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The HI-TORQUE Guide Wire is intended for general intravascular use to aid in the selective placement of interventional devices and implantable coronary venous leads in the coronary and/or peripheral vasculature during diagnostic and/or therapeutic procedures.

The HI-TORQUE Guide Wires are steerable guide wires available in a nominal diameter of 0.14".

The provided text describes a 510(k) submission for HI-TORQUE Guide Wires, seeking to expand their indications for use. It primarily focuses on demonstrating substantial equivalence to existing devices rather than presenting a novel device requiring extensive performance acceptance criteria and a dedicated study to prove those criteria.

Here's an analysis based on the provided text, addressing your questions where possible:

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

The submission does not explicitly state formal quantitative acceptance criteria for the expanded indication. Instead, it relies on demonstrating equivalence to predicate devices and showing acceptable performance in in vivo animal and human clinical studies for the specific new intended use (placement of coronary venous pace/sense leads).

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

• Animal Study: The sample size is not specified. The text only mentions "Animal studies were conducted." Data provenance is not specified, but typically animal studies for medical devices are conducted in controlled environments.
• Human Clinical Testing Data: The sample size is not specified. The text states, "HI-TORQUE Guide Wires were evaluated in a clinical investigation." The data provenance is not specified, but it was a clinical investigation, implying a prospective study design.

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)

This information is not provided in the document. Given that this is a 510(k) for an expanded indication and not a de novo device, the focus is on safety and effectiveness as demonstrated through the in vivo studies, rather than a diagnostic device requiring expert interpretation of results to establish ground truth.

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

This information is not provided. As explained above, the nature of this submission (expanded indication for a guide wire) does not typically involve a complex adjudication process for establishing a "ground truth" in the way a diagnostic algorithm might. The evaluation likely focused on procedural success, adverse events, and device performance metrics.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not what the HI-TORQUE Guide Wire is. The device is a physical medical instrument whose performance is assessed through its direct application in procedures.

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

No, a standalone algorithm-only performance study was not done. The HI-TORQUE Guide Wire is a physical medical device, not a software algorithm. Its performance is intrinsically linked to its use by a human operator (e.g., a cardiologist).

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

For the human clinical testing, the "ground truth" would likely be successful placement of the compatible coronary venous pace/sense lead and absence of significant adverse events. This would be determined by the treating physician and potentially confirmed through post-procedure imaging or clinical follow-up (outcomes data related to the procedure's success and safety).

8. The sample size for the training set

The concept of a "training set" is not applicable to this device. Training sets are used in machine learning for AI algorithms. This submission concerns a physical medical device.

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

Not applicable, as there is no training set for a physical medical device.

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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 compatible stent devices during therapeutic intravascular procedures.

The HI-TORQUE BALANCE MIDDLEWEIGHT™ UNIVERSAL Guide Wire is a steerable guide wire available in a maximum diameter of 0.0137" and in lengths of 175 cm, 190 cm and 300 cm. The distal segment of the guide wire, up to the hypotube, is coated with hydrocoat to reduce friction for improved guide wire movement within the catheter. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The proximal core has a maximum diameter of 0.0137". The proximal end of the guide wire is coated with PTFE, which reduces friction of the wire within a catheter. The BMW™ Universal Guide Wire is DOC® extendable in the 175 cm and 190 cm lengths.

The provided text describes a 510(k) summary for the HI-TORQUE BALANCE MIDDLEWEIGHT™ UNIVERSAL Guide Wire. The information necessary to fully populate the requested table regarding acceptance criteria and study details is limited. However, based on the available text, here's what can be extracted and inferred:

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

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

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: The text states "in vitro bench testing" and "in vivo performance evaluations." It doesn't specify the country of origin for these tests or whether they were retrospective or prospective. Typically, "in vitro" implies laboratory testing, and "in vivo" refers to testing in living organisms (animal or human), which, in a 510(k), would usually be animal studies or clinical data gathered as part of a substantial equivalence claim.

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)

• Not applicable/Not specified. This information is typically relevant for studies involving human interpretation (e.g., imaging studies assessed by radiologists), which is not the nature of this device's testing as described. The performance evaluations here are likely functional and mechanical tests.

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

• Not applicable/Not specified. Adjudication methods are typically used when there are multiple reviewers assessing an outcome or image, which is not indicated for the type of testing described (bench and in vivo performance).

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

• No, an MRMC comparative effectiveness study was not done. This type of study is specific to devices, particularly AI-powered ones, that assist human readers in interpreting data (e.g., medical images). This device is a guide wire, which is a physical tool, not an interpretive aid.

6. 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 or software. Therefore, the concept of "standalone" performance for an algorithm is not relevant.

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

• The "ground truth" for a medical device like a guide wire would typically be established through engineering specifications, established performance standards, and clinical outcomes related to its intended use and safety. For the provided text, the "ground truth" seems to be aligned with:
  • Predicate device performance: The new device must perform "similarly to the predicate devices."
  • Acceptance criteria: These would be pre-defined performance thresholds for various mechanical, material, and functional tests (though not explicitly detailed in the summary).
  • Safety and effectiveness: Demonstrated through the in vitro and in vivo testing program.

8. The sample size for the training set

• Not applicable. This device is a physical medical tool, not an AI or machine learning algorithm that requires a "training set."

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

• Not applicable, as there is no "training set" for this type of device.

Study Description based on the provided text:

The study involved in vitro bench testing and in vivo performance evaluations to demonstrate the substantial equivalence of the HI-TORQUE BALANCE MIDDLEWEIGHT™ UNIVERSAL Guide Wire to its predicate devices. The specific tests performed and their methodologies are not detailed in the summary, but they were sufficient to show that the new device "met the acceptance criteria and performed similarly to the predicate devices" and raised "no new safety or effectiveness issues." This implies a battery of tests designed to assess the guide wire's mechanical properties, lubricity, steerability, and biocompatibility, likely against established industry standards or the performance benchmarks of the predicate devices.

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