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The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to hazardous drugs.

The ChemoCLAVE® Cytotoxic Medication Preparation and Delivery System devices are sterile, single use CSTDs, which prohibit the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system. The Spiros and ChemoClave components comprise the primary components of the ChemoClave CSTD System, which connect to form a closed fluid path for transfer of hazardous medications. The devices which include the ChemoClave component are vial access devices, bag access devices, adapters, and administration sets. The devices which include the mating Spiros component are syringes, adapters, and administration sets. The Spiros and the ChemoClave will each independently self-seal when they are disconnected from one another.

The provided text describes the ChemoCLAVE Cytotoxic Medication Preparation and Delivery System and its substantial equivalence to a predicate device. However, the document does not contain information about the acceptance criteria for an AI/ML powered device, nor does it detail a study that proves a device meets such criteria.

The context of the document is a 510(k) premarket notification for a medical device (ChemoCLAVE Cytotoxic Medication Preparation and Delivery System) that is not an AI/ML powered device. The "acceptance criteria" discussed in the document refer to the performance of this physical medical device in functional and performance tests like microbial ingress testing, emission testing, hazardous drug exposure testing, and sterility validation, to demonstrate substantial equivalence to an existing predicate device.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/ML powered device meets those criteria based on the given text. The provided text is about a traditional medical device, not an AI/ML system.

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The ChemoCLAVE Cytotoxic Medication Preparation and Delivery System consists of 6 previously cleared components (CLAVE®, Spikes, SPIROS™, GENIE™, Vial Access, and Admin Sets) that can be combined into various configurations intended for use in the preparation and patient administration of cytotoxic medications.

The ChemoCLAVE Cytotoxic Medication Preparation and Delivery System is a combination of ICU Medical's products and tested for compatibility with lipids and/or cytotoxic agents. The "System" part is where these devices are packaged individually or sold together as a custom set upon order of the physician for the purpose of enabling the user a safe and inexpensive alternative to other passively closed systems.

The provided text describes a 510(k) submission for the ChemoCLAVE® Cytotoxic Medication Preparation and Delivery System. However, it does not contain information about acceptance criteria, the specific studies performed to prove those criteria were met, sample sizes, expert involvement, or ground truth establishment in the way typically associated with AI/ML device performance studies.

This document is a regulatory submission for a combination of existing, cleared medical devices (hardware components) rather than for a new AI/ML-driven diagnostic or treatment device. Therefore, the questions related to AI/ML device performance metrics (such as sensitivity, specificity, MRMC studies, training set details, etc.) are not applicable to this submission.

The "Safety and Performance" section states: "ICU Medical conforms to international standards in the design, development, and manufacturing of all of their unique disposable medical devices. Additionally, ICU Medical's Sterility Assurance Level, (SAL) has an established and validated history of meeting a 10⁻⁶ level." This indicates adherence to manufacturing quality and sterilization standards, which are different from performance metrics for an AI algorithm.

The core of this 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting novel performance study data for a new technology with specific acceptance criteria that would require a study design with sample sizes, expert ground truth, etc. It states, "The materials, performance, and operational features of both the submitted device and the predicate device are substantially equivalent and are safe and effective for their intended use."

Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria and study details for an AI/ML device using the provided text. The document does not contain that type of information.

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