(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.
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ATTACHMENT 6
970636
510(k) Summary Totalcare™ Modular Therapy System (MTS)
1. APPLICANT:
Hill-Rom, Inc. 1069 St. Route 46 East Batesville, IN 47006 Reg. No: 1824206
AUG 26 1997
CONTACT PERSON:
James G. Carpenter Manager, Regulatory Affairs Ph: (812)934-1671 Fx: (812)934-1675
DEVICE TRADE/PROPRIETARY NAME: 2.
Totalcare™ Modular Therapy System (MTS)
DEVICE COMMON/USUAL/CLASSIFICATION NAME:
Alternating Pressure Air Flotation Mattress
CLASSIFICATION:
General Hospital and Personal Use Devices 21 CFR 880.5550 80FNM Class II
PREDICATE (CURRENT) DEVICE: 3.
Hill-Rom " Flexicair® Eclipse™ ", K951001 Hill-Rom "Zoneaire™", K945729
The FLEXICAIR® ECLIPSE™ is a five-zone low airloss mattress replacement that can go on existing bed frames. All controls are connected to a microprocessor control board. The microprocessor controls the blower motor, the five proportional valves that maintain the proper pressure in each of the five zones, and monitors the intake manifold temperature and the control panel. It is intended to
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be used on a general Medsurg or specialty bed frame in areas thoughout the patient care environment. It is used in the prevention and treatment of bed sores as well as general use.
The ZONEARE™ is a six zone powered flotation mattress. It is managed with a microprocessor which controls the solenoid valves that maintain the proper pressure in each of the zones. The air system consists of a compressor, switching valve, low voltage transformer, power supply and microprocessor based electronic control board. It is intended for use with patients requiring pressure management sleep surfaces including the prevention and treatment of bed sores as well as general use.
4. DEVICE DESCRIPTION
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.
Design and construction:
The MTS consists of:
Air System - The PSS provides the pressurized air to the MTS control modules. The air system also provides means to attach and mount the control modules. It is constructed of steel or aluminum and polymer materials.
Control Modules - The control modules consist of software and proportional valves required to direct and control the flow of air from the air source to the patient surfaces as required for specified functions. These are constructed of steel or aluminum and polymer materials.
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Patient Surfaces - The patient surfaces consist of modules and components required to provide continuous patient support and specified therapies. Patient surface components generally rest upon the articulating deck/weigh frame of the PSS. These are constructed of multi-density foam, polyurethane sealed air cells, tubing and nonpermeable covers.
Power and Communication System - The power and communication system consists of electronic modules and cable assemblies required to exchange information between the user and the control modules. The power and communication system also provides power to the air system and control modules. Components of the power and communication system are in the MTS control modules and distributed throughout the PSS.
INTENDED USE: ર.
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 body pressure. It is used to prevent and treat conditions where pressure maintenance 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.
SUMMARY OF SIMILARITIES AND DIFFERENCES 6.
Differences in design between the subject device and the predicates are as follows.
Air Supply
The air supply for the subject device is integrated into the Totalcare™ Patient Support System bed . The distribution is managed by the air control modules. The Eclipse predicate incorporates the blower, controller and valves in an air supply unit that hangs on the footboard of the bed or can sit on the floor. The Zoneaire predicate is available as an incorporated system or as a footboard mounted system.
Mattress
The primary differences between the subject and predicate devices are the modular construction of the MTS as opposed to the fixed construction of the predicates. The MTS also is exclusive to the Totalcare™ Patient Support System bed, whereas the Eclipse and Zoneaire may be mounted on a variety of different manufacturers beds.
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Valves
The Zoneaire employs valves that are controlled directly by voltage to the valve with no feedback loop. The Flexicair Eclipse and the MTS utilize proportional valves which are self controlling to a set pressure and will match the output pressure with the signal from the controller.
The subject device and the predicate devices in this submission are substantially equivalent. The subject device has the same or similar materials, technology and performance characteristics as the predicate devices. The intended use for the subject device is the same as the predicates. Any differences between the subject and predicate devices are insignificant.
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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected and form a single, abstract shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James G. Carpenter Manager of Regulatory Affairs Hill-Rom, Inc. 1069 State Route 46 East Batesville, Indiana 47006-9167
AUG 26 הפנות AUG
K970636 Re: Totalcare™ Modular Therapy System (MTS) Regulatory Class: II Product Code: IOQ Dated: May 23, 1997 Received: May 28, 1997
Dear Ms. Carpenter:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. James G. Carpenter
This letter will allow you to beqin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Cola M. Witten, Ph.D., M.
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: Unknown
Device Name: TotalCare… MTS
Indications for Use:
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.
| Concurrence of CDHR, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) Division of General Restorative Devices 510(k) Number | ||
| Prescription Use(Per 21 CFR 801 109) | or | Over-The-Counter Use |
(Per 21 CFR 801.109)
§ 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.