(114 days)
Not Found
No
The device description and intended use focus on the mechanical and structural components of a hospital bed system designed for patient safety and containment. There is no mention of any computational or analytical functions that would suggest the use of AI or ML.
No
The device is described as a hospital bed system, canopy, and mattress system used as a less restrictive alternative to physical restraints. Its purpose is to provide a safe, controlled environment and prevent injury from falls or unassisted bed exits, rather than treating a medical condition or restoring function.
No
The Posey Bed 8070 is described as a hospital bed, canopy, and mattress system designed to provide a safe, controlled environment for patients at risk of injury from falls or unassisted bed exits, functioning as a less restrictive alternative to physical restraints. It does not perform any diagnostic functions or gather diagnostic information.
No
The device description clearly outlines a physical hospital bed system with a canopy, mattress, and various hardware components. There is no mention of software being the primary or sole component of the device.
Based on the provided information, the Posey Bed 8070 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a hospital bed system designed to provide a safe, controlled environment for patients at risk of injury from falls or unassisted bed exits. This is a therapeutic and safety function, not a diagnostic one.
- Device Description: The description details the physical components of the bed system (bed, canopy, mattress, etc.) and its features related to patient containment and safety. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Posey Bed 8070 does not perform any such function.
Therefore, the Posey Bed 8070 is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Posey Bed 8070 is a hospital bed, canopy, and mattress system 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 8070 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 8070 is a restraint, and must be prescribed by a licensed physician (Rx Only).
Product codes
OYS
Device Description
The patented Posey Bed 8070 is an enclosed bed canopy system which includes and attaches to a fully automatic, AC-powered adjustable hospital bed (either the Joerns Healthcare, Inc., Stevens Point, Wisconsin, Easy Care® 2003DC, Model B684DC or the Invacare Corporation, Elyria, Ohio, Model SC900DLX Low Electric Bed), which has a six-inch enclosed mattress compartment to help reduce the risk of patient entrapment. The device also features a 70 cubic-foot rectangular green nylon canopy with four zippered access panels for easy access to patients and four ports for intravenous lines, call bells and drainage bag openings. The bed has a control that allows the frame to be raised to 30 inches for patient care or lowered to 19 inches for ease of wheelchair transfers. A perimeter guard is available as a temporary guard for use when patient care is being given.
The Posey Bed 8070 does not have side rails, headboards or footboards. Contained within the canopy is a specialized compartment for the mattress to prevent the mattress from moving within the canopy and the patient from crawling under the mattress. These features provide a system that minimizes the potential for patient entrapment. Other safety features include a perimeter guard (reference: Soft Rails) that provides an additional measure to protect the patient from falling when the canopy is opened and a health care provider is attending to the patient. Optional accessories include filler cushions, cushions, cushions, bed support torso suface, incontinence pads, and travel covers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital, licensed physician (Rx Only)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Results of biocompatibility (ISO 10993), human factors, and performance testing (including to IEC 60601-2-38} have established that the Posey Bed 8070 is suitable for the intended use indicated and is substantially equivalent to the Soma Safe Enclosure. Human factors testing conducted by caregivers was used to validate the design of a training regimen and Instructions for Use for safe and effective device interactions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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510(k) Summary for the Posey Bed 8070
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
Robert Kelleher Sr. Vice President. Finance and Operations Phone: (626) 454-2109 (626) 443-5012 Fax: BKelleher@posey.com E-mail:
March 15, 2011
Posev Bed 8070
Enclosed Bed System
Protective Restraint (21 CFR §880.6760), Code ૦૫૬
The proposed device is substantially equivalent to the Soma Safe Enclosure as used with an ACpowered adjustable hospital bed described in K963701 previously cleared by the FDA via the 510(k) notification process.
The patented Posey Bed 8070 is an enclosed bed canopy system which includes and attaches to a fully automatic, AC-powered adjustable hospital bed (either the Joerns Healthcare, Inc., Stevens Point, Wisconsin, Easy Care® 2003DC, Model B684DC or the Invacare Corporation, Elyria, Ohio, Model SC900DLX Low Electric Bed), which has a six-inch enclosed mattress compartment to help reduce the risk of patient The device also features a 70 entrapment. cubic-foot rectangular green nylon canopy with four zippered access panels for easy access to patients and four ports for intravenous lines, call bells and drainage bag openings. The bed has a control that allows the frame to be raised to 30 inches for patient care or lowered to 19 inches for ease of wheelchair transfers. A perimeter guard is available as a temporary guard for use when patient care is being given.
The Posey Bed 8070 does not have side rails, headboards or footboards. Contained within the canopy is a specialized compartment for the mattress to prevent the mattress from moving
APR 2 2 2011
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within the canopy and the patient from crawling under the mattress. These features provide a system that minimizes the potential for patient entrapment.
Other safety features include a perimeter guard (reference: Soft Rails) that provides an additional measure to protect the patient from falling when the canopy is opened and a health care provider is attending to the patient.
Optional accessories include filler cushions, cushions, cushions, bed support torso suface, incontinence pads, and travel covers.
The Posey Bed 8070 is a hospital bed, canopy, and mattress system 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 8070 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 8070 is a restraint, and must be prescribed by a licensed physician (Rx Only).
TECHNICAL CHARACTERISTICS:
A comparison of device features demonstrate that the Posey Bed 8070 is substantially equivalent to the currently marketed Soma Safe Enclosure, as used with an AC-powered The Soma Safe adjustable hospital bed. Enclosure was originally manufactured by Nova Technologies. Inc. (Bristol. Connecticut) and is now manufactured by Vivax Medical Corp (Torrington, Connecticut). Both devices utilize equivalent fabrics, mesh, and zippers and are framed, enclosed canopies.
Results of biocompatibility (ISO 10993), human factors, and performance testing (including to IEC 60601-2-38} have established that the Posey Bed 8070 is suitable for the intended use indicated and is substantially equivalent to the Soma Safe Enclosure. Human factors testing conducted by caregivers was used to validate the design of a training regimen and Instructions for Use for safe and effective device interactions.
INTENDED USE:
PERFORMANCE TESTING:
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Robert Kelleher Senior Vice President Finance and Operations J.T. Posey, Company 5635 Peck Road Arcadia, California 91006
FEB - 3 2012
Re: K103817
Trade/Device Name: Posey Bed 8070 Regulation Number: 21 CFR 880.6760 Regulation Name: Protective Restraint Regulatory Class: I Product Code: OYS Dated: March 15, 2011 Received: March 16, 2011
Dear Mr. Kelleher:
This letter corrects our substantially equivalent letter of April 22, 2011. We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
The product code has changed from FMQ to OYS, patient bed with canopy/restraints. defined as an enclosed bed canopy system used as a passive restraint. OYS is a new product code under 21 CFR 880.6760, Class I, non-exempt.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In
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Page 2- Mr. Kelleher
addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/ default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Anthony D. Aunta
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/1 description: The image shows a constellation of stars. The stars are arranged in a scattered pattern, with some stars clustered together and others more isolated. The constellation appears to be Ursa Minor, also known as the Little Dipper.
Indications for Use
510(k) Number (If known): K103817
Device Name: Posey Bed 8070
Indications for Use:
The Posey Bed 8070 is a hospital bed, canopy, and mattress system 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 8070 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 8070 is a restraint, and must be prescribed by a licensed physician (Rx Only).
Prescription Use_ × (21 CFR §801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR §801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
4/22/11
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K103817