(203 days)
For the administration of fluids from a container into the patient's epidural space with Baxter infusion pumps.
The Solution Set for Epidural Use is a single use disposable device intended for the administration of fluids from a container into the epidural space. The set is used for epidural infusions of fluids (typically analgesic or anesthetic) as an intermittent or continuous infusion to reduce chronic or post-operative pain. The set consists of a nonvented spike, 60 drops per mL drip chamber, minidrip adapter, tubing, fixtured slide clamp, on-off roller clamp, and a male epidural lock connector. The connector is compliant to the provisional AAMI/CN6:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications.
The provided text describes the Baxter Healthcare Corporation's "Solution Set for Epidural Use" (K161323) and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.
The document is a 510(k) premarket notification for a traditional medical device (an epidural IV administration set), not an AI/ML device. Therefore, the questions regarding AI/ML device performance, sample sizes for training/test sets, ground truth establishment by experts, and MRMC studies are not applicable to this document.
The document focuses on:
- Substantial equivalence to an existing predicate device (Bard Epidural Spike Tubing Set, K925058).
- Nonclinical bench testing to evaluate functional performance (e.g., Drop Volume Test, Cannula Pull Out Test, Pump Tests).
- Biocompatibility testing (e.g., Cytotoxicity, Systemic Toxicity).
- Sterility testing.
- Shelf-life testing.
All these tests are reported to have "met the acceptance criteria," but the specific numerical acceptance criteria and the detailed results are not provided in this summary.
Therefore, I cannot fulfill your request using the provided text because it does not pertain to an AI/ML device and lacks the specific details about acceptance criteria and study results in the format you requested for an AI/ML model.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.