(113 days)
This Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.
The HI-TORQUE BALANCE MIDDLEWEIGHT™ ELITE Guide Wire is a steerable guide wire available in a maximum diameter of 0.0145" and in lengths of 190 cm and 300 cm. The distal segment of the guide wire is coated with hydrophilic coating to reduce friction for improved guide wire movement within the catheter. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The proximal core has a maximum diameter of 0.0145". The proximal end of the guide wire is coated with hydrophobic coating, which reduces friction of the wire within a catheter. The ELITE Guide Wire is DOC® extendable in the 190 cm lengths. Over the coin DOC is a Wire Identifier to aid in distinguishing between two wires during use.
The provided text describes the 510(k) submission for the HI-TORQUE BALANCE MIDDLEWEIGHT™ ELITE Guide Wire Family. It details the device, its intended use, and the performance testing conducted to demonstrate substantial equivalence to predicate devices.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| In vitro Bench Testing: | |
| Catheter compatibility (no new safety/effectiveness issues) | "met all acceptance criteria and performed similarly to the predicate devices." |
| Tensile strength (no new safety/effectiveness issues) | "met all acceptance criteria and performed similarly to the predicate devices." |
| Torque strength (no new safety/effectiveness issues) | "met all acceptance criteria and performed similarly to the predicate devices." |
| Torqueability (no new safety/effectiveness issues) | "met all acceptance criteria and performed similarly to the predicate devices." |
| Coating adherence and integrity (particulate testing) (no new safety/effectiveness issues) | "met all acceptance criteria and performed similarly to the predicate devices." |
| Friction testing (no new safety/effectiveness issues) | "met all acceptance criteria and performed similarly to the predicate devices." |
| Biocompatibility Testing: | |
| Cytotoxicity (no new safety/effectiveness issues) | "met all acceptance criteria and performed similarly to the predicate devices." |
| Hemolysis (direct and indirect) (no new safety/effectiveness issues) | "met all acceptance criteria and performed similarly to the predicate devices." |
| Acute systemic toxicity (no new safety/effectiveness issues) | "met all acceptance criteria and performed similarly to the predicate devices." |
| Complement activation (no new safety/effectiveness issues) | "met all acceptance criteria and performed similarly to the predicate devices." |
| Intracutaneous toxicity (no new safety/effectiveness issues) | "met all acceptance criteria and performed similarly to the predicate devices." |
| Sensitization (no new safety/effectiveness issues) | "met all acceptance criteria and performed similarly to the predicate devices." |
| Pyrogen (no new safety/effectiveness issues) | "met all acceptance criteria and performed similarly to the predicate devices." |
| In vivo thrombogenicity (no new safety/effectiveness issues) | "met all acceptance criteria and performed similarly to the predicate devices." |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" in the context of an AI/algorithm-driven device. The evaluation was based on in vitro bench testing and biocompatibility testing of the physical guide wire. The sample sizes for these physical product tests are not explicitly stated in the provided text. The data provenance is derived from these tests conducted by Abbott Vascular Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the provided document. The device is a physical medical device (guide wire), not an AI/software-as-a-medical-device (SaMD) that typically requires expert-established ground truth for performance evaluation. The "ground truth" for this device's performance relies on established scientific and engineering principles for material and mechanical properties, and biological responses, as measured in standard laboratory assays.
4. Adjudication method for the test set
This information is not applicable for the reason stated above.
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
No such study was conducted or is relevant for this physical guide wire device. This type of study is for evaluating AI-assisted diagnostic tools that involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical guide wire, not a standalone algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance evaluation was based on established standards and scientific principles related to:
- Physical and Mechanical Properties: Measured through in vitro bench tests (e.g., tensile strength, torque strength, friction, coating integrity).
- Biocompatibility: Measured through standardized in vitro and in vivo biocompatibility assays as per ISO standards and FDA guidance.
8. The sample size for the training set
This information is not applicable. The device is not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable.
§ 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.