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510(k) Data Aggregation
(90 days)
The ACS HI-TORQUE RULER™ Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA), or percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of equipment, such as compatible stent devices, during other diagnostic and therapeutic intravascular procedures. It should not be used with atherectomy devices. It is not intended for use in the cerebral vasculature.
The ACS HI-TORQUE RULER™ Guide Wire is a steerable guide wire intended to facilitate placement of balloon dilatation catheters during Percutaneous Transluminal Coronary Angioplasty (PTCA) and Percutaneous Transluminal Angioplasty (PTA), and other diagnostic and therapeutic intravascular procedures. It is not intended for use in the cerebral vasculature or for use with atherectomy devices.
The proximal and distal portions of the guide wire are constructed from a core assembly. A series of tapers, which reduce the diameter of the core wire distally, yields the desired tip flexibility. The distal 30 centimeters proximal to the tip of the ACS HI-TOROUE RULER™ Guide Wire are coated with Microglide® while the remaining portion is coated with polytetrafluoroethylene (PTFE). Both coatings are intended to reduce friction for improved movement of the wire within the catheter. The platinum alloy coils provide the physicians with a radiopaque tip.
This document describes the safety and effectiveness of the ACS HI-TORQUE RULER™ Guide Wire. The device is found substantially equivalent to predicate devices. The submission focuses on bench testing, biocompatibility testing, and animal testing to demonstrate performance.
Here's an analysis of the provided information, framed by your requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for a medical device (guide wire) and not an AI/software device, the "acceptance criteria" are not framed in terms of precision, recall, or other machine learning metrics. Instead, they are related to physical and biological performance attributes of the guide wire. The "reported device performance" are the results of the specific tests conducted.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Non-cytotoxic | Non-cytotoxic |
| Biocompatibility: Non-hemolytic | Non-hemolytic |
| Biocompatibility: Pass systemic injection test | Pass |
| Biocompatibility: Pass intracutaneous test | Pass |
| Biocompatibility: Pass intramuscular implant | Pass |
| Biocompatibility: Pass sensitization test | Pass |
| Biocompatibility: Non-pyrogenic | Non-pyrogenic |
| Bench Testing: Acceptable polyimide adhesion | Acceptable strength of polyimide adhesive (by pull test) |
| Bench Testing: Acceptable laser weld strength | Acceptable strength of laser weld on platinum bands (by pull test) |
| Bench Testing: Adequate tensile strength | Adequate tensile strength of distal tip (by pull test) |
| Bench Testing: Adequate torsional tip strength | Adequate torsional tip strength (by turns-to-failure test) |
| Bench Testing: Acceptable tip flexibility | Equivalent tip flexibility to predicate and acceptable |
| Bench Testing: 1:1 torque response | 1:1 torque response (by rotational accuracy test) |
| Animal Testing: Acceptable clinical performance | Acceptable clinical performance in compatible balloon dilatation catheters and stent delivery devices (after Microglide® application improvement) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size (for Bench and Biocompatibility): Not specified in terms of number of units tested for each individual test. The document generally states "These tests demonstrated..." without providing specific counts.
- Test Set Sample Size (for Animal Testing): "two subsequent animal studies" were performed. The number of animals or procedures within those studies is not specified.
- Data Provenance: The tests are likely performed by the manufacturer (Guidant Corporation / Advanced Cardiovascular Systems) in a laboratory setting. The country of origin for the data is not explicitly stated, but given the company's location (Santa Clara, California) and submission to the FDA, it's highly probable the data was generated in the United States. The testing is prospective for the specific device being submitted, as it was conducted specifically to gather data for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to a physical device submission like this.
- For Biocompatibility: Expert interpretation of test results would be performed by toxicologists, biologists, or lab personnel following established standards (e.g., ISO 10993). The number and qualifications of these experts are not provided.
- For Bench Testing: Engineers and material scientists would interpret the results against pre-defined engineering specifications. The number and qualifications are not provided.
- For Animal Testing: Veterinarians and possibly interventional cardiologists/radiologists (or equivalent in animal models) would assess clinical performance. The number and qualifications are not provided.
4. Adjudication Method for the Test Set
This is not applicable in the context of device performance testing as described. Adjudication methods (like 2+1) are typically used for establishing ground truth in medical image analysis or clinical endpoint assessment with multiple human readers. Here, the "ground truth" is defined by objective physical/chemical measurements or observed biological reactions.
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 submission is for a physical medical device (guide wire), not an AI/software device, and therefore no MRMC studies or AI assistance are part of its evaluation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
- For Biocompatibility: The "ground truth" is established by adherence to recognized biocompatibility standards and test methodologies (e.g., ISO 10993 series), which define what constitutes "non-cytotoxic," "non-hemolytic," "pass," etc. These are objective measures against established biological thresholds.
- For Bench Testing: The "ground truth" is established by engineering specifications and industry standards. For example, a pull test result is compared against a minimum tensile strength requirement, or a torque response is objectively measured.
- For Animal Testing: The "ground truth" is established through direct observation of the device's function and biological response in vivo, assessed by veterinary and medical professionals, following pre-defined endpoints for "acceptable clinical performance." This likely involves qualitative and quantitative assessments during the animal procedures.
8. The Sample Size for the Training Set
This section is not applicable as this is a physical device submission, not an AI/machine learning model submission. There is no "training set" in this context.
9. How the Ground Truth for the Training Set was Established
This section is not applicable as there is no training set.
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