(68 days)
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No
The document describes physical restraints and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a restraint used to prevent harm to patients or personnel, not to treat or cure a disease or condition. Its purpose is protective and preventative of injury, rather than therapeutic intervention.
No
The device description indicates that the Zimmer line of restraints are "intended for restless, confused, elderly, or unsteady patients" to "help prevent such patients from injuring themselves or clinical personnel." This describes a therapeutic or protective function, not a diagnostic one.
No
The device description clearly indicates the device is a physical restraint (Limb Holders, Foam Limb Holder, Wrist/Ankle Restraint) made of materials like polyester pile and soft flannel. There is no mention of software components.
No, 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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Zimmer restraints are physical devices applied to the patient's limbs (wrist/ankle) to prevent injury. They are used for patient management and safety, not for analyzing biological samples.
The information provided focuses on the physical application and purpose of the restraints, not on any diagnostic testing performed outside the body.
N/A
Intended Use / Indications for Use
The Zimmer line of restraints is intended for restless, confused, elderly, or unsteady patients. They help prevent such patients from injuring themselves or clinical personnel. The most common emergency indications for patient restraints are: emotional/psychological disturbance, threatened or attempted suicide, suspected drug/alcohol abuse, and seizure or cardiac arrest. Restraints may also be indicated for post-op patients in recovery, patients under sedation, and patients suffering from stroke, neuromuscular disorders, or Alzheimer's disease. Zimmer restraints are not intended for patients who may be exceptionally violent.
Product codes
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Device Description
Foam Limb Holder w/Quick Release Buckle Proprietary Names: Polvester Pile Wrist/Ankle Restraint Soft Flannel Wrist/Ankle Restraint Wrist Restraint, Universal
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
K96343/
Image /page/0/Picture/1 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter 'Z' inside of a circle. Below the circle, the word 'zimmer' is written in lowercase letters.
V - 6 1996
Patient Care Division 200 West Ohio Avenue P.O. Box 10 Dover, OH 44622-0010 Phone: 330 343-8801
510(k) Summary of Safety and Effectiveness
Contact Information: Paula S. Osorio Director, Quality Assurance & Regulatory Compliance Zimmer Patient Care Division 200 West Ohio Avenue Dover. Ohio U.S.A. 44622 Telephone (330) 364-9483 Fax (330) 343-0995
- Preparation Date: August 30, 1996
- Device Name(s): Limb Holders (protective restraints)
Foam Limb Holder w/Quick Release Buckle Proprietary Names: Polvester Pile Wrist/Ankle Restraint Soft Flannel Wrist/Ankle Restraint Wrist Restraint, Universal
- Classification Name: Protective Restraint
- Comparison Device: Same as above.
"The Zimmer line of restraints is intended for restless, confused, elderly, or Intended Use: unsteady patients. They help prevent such patients from injuring themselves or clinical personnel.
The most common emergency indications for patient restraints are: emotional/psychological disturbance, threatened or attempted suicide, suspected drug/alcohol abuse, and seizure or cardiac arrest. Restraints may also be indicated for post-op patients in recovery, patients under sedation, and patients suffering from stroke, neuromuscular disorders, or Alzheimer's disease.
Zimmer restraints are not intended for patients who may be exceptionally violent. Such patients may require devices made from heavier materials and specifically designed for patients with serious mental disturbances."
- Comparative Data: The devices used for comparative purposes are the limb holders as described in this submission. (See Tab G - June 14, 1996 Meeting Minutes, HIMA Body Holder Task Force and FDA CDRH - for rationale.)
These limb holders are currently exempt from 510(k) Premarket Notification Procedures and Good Manufacturing Practice Regulations, and they are legally marketed by Zimmer Patient Care Division as of the date of this submission. August 30, 1996. These limb holders have been manufactured and in commercial distribution for over 20 years.
The use of all patient restraints in nursing homes is subject to Health Care Financing Administration Regulations which prohibit the use of any restraint, physical or chemical, imposed for the purpose of discipline or convenience.
Image /page/0/Picture/19 description: The image shows a geometric design. The design appears to be a complex arrangement of triangles and other shapes, possibly forming a larger, more intricate pattern. The image is in black and white, which emphasizes the lines and shapes of the design.
1
Further, the "Revised Standards for Restraint and Seclusion", TX.7.1.3.2.4, 1996 Accreditation Manual for Hospitals, Volume 1, Joint Commission on Accreditation of Healthcare Organizations, applies to all organizations accredited under the 1996 AMH, Volume 1, the Comprehensive Accreditation Manual for Ambulatory Care and the Accreditation Manual for Mental Health, Chemical Dependency, and Mental Retardation Developmental Disabilities. The application of these standards, along with public awareness, and health care provider training, have contributed significantly to ensuring that the least restrictive restraint is used and that restraints are used only when needed for proper medical treatment and that their use is under appropriate supervision.
In our experience, the most significant problems involving restraints are not due to design or materials used, but rather are attributed to misuse or misapplication.