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The Dexterity™ Steerable Introducer is intended to be used for the percutaneous introduction of various cardiovascular catheters into the heart, including the left side of the heart through the inter-atrial septum.

The Cardiosolutions Dexterity™ Steerable Introducer is provided as a 9Fr and 14Fr Introducer. The set also consists of the following components based on the model#:
Size and Working Length: 14FR 65 and 85 CM, Included Accessories: Dilator, Stylet, Tear-away introducer sheath
Size and Working Length: 14Fr 105 CM, Included Accessories: Dilator, NA, Tear-away introducer sheath
Size and Working Length: 9Fr 65CM, Included Accessories: NA, Curved Stylet, NA
The Dexterity steerable introducer is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer provides both proximal tip and distal tip steering and is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The introducer sheath is reinforced Pebax and the distal tip has a radiopaque marker to improve fluoroscopic visualization. The device is provided in various diameters and working lengths. The device is provided sterile and is intended for single use only.
The purpose of this submission is to add an additional device working length, 105 CM, to the 14Fr Introducer product offering. In addition the intended use statement is modified to include the term percutaneous for clarification only. This change is not a change to the intended use of the device.

This document describes the Cardiosolutions Dexterity™ Steerable Introducer, a medical device designed for the introduction of cardiovascular catheters into the heart. The information provided outlines the acceptance criteria and the summary of testing performed to demonstrate substantial equivalence to predicate devices, rather than a standalone clinical study on human subjects with ground truth established by experts.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance tests conducted, implying these are the acceptance criteria, and states that "All test results demonstrate that the properties and performance of the device are substantially equivalent to the predicate device and suitable for its intended use." Specific quantitative performance values are not provided in this summary.

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

The document describes design verification testing on the modified device, specifically a 14Fr 105 CM Dexterity™ Steerable Introducer. It does not specify the sample size for each test. The testing is described as occurring in a laboratory setting (in vitro simulated use), and therefore the data provenance is laboratory testing, not human subject data from a specific country or retrospective/prospective study.

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

Not applicable. This device is a steerable introducer catheter, and the evaluation is based on engineering and performance specifications, not on expert interpretation of diagnostic images or clinical outcomes. The "ground truth" for these tests would be the established engineering specifications and standards (e.g., ISO 10555).

4. Adjudication Method for the Test Set:

Not applicable. The tests are objective engineering and performance tests, not subjective assessments requiring adjudication by multiple experts.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to existing predicate devices through engineering and performance testing, not on assessing the improvement of human readers with or without AI assistance. The device itself is an introducer, not an AI-powered diagnostic tool.

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 (catheter introducer), not an algorithm or AI system.

7. The Type of Ground Truth Used:

For the design verification tests, the ground truth is based on engineering specifications, international standards (ISO 10555), and FDA guidance documents for intravascular catheters.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set. The device is evaluated based on its physical and mechanical properties.

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

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

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The Percu-Pro™ Steerable Introducer is intended to be used for the introduction of various cardiovascular catheters into the heart, including the left side of the heart through the inter-atrial septum.

The Cardiosolutions Percu-Pro™ Steerable Introducer is provided as a 9Fr and 14Fr Introducer. The set also consists of a dilator (14Fr only), stylet, and tear-away introducer sheath. The steerable introducer is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer provides both proximal tip and distal tip steering and is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The introducer sheath is reinforced Pebax and the distal tip has a radiopaque marker to improve fluoroscopic visualization. The device is provided in 65 cm working lengths. The device is provided sterile and is intended for single use only. The purpose of this submission is to add an additional device diameter; 9Fr has 65 cm working lengths.

