(34 days)
The Alcyone MEMS Cannula (AMC) System consisting of the AMC and the AMC Extension Line Set. is intended for iniection of Cytarabine (cytosine arabinoside) or removal of cerebrospinal fluid (CSF) from the ventricles of the brain during intracranial procedures. The AMC System is not intended for implant. The device is intended for "single patient use only."
The AMC System is comprised of the AMC and its Extension Line sets. The AMC is a rigid cannula comprised of two independent channels. The fluid lumens are protected inside a 25cm rigid ceramic cannula. which transitions (steps-down) to a micro-tip. The micro-tip has two independent outlets at the tip that face sideways, designed to prevent plugging during insertion into the brain. The proximal end of the rigid cannula consists of a Y-connector with standard female luers that allow connection to each independent channel. AMC Extension Line Sets with standard male/female luers must be used with the AMC to connect the AMC to an infusion pump. The AMC must be used with a support structure (e.g. a stereotactic quide) to provide support and control during insertion. A safety-sheath, as with the predicate, and depth-stop, for user convenience, are provided on the AMC for this purpose.
This document is a 510(k) premarket notification for the Alcyone MEMS Cannula (AMC) System, aiming to demonstrate its substantial equivalence to a predicate device. It is a regulatory submission, not a study report per se, and as such, it focuses on demonstrating equivalence rather than establishing novel acceptance criteria or conducting a traditional clinical study with defined endpoints for performance metrics like sensitivity/specificity.
Therefore, many of the requested categories (acceptance criteria performance, sample size for test set with data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, how ground truth for training set was established) are not directly applicable or explicitly stated in the context of an AI/ML-driven device evaluation. This document is for a medical device (cannula) and its evaluation is based on engineering and preclinical testing.
However, I can extract information related to the device's characteristics and the tests performed to demonstrate its safety and performance equivalence to a predicate device. I will adapt the requested table and sections to best fit the available information.
1. Table of Acceptance Criteria (as implied by equivalence to predicate) and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical study (e.g., specific clinical performance thresholds like sensitivity/specificity for a diagnostic AI). Instead, it demonstrates that the AMC System's performance characteristics are equivalent to or meet the requirements for its intended use, similar to the predicate device. The "acceptance criteria" are implied by successful completion of various engineering, biocompatibility, and functional tests, and by demonstrating substantial equivalence to the predicate.
| Characteristic / Test | Implied Acceptance Criteria (Equivalence/Performance Requirement) | Reported Device Performance and Discussion |
|---|---|---|
| Indications for Use / Intended Use | Equivalent to predicate device. Intended for injection of Cytarabine or removal of CSF from ventricles, not for implant, single patient use. | Equivalent to Predicate. The AMC System has the same intended use. |
| Classification & Product Code | Equivalent to predicate device (Class I, HCD, 21 CFR 882.4060). | Equivalent to Predicate. |
| Leak Pressure Testing | Withstand pressure spikes with no leaks. | Passed. AMC and Extension line systems withstood pressure spikes with no leaks. |
| Infusion Flow Testing | Reach specified flow rate within specified time, capable of injecting fluid at maximum flow rate. (Target: 3.0mL/hr. (1.5mL/hr. per channel) at |
§ 882.4060 Ventricular cannula.
(a)
Identification. A ventricular cannula is a device used to puncture the ventricles of the brain for aspiration or for injection. This device is frequently referred to as a ventricular needle.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.