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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 peformed through intravenous (IV) and epidural routes of administration. The device will be available only by prescription and will carry the following legend: "Caution : Federal Law restricts this device to sale by or on the order of a physician". (21 CFR 801.109(b)(1))

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This document is a 510(k) clearance letter from the FDA for a medical device, specifically "Go Medical Patient Controlled Analgesia Devices (PCA) Devices." It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter confirms that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed. It outlines regulatory requirements that the manufacturer must adhere to, such as registration, listing, good manufacturing practices, and labeling.

Therefore, I cannot provide the requested information based on the content of this document.

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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 peformed through intravenous (IV) and epidural routes of administration. The device will be available only by prescription and will carry the following legend: "Caution : Federal Law restricts this device to sale by or on the order of a physician". (21 CFR 801.109(b)(1))

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about the acceptance criteria, study details, or performance metrics of the device as it pertains to AI or software algorithms.

Therefore, I cannot answer your request based on the provided input. The document
describes the regulatory approval process for the "Go Medical Patient Controlled Analgesia (PCA) Devices" and confirms its substantial equivalence to a legally marketed predicate device. It does not assess or report on any AI-driven performance or studies related to such.

Ask a specific question about this device

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.

Not Found

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.

Ask a specific question about this device