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.

Device 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.

AI/ML Overview

This submission describes a medical device, the Kenad Protective Mitt, and compares it to a legally marketed device. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way described in the prompt. The document primarily focuses on establishing substantial equivalence to a predicate device and relies on a historical safety record rather than a formal performance study with defined acceptance criteria.

The information requested in the prompt is not available in the provided text.
Here's a breakdown of why this information is missing:

A table of acceptance criteria and the reported device performance: Not provided. The document states a lack of complaints, which is a retrospective safety observation, not a prospective performance metric with acceptance criteria.
Sample size used for the test set and the data provenance: Not applicable. There was no formal "test set" or prospective study. The "sample" is the historical usage of "more than 5000 pairs over 5 years," which is observational rather than a controlled test. Data provenance is implied to be real-world usage in various medical settings.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment process is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication process is described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical restraint, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not a software/algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of device performance. The closest thing to "ground truth" here is the absence of reported patient injury or product failure complaints as an indicator of safety and effectiveness.
The sample size for the training set: Not applicable. This device does not involve a training set as it's not an AI or learning-based system.
How the ground truth for the training set was established: Not applicable.

Summary

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K963422

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.

KENADCatalog #	Description	KENADCatalog #	Description
50-1000	Adult w/ostays	50-1100	Adult w/stays
50-1010	Child w/ostays	50-1110	Child w/stays
50-1020	Infant w/ostays	50-1120	Infant w/stays

knad 4

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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. Theinside, which faces the hand, ispolyurethane, and the outside ispolyester 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

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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.

Regulation Number and Section

§ 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.