This is a 510(k) premarket notification for a medical device, not a study evaluating an AI algorithm. Therefore, many of the requested categories are not applicable.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

• Visual Surface Inspection
• Dimensional Verification
• Corrosion Resistance
• Tensile Break Force
• Tip Separation Force
• Freedom from Leakage Under Pressure
• Air Leakage During Aspiration
• Luer Hub Compliance
• Flexural Fatigue Tolerance
• In Vitro Simulated Use Studies
• Functional Performance Testing
• Radiopacity | "All test results demonstrate that the properties and performance of the device are suitable for its intended use." (Specific quantitative results are not provided in this summary.) |
  | Material/Biocompatibility | New device materials should be biocompatible or identical to predicate device materials. | "The materials used in the 9Fr Percu-Pro™ Steerable Introducer are identical to the 14Fr Percu-Pro™ Steerable Introducer predicate device. No additional biocompatibility is required." |
  | Shelf Life | The device should maintain its properties and performance over its intended shelf life. | Shelf life testing was completed (specific results not provided). |
  | Substantial Equivalence | The device must be substantially equivalent to the predicate device in terms of intended use, design, materials, technology, and function, with no new issues of safety or effectiveness. | "The 9Fr Percu-Pro™ Steerable Introducer is substantially equivalent to the predicate devices in terms of intended use, design, materials, technology, and function. There are no differences between devices which would raise new issues of safety or effectiveness." |

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

The document does not provide specific sample sizes for each mechanical and functional test. It generally states that "Design verification testing performed on the 9Fr device consisted of mechanical testing conducted in accordance with..."

• Sample Size: Not explicitly stated as a number of devices/units. The testing generally applies to the 9Fr device.
• Data Provenance: Not applicable in the context of clinical data for AI. These are engineering/device performance tests.

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

Not applicable. This is a device performance evaluation, not an AI study requiring expert ground truth for classification.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, this is not an MRMC study.

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

Not applicable. This device is a medical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" here is adherence to established engineering standards (ISO 10555) and FDA guidance for the performance of intravascular catheters. For material equivalence, the ground truth is the chemical composition of the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm.

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

Not applicable. This is not an AI algorithm.

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The Percu-Pro™ Steerable Introducer is intended to be used for the introduction of various cardiovascular catheters into the heart, including the left side of the heart through the inter-atrial septum.

The Cardiosolutions Percu-Pro™ Steerable Introducer is a 14Fr Introducer. The set also consists of a dilator, stylet, and tear-away introducer sheath. The steerable introducer is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer provides both proximal tip and distal tip steering and is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The introducer sheath is reinforced Pebax and the distal tip has a radiopaque marker to improve fluoroscopic visualization. The device is provided in 65 cm or 80 cm working lengths. The device is provided sterile and is intended for single use only.

Here's an analysis of the acceptance criteria and study information for the Percu-Pro™ Steerable Introducer based on the provided text:

Preamble: This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance standards. Therefore, the "acceptance criteria" are primarily related to meeting established industry standards and guidance for similar devices, and the "device performance" is reported in terms of compliance with these standards and suitability for intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as "Safety and Performance Testing." This testing included Biocompatibility and Hemocompatibility testing in accordance with ISO 10993, and Mechanical testing conducted in accordance with ISO 10555 and FDA Guidance.

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

• Sample Size: The document does not specify the exact sample size (number of devices or tests performed per criterion) for either the biocompatibility/hemocompatibility or mechanical testing. It lists the categories of tests conducted.
• Data Provenance: The studies were conducted by Cardiosolutions Inc. as part of their 510(k) submission. The location of the testing facilities is not explicitly stated. The nature of the tests (biocompatibility and mechanical properties) indicates they are "benchtop" or "laboratory" studies, not directly involving human patients (except for the in vivo thromboresistance study in dogs, which is an animal model). These were likely prospective tests designed to evaluate the physical and biological properties of the manufactured device.

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

• Not Applicable. For this type of device (intravascular catheter introducer), "ground truth" as typically defined in diagnostic AI studies (e.g., expert consensus on medical images) is not relevant. The "truth" is established by adherence to a pass/fail criterion for each technical standard or guidance document. The expertise would lie in the engineers and scientists performing and interpreting these technical tests in accordance with the specified ISO standards and FDA guidance. Their qualifications are not explicitly stated but are implicitly assumed to be appropriate for conducting such specialized testing.

4. Adjudication Method for the Test Set

• Not Applicable. Similar to the point above, adjudication in the sense of resolving disagreements among human readers on a diagnosis is not relevant here. The tests likely have clear pass/fail criteria based on quantitative measurements or qualitative observations by a single or multiple trained personnel, but not in a "reader adjudication" format typically seen in clinical studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC comparative effectiveness study is designed to assess the performance of diagnostic systems (e.g., AI with/without human readers). This 510(k) pertains to a medical device (introducer sheath) that is not a diagnostic system. The studies described are focused on the physical and biological properties of the device itself.

