(30 days)
The BridgePoint Medical BigBoss™ Catheter is intended to be used in conjunction with a guidewire in order to access discrete regions of the peripheral vasculature. It may be used to facilitate placement of guidewires and other interventional devices.
The BigBoss™ Catheter is a single use, over-the-wire, disposable percutaneous catheter consisting of a full length coiled stainless steel shaft with Pebax exterior. The coiled shaft provides torque and makes it possible to push the device, and also provides a guidewire lumen. The device will be available in two models that are differentiated by the distal shaft stiffness. The distal shaft stiffness is specified by the distal grind dimensions of the coiled shaft component. The distal shaft transitions to an enlarged (1mm diameter) rounded distal tip. This stainless steel tip provides an atraumatic element that is intended to enhance the catheter's ability to move within the vasculature with reduced risk of arterial tissue engagement while providing radiopaque visibility. The BigBoss Catheter is hydrophilic coated to enhance lubricity. A torque device. coaxially positioned over the proximal portion of the BigBoss Catheter, provides a comfortable user interface for device manipulation. The torque device (similar to a guidewire torque device) is positionable along the proximal portion of the catheter and includes a torsion release safety mechanism. This safety mechanism insures the torque input generated by the use remains within the torsional operating strength of the catheter shaft.
Here's a breakdown of the acceptance criteria and study information for the BigBoss™ Catheter, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text details in vitro bench testing and in vivo animal testing that confirm the performance characteristics relative to the predicate device. However, it does not explicitly state specific quantitative acceptance criteria (e.g., "tensile strength greater than X N") for each test, nor does it provide exact numerical measured performance values for the BigBoss™ Catheter. Instead, it concludes that "All test results demonstrated the materials, manufacturing processes, and design of the BigBoss™ Catheters met the established performance criteria and will perform as intended."
Therefore, here's a table based on the types of tests conducted and the general performance outcomes described:
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| In Vitro Bench Testing | Performance characteristics comparable to predicate device K081130 and K091841. | Met established performance criteria; performed as intended. |
| Tensile | Similar tensile strength to predicate. | Met criteria. |
| Dimensional | Dimensions within specified ranges and comparable to predicate. | Met criteria. |
| Guidewire Insert & Withdrawal | Smooth insertion and withdrawal of guidewire, comparable to predicate. | Met criteria. |
| Device Shaft Tip Deflection & Trackability | Appropriate flexibility and ability to track through vasculature, comparable to predicate. | Met criteria. |
| Kink Resistance | Resistant to kinking under expected use, comparable to predicate. | Met criteria. |
| Coating | Hydrophilic coating performs as intended (lubricity). | Met criteria. |
| Torque | Torsional operating strength within limits, comparable to predicate. | Met criteria. |
| Surface Defects | Absence of significant surface defects. | Met criteria. |
| Corrosion Resistance | Resistant to corrosion in physiological environment. | Met criteria. |
| Luer and Hub Tests | Functionality and secure connection of Luer and Hub. | Met criteria. |
| Radiopacity | Adequate visibility under fluoroscopy, comparable to predicate. | Met criteria. |
| Packaging | Packaging maintains sterility and device integrity. | Met criteria. |
| In Vivo Testing (Porcine) | No reported complications, no angiographic evidence of vessel injury or embolism, no abnormal pathologic findings, all animals survived. | No reported complications, all animals survived, no angiographic evidence of vessel injury or downstream embolism, no abnormal pathologic findings. |
| Biocompatibility Testing | Materials and processes must be non-toxic and non-sensitizing. | Successfully completed; materials and processes are non-toxic and non-sensitizing. |
| Cytotoxicity | Non-cytotoxic. | Met criteria. |
| Sensitization | Non-sensitizing. | Met criteria. |
| Irritation | Non-irritating. | Met criteria. |
| Acute Systemic Cytotoxicity | Non-acutely systemically cytotoxic. | Met criteria. |
| Pyrogen | Non-pyrogenic. | Met criteria. |
| Hemocompatibility | Hemocompatible (e.g., low hemolysis, low complement activation, low thrombogenicity). | Met criteria. |
| Thrombogenicity | Non-thrombogenic. | Met criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- In Vitro Bench Testing: The specific sample sizes for each bench test (e.g., number of catheters tested for tensile strength) are not explicitly provided.
- In Vivo Testing:
- Sample Size: 6 animals (porcine model). In each animal, BigBoss™ Catheters were inserted into four arteries, totaling 24 insertions.
- Data Provenance: Prospective animal study (porcine model). The country of origin is not specified but is implicitly within the scope of Good Laboratory Practices (GLP) for nonclinical laboratory studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- In Vitro Bench Testing: Not applicable in the context of expert ground truth as these are mechanical/physical property tests.
- In Vivo Testing: The assessment involved:
- Angiographic evaluation.
- Histology and pathology.
- Hematology and serum chemistry.
- Gross necropsy.
- The number and specific qualifications of the experts (e.g., veterinarians, pathologists) conducting these evaluations are not specified in the provided text.
4. Adjudication Method for the Test Set
- In Vitro Bench Testing: Not applicable. Results are typically quantitative measurements against defined specifications.
- In Vivo Testing: The text does not describe a specific adjudication method like "2+1" or "3+1" for interpreting findings. The assessments (angiography, histology, pathology, etc.) would typically be performed by relevant specialists, but a formal adjudication process involving multiple independent reviewers for discordant findings is not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses human reader performance (with and without AI assistance) and is not relevant to a medical device like a catheter.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. The BigBoss™ Catheter is a physical medical device, not a software algorithm, so this type of study is not applicable.
7. The Type of Ground Truth Used
- In Vitro Bench Testing: Ground truth is established by engineering specifications and comparative data against the predicate device for physical and mechanical properties.
- In Vivo Testing: Ground truth was established through a combination of:
- Angiographic evaluation: Visual assessment of vessel status.
- Histology and pathology: Microscopic and macroscopic examination of tissues for injury or abnormalities.
- Hematology and serum chemistry: Lab tests for physiological impacts.
- Gross necropsy: Post-mortem examination for overall health and specific organ assessment.
- This is a form of empirical observation and scientific measurement in an animal model.
- Biocompatibility Testing: Ground truth is established by validated laboratory assay results (e.g., ISO and ASTM standards) that demonstrate the biological safety of the materials.
8. The Sample Size for the Training Set
Not applicable. The BigBoss™ Catheter is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. (See point 8).
§ 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).