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The Pre-Formed guidewires are intended to facilitate the introduction and placement of interventional devices within the chambers of the heart including those used within transcatheter aortic valve procedures.

The 0.035" diameter, 260-300cm length guidewire is composed of two primary wire components: a core and a coil. Both components are manufactured from Stainless Steel per ASTM A313. The core wire is a stainless steel wire which forms the inner body of the guidewire. The coil component is the guidewire's outer layer and is a stainless steel wire coated in Green Polytetrafluoroethylene (PTFE), The coil and the core components are welded together on the distal and proximal ends, forming the guidewire. The distal ends are shaped into a double-curve.

The provided text describes a 510(k) submission for a "Pre-Formed Guidewire." This is a medical device, and the information pertains to proving its substantial equivalence to a legally marketed predicate device, rather than a study on an AI/ML powered device.

Therefore, many of the requested categories (such as human-in-the-loop performance, expert ground truth for AI, typical AI study design elements) are not applicable to this type of traditional medical device submission.

Here's an analysis based on the information provided, highlighting the applicable parts and noting the non-applicable ones:

1. Table of Acceptance Criteria and the Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" paired with "reported device performance" in the way one might expect for a quantitative AI performance evaluation. Instead, it lists the types of bench tests performed to demonstrate compliance with design input and substantial equivalence. The "reported device performance" is summarized as "the devices comply with the design input summary" and "resulted in the ability to demonstrate that the predetermined acceptance criteria were met."

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

• Test Set Sample Size: Not explicitly stated for each bench test. The document mentions "Test devices were manufactured and inspected."
• Data Provenance: The bench testing and animal study were conducted by Lake Region Medical, the manufacturer based in Chaska, Minnesota, USA. This is a prospective study in the sense that the tests were performed specifically for this 510(k) submission on newly manufactured devices.

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

• This is not applicable as the tests are for a physical medical device, not an AI/ML algorithm requiring expert ground truth for interpretation. Performance is measured objectively through physical and mechanical tests.

4. Adjudication method for the test set

• Not applicable for this type of physical device testing. Results are typically based on objective measurements against pre-defined specifications.

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

• Not applicable. This is not an AI/ML powered device or an AI assistance study.

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

• Not applicable. This is a physical medical device.

7. The type of ground truth used

• For the bench tests, the "ground truth" or reference is the "design input summary" and "predetermined acceptance criteria" derived from engineering specifications and applicable standards (e.g., FDA, ISO standards).
• For the animal study, the "ground truth" for comparison was the performance of the currently marketed predicate device.

8. The sample size for the training set

• Not applicable. There is no AI/ML training set mentioned.

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

• Not applicable. There is no AI/ML training set mentioned.

Summary of the Study Proving Device Meets Acceptance Criteria:

The device's safety and effectiveness (and thus meeting acceptance criteria) were demonstrated through a combination of bench testing and an animal study.

• Bench Testing: Several physical and mechanical tests were conducted on manufactured test devices. These included Dimensional, FDA Tensile Strength, FDA Tip Flexibility, FDA Catheter Compatibility, Packaging Study, Tip Shape Retention, Particulate, ISO Visual, ISO Fracture, ISO Flex, ISO Corrosion Resistance, and Linear Stiffness tests. The manufacturer states that these tests demonstrated "compliance with the design input summary" and "resulted in the ability to demonstrate that the predetermined acceptance criteria were met."
• Biocompatibility Testing: No new biocompatibility tests were performed because there were no changes to the materials used from the predicate device.
• Animal Study: A GLP (Good Laboratory Practice) animal study was conducted. This study's purpose was to evaluate the safety and performance of the new guidewire compared to the currently marketed predicate device. The conclusion was that "the guidewires are substantially equivalent to the legally marketed device."

The overall conclusion is that "the conclusions drawn from bench testing and biocompatibility testing demonstrate compliance with the design input summary which shows the device is at least as safe and effective as the current legally marketed device." The changes made to the device (additional tip shape, distal core grind diameter minimum made larger) did not alter its intended use or fundamental scientific technology, supporting the claim of substantial equivalence.

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The Pre-Formed guidewires are intended to facilitate the introduction and placement of interventional devices within the chambers of the heart including those within transcatheter aortic valve procedures. This guidewire is not intended for use in the cerebrovasculature or coronary arteries.

The 0.035" diameter, 260cm-300cm length guidewire is composed of two primary wire components: a core and a coil. Both components are made of stainless steel per ASTM A313. The core wire is a stainless steel wire which forms the inner body of the guidewire. The coil component is the guidewire's outer layer and is a stainless steel wire coated in Green Polytetrafluoroethylene (PTFE). The coil and core components are weld together on the distal and proximal ends, forming the guidewire. The distal end of the guidewire contains a double-curve.

This document describes the qualification testing for a "Pre-Formed Guidewire" and compares it to a predicate device for a 510(k) submission.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "applicable bench tests performed at baseline and aging," and states that "Test pieces were tested and inspected according to established requirements for visual/tactile, dimensional and mechanical attributes." It also states, "All test results support the claim of substantial equivalence." However, specific quantitative acceptance criteria (e.g., "tensile strength > X N") and the exact numerical results obtained for each test are not provided in this summary. The table below represents the categories of tests performed and the general statement of performance.

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

• Sample Size for Test Set: Not explicitly stated for each bench test, biocompatibility test, or the animal study. The document mentions "Test pieces were tested," implying multiple samples, but gives no numbers.
• Data Provenance: The document does not specify the country of origin for any data.
  • Bench Testing: Performed by Lake Region Medical.
  • Biocompatibility Testing: Performed by an unspecified lab.
  • Animal Study: A GLP (Good Laboratory Practice) Animal Study was completed, implying it was conducted under controlled conditions, but the location is not mentioned.
• Retrospective or Prospective: All testing appears to be prospective as it was specifically conducted to demonstrate equivalence for this 510(k) submission.

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

This type of information is generally not applicable to a medical device 510(k) submission for a guidewire. The "ground truth" for guidewire performance is established through objective, quantifiable physical, chemical, and biological testing as performed in the bench and animal studies, not through expert consensus on qualitative observations.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "ground truth" is based on objective measurements and established standards, rather than subjective interpretation requiring adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, comparing their performance with and without AI assistance. This submission describes a physical medical device (guidewire) where performance is assessed through bench and animal testing.

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

Not applicable. This is not an AI (algorithm-only) device. The device itself is a physical guidewire. Human intervention is inherently part of its use (e.g., a physician manipulating the guidewire).

7. The Type of Ground Truth Used

The "ground truth" for the Pre-Formed Guidewire's performance and safety was established through a combination of:

• Bench Testing: Objective measurements against established requirements for visual/tactile, dimensional, and mechanical attributes, often guided by standards like ISO 11070:1998 and FDA guidance.
• Biocompatibility Testing: Compliance with ISO 10993 series standards, involving various biological assays directly measuring material interaction with biological systems.
• GLP Animal Study: In-vivo evaluation of performance and safety, comparing the new device to a predicate device in a living system. This assesses real-world interaction and outcomes, often including histological and physiological assessments.

8. The Sample Size for the Training Set

Not applicable. This is a traditional 510(k) for a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data for model development.

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

Not applicable, as there is no training set.

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