(68 days)
Not Found
Not Found
No
The device description and intended use clearly describe a physical restraint system with no mention of software, data processing, or AI/ML terms.
No
The device is described as a restraint system used for patient control by securing ankles, which is not a therapeutic function.
No
The device description indicates it is a physical restraint system (Ankle Restraint System) used for patient control by securing ankles, and does not mention any function related to diagnosing medical conditions.
No
The device description clearly outlines physical components made of nylon webbing and hook and loop closures, 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 Ankle Restraint System is a physical restraint device used to secure a patient's ankles. It does not involve testing any biological samples.
- Intended Use: The intended use is for patient control and securing ankles, not for diagnostic testing.
Therefore, based on the provided information, the Ankle Restraint System falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Ankle Restraint System is intended to be used in situations requiring patient control while the patient is lying on a cot or stretcher. The Ankle Restraint System is intended to secure the patient's ankles by keeping them in a fixed position.
Product codes
Not Found
Device Description
The Ankle Restraint System is a restraint system that secures the patient's ankles in a fixed position. It consists of two individual ankle restraints that are permanently attached at a specific distance apart from each other to a long security strap. The security strap is constructed using a nylon woven webbing that is 2 inches wide and 17 inches long. Straps attached to both ends of the security strap secure the ankle restraint system to a cot or stretcher. The individual ankle restraints are also constructed using a nylon woven webbing. A nylon hook and loop closure is secured to the webbing and is used to securely close the ankle restraint.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankles
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)
Ankle Restraint System
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/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.
K96 34/6
NOV - 6 1996
Morrison Medical Products Ankle Restraint System
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 26, 1996
- Name of Device:
ﻤﺴﻪ،
Ankle Restraint System
- Name of Predicate Device(s)
Ankle Restraint System
4. Description of Device
In recent years there has been considerable effort in the health care community to assure that restraints are used only when needed, usually with patient consent and that the least restrictive restraint be used. Morrison Medical Products has developed the Ankle Restraint System to help serve in this purpose. The Ankle Restraint System is designed for situations requiring patient control. The Ankle Restraint System is a restraint system that secures the patient's ankles in a fixed position. It consists of two individual ankle restraints that are permanently attached at a specific distance apart from each other to a long security strap. The security strap is constructed using a nylon woven webbing that is 2 inches wide and 17 inches long. Straps attached to both ends of the security strap secure the ankle restraint system to a cot or stretcher. The individual ankle restraints are also constructed using a nylon woven webbing. A nylon hook and loop closure is secured to the webbing and is used to securely close the ankle restraint.
5. Statement of Intended Use
The Ankle Restraint System is intended to be used in situations requiring patient control while the patient is lying on a cot or stretcher. The Ankle Restraint System is intended to secure the patient's ankles by keeping them in a fixed position.
Page 19
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 "M" is formed by thick, black lines, and the text is in a simple, sans-serif font, also in black.
Morrison Medical Products Ankle Restraint System
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 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 Ankle Restraint System is safe and effective for its intended use and is substantially equivalent to the predicate device.
Page 20