(637 days)
The CADD®-Solis VIP Ambulatory Infusion Pump is indicated for intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.
PCA (patient-controlled analgesia) delivery is used for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both, such as patientcontrolled analgesia.
Continuous delivery allows the infusion of drug/fluid at a constant, programmed rate.
Intermittent delivery allows the infusion of a specific volume of drug/fluid at a regular, programmed interval.
Step delivery allows an incremental increase in infusion rate to a specified maximum infusion rate for a specified total infusion volume.
Taper delivery allows a plateau rate of infusion with the option of tapering at the beginning and/or end and has a programmable KVO rate at the end of the infusion.
The CADD™ Solis Medication Safety Software – Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD -Solis VIP Ambulatory Infusion Pump, CADD -Solis Ambulatory Infusion Pump or CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).
The CADD™ Solis Medication Safety Software -- Point of Care allows use of a computer to send therapy-based protocols developed by the CADD™-Solis Medication Safety Software - Administrator to the CADD® Solis Ambulatory Infusion Pump and CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).
The CADD®-Solis VIP Ambulatory Infusion Pump ("Solis VIP Pump") has a microprocessor and linear peristaltic pumping mechanism, similar in design to the Smiths Medical ASD, Inc. CADD®-Solis Ambulatory Infusion Pump (K072144) and CADD-Prizm® VIP Ambulatory Infusion Pump (K960826). The user activates the Solis VIP Pump via a color LCD screen and keypad user interface. Commands are issued to the microprocessor by activating the user interface. Microprocessor actions are controlled by a program, which is contained in the pump's memory.
The Solis VIP Pump consists of components, such as the user interface, sensors, communication ports, power ports, structural (housing) components, electronics, pumping mechanism, watchdog timer, pump battery and circuitry, real time clock, on-board memory, and pump log. The Solis VIP Pump exterior surface components include the pump housing, LCD lens, labels, and keypad, and the materials of construction for these components are widely used in the medical industry. The Solis VIP Pump is designed to be used with an infusion disposable, such as medication cassette reservoir.
The Solis VIP Pump provides measured drug therapy to patients in the hospital, homecare, and outpatient settings. The Solis VIP Pump is intended for therapies that require a Continuous. Intermittent. Tapering, or Step rates of infusion, and Patient Controlled Analgesia (including Clinician Bolus).
The CADD™-Solis Medication Safety Software-Administrator ("Administrator") module allows the user to create, edit, and save therapy-based protocols and pump settings within user-defined protocol libraries. The system administrator user determines user access and library editing capabilities. Other Administrator module features include barcode printing, reports, and sending and receiving pump protocol information.
The CADD™-Solis Medication Safety Software-Point of Care ("POC") module allows the user to download therapy based protocols to the Solis Pump, and Prizm Pump (software revision H or higher) and send and receive pump settings via USB connection.
The provided 510(k) summary for the CADD®-Solis VIP Ambulatory Infusion Pump and CADD™-Solis Medication Safety Software specifies performance testing and validation but does not describe an AI/algorithm-based device and therefore does not contain acceptance criteria related to AI performance, or detailed studies involving ground truth, expert consensus, or clinical outcomes that would typically be associated with AI/ML medical devices.
The document details performance testing typical for medical devices (electrical, mechanical safety, EMC, software validation, usability, biocompatibility) to demonstrate substantial equivalence to predicate devices, but lacks the specific types of studies requested in the prompt that are relevant to AI/ML device evaluation.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "All testing met pre-established specifications, and successfully demonstrated that the devices performed as intended." However, it does not provide a table with specific quantitative acceptance criteria or detailed performance metrics. It lists categories of tests performed:
| Test Category | Reported Device Performance |
|---|---|
| Electrical and mechanical safety tests | Met pre-established specifications; performed as intended. |
| Electromagnetic compatibility tests | Met pre-established specifications; performed as intended. |
| Solis VIP Pump software validation | Met pre-established specifications; performed as intended. |
| Administrator and POC software validation | Met pre-established specifications; performed as intended. |
| Usability/human factors validations | Met pre-established specifications; performed as intended. |
| Infusion disposable biocompatibility testing | Met pre-established specifications; performed as intended. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for any of the performance tests.
- Data Provenance: Not specified. The tests appear to be internal Smiths Medical ASD, Inc. verification and validation tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided. The testing described is for device functionality, safety, and software validation, not for an AI/ML algorithm requiring expert ground truth for classification or prediction tasks.
4. Adjudication method for the test set
- Not applicable and not provided.
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
- No MRMC or human-in-the-loop study involving AI is mentioned. The device is an infusion pump and associated software, not an AI diagnostic/analytic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of AI/ML algorithms. Software validation was performed, but this refers to the functional correctness of the pump's embedded software and the medication safety software, not an AI algorithm.
7. The type of ground truth used
- Not applicable for the types of tests described. The "ground truth" for these tests would be the functional requirements, safety standards (e.g., IEC 60601-1, IEC 60601-2-24), and software specifications.
8. The sample size for the training set
- Not applicable. No AI/ML training set is mentioned.
9. How the ground truth for the training set was established
- Not applicable. No AI/ML training set is mentioned.
Summary:
This 510(k) summary describes a traditional medical device (infusion pump) and its associated software. The testing performed is standard for such devices, focusing on meeting pre-established engineering specifications, software validation, usability, and compliance with general and particular safety standards. It predates the widespread regulatory focus on AI/ML in medical devices, and therefore, the requested information regarding AI-specific criteria (ground truth, expert review, training/test sets, MRMC studies) is not present in the document.
§ 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).