TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2

K122473 · Hill-Rom · IOQ · Jun 3, 2013 · Physical Medicine

Device Facts

• Record ID: K122473
• Device Name: TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2
• Applicant: Hill-Rom
• Product Code: IOQ · Physical Medicine
• Decision Date: Jun 3, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5170
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The TotalCare® Bed System is intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy. The TotalCare® Bed System is intended to provide a patient support to be used in health care environments. The TotalCare® Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare® Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution. The TotalCare® Bed System, dependent upon model, is capable of supporting patient populations up to 500 lbs.

Device Story

TotalCare Modular Therapy System is a powered hospital bed frame and control unit (GUI) designed to house various therapeutic surfaces. It articulates to provide multiple patient positions (treatment, sleeping, up-in-bed). Caregivers use the GUI to manage therapy settings and monitor alarms, including patient egress and head-of-bed angle. Used in clinical environments (acute care, ICU, PACU, ED) to provide patient support, Continuous Lateral Rotation Therapy, and Percussion/Vibration Therapy. The system assists in managing complications of immobility and pressure ulcers. Healthcare providers use the interface to adjust therapy and monitor patient status, facilitating clinical decision-making regarding patient positioning and therapeutic intervention. Benefits include reduced risk of pulmonary complications and pressure ulcers through automated therapy delivery.

Clinical Evidence

No clinical data was required for substantial equivalence. Evidence consists of bench testing and a literature review regarding safe patient handling and the benefits of therapy surfaces for patients with prolonged immobility.

Technological Characteristics

Powered hospital bed system with GUI control unit. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-4 (programmable electrical medical systems), and IEC 60601-2-38 (hospital bed safety). Features include articulation, Continuous Lateral Rotation Therapy, and Percussion/Vibration Therapy. Supports up to 500 lbs.

Indications for Use

Indicated for patients requiring support to treat/prevent pulmonary complications or pressure ulcers associated with immobility, or patients benefiting from Continuous Lateral Rotation or Percussion/Vibration therapy. Supports patients up to 500 lbs in acute, critical, step-down, surgical, sub-acute, PACU, and ED settings.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Stryker iBed Wireless with iBed Awareness (K103536)
• Hill-Rom TotalCare (K962942)
• Hill-Rom TotalCare Modular Therapy System (K970636)
• Hill-Rom Rumors DynamicAir (K972111)

Submission Summary (Full Text)

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Hill-Rom 510(k) submission, K122473

JUN

3 2013

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## 510K Summary

| Date Summary was<br>Prepared: | August 10, 2012 |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitted: | Ann Waterhouse, RAC<br>Director, Regulatory Affairs<br>1069 State Route 46 East<br>Batesville, IN 47006<br>[phone]<br>[phone] (facsimile) |
| Device Trade Name: | Hill-Rom TotalCare® Modular Therapy (Bed) System |
| Device Common Name: | Bed, Flotation Therapy, powered Bed,<br>AC powered adjustable hospital bed, Hydraulic adjustable<br>hospital bed |
| Device Product Codes and<br>Classification: | IOQ, Class II<br>Bed, floatation therapy, powered (21 CFR 890.5071)<br>FNL, Class II<br>Bed, AC powered adjustable hospital bed (21 CFR 880.5100)<br>FNK, Class II<br>Bed, Hydraulic adjustable hospital bed (21 CFR 880.5110) |
| Predicate Devices: | Stryker iBed Wireless with iBed Awareness (K103536)<br>Hill-Rom TotalCare (K962942)<br>Hill-Rom TotalCare Modular Therapy System (K970636)<br>Hill-Rom Rumors DynamicAir (K972111) |
| Device Description: | The TotalCare® Modular Therapy (Bed) System is a<br>control unit (GUI) and frame which can house several<br>therapeutic surfaces. The system can articulate to provide<br>different positions for treatment, sleeping, up-in-bed, and<br>other physician recommended positions. The Graphical<br>Caregiver Interface/ Graphical User Interface can be set for<br>alarms such as patient egress and head-of-bed angle. |
| Statement of Intended Use: | The TotalCare® Modular Therapy (Bed) System is<br>intended as a patient support system. It is to be used in<br>health care environments such as, but not limited to, acute<br>care, including critical care, step down/progressive care,<br>medical/surgical, high acuity sub-acute care, post<br>anesthesia care unit (PACU), and sections of the<br>emergency department (ED). The TotalCare® Bed System<br>is capable of being used with a broad patient population as<br>determined appropriate by the caregiver or institution.<br>The TotalCare® Bed System, dependent upon model, is<br>capable of supporting patient populations up to 500 Ibs. |

