POSEY BED

K103817 · J. T. Posey Co. · OYS · Apr 22, 2011 · General Hospital

Device Facts

• Record ID: K103817
• Device Name: POSEY BED
• Applicant: J. T. Posey Co.
• Product Code: OYS · General Hospital
• Decision Date: Apr 22, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1
• Attributes: Therapeutic

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).

Device Story

The Posey Bed 8070 is an enclosed bed canopy system integrated with an AC-powered adjustable hospital bed. It provides a safe, controlled environment for patients at high risk of falls or unassisted bed exit. The system includes a 70 cubic-foot rectangular nylon canopy with zippered access panels and ports for IV lines, call bells, and drainage bags. A specialized mattress compartment prevents mattress movement and patient entrapment. The bed frame is adjustable (19 to 30 inches) to facilitate patient care and wheelchair transfers. A perimeter guard is provided for use when the canopy is open. Operated by healthcare providers in clinical settings, the device serves as a less restrictive alternative to traditional physical restraints (belts, vests, jackets). It benefits patients by reducing injury risk while maintaining a secure environment.

Clinical Evidence

Bench testing only. Performance testing included biocompatibility (ISO 10993) and performance testing to IEC 60601-2-38. Human factors testing was conducted by caregivers to validate the training regimen and Instructions for Use.

Technological Characteristics

Enclosed bed canopy system; 70 cubic-foot rectangular nylon canopy; AC-powered adjustable hospital bed frame; zippered access panels; IV/drainage ports; specialized mattress compartment. Biocompatibility per ISO 10993; performance testing per IEC 60601-2-38.

Indications for Use

Indicated for patients at least 46 inches tall, weighing 46-300 lbs, who are at extreme risk of injury from falls or unassisted bed exit. Must be prescribed by a licensed physician.

Regulatory Classification

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.

Predicate Devices

• Soma Safe Enclosure (K963701)

Reference Devices

• Soft Rails

Submission Summary (Full Text)

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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: [phone] [phone] Fax: [e-mail] 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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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 [phone] or [phone] 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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### 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