Search Results
Found 1 results
510(k) Data Aggregation
(7 days)
The BioCardia Morph® Sheath Guide is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices may be introduced into the peripheral vasculature.
The BioCardia Morph® Sheath Guide is a single lumen steerable catheter introducer. It is designed to be delivered percutaneously with the use of an internal dilator and advanced to a desired location within the vasculature to facilitate delivery of therapeutic catheters. Steering of the device is accomplished by rotation of a knob on the handle which deflects the distal tip of the catheter shaft. The BioCardia Morph Sheath Guide is supplied with a dilator and includes a hemostasis valve through which the dilator, guidewires, and devices may be passed while minimizing blood loss.
The provided text describes a 510(k) premarket notification for the BioCardia Morph® Sheath Guide. However, it does not contain the specific details required to complete your request regarding acceptance criteria and a study proving the device meets those criteria.
The document primarily focuses on:
- Device Description: What the BioCardia Morph® Sheath Guide is.
- Intended Use: What it's designed to do.
- Equivalent Devices: Other similar devices on the market.
- Test Results (High-level): Mentions "in-vitro and animal testing" and "biocompatibility" but provides no specific acceptance criteria or detailed study results.
- Regulatory Communication: FDA's confirmation of substantial equivalence.
Therefore, I cannot populate the table or answer most of your detailed questions. The document explicitly states: "{1}------------------------------------------------ #### Test Results: #### Performance Results of in-vitro and animal testing demonstrate that the BioCardia Morph® Sheath Guide is safe and effective for its intended use." This is a summary statement, not a presentation of detailed acceptance criteria or study results.
Here's a breakdown of what can be extracted and what is missing:
Acceptance Criteria and Device Performance Study Details
| Information | Description / Status |
|---|---|
| 1. Acceptance Criteria Table & Reported Performance | Not provided in the text. The document states: "Results of in-vitro and animal testing demonstrate that the BioCardia Morph® Sheath Guide is safe and effective for its intended use" but offers no specific metrics, thresholds, or quantitative results against which acceptance criteria could be measured. |
| 2. Sample size and data provenance for test set | Not provided in the text. The document mentions "in-vitro and animal testing" but gives no details on sample size, animal models, or data provenance (e.g., country of origin, retrospective/prospective). |
| 3. Number and qualifications of experts for test set GT | Not applicable/Provided. The testing mentioned appears to be performance-based (e.g., mechanical, biocompatibility, animal-based procedural success) rather than requiring expert ground truth in the context of diagnostic interpretation. If any expert evaluation was involved (e.g., in animal studies), no details are provided. |
| 4. Adjudication method for test set | Not applicable/Provided. See point 3. |
| 5. MRMC comparative effectiveness study? Effect size? | No. This device is a steerable introducer sheath, not an AI or diagnostic imaging device that would typically involve a multi-reader multi-case (MRMC) comparative effectiveness study for human readers' performance with/without AI assistance. |
| 6. Standalone (algorithm only) performance done? | No. This is a physical medical device, not a software algorithm. The performance evaluation would be of the physical device's function, not an algorithm's. |
| 7. Type of ground truth used (test set) | Not applicable/Provided. The "ground truth" for a physical device like this relates to its mechanical performance, biocompatibility, and success in animal models (e.g., successful navigation, delivery of instruments). The specific metrics and methods for determining this are not detailed beyond "in-vitro and animal testing." |
| 8. Sample size for training set | Not applicable/Provided. This is a physical medical device and would not typically have a "training set" in the machine learning sense. The development and design validation would involve engineering tests (e.g., fatigue, tensile strength) and early-phase animal studies, but these are not referred to as a "training set." |
| 9. How ground truth for training set was established | Not applicable/Provided. See point 8. |
Ask a specific question about this device
Page 1 of 1