(133 days)
The Concentric Balloon Guide Catheter is indicated for use 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 Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.
Like the predicate device, the Modified FlowGate™ Balloon Guide Catheter is a coaxiallumen, braid-reinforced, variable stiffness catheter designed for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. A radiopaque marker is included on the distal end for angiographic visualization. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. A bifurcated luer hub on the proximal end allows attachments for flushing, inflation and aspiration. Modified FlowGate™ Balloon Guide Catheter dimensions and maximum recommended balloon inflation volume are indicated on product label.
The provided text is a 510(k) Summary for a medical device (Modified Balloon Guide Catheter) and does not describe a study involving an AI/ML device. Therefore, it does not contain information on acceptance criteria, reported device performance in the context of AI/ML, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or the type of ground truth used for AI/ML validation.
Instead, the document focuses on demonstrating substantial equivalence of a modified medical device to its predicate devices, as required for 510(k) clearance by the FDA. The "acceptance criteria" and "study" mentioned in this document refer to the verification and validation testing performed to ensure the modified device meets its design specifications and performs as safely and effectively as the predicate devices.
Here's an interpretation of the requested information based on the provided text, adapted for a medical device rather than an AI/ML system:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a single table of acceptance criteria and reported full device performance in a summary format. Instead, it lists various tests performed and states that the results were successful or met acceptance criteria. For biocompatibility, specific results and conclusions are provided.
Here's a synthesized table based on the information available:
| Acceptance Criteria Category/Test | Reported Device Performance Summary (Modified Balloon Guide Catheter) |
|---|---|
| Mechanical & Performance Tests | |
| Dimensional Verification | Device met predetermined dimensional requirements. |
| Simulated Use Testing | Device and accessories were successfully used per procedural instructions in a neurovascular model. |
| Balloon Testing (Symmetry, Compliance, Inflation/Deflation, Fatigue, Burst, Leakage) | Tests performed successfully; balloon demonstrated appropriate symmetry, compliance, inflation/deflation rates, fatigue strength, constrained burst, and leakage. |
| Tensile Testing (Mechanical Integrity) | Device demonstrated mechanical integrity under tensile loads. |
| Distal Shaft Flexibility Testing | Force to flex the distal shaft was within acceptable limits. |
| Soft Tip Deflection Testing | Force to deflect the distal edge of the soft tip was within acceptable limits. |
| Tip Patency Testing | Device distal tip maintained patency under aspiration. |
| Kink Resistance | Device shaft demonstrated resistance to kinking. |
| Hub Luer Fitting Testing | Extension Tubing accessory demonstrated compatibility with the hub luer fitting. |
| Extension Tubing Aspiration | Ability to aspirate using the Extension Tubing Accessory was confirmed. |
| Packaging Verification | Packaging successfully protected the device following climatic conditioning and distribution simulation. |
| Shelf Life Testing (Product and Packaging) | Demonstrated acceptable shelf life for both product and packaging. |
| Biocompatibility Tests (Predicate Device K122581) | |
| Sensitization (ISO 10993-10) | Non-sensitizer (no evidence of delayed dermal contact sensitization). |
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic (no biological activity with L929 cells). |
| Intracutaneous Reactivity (ISO 10993-10) | Non-irritant (no significantly greater biological reaction than controls). |
| Systemic Toxicity (Acute) (ISO 10993-11) | No acute systemic toxicity (no significantly greater biological reaction than controls). |
| Systemic Toxicity (Rabbit Pyrogen Test) (ISO 10993-11, USP 34 ) | Non-pyrogenic (no individual temperature rise of 0.5°C or more). |
| Hemocompatibility (Hemolysis) (ASTM F756) | Non-hemolytic (0.17% direct, 0.12% indirect hemolysis above negative control). |
| Hemocompatibility (Complement Activation) (ISO 10993-4) | Minimal complement activation potential (no statistically significant increase in C3a; significant increase in SC5b-9). |
| Hemocompatibility (Thrombogenicity) (ISO 10993-4) | No significant thrombosis (Grade 0-1 observed). |
| Biocompatibility Screening Tests (Subject Device K131492) | |
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic (no cytotoxicity or cell lysis). |
| Hemocompatibility (Hemolysis) (ISO 10993-4, ASTM Direct/Extract) | Non-hemolytic (hemolytic index 0.0% direct, 0.4% extract). |
| Fourier Transform Infrared (FTIR) Scan (ISO 10993-18) | Materials for test article and control sample are equivalent (97.90% match for distal tip). |
| Physicochemical Tests (USP ) | Met USP requirements (Non-volatile residue: 1 mg; Residue on ignition: , USP 34 ) which define acceptable biological responses and material properties. Test results are compared directly against the pass/fail criteria outlined in these standards. |
8. The Sample Size for the Training Set:
- Not applicable. This document describes a physical medical device, not an AI/ML system, so there is no "training set." The development of the device would involve engineering design, prototyping, and iterative testing, but not in the sense of a data-driven "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this type of device.
§ 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).