(708 days)
The BariAir bed is indicated for patients weighing up to 850 pounds to aid in the prevention and treatment of complications of immobility. Particularly:
- · patients who would benefit from a pressure relieving surface with the additional benefits of pulsation, percussion and/or continuous or regular turning from side to side.
- · patients whose body weight and size pose a significant risk of injury to the patient or nursing staff during the performance of routine nursing care procedures.
BariAir is a bariatric patient care system that combines the flexible patient-positioning capabilities of the predicato device (BariKare Plus) with a pressure relieving, dynamic low-air-loss mattress. The BariAir mattess is a three-section air mattress consisting of a scries of transverse, inflatable cushions that can be alternately inflated and deflated to provide pulsation therapy, four turning bladders to rotate the patient side to side, and an air bladder beneath the patient chest region cushions to provide vibration/percussion therapy. The BariAir device includes support and caster frames substantially the same as the predicate device.
BariAir also provides continuous lateral rotation therapy, automatically turning the patient, as well as other adjunct therapies such as pulsation and vibration/percussion.
This 510(k) summary (K955243) describes a device called BariAir, a low air loss bed. However, the provided document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria beyond establishing substantial equivalence to a predicate device.
The document is a 510(k) submission summary, which primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This regulatory pathway often relies on comparison to a predicate device and does not typically include detailed performance studies with acceptance criteria in the same way a Premarket Approval (PMA) application would.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text because it is not present.
The 510(k) summary highlights:
- Predicate Device: BariKare Plus.
- Device Description: BariAir combines features of the predicate device (flexible patient positioning, built-in scale) with a pressure-relieving, dynamic low-air-loss mattress. It offers pulsation, four turning bladders for rotation, and air bladders for vibration/percussion therapy.
- Intended Use: For patients up to 850 pounds to prevent and treat immobility complications, especially those needing pressure relief with pulsation, percussion, and/or turning, or where patient weight/size poses risk to patient/staff during routine care.
- Contraindication: Unstable spinal cord injuries.
- Substantial Equivalence: The FDA determined the BariAir device is substantially equivalent to devices marketed prior to May 28, 1976.
The FDA's finding of "substantial equivalence" is based on the comparison of the new device to a predicate device, focusing on similar technological characteristics and intended use. This typically does not involve new clinical performance studies with predefined acceptance criteria.
§ 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.