(64 days)
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No
The device description and intended use clearly describe a simple mechanical restraint strap with no mention of any computational or learning capabilities.
No.
The device is described as a restraint strap used to secure a patient to a backboard, which is a supportive device, not one that treats or diagnoses a medical condition.
No
The device description states its purpose is to secure a patient's body to a backboard, which is a supportive function, not a diagnostic one.
No
The device description clearly states the device is a physical strap made of acrylic coated polyester woven material with an adhesive band, indicating it is a hardware device, 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 Disposable Restraint Strap is a physical device used to secure a patient to a backboard. It does not perform any tests on bodily samples.
- Intended Use: The intended use is to "help secure a patient's body while lying on a backboard," which is a mechanical function, not a diagnostic one.
The description clearly indicates a physical restraint device, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Morrison Medical Disposable Restraint Strap is intended to help secure a patient's body while lying on a backboard.
Product codes
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Device Description
The Morrison Medical Disposable Restraint Strap is intended to help secure a patient's body while lying on a backboard. The straps are constructed of an acrylic coated polyester woven material with an adhesive band on each end of the strap. The patient is secured to the backboard by lying the strap across the patient's body and peeling the release paper from the strap. The strap is woven through the hand hold in the backboard and stuck back onto the polyester strap. After use the strap is cut off with scissors.
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)
Morrison Medical Disposable Restraint Strap
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 simple, sans-serif font and is all in black.
Image /page/0/Picture/2 description: The image shows a handwritten string of characters. The string appears to be 'x 963494'. The characters are written in a cursive style, with some connections between the numbers. The image is in black and white.
Morrison Medical Products Disposable Restraint Strap
Safety and Effectiveness Summary
1. Submitter's name. Address and Contact Person
Contact Person Submitter Joseph S. Tokarz; Manager, Regulatory Affairs Morrison Medical Products Hollister Incorporated 610 W. Town Street Columbus. OH 43215-4446 2000 Hollister Drive Libertyville, IL 60048 (847)680-2849, Fax: (847)918-3860 Ph:
Date Summary Prepared - August 29, 1996
2. Name of Device:
Morrison Medical Disposable Restraint Strap
3. Name of Predicate Device(s)
Morrison Medical Disposable Restraint Strap
4. Description of Device
The Morrison Medical Disposable Restraint Strap is intended to help secure a patient's body while lying on a backboard. The straps are constructed of an acrylic coated polyester woven material with an adhesive band on each end of the strap. The patient is secured to the backboard by lying the strap across the patient's body and peeling the release paper from the strap. The strap is woven through the hand hold in the backboard and stuck back onto the polyester strap. After use the strap is cut off with scissors.
5. Statement of Intended Use
The Morrison Medical Disposable Restraint Strap is intended to help secure a patient's body while lying on a backboard.
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 large, stylized "M" on the left, with the words "MORRISON MEDICAL PRODUCTS" stacked in three lines on the right. The font is bold and sans-serif, and the entire logo is in black and white.
Morrison Medical Products Disposable Restraint Strap
7. Biocompatibility
The materials used to manufacture this device are identical to a similar marketed device under comparable conditions of use. Morrison Medical Products is not aware of any reports or complaints of skin irritation associated with the materials used in this device.
8. Conclusion
Based upon the information presented above it is concluded that the proposed Morrison Medical Disposable Restraint Strap is safe and effective for its intended use and is substantially equivalent to the predicate device.
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