FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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

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).