(680 days)
Not Found
Modified PediKair is a critical care bed with an air mattress for supporting bedridden pediatric patients in a manner that helps prevent and treat complications of immobility such as skin breakdown and decubitus ulcers. The air mattress consists of a series of transverse, inflatable cushions that can be alternately inflated and deflated to provide pulsation therapy (as on the predicate device), an air bladder beneath the patient's chest region to provide vibration/percussion therapy, and left and right turning bladders to rotate the patient side to side. Inflatable support cushions on each side of the patient's head and body keep the patient positioned properly during rotation. PediKair includes the collapsible side rails and removable head and foot rails of the predicate device for maximum and immediate access to the patient-CPR can be performed without the hindrance of rails and without removing the patient from the bed.
As with the predicate device, the re-designed PediKair mattress is also a lowpressure air mattress. Low-pressure support mattresses are effective in preventing or reducing the incidence of decubitus ulcers in immobile patients by lowering the pressure on any portion of the body to below capillary pressure (25-35 mmHg).
Modified PediKair also provides kinetic therapy, which is effective in the care management and prevention of decubitus ulcers and in the treatment or mitigation of pulmonary complications caused by prolonged immobility. A continuously rotating surface, similar in concept and design to that of the KCI Pediatric RotoRest P-30 product (510(k) No. K822402), automatically turns the patient 40° (maximum) on one side of the body, to lying on his/her back, to 40° (maximum) on the opposite side of the body. The side support cushions, which automatically inflate when Modified PediKair is in use, and the bed's side rails keep the patient from falling out of the bed while in a rotated position, or while being rotated.
This appears to be a 510(k) premarket notification summary for a medical device called "Modified PediKair," a critical care bed. The provided text is a regulatory document from the FDA, not a scientific study report. As such, it does not contain the detailed information requested regarding acceptance criteria and a study proving device performance.
The document states that the FDA has determined the device is "substantially equivalent" to a predicate device, meaning it's similar enough that it doesn't require a new, extensive clinical trial for market approval. The information provided is primarily regulatory in nature.
Therefore, I cannot extract the following information because it is not present in the provided text:
- A table of acceptance criteria and the reported device performance: This document only describes the device's function and its substantial equivalence to a predicate device. It does not list specific performance metrics or acceptance criteria for those metrics.
- Sample size used for the test set and the data provenance: No test set is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is mentioned.
- Adjudication method: Not applicable as no test set or ground truth is discussed.
- 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: This device is a critical care bed, not an AI-powered diagnostic tool, so an MRMC study is not relevant and not discussed.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device.
- The type of ground truth used: Not applicable as device performance is discussed in terms of its features and comparison to a predicate, not against a "ground truth" derived from patient outcomes or pathology in a study context.
- The sample size for the training set: Not applicable as this is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of what is available in the document:
- Device Name: Modified PediKair
- Device Type: Critical care bed with an air mattress for pediatric patients.
- Purpose: To prevent and treat complications of immobility (skin breakdown, decubitus ulcers) and pulmonary complications.
- Key Features:
- Low-pressure air mattress (to lower pressure below capillary pressure, 25-35 mmHg).
- Pulsation therapy (alternately inflated/deflated cushions).
- Vibration/percussion therapy (air bladder beneath chest).
- Left and right turning bladders (rotates patient side to side, up to 40°).
- Inflatable side support cushions and bed's side rails to keep patient positioned.
- Collapsible side rails, removable head/foot rails for CPR access.
- Predicate Device: KCI Pediatric RotoRest P-30 product (510(k) No. K822402) for kinetic therapy function, and presumably an unspecified predicate for the general critical care bed features.
- Regulatory Outcome: Found substantially equivalent to devices marketed prior to May 28, 1976. This allows it to be marketed under general controls.
§ 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.