(25 days)
- The Paragon Infusion System with Bolus is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, subcutaneous, intramuscular and epidural.
- The Paragon Infusion System with Bolus is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the Paragon Infusion System with Bolus. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to devices already on the market prior to May 28, 1976, or reclassified. This substantial equivalence determination is based on a review of the company's premarket notification, which would have included data and information to support this claim. However, the details of that data and the specific performance criteria used for testing are not included in this FDA clearance letter.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: This information is not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
- Adjudication method for the test set: This information is not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is an infusion system, not an AI-assisted diagnostic tool, so an MRMC study is not applicable and is not mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This device is an infusion system, not an algorithm.
- The type of ground truth used: This information is not present.
- The sample size for the training set: This information is not present.
- How the ground truth for the training set was established: This information is not present.
The document primarily focuses on the regulatory clearance process, outlining the device's classification, product code, and indications for use. It also provides contact information for further inquiries regarding FDA regulations.
§ 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).