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The Enthermics Medical Systems EC-7701 Fluid Warming Cabinet is designed to safely store and warm irrigation fluids or injection fluids in accordance with the recommended warming temperatures and storage times stated in the fluid manufacturers' labeling.

The EC-7701 is a stainless steel fluid warming cabinet that utilizes a fully insulated electrothermal cable array that is wrapped inside the bottom and two sides of the cabinet to provide uniform radiant, conductive and convective heating. The device can be used to heat irrigation fluids to a temperature ranging from 90°F to 150°F, or injection fluids to a range of 90°F to 110°F. The device also contains an over-temperature alarm which provides an audible and visual alarm when the internal temperature reaches 10°F above the selected temperature.

This document, K993797 pertains to the Enthermics Medical Systems EC-7701 Fluid Warming Cabinet. As a submission for a 510(k) premarket notification, it focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against defined acceptance criteria through a clinical study.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment is not available in this document. This type of information is typically found in submissions for novel devices requiring clinical trials, not for devices demonstrating substantial equivalence to already marketed products.

The document states:

• "The EC-770l is nearly identical to the three predicate devices in all material respects."
• "All four devices use the same basic technology (non-electromagnetic heating) and utilize similar over-temperature alarm systems (audible and visual indicators)."
• "The only material difference between the EC-7701 and the predicate devices is the selectable modes of operation (irrigation or injection) on the EC-7701. The selectable modes, however, do not raise additional questions of safety or effectiveness."

This indicates that the FDA's clearance of this device is based on its similarity to existing, legally marketed devices, not on a new study demonstrating its efficacy against specific pre-defined acceptance criteria.

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Warm intravenous fluids.

HOT SHOT™ FLUID WARMER IV FLUIDS

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Hot Shot™ Fluid Warmer IV Fluids." This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. It primarily confirms that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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The Medical Solutions PIV IV Bag Warmer and Pressure Infusor is designed to hold and heat IV fluid bags and maintain temperatures to 980 F ( 3°F). It is also a pressure infusor designed to be inflated to increase pressure on the IV bag to assist the infusion of fluid.

Not Found

This is a Premarket Notification (510k) document for a Medical Solutions PIV System. This document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria, as typically found in clinical trial reports or validation studies.

Here's how this document relates to your request:

1. A table of acceptance criteria and the reported device performance: This document does not provide a table of acceptance criteria or specific reported device performance metrics in the way a study report would. It states the "Indications for Use" which specify its intended function: "designed to hold and heat IV fluid bags and maintain temperatures to 98°F (±3°F). It is also a pressure infusor designed to be inflated to increase pressure on the IV bag to assist the infusion of fluid." This implies the performance criteria would revolve around maintaining that temperature range and effectively increasing pressure for infusion. However, no specific data demonstrating compliance with these performance metrics is presented.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No information about a "test set" sample size or data provenance is provided. 510(k) submissions typically rely on a demonstration of "substantial equivalence" to a predicate device, which may involve bench testing and comparisons, but the specifics of such testing (including sample sizes) are not detailed in this high-level approval letter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not pertain to studies involving expert-established ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. 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: Not applicable. The device is a "PIV IV Bag Warmer and Pressure Infusor," not an AI diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as this is a hardware device for fluid warming and infusion, not a diagnostic or AI-driven system requiring a "ground truth" in the typical sense. Performance would be based on engineering specifications and physical measurements (e.g., temperature accuracy, pressure range).

8. The sample size for the training set: Not applicable. The device is not an AI/machine learning system that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary: This document is an FDA 510(k) clearance letter, indicating that the device has been deemed "substantially equivalent" to a legally marketed predicate device. This regulatory clearance process does not typically involve the detailed breakdown of study design, acceptance criteria, and performance metrics as requested, which would be found in a more comprehensive clinical or validation study report if one were performed and publicly available. The information provided is sufficient for regulatory approval based on the 510(k) pathway but not for a detailed scientific study analysis.

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The Medical Products, Inc. Controlled Temperature Cabinet Systems are designed to store and maintain the temperature of drugs and I.V. solutions in the ambulance or mobile vehicle environment to temperatures between 21º to 26ºC or 35º to 40ºC.

The Controlled Temperature Cabinet Systems must be ordered by temperature range. For drugs the range is 210 to 26°C and for I.V. solutions the temperature range is 35°co 40°C.

Warning: The owner of the ambulance or mobile vehicle should contact the manufacturer of the products to be placed inside the cabinets and obtain guidelines for exposing their product to temperatures other than those stated on the I.V. solution bag/bottle or drug container.

Controlled Temperature Cabinet System

This document is a 510(k) premarket notification approval letter for a Controlled Temperature Cabinet System, and therefore does not contain information about acceptance criteria or a study proving device performance against such criteria.

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 means the device was approved based on its substantial equivalence to a legally marketed predicate device, and not on a new study demonstrating its efficacy or performance against specific acceptance criteria.

The "Indications for Use" section on page 3 describes what the device is designed to do (store drugs and IV solutions within specific temperature ranges in an ambulance or mobile vehicle), but it does not provide performance metrics or acceptance criteria for those functions.

Therefore, I cannot provide the requested information from the given text.

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Ask a specific question about this device

Ask a specific question about this device