(187 days)
Not Found
No
The description mentions a "microprocessor controlled air system" and "software," but there is no mention of AI, ML, or any related concepts like training data, test data, or performance metrics typically associated with AI/ML devices. The functionality described is consistent with traditional automated control systems.
Yes
The product's intended use clearly states it is "used to prevent and treat conditions where reduction of interface pressure is beneficial." It also mentions "maintaining tissue viability around bony prominences, such as the buttocks and heels, both areas prone to ulceration and bed sores," which describes therapeutic benefits.
No
The device is described as a "patient Air Flotation Bed surface" used for prevention and treatment of conditions where pressure reduction is beneficial, not for diagnosis.
No
The device description explicitly states it consists of a mattress and a control unit with hardware components like a microprocessor-controlled air system and proportional air valves. While it mentions software within the Surface Control Modules, it is clearly integrated with and controls physical hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The provided description clearly states that this device is a mattress and control unit designed to manage interface pressure on a patient's body. Its purpose is to prevent and treat conditions related to pressure, such as bed sores.
- Lack of Specimen Analysis: There is no mention of this device collecting or analyzing any biological specimens from the patient. Its function is entirely external and mechanical, focused on supporting the patient's body.
Therefore, based on the provided information, this device falls under the category of a medical device used for patient support and pressure management, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
IOQ
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.
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
general patient population
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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.
2
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.
4
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)