(30 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 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.
This document pertains to the 510(k) premarket notification for the BridgePoint Medical Mantaray™ Catheter, a medical device. The information provided is for a traditional medical device (catheter) and does not involve AI/ML technology, thus many of the requested fields are not applicable.
Here's an analysis of the provided text:
1. Table of acceptance criteria and the reported device performance:
Since this is a 510(k) for a conventional medical device, the "acceptance criteria" are typically demonstrating substantial equivalence to a predicate device through various performance and safety tests. The "reported device performance" indicates that the Mantaray™ Catheter met these established criteria, confirming it performs as intended and is substantially equivalent. Specific quantitative targets or ranges for each test are not explicitly detailed in this summary but are implied to have been met.
| Acceptance Criteria (Type of Test) | Reported Device Performance |
|---|---|
| In vitro Bench Testing: | |
| Tensile | Met established criteria |
| Burst | Met established criteria |
| Fatigue | Met established criteria |
| Inflation & Deflation Time | Met established criteria |
| Dimensional | Met established criteria |
| Guidewire Insert & Withdrawal | Met established criteria |
| Flexibility | Met established criteria |
| Trackability | Met established criteria |
| Guidewire Re-Direction | Met established criteria |
| Markerband Movement & Removal | Met established criteria |
| Markerband & Guidewire Interaction | Met established criteria |
| Kink Resistance | Met established criteria |
| Coating | Met established criteria |
| Torque | Met established criteria |
| Surface Defects | Met established criteria |
| Corrosion Resistance | Met established criteria |
| Luer and Hub Tests | Met established criteria |
| Balloon Protector Removal | Met established criteria |
| Radiopacity | Met established criteria |
| In vivo Testing (Animal Model): | |
| Functional performance | No reported complications, no angiographic evidence of vessel injury or downstream embolism, no abnormal pathologic findings |
| Safety | All six animals survived the in-life period |
| Biocompatibility Testing: | |
| Cytotoxicity L929 MEM ISO | Successfully completed previously, non-toxic |
| Kligman Sensitization (Maximization) ISO | Successfully completed previously, non-sensitizing |
| Irritation- Intracutaneous Injection ISO | Successfully completed previously |
| Acute Systemic Cytotoxicity ISO | Successfully completed previously |
| Pyrogen - ISO | Successfully completed previously |
| Hemocompatibility (Direct and Indirect) Hemolysis ASTM | Successfully completed previously |
| In Vitro Hemocompatibility Assay ISO | Successfully completed previously |
| Complement Activation (Direct) Assay ISO | Successfully completed previously |
| In Vivo Thrombogenicity Assay ISO | Successfully completed previously |
| Unactivated Partial Thromboplastin Time ISO | Successfully completed previously |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size (In vivo): Six animals (porcine model). Each animal had Mantaray™ Catheters inserted into four arteries.
- Data Provenance: The in vivo testing was conducted using a porcine animal model. The country of origin for the data is not specified, but the applicant (BridgePoint Medical) is located in Plymouth, MN, USA. The study was prospective in nature for the in vivo portion. Bench testing data provenance is not specified.
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):
Not applicable for this type of device and study. "Ground truth" in the context of this 510(k) submission refers to objective measurements from bench testing and observations/pathology from the animal study, not expert consensus on medical images. The evaluation involved angiographic assessment, histology, pathology, hematology, serum chemistry, and gross necropsy. These would be performed by qualified veterinary pathologists, angiographers, and laboratory technicians, but their specific number and years of experience are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The in vivo study involved objective biological and pathological assessments and did not require adjudication of human reader interpretations. Bench testing results are typically objective measurements.
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 a conventional medical device (catheter) and does not involve AI/ML.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a conventional medical device (catheter) and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- In vitro (Bench Testing): Objective physical and mechanical measurements according to established testing protocols and ISO standards.
- In vivo (Animal Study): Angiographic evaluation, histology, pathology, hematology, serum chemistry, and gross necropsy. These are objective biological and pathological assessments.
8. The sample size for the training set:
Not applicable. This is a conventional medical device without machine learning components. "Training set" is not relevant here. The manufacturing process and materials were based on the predicate device (Stingray™ Catheter).
9. How the ground truth for the training set was established:
Not applicable. There is no training set as this is not an AI/ML 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).