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 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.

AI/ML Overview

The provided text describes the TriActiv FX® Embolic Protection System and its clinical evaluation, but it does not include a table of acceptance criteria or explicitly state acceptance criteria for device performance. It focuses on demonstrating non-inferiority to a predicate device based on clinical outcomes.

However, based on the clinical study results presented, we can infer what the implicit performance goals or "acceptance criteria" likely were, particularly in relation to the predicate device.

Here's an attempt to structure the information based on your request, inferring where explicit details are missing:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit acceptance criteria are not presented in a table in the submission, the table below infers the performance goals based on the non-inferiority study results compared to the predicate. The "Acceptance Criteria" here are derived from the need to demonstrate non-inferiority to the Active Control Arm of the PRIDE Trial (using Guardwire® Plus System or FilterWire® EX System).

Performance Metric	Acceptance Criteria (Implied for Non-Inferiority)	Reported Device Performance (ASPIRE Enrollment Phase)	Did the Device Meet Criteria?
Major Adverse Cardiac Events (MACE) to 30 days	Non-inferior to predicate (Active Control Arm MACE rate: 10.1%)	3.2% (3/93)	Yes (p<0.001 for non-inferiority, Difference -6.8% with upper 95% C.I. -2.7%)
Myocardial Infarctions (MI)	Non-inferior to predicate (Active Control Arm MI rate: 8.8%)	2.2% (2/93)	Yes (p=0.021 for non-inferiority, Difference -6.7% with upper 95% C.I. -3.1%)
Device Success	Non-inferior to predicate (Active Control Arm Device Success: 94.5%)	95.7% (89/93)	Yes (p=0.79 for non-inferiority, Difference 1.2% with -2.9% 95% CB)
Procedure Success/Patient	Non-inferior to predicate (Active Control Arm Procedure Success/Patient: 90.5%)	97.8% (90/92)	Yes (p=0.013 for non-inferiority, Difference 7.3% with 3.6% 95% CB)
Lesion Success/Lesion	Non-inferior to predicate (Active Control Arm Lesion Success/Lesion: 99.4%)	100% (103/103)	Yes (Difference 0.6% with -0.1% 95% CB)
Final TIMI Flow (TIMI 3)	Non-inferior to predicate (Active Control Arm TIMI 3 Flow: 97.8%)	95.9% (93/97)	The p-value (0.98) suggests no significant difference, supporting non-inferiority.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets (or in this case, is non-inferior to) these criteria is the ASPIRE (Angioplasty in SVGs with Post Intervention Removal of Embolic Debris) Study.

2. Sample Size and Data Provenance for the Test Set

Sample Size (Test Set): 93 patients (Enrollment Phase of the ASPIRE Study).
Data Provenance: Prospective, multi-center, non-randomized study conducted at 17 U.S. and 3 German investigational sites. Historical control data (318 patients) was used from the PRIDE Study (Active Control group: Medtronic Guardwire® or Boston Scientific Filterwire EX™).

3. Number of Experts and Qualifications for Ground Truth (Test Set)

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). Clinical trials like ASPIRE typically involve:

Investigating physicians: Board-certified interventional cardiologists are implicitly the "experts" performing the procedures and making clinical assessments that contribute to endpoint determination (e.g., MACE, MI).
Clinical Events Committee (CEC): Often, clinical events in such studies are adjudicated by an independent CEC composed of qualified physicians (e.g., cardiologists) from diverse backgrounds to ensure unbiased endpoint classification. The document does not explicitly mention a CEC, but it's a standard practice for studies of this nature.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1) for the test set. However, the reference to "adjusted based on subclassifications from a propensity score analysis" and comparison to a historical control group suggests a statistical approach to account for potential confounding factors rather than a specific expert adjudication model for individual case diagnosis. Clinical event definitions (e.g., for MACE, MI) would have been pre-specified in the study protocol, and their occurrence likely determined by the clinical investigators and potentially confirmed by an independent committee.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on clinical outcomes in patients, comparing the device's performance to a historical control group, rather than evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not done. The TriActiv FX® Embolic Protection System is a medical device (physical system for embolic protection), not an AI algorithm. The study evaluated the clinical performance of the device in vivo during PCI procedures.

