(147 days)
METIC™ – Airway Balloon Catheter is intended to dilate strictures of the airway.
The METIC™ – Airway Balloon Catheter is comprised of a single 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 at the proximal end is used for the placement of the stylet and injecting sterile water into the balloon.
The document describes the acceptance criteria and performance of the METIC™ Airway Balloon Catheter, but it does not involve a study based on artificial intelligence or machine learning. Instead, it describes laboratory and bench testing for a physical medical device. Therefore, several sections of your requested output, which are relevant to AI/ML studies, cannot be extracted from this document, as they are not applicable.
Here's the information that can be extracted relevant to the physical device's performance and testing:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Balloon Length | 24 mm and 40 ± 1mm | Not explicitly reported as "Reported Device Performance" in a separate column, but implied to meet specification as part of "Technological Characteristics" and deemed "as safe and as effective as the predicate device" in the conclusion. |
| Balloon Diameters | 5.00, 7.00, 9.00, 10.00, 12.00, 14.00 & 16.00 mm ± 10% at balloon Nominal pressure | Not explicitly reported as "Reported Device Performance" in a separate column, but implied to meet specification as part of "Technological Characteristics" and deemed "as safe and as effective as the predicate device" in the conclusion. |
| Balloon Profile | 5.0 X 24mm: 2.60 to 3.00 mm | |
| 7.0 X 24mm: 3.10 to 3.70 mm | ||
| 10.0 X 40mm: 3.80 to 4.50 mm | ||
| (Other sizes unspecified for profile) | Not explicitly reported as "Reported Device Performance" in a separate column, but implied to meet specification as part of "Technological Characteristics" and deemed "as safe and as effective as the predicate device" in the conclusion. | |
| Catheter Usable Length | 425 ± 10 mm | Not explicitly reported as "Reported Device Performance" in a separate column, but implied to meet specification as part of "Technological Characteristics" and deemed "as safe and as effective as the predicate device" in the conclusion. |
| Catheter Overall Length | 450 ± 10 mm | Not explicitly reported as "Reported Device Performance" in a separate column, but implied to meet specification as part of "Technological Characteristics" and deemed "as safe and as effective as the predicate device" in the conclusion. |
| Balloon Burst Test | Actual Burst Pressure: | |
| 5.0 X 24mm: ≥ 22 ATM | ||
| 7.0 X 24mm: ≥ 22 ATM | ||
| 9.0 X 24mm: ≥ 22 ATM | ||
| 10.0 X 40mm: ≥ 15 ATM | ||
| 12.0 X 40mm: ≥ 15 ATM | ||
| 14.0 X 40mm: ≥ 15 ATM | ||
| 16.0 X 40mm: ≥ 15 ATM | "The safety and effectiveness of METIC™ – Airway Balloon Catheter has been evaluated for the following performance and safety requirements: |
- Visual Inspection
- Dimensional Measurement
- Balloon Burst and Balloon Compliance
- Inflation and Deflation Time
- Catheter Bond Strength
- Flexibility and Kink
- Torquability
- Catheter Fatigue
- Balloon Hub Measurement
- Proximal Luer fitting
- Balloon Preparation, Deployment and Retraction"
The document then states in the conclusion: "The performance, biocompatibility, sterilization, packaging and shelf life study conducted on METIC™ – Airway Balloon Catheter demonstrated the device is as safe and as effective as the predicate device." Indicating these tests met the criteria. |
| Balloon Diameter @ Nominal Pressure | 5.0 X 24mm: 10 ATM
7.0 X 24mm: 10 ATM
9.0 X 24mm: 10 ATM
10.0 X 40mm: 7 ATM
12.0 X 40mm: 7 ATM
14.0 X 40mm: 7 ATM
16.0 X 40mm: 7 ATM | (See above for general statement on performance evaluation and conclusion) |
| Balloon Fatigue Test | Catheter shall withstand 10 cycles minimum to Rated Burst Pressure
Rated Burst Pressure:
5.0 X 24mm: 17 ATM
7.0 X 24mm: 17 ATM
9.0 X 24mm: 17 ATM
10.0 X 40mm: 10 ATM
12.0 X 40mm: 10 ATM
14.0 X 40mm: 10 ATM
16.0 X 40mm: 10 ATM | (See above for general statement on performance evaluation and conclusion) |
| Balloon Inflation Time | ≤ 25 seconds | (See above for general statement on performance evaluation and conclusion) |
| Balloon Deflation Time |
§ 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.