(304 days)
ON-Q* Pump is intended to provide continuous delivery of medication (such as local anesthetics) to or around surgical wound sites and/or close proximity to nerves for preoperative and postoperative regional anesthesia and/or pain management. Routes of administration include: intraoperative site, peripheral nerve block, percutaneous and epidural.
ON-Q* Pump is indicated to significantly decrease pain and narcotic use when used to deliver local anesthetics to or around surgical wound sites, or close proximity to nerves, when compared to narcotic only pain management.
ON-Q* Pump with Bolus device is intended for users 18 years of age and older.
The ON-Q* Pump with Bolus consists of an elastomeric pressure source (i.e. elastomeric pump) with an integrated administration set/line. The ON-Q* Pump with Bolus delivers continuous infusion (basal) and allows incremental fixedvolume boluses to be delivered on demand by the patient. In addition to the optional bolus component, the administration line may contain any of the following optional components:
- Filter
- Select-A-Flow variable flow rate assembly ●
- Y-adaptor ●
The bolus component controls the bolus and/or basal flow rate capability of the administration set that connects to the elastomeric pump. The bolus component is an integrated part of the pump system and cannot be used alone. The patient or healthcare provider presses a button to activate bolus delivery. The refill time determines the patient must wait prior to receiving another full bolus dose.
I am sorry, but the provided text does not contain any information about acceptance criteria for a medical device or a study proving that the device meets those criteria. The document appears to be an FDA 510(k) summary for a device called "ON-Q* Pump with Bolus," which discusses substantial equivalence to a predicate device.
The document includes:
- A brief description of the device and its intended use.
- A comparison of the subject device (ON-Q* Pump with Bolus) to a predicate device (K063530) in terms of indications for use, user population, environment of use, and technological characteristics.
- Discussions of differences in technological characteristics and explanations that these differences do not raise new questions of safety or effectiveness.
- A section on "Performance Testing" which lists various types of bench testing, design validation, human factors evaluation, packaging verification, sterilization verification, biocompatibility, drug stability, and MR compatibility that were performed. However, it does not specify concrete acceptance criteria with numerical targets or report the device's performance against such criteria in a tabular format as requested.
- It explicitly states "Clinical Tests: Not Applicable."
Therefore, I cannot fulfill your request to provide a table of acceptance criteria and reported device performance, or details about the sample size, data provenance, ground truth establishment, or clinical study methods, as this information is not present in the provided text.
§ 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).