(73 days)
1142, 1150, 1160
Not Found
No
The device description and intended use describe a simple mechanical strap and buckle system with no mention of AI or ML.
No
Explanation: The device is intended to limit patient movement for safety or to secure equipment, not to directly treat a medical condition.
No
The intended use of the device is to limit patient movement for treatment, examination, or protection, and to assist in securing equipment. It does not describe any function related to diagnosing a condition or disease.
No
The device description clearly states it is constructed of physical materials (nylon hook and loop) and is a physical strap with a buckle, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to limit patient movement and secure equipment. This is a physical restraint/securing function, not a diagnostic test performed on biological samples.
- Device Description: The device is a strap made of nylon hook and loop material. This is a physical device, not a reagent, instrument, or system used for in vitro examination of specimens.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis, monitoring, or treatment decisions based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Morrison Medical Products Cinch Strap with Buckle is intended to limit 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 position. The device is also intended to be used as an assist in securing equipment.
Product codes
Not Found
Device Description
The Morrison Medical Products Cinch Strap with Buckle is intended to limit a 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 position. The device is also intended to be used as an assist in securing equipment.
The Cinch Strap with Buckle is constructed of a nylon hook and loop material. Heat Sealed to one end is a nylon hook material that is used to secure the patient or equipment in the Cinch Strap with Buckle. The Cinch Strap with Buckle is available in the following sizes:
Series 1142 - 1" x 42" Series 1150 - 11/2" x 18" Series 1160 - 11/2 x 30"
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Cinch Strap with Buckle
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 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 and is aligned to the left.
Morrison Medical Products Cinch Strap with Buckle
NOV - 8 1996
Safety and Effectiveness Summary
1. Submitter's name, Address and Contact Person
| Submitter | Contact Person |
|---|---|
| Morrison Medical Products | Joseph S. Tokarz, Manager, Regulatory Affairs |
| 610 W. Town Street | Hollister Incorporated |
| Columbus, OH 43215-4446 | 2000 Hollister Drive |
| Libertyville, IL 60048 | |
| Ph: (847)680-2849, Fax: (847)918-3860 |
Date Summary Prepared - August 23, 1996
- Name of Device:
Cinch Strap with Buckle
3. Name of Predicate Device(s)
Cinch Strap with Buckle
4. Description of Device
The Morrison Medical Products Cinch Strap with Buckle is intended to limit a 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 position. The device is also intended to be used as an assist in securing equipment.
The Cinch Strap with Buckle is constructed of a nylon hook and loop material. Heat Sealed to one end is a nylon hook material that is used to secure the patient or equipment in the Cinch Strap with Buckle. The Cinch Strap with Buckle is available in the following sizes:
Series 1142 - 1" x 42" Series 1150 - 11/2" x 18" Series 1160 - 11/2 x 30"
5. Statement of Intended Use
The Morrison Medical Products Cinch Strap with Buckle is intended to limit the patient's movement to the extent necessary for treatment, examination, or protection of the patient
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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 Cinch Strap with Buckle
or others. The device can be used in the supine or sitting position. The device is also intended to be used as an assist in securing equipment.
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.
7. Biocompatibility
The subject devices are identical in component materials to the predicate devices. A biocompatibility review of these materials indicated little potential to evoke an adverse reaction. In addition, Morrison Medical Products is not aware of any reports or complaints of skin irritation associated with these materials.
8. Conclusion
Based upon the information presented above it is concluded that the proposed Morrison Medical Products Cinch Strap with Buckle is safe and effective for its intended use and is substantially equivalent to the predicate device.
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