(84 days)
Accessory device used to allow pressurized fluid flow in one direction and stop, or check flow in the opposite direction.
The Churchill Medical Systems Pressure Activated Check Valve consists of acrylic-polycarbonate alloy valve body and a silicone valve with male and female luer lock connections. The device opens at cracking pressures of greater than 3.5 PSI +/- 1 PSI and prevents back flow.
The provided text describes a 510(k) summary for a medical device called a "Pressure Activated Check Valve," but it does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the way typically expected for an AI/ML device.
This document is a premarket notification for a Class II medical device (a check valve accessory) and focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing detailed performance studies and acceptance criteria for a novel technology or AI algorithm.
Therefore, many of the requested categories for AI/ML device evaluations are not applicable or cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Not Explicitly Stated as AC) | Reported Device Performance (from "Device Description") |
|---|---|
| Device opens at a specific cracking pressure | Device opens at cracking pressures of greater than 3.5 PSI +/- 1 PSI |
| Prevents backflow | Prevents backflow |
| Conforms to applicable requirements set forth in ISO 10993, USPXX111, ISO 11607-1, ISO 11135, USP Pyrogenicity test requirements, and documented internal requirements for physical testing. | (Performance specifically to these standards is not detailed in the summary, but the device is stated to be tested in accordance with them.) |
Explanation: The document does not explicitly list "acceptance criteria" for performance. Instead, it describes the functional specifications of the device (cracking pressure, preventing backflow) as part of its description and states that it was tested "in accordance with" various physical, chemical, and biological specifications and standards.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not applicable/specified. The testing mentioned refers to physical, chemical, and biological specification testing of the device itself, not data used for an AI/ML model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable. The device is a mechanical check valve, not an AI/ML algorithm requiring expert-established ground truth from a test set (e.g., medical images).
4. Adjudication method for the test set:
- This is not applicable as there is no mention of a test set requiring adjudication by experts.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is not applicable. The device is a mechanical check valve, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- This is not applicable. The "ground truth" for a mechanical device would be its physical properties and functional performance against engineering specifications and relevant standards.
8. The sample size for the training set:
- This is not applicable. There is no AI/ML model for which a training set would be used.
9. How the ground truth for the training set was established:
- This is not applicable. There is no AI/ML model or training set.
Summary of the Study (Based on the Provided Text):
The "study" or performance evaluation described in the K011888 summary is a demonstration of substantial equivalence to a predicate device (KVQ Check Valve Accessory, K98441). This involves:
- Performance Summary: Stating that the device is manufactured and tested in accordance with physical, chemical, and biological specifications conforming to ISO 10993, USPXX111, ISO 11607-1, ISO 11135, USP Pyrogenicity test requirements, as well as documented internal requirements for physical testing.
- Conclusion: The device shares similar technical characteristics with existing check valves and "performs similarly to the predicate device." The summary results "confirm this device to be safe and effective and substantially equivalent to the predicate device."
This type of submission for a physical, mechanical medical device focuses on meeting established standards and demonstrating similarity to already approved devices, rather than an AI/ML-specific validation process.
§ 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.