(45 days)
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No
The document describes a physical restraint device and does not mention any computational or data-driven components.
No.
The device is clearly stated to be a patient safety device for physical restraint, not a therapeutic device. It is intended to help maximize patient safety and assist with a medical treatment program but does not provide therapy itself.
No
Explanation: The device is described as a patient safety device used for physical restraint, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical vest with sleeves and a zipper, intended for physical restraint. It is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "patient safety device when physical restraint of the patient is deemed necessary." It's used to limit a patient's movement in a bed or wheelchair.
- Device Description: The description reinforces its function as a physical restraint device.
- Lack of IVD Characteristics: The text does not mention any of the key characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or treatment.
- Using reagents or other in vitro methods.
The device is a physical restraint used for patient safety and management, not for diagnostic testing performed outside the body.
N/A
Intended Use / Indications for Use
Medline Zippered Sleeved Vest Restraints may be used either in a bed or wheelchair. They are intended for use with patients or residents that need a "gentle reminder" for the patient to stay in their bed or wheelchair. 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.
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's Zippered Sleeved Vests are intended to be utilized as a patient safety device when physical restraint of the patient is deemed necessary. TThey may be utilized in either a bed or wheelchair. The short sleeves and zippered back make the vest more difficult for the patient to remove. Vest may be used with detachable shoulder straps (provided) to help prevent sliding down in the wheelchair or bed.
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
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Indicated Patient Age Range
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Intended User / Care Setting
Hospitals and/or nursing homes; upon advice of 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
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 restrain 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.
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.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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 stylized, italicized font. Above and below the word, there are two black shapes that resemble a compass or a stylized star. The shapes are symmetrical and point outwards from the center of the word.
One Medline Place Mundelein, Illinois 60060.4486 1.847.949.3109 1 800 950 0128 Fax 1.847.949.2643
K96 3452
Corporate Ouality 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 28, 1996
| Device Name: | Protective Restraint, Vest |
|---|---|
| Wheelchair Accessory, Vest Restraint | |
| Proprietary: | Medline Zippered Sleeved Vest Restraint |
| Common: | Vest Restraint |
| Classification: | Protective Restraint |
| 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 Zippered Sleeved Vests are intended to be utilized as a patient safety device when physical restraint of the patient is deemed necessary. TThey may be utilized in either a bed or wheelchair. The short sleeves and zippered back make the vest more difficult for the patient to remove. Vest may be used with detachable shoulder straps (provided) to help prevent sliding down in the wheelchair or bed.
INTENDED USE
Medline Zippered Sleeved Vest Restraints may be used either in a bed or wheelchair. They are intended for use with patients or residents that need a "gentle reminder" for the patient to stay in their bed or wheelchair. 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.
1
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 Zipper Sleeved Vest Restraints 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. Vest restraints may get tight over the chest, possibly compromising breathing, in which case the patient may require a safety product with a pelvic portion between the legs.
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, 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 restrain 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.
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
Potential Hazards with Physical Restraint Devices; FDA Safety Alert, dated July 15, 1992 1. -
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.