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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the PercuSurge GuardWire Plus Temporary Occlusion and Aspiration System, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are derived from the "Non Clinical Performance Data Summary" and "Clinical Performance Data (SAFER Study Data Results Summary)" sections.

Disclaimer: The document does not explicitly list quantitative "acceptance criteria" in a structured table. Instead, it describes objectives and conclusions for the performance studies. The table below synthesizes these objectives/conclusions as the de-facto acceptance criteria and reports the device's demonstrated performance.

Acceptance Criteria (Objective/Conclusion)	Reported Device Performance
Non-Clinical Performance:
Vessel Occlusion: Demonstrate that the system provides temporary occlusion under pressure (1.0-3.5 psi) and flow rate (70-85 cc/min) conditions in vessel sizes of 4mm and 5mm.	The GuardWire elastomeric occlusion balloon "consistently occluded both 4 and 5mm vessels" under the specified pressure and flow rate conditions.
Fluid Evacuation: Demonstrate capability to evacuate different types of fluids (saline, water, 40% glycerol / 60% saline) at a minimum rate of 0.5ml/sec.	The GuardWire System Accessory Catheter and ancillary components were "capable of evacuating all three types of fluids." The flow rates obtained "exceeded the minimum specification of 0.5ml/sec" as established with the PercuSurge Medical Advisory Board.
Particle Evacuation: Demonstrate capability to evacuate particulates representative of debris found in blood following interventional procedures, evacuating at least 90% of particles.	The GuardWire System Accessory (Export) Catheter and ancillary components are "capable of evacuating at least 90% of particles." This met the requirement established by PercuSurge and the Medical Advisory Board.
Infusion Flow Rate: Demonstrate that the 8F Export® Aspiration Catheter meets pre-determined specifications and test acceptance criteria for infusion capabilities (using fluids commonly infused in interventional applications) after EtO sterilization.	"The testing conducted on the Export Aspiration Catheter demonstrates with the required statistical confidence that the current design meets all of the product specification requirements."
Additional Laboratory Studies (Aspirates): Further corroborate animal studies by determining the nature of material and its cellular component from aspirates, concluding that occlusion balloon and blood removal by aspiration did not affect the vessel wall.	Conclusion: "the occlusion balloon and blood removal by aspiration did not affect the vessel wall in the study cohort."
Animal Studies (Feasibility): Confirm feasibility of technology, compatibility with interventional devices, successful target vessel occlusion, capability of fluid delivery and blood evacuation, easy flow restoration, and no significant adverse effects on vessel histopathology. Demonstrate improvements and ease of use for GuardWire Plus design (superiority based on physician input).	The pilot studies "confirmed the feasibility of this technology." The system "was compatible with the interventional devices," "successfully occluded the target vessel," and "was capable of delivering fluid and evacuating blood." "Flow was restored easily." "Histopathology results showed that the use of the device had no significant adverse effects." Four additional animal studies "demonstrated that the modified design was superior based on physician input."
Additional Studies (Particles in Motion): Address if particles aggregate along the proximal side of the distal occlusion balloon prior to aspiration and after therapy, concluding that a distal or proximal occlusive device does not affect particle movement from therapy dilation and does not enhance particle adherence to a stent.	"The analyses and studies indicate that the use of a distal or proximal occlusive device does not have an effect of particle movement from therapy dilation." "The particles from therapy dilation would not aggregate at the balloon proximal surface during deflation or removal of the therapy balloon." "The presence of a distal occlusion balloon would not be expected to enhance particle adherence to a stent due to minor oscillation of the particles from heart rhythm."
Clinical Performance (SAFER Study): demonstrate the benefits of use of the GuardWire system for the target population, outweighing the risk of illness or injury, and reducing Major Adverse Cardiac Events (MACE).	MACE (Death, MI, Emergent CABG, TVR) in GuardWire vs. No GuardWire: 9.6% (N=39) vs. 16.5% (N=65). The "results as delineated above, support the benefits of use of the GuardWire system for the target population, outweigh the risk of illness or injury when used as indicated in accordance with the Instruction For Use."
Clinical Performance (Feasibility 1 - Single Center Experience): Demonstrate safety and clinical performance, compatibility with routine angioplasty and stent deployment, and use with interventional devices without affecting patient safety, intervention outcome, or balloon integrity.	Acute Complications (N=24 procedures, N=20 patients, 30 lesions; Duration 7/30/97 - 1/9/98): One Non-Q Wave MI (4%, related to device: 0). "The data demonstrate that the PercuSurge GuardWire System is safe. It is compatible with routine angioplasty and stent deployment. It can be used in conjunction with interventional devices without affecting the safety of the patient, outcome of the intervention or integrity of the balloon."
Clinical Performance (Feasibility 2 - Multi-Center Experience - SAFE Study): Determine safety and efficacy of treatment with the PercuSurge GuardWire system during stenting in saphenous vein bypass grafts.	Efficacy (N=103 patients, 105 lesions): Lesion Success: 99.0%, Procedure Success: 95.1%, Device Success: 85.4%, TLR-Free at 30 Days: 99.0%, TVR-Free at 30 Days: 99.0%, TVF-Free at 30 Days: 94.1%, MACE-Free at 30 Days: 94.1%. Safety: In-Hospital MACE: 4.9%, Out-of-Hospital MACE: 1.0%, Stent Thrombosis to 30 days: 1.0%, Bleeding Complications to 30 days: 1.9%, Vascular Complications to 30 days: 3.9%, CVA to 30 days: 0.0%. Conclusions: "The PercuSurge® GuardWire Plus™ System is compatible with routine angioplasty procedures, is capable on containing and retrieving atherosclerotic and thrombotic debris, and may aid in the prevention of distal embolization and "no-reflow" in diseased saphenous vein grafts."

