(23 days)
The Disposable Infusion Pump is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a preset rate for post-operative pain management.
The Symbios Disposable Infusion Pump Kit is a convenience kit that includes the components necessary to provide temporary infusion of a liquid into a patient. The components of the system are an elastomeric pump, a catheter needle/introducer, an infusion catheter and accessories. The pump is a disposable, self-contained, infusion system utilizing an inflatable elastomeric reservoir to mechanically pressurize a fluid and drive it through tubing to a small restrictor to provide infusion at a pre-set rate. The device is provided empty and no specific drug references are made in the labeling. The device is not intended for delivery of blood, blood products, lipids or fat emulsions.
The provided text describes a 510(k) summary for a Disposable Infusion Pump Kit and does not contain information about an AI/ML-based device. Therefore, I cannot extract the specific details related to acceptance criteria and studies that prove an AI device meets these criteria.
However, I can provide a summary of the device's characteristics and the changes that were submitted for 510(k) clearance, as an example of acceptance criteria and device performance for a traditional medical device:
Device Acceptance Criteria and Performance (Based on Modified Device Information)
The acceptance criteria for the modified Disposable Infusion Pump Kit and its reported performance are primarily based on equivalence to the predicate device K051474, with specific changes outlined below.
1. Table of Acceptance Criteria and the Reported Device Performance
| Feature/Parameter | Acceptance Criteria (Equivalent to Predicate) | Reported Device Performance (Modified Device) |
|---|---|---|
| Pump Performance | ||
| Fill Volume | 100 ml (Predicate) | 150 ml (Modified, previously capable but not tested to this volume) |
| Flow Rate | 2.0 ml/hr | 2.0 ml/hr |
| Flow Profile | Continuous | Continuous |
| Accuracy | ± 15% | ± 15% |
| Pressure Source | Strain energy of elastomeric membrane | Strain energy of elastomeric membrane |
| Reservoir Material | Synthetic rubber, latex-free elastomeric membrane | Synthetic rubber, latex-free elastomeric membrane |
| Catheter Needle/Introducer | ||
| FDA Status | Exempt (878.4200) | Exempt (878.4200) |
| Material - Needle | Stainless steel | Stainless steel |
| Material - Introducer Catheter | Teflon | Teflon or Polyethylene (Modified) |
| Needle Size | 16 GA | Up to 14 GA (Modified) |
| Needle Length | 2.75" | Up to 10" (Modified) |
| Sterility | ||
| Sterility Assurance Level | 10^-6 | 10^-6 |
| Sterilization Method | ANSI/AMMI/ISO 11135-1994 (EtO) | ANSI/AMMI/ISO 11135-1994 (EtO) |
| EtO Residuals | Ethylene Oxide |
§ 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).