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The Ranger Irrigation Fluid Warming System is intended to warm irrigation fluids.

The Ranger Irrigation Fluid Warming System consists of a warming device and an irrigation fluid warming disposable set. The warming device consists of the electronic control circuitry and aluminum plates contacted by heating elements. The irrigation disposable sets are an integral component of the total fluid warming system. One standard irrigation fluid warming disposable set is available. The irrigation sets include a warming cassette (heat exchanger), tubing, connectors, flow chamber with float, and clamps. The warming cassette fits inside a slot in the warming device; liquids are warmed as they pass through it.

This document pertains to the Ranger Irrigation Fluid Warming System, a device intended to warm irrigation fluids. However, the provided text does not contain acceptance criteria or detailed descriptions of specific studies designed to prove device performance against such criteria.

The document is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance metrics through detailed studies. Therefore, I cannot provide the requested table of acceptance criteria, device performance, sample sizes, ground truth information, or details about MRMC or standalone studies.

The text primarily includes:

• Device Name: Ranger Irrigation Fluid Warming System
• Intended Use: To warm irrigation fluids.
• Regulatory Information: Class II device, regulation number, product code.
• Predicate Devices: Bair Hugger Blood/Fluid Warmer (K973741), Bair Hugger Patient Warming System (K933726), Smiths Level 1 IR-600 Normothermic Irrigating Set (K873435).
• Comparison of Technological Characteristics: A table comparing features like flow rates, method of operation, electronics, temperature control, and alarms between the Ranger system and its predicate devices.
• Conclusion: States that the Ranger system has similar technological characteristics, components, materials, and intended use as predicate devices, and therefore does not raise new safety or effectiveness issues.
• Discussion of Nonclinical Studies and Clinical Tests: Explicitly states "Not applicable."

In summary, the provided document focuses on demonstrating substantial equivalence to existing devices rather than presenting data from studies proving performance against pre-defined acceptance criteria.

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