Study Details

This device is not an AI/ML powered device, so some of the questions (e.g., about experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, training set) are not directly applicable. However, I will provide the closest relevant information from the provided text.

Sample sizes used for the test set and the data provenance:
- Main Clinical Study (SAFER Study - Randomized Controlled Trial):
  - Test Set (GuardWire™ group): 406 patients, 442 lesions.
  - Control Set (No GuardWire™ group): 395 patients, 433 lesions.
  - Total Randomized: 801 patients, 875 lesions.
  - Data Provenance: Not explicitly stated, but likely multi-national as it refers to a "randomized study". These are generally prospective in nature.
- Feasibility 1 - Single Center Experience:
  - Test Set: 20 patients, 24 procedures, 30 lesions.
  - Data Provenance: Single center (St. Paul's Hospital, Vancouver, B.C., Canada). This was a prospective registry.
- Feasibility 2 - Multi-Center Experience (SAFE Study):
  - Test Set: 103 patients, 105 lesions.
  - Data Provenance: Multi-center prospective non-randomized consecutive pilot trial. Ten sites utilized in Canada, Germany, and Italy.
- Non-Clinical Performance Studies:
  - Vessel Occlusion & Fluid Evacuation & Particle Evacuation & Infusion Flow Rate: In-vitro studies, not patient data. Sample sizes for these components (e.g., number of tests performed) are not specified.
  - Additional Laboratory Studies (Aspirates): 40 aspirates. Origin is not explicitly stated but implies human clinical procedures.
  - Animal Studies: 8 separate animal safety and effectiveness studies, plus 4 additional animal comparative studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Clinical Studies: The clinical outcomes (e.g., MACE, MI, etc.) are typically established by clinical events committees (CEC) and/or site investigators based on predefined clinical endpoints and diagnostic criteria.
  - The SAFE Study mentions "independent data analysis for this study was conducted by CDAC-Cardiovascular Data Analysis Center, Beth Israel Deaconess Medical and Harvard Medical Centers" and "independent investigational site monitoring was conducted by MedPass International of Paris, France."
  - The definition of In-Hospital/Out-of-Hospital MACE states "as determined by the independent Clinical Events Committee."
- Qualifications: While the specific number and qualifications of individual experts on these committees are not detailed, in clinical trials, such committees are typically composed of experienced clinicians (e.g., cardiologists) specialized in the relevant field.
- Non-Clinical Studies: The "PercuSurge Medical Advisory Board" was involved in establishing minimum specifications for fluid and particle evacuation, indicating expert input on these non-clinical performance metrics.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- For the clinical studies, an "independent Clinical Events Committee" was responsible for determining MACE outcomes. While the specific adjudication method (e.g., how disagreements were resolved) is not detailed (e.g., 2+1), the existence of such a committee implies a structured review process.
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:
