(170 days)
No
The device description and intended use focus on a physical enclosure system for patient safety, with no mention of AI or ML technologies.
No.
The device is described as a restraint system designed to provide a safe, controlled environment for patients at risk of injury from falls or unassisted bed exits, rather than to treat a specific medical condition or disease.
No
The description of the device's function is to "help provide a safe, controlled environment for patients at extreme risk of injury from a fall or unassisted bed exit" and as a "less restrictive alternative to physical restraints." It does not mention any diagnostic capabilities.
No
The device description clearly outlines a physical, enclosed bed canopy system made of nylon, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to "help provide a safe, controlled environment for patients at extreme risk of injury from a fall or unassisted bed exit." This is a physical intervention for patient safety and fall prevention.
- Device Description: The description details a physical canopy system that attaches to a bed. It describes features like nylon canopy, zippered access panels, and ports for lines and bags. These are all physical components related to containing a patient within the bed.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on biological samples to gain information about a person's health status. The Posey Bed 8040/8060 does not perform any such tests. It is a physical restraint/enclosure system.
N/A
Intended Use / Indications for Use
The Posey Bed 8040/8060 is an A-Frame canopy system. When attached to a compatible commercially available hospital bed (not included) the 8040/8060 is designed to help provide a safe, controlled environment for patients at extreme risk of injury from a fall or unassisted bed exit. The Posey Bed 8040/8060 is a less restrictive alternative to physical restraints such as belts, vests, or jackets for patients at least 46 inches tall, weighing between 46 and 300 pounds. The Posey Bed 8040/8060 is a restraint, and must be prescribed by a licensed physician that includes Rx use in the home environment.
Product codes (comma separated list FDA assigned to the subject device)
OYS
Device Description
The Posey Bed 8040 and Posey Bed 8060 (Posey Bed 8040/8060) is an enclosed bed canopy system with an adjustable enclosed mattress compartment. The Posey Bed 8040 features a 73 cubic-foot, A-Frame, green nylon canopy with one zippered access panel and one drainage port opening. The Posey Bed 8060 features a 73 cubic-foot, A-Frame green nylon canopy with four zippered access panels for easy patient access, and ten ports for intravenous lines, call bells and drainage bags. When attached to a compatible commercially available hospital bed (not included), the 8040/8060 is designed to help provide a safe, controlled environment for patients at extreme risk of injury from a fall or unassisted bed exit.
The Posey Bed 8040 and 8060 hospital bed compatibility guidelines are:
- . Length of bed frame must be
§ 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
510(k) Pre-Market Notification: Posey Bed 8040 and Posey Bed 8060
K 113355
i
MAY - 2 2012
510(k) Summary for the Posey Bed 8040 and Posey Bed 8060
SUBMITTER:
CONTACT PERSON:
DATE PREPARED: DEVICE TRADE NAME: COMMON/USUAL NAME:
CLASSIFICATION NAME:
SUBSTANTIAL EQUIVALENCE:
DEVICE DESCRIPTION:
J. T. Posey Company 5635 Peck Road Arcadia, California 91006 USA
Bonnie Bishop, RAC Vice President, Quality Assurance and Regulatory Affairs Phone: (626) 454- 2195 (direct) (626) 443-3143, extension 195 Fax: (626) 443-5012 E-mail: BBishop@posey.com
April 24, 2012
Posey Bed 8040 and Posey Bed 8060
Enclosed bed canopy system used as passive restraint
Protective Restraint (21 CFR §880.676020), Code OYS
The proposed device when used with a compatible commercially available hospital bed is substantially equivalent to the Posey Bed 8070 as described in K103817 previously cleared by the FDA via the 510(k) notification process. The proposed device is also substantially equivalent to the Soma Safe Enclosure, cleared under K963701.
The Posey Bed 8040 and Posey Bed 8060 (Posey Bed 8040/8060) is an enclosed bed canopy system with an adjustable enclosed mattress compartment. The Posey Bed 8040 features a 73 cubic-foot, A-Frame, green nylon canopy with one zippered access panel and one drainage port opening. The Posey Bed 8060 features a 73 cubic-foot, A-Frame green nylon canopy with four zippered access panels for easy patient access, and ten ports for intravenous lines, call bells and drainage bags. When attached to a compatible commercially available hospital bed (not included), the 8040/8060 is designed to help provide a safe, controlled
1
environment for patients at extreme risk of injury from a fall or unassisted bed exit.
The Posey Bed 8040 and 8060 hospital bed compatibility guidelines are:
- . Length of bed frame must be ≤ 96" and does not retract