Search Results

The Introducer Sheath set is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.

The Introducer Sheath Set consists of a sheath and a dilator. The sheath is comprised of a sheath tube, a sheath hub, and a hemostatic valve. While the dilator comprises a dilator hub, a dilator tube and a rod cap. The sheath features a hydrophilic coating. Each set of products is equipped with a sheath and a dilator. The product is sterilized with ethylene oxide and is disposable.

N/A

Ask a specific question about this device

The Introducer Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements.
Do not use this device for neural placements.

The Introducer Sheath is intended for establishing a percutaneous access that facilitates the introduction of intravascular devices. The Introducer Sheath is composed of the Guiding Sheath and the Dilator. The Introducer Sheath is available in multiple effective lengths and curve shape configurations.

This document is an FDA 510(k) premarket notification letter for an "Introducer Sheath" device, which is a Class II medical device. The letter determines substantial equivalence to a legally marketed predicate device.

The provided document does NOT describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI-powered device or a study involving human readers. Instead, it details the non-clinical bench performance testing for a physical catheter introducer sheath.

Therefore, many of the requested information points, such as AI-specific acceptance criteria, human reader studies, or ground truth establishment for a training set, are not applicable to this document.

However, I can extract the information that is relevant to the physical device performance testing.

Here's an analysis of the provided information:

This document describes the regulatory approval of a physical medical device (an Introducer Sheath), not an AI/Software as a Medical Device (SaMD) or a study involving diagnostic image analysis.

As such, the information requested regarding AI acceptance criteria, human reader studies (MRMC), standalone algorithm performance, ground truth for AI, and training/test set sample sizes for AI is not present in this document. The document focuses on the mechanical, material, and sterility performance of a physical device.

Information relevant to the physical device's performance testing:

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

The document states: "Performance tests were conducted to ensure that the Introducer Sheath met the applicable design and performance requirements throughout its shelf life." and "The tests results indicate that the Introducer Sheath passed all the tests and it conforms to 150 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires."

Explicit Acceptance Criteria (implied by passing tests and conformity to standards):

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

The document refers to "Performance tests" and "tests results" but does not specify the sample sizes (e.g., number of units tested for each physical property) or the provenance (country of origin, retrospective/prospective) of the data. This is typically detailed in the full test reports that support the 510(k) submission, but not in the summary letter itself.

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. This is for a physical device, not an AI diagnostic tool or an imaging study requiring expert ground truth for interpretation.

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

Not applicable. This is for a physical device, not an AI diagnostic tool or an imaging study requiring expert 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

No. This is for a physical device. Clinical studies (including MRMC) were explicitly not included: "No clinical study is included in this submission."

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

Not applicable. This is for a physical device.

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

For a physical device, the "ground truth" is defined by established engineering and material science standards (e.g., ISO 11070:2014, ISO 10993 series for biocompatibility) and internal design specifications. There isn't "ground truth" in the diagnostic sense (like pathology for AI).

8. The sample size for the training set

Not applicable. This is for a physical device, not an AI model.

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

Not applicable. This is for a physical device, not an AI model.

Ask a specific question about this device

Introducer Sheath Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vern or artery and minimize blood loss associated with such introduction.

Not Found

I'm sorry, but this document does not contain the information requested regarding acceptance criteria and device performance for an AI/ML-based medical device study.

The provided text is a 510(k) clearance letter from the FDA for an "Introducer Sheath Kit" (product code DYB). This is a physical medical device (a catheter introducer), not an AI/ML-based software device.

Therefore, I cannot extract details about:

1. A table of acceptance criteria and reported device performance for an AI model.
2. Sample size, data provenance, expert qualifications, or adjudication methods for an AI test set.
3. MRMC studies or standalone AI performance.
4. Ground truth types or training set details for an AI model.

The letter focuses on the substantial equivalence of the "Introducer Sheath Kit" to legally marketed predicate devices, and discusses general regulatory requirements for medical devices.

Ask a specific question about this device

Introducer Sheath Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vern or artery and minimize blood loss associated with such introduction.

Not Found

The provided document is an FDA 510(k) clearance letter for an "Introducer Sheath Kits." This type of document does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria for a medical imaging device utilizing AI.

The letter focuses on the regulatory clearance process, establishing substantial equivalence to a predicate device, and outlining general controls and regulations that the manufacturer must adhere to. It concerns a physical medical device (introducer sheath kits) used for facilitating the introduction of guidewires and catheters.

Therefore, I cannot provide the requested information based on the given text.

To answer your questions about acceptance criteria and device performance studies, you would typically need a clinical study report or a data summary from a premarket submission (e.g., PMA or 510(k) summary for an AI/ML medical device), which would detail:

1. Acceptance criteria and reported performance: Specific metrics (e.g., sensitivity, specificity, AUC) and predefined thresholds.
2. Sample size and data provenance: Details of the dataset used for validation.
3. Experts for ground truth: Number and qualifications of readers/experts.
4. Adjudication method: How disagreements were resolved.
5. MRMC study information: If applicable, details on human reader performance with and without AI.
6. Stand-alone performance: Algorithm-only performance metrics.
7. Type of ground truth: How the "truth" was established for the test data.
8. Training set size: Number of cases used for model training.
9. Training set ground truth: How ground truth was established for the training data.

