(25 days)
The modified SmartInfuser PainPump is intended to provide continuous delivery of a local anesthetic through a catheter inserted directly into the surgical site for postoperative pain management.
The device comprises of the following parts:
- SmartCatheter (optional) -
- SmartInfuser set with SmartReg flow regulator, T Check Valve and Multi -Bolus (regulating set)
- Compression unit (pump) -
- 500 ml infusion bag (empty) -
- Peel-off introducer(optional) -
- Wound Dressing (Medical adhesive bandage) -
- 50/60cc luer lock syringe -
- -Medication label
- Pump label
- Instructions for use
- Carrying pouch
The provided text is a 510(k) summary for the SmartInfuser PainPump™, a disposable pain management system. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed studies on AI performance or specific acceptance criteria met through rigorous clinical trials for a new, innovative device.
Therefore, the document does not contain the information requested regarding acceptance criteria related to a device's performance measured against specific metrics, nor does it describe a study proving the device meets such criteria in the context of an AI-powered system.
Specifically:
- Table of acceptance criteria and reported device performance: Not present. The document focuses on showing substantial equivalence to a predicate device.
- Sample size for test set and data provenance: No test sets are described in the context of performance metrics.
- Number of experts used to establish ground truth and qualifications: Not applicable as there is no mention of ground truth establishment for an AI system.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not present. The device is a physical pump, not an AI-assisted diagnostic tool.
- Standalone (algorithm only) performance study: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
The document states that the modified SmartInfuser PainPump™ "has equivalent performance characteristics" to its predicate device (K042122) and "does not raise any additional concerns regarding safety and effectivity." This indicates that the acceptance criteria are implicitly tied to the performance and safety demonstrated by the predicate device, but these specific criteria and their measured outcomes are not explicitly detailed in this summary. The "study" here is a regulatory review for substantial equivalence, not a performance trial for an AI system.
§ 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).