(64 days)
Not Found
Not Found
No
The device description details a physical restraint system made of fabric and straps, with no mention of software, algorithms, or data processing.
No.
The device's intended use is for "Protective Restraints" and its description indicates it is a physical restraint (Vest Restraint, Wrist/Ankle Restraints) used to secure a patient. This function is not typically considered therapeutic as it does not treat or cure a disease or condition, but rather manages patient behavior or safety.
No
The device description clearly states its purpose is for "Protective Restraints" and describes how it physically secures a patient. There is no mention of it being used to diagnose any condition or disease.
No
The device description clearly details physical components made of fabric and straps, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is "Protective Restraints." This clearly indicates a physical restraint device used to limit a patient's movement for safety purposes.
- Device Description: The description details physical garments (vest and wrist/ankle restraints) made of fabric with straps and closures. This aligns with the description of a physical restraint device.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Use in a laboratory setting.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor medical conditions. This device is a physical restraint, which falls under a different regulatory category.
N/A
Intended Use / Indications for Use
Not Found
Product codes
80 FMQ
Device Description
Vest Restraint: The body of the vest restraint is constructed from two main pattern pieces, a front and a back which are cut from light weight polyester mesh fabric. The back is split down the center which results in there being two identical back pieces. The back opening facilitates the application of the garment to the patient. It contains a hook and loop closure which extends from the neck through to the bottom of the vest comes equipped with long straps attached just below waist level for securing the patient to the chair, wheelchair or bed; ties at the waist to adjust for proper fit: underarm loops to which the optional 54" long straps can be attached if additional support is required: and a modified v-neck. It is supplied in five sizes from X-small to X-large to fit chests from 28" to 56". It may be hand washed in warm water and air dried.
Wrist/Ankle Restraints: The wrist/ankle restraints are simply constructed from a polyester pile fabric with a knitted backing. They are secured to the wrist or ankle with a hook and loop closure and are supplied with a long strap which is used to secure the wrist/ankle restraint to a chair, wheelchair or bed. The wrist/ankle restraints are available with two types of buckles on the long straps; sliding metal buckle or a white (nylon acetal) quick-release buckle. Both styles are provided in one universal adult size. They may be hand washed in warm water and air dried.
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
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
OCT 31 1996
10f2 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
Registration No.: 1818910 |
|-----------------------------------|-------------------------------------------------------------------------------------------------|
| FIRM CONTACT: | Arlene Saull, RAC
Manager, Medical Device Submissions |
| TRADE NAME: | DePuy Mesh Vest Restraint with Sleeves
DePuy Wrist/Ankle Restraint |
| COMMON NAME: | Protective Restraints |
| CLASSIFICATION: | Class I per 21 CFR, 880.6760 Protective
Restraint |
| DEVICE PRODUCT CODE: | 80 FMQ Restraint, Protective |
| SUBSTANTIALLY EQUIVALENT DEVICES: | |
J. T. Posey Co. Vest Restraint
J. T. Posey Co. Limb Holders
DEVICE DESCRIPTION AND INTENDED USE:
Vest Restraint:
The body of the vest restraint is constructed from two main pattern pieces, a front and a back which are cut from light weight polyester mesh fabric. The back is split down the center which results in there being two identical back pieces. The back opening facilitates the application of the garment to the patient. It contains a hook and loop closure which extends from the neck through to the bottom of the vest comes equipped with long straps attached just below waist level for securing the patient to the chair, wheelchair or bed; ties at the waist to adjust for proper fit: underarm loops to which the optional 54" long straps can be attached if additional support is required: and a modified v-neck. It is supplied in five sizes from X-small to X-large to fit chests from 28" to 56". It may be hand washed in warm water and air dried.
Wrist/Ankle Restraints:
The wrist/ankle restraints are simply constructed from a polyester pile fabric with a knitted backing. They are secured to the wrist or ankle with a hook and loop closure and are supplied with a long strap which is used to secure the wrist/ankle restraint to a chair, wheelchair or bed. The wrist/ankle restraints are available with two types of buckles on the long straps; sliding metal buckle or a white (nylon acetal) quick-release buckle. Both styles are provided in one universal adult size. They may be hand washed in warm water and air dried.
000009
1
H96 3393
2012
BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy Mesh Vest Restraint with Sleeves and the DePuy Wrist/Ankle Restraints are substantially equivalent to protective restraints marketed by the J. T. Posey Co. based on their similarities in design, construction, materials, fasteners, and intended uses.