(88 days)
The Fogarty dilation atrioseptostomy catheter is indicated for enlarging interatrial openings for palliation of several congenital cardiac defects to increase mixing at atrial level or to decompress a hypertensive atrial chamber.
The Miller balloon atrioseptostomy catheter is indicated for enlarging interatrial openings for palliation of several congenital cardiac defects to increase mixing at atrial level or to decompress a hypertensive atrial chamber.
The Fogarty dilation atrioseptostomy catheter is a 5 French single-lumen catheter (with 8F uninflated balloon OD) with a wire-wound shaft that may be visualized using fluoroscopy. A latex balloon with a maximum inflated diameter of 15mm is located at the distal end of the catheter. The distal tip has a nominal angulation of 35° to facilitate manipulation of the inter-atrial opening. A removable stylet is provided to increase catheter body stiffness and for temporary straightening of the 35° tip angulation during insertion. The catheter contains a gate valve in order to inflate and deflate the balloon. The catheter shaft has depth markings in 10 cm spacing.
The Miller balloon atrioseptostomy catheter is a 5 French single-lumen catheter (with 9F uninflated balloon OD) with a wire-wound shaft that may be visualized using fluoroscopy. A latex balloon with a maximum inflated diameter of 19mm is located at the distal end of the catheter. The distal tip has a nominal angulation of 35° to facilitate manipulation of the balloon through the inter-atrial opening. A removable stylet is provided to increase catheter body stiffness and for temporary straightening of the 35° tip angulation during insertion. The catheter contains a gate valve in order to inflate and deflate the balloon. The catheter shaft has depth markings in 5 cm spacing. The Miller catheter contains a plug for occluding the vein or percutaneous sheath to reduce venous leakage.
The Fogarty dilation atrioseptostomy catheter and Miller balloon atrioseptostomy catheter are packaged in an identical tube configuration.
The provided text is a 510(k) summary for the Fogarty Dilation Atrioseptostomy Catheter and Miller Balloon Atrioseptostomy Catheter. It focuses on demonstrating substantial equivalence to a predicate device based on design descriptions, intended use, indications for use, and a summary of non-clinical (bench) testing.
This document describes a medical device (catheter) and its regulatory clearance, not an AI/ML powered device, therefore, the information requested about acceptance criteria and studies proving the device meets the criteria in the context of AI/ML performance (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance) is not applicable to the provided content.
The document details the device's physical characteristics, its intended use (enlarging interatrial openings for palliation of congenital cardiac defects), and asserts substantial equivalence to a predicate device based on common intended use and similar technological characteristics, with minor modifications.
Here's what can be extracted regarding "acceptance criteria" from the provided text, interpreted as performance tests for the physical catheter device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document summarizes "Performance testing" which acts as the acceptance criteria for the physical device. Specific numerical "reported device performance" values are not provided in this summary; rather, it lists the types of tests performed. It states that the devices meet the established performance criteria.
| Acceptance Criteria (Performance Test) | Reported Device Performance |
|---|---|
| Visual/Dimensional Inspection | Met established criteria |
| - Catheter length | Met established criteria |
| - Catheter tip angle | Met established criteria |
| - Depth marker spacing | Met established criteria |
| - Balloon nominal diameter | Met established criteria |
| Balloon pull force | Met established criteria |
| Deflation time | Met established criteria |
| Introducer compatibility | Met established criteria |
| Joint strength testing | Met established criteria |
| Air Leakage | Met established criteria |
| Biocompatibility | Met established criteria |
| Sterilization | Validated |
| Shelf life | Validated |
| Packaging (bubble leak) validations | Validated |
Regarding the other aspects you asked about, they are not present in this document as it does not concern an AI/ML powered device impacting diagnostic performance:
- Sample size used for the test set and data provenance: Not applicable. These are physical device bench tests.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. Ground truth for a physical device's performance usually comes from engineering specifications and physical measurements.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is for diagnostic systems.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a physical catheter.
- The type of ground truth used: For these non-clinical tests, the "ground truth" would be the engineering specifications and established test methodologies for mechanical, material, and sterility properties.
- The sample size for the training set: Not applicable (no AI/ML training).
- How the ground truth for the training set was established: Not applicable (no AI/ML training).
§ 870.5175 Septostomy catheter.
(a)
Identification. A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.(b)
Classification. Class II (performance standards).