(34 days)
The Pelvic Holder is intended for patients who require both slider control and restraint while in the wheelchair.
The Pelvic Holder is a diaper-shaped device made from either woven polyester or polyester mesh. The device fits between the patient's legs and is secured by webbing around the waist. Webbing is 1 1/8-inch-wide polyester and secures to the wheelchair. The purpose of the device is to prevent patient from sliding down in the wheelchair. The edges are finished with bias cut binding that corresponds to a size chart included on the package insert. The device is intended for wheelchair use only.
The provided text is a 510(k) summary for a medical device called a "Pelvic Holder." It describes the device, its intended use, and compares it to a predicate device. However, it does not contain any information regarding acceptance criteria, performance studies, or ground truth establishment.
Therefore, I cannot provide the requested information in the format of a table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
The document focuses on regulatory compliance and device description, not on a detailed performance evaluation study.
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FAX
TAB F: 510(k) Summary of Safety and Effectiveness
Name, address, phone and fax numbers for person submitting the 510(k) notification:
OCT - 7 1996
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: Pelvic Holder Same Wheelchair Accessory
Predicate device:
Pelvic Holder marketed by Skil-Care Corporation.
Device Description:
The Pelvic Holder is a diaper-shaped device made from either woven polyester or polyester mesh. The device fits between the patient's legs and is secured by webbing around the waist. Webbing is 1 1/8-inch-wide polyester and secures to the wheelchair. The purpose of the device is to prevent patient from sliding down in the wheelchair. The edges are finished with bias cut binding that corresponds to a size chart included on the package insert. The device is intended for wheelchair use only.
Indications for use:
The Pelvic Holder is intended for patients who require both slider control and restraint while in the wheelchair.
Comparative information:
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The device (devices) used for comparative purposes is (are) currently marketed as described in this submission. Device (devices) is (are): Pelvic Holder
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.
§ 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.