(133 days)
The Simpulse mattress is for supporting bedridden patients in a manner that helps prevent and treat complications of immobility such as skin breakdown and decubitus ulcers. It employs a series of transverse inflatable cushions that can be sequentially inflated and deflated to provide pulsation pressures beneath the patient.
The Simpulse is indicated for patients who would benefit from: A pressure relieving surface with the additional benefit of pulsation to assist in the prevention and treatment of the complications of immobility such as skin breakdown and decubitus ulcers.
The Simpulse™ is a powered, Pulsating Therapy Mattress that can be used as an Overlay or Mattress Replacement System and is designed for use in all care settings (home, acute and extended). The Simpulse provides pulsating air suspension therapy that combines the benefits of pressure relief with the advantages of pulsation therapy.
The Simpulse" is comprised of two major components: the Air Supply Unit, and the Mattress Assembly.
The Mattress Assembly is comprised of: the pulsating air surface, the air base, the underliner and the cover sheet. The pulsating air surface is the component that pulses. It consists of ten separate interlocking air cushions that are plumbed to provide pulsation (five cushions are plumbed to Channel A and five are plumbed to Channel B). By only inflating the 5 inch pulsating air surface, the Simpulse " can be used as a mattress overlay.
When the Simpulse is used as a Mattress Replacement System, the 3 inch air base is inflated and serves as a static pressure air base that keeps the patient suspended when the bed is articulated. It also serves as an air support and remains inflated in case of a power outage. The underliner serves as an envelope to provide structure to the mattress. It has tie points that snap together and hold the pulsating air surface in place in relation to the air base. It also has straps that secure the entire Mattress Assembly to the bed frame.
The cover sheet is a fitted sheet made of nylon with a urethane backing that fits over the Mattress Assembly and provides a protective barrier between the patient and the air bladders.
The Air Supply Unit is mountable on the footboard of a standard hospital bed or can be placed upright on the floor and is microprocessor controlled to achieve the two modes of operation (Pulsation and/or Static). All user input to the microprocessor control is accomplished through the membrane panel switch are located on the Air Supply Unit.
The Air Supply Unit utilizes two separate pump and valve assemblies to channel compressed air to the Mattress Assembly, creating two sections referred to as Channel A and Channel B. This provides a single target pressure for the entire mattress as well as the means for the mattress to pulsate. The hose set has a connection on one end that mates to an air connection on the side of the Air Supply Unit. This connection also serves as a CPR emergency air deflation system by simply disconnecting the hose from the Air Supply Unit. The other end connects to the air cushions (Channel A, Channel B and the Air Base).
The target pressure is set by pressing the "Soft/Firm" buttons located on the membrane control panel. These buttons have five LED's evenly spaced between them and the user can adjust the firmness of the mattress within the range of these five LED's. If the user pushes and holds one of the buttons, the LED location will not increment until the user releases the button and pushes it again. Once the user selects the pressure setting, the pressure feedback system will automatically maintain the pressure setting within a target pressure range of plus or minus 1" H2O. If the actual pressure moves out of the target pressure range, the microprocessor controller will activate the corresponding pump to increase the pressure or open the corresponding valve to decrease the pressure until the pressure is within the target pressure range.
In the Static mode, all of the cushions in the air surface are inflated to an equal pressure and operate in a continuous pressure feedback mode as previously described. In the Pulsating On mode, the cushion closest to the footboard will decrease in pressure together with every other cushion along the mattresses length (Channel A), while the other set of cushions (Channel B) increase in pressure. Once the cushions of Channel A reach the lowest point and begin to increase in pressure, the cushions of Channel B start to decrease in pressure. When the Channel B cushions reach the minimum pressure and then begin to increase in pressure, the cushions of Channel A will once again begin to decrease in pressure. This completes a full cycle. By pressing the "Pulsation Cycle Time" button, the pulsation cycle time can be adjusted over a range of between 5, 10 or 20 minutes. An LED light will indicate which time period has been selected.
The "Auto Firm" control will fill Channels A & B and the Air Base to a maximum inflation level. During the time that Auto Firm is activated, The Pulsation On/Off buttors, Pulsation Cycle Time Button and the Soft/Firm buttons as well as their respective LED indicators will be disabled. The mattress will stay at the maximum inflation level until the Auto Firm Off button is pushed or twenty minutes elapse from the time the Auto Firm On button was first pushed. The Simpulse will then default to the same settings of operation as before the AutoFirm was activated.
This document is a 510(k) Summary for the Simpulse™ mattress, dating from 1997. It describes a medical device and its intended use, but it does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The 510(k) summary is a regulatory document submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. It typically focuses on device description, indications for use, contraindications, and comparisons to predicate devices, rather than detailed performance studies with acceptance criteria in the manner requested.
Therefore, I cannot provide the requested information based on the provided text. The document does not include:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set or data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
§ 880.5550 Alternating pressure air flotation mattress.
(a)
Identification. An alternating pressure air flotation mattress is a device intended for medical purposes that consists of a mattress with multiple air cells that can be filled and emptied in an alternating pattern by an associated control unit to provide regular, frequent, and automatic changes in the distribution of body pressure. The device is used to prevent and treat decubitus ulcers (bed sores).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.