(70 days)
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No
The device description and intended use clearly describe physical restraints made of fabric and straps, with no mention of software, algorithms, or data processing.
No
The device is a restraint, which assists in patient control and safety, rather than providing therapy for a medical condition.
No
Explanation: The device description clearly states its purpose is to "restrain patients in a wheelchair or bed" and "assist cooperative patients who require minimum support in wheelchair." It is a physical restraint device, not one designed to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states the devices are made of physical materials (polyester, cotton, nylon, polyethelen) and are physical restraints, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist cooperative patients who require minimum support in wheelchair" and to "restrain patients in a wheelchair or bed." This describes a physical restraint device used on a patient, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details physical components like vests, jackets, mitts, straps, and materials (polyester, cotton, nylon, polyethylene). This aligns with a physical restraint device, not an IVD which would typically involve reagents, instruments for analysis, or software for interpreting biological data.
- Lack of IVD Characteristics: 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 analytes
- Providing diagnostic information
- Using reagents or laboratory equipment
Therefore, the description clearly points to a physical medical device used for patient restraint, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Economy Restraint, Jacket Restraint, Two Piece Vest Restraint, Safety Vest and Hand Control Mitt are incended for use to assist cooperative patients who require minimum support in wheelchair. The devices are labeled for prescription use and are not intended for lay use.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
These devices are vest, jacket and mitt style restraints used to restrain patients in a wheelchair or bed. These devices are made of polyester, cotton, nylon and polyethelen configured into either a mesh or weave substrate. Each device utilizes straps for securing (tie) the patient in place.
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
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
· BE AR. - . . . NP,
510K Summary
K96-3492
NOV 12 1996
Smith & Nephew DonJoy Inc.
277? Liker Avenue West
Carlshind, CA 92008-6601 USA.
Telephone: (619) 438-98091
Toll-free: (800) 336-5690
Telejas (619) 438-3210
Smith & Nephew
- SUMMARY OF SAFETY AND EFFECTIVENESS K. The Economy Restraint, Jacket Restraint, Two Piece Vest Restraint, Safety Vest and Hand Control Mitt are incended for use to assist cooperative patients who require minimum support in wheelchair. The devices are labeled for prescription use and are not intended for lay use. These devices are vest, jacket and mitt style restraints used to restrain patients in a wheelchair or bed. These devices are made of polyester, cotton, nylon and polyethelen configured into either a mesh or weave substrate. Each device utilizes straps for securing (tie) the patient in place. These devices have been commercially distributed for over four years and have not been associated with an MDR type complaint .
Smith & Nephew DonJoy, Inc.
Dan W. Mitch 8-28-96
Dan W. Miller Director of Regulatory Affairs and Quality Assurance
Image /page/0/Picture/6 description: The image shows a logo or emblem with the letters "DJ" stacked on top of each other in a bold, blocky font. Below the letters, the word "CONVOY" is written in a smaller, sans-serif font. Underneath the word "CONVOY", there is a handwritten number "5".