- This is not an AI/ML powered device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with AI assistance is not applicable and was not performed. The SAFER study was a randomized controlled trial comparing the device (GuardWire™) with standard care (No GuardWire™). The effect size of the GuardWire system on MACE reduction was a decrease from 16.5% (No GuardWire) to 9.6% (GuardWire).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is a medical device, not an algorithm. Therefore, "standalone" performance in the AI context isn't applicable. The device's performance is inherently tied to its use by a human interventional cardiologist. The non-clinical studies (e.g., vessel occlusion, fluid/particle evacuation) demonstrate components' "standalone" functional performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Clinical Studies (SAFER, Feasibility 1 & 2): Ground truth was established using clinical outcomes data (e.g., death, myocardial infarction, revascularization events) assessed by an independent Clinical Events Committee based on predefined diagnostic criteria.
- Non-Clinical Studies: Ground truth for these was based on physical measurements and engineering specifications (e.g., achieving occlusion, flow rates, percentage of particles evacuated), often guided by input from the "PercuSurge Medical Advisory Board."
- Animal Studies: Ground truth included histopathology results (evaluating vessel effects) and functional performance observed during procedures (occlusion, fluid delivery/evacuation).
- Additional Laboratory Studies (Aspirates): The "nature of the material and its cellular component" implies laboratory analysis of the aspirate content.
The sample size for the training set:
- This is not an AI/ML powered device, so there is no "training set" in that context. The development and iterative design improvements of the device would have been informed by the "8 separate animal safety and effectiveness studies" and "Four additional animal comparative studies," as well as "physician input," which could be considered analogous to iterative "training" feedback in a conventional development cycle.
How the ground truth for the training set was established:
- Not applicable as it's not an AI/ML device with a formal training set. The "ground truth" for the iterative development and modification of the device (GuardWire Plus design improvements) was established through animal studies and qualitative "physician input" on performance and ease of use.

Summary

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K003992

JUN - 1 2001

510(k) Summary

Submitter Information:	PercuSurge, Inc.
	540 Oakmead Parkway
	Sunnyvale, CA 94085
	Debora D. Hinman, Vice President, Regulatory Affairs
	and Quality Assurance
	Fax) 408/524-7875
	Tel) 408/530-2326

Trade Name:	PercuSurge GuardWire Temporary Occlusion andAspiration System
Common Name:	Distal Occlusion Balloon Catheter
Classification Name:(Approx.)	-Catheter, Intravascular Occluding, Temporary-Percutaneous Catheter-Guide Wire

Premarket Notification Number: K003992

N.A. Predicate Device: December 20, 2001 Date Prepared:

May 25, 2001 Date Updated:

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PercuSurge, IncorporatedSunnyvale, CaliforniaPremarket Notification [510(k)]Application	PercuSurge GuardWire System for Use inthe Percutaneous Interventional Treatmentof Saphenous Vein Bypass GraftsMarch 29, 2001
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Description

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:

2 6000 20 17 2000 11 21 2 6 1 160 00000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
Catalog	Wire	Wire	Balloon
Number	Diameter	Length	Range
G14-6-200 IDE	0.014"	200cm	- 6. Umm
G14-6-300 IDE	0.014"	300cm	3.0 - 6.0mm

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 with Teflon 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 GuardWire's occlusion balloon can accommodate vessel sizes ranging from 3mm in diameter. The distal tip of the wire is a shapeable radiopaque platinum 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 Nitinol 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.

