary For Embolization Protection Regulatory Class: II (two) Product Code: NFA Dated: September 21, 2006 Received: September 25, 2006

Dear Ms. Fatzinger:

Re:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 – Ms. Robin M. Fatzinger

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

R. bolmes

1 Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known):

K062890

Device Name:

TriActiv FX® Embolic Protection System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

uma R. Vochmer

(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices

510(k) Number K062870

Regulation Number and Section

§ 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).