(119 days)
The Smart Label for Propofol is intended for controlled rate delivery of small volume parenteral fluids when used with the InfusO.R. Pump. The Smart Label is intended for use with Propofol as indicated on the label at the specified concentration for delivery using the syringe size also indicated on the Smart Label.
AlV's Smart Label for Propofol is a replacement for the Smart Label manufactured by the Original Equipment Manufacturers (OEM) for the InfusO.R. pump. AIV does not manufacture the pump. The Smart Label for Propofol is an accessory for the pump and is also available as a replacement part.
The AIV Smart Label for Propofol uses the same type of construction and has the same technological characteristics as the predicate device - the accessory supplied with the InfusO.R. pump. This device is not a kit and does not contain any electronic components. Construction of this device is substantially equivalent to the predicate device.
AIV Smart Label for Propofol is not intended to make contact with the patient.
The AIV Smart Label for Propofol is limited by the indications for use of the InfusO.R. pump.
The provided document, K142333, describes the AIV Smart Label for Propofol, an accessory for the InfusO.R. pump, and its substantial equivalence to a predicate device. The document primarily focuses on non-clinical testing to demonstrate performance.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a formal table of "acceptance criteria." However, based on the non-clinical testing performed and the claims of substantial equivalence, the implicit performance criteria and reported outcomes are:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Verification Testing: | |
| Construction Consistency | Construction, material selection, content, and operation are consistent with technical specifications. Construction is substantially equivalent to the predicate device. |
| Proper Label Recognition by Pump | Proper recognition of the label by the pump was verified. The pump adjusts the delivery rate per the applied label and rotary switches. The pump will produce an error message if the label is not recognized, failing to a safe state. |
| Storage and Cleaning Tests: | |
| Maintain Operation After Cleaning | The devices were subjected to repeated cleaning cycles, and operation remained consistent with technical specifications (legibility to user and proper recognition by the pump). |
| Maintain Operation After Storage | Devices were subjected to storage environmental limits, and operation remained consistent with technical specifications (legibility to user and proper recognition by the pump). The "Analysis of Weak or Missing Magnet" report details findings related to label recognition if magnets weaken. |
| Performance Testing: | |
| Proper Recognition & Delivery | A test protocol was developed to confirm proper recognition and delivery dosage consistent with the predicate device and the technical specifications of the InfusO.R. pump. The accuracy of measurement (delivery dosage) is a function of the InfusO.R. pump once proper label content and detection are established. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for the test set (number of Smart Labels tested). It generally refers to "devices" being subjected to various tests.
- Data Provenance: The testing was performed by AIV at their facility in Harmans, MD, USA. The data is prospective, generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish ground truth in the context of clinical or interpretative assessment. The "ground truth" for this device (a magnetic label accessory) primarily relates to its physical properties, functionality (pump recognition), and legibility for the user. These aspects were validated through engineering tests performed by AIV personnel.
4. Adjudication Method for the Test Set
Not applicable. The testing described is primarily functional and physical validation by engineering personnel, not an interpretative assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a simple mechanical/magnetic accessory for an infusion pump, not an AI-powered diagnostic or interpretative tool that would involve human readers or MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not an algorithm, nor does it have an "algorithm only" performance. Its function is to interface with the InfusO.R. pump and guide the human user.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical testing was based on:
- Technical Specifications: Conformance to pre-defined engineering and design requirements for the label's construction, material, content, and magnetic coding.
- Predicate Device Performance: The AIV Smart Label's performance (such as pump recognition and legibility after cleaning/storage) was compared to the expected performance of an "substantially equivalent" accessory, implying the predicate device's established functionality serves as a reference.
- InfusO.R. Pump Specifications: The performance (delivery accuracy) after label recognition is attributed to the host InfusO.R. pump, implying the pump's validated specifications form part of the "ground truth" for the overall system's function.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML product and does not involve a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).