(53 days)
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No
The 510(k) summary describes a physical restraint device and contains no mention of AI, ML, or related technologies.
No.
The device is a restraint product intended to prevent patients from falling and to manage agitated patients. It is not used for diagnosis, prevention, monitoring, treatment, or alleviation of disease, nor for the treatment or alleviation of an injury or handicap.
No
The provided text describes a physical restraint device used to prevent falls, not a device used to diagnose a medical condition.
No
The device description clearly indicates a physical product ("Belts may be crossed on the front side of the wearer or the back side of the wearer") designed for physical restraint, not a software application.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Medline Body Holders are physical restraints used to prevent patients from falling out of a bed or wheelchair. They are applied externally to the body (waist, chest, or legs).
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples or performing any diagnostic tests.
The device is a physical restraint intended for patient safety and mobility management, not for diagnosing any medical condition.
N/A
Intended Use / Indications for 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.
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.
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.
Product codes
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Device 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Body, waist, legs, chest
Indicated Patient Age Range
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Intended User / Care Setting
Hospitals and/or nursing homes. Intended user is a physician or other trained, licensed healthcare professional.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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
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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.