(263 days)
The GlucoPro Infusion Pump is intended for the subcutaneous infusion of insulin.
The Gluc. Pro Infusion Pump is intended for use with the disposable compatible infusion sets and the GlucoPro syringe for subcutaneous delivery of insulin. The catheter or needle of the compatible infusion set is inserted into the subcutaneous tissue of the user and is connected to the syringe that it the drug reservoir. The syringe is installed in the infusion pump and attached by means of screw threads. The medicine solution is delivered and infused info the user continuously. The user sets continuous basal infusion rate and selects bolus delivery. The infusion punip contains many safety teatures including alarms to indicate infusion error or system malfunction.
The pump is 91 mm wide, 52 mm in leight, and 21 mm in depth. It weighs 80 grams. The power is supplied by a Duracell CR-2 (3V) ba tery (or equivalent) that should last 30 - 60 days.
The provided document is a 510(k) summary for the Glucopro Infusion Pump, submitted to the FDA in 2002. It describes the device, its intended use, and substantial equivalence to legally marketed predicate devices.
However, this document does not contain the specific information required to answer your request about acceptance criteria, detailed study results, sample sizes, ground truth establishment, or expert involvement. The 510(k) summary focuses on demonstrating substantial equivalence to existing devices, primarily on technical characteristics and intended use, rather than presenting a detailed performance study with quantifiable acceptance criteria.
Therefore, I cannot populate the table or provide the specific details you've requested based on the information provided in this 510(k) summary. The document does not describe a clinical study or a study specifically designed to prove device performance against predefined acceptance criteria for a new AI or diagnostic device. It's a regulatory document for an infusion pump, which typically relies on comparisons to predicate devices and engineering/bench testing rather than the detailed clinical performance studies you're inquiring about.
I can tell you the following based on the provided document:
- Device Name: Glucopro Infusion Pump
- Intended Use: For the subcutaneous infusion of insulin.
- Predicate Devices: Disetronic H-Tron Plus V100 infusion pump (K973044) and Minimed Model 507 (K960001).
- Study Type: This document describes a 510(k) premarket notification, which is a process to demonstrate substantial equivalence to a legally marketed predicate device, rather than a de novo study proving novel device performance against acceptance criteria. It primarily compares technical characteristics and intended use.
§ 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).