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PercuSurge, IncorporatedSunnyvale, California	PercuSurge GuardWire System for Use inthe Percutaneous Interventional Treatmentof Saphenous Vein Bypass Grafts
Premarket Notification [510(k)]Application	March 29, 2001

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 stainless steel 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.

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PercuSurge, IncorporatedSunnyvale, California	PercuSurge GuardWire System for Use inthe Percutaneous Interventional Treatmentof Saphenous Vein Bypass Grafts
Premarket Notification [510(k)]Application	March 29, 2001

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 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.

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PercuSurge, Incorporated Sunnyvale, California

PercuSurge GuardWire System for Use in the Percutaneous Interventional Treatment of Saphenous Vein Bypass Grafts

Premarket Notification [510(k)] Application

March 29, 2001

Technological Characteristics

ComparisonFeature:	TOBC:GuardWire® System	GuardWire TemporaryOcclusion and AspirationSystem:GuardWire® Plus System
SystemDescription:	The PercuSurge® GuardWire®Temporary Occlusion Balloon (TOB)System is comprised of three principalcomponents: the GuardWire®Temporary Occlusion Catheter, theMicroSeal™ Adapter and the Export®Aspiration Catheter. The GuardWire®Temporary Occlusion Catheter has adiameter that is similar to commonlyused .014" guide wires in lengths of200 and 300 cm and has a distalelastomeric balloon. The small profileof this device allows for the delivery ofa wide range of diagnostic andinterventional devices over its shaft.The GuardWire® is offered in fourvessel size ranges accommodatingvessel diameters from 3.0mm to5.0mm. For each vessel size,PercuSurge® provides a unique Micro-Inflation syringe with a fixed fluidvolume for a specific vessel size.	The PercuSurge GuardWire® IITemporary Occlusion and AspirationSystem is comprised of four principalcomponents: the GuardWire® IITemporary Occlusion Catheter, theMicroSeal™ Adapter the Export®Aspiration Catheter and the EZ FlatorInflation/Deflation device. The systemdescription is identical except for thesubstitution of the single EZ FlatorInflation/Deflation Device used forinflation, deflation and catheterpreparation. This one syringeaccommodates the original vesseldiameter of 3.0mm to 6.0mm with afluid volume for the specified vesselsize. Controlled volume delivery isidentical. It has an integrated deflationsyringe used for catheter preparationand balloon deflation, and also used asa reservoir for diluted contrastsolution.

Table 2: Comparison Chart

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PercuSurge, IncorporatedSunnyvale, California	PercuSurge GuardWire System for Use inthe Percutaneous Interventional Treatmentof Saphenous Vein Bypass Grafts
Premarket Notification [510(k)]Application	March 29, 2001

Indications forUse:	The TOB System is indicated for use inthe peripheral vasculature to facilitatethe localized infusion of therapeutic ordiagnostic fluids with or without vesselocclusion.	The PercuSurge GuardWire PlusTemporary Occlusion & AspirationSystem is indicated for use in thecoronary saphenous vein bypass graftsto:Contain and aspirateembolic material(thrombus/debris) whileperforming percutaneoustransluminal coronaryangioplasty or stentingprocedures. To subselectivelyinfuse/deliver diagnostic ortherapeutic agents with orwithout vessel occlusion.
BiocompatibilityData:	Cytotoxicity Study: ISO ElutionSensitization Study in Guinea PigsAcute Intracutaneous ReactivityStudy in the RabbitAcute Toxicity Study in the MouseHemolysis Study In-VivoIn-Vivo Thromboresistence StudyRabbit Pyrogen Study	Identical
SterilizationMethodValidationProtocol	EtO	EtO
Labeling	Instructions For Use, Pouch Labels,Box Labels (see K972777 submittedJuly 23, 1997, section VI)	System Instructions For Use, Pouchlabels, Box Labels (see examplesstarting on page 4).

