(36 days)
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Not Found
No
The device description details a purely mechanical safety belt with no mention of software, sensors, or computational elements that would be required for AI/ML.
No
The device is described as a safety belt to prevent patients from leaving their bed without assistance, indicating it's a restraint or safety device rather than a device intended for therapeutic treatment of a medical condition.
No
The description of the Roll Belt indicates it is a safety belt intended to prevent a patient from leaving the bed and to act as a reminder for them to seek assistance. It describes the physical construction and function of the belt, none of which involve diagnosing a medical condition.
No
The device description clearly outlines a physical product made of cotton duck pad and polyester webbing straps, indicating it is a hardware device.
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 (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Roll Belt Function: The Roll Belt is a physical restraint device used to prevent a patient from leaving their bed without assistance. It works by physically securing the patient to the bed frame.
- Lack of Specimen Analysis: The description of the Roll Belt does not involve the analysis of any biological specimens. It is a mechanical device.
Therefore, based on the provided information, the Roll Belt clearly falls outside the definition and function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Roll Belt is intended for the patient who requires a safety belt while in bed and who requires a reminder not to leave the bed without assistance.
Product codes
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Device Description
The Roll Belt has a cotton duck pad approximately 26 1/2 inches in length. At its narrowest end, the pad is approximately 6 1/2 inches wide, and at its widest end it is approximately eight inches wide. A 1 1/2-inch-wide, 88-inch-long strap made of polyester webbing is stitched to each end of the cotton duck pad. The wide end has a slot that is approximately 6 1/2 inches long and 1 1/2 inches wide. The webbing from the narrow end is inserted through the slot on the wide end, thereby closing the belt while it encircles the patient's waist. The straps criss-cross in front of the patient permitting him/her to roll from side to side. Both straps are secured to the bed frame. The edges of the device are finished with a bias cut binding.
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
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Key Metrics
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Predicate Device(s)
Roll Belt marketed by Skil-Care Corporation.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
OCT - 9 1996
oad. Yonkers. New York 10701
Skil-Care
CORPORATION
(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 1-914-963-2567 Fax:
Contact person: Arnold Silverman
Date summary was prepared: August 27, 1996
Device name:
Trade name: Common name: Classification name:
Roll Belt Bed Safety Belt Protective Restraint
Predicate device:
Roll Belt marketed by Skil-Care Corporation.
Device Description:
The Roll Belt has a cotton duck pad approximately 26 1/2 inches in length. At its narrowest end, the pad is approximately 6 1/2 inches wide, and at its widest end it is approximately eight inches wide. A 1 1/2-inch-wide, 88-inch-long strap made of polyester webbing is stitched to each end of the cotton duck pad. The wide end has a slot that is approximately 6 1/2 inches long and 1 1/2 inches wide. The webbing from the narrow end is inserted through the slot on the wide end, thereby closing the belt while it encircles the patient's waist. The straps criss-cross in front of the patient permitting him/her to roll from side to side. Both straps are secured to the bed frame. The edges of the device are finished with a bias cut binding.
Indications for use:
The Roll Belt is intended for the patient who requires a safety belt while in bed and who requires a reminder not to leave the bed without assistance.
/P
1
Comparative information:
The device (devices) used for comparative purposes is (are) currently marketed as described in this submission. Device (devices) is (are): Roll Belt.
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 restraint is used, that restraints are used only when needed for proper medical treatment, and that their use is under appropriate supervision.