(21 days)
The HI-TORQUE WHISPER Guide Wire is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature.
The general guide wire design consists of a stainless steel tapered core with a flexible tip, jacketed by polyurethane on the distal portion of the wire and polytetrafluoroethylene (PTFE) on the proximal portion of the wire. The polyurethane is subsequently covered with a hydrophilic coating to increase lubricity. The guide wires are available with either a straight distal tip that is shapeable, or as a pre-formed 'J' distal tip shaped specifically for accessing the coronary sinus (designated 'CS-J'). The straight tip can be manually shaped to accommodate specific patient anatomy or physician preference; the CS-J shape provides the convenience of an existing 'J' shape without manual shaping.
The HI-TORQUE WHISPER LS, MS/MS CS-J, and ES/ES CS-J guide wires with Hydrocoat hydrophilic coating are guide wires with a 0.014" maximum diameter and a length of 190 cm. The HI-TORQUE WHISPER DS/DS CS-J and EDS/EDS CS-J guide wires with Hydrocoat hydrophilic coating are guide wires with a 0.0145" maximum diameter and a length of 190 cm. These guide wires are all labeled as 0.014". These wires are constructed with a high tensile (Hyten) stainless steel core wire having a nominal diameter of 0.0128" (LS/MS versions) or 0.0132" (ES versions). The distal segment of each guide wire consists of a series of unique tapers and grinds which reduce the diameter and support at the distal core, thus yielding the desired flexibility and performance characteristics.
The provided text describes a 510(k) premarket notification for a medical device, specifically a guide wire. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving novel effectiveness or specific performance metrics against pre-defined acceptance criteria in the same way a new drug or a more complex AI/ML device would.
Therefore, the structure of the acceptance criteria and study information will differ from what might be expected for an AI-powered diagnostic device. The study described focuses on verification testing to ensure the device performs equivalently to the predicate, meeting established internal criteria for safety and function, rather than demonstrating a specific clinical performance improvement.
Here's an analysis based on the provided text:
Acceptance Criteria and Study Information for HI-TORQUE® WHISPER™ LS, MS/MS CS-J, ES/ES CS-J, DS/DS CS-J, and EDS/EDS CS-J Guide Wires
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of quantitative acceptance criteria and corresponding reported device performance values in the manner typically seen for clinical endpoints or AI/ML model metrics. Instead, the "Performance Data" section broadly states:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Overall Performance | "The HI-TORQUE WHISPER LS, MS/MS CS-J, ES/ES CS-J, DS/DS CS-J, and EDS/EDS CS-J Guide Wires meet the established acceptance criteria and perform in a manner equivalent to the predicate device." |
| Safety and Effectiveness | "No new safety or effectiveness issues were raised during the testing program." |
| Technological Characteristics | "Comparisons of the proposed and predicate device show that the technological characteristics such as materials, performance characteristics, sterilization and packaging are identical or substantially equivalent to the currently marketed device." |
Note: For medical devices seeking 510(k) clearance, the primary "acceptance criterion" is often a demonstration of substantial equivalence to a predicate device, meaning it's as safe and effective as a device already on the market. The specific internal engineering and performance criteria used for verification testing are typically not disclosed in the 510(k) summary, but are part of the detailed submission to the FDA. These would likely include criteria for mechanical properties (e.g., tensile strength, kink resistance, pushability, torqueability, tip flexibility), lubricity, and biocompatibility, all demonstrated to be comparable to or within acceptable limits relative to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (e.g., number of guide wires tested, number of simulated procedures) used for the verification testing. This information would be part of the more detailed submission to the FDA but is not included in the public K030019 summary.
Data Provenance: Not specified in the summary, but given the nature of a guide wire, the "test set" would primarily consist of in vitro (laboratory) testing, and potentially in vivo animal model testing. Human patient data is not the primary test set for this type of device clearance for substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not applicable in the context of this 510(k) submission. This device is a physical medical instrument, not an interpretive diagnostic tool requiring expert ground truth for image or data analysis. The "ground truth" for its performance is established through objective engineering and usability testing, not expert consensus on medical findings.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human experts when establishing ground truth for subjective interpretations, primarily in diagnostic studies involving image or data review. The verification testing for this guide wire would involve objective measurements and comparisons against technical specifications, not subjective interpretation requiring adjudication.
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 how human readers perform with vs. without AI assistance, which is irrelevant for a guide wire. The study described is verification testing against a predicate device, not a human-in-the-loop performance evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this question is not applicable. This device is not an algorithm; it is a physical medical instrument.
7. The Type of Ground Truth Used
The "ground truth" for a device like a guide wire is established through objective engineering measurements and functional testing to ensure it meets pre-defined specifications and performs safely and effectively as intended. This includes evaluations of:
- Mechanical properties: (e.g., tensile strength, pushability, torque response, tip flexibility, kink resistance)
- Dimensional accuracy: (e.g., diameter, length)
- Material compatibility: (e.g., biocompatibility)
- Sterility:
- Lubricity: (for hydrophilic coating)
- Visual inspection:
The comparison is made against the established performance characteristics of the predicate device and internal design specifications.
8. The Sample Size for the Training Set
This question is not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" for physical medical devices in this context.
§ 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.