Non Clinical Performance Data Summary

Vessel Occlusion

The objective of this study was to demonstrate that the individual PercuSurge system components listed below perform as a system and provide temporary occlusion under the previously stated pressure and flow rate conditions in vessel sizes of 4mm and 5mm. In summary, in all cases the GuardWire elastomeric occlusion balloon consistently occluded both 4 and 5mm vessels which were subjected to pressures recorded from 1.0-3.5 psi, and flow rates recorded from 70-85 cc/min. These conditions were selected because they

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PercuSurge, IncorporatedSunnyvale, California	PercuSurge GuardWire System for Use inthe Percutaneous Interventional Treatmentof Saphenous Vein Bypass Grafts
Premarket Notification [510(k)]Application	March 29, 2001

represent the range of blood pressures and flow rates that the system is expected to see in clinical use.

Fluid Evacuation

The objective of this study was to demonstrate that using the individual system components listed below, different types of fluids (i.e. saline, water, 40% glycerol / 60% saline) can be evacuated from a vessel at a minimum rate of 0.5ml/sec. In all cases, the GuardWire System Accessory Catheter and ancillary components were capable of evacuating all three types of fluids. In addition the flow rates obtained exceeded the minimum specification of 0.5ml/sec as established in conjunction with the PercuSurge Medical Advisory Board.

Particle Evacuation

The objective of this study was to demonstrate that the individual PercuSurge System components identified below could be used to evacuate particulates that were representative of the type of debris that may be found in blood following interventional procedures. It is concluded from this testing that the GuardWire System Accessory (Export) Catheter and ancillary components are capable of evacuating at least 90% of particles. This meets the evacuation capability requirement established by PercuSurge and in conjunction with the PercuSurge Medical Advisory Board. All components performed according to their individual specifications.

Infusion Flow Rate

The purpose of this qualification is to demonstrate that the 8F Export® Aspiration Catheter meets pre-determined specifications and test acceptance criteria after EtO sterilization. These fluids were selected to characterize the Accessory Catheter infusion capabilities because they are fluids commonly infused in interventional applications. The testing conducted on the Export Aspiration Catheter demonstrates with the required statistical confidence that the current design meets all of the product specification requirements.

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PercuSurge, IncorporatedSunnyvale, California	PercuSurge GuardWire System for Use inthe Percutaneous Interventional Treatmentof Saphenous Vein Bypass Grafts
Premarket Notification [510(k)]Application	March 29, 2001

Additional Laboratory Studies

The evaluation of 40 aspirates from different phases of the therapeutic procedures provided an opportunity to further corroborate the animal studies by determining the nature of the material and its cellular component.

The conclusion from this analysis is that the occlusion balloon and blood removal by aspiration did not affect the vessel wall in the study cohort.

Animal Studies

The PercuSurge GuardWire System has been studied in 8 separate animal safety and effectiveness studies and in accordance with the Instructions For Use. These pilot studies confirmed the feasibility of this technology.

The GuardWire System was compatible with the interventional devices with which it was tested and it successfully occluded the target vessel. It was capable of delivering fluid and evacuating blood. Flow was restored easily after the conclusion of each study. Further, the histopathology results showed that the use of the device had no significant adverse effects on the vessel in which it was used.

Four additional animal comparative studies were performed to demonstrate the improvements and ease of use in the design modifications on the GuardWire system (GuardWire Plus design). These studies were primarily oriented towards performance evaluation and demonstrated that the modified design was superior based on physician input.

