(43 days)
Medline Wheelchair Safety Belt Restraints are intended for use with patients or residents that need a "gentle reminder" for the patient to stay in their wheelchair or to remind them to seek assistance before standing. These products are also intended to help prevent falls or to help the patient feel safer in their wheelchair. Several of the designs are intended to enable the user to release them, per O.B.R.A. regulations. These products are designed for use with a carefully defined medical treatment program which addresses (but is not limited to) restorative nursing, patient release, and pressure sore prevention. Aggressive, agitated or restless patients require increased monitoring and a systematic review and evaluation of both their physical and psychological status.
Medline Patient Safety Products are intended to be used for those patients suffering from temporary medical related cognitive deficits, for agitated patients, for patients that are at risk for a life threating fall or fall that may cause serious injury or re-injury, or to help patients feel safer in wheelchair.
Medline Wheelchair Safety Belt Restraints are not intended for use with stretchers, on toilets or shower chairs or in the shower or tub.
Medline Patient Safety Products are not intended for use in a motorized vehicle, as they are not designed to withstand the force of a crash.
Medline Patient Safety Products are not intended for home use.
These devices are for use in hospitals and/or nursing homes to help maximize patient safety and are not intended to preclude good nursing care and common sense.
Medline's Wheelchair Safety Belts are intended to be utilized as a "gentle reminder" for patients to stay in their wheelchair or not to attempt to stand without assistance. They are intended to help the patient feel safer or more secure in their wheelchair. Two of the items are designed to be able to be released by the patient.
The first two items are not designed to be released by the wearer:
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A. Wheelchair Waist Belt
Made of 2" nylon web. Belt circles patient's waist and passes through a slid buckle in front for individual fit. Belt criss-crosses in back and attaches to kick spurs at rear of wheelchair. -
B. Economy Wheelchair Belt
Made of 2" nylon web. Similar to the Wheelchair Waist Belt except this item does not have the slide buckle in front. Belt goes around wearer's waist and attaches to the kick spurs using an adjustable loop.
The following three items are designed to be released by the wearer:
-
C. Two-Piece Safety Soft Belt
Hook and Loop (Velcro) closure enables the wearer to release the belt by themselves as required by the O.B.R.A. regulations. Padded belt made of blue knit material for extra comfort. -
D. Wheelchair Belt with Buckle
Made of 2" nylon web. Quick release buckle enables the wearer to release the belt by themselves as required by the O.B.R.A. regulations. -
ய் Wheelchair Belt with Hook & Loop
Made of 2" nylon web. Hookk and Loop closure in the front enables the wearer to release the belt by themselves as required by the O.B.R.A. regulations.
This documentation describes a medical device, specifically Medline Wheelchair Safety Belts, and details their intended use and safety considerations, but it does not contain information about acceptance criteria or a study proving that the device meets those criteria.
The provided text is a "SAFETY AND EFFECTIVENESS SUMMARY" for a 510(k) submission (K963569) to the FDA. This type of submission is for devices substantially equivalent to legally marketed predicate devices, and often relies on existing literature and comparisons rather than new clinical trials with acceptance criteria.
Here's a breakdown of why the requested information cannot be extracted from the given text:
- No acceptance criteria are defined: The document lists potential complications and benefits but does not quantify performance metrics or set thresholds for success (e.g., "The device must reduce falls by X%").
- No specific study is described that tests performance against acceptance criteria: The document mentions reviewing "thirteen articles" for safety and efficacy data, but these are general literature reviews, not a specific study conducted by Medline Industries with defined acceptance criteria and methods to evaluate its own device against them.
- No details on sample size, data provenance, ground truth establishment, MRMC studies, or standalone performance are provided.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor details about a study proving device acceptance, as this information is not present in the provided text.
The document primarily focuses on:
- Device Description: Discusses different types of wheelchair belts (e.g., Wheelchair Waist Belt, Two-Piece Safety Soft Belt).
- Intended Use: Specifies who can use the belts ("gentle reminder" for patients to stay in their wheelchair, prevent falls, help feel safer) and who cannot (stretchers, motorized vehicles, home use). It also highlights the importance of use within a defined medical treatment program and increased monitoring for aggressive patients.
- Safety and Effectiveness Summary: Reviews potential complications from the literature (e.g., emotional desolation, fractures, decubitus ulcers, death) attributed to incorrect use or patient selection of restraints in general. It also mentions benefits when used correctly.
- Regulatory Context: Indicates that these devices were legally marketed prior to the submission date and that their features have not changed. It also references O.B.R.A. regulations regarding patient release mechanisms.
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Image /page/0/Picture/0 description: The image shows the word "MEDLINE" in bold, italicized font. Below the word is a compass-like symbol with four points. The top point is wider than the bottom point.
Medline Industries, Inc.
