(33 days)
For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
The Pegasus 10 steerable guidewires have a nominal diameter of 0.014" and nominal lengths of 185 cm and 300cm. The wire is configured with a radiopaque distal tip and an embedded magnet used with a navigation system to navigate the wire through vasculature. The wire employs a stainless steel proximal core shaft joined to a nitinol distal ground core portion. The distal tip can either be straight or angled. A hydrophilic coating covers the distal portion of the wire and a PTFE coating covers the proximal end of the wire. The guidewires will be packaged in the standard Lake Region single pack packaging configuration (one wire in a dispenser, placed in a pouch, labeled and then placed in individual cartons). There will be no changes to the sterilization process for these guidewires.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Pegasus™ Guidewire.
Important Note: The provided document is a 510(k) Premarket Notification Summary for a medical device (guidewire). Such summaries primarily focus on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a detailed clinical study proving strict acceptance criteria for a novel device. Therefore, the information you're requesting, particularly details on sample sizes, expert qualifications, and specific AI-related metrics, is largely not present in this type of document because it's not typically required for a 510(k) for a guidewire.
This document describes a non-clinical, benchtop comparison to a predicate device.
Acceptance Criteria and Study to Prove Device Performance:
Due to the nature of a 510(k) Premarket Notification for a guidewire, the "acceptance criteria" are primarily focused on demonstrating substantial equivalence to a predicate device through non-clinical testing. The "study" referenced is a series of non-clinical, benchtop qualification tests.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a formal table of specific, quantitative acceptance criteria with corresponding performance metrics like a clinical trial report would. Instead, it states the following:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Equivalence to Predicate Device | Functionality and performance characteristics are comparable to currently marketed devices (predicate: Titan™). |
| Visual/Tactile Attributes | Met established specific inspection criteria. |
| Dimensional Attributes | Met established specific inspection criteria. |
| Mechanical Attributes | Met established specific inspection criteria. |
| Biocompatibility | Found to be acceptable per ISO 10993 series. |
| Risk Analysis (FMEA) | All verification and validation activities resulted in meeting predetermined acceptance criteria. |
| Quality Systems (for manufacturing changes) | Product remains equivalent to predicate products; changes will not have an adverse effect on safe and effective use. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified quantitatively. The document states "Test pieces were tested," implying a defined number, but the exact count is not provided.
- Data Provenance: The testing was "Non-Clinical Tests" performed by LRM (Lake Region Manufacturing, Inc.) and Stereotaxis. This indicates laboratory/benchtop testing, not human subject data. The country of origin for the data is implicitly the USA, where Lake Region is located. The study is not retrospective or prospective in the clinical sense, as it's non-clinical bench testing.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
- Not Applicable: This type of non-clinical testing for a guidewire does not involve "experts" establishing a "ground truth" in the clinical diagnostic sense. The comparison is against established engineering specifications and the performance of a predicate device.
4. Adjudication Method for the Test Set:
- Not Applicable: Adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in expert interpretations of clinical data (e.g., radiology images). This guidewire testing involves objective measurements and comparisons against engineering specifications and predicate device performance, not subjective human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No: A MRMC study is not mentioned because this is a non-clinical submission for a guidewire. Such studies are typically conducted for diagnostic imaging devices or AI-powered clinical decision support tools where human readers are interpreting medical cases.
- Effect Size of Human Readers with/without AI Assistance: Not applicable, as no AI component for human assistance is described in this device or associated testing.
6. Standalone (Algorithm Only) Performance Study:
- Yes, in the context of non-clinical performance: The device itself (guidewire) is being tested for its standalone physical and mechanical performance characteristics (e.g., steerability, tip strength, lubricity, biocompatibility) without a human-in-the-loop performance metric being specifically detailed, beyond proving equivalence to the predicate. There is no "algorithm" in the AI sense for a guidewire.
7. Type of Ground Truth Used:
- Engineering Specifications and Predicate Device Performance: The "ground truth" for this submission are the established engineering design specifications for the device, and the known, acceptable performance characteristics of the legally marketed predicate device (Titan™ guidewire). Biocompatibility has its own 'ground truth' in the form of ISO 10993 standards.
8. Sample Size for the Training Set:
- Not Applicable: This device is a physical guidewire and does not involve AI algorithms that require a "training set" of data.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable: As there is no AI training set, this question is not relevant.
§ 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.