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510(k) Data Aggregation
(26 days)
CRE BALLOON DILATATION CATHETER
Indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. The recommended application is printed on the package label referring to any combination of esophageal, pyloric and colonic dilatation.
The proposed CRE™ Balloon Dilatation Catheter is capable of 3 distinct and progressively larger size diameters via controlled radial expansion. It is designed to pass through the working channel of an endoscope and accept a 0.035 in (0.89 mm) guidewire through its guidewire lumen. This catheter comes packaged with a 0.035 in (0.89 mm), floppy tip guidewire preloaded in the guidewire lumen. The guidewire is 25 cm longer than the balloon catheter with the excess length extending from the hub end of the catheter. A guidewire locking device is attached to the guidewire hub of the catheter. The locking device will be packaged in the "OFF" or unlocked position. The guidewire may only be advanced or removed from the catheter when the switch on the locking device is in the "OFF" position. The guidewire may be held in place within the catheter by moving the switch to the "ON" position.
The provided text is a 510(k) summary for the Boston Scientific CRE™ Balloon Dilation Catheter. This document is a premarket notification for a medical device and does not contain information regarding software-based AI/ML device performance or clinical study details as requested.
The document focuses on demonstrating substantial equivalence to a predicate device (K974788 CRE™ Balloon Dilatation Catheter) through technological characteristics, materials, manufacturing processes, and in-vitro testing.
Therefore, I cannot provide the requested information about acceptance criteria, reported device performance in a clinical study, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.
The document explicitly states:
- "In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." (Section 7. Performance Data)
This indicates that any performance data mentioned in this specific submission is based on bench testing (in-vitro), not human clinical studies. The submission's purpose is to demonstrate substantial equivalence, not to detail a complex clinical performance study for a novel AI/ML device.
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(182 days)
CRE BALLOON DILATATION CATHETER
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:
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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.
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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.
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