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The Home Care Bead Bed is designed to provide Air Fluidized Therapy that helps prevent and treat complications of immobility such as skin breakdown and decubitus ulcers, while providing minimized dehydration.

The Head Cushion System is an air inflatable cushion system designed to raise a patient's upper body. This cushion system is a replacement to the foam cushion wedges presently available on the FluidAir Bead Bed.

The Home Care Bead Bed is indicated for patients who would benefit from advanced pressure relief and a dry patient environment. Particular classes of such patients include (among others), victims of the following:

• Pressure Ulcers especially draining wounds .
• . Skin Flaps and Grafts
• · Burns
• · Acute Exfoliative Dermatitis
• · Oncology:
  • · Aids in pain relief
  • · Reduces risk of Pathological Fractures

The Home Care Bead Bed is designed to provide Air Fluidized Therapy by supporting the patient on a surface of fluidized Microspheres (or "beads"). A large volume of air is forced upward through the microsphere mass causing the beads to behave as a fluid, helping reduce interface pressures while providing a dry patient environment with minimized dehydration. The Home Bead Bed is designed for home health care use allowing easy two-man transportation, installation and serviceability. The Home Bead Bed is a modification of the predicate fluidized bead bed, FluidAir® (by KCI), currently on the market and complies with the weight regulations for mobile and wood floor homes.

The Home Care Bead Bed is comprised of the Head Pedestal (containing the Head Cushion System Control unit), the Foot Pedestal (containing the Power-Controller unit), the Tank unit with the Soft Diffuser, a wooden Floor Board, the Beads, Filter Sheet and the Head Cushion System incorporated into the Cover Sheet.

The Foot Pedestal encloses the Air Supply unit that provides air to the soft diffuser and the Head Cushion System. The Air Supply unit contains similar components used in the FluidAir power unit such as blowers, heat exchanger, thermostat controls, cooling fans and filters. The Power-Control Unit located at the Foot Pedestal (refer to membrane diagram) has an "On/OFF" button and a "Fluidization" knob that allows the care giver to increase or decrease the fluidization. By turning the knob toward "MAX", the blower speed increases and sends more air through the Soft Diffuser thus increasing the fluidization rate. By turning the knob toward "MIN", the blower speed decreases and less air is blown through the diffuser thus decreasing the fluidization rate. The "Temp" knob on the Power-Control Unit allows the care giver to adjust the temperature of the air flowing to the beads. This heating and cooling regulation system is similar to the one used on the FluidAir.

The Head Cushion System consists of a head cushion (consisting of two air bladders) and a knee gatch bladder made of vinyl Gore-Tex® fabric and sewn onto a Gore-Tex® fabric cover sheet, similar to the FluidAir bed cover sheet, and placed atop the Home Care Bead bed. The two head cushion bladders and the knee gatch bladder are controlled by small bore servo valves located in the Head Pedestal. These valves are connected to individual port pins for appropriate control. The top head cushion bladder is operated in a pressure feedback mode, while the bottom head cushion operates only in an ON or OFF mode (no pressure feedback control). The knee gatch valve is plumbed in such a way as to draw air from the bottom head cushion bladder whenever the "High" setting is selected. Otherwise, the knee gatch bladder remains deflated. Forty (40) degrees of elevation can be achieved when both head cushions are inflated. The knee gatch bladder provides greater patient positioning when the bottom head cushion is elevated.

The Hand Control has an ON and OFF control for fluidization, and SOFT and FIRM and HIGH and LOW controls for the Head Cushion System. When the Head Cushion System's power is turned ON, the system defaults to the LOW setting of mid-range firmness for the Top Head cushion. The Bottom Head cushion and Knee Gatch cushion remain deflated. The FIRM and SOFT control buttons adjusts the firmness level of the Top cushion. The HIGH control button fully inflates the Bottom Head cushion and the Knee Gatch bladder. The head will elevate to a maximum of 40 degrees, depending on the firmness of the Top Head Cushion. The LOW control button returns the Low setting, which will return the head elevation to approximately 10 degrees. When the Head Cushion System is turned OFF, all cushions in the Head Cushion System are deflated.

This document is a 510(k) summary for the "Home Care Bead Bed" and describes its intended use, indications, and contraindications. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document states that the Home Care Bead Bed is a modification of a previously marketed device, the FluidAir® (K881917), and is considered "substantially equivalent." The FDA clearance (K972176) is based on this substantial equivalence, not on a new study demonstrating performance against specific acceptance criteria for the modified device.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, rather than detailed performance study results.

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