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The Paragon 8F Balloon Guide Catheter is in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Paragon 8F Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices.

Device Description

The Paragon™ 8F Balloon Guide Catheter (BGC) is a multi-lumen, braid-reinforced, variable stiffness catheter with a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A compliant balloon is mounted on the distal end. Balloon inflation can be facilitated through the side port of the bifurcated luer hub. The 10 mm long balloon can be inflated up to a maximum volume of 0.6 mL. At this volume, the balloon diameter is 10 mm. The through-lumen extends from the center port of the bifurcated luer hub to the distal tip. The external distal segment of the catheter shaft has hydrophilic coating to reduce friction during use. The coating starts from the proximal balloon bond and extends proximally for 19 cm in length. There are two Paragon 8F BGC configurations which have working lengths of 85 cm. The difference in device length resides in the proximal shaft segment only. The 16 cm distal flexible segment and the balloon are identical for both configurations.

The Paragon 8F Balloon Guide Catheter is compatible with minimum 0.110 inch inner diameter (ID) introducer sheaths, guidewires up to 0.038 inch outer diameter (OD), and 6F catheters up to 0.085 inch OD. The Paragon 8F Balloon Guide Catheter is sterile, non-pyrogenic, and intended for single use only.

AI/ML Overview

The provided text describes the acceptance criteria and the study proving the device meets these criteria for the Wallaby Medical Paragon 8F Balloon Guide Catheter (K232437). However, it focuses on the physical and biological performance of the catheter, not on an AI/ML-based medical device. Therefore, many of the requested fields related to AI/ML device validation (e.g., sample sizes for training/test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance) are not applicable to this submission.

Here's a breakdown of the available information based on the provided text, adapted to the context of a physical medical device.

Acceptance Criteria and Device Performance (for a Physical Medical Device)

