(50 days)
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.
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.
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.
This document, K963404, is a 510(k) premarket notification for a Class I medical device (Protective Restraint, Pelvic Holder). As such, it does not contain the kind of detailed study design, acceptance criteria, and performance data typically associated with a clinical trial for a novel device. Instead, the focus is on demonstrating substantial equivalence to a legally marketed predicate device.
Here's why many of your requested items cannot be found in this document:
- Acceptance Criteria & Reported Device Performance (Table): This document does not establish new, quantitative acceptance criteria for device performance because it's not a de novo clearance or a clinical trial for a new technology. The "performance" is inherently based on the established safety and effectiveness of predicate devices and general medical literature regarding restraints.
- Sample Size (Test Set), Data Provenance, Experts for Ground Truth, Adjudication, MRMC Study, Standalone Study, Type of Ground Truth, Training Set Size, Training Set Ground Truth: These concepts are central to clinical validation studies for devices that require proof of clinical efficacy or diagnostic accuracy. A 510(k) for a Class I mechanical restraint, especially one legally marketed prior to the submission, does not involve such studies. The "study" here is a literature review to confirm the general safety and effectiveness principles of such devices.
What is present in the document and how it relates to "acceptance criteria" and "study":
The "study" performed for this 510(k) is a literature review of existing safety and effectiveness data for protective restraint devices.
1. A table of acceptance criteria and the reported device performance:
As explained, there isn't a table of quantitative acceptance criteria for this specific device in the clinical sense. The "acceptance criteria" for a 510(k) of this nature are that the device is substantially equivalent to a predicate device and adheres to general safety principles for its class, as evidenced by existing medical literature.
The "reported device performance" is qualitative and based on the established understanding of pelvic holders from the cited literature.
| Acceptance Criteria (Implicit for 510(k) of this type) | Reported Device Performance (from literature review) |
|---|---|
| Safety: Device, when used correctly, does not introduce new or unexpected risks beyond those associated with all protective restraints. | The literature review acknowledges potential hazards (emotional desolation, agitation, fractures, chafing, burns, nerve damage, circulatory impairment, decubitus ulcers, death, strangulation) but attributes them to incorrect supervision, handling, application, patient selection, or inadequate monitoring, rather than inherent device defect, assuming proper use. The device itself is not described as introducing new types of harm. |
| Effectiveness: Device effectively serves its intended purpose. | When used correctly and for indicated circumstances, protective restraints (including pelvic holders) provide benefits such as: - Precluding patients with temporary medical-related cognitive deficits from impairing resolution of physical problems. - Temporarily reducing 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. - Helping patients feel safer in a bed or wheelchair. |
| Substantial Equivalence: Device shares fundamental technological characteristics with legally marketed predicate devices and has the same intended use. (Not explicitly stated as "performance" but a core "acceptance criterion" for 510(k) submission). | The submission states: "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." This is the basis for substantial equivalence, implying performance similar to existing, accepted devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable. There was no specific "test set" of patients or devices. The "data" comes from a review of previously published medical and regulatory literature.
- Data Provenance: The articles cited in the literature review would have their own provenance, but this document does not detail it. The journals cited (e.g., American Journal of Nursing, Journal of Psychosocial Nursing) suggest a retrospective review of existing publications, likely originating from the US and possibly other countries (e.g., article from St. James Hospital Dublin).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. There was no "test set" with "ground truth" to be established by experts for this specific device. The experts involved would be the authors of the cited articles and the FDA personnel who developed the alerts and rules referenced. The qualifications of these individuals are not detailed in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set requiring expert adjudication was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a mechanical restraint, not an imaging or diagnostic device. AI assistance and MRMC studies are not relevant to its regulatory pathway or testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the context of a prospective study. The "truth" or understanding of safety and effectiveness is derived from published medical literature, regulatory alerts (FDA), and company documents concerning protective restraints in general. This includes descriptions of potential complications (outcomes data) and general expert understanding summarized in those publications.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable.
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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 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.
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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, 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.
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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, 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.
.
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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
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.