Ask a specific question about this device

Ask a specific question about this device

The Boston Scientific/EP Technologies intracardiac introducing sheaths and accessories are designed to facilitate the intracardiac placement of interventional devices.

The intracardiac introducing sheath and accessories consists of: (1) a disposable introducer sheath, (2) a vessel dilator and (3) guidewire. The intracardiac introducing sheath consists of a braided shaft, a soft distal tip, and marker band. The sheath comes with either a Hemostasis valve or a luer fitting. The introducer sheaths are constructed in a range of curve reach configurations, diameters and lengths to respond to physician preferences. The introducer sheath configurations covered under the subject 510(k) Premarket Notification include 8.5F and 9.5F diameter, angles ranging form 0° - 180

The provided text describes a 510(k) premarket notification for an "Intracardiac Introducing Sheath and Accessories." This is a medical device, and the submission aims to demonstrate its substantial equivalence to previously marketed predicate devices, not an AI/ML powered device. Therefore, many of the requested categories (such as sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding acceptance criteria and the study performed based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is an in vitro testing program designed to demonstrate the "substantial equivalence" of the subject device (Intracardiac Introducing Sheath and Accessories) to its predicate devices. The study involved a series of controlled laboratory tests measuring various physical, mechanical, and functional properties.

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

• Sample Size: The document does not specify the exact sample sizes used for each in vitro test. It generally refers to "manufactured sheaths and dilators" and "packaged units." For in vitro testing, this typically involves a representative number of devices to achieve statistical significance for the specific tests performed, but the exact count is not provided.
• Data Provenance: The data provenance is from laboratory testing (in vitro) conducted by Boston Scientific Corporation/EP Technologies. There is no mention of country of origin for the data (as it's in vitro testing, often performed internally or by contract labs), nor is it retrospective or prospective in the clinical sense.

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

• Number of Experts & Qualifications: Not applicable. For this type of in vitro device performance testing, "ground truth" is typically established by predefined engineering specifications, industry standards (e.g., ISO 11135 for sterilization), and comparison to the performance of predicate devices, rather than expert clinical consensus. The testing engineers and quality control personnel are the "experts" in this context, ensuring adherence to protocols and specifications.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable in the clinical sense. In vitro testing results are compared against predetermined acceptance criteria (e.g., a tensile strength minimum, a leak rate maximum, visual inspection criteria, or direct comparison to predicate device performance). Any discrepancies would be handled by internal quality control and engineering review processes.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI/ML devices where human readers interpret medical images. This submission is for a physical medical device (an introducer sheath).

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Standalone Performance: Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used:

• Ground Truth Type: The "ground truth" or reference standard for this device's performance relies on:
  • Engineering Specifications: Predefined performance metrics (e.g., bond strength, leak rates, friction forces).
  • Industry Standards: Compliance with relevant international standards (e.g., ISO 11135 for sterilization).
  • Predicate Device Performance: Direct comparison of the subject device's performance to that of the legally marketed predicate devices, demonstrating similar safety and effectiveness.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This is not an AI/ML algorithm that requires a training set. The device itself is manufactured to specifications.

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

• Ground Truth for Training Set: Not applicable.

Ask a specific question about this device

The Boston Scientific/EP Technologies intracardiac introducing sheaths and accessories are designed to facilitate the intracardiac placement of interventional devices. The Introducing sheath may be exchanged and used in a transseptal position after transseptal puncture has been obtained by another sheath.

The intracardiac introducing sheath and accessories consists of: (1) a disposable introducer sheath, (2) a vessel dilator and (3) guidewire. The intracardiac introducing sheath consists of a braided shaft a soft distal tip and marker band. The sheath comes with either a Hemostasis valve or a luer fitting. The introducer sheaths are constructed in a range of curve reach configurations, diameters and lengths to respond to physician preferences. The introducer sheath configurations covered under the subject 510(k) Premarket Notification include 8.5F and 9.5F diameter, angles ranging form 0° - 180

The provided document is a 510(k) summary for an "Intracardiac Introducing Sheath and Accessories." This type of submission focuses on demonstrating substantial equivalence to predicate devices for medical devices, rather than establishing efficacy through clinical trials with specific performance metrics akin to software device approval.

Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/software device does not apply to this document.

