(34 days)
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No
The device description details a physical restraint vest made of fabric and straps, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The provided information describes a "Safety Vest" intended for patient restraint and posture support, not for treating or diagnosing a disease or condition. It is a physical restraint device.
No.
The device descriptions and intended use clearly state that these are restraint and posture support devices, not diagnostic ones. They do not perform any assessment, measurement, or analysis of a patient's condition to identify a disease or medical problem.
No
The device description clearly details physical components made of woven polyester or polyester mesh, straps, and bindings, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used outside of the body (in vitro) to diagnose, monitor, or screen for diseases or conditions.
- Device Description and Intended Use: The description and intended use of the Safety Vest, Economy Safety Vest, and Vest with Shoulder Straps clearly indicate they are physical restraints and posture support devices used on the patient's body while in a wheelchair or bed. They do not involve the examination of any bodily specimens.
Therefore, based on the provided information, these devices fall under the category of physical restraints or support devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Safety Vest is intended for patients who require restraint while in the wheelchair or bed.
Economy Safety Vest is intended for patients who require restraint while in the wheelchair or bed.
Vest with Shoulder Straps is intended for patients who require restraint and posture support while in the wheelchair.
Product codes
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Device Description
Safety Vest: A vest-style, upper body device made from either woven polyester or polyester mesh. A 1 1'8-inch-wide polyester strap attached to one side of the vest at the waist is threaded through a slot on the other causing the vest to criss-cross and close in front of the patient. The waist strap secures to the kickspurs of the wheelchair or to the bed frame. The edges of the garment are finished with a bias cut binding, the color of which corresponds to a size chart included on the package insert. Device is intended for wheelchair or bed use.
Economy Safety Vest: Identical to above except that it is made from a lighter weight woven polyester material and is not available in polvester mesh. Unlike the above device which is intended for multiple uses, this is a singe-patient-use device. This fact is noted on the garment label along with a notation that it is not to be laundered.
Vest with Shoulder Straps: Identical with Safety Vest with the addition of 1 1/8-inchwide webbing straps sewn to the shoulder area. These straps are secured to the pushhandles to provide patient posture support. This device is for wheelchair use only.
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
upper body
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
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Key Metrics
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Predicate Device(s)
Safety Vest, Economy Safety Vest, and Vest with Shoulder Straps marketed by Skil-Care Corporation.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
Image /page/0/Picture/0 description: The image shows the logo for Skil-Care Corporation. The logo is in black and white, with the words "Skil-Care" in a bold, sans-serif font. The word "Corporation" is printed below in a smaller font. To the right of the text is a graphic of a medical device.
67 Saw Mill River Road, Yonkers, New York 10701
TAB F: 510(k) Summarv of Safety and Effectiveness
(914) 963-2040
(800) 431-2972
FAX (914) 963-2567
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 1-914-963-2567 Fax:
OCT - 7 1996
Contact person: Arnold Silverman
Date summary was prepared: August 27, 1996
Device name:
| Trade name: | Safety Vest, Economy Safety Vest, Vest with
Shoulder Straps |
|----------------------|----------------------------------------------------------------|
| Common name: | Same |
| Classification name: | Wheelchair Accessory |
Predicate device:
Safety Vest, Economy Safety Vest, and Vest with Shoulder Straps marketed by Skil-Care Corporation.
Device Description:
Safety Vest: A vest-style, upper body device made from either woven polyester or polyester mesh. A 1 1'8-inch-wide polyester strap attached to one side of the vest at the waist is threaded through a slot on the other causing the vest to criss-cross and close in front of the patient. The waist strap secures to the kickspurs of the wheelchair or to the bed frame. The edges of the garment are finished with a bias cut binding, the color of which corresponds to a size chart included on the package insert. Device is intended for wheelchair or bed use.
Economy Safety Vest: Identical to above except that it is made from a lighter weight woven polyester material and is not available in polvester mesh. Unlike the above device which is intended for multiple uses, this is a singe-patient-use device. This fact is noted on the garment label along with a notation that it is not to be laundered.
1
Vest with Shoulder Straps: Identical with Safety Vest with the addition of 1 1/8-inchwide webbing straps sewn to the shoulder area. These straps are secured to the pushhandles to provide patient posture support. This device is for wheelchair use only.
Indications for use:
Safety Vest is intended for patients who require restraint while in the wheelchair or bed.
Economy Safety Vest is intended for patients who require restraint while in the wheelchair or bed.
Vest with Shoulder Straps is intended for patients who require restraint and posture support while in the wheelchair.
Comparative information:
The device (devices) used for comparative purposes is (are) currently marketed as described in this submission. Device (devices) is (are): Safety Vest. Economy Safety Vest, Vest with Shoulder Straps.
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 marketing and commercially distributing these devices for approximately 18 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.