(150 days)
The BioCardia Morph Universal Deflectable Guide Catheter 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 or chambers and coronary vasculature of the heart.
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This device, the BioCardia Morph Universal Deflectable Guide Catheter, is a medical device and not an AI/ML product. Therefore, the questions related to AI/ML product evaluation (such as acceptance criteria for AI performance, sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC studies, and standalone performance) are not applicable.
The submission is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance against specific acceptance criteria in the way an AI/ML product would.
Here’s the information gleaned from the provided text, focusing on the equivalence determination for a medical device:
1. Table of Acceptance Criteria and Reported Device Performance:
For a traditional medical device 510(k), specific numerical "acceptance criteria" for performance metrics like sensitivity, specificity, or AUC are typically not established in the same way as for an AI/ML device. Instead, the performance is demonstrated through comparison to a predicate device and adherence to recognized standards.
| Acceptance Criteria (Implicit for 510(k) Equivalence) | Reported Device Performance (from "Test Results" section) |
|---|---|
| Performance for Intended Use: Device is safe and effective for its intended use. | "Results of in-vitro and animal testing demonstrate that the BioCardia Morph Universal Deflectable Guide Catheter is safe and effective for its intended use." |
| Biocompatibility: Materials meet requirements for biological safety. | "The materials used in the BioCardia Morph Universal Deflectable Guide Catheter are identical to those used in other diagnostic catheters and meet the requirements of ISO 10993-1." |
| Substantial Equivalence: Device is substantially equivalent to legally marketed predicate devices in intended use and/or method of operation. | The FDA determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. |
2. Sample size used for the test set and the data provenance:
- The document mentions "in-vitro and animal testing."
- Sample Size: Specific numbers for samples used in in-vitro or animal testing are not provided in this summary.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as there is no mention of human expert-based ground truth establishment for this type of medical device evaluation. Performance is assessed through engineering tests and animal studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for the evaluation of this traditional medical device.
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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this medical device would be based on engineering measurements for in-vitro performance (e.g., deflection force, torque transmission, guidewire passage) and physiological/anatomical observations and safety assessments in animal models. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" in the AI/ML sense.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" or corresponding ground truth for this traditional medical device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).