Here's why and what information is available:

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

• Acceptance Criteria: Not explicitly stated as numerical performance targets (e.g., sensitivity, specificity). The acceptance criteria for this device revolve around demonstrating substantial equivalence to predicate devices in terms of design features, materials, and in vitro performance, ensuring no new safety or effectiveness issues.
• Reported Device Performance:

  Test Type	Reported Performance
  Biocompatibility testing	Qualified the equivalence between the subject device and dilators.
  Sterilization validation	Validated per ISO 11135 guidelines.
  Reliability testing	Included shipping and accelerated aging of packaged units.
  Tensile testing	Performed on critical bond joints.
  Rotational testing	Performed on the sheath to luer bond.
  Leak, friction forces, insertion	Performed in an in vitro setup, indicating performance as well as predicate devices for these aspects.

2. Sample sized used for the test set and the data provenance:

• This document describes in vitro testing, not a clinical study with human subjects or a dataset for AI. Therefore, concepts like "test set sample size" and "data provenance" (country of origin, retrospective/prospective) are not applicable. The tests were performed on manufactured units of the device itself.

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

• Not applicable. This is not a study requiring expert readers to establish ground truth. Device performance was assessed through engineering and laboratory tests.

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

• Not applicable. No adjudication process is relevant for this type of in vitro testing.

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 device is an intracardiac introducing sheath, not an AI-powered diagnostic or assistive tool.

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

• Not applicable. The device is a physical medical instrument, not an algorithm.

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

• "Ground truth" in this context refers to established engineering standards, material properties requirements, and performance specifications for medical devices. For example, sterilization validation adheres to ISO 11135 guidelines, and tensile strength tests have defined pass/fail criteria based on material science and predicate device performance. The in vitro tests verify that the device meets these engineering and safety standards.

8. The sample size for the training set:

• Not applicable. There is no concept of a "training set" for this type of device submission.

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

• Not applicable.

Summary of available information:

The document details a 510(k) submission for a physical medical device. The "performance data" provided consists of various in vitro engineering and biocompatibility tests designed to demonstrate that the new device is substantially equivalent to existing predicate devices and does not raise new safety or effectiveness concerns. It does not involve AI or clinical studies with human subjects in the way your questions are framed.

Ask a specific question about this device

The introducer sheath and dilator are intended to be used in percutaneous access for the purpose of facilitating catheter placement by allowing multiple catheter and/or guidewire exchanges.
The Introducer Sheath and Dilator is used for percutaneous introduction of catheters and guide wires.

The introducer set consists of a tapered dilator with a slightly shorter sheath that splits for removal after catheter placement. The sheath is peeled away from the catheter by breaking the handle at the hub.

The provided text describes a 510(k) premarket notification for an "Introducer Sheath and Dilator" (K971165). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study with detailed statistical outcomes.

Therefore, many of the specific details requested regarding acceptance criteria, study design, sample sizes, expert ground truth, and AI performance are not applicable to this 510(k) submission.

Here's an breakdown of the available information:

Description of the Device and its Intended Use:

The introducer sheath and dilator are intended to be used in percutaneous access for the purpose of facilitating catheter placement by allowing multiple catheter and/or guidewire exchanges. The set consists of a tapered dilator with a slightly shorter sheath that splits for removal after catheter placement. The sheath is peeled away from the catheter by breaking the handle at the hub.

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the submission. 510(k)s for devices like this typically don't include a table of performance metrics and acceptance criteria in the same way a new, high-risk device might. The "performance" is implicitly deemed acceptable if it is substantially equivalent to predicate devices that are already on the market and considered safe and effective.

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

This information is not provided. Clinical studies with test sets, as understood in the context of performance metrics and AI, were not part of this 510(k) submission. The substantial equivalence was likely based on design comparisons and perhaps bench testing, but specific sample sizes for a "test set" are not mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable/not provided. Ground truth in the context of a 510(k) equivalence claim usually refers to the established safety and effectiveness of the predicate devices already on the market, rather than a new "ground truth" being established for the submitted device through expert review of a test set.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided. There is no mention of a formal test set requiring an adjudication method.

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

No, a MRMC comparative effectiveness study was not performed or reported. This type of study is more common for diagnostic imaging AI devices, not for an introducer sheath and dilator.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone performance study as would be conducted for an AI algorithm was not performed or reported. This device is a physical medical instrument, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" in this context is the established safety and effectiveness of legally marketed predicate devices. The submission states: "The proposed introducer dilator has been shown to be substantially equivalent to Cook's Peel-Away® Introducers and to B. Braun's Tearaway Introducer." This means the predicate devices' historical performance and acceptance served as the benchmark.

8. Sample Size for the Training Set:

This information is not applicable/not provided. This device is not an AI algorithm, so there is no training set in that sense.

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

This information is not applicable/not provided for the same reason as above.

In summary: K971165 is a 510(k) premarket notification for an introducer sheath and dilator. Its "acceptance criteria" were met by demonstrating substantial equivalence to existing, legally marketed predicate devices (Cook's Peel-Away® Introducers and B. Braun's Tearaway Introducer). The submission text does not detail specific performance metrics, clinical study results, or AI-related evaluations that would typically include the requested information. The FDA's letter confirms that based on the provided information, the device was found substantially equivalent and could proceed to market.

Ask a specific question about this device