(84 days)
Not Found
No
The device description and performance summary focus on the physical components and safety record of a vest restraint, with no mention of AI or ML technologies.
No.
Explanation: The device is a restraint used to limit patient movement for safety and control, not to actively treat a medical condition or disease.
No
The device, Kenad Vest Restraints, is used to limit patient movement for treatment, examination, protection, or posture control. It does not diagnose any medical condition.
No
The device description explicitly lists physical components such as fabric, metal buckles, and plastic buckles, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for limiting patient movement for treatment, examination, protection, or posture control. This is a physical restraint device used on the patient's body.
- Device Description: The description details the physical components of a vest restraint (fabric, buckles, straps).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (on the body) as a physical restraint.
N/A
Intended Use / Indications for Use
Kenad Vest Restraints are indicated for medical purposes where patient movement must be limited to the extent necessary for treatmant, examination, protection of the patient or others, or posture control.
Product codes
Not Found
Device Description
The Kenad Vest Restraints subject to this Premarket Notification are devices that comprise the following modules, cited in this document
Vest- blue, flame retardant polyester cotton twill fabric.
Shoulder Ring- nickle plated, polished metal buckle.
Side Strap- flexible, polypropylene material.
Quick Release Buckle- plastic buckle.
Anchor Strap- flexible, polypropylene material.
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
Kenad Vest Restraints are used with adults and children.
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
More than 5000 Kenad Vest Restraints were sold over the last 6 years. Assuming 100% usage, there have been more than 5000 patient contacts with Vest Restraints over the last 5 years. During this time, Kenad received no patient injury or product failure complaints about Vast Restraints.
Key Metrics
Not Found
Predicate Device(s)
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.
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NOV 222 1996
510(k) SUMMARY
PERSONNEL AND DATE (807.92(a)(1)) 1.
1.1. Submitter
Kenad SG Medical Inc. 2692 Huntley Mamphis, TN 38132
1.2.. Contact Person
Kenneth Elmore President and CEO Kenad SG Medical Inc.
1.3.. Date Of summary Preparation
This summary was prepared in July 1996.
2. DEVICE NAME (807.92(a)(2))
As noted in the Cover Letter, three similar devices are grouped within this 510(k) notification. These devices differ only in minor design aspects. Their function, application and use is Identical.
2.1. Trade Or Propristary Name
Vest Restraint Is the trade or proprietary name for the devices subject to this Premarket Notification Submission. Within this name are the following:
Pediatric Patient Protective Vest (Without Sleeves)
Patient Protective Vest (Without Sleeves)
Patiant Protective Vest (With Sleeves)
Patient Protective Vest (With Sleeves With Tails)
These devices are available in sizes: X-Small, Small, Medium, Large, X-Large and XX-Large.
2.2. Common Or Usual Name
Protective Restraint 21CFR 880.6760
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3. LEGALLY MARKETED DEVICE (807.92(a)(3))
The Kenad Vest Restraints subject to this Premarker Notification Submission are comparable to Vest Restraints from Danek Medical, Inc. Danek successfully filed a Premarket notification for their Vest Restraints at Document Control number K823815, January 17, 1983.
DEVICE DESCRIPTION (807.92(a)(4)) 4.
4.1. General Description
The Kenad Vest Restraints subject to this Premarket Notification are devices that comprise the following modules, cited in this document
| Vest- | blue, flame retardant polyester cotton twill fabric. |
|---|---|
| Shoulder Ring- | nickle plated, polished metal buckle. |
| Side Strap- | flexible, polypropylene material. |
| Quick Release Buckle- | plastic buckle. |
| Anchor Strap- | flexible, polypropylene material. |
4.2. How Vest Restraints Function
Vest Reatraints are placed about the upper body as a jacket. The jacket is fixed comfortably, yet snugly in place by crossing the side straps. The restraint is then affixed to a stationary part of a bed or chair via the Side Strap, Quick Release Buckle and Anchor Strap.
INTENDED USE (807.92(a)(5)) த.
5.1. Indications
Kenad Vest Restraints are indicated for medical purposes where patient movement must be limited to the extent necessary for treatmant, examination, protection of the patient or others, or posture control.
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5.2. Patient Population
Kenad Vest Restraints are used with adults and children.
Indications Different From Substantially Equivalent Device 5.3.
Indications and patient populations for the Kenad devices are identical to the legally marketed device cited in this document
COMPARISON TO LEGALLY MARKETED DEVICE (807.92(a){6)} 6.
Kenad Vest Restraints are comparable to vest these devices are provided in this Provided in this Premarket Notification Submission.
7. PERFORMANCE DATA (807.92(b))
More than 5000 Kenad Vest Restraints were sold over the last 6 years. Assuming 100% usage, there have been more than 5000 patient contacts with Vest Restraints over the last 5 years. During this time, Kenad received no patient injury or product failure complaints about Vast Restraints.
8. SAFETY, EFFICACY AND PERFORMANCE CONCLUSION (807.92(b)(3))
The absence of patient injury or product failure complaints following approximately 5000 product uses over 5 years indicates Kenad Vest Restraints are safe and effective.