(29 days)
The BridgePoint Medical Peripheral System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of other interventional devices.
The additional models and modified Mantaray™ Guidewires are conventionally constructed, single use, disposable guidewires that consist of a full-length stainless steel shaft with proximal PTFE coating where the distal portion of the stainless steel core is taper ground to provide distal flexibility. The distal portion also includes a coaxially positioned coil constructed of platinum/tungsten material for visibility under fluoroscopy. The coil is fixed to the stainless steel core wire via silver alloy solder and is coated with hydrophilic coating. The distal tip of the guidewire is supplied with an angled geometry which transitions to a conventional rounded tip. A short extension with an approximate diameter of 0.0035"-0.0065" (which is a monolithic extension of the core wire) extends approximately 0.007" distal of the rounded tip.
This document describes the BridgePoint Medical Peripheral System: Mantaray™ Guidewires, a Class II Percutaneous Guidewire, and its special 510(k) submission (K121745) for modified models. The submission focuses on demonstrating substantial equivalence to previously cleared Mantaray™ Guidewires (K120881, K120533).
Based on the provided text, the device is a medical guidewire, and the "acceptance criteria" and "device performance" refer to the results of in vitro bench testing and biocompatibility testing used to demonstrate substantial equivalence to a predicate device.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the modified guidewires were to meet the "original design requirements of the currently marketed Mantaray™ Guidewires" as demonstrated through bench tests and to demonstrate biocompatibility.
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Mechanical/Physical Performance | Tensile | Met established performance criteria |
| Dimensional | Met established performance criteria | |
| Guidewire Insert & Withdrawal | Met established performance criteria | |
| Flexibility | Met established performance criteria | |
| Fatigue | Met established performance criteria | |
| Torque | Met established performance criteria | |
| Surface Defects | Met established performance criteria | |
| Coating | Met established performance criteria | |
| Corrosion | Met established performance criteria | |
| Tip Memory | Met established performance criteria | |
| Radiopacity | Met established performance criteria | |
| Biocompatibility | Cytotoxicity | Met established performance criteria |
| Irritation | Met established performance criteria | |
| Kligman Sensitization | Met established performance criteria | |
| Acute Systemic Cytotoxicity | Met established performance criteria | |
| Hemocompatibility (Direct & Indirect) | Met established performance criteria | |
| In Vitro Hemocompatibility | Met established performance criteria | |
| Complement Activation Assay (Indirect) | Met established performance criteria | |
| In Vivo Thrombogenicity | Met established performance criteria | |
| Pyrogen | Met established performance criteria | |
| Unactivated Partial Thromboplastin Time | Met established performance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for each in vitro bench test or biocompatibility test. It generally states that the "additional models and modified Mantaray™ Guidewires have been evaluated using the following in vitro bench testing." Given that this is a 510(k) submission for a modification to an existing device, the testing would have been conducted internally by BridgePoint Medical. The data provenance is prospective in the sense that the tests were performed specifically for this submission, using new samples of the modified devices. These are not clinical studies, so country of origin of patient data is not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable (N/A) because the device is a guidewire, and the "ground truth" for its performance is established through in vitro bench testing and biocompatibility assessments against predefined engineering specifications and ISO standards, not through expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
This is not applicable (N/A) for the same reasons as #3. Adjudication methods are typically used in clinical studies or studies involving human judgment (e.g., radiologist reads) to resolve discrepancies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study assesses the impact of a device (often AI-based) on human reader performance in interpreting medical data. The Mantaray™ Guidewires are physical medical devices, and their performance is evaluated through bench testing, not through human interpretation of cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable (N/A). The Mantaray™ Guidewire is a physical medical device, not an algorithm or software. Its performance is inherent to its physical properties and design, not an independent algorithm.
7. The type of ground truth used
The "ground truth" for the performance of the Mantaray™ Guidewires is based on:
- Engineering specifications and standards: The device's physical and mechanical properties (tensile strength, flexibility, radiopacity, etc.) were tested against established design requirements and likely relevant industry standards.
- Biocompatibility standards: The materials used were tested against accepted biocompatibility standards to ensure they are safe for human contact.
- Predicate device comparison: The ultimate "ground truth" for this 510(k) is the demonstration of substantial equivalence to the previously cleared Mantaray™ Guidewires, meaning the modified device performs comparably to a device already deemed safe and effective.
8. The Sample Size for the Training Set
This is not applicable (N/A). There is no "training set" as this is not a machine learning or AI-driven device. The guidewires are manufactured physical products.
9. How the Ground Truth for the Training Set was Established
This is not applicable (N/A) for the same reason as #8.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.