(86 days)
Not Found
Not Found
No
The device description and intended use clearly describe physical restraints made of fabric and straps, with no mention of software, algorithms, or any technology that could incorporate AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The devices are designed for patient restraint to prevent self-injury or interruption of medical care, which is a supportive and protective function, not a direct therapeutic one for treating a condition or disease.
No
The device descriptions and intended use clearly state that these are restraint devices, not diagnostic devices. They are designed to protect patients from self-injury or interruption of medical care by physical restraint.
No
The device description clearly states the devices are physical restraints constructed of materials like nylon mesh, webbed straps, cotton canvas, and foam, indicating they are hardware devices, not software.
Based on the provided information, the Johnson & Johnson Safety Vests and Limb Holders are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use is to physically restrain patients to prevent self-injury or interruption of medical care. This is a physical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The devices are described as physical restraints made of materials like nylon mesh, canvas, cotton, and foam. There is no mention of reagents, assays, or any components typically associated with in vitro diagnostics.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status
Therefore, these devices fall under the category of physical restraints and are not IVDs.
N/A
Intended Use / Indications for Use
The Johnson & Johnson Safety Vests are designed to protect patients that are at risk of self injury or interruption of medical care by restraining them . These products can be used in restraining patients to a bed or chair.
The Johnson & Johnson Limb Holders are designed to protect patients that are at risk of self injury or interruption of medical care by restraining them . These products can be used in restraining patients to a bed or chair.
Product codes (comma separated list FDA assigned to the subject device)
80 FMQ
Device Description
The Johnson & Johnson Safety Vests are constructed of lightweight nylon mesh with webbed tie straps and shoulder loops. These vests may be attached to either a chair or a bed.
The Johnson & Johnson Canvas Limb Holder is constructed of a cotton canvas wrist protector with a soft cotton lining, and a polyester strap. The Economy Limb Holder is constructed of a nylon laminated foam with hook and loop closure and polyester straps.
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): 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
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Summary of Safety & Effectiveness Data for the Johnson & Johnson Safety Vests
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
1. Contact Person
Johanna Adler, Assoc. Regulatory Affairs Specialist, (508) 828-3268.
2. Device Name
| Proprietary Name: | Johnson & Johnson Safety Vests |
|---|---|
| Common Name: | Safety Vests |
| Classification Name: | Protective Restraint |
| Regulatory Class: | Class I by 21 CFR § 880.6760 |
| Product Code: | 80 FMQ |
| Owner/ Operator # | 9001269 |
3. Device Classification
Classification for Johnson & Johnson Safety Vests has been placed in Class I by 21 CFR § 880.6760
4. Statement of Substantial Equivalence
The safety and effectiveness of the Johnson & Johnson Safety Vest and the Safety Vest Poncho Style is substantiated by its similarity in design, characteristics, and indications for use, to the currently marketed Posey Waist & Chest Vest and the Posey Criss-Cross Vest, by J.T. Posey Company.
ર. Indications for Use
The Johnson & Johnson Safety Vests are designed to protect patients that are at risk of self injury or interruption of medical care by restraining them . These products can be used in restraining patients to a bed or chair.
હ. Physical Description
The Johnson & Johnson Safety Vests are constructed of lightweight nylon mesh with webbed tie straps and shoulder loops. These vests may be attached to either a chair or a bed.
1
Summary of Safety & Effectiveness Data for the Johnson & Johnson Limb Holders
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
1. Contact Person
Johanna Adler, Assoc. Regulatory Affairs Specialist, (508) 828-3268.
Device Name 2.
| Proprietary Name: | Johnson & Johnson Limb Holders |
|---|---|
| Common Name: | Limb Holders |
| Classification Name: | Protective Restraint |
| Regulatory Class: | Class I by 21 CFR § 880.6760 |
| Product Code: | 80 FMQ |
| Owner/ Operator # | 9001269 |
3. Device Classification
Classification for Johnson & Johnson Limb Holders has been placed in Class I by 21 CFR § 880.6760
4. Statement of Substantial Equivalence
The safety and effectiveness of the Johnson & Johnson Canvas Limb Holder and the Economy Limb Holder is substantiated by its similarity in design, technological characteristics, and indications for use, to the currently marketed Posey-Van Pelt Limb Holder and the Posey Economy Limb Holder, by J.T. Posey Company.
ਹੈ.
Indications for Use
The Johnson & Johnson Limb Holders are designed to protect patients that are at risk of self injury or interruption of medical care by restraining them . These products can be used in restraining patients to a bed or chair.
Physical Description 6.
The Johnson & Johnson Canvas Limb Holder is constructed of a cotton canvas wrist protector with a soft cotton lining, and a polyester strap. The Economy Limb Holder is constructed of a nylon laminated foam with hook and loop closure and polyester straps.