(67 days)
- Medi-SIS Syringe Infusion System was designed for general drug and solution infusion uses with the limitation being the volume of drug to be infused. The routes of administration include those of the similar size syringes, (i.e. intravenous infusions and subcutaneous infusions) ... ....................................................................................................................................
- The administration set is intended for single patient use only.
- The Medi-SIS driver can be reused up to 5,000 times.
- The Medi-SIS system is intended for general infusion use. The Medi-SIS Syringe Infusion System is not limited to any specific type of therapy.
4.1 The Medi-SIS Syringe Infusion System is not intended for the delivery of blood, blood products or TPN solutions.
The Medi-SIS Syringe Infusion System consists of a plastic, spring driven infusion pump and various administration sets. Two models of the Medi-SIS pump have been developed to accommodate 20 and 60 ml syringes.
The provided documentation describes the I-Flow Medi-SIS Syringe Infusion System, specifically regarding a change in labeling to include Sherwood Monoject Syringes in addition to the previously approved Becton-Dickinson® brand syringes. The submission (K972173) is a 510(k) summary rather than a full study report, and therefore much of the information typically found in a comprehensive clinical or performance study is not present. However, it does provide performance test data related to the device's function.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a separate section. However, it implicitly assesses performance against the "labeled delivery time" of the device and states that performance within ±15% of the labeled time is considered acceptable. It also notes that slower delivery rates (even beyond this range) might not affect safety or efficacy for certain drug types.
| Performance Metric | Acceptance Criteria (Implied) | 20ml Sherwood Monoject Syringe (Lot # 724040) | 20ml Sherwood Monoject Syringe (Lot # 723462) | 60ml Sherwood Monoject Syringe |
|---|---|---|---|---|
| Delivery Time (20ml/15min set) | Within ±15% of labeled 15min (implicitly, though deviations noted) | 19.07 min (27% increase) | 19.60 min (31% increase) | N/A |
| Delivery Time (20ml/30min set) | Within ±15% of labeled 30min (implicitly, though deviations noted) | 37.14 min (24% increase) | 38.60 min (29% increase) | N/A |
| Delivery Time (60ml/30min set) | Within ±15% of labeled 30min (±4.5 min) | N/A | N/A | 28.09 min (6% decrease) |
| Delivery Time (60ml/60min set) | Within ±15% of labeled 60min (±9 min) | N/A | N/A | 56.57 min (6% decrease) |
| Residual Volume (20ml syringe) | " |
§ 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).