(182 days)
The CRE™ Balloon Dilatation Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the esophagus.
The Microvasive CRE™ Balloon Dilatation Catheter is capable of 3 distinct and progressively larger size diameters. Specific balloon sizes are printed on each package and hub label. The major components of the CRE™ Balloon Dilatation Catheter are the hub, catheter shaft, and the balloon.
The provided text describes a 510(k) premarket notification for the CRE™ Balloon Dilatation Catheter. This is a medical device submission, not an AI/ML device. Therefore, the standard acceptance criteria and study types typically associated with AI/ML devices (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, training/test sets, etc.) are not applicable here.
The document discusses the following:
1. Acceptance Criteria and Device Performance:
-
Acceptance Criteria for medical devices in 510(k) submissions like this primarily revolve around demonstrating substantial equivalence to a previously legally marketed predicate device. This means showing that the new device is as safe and effective as the predicate.
-
Reported Device Performance: The document states:
- "Laboratory testing regarding characteristics was performed on the CRE™ Balloon Dilatation Catheter to verify its safety and performance."
- "A biocompatibility assessment was performed on the patient- and fluid-contact materials of the CRE™ Balloon Dilatation Catheter with satisfactory results."
- "The information presented provides assurance that the CRE™ Balloon Dilatation Catheter will meet the minimum requirements that are considered acceptable for its intended use."
Table of Acceptance Criteria and Reported Device Performance (as inferred from a 510(k) type submission):
| Acceptance Criteria (for 510(k) substantial equivalence) | Reported Device Performance |
|---|---|
| Safety: Device is as safe as the predicate. | "Laboratory testing regarding characteristics was performed... to verify its safety." "A biocompatibility assessment was performed... with satisfactory results." The FDA's letter indicates the device is considered substantially equivalent for safety. |
| Performance/Effectiveness: Device performs as intended and is as effective as the predicate. | "Laboratory testing regarding characteristics was performed... to verify its performance." "A comparison of the descriptive characteristics... demonstrate the CRE™ Balloon Dilatation Catheter is equivalent in its indications for use, while being very similar in design and materials." The FDA's letter indicates the device is substantially equivalent for effectiveness. |
| Biocompatibility: Materials are safe for patient contact. | "A biocompatibility assessment was performed on the patient- and fluid-contact materials of the CRE™ Balloon Dilatation Catheter with satisfactory results." |
| Manufacturing Quality: Compliance with quality systems. | The FDA letter states: "A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions." |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided as this is a medical device (catheter), not a software/AI device. The "testing" mentioned is likely mechanical, material, and biocompatibility testing, not "test set" in the AI/ML context.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided as it's not relevant to a physical medical device submission for substantial equivalence. "Ground truth" in the AI/ML sense is not established for this type of device.
4. Adjudication Method:
This information is not provided as it's not relevant to a physical medical device submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC study was not done or reported. This type of study is for evaluating human performance, typically with or without AI assistance, and is not applicable to a physical medical device like a balloon catheter.
6. Standalone (Algorithm Only) Performance:
Not applicable. This device is a physical balloon dilatation catheter, not an algorithm.
7. Type of Ground Truth Used:
Not applicable in the AI/ML sense. For this device, the "truth" is established by adherence to engineering specifications, material properties, and biological safety standards, as verified through laboratory and biocompatibility testing. The predicate devices serve as the benchmark for "truth" in terms of clinical utility and safety profile.
8. Sample Size for the Training Set:
Not applicable. No "training set" in the AI/ML sense is used for this physical device.
9. How Ground Truth for the Training Set was Established:
Not applicable.
In summary: The document establishes the device's conformance primarily through bench testing, biocompatibility assessment, and comparison to predicate devices to demonstrate substantial equivalence, rather than through clinical trials or AI/ML specific validation studies.
§ 876.5365 Esophageal dilator.
(a)
Identification. An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.