(72 days)
Best Strap Restraint
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No
The device description and intended use describe a simple mechanical restraint system with no mention of AI or ML capabilities.
No.
The README states that the device is a restraint system to secure a patient's body. There is no indication that it is used for treatment or diagnosis.
No
The device is described as a restraint system used to secure a patient's body for transport, not to diagnose a medical condition.
No
The device description explicitly states it is comprised of "five nylon straps with Hook and Loop," which are physical hardware components, not software.
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 Function: The Morrison Medical Best Strap Restraint is a physical restraint system used to secure a patient to a backboard. It does not perform any tests on bodily samples.
- Intended Use: The intended use clearly states it's for "securing a patient's body," not for diagnostic testing.
Therefore, based on the provided information, the Morrison Medical Best Strap Restraint is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Morrison Medical Best Strap Restraint is a restraint system intended to help to secure a patient's body at the shoulder, chest, pelvis, thighs and ankles while lying on a backboard.
Product codes
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Device Description
The Morrison Medical Best Strap is a restraint system comprised of five nylon straps with Hook and Loop that helps to secure a patient's body at the shoulder, chest, pelvis, thighs and ankles while lying on a backboard. The straps are color coded to assist in the application of the device. The straps are threaded around the backboard or stretcher frame and secured with the Hook and Loop to allow for quick and easy application and release.
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
shoulder, chest, pelvis, thighs and ankles
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)
Best Strap 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 large, stylized letter "M" on the left, followed by the words "MORRISON" stacked on top of "MEDICAL" and "PRODUCTS" on the right. The text is in a bold, sans-serif font.
Morrison Medical Products Best Strap 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 23, 1996
2. Name of Device:
Best Strap Restraint
3. Name of Predicate Device(s)
Best Strap Restraint
4. Description of Device
The Morrison Medical Best Strap is a restraint system comprised of five nylon straps with Hook and Loop that helps to secure a patient's body at the shoulder, chest, pelvis, thighs and ankles while lying on a backboard. The straps are color coded to assist in the application of the device. The straps are threaded around the backboard or stretcher frame and secured with the Hook and Loop to allow for quick and easy application and release.
5. Statement of Intended Use
The Morrison Medical Best Strap Restraint is a restraint system intended to help to secure a patient's body at the shoulder, chest, pelvis, thighs and ankles while lying on a backboard.
6. Statement of Technological Characteristics of the Device
The Morrison Medical Best Strap is a restraint system comprised of five nylon straps with Hook and Loop that helps to secure a patient's body at the shoulder, chest, pelvis, thighs and ankles while lying on a backboard. The straps are color coded to assist in the application of the device. The straps are threaded around the backboard or stretcher
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Image /page/1/Picture/0 description: The image shows the logo for Morrison Medical Products. The logo consists of a large, stylized letter "M" on the left, followed by the words "MORRISON", "MEDICAL", and "PRODUCTS" stacked vertically on the right. The text is in a bold, sans-serif font.
Morrison Medical Products Best Strap Restraint
frame and secured with the Hook and Loop to allow for quick and easy application and release.
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.
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 Best Strap Restraint is safe and effective for its intended use and is substantially equivalent to the predicate device.
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