(35 days)
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Not Found
No
The device description details a physical garment with mechanical ties and a pad, with no mention of software, data processing, or AI/ML terms.
No.
The device is described as providing physical support and preventing sliding, but does not claim to treat any medical condition or restore health. While it aids patients, its primary function is assistive, not therapeutic.
No
The device is described as a garment providing support and preventing sliding for patients in wheelchairs. Its function is to restrain and position, not to diagnose medical conditions or provide information for diagnosis.
No
The device description clearly describes a physical garment (sleeved jacket) made of polyester with hardware components like a brass zipper and webbing ties. It is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide support and prevent sliding for patients seated in a wheelchair. This is a physical support function, not a diagnostic test performed on biological samples.
- Device Description: The device is a garment designed to be worn on the body and secured to a wheelchair. It does not involve any reagents, instruments, or procedures for analyzing biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no indication of diagnosing a disease or condition based on in vitro testing.
Therefore, this device falls under the category of a medical device providing physical support, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The sleeved jacket is intended for patients who require support while seated in a wheelchair.
The sleeved jacket with slider control is intended for patients who require support and additional support to prevent sliding forward while seated in a wheelchair.
Both are intended for patients who have a history of removing vest-style and poncho-style restraints.
Product codes
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Device Description
Sleeved Jacket: The sleeved jacket is a polyester upper body garment, designed to be worn over clothing, with short sleeves, a brass back zipper, and 1 & 1/8 inch polyester webbing ties sewn across the back at the shoulder area and across the front at the waist. The ties are tied to the wheelchair push handles and kick spurs, respectively, to provide patients with postural support. The edges of the garment are finished with bias cut binding in a color to correspond with the garment size as described in the insert labeling.
Sleeved Jacket with Slider Control: The Sleeved Jacket with Slider Control has the same features as the sleeved jacket with the addition of a crotch pad sewn to the bottom center front. The pad is lined with 1/4 inch polyurethane foam and has a 1 & 1/8 inch polyester webbing strap sewn on that is either placed directly under the patient or under the seat of the wheel chair and secured to the wheelchair cross brace to prevent the patient from sliding down.
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)
The Sleeved Jacket and Sleeved Jacket with Slider Control currently marketed by Skil-Care Corporation
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 890.3910 Wheelchair accessory.
(a)
Identification. A wheelchair accessory is a device intended for medical purposes that is sold separately from a wheelchair and is intended to meet the specific needs of a patient who uses a wheelchair. Examples of wheelchair accessories include but are not limited to the following: armboard, lapboard, pusher cuff, crutch and cane holder, overhead suspension sling, head and trunk support, and blanket and leg rest strap.(b)
Classification. Class I (general controls). If the device is not intended for use as a protective restraint as defined in § 880.6760 of this chapter, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records, and § 820.198, regarding complaint files.
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167 Saw Mill River Road. Yonkers. New York 10701
Image /page/0/Picture/1 description: The image shows the logo for Skil-Care Corporation. The words "Skil-Care" are in bold, black font on the top line, with a line underneath the word "Care". The word "Corporation" is in a smaller, black font on the bottom line. The logo is simple and professional.
MT =8 1996
(914) 963-2040
(800) 431-2972
FAX (914) 963-2567
TAB F: 510(k) Summary of Safety and Effectiveness
Name, address, phone and fax numbers for person submitting the 510(k) notification:
Arnold Silverman, President Skil-care Corporation 167 Saw Mill River Road Yonkers, NY 10701 Phone: 1-914-963-2040 Fax: 1-914-963-2567
Contact Person: Arnold Silverman
Date summary was prepared: August 18, 1996
Device name:
| Trade name: | Sleeved Jacket and Sleeved Jacket with Slider Control |
|---|---|
| Common name: | Same |
| Classification name: | Wheelchair Accessory |
Predicate device:
The Sleeved Jacket and Sleeved Jacket with Slider Control currently marketed by Skil-Care Corporation
Device Description:
Sleeved Jacket: The sleeved jacket is a polyester upper body garment, designed to be worn over clothing, with short sleeves, a brass back zipper, and 1 & 1/8 inch polyester webbing ties sewn across the back at the shoulder area and across the front at the waist. The ties are tied to the wheelchair push handles and kick spurs, respectively, to provide patients with postural support. The edges of the garment are finished with bias cut binding in a color to correspond with the garment size as described in the insert labeling.
Sleeved Jacket with Slider Control: The Sleeved Jacket with Slider Control has the same features as the sleeved jacket with the addition of a crotch pad sewn to the bottom center front. The pad is lined with 1/4 inch polyurethane foam and has a 1 & 1/8 inch polyester webbing strap sewn on that is either placed directly under the patient or under the seat of the wheel chair and secured to the wheelchair cross brace to prevent the patient from sliding down.
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Indications for Use:
The sleeved jacket is intended for patients who require support while seated in a wheelchair.
The sleeved jacket with slider control is intended for patients who require support and additional support to prevent sliding forward while seated in a wheelchair.
Both are intended for patients who have a history of removing vest-style and poncho-style restraints.
Comparative information:
The devices used for comparative purposes are the Sleeved Jacket and Sleeved Jacket with Slider Control , currently marketed and as described in this submission.
These devices are currently exempt from 510(k) Premarket Notification Procedures and Good Manufacturing Practice Regulations and are legally marketed by Skil-Care Corporation as of the date of this submission. Skil-Care Corporation has been manufacturing and commercially distributing these devices for approximately ten years.
The difference from our currently marketed devices are that the labeling will be changed to incorporate many of the suggestions in FDA's draft document, "Guidance on the Content of Premarket Notification [510(k)] Submissions for Protective Restraints."
The use of all patient restraints in nursing homes are subject to Health Care Financing Administration's Regulations which prohibit the use of any restraint, physical or chemical, imposed for the purpose of discipline or convenience. Further, most health care facilities are accredited. HCFA rules governing appropriate use and accreditation standards for device use and personnel training provide the control necessary to ensure that the devices are used correctly. The application of these standards along with public awareness, and health care provider training have contributed significantly to ensuring that the least restrictive restraint is used, that restraints are used only when needed for proper medical treatment, and that their use is under appropriate supervision.
Skil-Care 510(k) Summary of Safety and Effectiveness Sleeved Jacket and Sleeved Jacket with Slider Control Page 2 of 2