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The Disposable Infusion Pump is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a presely for post-operative pain management.

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The provided text is a Food and Drug Administration (FDA) letter regarding the 510(k) premarket notification for the "GOPump Rapid Recovery System, Disposable Infusion Pump Kit." This document is a regulatory approval letter and does not contain the acceptance criteria or the study details that would demonstrate the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on the regulatory classification and approval process, not on the technical performance studies of the device.

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The Disposable Infusion Pump is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a preset rate for post-operative pain management.

The Biomet Disposable Infusion Pump Kit is a convenience kit that includes the components necessary to provide temporary infusion of a liquid into a patient. The components of the system are an elastomeric pump, an IV catheter/introducer and an infusion catheter. The pump is a disposable, self-contained, infusion system utilizing an inflatable elastomeric reservoir to mechanically pressurize a fluid and drive it through tubing to a small restrictor to provide infusion at a pre-set rate. The device is provided empty and no specific drug references are made in the labeling. The device is not intended for delivery of blood, blood products, lipids or fat emulsions.

The provided document is a 510(k) premarket notification letter from the FDA for a Disposable Infusion Pump Kit. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a more extensive validation report.

The 510(k) summarizes the device description and its intended use but lacks the specific performance metrics (like accuracy of flow rate, duration of infusion, etc.), the methodology of a study to test these metrics, or the results of such a study.

Therefore, I cannot fulfill your request for the tables and study details based solely on the provided text. The information requested (sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) are components of a detailed performance validation study, which is not present in this regulatory letter.

The relevant information in the provided document is mostly regulatory in nature:

• Proprietary Name: Disposable Infusion Pump Kit
• Common Name: Disposable Infusion Pump Kit
• Classification Name: Pump, Infusion, Elastomeric, External (21 CFR 880.5725), Catheter, Intravascular, short term (21 CFR 880.5200), Catheter, Conduction, Anesthetic (21 CFR 868.5120)
• Device Product Code: MEB, FOZ, BSO
• Intended Use: The Disposable Infusion Pump is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management.
• Regulatory Conclusion: Substantially Equivalent to predicate devices.

To answer your specific questions, information beyond what is in this document would be needed.

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