(73 days)
Not Found
Not Found
No
The device description details a physical restraint system made of nylon straps and metal buckles, with no mention of software, algorithms, or any computational components. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a restraint for securing a patient during transport, not for treating any medical condition or disease.
No
The device description indicates it is a restraint system used for securing patients during transport, not for diagnosing medical conditions.
No
The device description clearly states it is constructed from physical components like nylon straps, buckles, and connectors, indicating 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 perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Morrison Medical Torso/Waist Restraint is a physical restraint device used to secure a patient during transport. It does not perform any tests on biological samples.
The provided information clearly describes a device for patient immobilization, not for diagnostic testing.
N/A
Intended Use / Indications for Use
The Morrison Medical Torso/Waist Restraint is intended to help secure a patient at the torso and waist in an ambulance or other emergency vehicle while in transport to a hospital or other critical care facility.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Morrison Medical Torso/Waist Restraint is constructed by combining two adjustable, nylon, "over-the-shoulder" straps that secure the upper torso and two adjustable nylon straps that secure the waist. All four straps are joined at the waist and are secured with a metal push button buckle and metal connectors. The Nylon webbing is available in multiple colors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
torso and waist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
emergency personnel; ambulance or other emergency vehicle
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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/2 description: The image shows the logo for Morrison Medical Products. The logo consists of a large, bold letter "M" on the left side, and the words "MORRISON MEDICAL PRODUCTS" stacked on top of each other on the right side. The letter "M" is in a sans-serif font and is black, as are the words to the right.
NOV - 8 1996
Morrison Medical Products Torso/Waist Restraint
510(k) Summary
1. 1. Submitter's name, Address and Contact Person
Submitter Contact Person Morrison Medical Products Inc. Joseph S. Tokarz, Manager, Regulatory Affairs 610 W. Town Street Hollister Incorporated Columbus, OH 43215-4446 2000 Hollister Drive Libertyville, IL 60048 (847)680-2849, Fax (847)918-3860 Ph
Date Summary Prepared - November 7, 1996
2. Name of Device:
Morrison Medical Torso/Waist Restraint
3. Name of Predicate Device(s)
Morrison Medical Torso/Waist Restraint
4. Description of Device
The Morrison Medical Torso/Waist Restraint is intended to be used by emergency personnel to help secure a patient at the torso and waist, while lying on a cot or stretcher, in an ambulance or other emergency vehicle while in transport to a hospital or other critical care facility. The restraint can be used in the supine or elevated positions.
The Morrison Medical Torso/Waist Restraint is constructed by combining two adjustable. nylon, "over-the-shoulder" straps that secure the upper torso and two adjustable nylon straps that secure the waist. All four straps are joined at the waist and are secured with a metal push button buckle and metal connectors.
The nylon webbing is available in multiple colors.
5. Statement of Intended Use
The Morrison Medical Torso/Waist Restraint is intended to help secure a patient at the torso and waist in an ambulance or other emergency vehicle while in transport to a hospital or other critical care facility.
1
Image /page/1/Picture/2 description: The image shows the logo for Morrison Medical Products. The logo consists of a large, bold letter "M" on the left side, and the words "MORRISON MEDICAL PRODUCTS" stacked on top of each other on the right side. The letter "M" is in a sans-serif font and is black, and the words "MORRISON MEDICAL PRODUCTS" are also in a sans-serif font and are black.
Morrison Medical Products Torso/Waist Restraint
6. Statement of Technological Characteristics of the Device
The Morrison Medical Torso/Waist Restraint is constructed by combining two adjustable, nylon, "over-the-shoulder" straps that secure the upper torso and two adjustable nylon straps that secure the waist. All four straps are joined at the waist and are secured with a metal push button buckle and metal connectors. The Nylon webbing is available in multiple colors.
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 Assessment
The subject devices are identical in components 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
ﻌﻠﻴﺔ ﺍﻟ
Based upon the information presented above it is concluded that the proposed Morrison Medical Torso/Waist Restraint is safe and effective for its intended use and is substantially equivalent to the predicate device.