(128 days)
No
The device description focuses on the physical components of a hospital bed system (canopy, mattress, frame) and its function as a restraint. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No
Explanation: The device is a restraint system designed to provide a safe, controlled environment for patients at risk of injury from falls or unassisted bed exits, rather than treating a medical condition or disease.
No
The Posey Bed 8070 is a hospital bed system designed to provide a safe, controlled environment and act as a less restrictive physical restraint. It does not perform any diagnostic functions like detecting, identifying, or monitoring medical conditions or diseases.
No
The device description clearly outlines a physical hospital bed system including a bed, canopy, and mattress, which are hardware components. There is no mention of software being the primary or sole component of the device.
Based on the provided text, 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, canopy, and mattress system designed to provide a safe, controlled environment for patients at risk of injury from falls or unassisted bed exits. This is a physical support and restraint device, not a device used to examine specimens from the human body.
- Device Description: The description details the physical components of the bed system (bed frame, canopy, mattress, access panels, ports, etc.). There is no mention of reagents, assays, or any components used for testing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using reagents or calibrators
The Posey Bed 8070 is a medical device, specifically a physical restraint and support system, but it does not fit the definition of an In Vitro Diagnostic device.
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 that includes Rx use in the home environment.
Product codes
OYS
Device Description
The proposed device, the Posey Bed 8070 with modified labeling to include home use, is the same unchanged device previously cleared by the FDA under K103817 via the 510(k) notification process, and is substantially equivalent for design and materials. This 510(k) establishes that the Posey Bed 8070 is also substantially equivalent to the Soma Safe Enclosure, as used with an AC-powered hospital bed, for the home use adjustable environment, (K963701).
The 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-POS 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, torso cushions, bed support surface, 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 that includes Rx use in the home environment.
The Posey Bed 8070 is the same product as that previously cleared under K103817, however, it is now being proposed for expanded use in the home environment. A comparison of device features in K103817 demonstrated that the Posey Bed 8070 is substantially equivalent to the currently marketed Soma Safe Enclosure, as used with an AC-powered adjustable hospital bed. Both devices utilize equivalent fabrics, mesh and zippers and are framed, enclosed canopies.
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
Prescribed by a licensed physician for home use.
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
Results of biocompatibility (ISO 10993), human factors, and performance testing have established that the Posey Bed 8070 for use in a home care environment is suitable for the intended use indicated and is substantially equivalent to the previously cleared Posey Bed 8070 and the Soma Safe Enclosure.
The human factors testing conducted by caregivers was used to validate the design of a training regimen and Instructions for Use to include safe and effective device interactions in a home environment.
Key Metrics
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.
0
KI13351
iv
510(k) Pre-Market Notification: Posey Bed 8070 (Rx Home Use/Additional Patient Environment)
MAR 2 1 2012
510(k) Summary for the Posey Bed 8070
| SUBMITTER: | J. T. Posey Company
5635 Peck Road ·
Arcadia, California 91006 USA |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | 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 |
| DATE PREPARED: | November 9, 2011 |
| DEVICE TRADE NAME: | Posey Bed 8070 |
| COMMON/USUAL NAME: | Enclosed Bed System |
| CLASSIFICATION NAME: | Protective Restraint (21 CFR §880.6760), Code
FMQ |
SUBSTANTIAL EQUIVALENCE:
DEVICE DESCRIPTION:
The proposed device, the Posey Bed 8070 with modified labeling to include home use, is the same unchanged device previously cleared by the FDA under K103817 via the 510(k) notification process, and is substantially equivalent for design and This 510(k) establishes that the Posey materials. Bed 8070 is also substantially equivalent to the Soma Safe Enclosure, as used with an AC-powered hospital bed, for the home use adjustable environment, (K963701).
The 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-POS 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 The bed has a control that allows the openings.
1
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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 These features provide a system that mattress. 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, torso cushions, bed support surface, 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 that includes Rx use in the home environment.
The Posey Bed 8070 is the same product as that previously cleared under K103817, however, it is now being proposed for expanded use in the home environment. A comparison of device features in K103817 demonstrated that the Posey Bed 8070 is substantially equivalent to the currently marketed Soma Safe Enclosure, as used with an AC-powered adjustable hospital bed. Both devices utilize equivalent fabrics, mesh and zippers and are framed, enclosed canopies.
INTENDED USE:
TECHNICAL CHARACTERISTICS:
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vi
PERFORMANCE TESTING:
Results of biocompatibility (ISO 10993), human factors, and performance testing have established that the Posey Bed 8070 for use in a home care environment is suitable for the intended use indicated and is substantially equivalent to the previously cleared Posey Bed 8070 and the Soma Safe Enclosure.
The human factors testing conducted by caregivers was used to validate the design of a training regimen and Instructions for Use to include safe and effective device interactions in a home environment.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Bonnie Bishop, RAC Vice President, Quality Assurance and Regulatory Affairs J.T. Posey Company 5635 Peck Road Arcadia, California 91006
MAR 2 1 2012
Re: K113357
Trade/Device Name: Posey Bed 8070 (for home use) Regulation Number: 21 CFR 880.6760 Regulation Name: Protective Restraint Regulatory Class: I Product Code: OYS Dated: February 22, 2012 Received: February 23, 2012
Dear Ms. Bishop:
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.
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 addition. FDA may publish further announcements concerning your device in the Federal Register.
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Page 2- Ms. Bishop
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/ucm 115809.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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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
5
5 10(k) Pre-Market Notification: Posey Bed 8070 (Rx Home Use/Additional Patient Environment)
Indications for Use
510(k) Number (If known):
Device Name: Posey Bed 8070 (for home 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 that includes Rx use in the home environment.
Prescription Use X (21 CFR 8801 Subpart D)
.4
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) S
/Division Sign-Off) Division of Anesthesiology, General Hospital ifection Control, Dental Devices
510(k) Number: K113357
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