(62 days)
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No
The device description and intended use describe a physical restraint made of nylon and metal, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device's intended use is for protection and restraint, not for treating a disease or condition.
No
Explanation: The device description states its purpose is to be a protective limb restraint limiting patient movement for "treatment, examination, or protection." It does not claim to diagnose any condition or disease.
No
The device description explicitly states it is constructed of physical materials (nylon webbing, metal D-Ring, hook and loop material) and is intended to physically restrain a patient. This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Morrison Medical Wrist Restraint Function: The description clearly states the device is a physical restraint used to limit a patient's movement. It does not involve the analysis of any biological specimens.
The device description and intended use are entirely focused on physical restraint for patient safety and treatment, which falls under the category of a physical medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Morrison Medical Wrist Restraint is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or sitting positions.
Product codes
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Device Description
The Morrison Medical Wrist Restraint is constructed of a nylon woven webbing and metal D-Ring. There is nylon hook and loop material sewn onto the nylon webbing. This nylon hook and loop combination is intended to secure the wrist restraint to the patient. The Wrist Restraint is intended to restrain the patient to a chair, cot or stretcher.
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)
Morrison Medical Wrist Restraint
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.
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Image /page/0/Picture/0 description: The image shows the logo for Morrison Medical Products. The logo consists of a stylized black shape on the left, resembling a triangle with a cutout. To the right of the shape, the words "MORRISON MEDICAL PRODUCTS" are stacked in three lines, with each word in bold, sans-serif font. The overall design is simple and professional.
Image /page/0/Picture/2 description: The image contains a handwritten alphanumeric string. The string appears to be "K9603419". The characters are written in a cursive style with thick strokes, and the overall impression is that of a quickly written note or label.
Morrison Medical Products Wrist Restraint
Safety and Effectiveness Summary
1. Submitter's name, Address and Contact Person
Submitter Morrison Medical Products 610 W. Town Street Columbus, OH 43215-4446 Contact Person Joseph S. Tokarz; Manager, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 (847)680-2849, Fax: (847)918-3860 Ph:
Date Summary Prepared - August 28, 1996
2. Name of Device:
Morrison Medical Wrist Restraint
3. Name of Predicate Device(s)
Morrison Medical Wrist Restraint
4. Description of Device
The Morrison Medical Wrist Restraint is constructed of a nylon woven webbing and metal D-Ring. There is nylon hook and loop material sewn onto the nylon webbing. This nylon hook and loop combination is intended to secure the wrist restraint to the patient. The Wrist Restraint is intended to restrain the patient to a chair, cot or stretcher.
5. Statement of Intended Use
The Morrison Medical Wrist Restraint is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or sitting positions.
6. Statement of Technological Characteristics of the Device
The subject devices are identical in intended use, design, materials, manufacturing process, physical and mechanical specifications and issues of safety and effectiveness to the devices prior to the submission of this notification. The only difference is that the product labeling has been revised to comply with the Agency's labeling requirements set forth in the draft "Guidance on the Content of Premarket Notification [510(k)] Submissions for Protective Restraints" dated December 1995.
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Image /page/1/Picture/0 description: The image shows the logo for Morrison Medical Products. The logo consists of a black geometric shape on the left, resembling an abstract letter "M" or an arrow pointing upwards. To the right of the shape, the words "MORRISON MEDICAL PRODUCTS" are stacked in three lines, with each word in bold, sans-serif font. The overall design is simple and professional, conveying a sense of reliability and expertise in the medical field.
Morrison Medical Products Wrist Restraint
7. Biocompatibility
The subject devices are identical in component materials to the predicate devices. Morrison Medical Products is not aware of any reports or complaints of skin irritation associated with the materials used in these devices. A biocompatibility review of these materials indicated little potential to evoke an adverse reaction.
8. Conclusion
Based upon the information presented above it is concluded that the proposed Morrison Medical Wrist Restraint is safe and effective for its intended use and is substantially equivalent to the predicate device.
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