(77 days)
The Infiltration Pump indications for use are lipoplasty general tumescent infiltration to include body contouring. The Infiltration Pump is not intended for intravenous use.
The principles of operation and technology incorporated in the Infiltration Pump are equivalent to peristaltic infiltration/irrigation devices, which use peristalsis-type action to move fluid through a tube by alternating mechanical squeezing of fluid-filled tubing with a roller.
The Infiltration Pump uses a multiple roller pump and a mechanical tubing clamp to squeeze and hold tubing and assist in moving fluid from an IV fluid bag to the infiltration site. As with all peristaltic pumps, the Infiltration Pump contacts only the tubing and never directly contacts the fluid, thus fluid sterility cannot be compromised by the pumping action.
The provided 510(k) summary for the Infiltration Pump (K050324) states that the device's substantial equivalence is based on the "principles of operation and technology incorporated" being equivalent to existing peristaltic infiltration/irrigation devices.
Therefore, this submission is a traditional 510(k) submission based on substantial equivalence to predicate devices, and not a de novo submission requiring clinical performance studies and defined acceptance criteria.
As such, the document does not contain information on:
- Acceptance criteria or reported device performance for a study.
- Sample size, data provenance, or ground truth for a test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- Standalone algorithm performance.
- Type of ground truth used (pathology, outcomes data, etc.) beyond conceptual equivalence.
- Sample size for a training set.
- How ground truth for a training set was established.
The document primarily focuses on establishing "substantial equivalence" to predicate devices, which means demonstrating that the new device is as safe and effective as a legally marketed device that is not subject to premarket approval. This typically involves comparing technological characteristics, indications for use, and performance claims to the listed predicates (PSI-TEC Peristaltic Infiltration Pump K040149 and Klein Surgical Infiltration Pump, Model KIP-II K031432).
To fulfill the request, a clinical study with detailed acceptance criteria and performance metrics would be required, which is beyond the scope of this 510(k) summary.
§ 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).