(269 days)
The EndoRotor® System is intended for use in airway procedures including removal of granulation tissue and endobronchial lesions.
The EndoRotor® Airway Microdebridement System is a powered resection tool consisting of a power Console with Foot Control, Specimen Trap with pre-loaded filter, and a singleuse Catheter with a cutting tool mounted on the distal end. The EndoRotor's flexible design allows it to be used within the working channel of flexible bronchoscopes in tortuous paths. The Console houses the control panel, drive motor, vacuum control valve, and peristaltic irrigation pump drive. The Catheter includes a debriding cutter and allows for aspiration from the resection site through the bronchoscope working channel to the Specimen Trap.
The provided text describes regulatory information for a medical device (EndoRotor Airway Microdebridement System) and its substantial equivalence determination by the FDA. It does not contain information about acceptance criteria and a study that proves a device meets acceptance criteria in the context of an AI/algorithm-based diagnostic or assistive device.
Instead, the document details:
- Device Identification: EndoRotor Console, Catheter, Specimen Trap, Filter Set, Roll Stand (K190715).
- Intended Use: Airway procedures including removal of granulation tissue and endobronchial lesions.
- Regulatory Classification: Class II, product code ERL (Ear, nose, and throat electric or pneumatic surgical drill).
- Comparison to Predicate Device: XPS 3000 System (Medtronic XOMED, K041413). It highlights similarities in principle of operation (mechanical resection using rotational movement) and differences such as access (flexible bronchoscope vs. rigid), and components (specimen trap).
- Non-Clinical Testing: Biocompatibility, sterilization validation, pyrogenicity, shelf-life, packaging, transport, and functional testing for the catheter; design verification, power-up/set-up, functional, electrical safety, and electromagnetic compatibility testing for the console; procedural testing for the specimen trap. These tests "Met established acceptance criteria." However, specific numerical acceptance criteria and reported performance values are not detailed.
- Clinical Testing: No new clinical study was conducted. Substantial equivalence was based on prior clearance for gastrointestinal use (K181127) where the device demonstrated safety and performance in regions with thin tissue walls, implying its suitability for airway applications.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance data for an AI/algorithmic device based on the provided text, as this document pertains to a mechanical surgical device. The questions about sample size of test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training sets, and how ground truth was established are all relevant to AI/algorithmic device validation, which is not what this document describes.
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.