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The Stryker PainPump2 delivers controlled amounts of medication and narcotics directly to the intraoperative site for pain management. The pump infuses the medication at an hourly flow rate and provided the option for patient controlled bolus doses. Medications and narcotics are infused through intramuscular, subcutaneous, and epidural routes.

The Stryker PainPump2 delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. The pump infuses the medication at an hourly flow rate and provided the option for patient controlled bolus doses. Medications are infused through intramuscular and subcutaneous routes.

The Stryker PainPump2 is intended for controlled delivery of local anesthetics and narcotics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutancous.

The Stryker PainPump2 is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

PainPump2 is an electromechanical pump designed to deliver controlled amounts of medication to the patient for pain management and/or antibiotic delivery. Medication is delivered to the treatment site using an hourly flow rate or combination of hourly flow rate and bolus PCA (Patient Controlled Analgesia) dosing option. Pain Management routes of administration may be intramuscular, subcutaneous or epidural. Antibiotic routes of administration may be intramuscular or subcutaneous.

I am sorry but this document does not contain the information you are looking for. This document is a 510(k) premarket notification for a medical device which mainly discusses the device's substantial equivalence to other legally marketed devices, its indications for use, and regulatory information. It does not include details on acceptance criteria, study designs, sample sizes, ground truth establishment, or expert qualifications related to device performance evaluation.

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