(68 days)
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No
The device description and intended use clearly describe physical restraints, with no mention of AI or ML technology.
No
The device, "Zimmer line of restraints," is described as preventing patients from injuring themselves or clinical personnel, and is used for conditions like emotional/psychological disturbance, post-op recovery, and neurological disorders. Its primary function is restraint for safety and management, not directly treating a disease or condition to restore health or alleviate symptoms. It is a safety and management device rather than a therapeutic device in the sense of providing active treatment or cure.
No
Explanation: The device is a restraint system designed to prevent patients from injuring themselves or others, and its use is based on existing patient conditions, not for identifying or diagnosing a medical condition.
No
The device description explicitly states "Vest Restraints," which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a physical restraint device used to prevent patient injury and manage behavior. This is a physical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as "Vest Restraints," which are physical devices.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on in vitro analysis.
The device is clearly a physical restraint used for patient management and safety, not for in vitro diagnostic purposes.
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. Such patients may require devices made from heavier materials and specifically designed for patients with serious mental disturbances."
Finally, these restraints are labeled with the prescription legend, and thus. should only be used on the order of a physician.
Product codes
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Device Description
Proprietary Names: Economy Safety Vest Restraint Safety Vest Restraint Shoulder Tie Safety Vest Heavy Duty Vest Restraint Mesh Safety Vest Restraint Sleeveless Zipper Vest Restraint Sleeved Zipper Vest Restraint
Classification Name: Protective Restraint
The only difference is in the addition of color coded banding on each unit.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a large, stylized letter "Z" inside of a circle. Below the circle, the word "zimmer" is written in lowercase letters.
NOV - 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): Vest Restraints
Proprietary Names: Economy Safety Vest Restraint Safety Vest Restraint Shoulder Tie Safety Vest Heavy Duty Vest Restraint Mesh Safety Vest Restraint Sleeveless Zipper Vest Restraint Sleeved Zipper Vest Restraint
Classification Name: Protective Restraint
Gomparison Device: Same as above. (Note: This submission revised binding color of these products only.)
Intended 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. Such patients may require devices made from heavier materials and specifically designed for patients with serious mental disturbances."
Finally, these restraints are labeled with the prescription legend, and thus. should only be used on the order of a physician.
Zimmer Patient Care Division makes no additional claims in relation to these vest restraint products.
Comparative Data: The devices used for comparative purposes are the vest restraints as described in this submission. (See Tab G - June 14, 1996 Meeting Minutes, HIMA Body Holder Task Force and FDA CDRH - for rationale.)
Image /page/0/Picture/19 description: The image shows a geometric design that appears to be a stylized snowflake or a complex pattern of triangles arranged in a circular fashion. The design is intricate, with multiple layers of triangles intersecting and overlapping to create a symmetrical and visually appealing image. The image is black and white, which emphasizes the geometric shapes and patterns.
1
These vest restraints 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 vest restraints have been manufactured and in commercial distribution for over 20 years.
The only difference is in the addition of color coded banding on each unit. The rationale for exceptions to the labeling quidance is detailed in Tab C.
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.
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.