(17 days)
The BridgePoint Medical Mantaray™ Catheter is indicated for directing, steering, controlling, and supporting a guidewire in order to access discrete regions of the peripheral vasculature.
The modified Mantaray™ Catheter is a single use, over-the-wire, disposable, dual lumen percutaneous catheter that facilitates the placement, support and steering of a guidewire into discrete regions of the peripheral vasculature through the central guidewire lumen or through one of two sideports (identified by radiopaque markers). The sideports connect with the central guidewire lumen and facilitate guidewire steering (at an angle to the central lumen) by allowing the guidewire to exit the catheter. The catheter contains a small non-compliant balloon segment used for fluoroscopic orientation on the distal tip of the flexible shaft.
The provided text describes a 510(k) summary for the BridgePoint Medical Mantaray™ Catheter. It outlines the device, its intended use, and a comparison to a predicate device, focusing on modifications made. The document details performance data derived from in vitro bench testing.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria with specific numerical limits. Instead, it lists a series of performance characteristics that were evaluated to confirm the device meets original design requirements and is substantially equivalent to the predicate. The performance is reported as meeting these requirements through bench testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Tensile strength | Met (confirmed via in-vitro bench testing) |
| Burst strength | Met (confirmed via in-vitro bench testing) |
| Fatigue | Met (confirmed via in-vitro bench testing) |
| Inflation & Deflation Time | Met (confirmed via in-vitro bench testing) |
| Dimensional accuracy | Met (confirmed via in-vitro bench testing) |
| Hydration | Met (confirmed via in-vitro bench testing) |
| Guidewire Insert & Withdrawal | Met (confirmed via in-vitro bench testing) |
| Flexibility | Met (confirmed via in-vitro bench testing) |
| Trackability | Met (confirmed via in-vitro bench testing) |
| Guidewire Re-Direction | Met (confirmed via in-vitro bench testing) |
| Markerband Movement & Removal | Met (confirmed via in-vitro bench testing) |
| Markerband & Guidewire Interaction | Met (confirmed via in-vitro bench testing) |
| Kink Resistance | Met (confirmed via in-vitro bench testing) |
| Coating performance | Met (confirmed via in-vitro bench testing - specifically regarding its removal) |
| Torque | Met (confirmed via in-vitro bench testing) |
| Surface Defects | Met (confirmed via in-vitro bench testing) |
| Balloon Protector Removal | Met (confirmed via in-vitro bench testing) |
| Overall Goal: Substanti al equivalence to predicate device in performance. | Achieved: "results in a device that meets the original design requirements of the currently marketed Mantaray™ Catheter as demonstrated in the bench tests above." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify exact sample sizes for each bench test. It states that "in vitro bench testing" was used. The data provenance is not explicitly mentioned (e.g., country of origin), and the tests are described as in vitro bench testing, implying a controlled, laboratory setting rather than a clinical study. It is not retrospective or prospective in the clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The evaluation was based on in vitro bench testing, which typically relies on engineers and technicians demonstrating adherence to specifications, rather than clinical experts establishing ground truth in the way medical imaging or diagnosis studies would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Given the nature of in vitro bench testing for a mechanical device, a formal adjudication method like those used for expert consensus in clinical studies is not applicable or described.
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
No, an MRMC comparative effectiveness study was not done. This device is a catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is a physical medical catheter, not an algorithm. Performance was evaluated based on its physical characteristics and functionality in a standalone manner (in vitro).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is adherence to established engineering specifications and functional requirements for a percutaneous catheter, as assessed through various in vitro bench tests. The predicate device's performance served as a benchmark for substantial equivalence.
8. The sample size for the training set
This information is not applicable. The device is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
This information is not applicable. As stated above, there is no "training set." The "ground truth" for the device's design and manufacturing would have been established through engineering design specifications and quality control procedures, informed by the predicate device's characteristics and clinical needs.
§ 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).