(84 days)
Not Found
Not Found
No
The device description and performance summary describe a physical restraint device with no mention of software, data processing, or AI/ML terms.
No
The device is described as "Protective Mitts" that limit hand and finger movement to prevent patients from grasping tubes or picking/scratching dressings and wounds. This is a preventative and restrictive device, not one that directly treats a medical condition.
No
The device is a protective mitt designed to limit hand and finger movement for safety; it does not diagnose medical conditions.
No
The device description clearly outlines physical components like flexible material, mesh, straps, buckles, and an aluminum strip, indicating it is a hardware 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 is to limit hand and finger movement to prevent grasping tubes or picking/scratching. This is a physical restraint/protective function, not a diagnostic test performed on samples from the human body.
- Device Description: The description details physical components like flexible materials, mesh, straps, buckles, and an aluminum strip. These are all physical components, not reagents, instruments, or software used for in vitro testing.
- No Mention of In Vitro Testing: There is no mention of analyzing samples (blood, urine, tissue, etc.) or performing any tests outside of the body.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Kenad Protective Mitts do not fit this description.
N/A
Intended Use / Indications for Use
Kenad Protective Mitts are indicated for medical purposes where hand and finger movement must be limited to prevent grasping tubes or picking or scratching dressings and wounds.
Product codes
880.6760
Device Description
The Kenad Protective Mitts comprise the following modules:
- Mitt: Two sided flexible material. The inside, which faces the hand, is polyurethane, and the outside is polyester foam.
- Mesh Port Covering: Nylon mesh.
- Wrist Strap and Buckle: Flexible polypropylene and polished nickle plated buckle.
- Stay: Inflexible aluminum strip.
How Protective Mitts Function: The hand is placed into the mitt which is comfortably fitted at the wrist with a Velcro closure. The wrist is then snuggly surrounded by the Wrist Strap and Buckle. If needed, the Wrist Strap can be joined via a Quick release Buckle to an Anchor Strap to limit limb movement. Stays placed in some mitts limit mitt flexibility to limit hand motion within the mitt.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand and fingers
Indicated Patient Age Range
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
More than 5000 pairs of Kenad Protective Mitts were sold over the last 5 years. Assuming 100% usage, there have been more than 10,000 patient hand contacts over the last 5 years. During this time, Kenad received no patient injury or product failure complaints about the Protective Mitts. The absence of patient injury or product failure complaints following more than 10,000 product uses over 5 years indicates these products are safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
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, six 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
Protective Mitt is the trade or proprietary name for the devices which are the subject of this Premarket Notification Submission. Within this name, there are four Kenad Protective Mitts.
| KENAD
Catalog # | Description | KENAD
Catalog # | Description |
|--------------------|---------------------|--------------------|--------------------|
| 50-1000 | Adult w/o
stays | 50-1100 | Adult w/
stays |
| 50-1010 | Child w/o
stays | 50-1110 | Child w/
stays |
| 50-1020 | Infant w/o
stays | 50-1120 | Infant w/
stays |
knad 4
1
2.2. Common Or Usual Name
Protective Rostraint 21CFR 880.6760
3. LEGALLY MARKETED DEVICE (807.92(8)(3))
The Kenad Protective Mitts subject to this Premarket Notification Submission are comparable to Protective Mitts from Danek Medical. Inc. Danek filed a premarket notification for Protective Mitts November 23, 1982
DEVICE DESCRIPTION (807.92(a)(4)} ব .
4.1. General Description
The Kenad Protective Mitts subject to this Premarket Notification are devices that comprise the following modules, cited in this document
| Mitt- | Two sided flexible material. The
inside, which faces the hand, is
polyurethane, and the outside is
polyester foam. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Mesh Port Covering- | Nylon mesh. |
Wrist Strap and Buckle- Flexible polypropylene and polished nickle plated buckle.
Stay-Inflexible aluminum strip.
4.2. How Protective Mitts Function
The hand is placed into the mitt which is comfortably fitted at the wrist with a Velcro closure. The wrist is then snuggly surrounded by the Wrist Strap and Buckle.
If needed, the Wrist Strap can be joined via a Quick release Buckle to an Anchor Strap to limit limb movement.
Stays placed in some mitts limit mitt flexibility to limit hand motion within the mitt.
knade
2
ഗ INTENDED USE (807.92(a)(5))
5.1. Indications
Kenad Protective Mitts are indicated for medical purposes where hand and finger movement must be limited to prevent grasping tubes or picking or scratching dressings and wounds.
5.2. Patient Population
Kenad Protective Mitts are used with adults and children.
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(a)(6)) 8.
Kenad Protective Mitts are comparable to Protective Mitts from Danek Medical, Inc. A comparison of these devices are provided in this Premarket Notification Submission.
7. PERFORMANCE DATA (807.92(b))
More than 5000 pairs of Kenad Protective Mitts were sold over the last 5 years. Assuming 100% usage, there have been more than 10,000 pations hand contacts over the last 5 years. During this time, Kenad received no patient injury or product failure complaints about the Protective Mitts.
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 these products are safe and effective.