(45 days)
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.
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.
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.
The provided text describes a medical device, the Medline Zippered Sleeved Vest Restraint, and discusses its safety and effectiveness based on a review of existing literature. However, it does not contain information about a specific study conducted to prove the device meets acceptance criteria. Instead, it relies on a summary of and citation to safety and effectiveness data found in a search of medical literature and company documents.
Therefore, the following information is not present in the provided text:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information about a standalone (algorithm only) performance study.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a specific device study.
- Sample size for the training set.
- How ground truth for the training set was established.
The text does explain the device's intended use, general description, and lists potential hazards and benefits identified in a literature review. It explicitly states: "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."
Summary of what can be extracted related to "acceptance criteria" and "study":
1. Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria (Implied from Literature Review): The device is safe and effective when used correctly and for indicated circumstances. This is derived from the "Specific safety and effectiveness data outlined in the literature" which discusses both complications and benefits. The implication is that the device should avoid the listed complications and achieve the listed benefits.
- Saftey: Avoidance of emotional desolation, agitation, fractures, chafing, burns, nerve damage, circulatory impairment, decubitus ulcers, death, and strangulation due to inappropriate use or application.
- Effectiveness: Precluding patients with temporary medical-related cognitive deficits from impairing the resolution of their physical problems; temporarily reducing the mobility of agitated patients; helping patients feel safer in a bed or wheelchair.
- Reported Device Performance: The document does not provide specific performance metrics for the Medline Zippered Sleeved Vest Restraint itself. Instead, it refers to a general understanding of protective restraints' safety and efficacy based on the reviewed articles.
2. The "Study" (Literature Review) that Proves the Device Meets Acceptance Criteria:
The "study" referenced is a literature review conducted for the 510(k) submission.
- Nature of the Study: A reasonable search of all information known or otherwise presently available to Medline Industries, Inc. was conducted, specifically examining articles in medical literature and company documents concerning safety and effectiveness information for safety restraints.
- Data Provenance (Source of "Study" Data): The data comes from 13 reviewed articles in medical literature, including publications from the FDA, nursing journals, and conference papers from various years (e.g., 1985, 1986, 1991, 1992). The data is retrospective, as it's based on existing published information. The countries of origin for the data are not explicitly stated for all articles, but references to the American Journal of Nursing and FDA Medical Alerts suggest a significant U.S. origin.
- Sample Size: The sample size is not applicable in the traditional sense of a clinical trial. The "sample" is the set of 13 articles reviewed. The number of patients or cases discussed within those articles is not specified.
- Number of Experts and Qualifications: Not specified. The literature itself would have been written by experts, but the process of Medline's review does not detail the number or qualifications of the individuals who performed the literature search and summary.
- Adjudication Method: Not applicable. This was a literature review, not a study involving expert adjudication of cases.
- MRMC Comparative Effectiveness Study: No.
- Standalone Performance Study: No. This document describes a review of existing literature, not a standalone study of the Medline device.
- Type of Ground Truth: The "ground truth" is derived from the consensus and findings reported in the peer-reviewed medical literature and regulatory alerts regarding the safety and effectiveness of protective restraints in general. This includes reported outcomes data (complications, benefits) from various clinical experiences and expert opinions within those publications.
- Sample Size for Training Set: Not applicable. There is no "training set" as this is not an AI or machine learning device, nor is it a de novo clinical trial.
- How Ground Truth for Training Set was Established: Not applicable.
In essence, the document asserts the device's safety and effectiveness by demonstrating that its characteristics align with generally accepted knowledge and research on protective restraints, as summarized from existing medical literature. It's a pre-market notification (510(k)) where equivalence to legally marketed predicate devices and established safety/effectiveness principles from literature are the primary means of demonstrating compliance, rather than a new standalone clinical study.
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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.
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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.
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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 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.
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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.
§ 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.