(77 days)
The aeris Balloon Dilation Catheter is intended for use in adult and pediations to dilate strictures of the airway.
The aeris Balloon Dilation Catheter is comprised of a sinqle lumen catheter with a high pressure balloon near the distal tip. A stylet is provided to facilitate advancement of the balloon dilation catheter to the desired location. The stylet must be removed before inflation of the high pressure balloon. A luer lock at the proximal end is used for placement of the stylet and injecting sterile water into the balloon. Two radiopaque markers, located on the catheter, inside the balloon, can be used to confirm balloon placement under Fluoroscopy.
The aeris Balloon Dilation Catheter includes inflation balloons of diameters 5, 7, 8, 9, 10, 12, 14, and 16 mm with complementing characteristics as shown in Table 1.
The provided text describes the acceptance criteria and the results of various bench tests for the aeris Balloon Dilation Catheter as part of a 510(k) submission for substantial equivalence. It does not include information about a study involving human readers, AI, or specific details on studies for ground truth establishment for a test set. This is a technical device submission, not an AI/algorithm-based diagnostic device.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides multiple tables summarizing the bench testing results for different sizes of the aeris Balloon Dilation Catheter and a comparison with predicate devices. For conciseness, a combined table of the types of tests and their general acceptance criteria and performance will be presented, referencing the detailed tables for specific values.
| Test Category | Study Endpoint | Requirement | Acceptance Requirement | Reported Device Performance (aeris Balloon Dilation Catheter) |
|---|---|---|---|---|
| Functional Performance | ||||
| Balloon Working Length | Balloon pressure at 1 ATM | Balloon working length within tolerance | 5x30mm: 30 ± 1 mm | |
| 9x30mm: 30 ± 0.6 mm | ||||
| 16x40mm: 40 ± 1 mm | Pass | |||
| Inflation Time | Balloon pressure at recommended use pressure (17 ATM for 5/9mm, 10 ATM for 16mm) | Balloon able to inflate | recommended use pressure | 5x30mm & 9x30mm: Balloon failure pressure > 17 ATM |
| 16x40mm: Balloon failure pressure > 10 ATM | Pass | |||
| Balloon Hub Measurement | Balloon pressure at recommended use pressure (17 ATM for 5/9mm, 10 ATM for 16mm) | Measure diameter of hub and working length | 5x30mm & 9x30mm: Hub diameter minus working length diameter |
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.