(84 days)
Not Found
No
The device description details a physical restraint system with no mention of software, algorithms, or any technology that would incorporate AI or ML.
No
The device is described as a restraint to limit patient movement for safety or treatment, not to provide therapy itself.
No
The device is described as a restraint for limiting patient movement, not for diagnosing medical conditions.
No
The device description explicitly lists physical components like a belt, straps, and a buckle, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Kenad Waist Holder is a physical restraint device designed to limit patient movement. It does not involve the analysis of any biological specimens.
- Intended Use: The intended use is to limit patient movement for treatment, examination, or protection, not to diagnose or monitor a medical condition through laboratory testing.
The description clearly indicates a physical device used externally on the patient, not a test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
Kenad Waist Holders are indicated for medical purposes where patient movement must be limited to the extent necessary for treatment, examination or protection of the patient or others.
Product codes
Not Found
Device Description
The Kenad Waist Holders subject to this Premarket Notification are devices that comprise the following modules, cited in this document
Blue, polyurethane foam Belt-
Side Strap-Flexible, polypropylane
Quick Release Buckle-Plastic buckle
Anchor Strap-Flexible, polypropylane
Walst Holders are placed comfortably around the waist as a belt. The Side Straps are then affixed by Quick Disconnect to an Anchor Strap affixed to an immovable object either on a bed, for bed application, or on a chair, for chair application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Around the waist.
Indicated Patient Age Range
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
More than 10,000 Kenad Waist Holders were sold over the last 5 years. Assuming 100% usage, there have been more than 10,000 patient contacts with Waist Holders over the last 5 years. During this time, Kenad received no patient injury or product failure complaints about the Waist Holders.
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.
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
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
P.02
NOV 22 1996
510(k) SUMMARY
PERSONNEL AND DATE (807.92(a)(1)) 1 .
1.1. Submitter
Kenad SG Medical Inc. 2692 Huntley Memphis, 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 thru August 1996.
2. DEVICE NAME (807.92(a)(2))
As noted in the Cover Letter, four 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 Proprietary Name
Waist Holder is the trade or proprietary name for the devices which are the subject of this Premarker Notification Submission. Within this name are four Kenad Waist Holders.
| KENAD Catalog # | Size |
|---|---|
| 50-3400 | Pediatric |
| 50-3500 | Adult |
| 50-3600 | Adult Universal w/Slit |
| 50-3700 | Adult X-Wide |
2.2. Common Or Usual Name
Protective Restraint 21CFR 880.6760
knada
1
LEGALLY MARKETED DEVICE (807.92(a)(3)) 3.
The Kenad Waist Holder subject to this Premarker Notification Submission is comparable to Waist Holder from Danek Medical, Inc. Danek successfully filed a Premarket notification for waist holders at Document Control number K823815, January 17, 1983.
DEVICE DESCRIPTION (807.92(a)(4)) 4.
4.1. General Description
The Kenad Waist Holders subject to this Premarket Notification are devices that comprise the following modules, cited in this document
Blue, polyurethane foam Belt-
Side Strap-Flexible, polypropylane
Quick Release Buckle-Plastic buckle
Anchor Strap-Flexible, polypropylane
4.2. How Waist Holder Functions
Walst Holders are placed comfortably around the waist as a belt. The Side Straps are then affixed by Quick Disconnect to an Anchor Strap affixed to an immovable object either on a bed, for bed application, or on a chair, for chair application.
INTENDED USE (807.92(a)(5)) 5.
5.1. Indications
Kenad Waist Holders are indicated for medical purposes where patient movement must be limited to the extent necessary for treatment, examination or protection of the patient or others.
5.2. Patient Population
Kenad Waist Holders are used with adults and children.
knada
.
2
5.3. Indications Different From Substantially Equivalent Device
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(8)(8)) 6.
Kenad Waist Holders are comparable to Waist Holders from Danek Medical, Inc. A comparison of these devices are provided in this Premarket Notification Submission.
7. PERFORMANCE DATA (807.92(b))
More than 10,000 Kenad Waist Holders were sold over the last 5 years. Assuming 100% usage, there have been more than 10,000 patient contacts with Waist Holders over the last 5 years. During this time, Kenad received no patient injury or product failure complaints about the Waist Holders.
8. SAFETY, EFFICACY AND PERFORMANCE CONCLUSION (807.92(b)(3))
The absence of patient injury or product failure complaints following more than 10,000 product uses over 5 years indicates the Kenad Waist Holders are safe and effective.