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For the introduction of various types of pacing or defibrillator leads and catheters.

The 5.5 F Worley Advanced LVI Lateral Vein Introducer is intended to access the coronary venous system either alone or in a telescopic assembly with other devices. The 5.5 F Worley Advanced LVI Lateral Vein Introducer serve as a conduit to quide devices, including guidewires, pacemaker or defibrillator leads, and catheters, or to deliver contrast medium into specific branches of the coronary venous system. They have direct contact to the inner heart. 5.5 F Worley Advanced LVI Lateral Vein Introducers come with various curve configurations to facilitate sub-selective access to angulated lateral vein branches. 5.5 F Worley Advanced LVI Lateral Vein Introducers are designed as single use devices and for short term application (

The document describes a 510(k) premarket notification for the "5.5 F Worley Advanced LVI Lateral Vein Introducer". This is a medical device and not an AI/ML product. Therefore, the requested information about acceptance criteria, study details, ground truth, and training data, which are typically associated with AI/ML device evaluations, are not applicable to this submission.

The document primarily focuses on establishing substantial equivalence to a predicate device (Coronary Sinus Guide and Lateral Vein Introducer Kits - K120158) based on intended use, technological characteristics, and safety and performance testing.

Here's a breakdown of the relevant information provided:

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

The document lists "Performance Testing (Verification)" categories and specific tests performed. However, it does not explicitly state numerical acceptance criteria or the specific quantitative results reported for each test. Instead, it indicates that the device has been "thoroughly tested through verification of product specifications and user requirements" and that it "meets the requirements that are considered essential for its intended use."

Here's a table summarizing the types of tests performed:

• Sheath introducer outer diameter (O.D.)
• Sheath introducer inner diameter (I.D.)
• Sheath introducer free length, overall length | Implied to meet specifications. |
  | Functional Tests | - Sheath introducer soft tip joint integrity
• Sheath introducer valve housing separation
• Sheath introducer tube/valve housing pull force
• Sheath introducer radiopaque tube segment joint pull force
• Sheath introducer tube joint pull force | Implied to meet specifications. |
  | Simulated Use Test | - Sheath introducer tube slitting with slitter
• Sheath introducer radiopaque tip bend | Implied to meet specifications. |
  | Visual Tests | - Kit pouch integrity
• Kit package integrity
• Sheath Introducer visual appearance
• Guiding catheter visual appearance
• LVI visual appearance
• Slitter (Cutter) visual appearance | Implied to meet specifications. |
  | Sterilization Validation | (Mentioned as performed) | Implied to meet specifications. |
  | Biocompatibility Testing | - Cytotoxicity | Implied to meet specifications. |
  | Risk Analysis | (Mentioned as performed during development) | Implied to mitigate risks to acceptable levels. |
  | Requirements/Specification Reviews | (Mentioned as performed during development) | Implied to ensure requirements are met during design. |
  | Design Reviews | (Mentioned as performed during development) | Implied to ensure design meets requirements. |

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

This information is not provided in the document, as it pertains to clinical trial data or performance study data for AI/ML models, which is not the subject of this 510(k) for a physical medical device. The "Performance Testing (Verification)" refers to engineering and quality control tests, not patient data in the context of AI/ML.

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 applicable/provided. Ground truth and expert adjudication are concepts typically associated with the evaluation of AI/ML algorithms, not for the substantial equivalence demonstration of a physical medical device like an introducer.

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

This information is not applicable/provided for the reasons stated above.

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 information is not applicable/provided as this is not an AI/ML device.

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

This information is not applicable/provided as this is not an AI/ML device.

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

This information is not applicable/provided for the reasons stated above. The "ground truth" for a physical device is its adherence to engineering specifications, material properties, and functional performance criteria.

8. The sample size for the training set:

This information is not applicable/provided as this is not an AI/ML device.

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

This information is not applicable/provided as this is not an AI/ML device.

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