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K Number
K083738
Device Name
HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05
Manufacturer
Abbott Vascular
Date Cleared
2009-03-11

(85 days)

Product Code
DQX
Regulation Number
870.1330
Type
Special
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Hi-Torque Flex-T Guide Wire is intended for use in angiographic procedures to introduce and position diagnostic and interventional devices within the peripheral vasculature during percutaneous procedures. The wire can be torqued to facilitate navigation through tortuous vessels. The Hi-Torque Flex-T Guide Wire is not intended for use in coronary or neurovasculature.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a medical device called the "HI-Torque Flex-T Guide Wire." This type of letter generally does not include detailed study results, acceptance criteria, or performance data beyond stating that the device is substantially equivalent to a predicate device.

Therefore, most of the requested information cannot be extracted from this document. The letter focuses on the regulatory clearance process rather than specific clinical trial or performance study details.

Here's what can be inferred or stated based on the document:

  1. A table of acceptance criteria and the reported device performance:

    • Cannot be provided. The document does not specify acceptance criteria (e.g., specific thresholds for tensile strength, torque transmission, or clinical success rates) or detailed reported device performance against such criteria. The letter primarily states that the device is "substantially equivalent" to a predicate device, implying that its performance is considered acceptable based on that comparison, but the specific metrics are not present here.

  2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

    • Cannot be provided. The document does not describe a test set, sample sizes, or data provenance from a specific study.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

    • Cannot be provided. This information pertains to a study, which is not detailed in this regulatory clearance letter.

  4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

    • Cannot be provided. This information is typically found in study protocols and reports, not in an FDA clearance letter.

  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:

    • Cannot be provided. This device is a guide wire, a physical medical instrument, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be applicable or expected.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • Not applicable. As stated above, this is a physical medical device, not an algorithm or software.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    • Cannot be provided. Pertains to a study not detailed here. For a guide wire, "ground truth" might relate to physical properties, in vitro testing, or clinical outcomes, but the specifics are not in this document.

  8. The sample size for the training set:

    • Cannot be provided. Pertains to an AI/machine learning model, which this device is not.

  9. How the ground truth for the training set was established:

    • Not applicable. Pertains to an AI/machine learning model, which this device is not.

Summary based on the provided document:

The document is an FDA 510(k) clearance letter for the "HI-Torque Flex-T Guide Wire." It confirms that the device is substantially equivalent to legally marketed predicate devices. The letter specifies the "Indications for Use" stating that the guide wire is intended for "angiographic procedures to introduce and position diagnostic and interventional devices within the peripheral vasculature during percutaneous procedures," and "The wire can be torqued to facilitate navigation through tortuous vessels." It also explicitly states limitations: "The Hi-Torque Flex-T Guide Wire is not intended for use in coronary or neurovasculature."

This letter does not include the detailed technical or clinical study data, acceptance criteria, or performance metrics that would typically be found in a comprehensive study report. The substantial equivalence determination by the FDA implies that the manufacturer demonstrated sufficient evidence (often non-clinical testing and comparison to predicates) to meet regulatory requirements, but the specifics of that evidence are not in this summary letter.

§ 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.