(63 days)
Medline's Limb holders are intended to be utilized as a patient safety device when limited movement of the limb is deemed necessary.
Medline's Limb holders are intended to be utilized as a patient safety device when limited movement of the limb is deemed necessary. The limb holders are all of the same basic design, some with different linings on the cuff, others utilize buckles, hook and loop closures ("velcro") or D-rings. They may be used either at the wrist or ankle and may tie to the bed frame or wheelchair.
The provided document is a Safety and Effectiveness Summary for Medline's protective limb restraints. It describes the devices, their intended use, and a literature review conducted to support their safety and effectiveness. However, it does not contain any information regarding specific acceptance criteria for a device's performance, nor does it describe a study conducted by Medline to prove the device meets such criteria.
The document primarily focuses on:
- Description of various Medline limb holders: detailing their design, materials, and adjustment mechanisms.
- General statement of their intended use: as a patient safety device to limit limb movement.
- Discussion of general safety and effectiveness in the context of protective restraints: outlining potential complications found in literature (e.g., emotional desolation, agitation, fractures, nerve damage, circulatory impairment, etc.) and noting the benefits when used correctly.
- Emphasis on proper use: highlighting the importance of patient monitoring, appropriate patient and restraint selection, correct application, and physician/trained professional advice.
- A list of thirteen articles reviewed: to establish the safety and efficacy of protective restraints in general, rather than providing specific performance data for Medline's products.
Therefore, I cannot fulfill the request for information on acceptance criteria and a study proving device performance because that data is not present in the provided text.
To reiterate:
- A table of acceptance criteria and the reported device performance: Not provided.
- Sample sized used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method for the test set: Not provided.
- 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: Not provided. (This question is also irrelevant as the device is a physical restraint, not an AI imaging or diagnostic tool).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided. (Again, irrelevant for a physical restraint).
- The type of ground truth used: Not provided.
- The sample size for the training set: Not provided.
- How the ground truth for the training set was established: Not provided.
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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 the word is a symbol that resembles a compass rose or a stylized star. The symbol has four points, with the top point being the most prominent.
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
ﭘﺮ
OCT 29 1996
Medline Industries, Inc. One Medline Place Mundelein. IL 60060 Phone #: (847) 949-2639 Fax #: (847) 949-2643 Lara N. Simmons Corporate Regulatory Affairs Manager
August 20, 1996
| Device Name: | Protective Restraint, Limb HolderWheelchair Accessory, Limb Holder |
|---|---|
| Proprietary: | Medline Economy Limb Holder, Medline Deluxe Limb Holder, Medline Cinch-Type Limb Holder, Medline Padded Limb Holder, Medline Adjustable Limb Holder, Medline Quick Control Limb Holder, Medline Modified Cinch-Type Limb Holder. |
| Common: | Limb 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's Limb holders are intended to be utilized as a patient safety device when limited movement of the limb is deemed necessary. The limb holders are all of the same basic design, some with different linings on the cuff, others utilize buckles, hook and loop closures ("velcro") or D-rings. They may be used either at the wrist or ankle and may tie to the bed frame or wheelchair.
The various types of limb holders are discussed as follows:
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Deluxe Limb Holder - Lined with synthetic fur to minimize chafe and irritation. Hook and loop closure to help prevent tightening or loosening of cuff. Straps adjust via sewn in loops. May tie to bed frame or wheelchair frame. These limb holders are available in either cotton or nylon. Reference Attachment A for a picture of this device. ltem is washable.
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Padded Limb Holder - Lined with synthetic fur to minimize chafe and irritation. Cuff adjusts using a corset buckle that helps prevent tightening or loosening of cuff. Belts
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may be detachable or non-detachable at cuff, and adjust via corset buckles. Reference Attachment A for a picture of this device. Item is washable.
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Quick Control Limb Holder - Lined with synthetic fur to minimize chafe and irritation. Cuff adjusts using a hook and loop closure with two adjustment rings. Reference Attachment A for a picture of this device. Item is washable.
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Adjustable Limb Holder - Lined with cotton to help minimize chafe and irritation. straps adjust via sewn on loops. Reference Attachment A for a picture of this device. Item is washable. Cuff backing may be Cotton Flannel or Nylon.
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Cinch-Type Limb Holder - Lined with one-piece foam to minimize chafe and irritation. Hook and loop closure tab will adhere anywhere on the foam backing. Straps adiust via metal "D" rings. Reference Attachment A for a picture of this device. Item may be washed or discarded.
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Modified Cinch-Type Limb Holder - Lined with one-piece foam to minimize chafe and irritation. Hook and loop closure tab will adhere anywhere on the foam backing. Straps adjust via metal "D" rings. This item differs from the Cinch-Type Limb Holder in that the wrist strap is independent of the anchor strap. Reference Attachment A for a picture of this device. Item may be washed or discarded.
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Economy Limb Holder - Cuff is made of orthopedic felt. Straps adjust using corset buckles. Reference Attachment A for a picture of this device. Item may be washed or discarded.
8.0 Single Patient Use Limb Holder - Cuff is made of foam that closes with a hook and loop tab with a nylon "D" ring. This item is the same in design as our Cinch-Type Limb Holder but is not washable and is labeled for single patient use only.
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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 limiting the movement of a restrained limb to a desired range or limit.
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.