(45 days)
Elcam Stopcocks and Manifolds are indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.
Elcam Stopcocks and Manifolds are composed of a body with two or three ports and a handle. Each port has either a male or female connector. Male connectors also include a nut for locking over the female connector of another component. A small amount of lubricant is applied between the stopcock body and handle. Elcam Stopcocks and Manifolds will be available in a wide variety of configurations for use according to the particular situation and the clinician's preference.
This document is a 510(k) summary for Elcam Stopcocks and Manifolds, a medical device. It describes the device, its intended use, and its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Device Performance
The provided document does not explicitly state specific quantitative acceptance criteria for the Elcam Stopcocks and Manifolds device. Instead, it relies on demonstrating substantial equivalence to a predicate device and satisfactory results from standard performance and biocompatibility testing. Since no explicit numerical criteria are offered, a table cannot be constructed with "reported device performance" against those criteria.
However, we can infer the general acceptance conditions from the information provided:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Elcam Stopcocks and Manifolds are "substantially equivalent to Elcam/RAM Development stopcocks, 510(k) No. K862691." Both have the same indications for use and basic shape using luer fittings. The new device has additional materials, is available sterile, and has a wider range of inner diameters. The FDA concurred with this assessment in the substantial equivalence determination letter. |
| Function and Stress-Testing (e.g., flow control, durability) | "Standard testing relating to function and stress-testing has been conducted on Elcam Stopcocks and Manifolds, including testing related to product label claims and testing comparing performance with existing products or materials." The results are described as satisfactory, implying they met the implicit expectations for these tests. |
| Biocompatibility | "A biocompatibility assessment was performed on the patient-contact and fluid-path materials of Elcam Stopcocks and Manifolds with satisfactory results." This indicates the materials are safe for their intended contact with patients and fluids. |
| Compliance with General Controls | The FDA letter states the device must comply with "general controls provisions of the Act," including annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. While not part of a specific performance study, compliance with these regulations is a critical aspect of device acceptance and market authorization. |
Study Details
Based on the provided text, the following information can be extracted regarding any "study" conducted:
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Sample size used for the test set and the data provenance:
- Sample size: Not specified. The document uses phrases like "Standard testing" and "A biocompatibility assessment was performed," but does not provide any numerical sample sizes for these tests (e.g., number of stopcocks tested, number of material samples).
- Data provenance: Not explicitly stated. The manufacturer is Elcam Plastic Kibbutz BarAm Merom Hagalil 13860 Israel. The testing was conducted as part of their submission to the US FDA. The nature of the testing (bench, in-vitro, etc.) is implied rather than explicitly detailed as retrospective or prospective clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. For mechanical devices like stopcocks and manifolds, "ground truth" is typically established by engineering specifications, validated test methods, and industry standards, rather than expert clinical consensus in the way it would be for diagnostic algorithms. The "satisfactory results" mentioned for performance and biocompatibility testing imply that the results met predefined engineering and safety standards, but no expert panel is detailed.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth for diagnostic imaging algorithms where there's subjectivity. For performance and biocompatibility testing of a simple medical device, results are usually objectively measured against predefined criteria.
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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, an MRMC study was not done. This type of study is relevant for diagnostic imaging or AI-assisted interpretation, which is not the nature of this device (stopcocks and manifolds for fluid control).
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a manual, mechanical component. There is no algorithm involved.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For performance testing: Ground truth would be defined by engineering specifications, established industry standards (e.g., for luer fittings, pressure resistance, flow rates), and regulatory requirements for fluid administration devices.
- For biocompatibility: Ground truth would be established by validated toxicology and material safety standards (e.g., ISO 10993 series).
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The sample size for the training set:
- Not applicable. This is a mechanical device, not an AI/machine learning algorithm, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable, as there is no training set 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.