(90 days)
The intended use of Nova Technologies, Inc.'s Novabed System is to transfer a patient from or to the bed.
The cleared model of the Novabed System, which consists of a bed, a wheelchair, and a footrest attachment, is used to transfer a patient from or to a bed. The bed has a conveyor sheet which is pulled by rollers towards the foot of the bed during a patient transfer from the bed and towards the head of the bed during patient transfer to the bed. Each end of the conveyor sheet is connected to a motorized roller at each end of the bed. During transfer, the patient is moved to the end of the bed and, when partially on the pivoted wheelchair seat and legrest and partially on the bed, the patient is elevated to a vertical sitting position by the elevation of the bed against which the patient's back is resting. As the patient is elevated to a sitting position by the bed, the wheelchair automatically pivots until the seat is horizontal and the legrest vertical. The transfer is complete when the attendant disconnects the wheelchair from the bed and mounts the backrest to the wheelchair.
Nova is seeking clearance to modify the cleared Novabed System and market four models of the device with the modifications. Nova intends to make the following modifications to the cleared Novabed System: (1) integrate the tilt table's footrest into the bed; (2) replace the discrete logic in the bed's electronic control unit with a microprocessor; (3) replace the motor used to automatically pivot the wheelchair ("the pivot motor") with a lever that an attendant can use to manually pivot the wheelchair: (4) replace the pivot motor and linkage mounted on the wheelchair with a motor and draw-bar mounted on the bed; (5) replace the wire cable driven by a linear actuator with a parallel linkage with a cantilever driven by a linear actuator to raise or lower the bed; (6) replace the wire cable that is used to create a data link between the bed and wheelchair with optical couplers; and (7) replace circuits in the sheet motor with reversible motor drive circuitry.
The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. Instead, it describes a 510(k) summary for the "Novabed Patient Transfer System," focusing on its intended use, substantial equivalence to a predicate device, and proposed modifications.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input. The requested details such as sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, and training set information are not present in this document.
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JAN 22 1997
510(k) Summary
Nova Technologies, Inc.'s
Novabed Patient Transfer System
Submitter's Name, Address, and Telephone Number
Nova Technologies, Inc. 545 Middle Street Bristol, CT 06010 Telephone: (860) 589-8200 (860) 589-5944 Facsimile:
Contact Person
Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. 555 13th Street, N.W. Washington, D.C. 20004-1109 (202) 637-5794 Phone: (202) 637-5910 Facsimile:
as Regulatory Counsel to Nova Technologies, Inc.
Date Prepared
October 11, 1996
Name of Device
Novabed Patient Transfer System
Classification Names
Powered Patient Transfer System, AC-Powered Hospital Bed, and Mechanical Wheelchair
Common Name
Patient Transfer System
Product Codes -
FRZ, FNL, and IOR
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Predicate Devices
Novabed Patient Transfer System
Intended Use
The intended use of Nova Technologies, Inc.'s Novabed System is to transfer a patient from or to the bed.
Substantial Equivalence
The cleared model of the Novabed System, which consists of a bed, a wheelchair, and a footrest attachment, is used to transfer a patient from or to a bed. The bed has a conveyor sheet which is pulled by rollers towards the foot of the bed during a patient transfer from the bed and towards the head of the bed during patient transfer to the bed. Each end of the conveyor sheet is connected to a motorized roller at each end of the bed. During transfer, the patient is moved to the end of the bed and, when partially on the pivoted wheelchair seat and legrest and partially on the bed, the patient is elevated to a vertical sitting position by the elevation of the bed against which the patient's back is resting. As the patient is elevated to a sitting position by the bed, the wheelchair automatically pivots until the seat is horizontal and the legrest vertical. The transfer is complete when the attendant disconnects the wheelchair from the bed and mounts the backrest to the wheelchair.
Nova is seeking clearance to modify the cleared Novabed System and market four models of the device with the modifications. Nova intends to make the
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following modifications to the cleared Novabed System: (1) integrate the tilt table's footrest into the bed; (2) replace the discrete logic in the bed's electronic control unit with a microprocessor; (3) replace the motor used to automatically pivot the wheelchair ("the pivot motor") with a lever that an attendant can use to manually pivot the wheelchair: (4) replace the pivot motor and linkage mounted on the wheelchair with a motor and draw-bar mounted on the bed; (5) replace the wire cable driven by a linear actuator with a parallel linkage with a cantilever driven by a linear actuator to raise or lower the bed; (6) replace the wire cable that is used to create a data link between the bed and wheelchair with optical couplers; and (7) replace circuits in the sheet motor with reversible motor drive circuitry.
The modified models of the Novabed System have the same intended use as the cleared Novabed System: to transfer a patient to or from the bed. They also have equivalent principles of operation and technological characteristics as they use a conveyor sheet to pull the patient along the bed to a footrest that functions as a tilt table or wheelchair with a footrest that is attached to a bed and they pivot the wheelchair to align it with the bed for patient transfer. The minor technological differences between certain modified models of the device and the cleared Novabed System namely, the integration of the footrest, the attachment of the wheelchair pivot motor to the bed and the use of different linkage, the use of a parallel linkage with a cantilever, the use of an optical coupler, the use of a handheld lever to pivot the wheelchair, and the use of reversible motor drive circuitry in the sheet motor, do not raise new questions of safety or effectiveness. In addition.
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the software verification and validation demonstrate that the use of the microprocessor does not raise any new questions of safety or effectiveness. Thus, the modified models of the Novabed System are substantially equivalent to the cleared Novabed System.
§ 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.