(272 days)
This device provides additional access ports into a standard angiographic fluid delivery system and can be used in conjunction with syringes and other accessories where angiographic injection is indicated. This product's medium/high nressure designation does not preclude its use for low pressure modalities.
The SDM Angiographic Manifold consist of one or more stopcocks, where the multiple stopcock configurations are connected in line to form a manifold, with some models of each also having a high pressure extension line attached. These devices have bodies made of nolvearbonate and handle plugs made of polyethylene. The plugs are lightlv siliconized for smooth rotation. Each of the devices will be supplied single packaged and sterile. Packaging will consist of a standard Tyvek/Poly pouch.
This document describes a 510(k) premarket notification for the "SDM Angiographic Manifold with Extension Lines," a medical device. As such, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of AI/ML or diagnostic performance.
510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device rather than conducting de novo clinical trials to establish acceptance criteria for performance metrics in the way often associated with AI/ML devices (e.g., sensitivity, specificity).
Therefore, I cannot provide the requested information for the following reasons:
The document does not:
- Define "acceptance criteria" related to device performance in a quantified way (e.g., sensitivity, specificity, accuracy).
- Describe a "study that proves the device meets the acceptance criteria" in terms of clinical outcomes or diagnostic performance.
- Mention any AI or machine learning components.
- Discuss sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.
Instead, the document focuses on:
- Substantial Equivalence: Comparing the device to existing predicate devices in terms of intended use, materials, and design.
- Biocompatibility Evaluation: Stating that materials are generically the same as predicate devices and that testing showed biocompatibility per ISO Standard 10993, Part I.
Conclusion:
The provided document is a 510(k) summary for a physical medical device (angiographic manifold) seeking to demonstrate substantial equivalence, not a performance study for an AI-powered diagnostic tool. Therefore, the requested information elements (acceptance criteria table, sample sizes, expert details, etc.) are not applicable or present in this context.
§ 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.