(190 days)
The K.M.I. Irrigation or Infusion pump "K" Pump is intended for the administration of sterile solutions drawn from containers using standard sterile administration sets with a 3/8 diameter silicone peristaltic section. The "K" Pump is intended for the rapid introduction of sterile fluids into the wound site for wound irrigation. The "K" pump may also be used with K.M.I.'s DIK Irrigation System.
Not Found
Based on the provided text, the document is an FDA 510(k) clearance letter for the "K" Pump, an irrigation or infusion pump. This type of document primarily confirms that a new medical device is substantially equivalent to a previously cleared device, meaning it has the same intended use and technological characteristics as a predicate device, or has different technological characteristics but does not raise different questions of safety and effectiveness.
Crucially, this document does not contain information about specific acceptance criteria or a study that proves the device meets those criteria in the way a performance study report would.
Therefore, I cannot provide the requested information in the table format because the details are not present in the provided text.
Here's why and what's missing:
- Acceptance Criteria & Reported Performance: The letter only states that the device is "substantially equivalent" to a predicate device. It does not list specific performance metrics (e.g., accuracy, flow rate, pressure limits) for the "K" Pump, nor does it provide data from a study demonstrating achieved performance against those criteria.
- Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set, Ground Truth Establishment: These are all elements typically found in detailed clinical or performance study reports, which are not included in this FDA clearance letter. The letter refers to a 510(k) notification, which would have contained some technical and performance data, but that notification itself is not provided here.
In summary, the provided document (an FDA 510(k) clearance letter) is a regulatory approval and does not contain the detailed study information, acceptance criteria, or performance data you are requesting.
§ 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).