Additional Studies

The first test entitled Particles in Motion Distal to the Therapy Balloon, was completed on 4/12/98 and addresses the question of whether particles would have a tendency to aggregate along the proximal side of the distal occlusion balloon prior to aspiration and after therapy. The analyses and studies indicate that the use of a distal or proximal occlusive device does not have an effect of particle movement from therapy dilation. The particles from therapy dilation would not aggregate at the balloon proximal surface during deflation or removal of the therapy balloon. The presence of a distal occlusion balloon would not be expected to enhance particle adherence to a stent due to minor oscillation of the particles from heart rhythm.

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PercuSurge, IncorporatedSunnyvale, CaliforniaPremarket Notification [510(k)]Application	PercuSurge GuardWire System for Use inthe Percutaneous Interventional Treatmentof Saphenous Vein Bypass GraftsMarch 29, 2001
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Clinical Performance Data (SAFER Study Data Results Summary)

Table 3. Major Adverse Events - In- and Out-of-Hospital (to 30 days) All Patients Treated (N=801 Patients, 875 Lesions) Data listed as per patient

		GuardWire™(N=406 Patients,N=442 Lesions)		No GuardWire™(N=395 Patients,N=433 Lesions)		All Randomized(N=801 Patients,N=875 Lesions)
Combined In- and Out-of-Hospital Complications (to 30 days)	Number	%	Number	%	Number	%
MACE (Death, MI, Emergent CABG, TVR)	39	9.6%	65	16.5%	104	13.0%
Death	4	1.0%	9	2.3%	13	1.6%
Myocardial Infarction (Q wave or non-Q wave)	35	8.6%	58	14.7%	93	11.6%
Q Wave MI	5	1.2%	5	1.3%	10	1.2%
Non-Q Wave MI	30	7.4%	54	13.7%	84	10.5%
Emergent CABG	0	0.0%	2	0.5%	2	0.2%
Target Lesion Revascularization	4	1.0%	8	2.0%	12	1.5%
TL-CABG	0	0.0%	1	0.3%	1	0.1%
TL-PTCA	4	1.0%	7	1.8%	11	1.4%
Target Vessel Revascularization not involvingthe Target Lesion	5	1.2%	2	0.5%	7	0.9%
TV/non-TL-CABG	0	0.0%	0	0.0%	0	0.0%
TV/non-TL-PTCA	5	1.2%	2	0.5%	7	0.9%
Transfusion	21	5.2%	22	5.6%	43	5.4%
Vascular Surgical Repair	4	1.0%	13	3.3%	17	2.1%
Cerebrovascular Accident (CVA)	3	0.7%	0	0.0%	3	0.4%
Perforation	1	0.2%	6	1.5%	7	0.9%
Subacute Closure	5	1.2%	6	1.5%	11	1.4%
Hemorrhagic/Vascular	16	3.9%	22	5.6%	38	4.7%

Conclusions

The results as delineated above, support the benefits of use of the GuardWire system for the target population, outweigh the risk of illness or injury when used as indicated in accordance with the Instruction For Use.

Prior Clinical Study Results

Prior to the initiation of the SAFER randomized study, PercuSurge sponsored and conducted two consecutive feasibility studies to establish the feasibility and initial clinical performance of the PercuSurge GuardWire System. The first feasibility study was conducted as a registry in a single center under the direction of John Webb MD, FRCPC, FACC, Director of Interventional Cardiology, St. Paul's Hospital, Vancouver, B.C., Canada. The second feasibility study was conducted as a multi-center prospective registry under the direction of This material constitutes confidential and proprietary information of PercuSurge, Incorporated (PercuSurge), and is directed to the person to whom it is given by an authorized representative of PercuSurge. This material may not be distributed, reproduced or divulged without written consent from PercuSurge.

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PercuSurge, IncorporatedSunnyvale, California	PercuSurge GuardWire System for Use inthe Percutaneous Interventional Treatmentof Saphenous Vein Bypass Grafts
Premarket Notification [510(k)]Application	March 29, 2001

Professor Eberhard Grube MD, Director of Cardiology, Siegburg Heart Center, Siegburg, Germany.

Summaries of both feasibility studies follow below.

