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The Vygon LIFECATH S PICC and Midline catheters are intended for use in patients who require mid-long term IV therapy. It may be used to administer hyperalimentation antibiotics, chemotherapy, drugs for pain management or intravenous fluid.

The Lifecath S peripherally inserted central catheters and midline catheters are fabricated of barium impregnated silicone elastomer. The catheters are supplied with a guidewire to aid in insertion. The 60 cm PICC is available as a 2Fr, 3Fr, 4Fr, and 5Fr single lumen catheter, and 4Fr, 5Fr and 6Fr catheter. The 20 cm midline catheter is available as a 2Fr, 3Fr, 4Fr, and 5Fr single lumen catheter, and 4Fr, 5Fr and 6Fr catheter. Both catheters have a fixation hub and an extravascular extension line. The catheters are marked every centimeter from the hub to the proximal tip. The fixation hub is marked with the catheter French size, and the extension lines are marked with the gauge size. A clamp is attached to each extension line, and is marked with the priming volume.

This FDA 510(k) submission (K062425) does not describe a study related to a software or AI/ML-driven medical device. Instead, it concerns the Vygon Lifecath S PICC and Midline catheters, which are physical medical devices.

Therefore, most of the requested information about acceptance criteria, study details, expert involvement, MRMC studies, standalone performance, training sets, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable to this submission.

The document indicates that the device met acceptance criteria by demonstrating "substantial equivalence" to predicate devices through:

1. Biocompatibility data: Showing materials are non-irritant and non-toxic.
2. Performance testing: Demonstrating that the device performs similarly to predicate devices.
3. Risk Assessment: Conducted in compliance with ISO 14971.

The conclusion states that based on these activities, the Lifecath S is substantially equivalent to the predicate devices and is safe and effective for its intended use.

Summary of inapplicable AI/ML-specific criteria:

• Table of acceptance criteria and reported device performance (for AI/ML): Not applicable, as this is a physical medical device. The "performance" here refers to physical characteristics and biocompatibility, not AI model metrics.
• Sample size and data provenance (for AI/ML test set): Not applicable.
• Number of experts and qualifications (for AI/ML ground truth): Not applicable.
• Adjudication method (for AI/ML test set): Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone performance (AI algorithm only): Not applicable.
• Type of ground truth (for AI/ML): Not applicable.
• Sample size for training set (for AI/ML): Not applicable.
• How ground truth for training set was established (for AI/ML): Not applicable.

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