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Hill-Rom 510(k) submission, K122473

| Indications for Use: | The TotalCare® Bed System is intended to be used to treat<br>or prevent pulmonary or other complications associated<br>with immobility; to treat or prevent pressure ulcers; or for<br>any other use where medical benefits may be derived from<br>either Continuous Lateral Rotation Therapy or<br>Percussion/Vibration Therapy. The TotalCare® Bed<br>System is intended to provide a patient support to be used<br>in health care environments. The TotalCare® Bed System<br>may be used in a variety of settings including, but not<br>limited to, acute care, including critical care, step<br>down/progressive care, medical/surgical, high acuity sub-<br>acute care, post anesthesia care unit (PACU), and sections<br>of the emergency department (ED). The TotalCare® Bed<br>System is capable of being used with a broad patient<br>population as determined appropriate by the caregiver or<br>institution.<br>The TotalCare® Bed System, dependent upon model, is<br>capable of supporting patient populations up to 500 lbs. |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-Clinical Performance<br>Summary: | Hill-Rom has verified and validated that the TotalCare®<br>Modular Therapy Bed System meets functional,<br>performance, safety and efficacy specifications and<br>requirements in compliance with the following international<br>standards:<br><br>IEC 60601-1, Medical Equipment - part 1: General<br>Requirements for Safety, 1990+AI ; 1993+A2<br>1995+Al3;11996<br><br>IEC 60601-1-2; 2001Medical Electrical Equipment Part 1-2<br>General Requirements for Basic Safety and Essential<br>Performance-Collateral Standard: Electromagnetic<br>Compatibility Requirements and Tests<br><br>IEC 60601-1-4; 1996-A 1; 1999 Medical electrical<br>Equipment, Part 1: General requirements for safety-4:<br>Collateral standard: Programmable electrical medical<br>systems<br><br>IEC 60601-2-38 Particular requirements for the safety of<br>Electrically Operated hospital beds. |
| Supporting Data: | Clinical testing was not required for determination of<br>substantial equivalence. A literature review was compiled of<br>articles related to safe patient handling and benefits of<br>therapy surfaces and beds of this type for patients<br>experiencing prolonged immobility. Those articles can be<br>found in the Clinical articles section of the 510(k). |
| Conclusion: | The data herein supports this device, Hill-Rom TotalCare®<br>Modular Therapy (Bed) System as safe, effective, and<br>performing as well as or better than the predicate devices,<br>and therefore is substantially equivalent. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.

## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 3, 2013

Ms. Ann Waterhouse Director of Regulatory Affairs Hill-Rom 1069 Sate Route46 East BATESVILLE, IN 47006-9167

Re: K122473

Trade/Device Name: TotalCare®™ Modular Therapy System Regulation Number: 21 CFR 890.5170 Regulation Name: Powered Flotation Therapy Bed Regulatory Class: II Product Code: IOQ Dated: May 10, 2013 Received: May 21, 2013

Dear Ms. Waterhouse:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 - Ms. Waterhouse

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

| | Susan Runner, DDS, MA |
|--|-----------------------|
|--|-----------------------|

| | Digitally signed by Mary S. Runner-S<br>DN: c=US, o=U.S. Government, ou=HHS,<br>ou=FDA, ou=People, cn=Mary S. Runner- |
|--|-----------------------------------------------------------------------------------------------------------------------|
| | 0.9.2342.19200300.100.1.1=1300087950<br>Date: 2013.06.03 15:18:41 -04'00' |

| | Kwame Ulmer M.S. |
|--|-----------------------------------------------|
| | Acting Division Director |
| | Division of Anesthesiology, General Hospital, |
| | Respiratory, Infection Control and |
| | Dental Devices |
| | Office of Device Evaluation |
| | Center for Devices and |
| | Radiological Health |

Enclosure

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## Indications for Use

510(k) Number (if known): _K122473

Device Name: Hill-Rom TotalCare®™ Modular Therapy System

Indications for Use:

The TotalCare® Bed System is intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy. The TotalCare® Bed System is intended to provide a patient support to be used in health care environments. The TotalCare® Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare® Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.

The TotalCare® Bed System, dependent upon model, is capable of supporting patient populations up to 500 lbs.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | Over-The-Counter Use X<br>(21 CFR 801 Subpart C) |
|-------------------------------------------------|--------------------------------------------------|
|-------------------------------------------------|--------------------------------------------------|

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Richard C. Chapman<br>2013.06.03 15:01:07<br>-04'00' |
|-----------------------------------------------------------------------------------|------------------------------------------------------|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital<br>Infection Control, Dental Devices | |
| 510(k) Number: | K122473 |