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The UroSurge UroTherm™ Fluid Warming System is intended to varm sterile irrigating solutions to normothermic temperatures (37°C) for use in medical/surgical procedures. Not for use with blood or blood products.

UroSurge UroTherm™ Fluid Warning System

The provided text is a 510(k) Pre-market Notification letter from the FDA, which primarily confirms that the UroSurge UroTherm Fluid Warming System is substantially equivalent to a legally marketed predicate device. This document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as this information is not present in the provided text.

The document focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study report.

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GO Medical Patient Controlled Analgesia Devices™, if properly used, are intended to provide a safe and effective means of delivering various analgesic medications to in-patients and out-patients, on both an acute and/or chronic basis. This can be performed through intravenous (IV) and Epidural routes of administration.

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This document is a 510(k) clearance letter for a Patient Controlled Analgesia (PCA) device, not a study report or a document detailing acceptance criteria and performance data. Therefore, the requested information cannot be extracted from the provided text.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976...". This indicates that the device was cleared based on substantial equivalence to a predicate device, rather than through a direct demonstration of meeting specific performance acceptance criteria via a study described in this document.

To answer your questions, one would need access to the actual 510(k) submission (K972158) from GO Medical, which might contain the testing and performance data that supported the claim of substantial equivalence.

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The UroSurge UroStent™ is intended to be used for temporary drainage from the ureteropelvic junction to the bladder. Double pigtail stents have been employed to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. These stents may be placed using endoscopic, percutaneous, or open surgical techniques. The duration of the placement of these stents must not remain indwelling more than twenty nine (29) days. This product is intended for one-time use only. If the patient's status permits, the stent may be replaced with a new stent.

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The provided documents do not contain information about acceptance criteria or a study that proves the UroSurge UroStent™ meets acceptance criteria. The documents are a 510(k) clearance letter from the FDA and an Indications For Use Statement. They confirm the device's substantial equivalence to previously marketed devices and define its intended use, but they do not describe performance metrics, study designs, or data analysis related to specific acceptance criteria.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.

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Ask a specific question about this device