(65 days)
The Airway Balloon Catheter is an instrument intended to dilate strictures of the airway tree.
The Modified Airway Balloon Catheter is a catheter with a high pressure balloon on the distal tip. The device is designed with a coaxial lumen for inflation and stylet access, if required. The Modified Airway Balloon Catheter encompasses a 18x40mm balloon catheter and reduces the deflation time specification.
The provided document is a 510(k) summary for the Acclarent Inspira AIR Balloon Dilation System, an airway balloon catheter. It focuses on demonstrating substantial equivalence to predicate devices, rather than being a clinical study report of an AI/ML diagnostic device. Therefore, much of the requested information (e.g., sample size for test/training sets, ground truth methodology, expert qualifications, MRMC studies, standalone performance) is not applicable or present in this type of submission.
However, I can extract the acceptance criteria and reported performance for the Modified Airway Balloon Catheter.
1. Table of Acceptance Criteria and Reported Device Performance:
| Attribute | Acceptance Criteria (from predicate devices) | Reported Device Performance (Modified Airway Balloon Catheter) |
|---|---|---|
| Balloon Diameters | 5 mm, 7 mm, 10 mm, 14 mm (for predicate K090660); Various (for K023337) | 18 mm |
| Balloon Length | 24 mm, 40 mm (for predicate K090660); 30 mm, 55 mm (for K023337) | 40 mm |
| Deflation Time | ≤15 seconds, ≤25 seconds (for predicate K090660); Unknown (for K023337) | ≤15 seconds |
| Maximum Inflation Pressure | 10-16 ATM (for predicate K090660); 6-9 ATM (for K023337) | 8 ATM |
| Flexible | Yes (for both predicates) | Yes |
| Shaft Design | Coaxial Lumen (for both predicates) | Coaxial Lumen |
| Used with Stylet | Optional (for K090660); Yes (Guidewire) (for K023337) | Optional |
| Technological Characteristics | To dilate strictures of airway tree (for both predicates) | To dilate strictures of airway tree |
Study Proving Device Meets Acceptance Criteria:
The document states: "The Modified Airway Balloon Catheter and Accessories met all performance acceptance criteria." This indicates that internal testing was conducted to verify against the established specifications which are based on the predicate devices. The specifics of these tests (e.g., number of units tested, precise methodology of deflection time measurement, etc.) are not detailed in this summary document, which is typical for a 510(k) summary rather than a full study report.
Relevant Missing Information (Not applicable or not typically included in a 510(k) summary for this type of device):
- Sample size used for the test set and the data provenance: Not specified. This is a medical device approval based on technological characteristics and performance specifications for a balloon catheter, not an AI/ML diagnostic device using a dataset. The "test set" here refers to physical device testing rather than a data set for an algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for diagnostic algorithms (e.g., consensus reads, pathology) is not relevant for evaluating the physical performance specifications of a balloon catheter.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable. This is not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used: Not applicable in the context of diagnostic algorithms. For the physical device, the "ground truth" is measured physical properties and performance against engineering specifications.
- The sample size for the training set: Not applicable. There is no algorithm being trained.
- How the ground truth for the training set was established: Not applicable.
§ 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.