(57 days)
The BridgePoint Medical Stingray™ Guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Stingray™ Guidewires are not to be used in the cerebral blood vessels.
When used as part of the BridgePoint Medical System (consisting of the CrossBoss™ Catheter, Stingray™ Catheter, and Stingray™ Guidewire), the Stingray™ Guidewire is indicated for use to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention.
The modified Stingray™ 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 hydrophilic coated. 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" (which is a monolithic extension of the core wire) extends approximately 0.007" distal of the rounded tip.
Here's a breakdown of the acceptance criteria and the study details for the BridgePoint Medical Stingray™ Guidewire, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific quantitative performance metrics against predefined acceptance criteria for a new, distinct function. Instead, the "acceptance criteria" are implied by the performance of the predicate device and the design requirements for the modified guidewires. The study aimed to show that the modifications did not negatively impact the performance of the original design.
Therefore, the table below reflects this approach:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintain physical attributes (flexibility, radiopacity, lubricity, tensile, torque, etc.) comparable to predicate devices. | The modified Stingray™ Guidewires were evaluated using in vitro bench testing for: Tensile, Dimensional, Guidewire Insert & Withdrawal, Flexibility, Fatigue, Coating, Torque, Surface Defects, and Tip Memory, and Corrosion. All results demonstrated that the modified guidewires met the original design requirements of the currently marketed Stingray™ Guidewires. |
| Biocompatibility of new materials (core wire, PTFE colorant) comparable to existing standards. | Biocompatibility tests included: Cytotoxicity, Kligman Sensitization, Irritation, Acute Systemic Cytotoxicity, Pryogen, Hemocompatibility (In Vitro & Complement Activation Assay), In Vivo Thrombogenicity, and Unactivated Partial Thromboplastin Time. All results demonstrated the materials, manufacturing processes, and design met established performance criteria and will perform as intended. |
| Performance as intended for facilitating placement of balloon dilatation catheters or other intravascular devices during PTCA and PTA. | The modifications (core wire material change from 304 to 302 stainless steel, PTFE colorant change, and platinum tungsten coil diameter change from 0.0025" to 0.0020" for specific models) were demonstrated to meet the original design requirements through bench testing. In vivo testing on the modified device was not deemed necessary as animal studies were successfully completed with the currently marketed Stingray™ Guidewires (the predicate). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "in vitro bench testing" and "biocompatibility tests" but does not specify the number of test articles or samples used for each test.
- Data Provenance: The studies were in vitro bench tests and biocompatibility tests. The document does not specify the country of origin for the data, but the submission is to the U.S. FDA, implying adherence to relevant US standards. The nature of these tests means they are not retrospective or prospective patient data, but rather controlled laboratory experiments.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This section is not applicable for this type of submission. The "ground truth" for this device's performance evaluation is based on engineering specifications, material science, and established biocompatibility standards. It does not involve human interpretation or consensus from clinical experts for the primary performance evaluation. The success is determined by meeting predefined engineering and biological criteria.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., medical imaging reads) to resolve discrepancies. Given that this study relied on objective bench testing and biocompatibility assessments, no human adjudication was required.
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
This section is not applicable. This is a submission for a modified medical guidewire, not an AI software device. Therefore, no MRMC study or AI-related comparative effectiveness analysis was performed or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This section is not applicable. This device is a physical medical guidewire, not an algorithm or AI software. There is no "standalone performance" in the context of an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Engineering Specifications and Design Requirements: The performance criteria used for the bench tests (tensile, flexibility, torque, etc.) are derived from the original design requirements for the Stingray™ Guidewires, which are established engineering standards for medical guidewires.
- Biocompatibility Standards: The biocompatibility tests are assessed against recognized international standards for biological evaluation of medical devices (e.g., ISO 10993 series).
- Predicate Device Performance: The primary ground truth is the established performance and safety profile of the legally marketed predicate Stingray™ Guidewires (K081187 and K083727), to which the modified device is compared for substantial equivalence.
8. The Sample Size for the Training Set
This section is not applicable. This is not an AI or machine learning device, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as point 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.