(107 days)
Not Found
Not Found
No
The device description and intended use clearly describe a physical restraint device made of fabric, with no mention of software, data processing, or any technology that would incorporate AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The device is a protective restraint to limit patient movement for examination or protection, not to treat a medical condition or ailment.
No
Explanation: The device is described as a "protective restraint" used to "limit patient movement" for examination or protection. It does not perform any diagnostic function such as detecting, diagnosing, or monitoring a disease or condition.
No
The device description clearly states it is a physical protective restraint made of materials like cotton cloth, flannel, cool knit, or cotton sheeting, indicating it is a hardware device.
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 patient movement thereby enabling examination or protection of the patient or others." This is a physical restraint for patient safety and management.
- Device Description: The device is described as a "protective restraint device" made of materials like cotton cloth, flannel, etc.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on biological samples. This device is a physical restraint.
N/A
Intended Use / Indications for Use
The DeRoyal Industries, Inc. Pelvic Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movement thereby enabling examination or protection of the patient or others. The Pelvic Holder is a protective restraint which can be used with a bed or wheelchair.
Product codes (comma separated list FDA assigned to the subject device)
80FMQ
Device Description
The DeRoyal Industries, Inc. Pelvic Holder is a protective restraint device that is intended for medical purposes to limit patient moyement thereby enabling examination or protection of the patient or others.
Device Design/Materials Used/Physical Properties: The DeRoyal Pelvic Holder is designed similar to those marketed by other manufacturers. The Pelvic Holder is primarily comprised of either cotton cloth, flannel, cool knit, or cotton sheeting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
DeRoyal Industries, Inc. Pelvic Holder
X963465
510(k) Summary
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED
SUBMITTER INFORMATION
NAME: DeRoyal Industries, Inc. 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. Pelvic Holder Pelvic Holder Restraint, Protective (80FMQ)
PREDICATE OR LEGALLY MARKETED DEVICES
J.T. Posey Company DeRoyal Industries, Inc.
DEVICE DESCRIPTION
The DeRoyal Industries, Inc. Pelvic Holder is a protective restraint device that is intended for medical purposes to limit patient moyement thereby enabling examination or protection of the patient or others.
Device Design/Materials Used/Physical Properties: The DeRoyal Pelvic Holder is designed similar to those marketed by other manufacturers. The Pelvic Holder is primarily comprised of either cotton cloth, flannel, cool knit, or cotton sheeting.
DEVICE INTENDED USE
The DeRoyal Industries, Inc. Pelvic Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movement thereby enabling examination or protection of the patient or others. The Pelvic Holder is a protective restraint which can be used with a bed or wheelchair.
TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)
| Characteristic | DeRoyal Device | Other Devices |
|---|---|---|
| Materials | The body is comprised of either cotton cloth, | |
| flannel, cool knit, or cotton sheeting | Same | |
| Style Variations | Disposable or Extra Security | 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 | |
| Tendency to Leave Bed or Wheelchair | Same |