K Number
K963504
Device Name
MEDLINE OPEN END FINGER CONTROL MITT
Manufacturer
Date Cleared
1996-10-29

(56 days)

Product Code
Regulation Number
880.6760
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Medline Hand Protectors and Finger Control Mitts may be used with either a wheelchair or a bed. They are intended to help protect the patient who might possibly harm themselves or others if the hands and fingers are not restricted. May be used with stroke patients to help prevent contracture or to help fingers in rehabilitation. Effectively helps minimize the possibility of the patient removing catheters and IV tubes and helps prevent scratching and itching. 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 protect patients from harming themselves or others, to help prevent patients from removing or disabling other medical devices or equipment (catheters, IV lines, etc.), or to help prevent patients from removing, scratching or picking wound sites, incisions, stitches or bandages. Medline Hand Protectors and Finger Control Mitts 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.
Device Description
Medline Hand Protectors and Finger Control Mitts are designed for use with either a bed or wheelchair. They are intended to help protect the patient who might possibly harm themselves or others if the hands and fingers are not restricted. Medline Hand Protectors and Finger Control Mitts may be used with stroke patients to help prevent contracture or to help fingers in rehabilitation. They can effectively help minimize the possibility of the patient removing catheters and I.V. tubes and help prevent scratching and itching. They are made of cotton, canton flannel or Koolnit ™ and are secured by polyester web straps.
More Information

Not Found

Not Found

No
The device description and intended use clearly describe a physical restraint device made of fabric and straps. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on the safety and efficacy of physical restraints based on literature review, not on the performance of an AI/ML algorithm.

Yes.
The device is used to prevent contracture, aid in rehabilitation, and prevent scratching/itching, which are direct therapeutic benefits.

No

Explanation: The device, Medline Hand Protectors and Finger Control Mitts, is described as a protective restraint to prevent self-harm, injury to others, or interference with medical devices, not for diagnosing conditions.

No

The device description clearly states it is made of physical materials (cotton, canton flannel, Koolnit™, polyester web straps) and is a physical restraint device. It does not involve any software components.

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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
  • Device Function: The Medline Hand Protectors and Finger Control Mitts are physical restraints designed to restrict hand and finger movement. Their purpose is to prevent self-harm, harm to others, removal of medical devices, and to aid in rehabilitation.
  • Lack of Diagnostic Testing: The description and intended use do not involve any form of testing on biological samples or providing diagnostic information about a patient's health status.

The device is a physical restraint used for patient safety and management, not for in vitro diagnostic testing.

N/A

Intended Use / Indications for Use

Medline Hand Protectors and Finger Control Mitts may be used with either a wheelchair or a bed. They are intended to help protect the patient who might possibly harm themselves or others if the hands and fingers are not restricted. May be used with stroke patients to help prevent contracture or to help fingers in rehabilitation. Effectively helps minimize the possibility of the patient removing catheters and IV tubes and helps prevent scratching and itching.

Medline Patient Safety Products are intended to be used for those patients suffering from temporary medical related cognitive deficits, for agitated patients, to help protect patients from harming themselves or others, to help prevent patients from removing or disabling other medical devices or equipment (catheters, IV lines, etc.), or to help prevent patients from removing, scratching or picking wound sites, incisions, stitches or bandages.

Product codes

Not Found

Device Description

Medline Hand Protectors and Finger Control Mitts are designed for use with either a bed or wheelchair. They are intended to help protect the patient who might possibly harm themselves or others if the hands and fingers are not restricted. Medline Hand Protectors and Finger Control Mitts may be used with stroke patients to help prevent contracture or to help fingers in rehabilitation. They can effectively help minimize the possibility of the patient removing catheters and I.V. tubes and help prevent scratching and itching. They are made of cotton, canton flannel or Koolnit ™ 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

Hands and fingers

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Use in hospitals and/or nursing homes. Intended to be used upon advice of a physician or other trained, licensed healthcare professional.

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

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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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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 a stylized, sans-serif font. Above and below the text are two triangular shapes pointing upwards and downwards respectively. The two triangles and the text are all in black.

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

K965504

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 27, 1996

Protective Restraint, Hand Protector or Finger Control Mitt Device Name: Proprietary: Medline Open End Finger Control Mitt, Medline Closed End Finger Control Mitt. Medline Rigid Palm Hand Restraint, Medline Flexible Palm Hand Restraint Common: Hand Restraint Classification: Protective Restraint

These devices have been legally marketed prior to the date of this submission, and, in fact, prior to May 28, 1976. The intended use and claims, technological features, materials and physical and mechanical specifications have not been changed.

1.0 General Description

Medline Hand Protectors and Finger Control Mitts are designed for use with either a bed or wheelchair. They are intended to help protect the patient who might possibly harm themselves or others if the hands and fingers are not restricted. Medline Hand Protectors and Finger Control Mitts may be used with stroke patients to help prevent contracture or to help fingers in rehabilitation. They can effectively help minimize the possibility of the patient removing catheters and I.V. tubes and help prevent scratching and itching. They are made of cotton, canton flannel or Koolnit ™ and are secured by polyester web straps.

INTENDED USE OF THE DEVICE

Medline Hand Protectors and Finger Control Mitts may be used with either a wheelchair or a bed. They are intended to help protect the patient who might possibly harm themselves or others if the hands and fingers are not restricted. May be used with stroke patients to help prevent contracture or to help fingers in rehabilitation.

1

Effectively helps minimize the possibility of the patient removing catheters and IV tubes and helps prevent scratching and itching.

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 protect patients from harming themselves or others, to help prevent patients from removing or disabling other medical devices or equipment (catheters, IV lines, etc.), or to help prevent patients from removing, scratching or picking wound sites, incisions, stitches or bandages.

Medline Hand Protectors and Finger Control Mitts 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.