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The Xtractor™ device is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters, and foreign objects.

The Xtractor™ device is a single use sterilized device designed to be advanced through the veins over a cardiac pacemaker/defibrillator lead. The device is a motor driven mechanical tool that is introduced over the lead and follows its path, using a flexible and steerable shaft connected to a control handle. The proximal section of the shaft maintains pushability while the distal section is very flexible, to facilitate easy passage through vein curves and junctions. The device' distal tip is designed to facilitate dilation of fibrous binding tissue and passage through calcified binding sites along the implanted lead (for example by use of combined rotational and impact movements). The device' control handle, which is connected to the shaft, contains a steering mechanism for assisting the device maneuverability, and a motorized power transmission mechanism to activate the device tip. The Xtractor™ device is visible under fluoroscopy during the procedure.

The provided document does not contain information about the acceptance criteria and study that proves the device meets them as typically presented for AI/ML-driven medical devices.

The document is a 510(k) premarket notification for the Xtractor™ device, which is a mechanical device for lead extraction, not an AI/ML diagnostic or prognostic tool. Therefore, it does not include details such as:

• A table of acceptance criteria and reported device performance related to diagnostic accuracy (e.g., sensitivity, specificity, AUC).
• Sample sizes for test sets used for diagnostic accuracy, data provenance, or the number/qualifications of experts for ground truth.
• Adjudication methods for ground truth.
• Results from multi-reader, multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth (pathology, outcomes data, etc.) for diagnostic accuracy.
• Training set sample size or ground truth establishment for a machine learning model.

Instead, the performance data section focuses on standard medical device testing for a physical device, including:

• Biocompatibility: Tests like cytotoxicity, irritation, sensitization, systemic toxicity, complement activation, hemolysis, and pyrogenicity per ISO 10993-1.
• Sterilization, Packaging, and Shelf Life Testing: Validation per ISO 11135-1, transportation simulation, and environmental tests.
• Performance Testing (Mechanical/Physical):
  • Bending Test
  • Corrosion Resistance (ASTM A967/A967M)
  • Device Radiopacity
  • Dimensional Verification
  • Tensile Strength
  • Extended Use
  • Torque Test
  • Simulated Use (in an anatomical model simulator at T0 and Tx shelf life)
  • Hydrophilic Coating Testing (particles, visual, pinch test)
  • Xtractor™ vs. Predicate comparison test
• Software Validation: Conducted as per FDA guidance for contained software, with a moderate level of concern.
• Electrical Safety and EMC: Per IEC 60601-1 and IEC 60601-1-2.

The document states that "All tests passed and met the predefined acceptance criteria," but it does not explicitly list these criteria in a table alongside reported performance for each test. The predefined acceptance criteria would be specific thresholds or results required for each of the performance tests listed above (e.g., "no signs of defects, wear or deformations" for extended use, or specific values for tensile strength, etc.). An "Xtractor™ vs. Predicate comparison test" is mentioned, indicating a direct comparison was likely part of the performance evaluation.

In summary, the provided text details the type of non-clinical performance studies conducted for a mechanical medical device to demonstrate safety and effectiveness for 510(k) clearance, rather than the kind of AI/ML evaluation typically requested in the prompt.

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