(211 days)
The Stereotaxis Endovascular Guide Wire is intended to introduce and position over-the-wire catheters and other over-the-wire therapeutic devices within the coronary and peripheral vasculature during PTCA or other intravascular interventional procedures.
The Stereotaxis Endovascular Guide Wire is a steerable guide wire that has a nominal diameter of 0.014 in/ 0.36mm and a nominal length of 210/300 cm. The guide wire is designed only for use in conjunction with the Stereotaxis Magnetic Navigation System. The wire is configured with a tapered distal tip and an embedded magnet, which is used for navigating the wire through the vasculature. A hydrophilic coating extends from the base of the distal coil to the proximal end of the wire. This device is sterilized with 100% ethylene oxide.
The Endovascular Guide Wire is a conventional 0.014" hydrophilically coated endovascular guide wire modified to accommodate magnetic actuation and control. It is designed to navigate within the vasculature to deliver a suitable catheter or interventional device to a desired site.
The finished length of the Endovascular Guide Wire is 210cm to 300cm. A taper runs 30cm proximal to the distal tip. The pushable shaft is a continuous wire that allows axial force, applied at the proximal end, to be transmitted to the tip of the guide wire. The Endovascular Guide Wire is used with an introducer sheath to access the human vasculature.
The provided text describes the Stereotaxis Endovascular Guide Wire and its 510(k) summary, aiming for substantial equivalence to predicate devices rather than establishing specific acceptance criteria and proving performance against them through a clinical study with detailed metrics.
Based on the provided information, I can extract the following:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence Claim) | Reported Device Performance (from "Performance data" section) |
|---|---|
| Equivalence in performance to predicate devices (BSC Choice Guide Wire and ACS BMW Guide Wire) | "Bench testing and preclinical in-vivo testing demonstrate that the Stereotaxis Endovascular Guide Wire performs in an equivalent manner to both the BSC Choice Guide Wire and the ACS BMW Guide Wire predicate devices." |
| Safety and effectiveness for its intended use (introducing and positioning over-the-wire catheters and therapeutic devices within the coronary and peripheral vasculature during PTCA or other intravascular interventional procedures). | Implied by the successful completion of bench and preclinical in-vivo testing and the FDA's determination of substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for the test set (number of devices, test cases, or animal subjects). It only mentions "Bench testing and preclinical in-vivo testing." The data provenance is not explicitly stated in terms of country of origin, but "preclinical in-vivo testing" suggests animal studies, and "bench testing" refers to laboratory-based evaluations. It's likely prospective for the testing conducted for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide any information about experts used to establish ground truth or their qualifications. The evaluation relies on "bench testing and preclinical in-vivo testing," which would typically involve engineering and scientific evaluation rather than expert clinical consensus on a test set.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method. Given the nature of bench and preclinical testing for a guidewire, a formal adjudication process with multiple experts is generally not applicable in the same way it would be for diagnostic AI.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not reported. The information focuses on device performance and substantial equivalence, not on human reader performance with or without AI assistance. This device is a medical instrument, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. This device is a physical medical instrument, not an algorithm. Standalone performance as it applies to AI algorithms is not relevant here.
7. The Type of Ground Truth Used
The "ground truth" for this guidewire's performance would be established through objective measurements and observations during:
- Bench testing: Measuring physical properties, mechanical performance, maneuverability, and other relevant characteristics against pre-defined specifications or predicate device performance.
- Preclinical in-vivo testing: Observing the guidewire's ability to navigate vasculature, facilitate catheter delivery, and its interaction with biological systems in an animal model, often assessed against control or predicate devices. This would involve surgical observations and potentially imaging.
8. The Sample Size for the Training Set
N/A. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, not for the development and testing of a guidewire in this context.
9. How the Ground Truth for the Training Set Was Established
N/A. As mentioned above, the concept of a training set and its ground truth establishment is not applicable to this type of device. The development process would involve iterative design, prototyping, and testing against engineering specifications and preclinical models.
§ 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.