(189 days)
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
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.
This document is a 510(k) Premarket Notification Summary for an AC powered hospital bed (TotalCare®). The provided text describes the device's intended use, classification, and lists performance standards it complies with.
However, the provided text does not contain any information about acceptance criteria, device performance metrics (such as sensitivity, specificity, accuracy), or any study details that would prove the device meets such criteria.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results or effect size.
- Standalone performance study details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document focuses on regulatory compliance with electrical and safety standards for an AC powered hospital bed, not on clinical performance metrics typically associated with AI/medical imaging devices where such detailed performance studies and acceptance criteria are relevant.
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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: (812) 934-1671 Fx: (812) 934-1675
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
ldentification 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 lonizing 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 ●
§ 880.5100 AC-powered adjustable hospital bed.
(a)
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.(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 § 880.9.