(53 days)
Medline Body Holders may be used either in a bed or wheelchair. They are intended to be used to help prevent patients from falling out of bed. They may be used to restrain the waist, chest, or legs. The Body Holders may be used in one of two ways in bed: First, the belts may be crossed in front of the wearer, providing the greatest amount of restraint and limiting the ability to roll. Second, the belts may be crossed in back of the wearer, allowing the ability to roll. The caregiver must determine the method which best suits the amount of mobility desired and provides the greatest comfort and security for the patient.
For use in a wheelchair, use the front side application ONLY.
Medline Patient Safety Products are intended to be used for those patients suffering from temporary medical related cognitive deficits, for agitated patients, or to help patients feel safer in a bed or wheelchair.
Medline Body Holders are designed for use with either a bed or wheelchair. When used in bed, it may be positioned to secure waist, legs or chest. Belts may be crossed on the front side of the wearer or the back side of the wearer. If limited movement is desired, the belts should be crossed on the front side of the wearer. If the belts are crossed on the back side of the wearer, they will be able to roll from side to side.
For use in a wheelchair, use the front side application ONLY.
I apologize, but the provided text describes a medical device, specifically a "Protective Restraint, Body Holder" manufactured by Medline Industries, Inc. The document is a 510(k) submission from 1996, which is a premarket notification demonstrating that a device is at least as safe and effective as a legally marketed predicate device.
The document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria in the way you've outlined for a typical AI/software-as-a-medical-device (SaMD) submission.
Instead, the document focuses on:
- General Description and Intended Use: Explaining what the Medline Body Holder is, how it's used with beds or wheelchairs, and for what purpose (e.g., preventing falls, temporary cognitive deficits, agitated patients).
- Safety and Effectiveness Summary: This section summarizes a literature review of existing information on protective restraints. It identifies potential complications associated with their use (e.g., emotional desolation, fractures, decubitus ulcers, death, strangulation) but attributes these to incorrect supervision, handling, application, patient selection, or inadequate monitoring. It then highlights the benefits when used correctly.
- Citation: A list of thirteen articles reviewed for the 510(k) submission, primarily related to the safety and efficacy of protective restraints in general medical literature and FDA alerts.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided text. The document is for a physical medical device submitted under a regulatory pathway that relies on demonstrating substantial equivalence to pre-1976 or previously cleared predicate devices, rather than a de novo clinical study with quantitative performance metrics as you would typically find for a modern SaMD.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in a bold, sans-serif font. Above and below the text are two triangular shapes that resemble the top and bottom points of a compass. The logo is black and white.
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 18 1996
August 21, 1996
| Device Name: | Protective Restraint, Body Holder |
|---|---|
| Proprietary: | Medline Body Holder |
| Common: | Body Holder |
| Classification: | Protective Restraint |
These devices have been legally marketed prior to the date of this submission, and, in fact, prior to 1976. The intended use and claims, technological features, materials and physical and mechanical specifications have not been changed.
1.0 General Description
Medline Body Holders are designed for use with either a bed or wheelchair. When used in bed, it may be positioned to secure waist, legs or chest. Belts may be crossed on the front side of the wearer or the back side of the wearer. If limited movement is desired, the belts should be crossed on the front side of the wearer. If the belts are crossed on the back side of the wearer, they will be able to roll from side to side.
For use in a wheelchair, use the front side application ONLY.
INTENDED USE
Medline Body Holders may be used either in a bed or wheelchair. They are intended to be used to help prevent patients from falling out of bed. They may be used to restrain the waist, chest, or legs. The Body Holders may be used in one of two ways in bed: First, the belts may be crossed in front of the wearer, providing the greatest amount of restraint and limiting the ability to roll. Second, the belts may be crossed in back of the wearer, allowing the ability to roll. The caregiver must determine the method which best suits the amount of mobility desired and provides the greatest comfort and security for the patient.
For use in a wheelchair, use the front side application ONLY.
{1}------------------------------------------------
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, or to help patients feel safer in a bed or wheelchair.
Medline Body Holders are not intended for use with stretchers, on toilets or shower chairs or in the shower or tub, and should always be secured to the movable portion of the bed frame, never to the side rails.
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.
{2}------------------------------------------------
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, FDA 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 restraints 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.
$"$
{3}------------------------------------------------
CITATION
Physical Restraints: An FDA Update, American Journal of Nursing From FDA Nurses 1992; 74: November 1992, Mary D. Weick, RN, MSN.
Potential Hazards With Protective Restraint Devices; FDA Medical Alert, dated November 14, 1991; MDA91-3
The Misuse of Physical Restraints in the Confused Patient; This paper was presented by Ms. Barbara Fitgerald, Ward Sister, Geriatric Unit, St. James Hospital Dublin at the INO Nursing Association for the Elderly Day Conference in April, 1986.
Federal Register/Vol. 57, No. 119/Friday, June 19, 1992/ Proposed Rules
ﺎﻧ
Potential Hazards with Physical Restraint Devices; FDA Safety Alert, dated July 15, 1992
Restraint and Seclusion; Journal of Psychosocial Nursing, June 1985, Vol. 23, No. 6, Janice M. Roper, RN, MS, Adam Courtts, MS Janet Sather, RN, and Rosella Taylor, RN.
§ 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.