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, not a software algorithm or AI. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

• The "ground truth" for this device's evaluation is primarily based on defined scientific and engineering standards and specifications. This includes:
  • ISO 10993 series: For biocompatibility and hemocompatibility, which sets criteria for acceptable biological response.
  • ISO 10555 series: For sterile, single-use intravascular catheters, which defines mechanical requirements.
  • FDA Guidance: On Premarket Notification 510(k) Submission for Short Term and Long Term Intravascular Catheters, which provides additional criteria.
  • For the in vivo dog study mentioned, the ground truth would be the observed biological response to the device in the animal model, interpreted against established safety benchmarks for thrombus formation.

8. The Sample Size for the Training Set

• Not Applicable. This is a hardware medical device, not an AI or machine learning algorithm that requires a "training set." The device is manufactured according to a design, and then tested for compliance with established standards.

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

• Not Applicable. As there is no training set for this hardware device, the concept of establishing ground truth for it does not apply.

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The Percu-Pro™ Messenger Balloon Catheter is intended to facilitate the placement of interventional devices during diagnostic and interventional cardiovascular procedures. The device is not intended for coronary or neurovascular use.

The Cardiosolutions Percu-Pro™ Messenger Balloon Catheter is a 5Fr catheter with a bifurcated proximal hub. The catheter shaft and connection ends are made from Pebax and the distal tip balloon is made from latex.

This document does not contain information about a study proving that a device meets acceptance criteria, an AI/ML device, or a standalone algorithm.

The document is a 510(k) summary for the Percu-Pro™ Messenger Balloon Catheter, which is a physical medical device (a catheter). The summary details its design, intended use, and comparison to predicate devices to establish substantial equivalence, rather than providing performance metrics like accuracy, sensitivity, or specificity that would be typical for an AI system.

Therefore, I cannot provide the requested information.

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The Percu-Pro™ Guidewire is intended to facilitate the placement of devices during diagnostic and interventional vascular procedures in the peripheral vasculature. The guidewire is not intended for use in coronary arteries or for neurovascular use.

The Percu-Pro™ GuideWire is constructed of a stainless steel core wire The proximal end of the core and is finished with a PTFE jacket. The coil covered distal end of the core is tapered to a ribbon tip to increase flexibility and is finished with a silver brazed ball tip. The guidewire is provided sterile and is a single use device.

The provided 510(k) summary for the Percu-Pro™ GuideWire (K094062) describes pre-clinical safety and performance testing but does not include acceptance criteria or a study with specific performance metrics for the device itself against established criteria. Instead, it states that "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices."

The submission focuses on demonstrating substantial equivalence to predicate devices (TechDevice Guidewire K053251 and TFX Guidewire K963320) based on "intended use, design, materials, technology, and performance," asserting that "There are no differences between devices which would raise new issues of safety or effectiveness."

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details about a study proving the device meets those criteria, as such information is not present in the provided document.

However, I can extract information about the pre-clinical testing conducted, which supports the safety and performance claims for substantial equivalence:

Pre-Clinical Safety and Performance Testing Information (from the 510(k) Summary):

• Type of Testing: Biocompatibility and hemocompatibility, tensile strength, torque strength, resistance to fracture, torqueability, and tip flexibility.
• Methodology: Conducted "in accordance with protocols based on the requirements of industry standards and guidance documents."

Missing Information (Not available in the provided document):

1. Table of Acceptance Criteria and Reported Device Performance: Not specified.
2. Sample Size for Test Set and Data Provenance: Not specified for any performance testing.
3. Number of Experts and Qualifications for Ground Truth: Not applicable, as performance testing against specific criteria is not detailed.
4. Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable (this is a medical device, not an AI diagnostic tool).
6. Standalone Performance Study (Algorithm only): Not applicable (this is a medical device, not an AI algorithm).
7. Type of Ground Truth Used: Not applicable, as performance testing against specific criteria is not detailed.
8. Sample Size for Training Set: Not applicable (this is a medical device, not an AI algorithm).
9. How Ground Truth for Training Set was Established: Not applicable.

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