(70 days)
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Not Found
No
The summary describes simple physical restraints made of common materials, with no mention of any computational or data-driven components.
No.
The intended use states these devices are used to restrain patients, which is not a therapeutic purpose aiming to treat or prevent disease.
No
Explanation: The device is described as a restraint used to secure patients in a wheelchair or bed. Its function is to restrain, not to diagnose medical conditions or provide information for diagnosis.
No
The device description clearly states the devices are made of physical materials (polyester, cotton, nylon, polyethelen) and are configured into physical belts and restraints, indicating they are hardware devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these devices are used to restrain patients in a wheelchair or bed. This is a physical restraint function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the materials and configuration for physical restraint. There is no mention of reagents, assays, or any components typically associated with in vitro diagnostic testing.
- Lack of IVD Indicators: The document does not mention any of the key characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, these devices fall under the category of physical restraints and are not IVDs.
N/A
Intended Use / Indications for Use
These devices are Universal Gait Belt, Wheelchair Belt, Foam Limb Restraint, Double Buckle Limb Restraint, Comfort Safety Belt, Comfort Slider Belt, Universal Roll Belt and belt style restraints used to restrain patients in a wheelchair or bed.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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
The devices are labeled for prescription use and are not intended for lay use.
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
510(k) Summary
K96-3490
NOV 12 1996
2777 Loker Avenue Wes
Carlsbad. CA 921X18-06 LS.A.
Telephone: (619) 4,38-9091
Toll-free 1800) 330-5600
Jeklas (0191438-3210
Smith+Nephew
- SUMMARY OF SAFETY AND EFFECTIVENESS K -These devices are Universal Gait Belt, Wheelchair Belt, Foam Limb Restraint, Double Buckle Limb Restraint, Comfort Safety Belt, Comfort Slider Belt, Universal Roll Belt and belt style restraints used to restrain patients in a wheelchair or bed. The devices are labeled for prescription use and are not intended for lay use. 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 for years and have not been associated with an MDR type complaint.
Smith & Nephew DonJoy, Inc.
Ron W. Wile 8-28-96
Dan W. Miller Director of Regulatory Affairs and Quality Assurance
Image /page/0/Picture/13 description: The image shows a logo with the letters "DJ" stacked on top of the word "DONJOY". The letters and word are in a bold, sans-serif font and are black against a white background. There is a curved line above the "DJ" letters, possibly part of a larger design element.