(36 days)
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No
The device description details a physical garment used for restraint, with no mention of software, algorithms, or data processing that would indicate AI/ML technology.
No.
The device is described as a restraint for patients to prevent them from removing restraints or sliding, which falls under patient safety/positioning, not for treating a disease or condition.
No
This device is a physical restraint designed to prevent patients from moving or sliding, not to diagnose a medical condition.
No
The device description clearly describes physical garments (polyester upper body, jacket-style garment, webbing ties, metal clips, strap) and does not mention any software components.
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 testing is done outside of the body (in vitro).
- Device description: The Sleeper Jacket and Houdini Safety Sleeper are physical garments designed to be worn by a patient to provide restraint. They do not involve the analysis of any biological specimens.
- Intended Use: The intended use is for physical restraint of patients, not for diagnostic testing.
Therefore, based on the provided information, this device clearly falls outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Sleeper Jacket and the Houdini Safety Sleeper are intended for patients who require restraint while in bed or in the wheelchair and who easily remove standard vest-style and poncho-style restraints.
The Houdini Safety Sleeper is recommended for patients who slide or move toward the foot of the bed or who slide off the wheelchair seat.
Product codes
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Device Description
Sleeper Jacket: A polyester upper body, jacket-style garment. It has short sleeves, a brass back zipper, 1 1/8-inch-wide- polyester webbing ties sewn across the waist. Each webbing end is terminated with a metal clip that secures to the bed frame. The webbing criss-crosses in front of the patient to allow him/her to roll from side to side while sleeping in bed. The edges of the garment are finished with bias cut binding in a color that corresponds to the garment size as described on package insert. The device has instructions that show how it can be applied in both the bed and the wheelchair.
Houdini Safety Sleeper: Has the same features as the Sleeper Jacket with the addition of a 1 1/2-inch-wide strap sewn to the back of the garment. The strap is brought between the patient's legs and secured in front of the garment. The purpose of this strap is to prevent the patient from sliding down in the bed or wheelchair.
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)
Sleeper Jacket and Houdini Safety Sleeper 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.
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Image /page/0/Picture/1 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 "Care" is underlined. Below the company name is the word "CORPORATION" in a smaller, sans-serif font.
K963457
TAB F: 510(k) Summary of Safety and Effectiveness
OCT - 9 1996
(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 Fax: 1-914-963-2567
Contact person: Arnold Silverman
Date summary was prepared: August 27, 1996
Device name:
| Trade name: |
|---|
| Common name: |
| Classification name: |
Sleeper Jacket, Houdini Safety Sleeper Bed Safety Restraint Jacket Protective Restraint
Predicate device:
Sleeper Jacket and Houdini Safety Sleeper marketed by Skil-Care Corporation.
Device Description:
Sleeper Jacket: A polyester upper body, jacket-style garment. It has short sleeves, a brass back zipper, 1 1/8-inch-wide- polyester webbing ties sewn across the waist. Each webbing end is terminated with a metal clip that secures to the bed frame. The webbing criss-crosses in front of the patient to allow him/her to roll from side to side while sleeping in bed. The edges of the garment are finished with bias cut binding in a color that corresponds to the garment size as described on package insert. The device has instructions that show how it can be applied in both the bed and the wheelchair.
Houdini Safety Sleeper: Has the same features as the Sleeper Jacket with the addition of a 1 1/2-inch-wide strap sewn to the back of the garment. The strap is brought between the patient's legs and secured in front of the garment. The purpose of this strap is to prevent the patient from sliding down in the bed or wheelchair.
1
Indications for use:
The Sleeper Jacket and the Houdini Safety Sleeper are intended for patients who require restraint while in bed or in the wheelchair and who easily remove standard vest-style and poncho-style restraints.
The Houdini Safety Sleeper is recommended for patients who slide or move toward the foot of the bed or who slide off the wheelchair seat.
Comparative information:
The device (devices) used for comparative purposes is (are) currently marketed as described in this submission. Device (devices) is (are): Sleeper Jacket and Houdini Safety Sleeper.
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.