1. Feasibility 1 - Single Center Experience
  To establish the safety and clinical performance of the PercuSurge GuardWire System, PercuSurge in cooperation with John Webb MD, FRCPC, FACC, Director of Interventional Cardiology, St. Paul's Hospital, Vancouver, B.C., Canada, conducted a study where 30 lesions, (20 patients, 24 procedures) were treated with PTCA and/or stented in conjunction with the PercuSurge GuardWire (then known as the TOBC System). Pursuant to Section 15.2 of the Canadian Medical Devices Regulation, PercuSurge submitted the clinical protocol to the Canadian Devices Bureau, Ottawa, Ontario on March 28, 1997. The clinical study was approved on May 2, 1997 (File Number IU-CV00797). The study was also approved by the University of British Columbia Office of Research Services Administration, Clinical Research Ethics Board on July 22, 1997 (File Number C97-0235) and the St. Paul's Hospital Ethics Committee for human experimentation (File Number P97-0065).

No. of Patients Treated	20
No. of Procedures Performed	24
No. of Lesions Treated	30
Age of SVG in Years	$8.7 \pm 5.0$
Duration	7/30/97 - 1/9/98

Table 4: Study Baseline Information

	VesselPerforation	Non-QWave MI	Q-WaveMI	EmergencyCABG	Death	Total
Count of Patient	0	1*	0	0	0	1
Percentage	0%	4%	0%	0%	0%	4%
Relationship toDevice	N/A	0	N/A	N/A	N/A	0

Table 5: Acute Complications: Procedure N=24

Non-O Wave MI: determined by >3x enzyme

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PercuSurge, IncorporatedSunnyvale, California	PercuSurge GuardWire System for Use inthe Percutaneous Interventional Treatmentof Saphenous Vein Bypass Grafts
Premarket Notification [510(k)]Application	March 29, 2001

Conclusions

The data demonstrate that the PercuSurge GuardWire System is safe. It is compatible with routine angioplasty and stent deployment. It can be used in conjunction with interventional devices without affecting the safety of the patient, outcome of the intervention or integrity of the balloon.

Feasibility 2 - Multi-Center Experience 2.

A multi-center prospective non-randomized consecutive pilot trial, entitled the SAFE Study, "Saphenous Vein Graft Angioplasty Free of Emboli," was conducted as a multi-center prospective registry under the direction of Professor Eberhard Grube MD, Director of Cardiology, Siegburg Heart Center, Siegburg, Germany The purpose of the SAFE study was to determine the safety and efficacy of treatment with the PercuSurge GuardWire system during stenting in saphenous vein bypass grafts . Ten sites were utilized in Canada, Germany, and Italy. In addition, independent data analysis for this study was conducted by CDAC-Cardiovascular Data Analysis Center, Beth Israel Deaconess Medical and Harvard Medical Centers and independent investigational site monitoring was conducted by MedPass International of Paris, France.

Table 6. Principal Effectiveness and Safety Results All Patients Treated (N=103 Patients, 105 Lesions) (on following page)

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PercuSurge, Incorporated
Sunnyvale, California

PercuSurge GuardWire System for Use in the Percutaneous Interventional Treatment of Saphenous Vein Bypass Grafts

Premarket Notification [510(k)] Application

March 29, 2001

Efficacy Measures	All Patients(N=103 Patients,N=105 Lesions)
Lesion Success	99.0% (104 / 105)
Procedure Success	95.1% (98 / 103)
Device Success	85.4% (88 / 103)
Post-Procedure In-Stent MLD (mm)	3.10 $\pm$ 0.54 (91)(1.88,4.52)
Post-Procedure In-Stent % DS	6.6% $\pm$ 14.0%(91)(-41.8%,40.0%)
TLR-Free at 30 Days*	99.0%
TVR-Free at 30 Days*	99.0%
TVF-Free at 30 Days*	94.1%
MACE-Free at 30 Days*	94.1%

Safety Measures and Other Clinical Events

In-Hospital MACE	4.9% (5 / 103)
Out-of-Hospital MACE	1.0% (1 / 103)
Stent Thrombosis to 30 days	1.0% (1 / 103)
Bleeding Complications to 30 days	1.9% (2 / 103)
Vascular Complications to 30 days	3.9% (4 / 103)
CVA to 30 days	0.0% (0 / 103)

Numbers are % (counts/sample size) and Mean ± SD.

