(70 days)
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No
The device description and intended use clearly define a physical restraint device with no mention of software, data processing, or AI/ML terms.
No.
The device is a restraint designed to limit movement for examination or protection, not to diagnose, cure, mitigate, treat, or prevent disease.
No
Explanation: The device is described as a protective restraint device used to limit movements for examination or protection, not to diagnose a condition.
No
The device description clearly states the device is comprised of physical materials (polyester and cotton) and is a protective restraint device, indicating it is a hardware device, not software.
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, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The DeRoyal Industries, Inc. Pediatric Mittens are described as a "protective restraint device" used to limit physical movement.
- Intended Use: The intended use is to "limit pediatric patient finger, hand, and/or limb movements thereby enabling examination or protection of the patient or others." This involves direct physical interaction with the patient, not the analysis of biological specimens.
The device's function is purely mechanical and related to physical restraint, which is not the purpose of an IVD.
N/A
Intended Use / Indications for Use
The DeRoval Industries. Inc. Pediatric Mittens are indicated for use, at the discretion of a responsible licensed healthcare professional, to limit pediatric patient finger, hand, and/or limb movements thereby enabling examination or protection of the patient or others. The Pediatric Mittens can be attached to a bed or used alone.
Product codes
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Device Description
The DeRoyal Industries, Inc. Pediatric Mittens are a protective restraint device that are intended for medical purposes to limit pediatric patient finger and hand movements thereby enabling examination or protection of the patient or others. Limb restraint straps that attach to the Pediatric Mittens are optional, if needed.
Device Design/Materials Used/Physical Properties: The DeRoyal Pediatic Mittens are designed similar to those marketed by other manufacturers. The Pediatric Mittens are primarily comprised of 100% polyester and cotton with hook and loop fasteners.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
pediatric patient
Intended User / Care Setting
responsible licensed healthcare professional
Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
DeRoyal Industries, Inc. Pediatric Mittens
510(k) Summarv
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: COMMON/USUAL NAME: CLASSIFICATION NAME (if known): DeRoyal Industries, Inc. Pediatric Mittens Pediatric Mittens Restraint, Protective (80FMQ)
PREDICATE OR LEGALLY MARKETED DEVICES
J.T. Posey Company DeRoyal Industries, Inc.
DEVICE DESCRIPTION
The DeRoyal Industries, Inc. Pediatric Mittens are a protective restraint device that are intended for medical purposes to limit pediatric patient finger and hand movements thereby enabling examination or protection of the patient or others. Limb restraint straps that attach to the Pediatric Mittens are optional, if needed.
Device Design/Materials Used/Physical Properties: The DeRoyal Pediatic Mittens are designed similar to those marketed by other manufacturers. The Pediatric Mittens are primarily comprised of 100% polyester and cotton with hook and loop fasteners.
DEVICE INTENDED USE
The DeRoval Industries. Inc. Pediatric Mittens are indicated for use, at the discretion of a responsible licensed healthcare professional, to limit pediatric patient finger, hand, and/or limb movements thereby enabling examination or protection of the patient or others. The Pediatric Mittens can be attached to a bed or used alone.
TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)
| Characteristic | DeRoyal Device | Other Devices |
|---|---|---|
| Materials | Primarily comprised of 100% polyester cool knit, blue purr, and 100 % cotton white twill tape. Fasteners are made of hook and loop. | Same |
| Size | Infant and child | Same |
| Vehicles for Attachment | Attachment to bed is optional, if needed | Same |
| Length of use | Doctor must prescribe every 24 hours | Same |
| Level of Patient Activity | Finger, hand, or limb interference by pediatric patient | Same |