HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

• K Number: K072460
• Device Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
• Manufacturer: ABBOTT VASCULAR, INC.
• Date Cleared: 2008-04-11 ( 224 days)
• Product Code: DQX
• Regulation Number: 870.1330
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: K013833

Intended Use

This HI-TORQUE 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.

Device Description

The HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire is a steerable guide wire available in a diameter of 0.0140" and in lengths of 190 cm DOC extendable length and a 300 cm exchange length. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The distal segment of the guide wire is coated with a new lubricious coating to improve guide wire movement in the catheter. The proximal end of the guide wire utilizes SMOOTHGLIDE coating technology.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire, based on the provided text:

Acceptance Criteria and Device Performance (Based on provided text)

The provided text does not contain a detailed table of specific acceptance criteria with numerical targets. Instead, it states a general conclusion about meeting acceptance criteria and performance comparability.

Acceptance Criteria Category	Reported Device Performance
Overall Performance	Met acceptance criteria
Comparability	Performed comparable to the predicate device
Safety and Effectiveness	No new safety or effectiveness issues raised

Study Details:

1. Sample sizes used for the test set and data provenance:

   • Test Set Sample Size: Not specified in the provided text.
   • Data Provenance: The study was "in vitro bench testing," meaning it was conducted in a laboratory setting, not with human or animal subjects. Therefore, there is no information about country of origin or whether it was retrospective or prospective in the clinical sense.

2. Number of experts used to establish the ground truth for the test set and their qualifications:

   • Not applicable/Not specified. This was an in vitro bench test, not an evaluation relying on expert interpretation of clinical data or images.

3. Adjudication method for the test set:

   • Not applicable/Not specified. This was an in vitro bench test, not a study requiring adjudication of expert opinions.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This device is a guide wire, not an AI-powered diagnostic or assistive technology. The study was an in vitro bench test.

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

   • Not applicable. This device is a physical medical instrument (guide wire), not an algorithm. The study was an in vitro bench test of its physical properties and functionality.

6. The type of ground truth used:

   • The "ground truth" for this in vitro bench testing would be established engineering specifications, performance standards, and the performance characteristics of the predicate device. The text indicates the device "met the acceptance criteria" and "performed comparable to the predicate device."

7. The sample size for the training set:

   • Not applicable. This was an in vitro bench test of a physical device, not an AI model that requires a training set.

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

   • Not applicable. As noted above, this was not an AI study requiring a training set with established ground truth.

Regulation Number and Section

§ 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.