(62 days)
Churchill Medical Systems Stopcock is a valve for use in I.V. therapy and pressure monitoring to direct and control the flow of medical fluids.
The Churchill Medical Systems 4 way stopcock consist of a housing with two one male luer with rotating lock ring. The diversion handle opens or closes each port.
The provided text describes a 510(k) summary for the Churchill Medical Systems 4 Way Stopcock. This document is a premarket notification for a medical device and does not detail a study proving specific acceptance criteria in the way a clinical trial or performance study for an AI/ML medical device would. Instead, it focuses on demonstrating substantial equivalence to a predicate device through physical, chemical, and biological specifications and internal performance testing, rather than an AI model's performance.
Therefore, many of the requested sections about AI/ML device performance, such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this type of device submission.
However, I can extract the relevant information from the provided text regarding the closest equivalents to "acceptance criteria" and "device performance" as presented in this 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What the device was tested against) | Reported Device Performance (How the device met the criteria) |
|---|---|
| Conformance to applicable requirements set forth in ISO 10993 (Biological Evaluation of Medical Devices) | Device is manufactured and tested in accordance with biological specification conforming to ISO 10993. |
| Conformance to applicable requirements set forth in USP XXII (United States Pharmacopeia) | Device is manufactured and tested in accordance with chemical specification conforming to USP XXII. |
| Conformance to applicable requirements set forth in ISO 11607-1 (Packaging for terminally sterilized medical devices) | Device is manufactured and tested in accordance with physical specification conforming to ISO 11607-1. |
| Conformance to applicable requirements set forth in ISO 11135 (Sterilization of health care products - Ethylene oxide) | Device is manufactured and tested in accordance with physical specification conforming to ISO 11135. |
| Conformance to USP Pyrogenicity test requirements | Device is manufactured and tested in accordance with USP Pyrogenicity test requirements. |
| Conformance to documented internal requirements for physical testing | Device is manufactured and tested in accordance with documented internal requirements for physical testing. |
| Performance similar to predicate device (Ohmeda Connecta Plus 1 and Plus 3, 2 and 3 way stopcocks - K974083) | "Testing summary results confirm this device to be safe and effective and substantially equivalent to the predicate device." |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is the sum of various tests conducted by Churchill Medical Systems, Inc. in accordance with established international and national standards and internal protocols.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in the provided text. The submission mentions "testing summary results" and conformance to various standards, implying that samples were tested to demonstrate compliance, but specific quantities are not provided.
- Data Provenance: Not specified. The testing was conducted internally by Churchill Medical Systems, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical medical device (stopcock), not an AI/ML algorithm requiring expert ground truth for image or data interpretation. The "ground truth" here is the adherence to the specified physical, chemical, and biological performance parameters as defined by the standards (ISO, USP) and internal requirements.
4. Adjudication method for the test set:
- Not Applicable. As above, this is for a physical device, not an AI/ML algorithm interpretation. Performance is assessed against quantitative and qualitative standards.
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:
- No. This is a physical medical device (stopcock), not an AI-assisted diagnostic tool. Therefore, an MRMC study is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device. It does not involve an algorithm.
7. The type of ground truth used:
- The "ground truth" for this device's performance is compliance with established international standards (ISO), national pharmacopeia (USP), and internal validated specifications for physical properties, chemical compatibility, biological safety (e.g., cytotoxicity, sensitization, pyrogenicity), and sterility. The device is also compared to the performance characteristics of a predicate device to demonstrate substantial equivalence.
8. The sample size for the training set:
- Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. As above, a training set is not applicable for this type of device.
§ 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.