(72 days)
Not Found
Not Found
No
The summary describes a physical restraint device made of cotton or polyester with fasteners, with no mention of software, algorithms, or data processing.
No.
The provided text describes the device as a protective restraint device intended to limit limb movements for examination or protection, not for treating a disease or illness.
No.
The device is a protective restraint intended to limit limb movements, not to diagnose medical conditions.
No
The device description explicitly states the mittens are comprised of physical materials (cotton or polyester) with fasteners, 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 is to "limit limb movements thereby enabling examination or protection of the patient or others." This is a physical restraint function, not a diagnostic test performed on samples from the human body.
- Device Description: The description details a physical device made of cotton or polyester with fasteners, designed to control hand and finger movements. This aligns with a physical restraint, not a diagnostic instrument or reagent.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health condition through in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The DeRoyal Industries, Inc. Mittens are indicated for use, at the discretion of a responsible licensed healthcare professional, to limit limb movements thereby enabling examination or protection of the patient or others. The Mittens are intended to be attached to a bed.
Product codes (comma separated list FDA assigned to the subject device)
80FMQ
Device Description
The DeRoyal Industries, Inc. Mittens are a protective restraint device that are intended for medical purposes to control hand and finger movements and/or limit limb movements thereby enabling examination or protection of thers.
Device Design/Materials Used/Physical Properties: The DeRoyal Mittens are designed similar to those marketed by other manufacturers. The Mittens are primarily comprised of 100% cotton or polyester with hook and loop or buckle fasteners.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
responsible licensed healthcare professional
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)
Not Found
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.
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 1 4 1996
K96-3469
DeRoyal Industries, Inc. Mittens
510(k) Summary
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED
SUBMITTER INFORMATION
DeRoyal Industries, Inc. NAME: ADDRESS: 200 DeBusk Lane Powell, TN 37849
TELEPHONE: CONTACT: DATE OF PREPARATION: (423) 938-7828 Camille Matlock August 30, 1996
DEVICE NAMES
| NAME: | DeRoyal Industries, Inc. Mittens |
|---|---|
| COMMON/USUAL NAME: | Mittens |
| CLASSIFICATION NAME (if known): | Restraint, Protective (80FMQ) |
PREDICATE OR LEGALLY MARKETED DEVICES
J.T. Posey Company DeRoyal Industries, Inc.
DEVICE DESCRIPTION
The DeRoyal Industries, Inc. Mittens are a protective restraint device that are intended for medical purposes to control hand and finger movements and/or limit limb movements thereby enabling examination or protection of thers.
Device Design/Materials Used/Physical Properties: The DeRoyal Mittens are designed similar to those marketed by other manufacturers. The Mittens are primarily comprised of 100% cotton or polyester with hook and loop or buckle fasteners.
DEVICE INTENDED USE
The DeRoyal Industries, Inc. Mittens are indicated for use, at the discretion of a responsible licensed healthcare professional, to limit limb movements thereby enabling examination or protection of the patient or others. The Mittens are intended to be attached to a bed.
| Characteristic | DeRoyal Device | Other Devices |
|---|---|---|
| Materials | Primarily comprised of 100% cotton or polyester | Same |
| Size | Small, Medium, Large, and Extra-Large | Same |
| Vehicles for Attachment | Bed | Same |
| Length of use | Doctor must prescribe every 24 hours | Same |
| Level of Patient Activity | Mildly agitated | |
| Limb interference by patient | Same |