(70 days)
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Not Found
No
The device description and intended use clearly describe a physical wheelchair accessory made of common materials, with no mention of software, data processing, or any terms related to AI/ML.
No
The device description states it is a wheelchair accessory used to assist cooperative patients, not to treat or cure a medical condition.
No
The provided text describes devices (Safety Poncho, Slider Poncho, Pelvic Holder) as wheelchair accessories intended to assist cooperative patients by providing minimum support and securing them in place. These devices are physical restraints/supports, not tools for diagnosing medical conditions.
No
The device description clearly states the devices are made of physical materials (polyester, cotton, nylon, vinyl) and are physical accessories for wheelchairs, 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 the devices are for assisting cooperative patients in wheelchairs for support. This is a physical support function, not a diagnostic test performed on samples from the human body.
- Device Description: The description details physical accessories made of fabrics and straps for securing a patient. This aligns with a physical support device, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The devices described here do not fit this definition.
N/A
Intended Use / Indications for Use
The Safety Poncho, Slider Poncho and the Pelvic Holder are intended 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 and pelvic holder style wheel chair accessories used to assist cooperative patients who require minimum support in a wheelchair. These devices are made of wolyester, cotton, nylon and vinyl 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
& Nephew DonJoy Inc.
510(K) Summary
K96-3489
NOV 1 2 1996
- SUMMARY OF SAFETY AND EFFECTIVENESS K .
- The Safety Poncho, Slider Poncho and the Pelvic Holder are intended 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 and pelvic holder style wheel chair accessories used to assist cooperative patients who require minimum support in a wheelchair. These devices are made of wolyester, cotton, nylon and vinyl 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 i
Smith & Nephew DonJoy, Inc.
TWO
B Willen 10-31-86
Dana a. White 8-28-96
Dan W. Miller Director of Regulatory Affairs and Quality Assurance
Image /page/0/Picture/14 description: The image shows a logo with the number 5 at the top. Below the number is the text "DJ" in a bold, stylized font. Underneath "DJ" is the text "DONJOY" in a smaller, less bold font. The logo appears to be for a DJ named Donjoy.