(210 days)
ClearLine IV™ is intended for detection and automatic removal of air in intravenous (IV) lines during administration of IV solutions, blood, and blood products. It is indicated for use in critical care areas such as the operating room (OR), postanesthesia care unit (PACU), and intensive care unit (ICU). ClearLine IV™ is placed between the patient and the V source and can be used with or without fluid warmers.
The ClearLine IV™ is a modification to the predecessor device, the AirPurge™ System. Both devices consist of two main components, the control unit and the sterile, single-use disposable cartridge. The control unit is mounted to the I.V. pole using a pole clamp attached to the back of the control unit. The disposable cartridge is loaded onto the control unit and connected to the infusion line between the infusion source and the patient. During infusion, air entering the cartridge will be detected by an ultrasonic sensor in the control unit, which will automatically close the patient line and divert the fluid flow containing the air to the waste collection bag. A second ultrasonic sensor in the control unit monitors the line to the waste collection bag. When both sensors detect liquid again, flow to the patient is resumed.
The provided text describes a 510(k) premarket notification for a medical device called ClearLine IV™, an automated air removal system for IV lines. It focuses on demonstrating the device's substantial equivalence to a predicate device (AirPurge™ System) through non-clinical testing.
However, the document does not contain information related to a study that proves the device meets acceptance criteria through the analysis of "reported device performance" in the context of an AI/ML-based medical device evaluating images or data with human experts.
The "acceptance criteria" and "device performance" described in the document relate to functional requirements of a mechanical/electronic device (e.g., air sensor response time, minimal detectable air volume, flow rates, software functions, electrical safety, biocompatibility, sterilization validation, package integrity, and human factors).
Therefore, it's not possible to extract the requested information (table of acceptance criteria with reported device performance for an AI/ML output, sample sizes for test/training sets in an AI/ML context, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, type of ground truth used for AI, etc.) from the provided text.
The document explicitly states under "J. Clinical Testing": "Clinical testing was not required to support this 510(k)." This further indicates that the device's validation did not involve studies with human subjects or expert readers interpreting data in a clinical performance setting as would be expected for an AI/ML medical device.
In summary, the provided text does not contain the information necessary to describe an AI/ML device's acceptance criteria and the study that proves it meets those criteria in the manner requested by the prompt.
§ 880.5445 Intravascular administration set, automated air removal system.
(a)
Identification. An intravascular administration set, automated air removal system, is a prescription device used to detect and automatically remove air from an intravascular administration set with minimal to no interruption in the flow of the intravascular fluid. The device may include an air identification mechanism, software, an air removal mechanism, tubing, apparatus to collect removed air, and safety control mechanisms to address hazardous situations.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Provide an argument demonstrating that all reasonably foreseeable hazards have been adequately addressed with respect to the persons for whose use the device is represented or intended and the conditions of use for the device, which includes the following:
(i) Description of the device indications for use, design, and technology, use environments, and users in sufficient detail to determine that the device complies with all special controls.
(ii) Demonstrate that controls are implemented to address device system hazards and their causes.
(iii) Include a justification supporting the acceptability criteria for each hazard control.
(iv) A traceability analysis demonstrating that all credible hazards have at least one corresponding control and that all controls have been verified and validated in the final device design.
(2) Appropriate software verification, validation, and hazard analysis must be performed.
(3) The device parts that directly or indirectly contact the patient must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility of fluid path contacting components and the shelf life of these components.
(5) The device must be designed and tested for electrical safety and electromagnetic compatibility (EMC).
(6) Nonclinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Device system and component reliability testing must be conducted.
(ii) Fluid ingress protection testing must be conducted.
(iii) Testing of safety controls must be performed to demonstrate adequate mitigation of hazardous situations, including sensor failure, flow control failure, improper device position, device malfunction, infusion delivery error, and release of air to the patient.
(7) A human factors validation study must demonstrate that use hazards are adequately addressed.
(8) The labeling must include the following:
(i) The device's air identification and removal response time.
(ii) The device's minimum air volume identification sensitivity.
(iii) The minimum and maximum flow rates at which the device is capable of reliably detecting and removing air.
(iv) Quantification of any fluid loss during device air removal operations as a function of flow rate.