(130 days)
In selective areas of peripheral and coronary vessels, the Bullfrog Micro-Infusion Device is intended for the infusion of diagnostic and therapeutic agents that are indicated for delivery into the vessel wall or perivascular area. The Bullfrog Micro-Infusion Device is also intended for the infusion of diagnostic and therapeutic agents intraluminally.
The Mercator MedSystems Bullfrog Micro-Infusion Device is a wire-guided, singleoperator, endovascular catheter that consists of a perpendicular microneedle, which is sheathed by and contained within a semi-rigid polymer actuator balloon. The device is designed to be advanced to target vasculature and hydraulically actuated to move the microneedle through the external elastic lamina to deliver substances to adventitial and perivascular tissues. A compliant stabilizing balloon inflates with the actuator to provide a force opposite the needle tip for proper seating of the needle is retracted within the sheathing structure by vacuuming the hydraulic actuator.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Bullfrog Micro-Infusion Device, based only on the input you provided.
Note: The provided document is a 510(k) summary for a medical device. These summaries typically highlight that performance tests were done and met criteria, but they do not usually contain the detailed acceptance criteria or the full study results that would be found in a complete test report or clinical study report. Therefore, much of the requested information (especially specific numerical acceptance criteria, detailed study parameters, and specific quantitative results) is not present in this document.
While the document states that performance testing, biocompatibility, sterilization validation, and in-vivo safety and effectiveness studies were conducted and all tests met pre-determined specifications and acceptance criteria, it does not provide the specific acceptance criteria or the detailed results of these studies. It also explicitly states "N/A" for "Indications for Use" under a section heading, which is likely a formatting error as it also lists indications for use earlier in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Not provided in detail) | Reported Device Performance (Summary) |
|---|---|---|
| Mechanical Performance | Pre-determined specifications and acceptance criteria (details not provided) | All tests met the pre-determined specifications and acceptance criteria. (General statement) |
| Fluid Delivery Performance | Pre-determined specifications and acceptance criteria (details not provided) | All tests met the pre-determined specifications and acceptance criteria. (General statement) |
| Biocompatibility | In accordance with ISO 10993, Biological Evaluation of Medical Devices. (Specific criteria not provided) | The biocompatibility assessment was conducted in accordance with ISO 10993. (General statement implying compliance) |
| Sterilization Validation | Pre-determined specifications and acceptance criteria (details not provided) | All tests met the pre-determined specifications and acceptance criteria. (General statement) |
| In-Vivo Safety | Pre-determined specifications and acceptance criteria (details not provided) | All tests met the pre-determined specifications and acceptance criteria. (General statement). Labeling contains instructions, cautions, and warnings for safe and effective use. |
| In-Vivo Effectiveness | Pre-determined specifications and acceptance criteria (details not provided) | All tests met the pre-determined specifications and acceptance criteria. (General statement) |
| Risk Profile Comparison | Same risk profile as the predicate device (qualitative) | Risk analysis has shown that the Bullfrog Micro-Infusion Device has the same risk profile as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for any specific test sets (e.g., for mechanical, fluid delivery, or in-vivo studies). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only mentions "in-vivo safety and effectiveness studies" without details.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The document describes a medical device, and the "ground truth" concept as usually applied to AI algorithms (e.g., expert consensus on images) is not applicable or detailed here. For device performance, the "ground truth" would typically be defined by the physical or biological reality measured during testing against defined specifications.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study is mentioned for the Bullfrog Micro-Infusion Device. This type of study is typically associated with diagnostic imaging or AI algorithms, not directly with a physical interventional medical device as described here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The Bullfrog Micro-Infusion Device is a physical interventional medical device, not an algorithm. Therefore, "standalone algorithm performance" is not applicable in this context.
7. The Type of Ground Truth Used
For a physical device, the "ground truth" is established through engineering specifications, physical measurements, chemical analyses (biocompatibility), and biological outcomes (in-vivo studies, safety/effectiveness). The document generally states that tests met "pre-determined specifications and acceptance criteria," which implies that these specifications serve as the "ground truth" against which performance was measured. No specific mention of expert consensus, pathology, or outcomes data as a distinct ground truth source (like in imaging studies) is given for the device's technical performance.
8. The Sample Size for the Training Set
This information is not applicable. The Bullfrog Micro-Infusion Device is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as it is a physical device and not an AI algorithm.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).