(69 days)
Morrison Medical Stretcher/Cot and Backboard Restraints
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No
The device description focuses on physical components and their function in securing a patient, with no mention of AI or ML technologies.
No
The device is used to secure a patient's body to a stretcher, cot or backboard; it does not treat or cure any medical condition.
No
Explanation: The device is described as "Stretcher/Cot and Backboard Restraints" intended to secure a patient's body. There is no mention of it being used for diagnosis, making measurements, or gathering information about a patient's health condition.
No
The device description clearly details physical components like webbing, buckles, and materials (nylon, polypropylene, vinyl coated polyester), indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Morrison Medical Stretcher/Cot and Backboard Restraints are intended to secure a patient's body to a stretcher, cot, or backboard. This is a physical restraint function, not a diagnostic test performed on a biological sample.
- Lack of Diagnostic Elements: The description does not mention any analysis of biological samples, detection of biomarkers, or any other activity related to diagnosing a medical condition.
Therefore, the intended use and device description align with a medical device used for patient transport and immobilization, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Morrison Medical Stretcher/Cot and Backboard Restraints are intended to help secure a patient's body to a stretcher, cot or backboard.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Morrison Medical Stretcher/Cot and Backboard Restraints are intended to be used by qualified and properly trained personnel to help secure a patient's body to a stretcher, cot or backboard.
The Morrison Medical Stretcher/Cot and Backboard restraints connect to or wrap around a stretcher, cot or backboard. The restraints are constructed by combining various webbing, buckles/closures and end styles. The webbing is available in nylon. polypropylene and vinyl coated polyester materials. The webbing that is used is dependent on user preference. The Morrison Medical Stretcher/Cot and Backboard Restraints are available as a reusable or disposable (series 139x) restraint. The restraint is available in either a one-piece length or two-piece lengths depending on user preference. The one-piece restraint wraps around a patient and the stretcher, cot or backboard and is secured with a buckle. The two-piece restraint is connected to the frame on both sides of the stretcher, cot or backboard with an end-style (end-style description below) and is secured together with a buckle/closure. (See chart below for a detailed description of the one- and two-piece length presentation)
The buckles are available in six different styles (see chart below) depending once again on user preference. On the end of the two-piece restraint webbing is an end style. The end style is the component of the restraint that connects to the stretcher, cot or backboard. There are four different end styles available (see chart below), depending on the whether the restraint will be used with a stretcher, cot or backboard and depending on user preference.
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
qualified and properly trained personnel
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): 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.
Morrison Medical Stretcher/Cot and Backboard Restraints
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.
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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).
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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 "M" on the left, followed by the words "MORRISON", "MEDICAL", and "PRODUCTS" stacked vertically on the right. The "M" is formed by three thick, black shapes that create a geometric design. The text is in a bold, sans-serif font, and the entire logo is in black and white.
Image /page/0/Picture/2 description: The image shows a handwritten text string. The string appears to be a combination of a letter and numbers. The text string is "K 963399".
Safety and Effectiveness Summary
1. Submitter's name. Address and Contact Person
| Submitter | Morrison Medical Products |
|---|---|
| Contact Person | |
| Joseph S. Tokarz, Manager, Regulatory Affairs | |
| Hollister Incorporated | |
| 2000 Hollister Drive | |
| 610 W. Town Street | |
| Columbus, OH 43215-4446 | Libertyville, IL 60048 |
| Ph: (847)680-2849, Fax: (847)918-3860 |
Date Summary Prepared - August 27, 1996Date Summary Prepared - August 27, 1996
2. Name of Device:
Morrison Medical Stretcher/Cot and Backboard Restraints
3. Name of Predicate Device(s)
Morrison Medical Stretcher/Cot and Backboard Restraints
4. Description of Device
The Morrison Medical Stretcher/Cot and Backboard Restraints are intended to be used by qualified and properly trained personnel to help secure a patient's body to a stretcher, cot or backboard.
The Morrison Medical Stretcher/Cot and Backboard restraints connect to or wrap around a stretcher, cot or backboard. The restraints are constructed by combining various webbing, buckles/closures and end styles. The webbing is available in nylon. polypropylene and vinyl coated polyester materials. The webbing that is used is dependent on user preference. The Morrison Medical Stretcher/Cot and Backboard Restraints are available as a reusable or disposable (series 139x) restraint. The restraint is available in either a one-piece length or two-piece lengths depending on user preference. The one-piece restraint wraps around a patient and the stretcher, cot or backboard and is secured with a buckle. The two-piece restraint is connected to the frame on both sides of the stretcher, cot or backboard with an end-style (end-style description below) and is secured together with a buckle/closure. (See chart below for a detailed description of the one- and two-piece length presentation)
The buckles are available in six different styles (see chart below) depending once again on user preference. On the end of the two-piece restraint webbing is an end style. The
1
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, followed by the words "MORRISON", "MEDICAL", and "PRODUCTS" stacked vertically on the right. The font used for the text is bold and sans-serif.