Acceptance Criteria Category	Specific Test / Requirement	Reported Device Performance (Table 2 & 3 summary)
Design Verification (Bench)	Visual Inspection: Verify visual surface requirements.	Pass – all samples met the pre-determined acceptance criteria.
	Dimensional Inspection: Verify dimensional specifications.	Pass – all samples met the pre-determined acceptance criteria.
	Simulated Use: Evaluate device performance and accessories in a simulated anatomy model.	Pass – all samples met the pre-determined acceptance criteria.
	Kink Resistance: Evaluate device around clinically relevant radii and verify kink resistance.	Pass – all samples met the pre-determined acceptance criteria.
	Coating Lubricity: Evaluate frictional forces and verify coating lubricity.	Pass – all samples met the pre-determined acceptance criteria.
	Radiopacity: Evaluate marker band visibility under fluoroscopy.	Pass – all samples met the pre-determined acceptance criteria.
	Delivery/Retrieval: Evaluate device in an anatomical model and verify frictional force.	Pass – all samples met the pre-determined acceptance criteria.
	Balloon Inflation Time: Verify balloon inflation time.	Pass – all samples met the pre-determined acceptance criteria.
	Balloon Deflation Time: Verify balloon deflation time.	Pass – all samples met the pre-determined acceptance criteria.
	Distal Tip Stiffness: Evaluate distal tip deflection force and verify stiffness.	Pass – all samples met the pre-determined acceptance criteria.
	Coating Integrity: Evaluate device pre- and post-insertion/retrieval through a simulated vascular model and verify coating integrity.	Pass – all samples met the pre-determined acceptance criteria.
	Torque Strength: Evaluate device integrity after applied hub rotations with distal end held stationary and verify torque strength.	Pass – all samples met the pre-determined acceptance criteria.
	Shaft & Hub Tensile: Verify tensile strength.	Pass – all samples met the pre-determined acceptance criteria.
	Liquid Leak: Verify liquid leak requirements per ISO 10555-1.	Pass – all samples met the pre-determined acceptance criteria.
	Air Leak: Verify air leak requirements per ISO 10555-1.	Pass – all samples met the pre-determined acceptance criteria.
	Hub Compatibility: Verify BGC bifurcated luer hub requirements per ISO 80369-7.	Pass – all samples met the pre-determined acceptance criteria.
	RHV Luer: Verify RHV luer requirements per ISO 80369-7.	Pass – all samples met the pre-determined acceptance criteria.
	Static Burst: Verify static burst requirements per ISO 10555-1.	Pass – all samples met the pre-determined acceptance criteria.
	Dynamic Burst: Verify dynamic burst requirements per ISO 10555-1.	Pass – all samples met the pre-determined acceptance criteria.
	Resistance to Lumen Collapse: Demonstrate main lumen does not collapse under aspiration.	Pass – all samples met the pre-determined acceptance criteria.
	Corrosion Resistance: Verify corrosion resistance requirements per ISO 10555-1.	Pass – all samples met the pre-determined acceptance criteria.
	Extension Tubing Tensile: Verify tensile strength requirements per ISO 10555-1.	Pass – all samples met the pre-determined acceptance criteria.
	Particulate: Evaluate device within a simulated anatomy model and verify particulate count similar to comparator device.	Pass – all samples met the pre-determined acceptance criteria.
	Balloon Fatigue: Evaluate repetitive balloon inflation and deflation cycles and verify fatigue.	Pass – all samples met the pre-determined acceptance criteria.
	Balloon Joint Integrity: Evaluate tensile force and verify balloon joint integrity.	Pass – all samples met the pre-determined acceptance criteria.
	Balloon Burst Volume: Verify balloon burst volume.	Pass – all samples met the pre-determined acceptance criteria.
	Balloon Diameter to Inflation Volume (Compliance): Characterize balloon diameter for pre-defined inflation volumes.	All samples were characterized.
	Shelf Life: Verify device performance after accelerated aging.	Pass – all samples met the pre-determined acceptance criteria.
	Transit Testing: Subject device, accessories, and packaging to environmental conditioning and shipping simulation and verify performance.	Pass – all samples met the pre-determined acceptance criteria.
	Packaging - Bubble Leak: Evaluate packaging per ASTM F2096-11 and verify requirements.	Pass – all samples met the pre-determined acceptance criteria.
	Packaging - Pouch Seal Strength: Evaluate packaging per ASTM F88 Technique A (unsupported peel) and verify requirements.	Pass – all samples met the pre-determined acceptance criteria.
	Sterility: Subject device, accessories, and packaging to sterilization and verify requirements.	Pass – all samples met the pre-determined acceptance criteria (Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11135:2014).
Biocompatibility	MEM Elution Cytotoxicity (BGC, 3-way stopcock, extension tubing, syringe, sheath, RHV): Evaluate for cytotoxicity.	Non-cytotoxic (scores of 0, no cytotoxic potential to L-929 mouse fibroblast cells).
	ISO Intracutaneous Irritation (BGC, 3-way stopcock, extension tubing, syringe, sheath, RHV): Evaluate for irritation.	Non-irritant / Negligible Irritant (delta between test article and vehicle control = 0.5°C).
	Complement Activation - SC5b-9 Assays (BGC): Evaluate potential to activate complement system.	Not a potential activator of complement system (results within acceptable range, not statistically different than activated NHS control or negative control).
	ASTM Hemolysis - Direct Contact and Extract Method (BGC, 3-way stopcock, extension tubing, syringe, sheath, RHV): Evaluate for hemolysis.	Non-hemolytic (blank corrected hemolytic index: 0.1 or 0.0).
	Thromboresistance Evaluation (BGC): Evaluate resistance to thrombus formation.	Thromboresistance of the test device is similar to control (no adverse effects or clinical signs during test period, no thrombus score >3 for test or control device).
	In Vitro Hemocompatibility Assay (BGC): Evaluate effects on blood components.	Test article not a risk for adversely affecting concentrations of various cellular and non-cellular components in blood (test article results were within acceptable range).
	Partial Thromboplastin Time (PTT) (BGC): Evaluate clotting risk.	Not at risk for clotting (test article 99.5% of negative control, not statistically different from comparison article).
	Chemical Characterization (BGC): Evaluate extractable and leachable chemicals.	The risk is acceptable (extractable and leachable chemical characterization and toxicological risk assessment suggest negligible adverse toxic effect during intended clinical use).

Since this is for a physical medical device (catheter) and not an AI/ML software, the following sections are either not applicable ("N/A") or cannot be extracted from the provided text, as they pertain specifically to AI/ML software validation.

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

Sample Size for Test Set: The exact number of samples for each bench test is not explicitly stated in the summary, other than "all samples" met the criteria. For biocompatibility, it refers to standard GLP (Good Laboratory Practice) animal and in vitro studies, which have their own sample size guidelines.
Data Provenance: N/A. This applies to clinical data for AI/ML. The "data" here is the physical performance and biocompatibility of the device, typically conducted in a laboratory setting.
Retrospective or Prospective: N/A. (Applies to AI/ML clinical data).

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

N/A. Ground truth in this context refers to established standards (e.g., ISO, ASTM), specified design requirements, and GLP guidelines for testing. Expert interpretation of images or other data to establish a "truth" is not relevant here.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

N/A. This is relevant for AI/ML where multiple human readers interpret data. For physical device testing, results are objective measurements against predefined criteria.

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:

N/A. This is a physical device, not an AI/ML algorithm.

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

N/A. This is a physical device, not an AI/ML algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For bench testing: Pre-defined engineering specifications, industry standards (ISO, ASTM), and design requirements.
For biocompatibility: Standardized biological evaluation methods and acceptance criteria defined in ISO 10993 series. Animal studies (e.g., guinea pig, rabbit) are the "ground truth" for assessing biological responses.

8. The Sample Size for the Training Set:

N/A. This applies to AI/ML software. This device does not have a "training set."

9. How the Ground Truth for the Training Set was Established:

N/A. This applies to AI/ML software.

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