(42 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 guidewire.
The provided text describes a 510(k) premarket notification for the "CRE™ Pulmonary Balloon Dilatation Catheter." This filing aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through a clinical study with an AI component.
Therefore, the requested information about acceptance criteria, study design, expert involvement, and AI performance is not applicable or cannot be extracted from this document, as this is a traditional medical device submission (a physical device, not a software/AI device).
The document states: "Boston Scientific Corporation has demonstrated that the CRE™ Pulmonary Balloon Dilatation Catheter is substantially equivalent to the currently marketed CRE™ Balloon Dilatation Catheter." This conclusion is based on "a thorough comparison of the descriptive characteristics between the proposed devices and the predicate devices show equivalence."
Key Findings from the document:
- Device Type: The device is a physical medical instrument: "an inflatable balloon on a catheter shaft with lumens for inflation and guidewire."
- Purpose of Submission: The 510(k) submission aims to show "substantial equivalence" of the new CRE™ Pulmonary Balloon Dilatation Catheter to a predicate device (the currently marketed CRE™ Balloon Dilatation Catheter). This is a common regulatory pathway for devices that are similar to existing ones.
- Method of Equivalence: Equivalence was demonstrated through a "thorough comparison of the descriptive characteristics." This implies engineering and design comparisons, not necessarily a clinical study with new performance metrics.
- No AI or Software Component: There is no mention of any AI, software, or algorithm in the description of the device or the justification for its equivalence.
- Acceptance Criteria and Device Performance: Since this is a substantial equivalence claim based on descriptive characteristics, there are no specific performance acceptance criteria or a study proving the device meets them in the context of typical AI/software device evaluation (e.g., sensitivity, specificity, accuracy). The acceptance criterion is "substantial equivalence" to the predicate device.
Therefore, the table and other requested information fields are largely inapplicable to this specific document.
Here is an attempt to populate the table and sections based on the available information, noting the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate device (CRE™ Balloon Dilatation Catheter) | "Thorough comparison of the descriptive characteristics between the proposed devices and the predicate devices show equivalence." |
2. Sample size used for the test set and the data provenance
- Not Applicable. This is a physical device submission demonstrating substantial equivalence to a predicate device via descriptive characteristics, not through a clinical performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication method for the test set
- Not Applicable. No test set or adjudication method is described.
5. 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 a physical device without an AI component. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device without an algorithm.
7. The type of ground truth used
- Not Applicable. No ground truth in the context of AI/software performance is used. The "ground truth" for this submission is the established performance and safety profile of the predicate device, to which the new device is compared descriptively.
8. The sample size for the training set
- Not Applicable. This is a physical device, not an AI/ML model requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is a physical device, not an AI/ML model requiring a training set.
§ 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.