TOTALCARE

K962942 · Hill-Rom, Inc. · FNL · Feb 3, 1997 · General Hospital

Device Facts

• Record ID: K962942
• Device Name: TOTALCARE
• Applicant: Hill-Rom, Inc.
• Product Code: FNL · General Hospital
• Decision Date: Feb 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5100
• Device Class: Class 2

Indications for Use

The subject device is intended to be used as a comprehensive product ideally suited to be used in health care environments. The product 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 product is capable of being used with a broad patient population as determined appropriate by the caregiver or institution. The device is intended to provide significant improvements in caregiving and a safer environment for caregiver and patient.

Device Story

TotalCare is an AC-powered hospital bed for healthcare environments. Device utilizes manual, hydraulic, and electric power to adjust bed positioning. Components include mechanical, electromechanical, and electronic systems. Caregivers customize bed configurations based on patient needs. Optional radiotranslucent surface allows for imaging. Device enhances caregiving environment and patient safety. Used in acute, critical, and sub-acute care settings.

Clinical Evidence

Bench testing only. Compliance with UL 2601-1, CSA C22 No. 601.1, UL 1069, IEC 601-1, IEC 601-1-2, and IEC 601-2-38 (draft). Radiotranslucent surface tested for compliance with 21 CFR 1020.

Technological Characteristics

AC-powered hospital bed; mechanical, hydraulic, and electromechanical actuation. Includes electronic components. Optional radiotranslucent surface. Standards: UL 2601-1, CSA C22 No. 601.1, UL 1069, IEC 601-1, IEC 601-1-2, IEC 601-2-38.

Indications for Use

Indicated for use in healthcare environments including acute care, critical care, step-down/progressive care, medical/surgical, high-acuity sub-acute care, PACU, and ED. Suitable for a broad patient population as determined by the caregiver or institution.

Regulatory Classification

Identification

An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.

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 § 880.9.

Predicate Devices

• Advance Series (K922352)
• Burke Bariatric Treatment System (K925576)
• Critical Care Hospital Bed (K915437)

Submission Summary (Full Text)

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K962942
FEB - 3 1997
July 22, 1996

# 510(k) PREMARKET NOTIFICATION SUMMARY

## Submitter's name and address:

Hill-Rom, Incorporated
1069 St. Route 46 East
Batesville, IN 47006

## Contact person, telephone number and fax number:

James G. Carpenter
Hill-Rom, Incorporated
Ph: [phone]
Fx: [phone]

## Device Trade or proprietary name:

TotalCare®

## Device common or usual name:

AC powered hospital bed

## Device classification name:

General Hospital and personal use devices
80FNL
880.5100, AC powered hospital bed

## Identification of the marketed device(s) to which equivalence is claimed:

K922352 Advance Series, Hill-Rom, Inc.
K925576 Burke Bariatric Treatment System, Burke Mobility Products
K915437 Critical Care Hospital Bed, Hill-Rom, Inc.

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# Summary:

The subject hospital bed and predicate hospital beds in this submission are substantially equivalent. The subject device has the same or similar materials, technology and performance characteristics as the predicate devices. The subject device is intended to be used as a comprehensive product ideally suited to be used in health care environments.

The product 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 product is capable of being used with a broad patient population as determined appropriate by the caregiver or institution. The device is intended to provide significant improvements in caregiving and a safer environment for caregiver and patient.

These capabilities are achieved using manual, hydraulic and/or electric power. Various proposed accessories, and options will be available to supplement the capabilities and convenience of the product in the field. The product consists of mechanical, electromechanical, hydraulic, and electronic components. These may be selected by the caregiver or institution to customize the bed to specific patient population needs.

Performance standards for the device have not been established under Section 514 of the FD&C Act. The platform has an optional radiotranslucent surface. Testing and procedures for the surface have been implemented to assure compliance with performance standards established under 21 CFR 1020 "Performance Standard for Ionizing Radiation Emitting Products." The products shall comply with the following documents:

- UL 2601-1 (1st Edition) Medical Electrical Equipment Regulatory Standard
- CSA C22, No. 601.1 Canadian Safety Standard
- UL 1069 (4th Edition) Hospital Signaling & Nurse Call Equipment Regulatory Standard
- IEC 601-1 (Second Edition) Medical Electrical Equipment - General Requirements for Safety
- IEC 601-1-2 (First Edition) Collateral Standard - Electromagnetic Compatibility
- IEC 601-2-38 (Draft) Particular Bed Standard