(50 days)
Not Found
No
The device description and intended use clearly describe a physical restraint made of fabric and straps. There is no mention of any computational or data-driven components, let alone AI or ML. The performance studies focus on literature review regarding the safety and effectiveness of physical restraints in general.
No.
The device is described as a "Patient Safety Product" and a "protective restraint device" used to help keep patients upright, prevent sliding, or make them feel safer. It is explicitly stated that these products are "not intended to preclude good nursing care and common sense," and the intended use does not mention treating a disease or improving a clinical condition. It is a support/restraint device, not a therapeutic one.
No
Explanation: The "Intended Use / Indications for Use" section clearly states that the Medline Pelvic Holders are used to help keep patients upright and prevent sliding, and to help patients feel safer. None of the descriptions mention diagnosis or identifying a medical condition. It's a support and safety device, not a diagnostic one.
No
The device description explicitly states it is made of "canton flannel and are secured by polyester web straps," indicating it is a physical, hardware-based device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use of the Medline Pelvic Holders clearly state their purpose is to physically restrain patients in beds or wheelchairs to maintain position and prevent sliding. They are external physical devices, not used for testing biological samples.
The text focuses on the physical application and function of the device for patient positioning and safety, not on any form of diagnostic testing.
N/A
Intended Use / Indications for Use
Medline Pelvic Holders may be used either in a bed or wheelchair. They are intended to be used to help keep the patient upright and to help prevent them from sliding down in a wheelchair or for use in a bed to help prevent the patient from sliding down. They may be used alone or in tandem with a vest restraint.
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, to help patients maintain position or to help prevent them from sliding down in a bed or wheelchair, or they may be used to help patients feel safer in a bed or wheelchair.
Product codes
Not Found
Device Description
Medline Pelvic Holders are designed for use with either a bed or wheelchair. They are used to help hold the patient upright and help prevent sliding in a wheelchair, or to help prevent the patient from sliding down in bed. They may be used alone or in combination with a vest restraint. They are made of canton flannel and are secured by polyester web straps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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. 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 monitoring 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, helping patients maintain an upright position in a wheelchair, helping to prevent patients from sliding down in a bed or wheelchair, 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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 bold, sans-serif font. Above the text is a compass-like symbol with four points. The symbol is black and appears to be pointing in the four cardinal directions.
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
10/11/96
OCT 18 1996
August 26, 1996
| Device Name: | Protective Restraint, Pelvic Holder |
|---|---|
| Proprietary: | Medline Pelvic Holder |
| Common: | Pelvic Holder |
| Classification: | Protective Restraint |
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 Pelvic Holders are designed for use with either a bed or wheelchair. They are used to help hold the patient upright and help prevent sliding in a wheelchair, or to help prevent the patient from sliding down in bed. They may be used alone or in combination with a vest restraint. They are made of canton flannel and are secured by polyester web straps.
INTENDED USE
Medline Pelvic Holders may be used either in a bed or wheelchair. They are intended to be used to help keep the patient upright and to help prevent them from sliding down in a wheelchair or for use in a bed to help prevent the patient from sliding down. They may be used alone or in tandem with a vest restraint.
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, to help patients maintain position or to help prevent them from sliding down in a bed or wheelchair, or they may be used to help patients feel safer in a bed or wheelchair.
Mediine Pelvic 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 restrain is contraindicated), incorrect restraint selection, errors in correctly applying the device, and/or inadequate monitoring 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, helping patients maintain an upright position in a wheelchair, helping to prevent patients from sliding down in a bed or wheelchair, 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
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.