(102 days)
The CRE™ Pulmonary Balloon Dilatation Catheter is intended to be used endoscopically to dilate strictures of the airway tree.
The CRE™ Pulmonary Balloon Dilatation Catheter is used to access the airway tree via a bronchoscope for the purpose of dilating strictures. It consists of an inflatable balloon on a catheter shaft with lumens for inflation and passage of a guidewire.
The provided text describes a medical device, the CRE™ Pulmonary Balloon Dilatation Catheter, and its 510(k) submission for clearance. However, the document does not contain specific acceptance criteria, detailed information about a study proving the device meets those criteria, or the other requested details such as sample sizes, expert qualifications, or ground truth establishment.
The document states:
- "In-Vitro Testing has been performed and all full devices met the required specifications for the completed tests."
- "A summary of the test results has been provided for Kink Resistance, Scope Insertion, Scope Removal, Inflation Time and Deflation Time."
This indicates that performance testing was conducted, and the device met its internal specifications, but these specifications themselves are not presented as "acceptance criteria" in the format requested. The document is a 510(k) summary, which typically provides an overview rather than granular study details.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: The specific criteria values and detailed performance metrics are not included.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is in-vitro testing, not expert-adjudicated clinical data.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not mentioned and unlikely for this type of device and submission.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: For in-vitro testing, the "ground truth" would be the predetermined engineering specifications or physical measurements, which are not detailed here. No clinical ground truth (pathology, outcomes) is reported.
- Sample size for the training set: Not applicable as this is a physical device, not an AI algorithm.
- How the ground truth for the training set was established: Not applicable for the same reason.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (K023337) based on the modification of catheter shaft working length and adherence to manufacturing specifications via in-vitro testing. It does not provide the detailed study information you requested for an AI/algorithm-based device or a clinical outcome study.
§ 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.