(198 days)
For the administration of anesthetic agents into the epidural space. B. Braun recommends that the epidural catheter be removed or replaced every 72 hours.
B. Braun Medical Inc. intends to introduce into interstate commerce the Soft Tip Epidural Catheter Kit. These have the same design, components, and performance characteristics as the catheters currently marketed by B. Braun Medical and covered under K813186 for the Perifix Set. The intended use is for the repeated administration of anesthetic agents into the epidural space. The only difference is the soft tip of the catheter. Soft tip epidural catheters are less traumatic and reduce the incidence of catheter induced paresthesias.
The provided text is a 510(k) summary for a medical device (Soft Tip Epidural Catheter Kit) seeking substantial equivalence to existing devices. It does not describe a study involving acceptance criteria and device performance in the context of AI or diagnostic algorithms. Instead, it focuses on demonstrating that the new device is as safe and effective as previously cleared predicate devices through material equivalence, design similarity, and standard quality control testing for manufacturing release.
Therefore, I cannot provide the requested information about acceptance criteria for device performance, especially those related to AI model evaluation, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance.
The document discusses:
- Device Description: The Soft Tip Epidural Catheter Kit has the same design, components, and performance characteristics as the predicate device (Perifix Set - K813186) with the only difference being a "soft tip" which is claimed to be less traumatic and reduce catheter-induced paresthesias. It also references another predicate (Arrow's Flex Tip Plus - K801912).
- Material Biocompatibility: B. Braun Medical certifies that biocompatibility tests, as recommended in Tripartite Guidance, will be completed for all materials.
- Safety and Effectiveness: "All finished products are tested and must meet all required release specifications before distribution." These tests include sterility, pyrogenicity, physical testing, and visual examination. Physical testing is defined by Quality Control Test Procedure documents that conform to product design specifications.
- Intended Use: For the repeated administration of anesthetic agents into the epidural space.
The document does not contain information about:
- Specific acceptance criteria for device performance beyond general "required release specifications" or "product design specifications."
- A study proving the device meets these criteria in terms of clinical outcomes or comparative performance against a predefined benchmark, other than demonstrating substantial equivalence to predicates.
- Any details about AI or diagnostic algorithms.
- Sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
- Training set information.
In summary, the provided text is a regulatory submission for substantial equivalence based on manufacturing and material similarity to predicate devices, not a study evaluating performance against specific acceptance criteria for AI or diagnostic effectiveness.
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).