Search Results

The ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with Hydrocoat™ Hydrophilic Coating is steerable wire intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

The ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with Hydrocoat™ Hydrophilic Coating is also intended to facilitate the placement of equipment, such as atherectomy and stent devices, during other diagnostic and therapeutic intravascular procedures.

The ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is a steerable guide wire with a nominal diameters of 0.014" and two lengths: a 190 cm extendable length and a 300 cm exchange length. The proximal end of the 190 cm models are tapered to fit into the hypotube portion of the ACS DOC® Guide Wire Extension (K902755, September 4, 1990).

The ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating has a radiopaque tip and is are available with either a straight tip configuration, which allows the physician to shape the guide wire tip in a preferred shape, or a pre-shaped "J" tip configuration, which allows the physician the convenience using a guide wire with the tip pre-shaped.

The hydrophilic coating is intended to facilitate wire movement within 0.014" diameter devices. The proximal shaft of the ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is coated with polytetrafluoroethylene (PTFE).

This 510(k) summary describes a medical device, the ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating, and its performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the new device "met the acceptance criteria and performed similar to the predicate ACS HI-TORQUE® IRON MAN™ Guide Wire." While specific quantitative acceptance criteria are not provided, the "similar performance" to the predicate device serves as the de facto acceptance criterion. The performance data is summarized as follows:

• Accelerated Aging
• Distal Tip Pull Test
• Distal Tip Turns-to-Failure Test
• Rotational Accuracy Test
• Tip Flexibility Test
• Coating Adherence/Integrity
  In vivo Animal Testing: Performed equivalently to predicate devices in a canine model with healthy coronary arteries. |

2. Sample Sizes and Data Provenance for the Test Set:

• Bench Testing: The document does not specify the exact sample sizes used for each bench test.
• In vivo Animal Testing: The test set involved a "canine model with healthy coronary arteries." The specific number of animals or trials is not provided.
• Data Provenance: The data appears to be prospective as it was generated specifically for the 510(k) submission. The country of origin is not explicitly stated but can be inferred to be the United States, given the submission to the FDA.

3. Number of Experts and Qualifications for Ground Truth:

This section is not applicable as the described study is for a medical device (guide wire) and the performance assessment is based on physical and mechanical testing, not interpretation of medical images or patient data by experts. Therefore, there is no "ground truth" established by experts in the context of radiology or clinical diagnosis.

4. Adjudication Method:

This section is not applicable for the same reasons as point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This section is not applicable. The study described is for a medical device (guide wire) and focuses on its physical and mechanical performance compared to a predicate device, not on the improvement of human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

This section is not applicable. The device is a physical medical device (guide wire), not a software algorithm or AI model.

7. Type of Ground Truth Used:

The "ground truth" for the device's performance is established through objective physical and mechanical measurements derived from bench testing and physiological observations/measurements from the in vivo animal study. The comparison to the predicate device's known performance serves as the benchmark.

8. Sample Size for the Training Set:

This section is not applicable. The device is a physical medical device, not a machine learning model, so there is no concept of a "training set."

9. How Ground Truth for the Training Set Was Established:

This section is not applicable for the same reasons as point 8.

Ask a specific question about this device