(141 days)
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No
The summary describes a physical restraint device made of fabric and fasteners, with no mention of software, algorithms, or data processing.
No.
The device is a restraint used to limit movement for examination or protection, not to treat a medical condition or restore function.
No
Explanation: The device is described as a "protective restraint" intended to limit movements for examination or protection, not to diagnose a condition.
No
The device description clearly states it is a physical restraint made of materials like cool knit, cotton, polyester straps, and fasteners, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states the device is a "Poncho Vest Restraint" intended to "limit movements thereby enabling examination or protection of the patient or others." It is a physical restraint used externally on the patient.
- Lack of Biological Sample Testing: There is no mention of the device being used to test biological samples or analyze any substances from the body.
Therefore, the DeRoyal Industries, Inc. Poncho Vest Restraint falls under the category of a physical restraint device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The DeRoyal Industries, Inc. Poncho Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit movements thereby enabling examination or protection of the patient or others. The Poncho Vest Restraint is a protective restraint that is intended to be used with a bed or wheelchair.
Product codes
FMQ
Device Description
The DeRoyal Industries, Inc. Poncho Vest Restraint device that is intended for medical purposes to limit movements thereby enabling examination or protection of the patient or others. Device Design/Materials Used/Physical Properties: The DeRoyal Poncho Vest Restraint is designed similar to those marketed by other manufacturers. The Poncho Restraint is primarily comprised of cool knit or cotton with polyester straps. The fasteners are made of a nylon hook and loop or steel nickel plated buckles.
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
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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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§ 890.3910 Wheelchair accessory.
(a)
Identification. A wheelchair accessory is a device intended for medical purposes that is sold separately from a wheelchair and is intended to meet the specific needs of a patient who uses a wheelchair. Examples of wheelchair accessories include but are not limited to the following: armboard, lapboard, pusher cuff, crutch and cane holder, overhead suspension sling, head and trunk support, and blanket and leg rest strap.(b)
Classification. Class I (general controls). If the device is not intended for use as a protective restraint as defined in § 880.6760 of this chapter, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records, and § 820.198, regarding complaint files.
0
JAN 22 1997
DeRoyal Industries, Inc. Poncho Vest Restraint
510(k) Summary
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED
SUBMITTER INFORMATION
| NAME: | DeRoyal Industries, Inc. | TELEPHONE: | (423) 938-7828 |
|---|---|---|---|
| ADDRESS: | 200 DeBusk Lane | ||
| Powell, TN 37849 | CONTACT: | Camille Matlock | |
| DATE OF PREPARATION: | August 30, 1996 |
DEVICE NAMES
| NAME: | DeRoyal Industries, Inc. Poncho Vest Restraint |
|---|---|
| COMMON/USUAL NAME: | Poncho Vest Restraint |
| 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. Poncho Vest Restraint device that is intended for medical purposes to limit movements thereby enabling examination or protection of the patient or others.
Device Design/Materials Used/Physical Properties: The DeRoyal Poncho Vest Restraint is designed similar to those marketed by other manufacturers. The Poncho Restraint is primarily comprised of cool knit or cotton with polyester straps. The fasteners are made of a nylon hook and loop or steel nickel plated buckles.
DEVICE INTENDED USE
The DeRoyal Industries, Inc. Poncho Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit movements thereby enabling examination or protection of the patient or others. The Poncho Vest Restraint is a protective restraint that is intended to be used with a bed or wheelchair.
TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)
| Characteristic | DeRoyal Device | Other Devices |
|---|---|---|
| Materials | Primarily comprised of cotton flannel or polyester cool knit. | |
| The straps are made of polyester or nylon. Fasteners are | ||
| made of hook and loop or steel nickel plated buckles. | Same | |
| Size | X-Small, Small, Medium, Large, X-Large, XX-Large, XXX- | |
| Large | Same | |
| Vehicles for Attachment | Bed or Wheelchair | Same |
| Length of use | Doctor must prescribe every 24 hours | Same |
| Level of Patient Activity | Mildly agitated or disoriented | Same |