(77 days)
The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
The C2000 Automated Manifold Assembly Kit is the disposable patient contact intravenous tubing that attaches to Part A via a connector. This kit is contains the patient manifold, saline spike, 3-way pressure stopcock, high pressure line, and a syringe cap. This kit is designed to be connected to the users own pressure monitoring equipment to measure homodynamic waveform.
The provided text describes a 510(k) premarket notification for the "C2000 Automated Kit Assembly" (later referred to as "C2000 Automated Manifold Kit") manufactured by ACIST Medical Systems, Inc. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a novel device that requires extensive clinical studies with new acceptance criteria.
Therefore, the document does not contain the information requested in the prompt, as the submission method (510(k)) relies on demonstrating similarity to an already approved device rather than establishing new performance criteria through dedicated studies.
Specifically:
- A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on comparing the new device's characteristics (materials, design, operating principle, etc.) to the predicate device, not on meeting specific, de novo clinical performance criteria.
- Sample size used for the test set and the data provenance: Not provided. No specific test set or clinical study data proving performance against acceptance criteria is included.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth is mentioned.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this type of study is not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a component of an angiographic injection system, not an algorithm.
- The type of ground truth used: Not applicable, as no ground truth establishment is described for performance evaluation.
- The sample size for the training set: Not applicable. This device is hardware; there's no mention of a "training set" in the context of an algorithm.
- How the ground truth for the training set was established: Not applicable.
Summary of the document's approach:
The submission leverages the "substantial equivalence" pathway, meaning the manufacturer aims to show that their new device is as safe and effective as a legally marketed predicate device (ACIST Angiographic Contrast Management System cleared under K984231). The key arguments for substantial equivalence are based on:
- Identical Indications for Use: "The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures."
- Similarities in Design and Function: The subject device and predicate device have "The same operating principle; The same basic design; materials; The same manufacturing environment; The same sterilization process; and The same packaging configurations."
The FDA's letter confirms that they "determined the device is substantially equivalent...to legally marketed predicate devices." This determination is based on the comparison provided by ACIST Medical Systems, Inc., rather than new, independent clinical performance studies with specific acceptance criteria as would be typical for de novo device approvals or algorithm-based devices.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.