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The Stryker AntiMic Catheter Kit is intended to provide continuous or intermittent delivery of medication (such as local anesthetics) to or around surgical wound sites for preoperative, perioperative, and postoperative pain management. The Stryker AntiMic Catheter Kit is contraindicated for the epidural space and in neonatal populations.

The Stryker AntiMic Catheter Kit contains an anti-microbial agent which may destroy or inhibit the growth of microorganisms on both the inner and outer surfaces of the catheter. The antimicrobial agent is intended to reduce the possibility that the catheter may become microbially compromised. The antimicrobial agent is not intended to be used as a treatment for existing infections.

The Stryker AntiMic catheter is intended to be used with the Stryker Pain Pump Systems. Catheters are available in the following sizes: Standard; and 2.5", 5.0", and 10" Extended Fenestration. The Standard catheter has a closed tip with three holes arranged radially along the lateral surface at the distal end of the device. The Extended Fenestration catheters have a closed tip with multiple holes arranged radially along the lateral surface at the distal end of the device.

The catheter contains an antimicrobial agent that is intended to inhibit the growth of microorganisms and reduce the possibility of the catheter becoming microbially compromised.

The provided 510(k) summary for the Stryker AntiMic Catheter Kit does not contain the detailed information necessary to complete the requested table and study information.

This document focuses on establishing substantial equivalence to predicate devices rather than presenting performance data from a specific study against predefined acceptance criteria. Clinical trial or performance data, sample sizes, expert qualifications, and ground truth methodologies are typically found in more comprehensive study reports or regulatory submissions, which are not part of this 510(k) summary.

Therefore, I cannot provide the requested information from the given text.

Explanation of limitations based on the provided document:

• No acceptance criteria or reported device performance: The document declares substantial equivalence based on similar intended use and technological characteristics to predicate devices. It does not define specific acceptance criteria (e.g., a certain percentage reduction in infection, a specific tensile strength) or provide numerical performance data for the Stryker AntiMic Catheter.
• No sample sizes, data provenance, expert information, adjudication methods, or MRMC studies: These details are relevant for studies specifically designed to demonstrate safety and effectiveness or to compare performance, which are not presented in this 510(k) summary. The summary simply states that "performance characteristics" are similar to predicate devices, implying that any underlying data would have been part of the predicate device's approvals or internal testing by Stryker, but no such data is included here.
• No standalone algorithm performance or ground truth type: This device is a physical medical catheter, not an AI or algorithmic device. Therefore, the concepts of "standalone algorithm performance," "training set," and "ground truth" (in the context of clinical decision-making or diagnostic AI) do not apply to this submission.
• No training set information: As it's not an AI/algorithm-based device, there is no training set mentioned.

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