end style is the component of the restraint that connects to the stretcher, cot or backboard. There are four different end styles available (see chart below), depending on the whether the restraint will be used with a stretcher, cot or backboard and depending on user preference.
| Length/No. of
| Straps | Description |
|---|---|
| Five foot section; | |
| two piece strap | The two sections of webbing are connected to each other by the preferred |
| buckle to form a five foot section. At the end of each section is the | |
| preferred end style that connects to the stretcher/cot or backboard frame. | |
| Seven foot | |
| section; | |
| two piece strap | The two sections of webbing are connected to each other by the preferred |
| buckle to form a seven foot section. At the end of each section is the | |
| preferred end style that connects to the stretcher/cot or backboard frame. | |
| Seven foot | |
| section; | |
| one piece strap | The restraint is constructed with the preferred webbing and buckle of |
| choice. One component of the buckle is secured to each end of the | |
| seven foot strap. | |
| Nine foot section; | |
| one piece strap | The restraint is constructed with the preferred webbing and buckle of |
| choice. One component of the buckle is secured to each end of the nine | |
| foot strap. |
One-Piece and Two-Piece Webbing and Strap Length Presentation:
Restraint Buckles/Closures
The buckle/closure that connects the webbing material is intended to close together to secure the patient while he/she is lying on the stretcher/cot or backboard. The style of buckle/closure that is used is based on user preference. All the buckles/closures perform the same basic function, closing together to secure the patient onto the stretcher/cot or backboard.
On the following page is a chart that provides the name and description of each buckle/closure style.
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Image /page/2/Picture/0 description: The image shows the logo for Morrison Medical Products. The logo consists of a large, stylized letter "M" on the left, with the words "MORRISON", "MEDICAL", and "PRODUCTS" stacked vertically to the right of the "M". The text is in a simple, sans-serif font and is all capitalized. The logo is black and white.
| Name of buckle/closure | Description |
|---|---|
| Metal Push Button (auto) | Similar to an auto seat belt. Push ends together to secure; |
| push button to release. | |
| Plastic side release | Polypropylene quick release closure. Push ends together to |
| secure; squeeze sides together to release | |
| Metal Cam (friction) | |
| Plastic Cam (friction) | Metal Buckle. Thread webbing through back of buckle and |
| press buckle lever down to secure; pull buckle lever up and | |
| unthread webbing to release | |
| Metal Roller Buckle | |
| (friction) | Metal Roller Buckle. Thread webbing through buckle and |
| move sliding bar to roller bar to secure; move sliding bar off | |
| roller bar and unthread webbing to release | |
| Metal Double D-Ring | 2" Metal Double D-Rings. Thread webbing through Double |
| D-Ring to secure; unthread webbing to release |
End Styles
The end style is the component of the restraint that connects to the stretcher/cot or backboard. There are four different end styles available depending on whether the restraints will to be used with a stretcher/cot or backboard and depending on user preference. Below is a chart which shows the name and description of each end style.
| Name | Description |
|---|---|
| Loop-Lok™ End | Loop-Lok ends can be used with stretchers/cots and backboards. |
| Webbing wraps around stretcher frame or backboard hand hold and through end of webbing where loop is sewn. Unthread loop to release | |
| Non-Swivel Speed Clip | Non-Swivel Speed Clips are to be used with specially designed backboards containing speed clip pins only. |
| Clips onto backboard pin and locks shut. Does not swivel. Push lock in to release. | |
| Metal Swivel Speed Clip | |
| Plastic Swivel Speed Clip | Swivel Speed Clips are to be used with specially designed backboards containing speed clip pins only. |
| Clips onto backboard pin and locks shut. Push lock in to release. |
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Image /page/3/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 "M" is formed by a combination of solid black shapes, creating a modern and geometric design. The text is in a bold, sans-serif font, emphasizing the company's name and industry.
5. Statement of Intended Use
Morrison Medical Stretcher/Cot and Backboard Restraints are intended to help secure a patient's body to a stretcher, cot or backboard.
6. Statement of Technological Characteristics of the Device
The Morrison Medical Stretcher/Cot and Backboard restraints connect to or wrap around a stretcher, cot or backboard. The restraints are constructed by combining various types of webbing materials, buckles/closures and end styles.
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 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 Stretcher/Cot and Backboard restraints are safe and effective for their intended use and are substantially equivalent to the predicate devices.