(187 days)
The product is a device intended for medical purposes that consists of a mattress and a control unit which provides automatic changes in distribution and control of interface pressure. It is used to prevent and treat conditions where reduction of interface pressure is beneficial. The device is intended to provide a patient surface suitable for use with the general patient population in a variety of health care environments as determined appropriate by health care professionals. The TotalCare.. Modular Therapy System (MTS) is intended to be used in conjunction with the TotalCare. Patient Support System (PSS). The MTS is not intended for use with patients with unstable cervical fractures.
The TotalCare~ Modular Therapy System (MTS) is a patient Air Flotation Bed surface operated by a microprocessor controlled air system and proportional air valves. The mattress surface is of a modular design This allows the healthcare facility to add treatment and/or prevention opiions as the patient condition requires. The Surface Control Modules contain the software and proportional air valves and dock with the TotalCarem Patient Support System (PSS) Bed. The MTS surface maintains peripheral circulation by even distribution of the patient's weight over bladders filled with air. The even distribution of pressure on the skin reduces capillary closure, thereby helping maintain tissue viability around bony prominences, such as the buttocks and heels, both areas prone to ulceration and bed sores. The surface cover is non-permeable and will not allow the accumulation of perspiration and other bacteria producing body fluids within the cover or bladder of the bed. By wiping of the cover to remove any accumulation of fluids, followed by wiping of the surface of the cover with an antiseptic agent, contamination of the patient is reduced or eliminated.
This document is a 510(k) summary for the Totalcare™ Modular Therapy System (MTS), an alternating pressure air flotation mattress. It focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against such criteria. The submission is primarily a regulatory filing rather than a scientific study report.
Therefore, many of the requested sections regarding acceptance criteria and study details cannot be fully addressed from the provided text.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the Totalcare™ MTS against such criteria. The focus is on demonstrating "substantial equivalence" to predicate devices rather than proving performance against predefined clinical or engineering benchmarks.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. The document does not describe a performance study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. The document does not describe a performance study with ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. The document does not describe a performance study with adjudication.
5. 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
Not applicable. The Totalcare™ MTS is a medical device (a mattress and control unit), not an AI-based diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Totalcare™ MTS is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The document does not describe a performance study that would require establishing ground truth. The primary basis of the 510(k) is comparison to predicate devices, implying that the predicates' established safety and effectiveness serve as a de facto "ground truth" for the new device's substantial equivalence.
8. The sample size for the training set
Not applicable. The document does not describe a performance study that would involve a training set.
9. How the ground truth for the training set was established
Not applicable. The document does not describe a performance study that would involve a training set.
Summary of what the document does provide regarding device evaluation:
The document establishes that the Totalcare™ Modular Therapy System (MTS) is substantially equivalent to two predicate devices:
Key points for substantial equivalence:
- Intended Use: The intended use for the Totalcare™ MTS is described as the same as the predicate devices: "to prevent and treat conditions where pressure maintenance is beneficial." It provides a patient surface suitable for the general patient population in healthcare environments.
- Materials, Technology, and Performance Characteristics: The document states that the subject device "has the same or similar materials, technology and performance characteristics as the predicate devices."
- Differences:
- Air Supply: The MTS air supply is integrated into the Totalcare™ Patient Support System bed, while predicates have external or footboard-mounted units.
- Mattress Construction: The MTS has a modular design, allowing addition of treatment options, unlike the fixed construction of predicates. It is also exclusive to the Totalcare™ PSS bed, whereas the predicates could be mounted on various beds.
- Valves: The MTS (and Flexicair Eclipse) use proportional valves with feedback loops for self-controlling set pressure, while the Zoneaire uses valves controlled directly by voltage without a feedback loop.
The conclusion is that "Any differences between the subject and predicate devices are insignificant" in terms of safety and effectiveness, thus demonstrating substantial equivalence. The FDA concurred with this assessment in their letter.
§ 890.5170 Powered flotation therapy bed.
(a)
Identification. A powered flotation therapy bed is a device that is equipped with a mattress that contains a large volume of constantly moving water, air, mud, or sand. It is intended for medical purposes to treat or prevent a patient's bedsores, to treat severe or extensive burns, or to aid circulation. The mattress may be electrically heated.(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 § 890.9.