One Medline Place Mundelein, Illinois 60060.4486
1.847.949.3109 1.800.950.0128 Fax 1.847.949.2643
Corporate Quality Assurance/Regulatory Affairs
SAFETY AND EFFECTIVENESS SUMMARY
Medline Industries, Inc. One Medline Place Mundelein, IL 60060 Phone #: (847) 949-2639 Fax #: (847) 949-2643 Lara N. Simmons Corporate Regulatory Affairs Manager
OCT 1 8 1996
August 29, 1996
Device Name: Wheelchair Accessory, Wheelchair Safety Belt Proprietary: Medline Wheelchair Safety Belt, Medline Two-Piece Safety Soft Belt, Medline Wheelchair Belt, Medline Wheelchair Lock Belt Common: Wheelchair Belt Classification: Wheelchair Accessory
These devices have been legally marketed prior to the date of this submission. The intended use and claims, technological features, materials and physical and mechanical specifications have not been changed.
1.0 General Description
.......
Medline's Wheelchair Safety Belts are intended to be utilized as a "gentle reminder" for patients to stay in their wheelchair or not to attempt to stand without assistance. They are intended to help the patient feel safer or more secure in their wheelchair. Two of the items are designed to be able to be released by the patient.
The first two items are not designed to be released by the wearer:
-
A. Wheelchair Waist Belt
Made of 2" nylon web. Belt circles patient's waist and passes through a slid buckle in front for individual fit. Belt criss-crosses in back and attaches to kick spurs at rear of wheelchair. -
B. Economy Wheelchair Belt
Made of 2" nylon web. Similar to the Wheelchair Waist Belt except this item does not have the slide buckle in front. Belt goes around wearer's waist and attaches to the kick spurs using an adjustable loop.
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The following three items are designed to be released by the wearer:
-
C. Two-Piece Safety Soft Belt
Hook and Loop (Velcro) closure enables the wearer to release the belt by themselves as required by the O.B.R.A. regulations. Padded belt made of blue knit material for extra comfort. -
D. Wheelchair Belt with Buckle
Made of 2" nylon web. Quick release buckle enables the wearer to release the belt by themselves as required by the O.B.R.A. regulations. -
ய் Wheelchair Belt with Hook & Loop
Made of 2" nylon web. Hookk and Loop closure in the front enables the wearer to release the belt by themselves as required by the O.B.R.A. regulations.
INTENDED USE
Medline Wheelchair Safety Belt Restraints are intended for use with patients or residents that need a "gentle reminder" for the patient to stay in their wheelchair or to remind them to seek assistance before standing. These products are also intended to help prevent falls or to help the patient feel safer in their wheelchair. Several of the designs are intended to enable the user to release them, per O.B.R.A. regulations. These products are designed for use with a carefully defined medical treatment program which addresses (but is not limited to) restorative nursing, patient release, and pressure sore prevention. Aggressive, agitated or restless patients require increased monitoring and a systematic review and evaluation of both their physical and psychological status.
Medline Patient Safety Products are intended to be used for those patients suffering from temporary medical related cognitive deficits, for agitated patients, for patients that are at risk for a life threating fall or fall that may cause serious injury or re-injury, or to help patients feel safer in wheelchair.
Medline Wheelchair Safety Belt Restraints are not intended for use with stretchers, on toilets or shower chairs or in the shower or tub.
Medline Patient Safety Products are not intended for use in a motorized vehicle, as they are not designed to withstand the force of a crash.
Medline Patient Safety Products are not intended for home use.
These devices are for use in hospitals and/or nursing homes to help maximize patient safety and are not intended to preclude good nursing care and common sense.
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A reasonable search of all information known or otherwise presently available to Medline Industries, Inc. has been conducted. Such a search is defined as examining articles in medical literature, and company documents concerning safety and effectiveness information for safety restraints. Following is a summary of and citation to the safety and effectiveness data found in that search.
Specific safety and effectiveness data outlined in the literature include actual as well as potential complications which may occur and are summarized as follows:
Emotional desolation, agitation, fractures, chafing, burns, nerve damage, circulatory impairment, decubitus ulcers, death, and strangulation attributed to incorrect supervision, handling or application of protective restraint devices by medical or paramedical personnel. These incidences seem to be the result of inappropriate patient selection (physically restraining a patient for whom physical restraint is contraindicated), incorrect restraint selection, errors in correctly applying the device, and/or inadequate monitory of patients when restrained.
When used correctly and for indicated circumstances, protective restrains provide benefits to many patients, such as precluding patients with temporary medical related cognitive deficits from impairing the resolution of their physical problems by involuntarily discontinuing life-support or other needed medical interventions, temporarily reducing the mobility of agitated patients, or helping patients feel safer in a bed or wheelchair.
Medline Industries, Inc. offers a variety of additional materials to help insure the safe and proper use of it's patient safety products, including posters and videos. Medline Industries, Inc. stresses the importance of patient monitoring, and that these products should only be used upon advice of a physician or other trained, licensed healthcare professional.
A total of thirteen articles were reviewed for this 510(k) submission. The articles listed in the citation contained pertinent data for establishing the safety and efficacy of protective restraints.
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§ 880.6760 Protective restraint.
(a)
Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.