(189 days)
Not Found
No
The summary does not mention AI, ML, or related concepts, and the device description focuses on traditional mechanical and electronic components.
No
The device is described as a customizable hospital bed for various healthcare environments, aiming to improve caregiving and safety. It doesn't mention any direct therapeutic action or medical treatment for a disease or condition. The listed predicate devices are also hospital beds, which are not typically considered therapeutic devices.
No
The provided text describes a "subject device" as a comprehensive product for healthcare environments, capable of customizing a bed and providing a safer environment for caregivers and patients. There is no mention of it being used to diagnose conditions or process medical data for diagnostic purposes. Its intended use is described in terms of caregiving improvements and safety, not diagnosis.
No
The device description explicitly states that the product consists of mechanical, electromechanical, hydraulic, and electronic components, indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description focuses on providing improvements in caregiving and a safer environment for patients and caregivers within healthcare settings. It describes a product used with patients, not for testing samples from patients to diagnose or monitor conditions.
- Device Description: The components listed (mechanical, electromechanical, hydraulic, electronic) are typical of medical equipment used for patient care, such as hospital beds, rather than laboratory or testing equipment.
- Lack of IVD-specific information: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), diagnostic testing, or providing diagnostic information.
The description strongly suggests this device is a type of medical bed or similar patient care equipment used in a clinical setting. IVD devices are specifically designed for testing samples outside of the body to provide diagnostic information.
N/A
Intended Use / Indications for Use
The subject hospital bed 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.
Product codes
80FNL
Device Description
The product consists of mechanical, electromechanical, hydraulic, and electronic components. 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 platform has an optional radiotranslucent surface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
broad patient population
Intended User / Care Setting
health care environments 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).
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
§ 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.
0
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.
1
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 ●