*Survival estimates by Kaplan-Meier method.

Lesion Success = Attainment of <50% residual stenosis using any percutaneous method, e.g., the assigned treatment followed by another device (such as an additional stent). If no in-stent measurements were available, in-lesion measurements were used, and if no QCA was available, visual estimates were used.

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PercuSurge, IncorporatedSunnyvale, California	PercuSurge GuardWire System for Use inthe Percutaneous Interventional Treatmentof Saphenous Vein Bypass Grafts
Premarket Notification [510(k)]Application	March 29, 2001

Procedure Success = Attainment of <50% final diameter stenosis using any percutaneous method without the occurrence of in-hospital death, MI, or target vessel revascularization. If no in-stent measurcments were available, in-lesion measurements were used, and if no QCA was available, visual estimates were used. Device Success = Deployment, occlusion of flow by crossing the lesion, and inflation and aspiration per Instructions For Use. TLR-Free = No clinically-driven target lesion revascularization. TVR-Free = No clinically-driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. TVF-Free = No target vessel revascularization, MI, or death that could not be clearly attributed to a vessel other than the target vessel. and CE-Free = No death, Q wave or non-Q wave MI, emergent bypass surgery, or target vessel revascularization. In-Hospital MACE = Death, Q wave or non-Q wave MI, emergent bypass surgery, or target vessel revascularization prior to hospital discharge as determined by the independent Clinical Events Committee. Out-of-Hospital MACE = Death, Q wave or non-Q wave MI, emergent bypass surgery, or target vessel revascularization after hospital discharge, as determined by the independent Clinical Events Committee. Stent Thrombosis = Angiographic thrombus or subacute closure within the stented vessel, or any death not attributed to a non-cardiac cause in the absence of documented angiographic stent patency within the first 30 days. Bleeding Complications = Transfusions of blood products due to blood loss from the index percutaneous revascularization procedure. Vascular Complications = Hematoma at access site >4 cm, false aneurysm, AV fistula, retroperitoneal bleed, peripheral ischemia/nerve injury, procedure related transfusion or vascular surgical repair. thansfactor of Yestourical deficits recorded by the clinical sites that persisted >24 hours.

Conclusions: The PercuSurge® GuardWire Plus™ System is compatible with routine angioplasty procedures, is capable on containing and retrieving atherosclerotic and thrombotic debris, and may aid in the prevention of distal embolization and "no-reflow" in diseased saphenous vein grafts.

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Image /page/13/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 1 2001

Ms. Debora D. Hinman Vice President, Regulatory Affairs and Quality Assurance PercuSurge, Inc. 540 Oakmead Parkway Sunnyvale, CA 94085

K003992 Re:

The PercuSurge GuardWire Plus Temporary Occulusion & Aspiration System Regulation Number: 870.1250 Regulatory Class: II (two) Product Code: 74 NFA Dated: March 29, 2001 Received: March 30, 2001

Dear Ms. Hinman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 Coreetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Debora D. Hinman

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K003992

Device Name: PercuSurge GuardWire Temporary Occlusion and Aspiration System

Indications for Use:

The PercuSurge GuardWire Plus Temporary Occlusion & Aspiration System is indicated for usc in the coronary saphenous vein bypass grafts 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.

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

Concurence of CDRH, Office of Device Evaulation (ODE)

t colle

Division of Cardiovascular & Respiratory Devices
510(k) Number K063492

(Posted July 1, 1998)

(Optional Format 3-10-98)

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).