7. Type of Ground Truth Used

The "ground truth" for the clinical study was based on clinical outcomes data from patients, including:

Major Adverse Cardiac Events (MACE) - a composite endpoint typically including death, MI, and target vessel revascularization (TVR).
Individual clinical events such as MI (Q wave and non-Q wave), death (cardiac and non-cardiac), stroke, hemorrhagic/vascular complications.
Device success, procedure success, and lesion success, which are defined by criteria related to the technical performance of the device and immediate post-procedure findings (e.g., final stenosis by QCA, TIMI flow).

These outcomes are collected and reported by clinical investigators in accordance with the study protocol.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an algorithm or AI. Since this is a physical medical device, there is no algorithm training set. The "training" referred to in the document is for the human investigators learning to use the device: "Investigators in the study were allowed up to 3 'roll-in' patients, for training purposes, which accounted for 20 of the 113 patients." These "roll-in" patients were excluded from the primary efficacy analysis (N=93).

9. How Ground Truth for the Training Set Was Established

As there is no algorithm training set, this question is not applicable. The "roll-in" patients were used for physician training, and their outcomes were not part of the primary efficacy analysis.

Summary

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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 Corporation735 Pennsylvania DriveExton, PA 19341 USARobin M. Fatzinger, RACV.P. of Clinical & Regulatory AffairsTel: (484) 713-2100e-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

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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.

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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 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.

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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 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<0.001). Patients in ASPIRE also had a lower rate Active 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%)
1	0 (0%)	2 (0.6%)
2	4 (4.1%)	3 (0.9%)	0.98
3	93 (95.9%)	313 (97.8%)

Table 1: ASPIRE Principle Results

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

sees are aroups and the Enrollment Phase and the PRIDE Active Control (one-sided 95%)
upper confidence bound on the difference) upper confidence bound on the difference)

of North and and is and and the protocol, but is shown for comparison to cardiac death, which is
a MACE as defined in the rrotocol a MACE as debined in the procol
a MACE as defined as altinct in the proboci, out s successfuly deline andecident, which
a MACE as defined as altainment of all of the flowing:

location, the dovice operated as intended, the device was successfully retrieved.

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

Final stenosis < 50% by QCA
7 Pt 14,000 units Heparin

1 Mar stellosis < 50% by QCA
7 Pt 14-003 censored. TriActiv FX System used for IVUS lesion evaluation. No PCI. Medical treatment only.
7 Pt 14-003 censored. TriActiv FX Sy

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Statement of Substantial Equivalence:

Kensey Nash Corporation considers the TriActiv FX® Embolic Protection System Substantially equivalent to the TriActiv® System (K042040) based on comparison of intended use and the results of in-vitro testing, in-vivo testing and clinical evaluation.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

|JUL 1 1 2006

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

Re: K061772

Trade/Device Name: TriActiv FX Embolic Protection System Regulation Number: 21 CFR 870.1250 Regulation Name: Distal Embolic Protection Guidewire Regulatory Class: Class II Product Code: NFA Dated: June 22, 2006 Received: June 23, 2006

Dear Ms. Fatzinger:

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 ideications for use stated in the enclosure) to legally marketed predicate devices market to in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmants, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Dr vo 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, isting 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.

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: registred. - Tournitiation and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as as a forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the ecctronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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Page 2 - Ms. Robin Fatzinger

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/cdrl/industry/support/index.html.

Sincerely yours,

R. bohner

Image /page/7/Picture/6 description: The image shows a black and white drawing of a signature. The signature is illegible, but it appears to be written in cursive. The signature is on a white background. The signature is made up of a series of loops and curves.

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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Section 4 - Indications for Use Statement

510(k) Number (if known):

K06172

Device Name:

TriActiv FX® Embolic Protection System

Indications for Use:

Prescription Use A (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)

R. Lochner

'Division Sign-Off) Division of Cardiovascular Devices

510(k) Number Ko 61772

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).