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

The HI-TORQUE BALANCE™ Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating have the following intended uses:

• To facilitate the placement of balloon dilatation catheters during percutaneous . transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
• The wire is also intended to facilitate the placement of equipment such as . atherectomy, IVUS and compatible stent devices during other diagnostic and therapeutic intravascular procedures.

The HI-TOROUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating are steerable guide wires 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, approved September 4, 1990).

The wires are constructed from a stainless steel proximal shaft and a distal superelastic ELASTINITE Shaft for flexibility and performance. The distal end of this guide wires have radiopaque tips that are available either as a straight, shapeable configuration or as a preshaped J configuration. The guide wires have proximal markers at 90 and 100 cm from the distal tip. The hydrophilic coating is applied to the distal portion of the wire guide wire. The proximal shaft of the guide wire is coated with polytetrafluoroethylene.

The provided 510(k) summary (K973494) describes the performance testing for the HI-TORQUE BALANCE™ Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating.

Here's an analysis of the acceptance criteria and study findings based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Bench testing was performed to demonstrate that the HI-TORQUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similar to the predicate HI-TORQUE BALANCE® Guide Wire." Similarly, for in vivo testing, it states "The results showed that the new wires performed in an equivalent manner to the predicate devices." And finally, "The results from the bench tests plus the animal testing showed that the new HI-TORQUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating met acceptance criteria and performed in a manner equivalent the predicate HI-TORQUE BALANCE® Guide Wire and the HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire."

However, the specific quantitative acceptance criteria or detailed numerical performance results for each test were not explicitly provided in the summary. The acceptance criterion appears to be general equivalence or similarity to the predicate device.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: The document does not specify the exact number of units or animals used in the bench tests or the in vivo animal testing. It generally refers to "bench testing" and "in vivo animal testing in a canine model."

Data Provenance:

• Bench tests: Not explicitly stated, but typically conducted internally by the manufacturer.
• In vivo animal testing: Performed in a "canine model," which implies an experimental, prospective study. The country of origin is not specified but is presumably where the manufacturer (Guidant Corporation) is based or where their testing facilities are located.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to the provided document. The performance testing described (bench tests and animal studies) involves physical and mechanical properties, not interpretation or diagnosis requiring human experts or ground truth in the context of diagnostic accuracy. The "ground truth" here is the objective measurement of physical properties or observed physiological responses in the animal model.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., image reading) to establish a consensus ground truth. The device's performance was evaluated through objective bench tests and animal studies, not through human interpretation requiring adjudication.

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 question is not applicable. The device is a medical guidewire, not an AI or imaging device that would be subject to MRMC studies or human reader comparisons. Performance was assessed through physical testing and animal models, not human interpretation.

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

This question is not applicable. The device is a physical guidewire, not an algorithm, so standalone algorithm performance is not relevant. The performance tests described (bench and animal) are inherently "standalone" in the sense that they evaluate the device itself.

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

For the bench tests, the "ground truth" would be the objectively measured physical properties and performance characteristics against predefined engineering specifications (implied to be equivalent to the predicate device). For the in vivo animal testing, the "ground truth" would be the observed physiological responses, device maneuverability, and safety outcomes within the healthy coronary arteries of the canine model, compared to the predicate device.

8. The sample size for the training set

This question is not applicable. The device is a physical guidewire, not a machine learning model, so there is no "training set."

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

This question is not applicable as there is no training set for a physical medical device.

Ask a specific question about this device

To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
To facilitate the placement of equipment such as compatible stent devices during other diagnostic or therapeutic intravascular procedures.

The ACS HI-TORQUE ALL STAR™ 0.014" Guide Wire with Microglide® Coating is a steerable guide wire with a nominal diameter 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 is tapered to fit into the hypotube portion of the ACS DOC® Guide Wire Extension (K902755, cleared September 4, 1990). The proximal shaft of this guide wire is coated with polytetrafluoroethylene (PTFE) and the distal working end is coated with Microglide® Coating, a silicon based material. The distal end has a 3 cm, flexible, radiopaque tip that is provided either as a straight, shapeable configuration or as a preshaped J configuration. These guide wires have proximal markers at 90 and 100 cm from the distal tip.
Two features distinguish the new guide wire from the predicate guide wire: the addition of a segment of tetrafluoroethylene (TFE) shrink tubing around the distal portion of the guide wire proximal to the 3 cm tip and a more flexible 3 cm tip.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ACS HI-TORQUE ALL STAR™ 0.014" Guide Wire:

The provided document describes a 510(k) submission for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trials with detailed statistical analysis as might be seen for novel devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests conducted, but unfortunately, it does not explicitly state the specific quantitative acceptance criteria for each test. Instead, it states that the device "met acceptance criteria" and "performed similar to the predicate" or "performed in a manner equivalent to the ACS HI-TORQUE EXTRA S'PORT™ 0.014″ Guide Wire."

• Distal Tip Pull Test
• Distal Tip Turns-to-Failure Test
• Rotational Accuracy Test
• Tip Flexibility Test |
  | Not explicitly stated (implied to be parity/non-inferiority to predicate) | In vivo animal testing: Performed in a manner equivalent to the predicate guide wire in a canine model with healthy coronary arteries. |

2. Sample Size Used for the Test Set and Data Provenance

• Bench Tests: The specific sample sizes for each of the four bench tests (Distal Tip Pull, Distal Tip Turns-to-Failure, Rotational Accuracy, Tip Flexibility) are not provided in the summary.
• Animal Testing: The sample size (number of animals) for the canine model testing is not provided.
• Data Provenance:
  • Bench Tests: Performed in a laboratory setting. No country of origin is specified, but given the submitter's address in Temecula, CA, USA, it's highly likely to be U.S.-based. This would be considered a controlled prospective test.
  • Animal Testing: Conducted in a canine model with healthy coronary arteries. This is an in vivo animal study, not human data. The specific location and whether it was retrospective or prospective is not stated, but animal studies are typically prospective by design.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• This information is not applicable and therefore not provided in the context of this device submission. The tests performed are engineering/performance-based (bench tests) and animal studies, which do not typically involve human experts establishing clinical "ground truth" in the way a diagnostic AI device would. The "ground truth" in this context would be the objective measurements from the bench tests and observations from the animal study.

4. Adjudication Method for the Test Set

• This information is not applicable and therefore not provided. As explained above, for engineering performance tests and animal studies, there isn't a need for expert adjudication in the same way there would be for a clinical diagnostic study involving subjective interpretation.

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

• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices where human readers interpret images or data, and AI assistance is being evaluated. This device is a guide wire, which is an interventional tool, not a diagnostic AI device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• This information is not applicable. The device is a physical medical instrument (guide wire), not an algorithm or AI software. All performance tests are inherently standalone in the sense that they evaluate the physical properties and performance of the guide wire itself, without human-in-the-loop interaction as a performance variable.

7. Type of Ground Truth Used

• Bench Tests: The ground truth for the bench tests would be the established engineering specifications and measurement standards for guide wire performance (e.g., specific force required for pull, number of turns to failure, degree of rotational accuracy, flexibility measurements).
• Animal Testing: The ground truth for the animal testing would be direct observation of the guide wire's performance in vivo within the canine coronary anatomy, assessed through methods like fluoroscopy or necropsy, and compared against the control (predicate device).

8. Sample Size for the Training Set

• This information is not applicable and therefore not provided. This device is a physical medical product, not an AI/machine learning model that requires a training set.

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

• This information is not applicable as there is no training set for a physical medical device.

Ask a specific question about this device