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.

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 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.

AI/ML Overview

This document is a 510(k) Pre-Market Notification for the Posey Bed 8070, seeking clearance for expanded use in a home environment. It is primarily a submission to the FDA for regulatory clearance and focuses on establishing substantial equivalence to previously cleared devices.

Therefore, the document does not contain the kind of detailed information about acceptance criteria and a study design with specific performance metrics (like sensitivity, specificity, or reader improvement with AI) that would be relevant for an AI/ML medical device.

Here's a breakdown based on the information provided, and why most of the requested fields cannot be filled:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided text. The document is for a physical medical device (an enclosed bed system), not an AI/ML algorithm that predicts or diagnoses. Performance is assessed through demonstrating safety and substantial equivalence to existing devices.

Acceptance Criteria	Reported Device Performance
Not applicable (physical device clearance, not AI/ML performance)	Not applicable (physical device clearance, not AI/ML performance)

2. Sample Size Used for the Test Set and Data Provenance

This information is not available in the provided text in the context of an AI/ML test set. The performance testing mentioned includes "biocompatibility (ISO 10993), human factors, and performance testing."

Sample Size for Test Set: Not specified for any quantitative testing that would typically be associated with an AI/ML device.
Data Provenance: Not applicable in the context of AI/ML data provenance. The human factors testing involved "caregivers," but the number or details are not provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not available. Ground truth for an AI/ML device typically involves expert annotations or diagnoses. For this physical device, "human factors testing" involved caregivers, but they are not described as experts establishing a ground truth for an AI model.

4. Adjudication Method

This information is not available. Adjudication methods (like 2+1, 3+1) are relevant for reconciling discrepancies in expert opinions when establishing ground truth for AI/ML models. This concept does not apply to the testing described for the Posey Bed 8070.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not available. An MRMC study is specific to evaluating diagnostic performance, often comparing human readers with and without AI assistance. This type of study is not mentioned as part of the clearance for the Posey Bed 8070.

6. Standalone (Algorithm Only) Performance Study

This information is not available. This refers to the performance of an AI algorithm without human intervention. The Posey Bed 8070 is a physical device, not an algorithm.

7. Type of Ground Truth Used

The concept of "ground truth" as it applies to AI/ML models (e.g., expert consensus, pathology, outcomes data) is not applicable here. For the Posey Bed 8070, the "truth" is established through demonstrating safety, functionality, and substantial equivalence to legally marketed predicate devices, as well as adherence to standards like ISO 10993 for biocompatibility and human factors validation.

8. Sample Size for the Training Set

This information is not available, as this device does not involve an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not available, as this device does not involve an AI/ML model that requires a training set and associated ground truth.

Summary of what the document does indicate about performance and acceptance:

The document states that the Posey Bed 8070, for home care use, is found to be "substantially equivalent" to:

The previously cleared Posey Bed 8070 (under K103817).
The Soma Safe Enclosure (K963701).

Performance testing mentioned includes:

Biocompatibility (ISO 10993): This establishes that the materials used in the device are not harmful to biological systems. Meeting this standard acts as an acceptance criterion for material safety.
Human Factors Testing: Conducted by caregivers, this 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." This implies that the device's usability and safety for its intended users (caregivers and patients in a home setting) were assessed and found acceptable through this testing.
Performance Testing: A general category mentioned alongside biocompatibility and human factors, which likely refers to testing to ensure the bed's physical components function as intended (e.g., bed frame raising/lowering, canopy zippers, mattress compartment preventing entrapment).

The key "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to existing, legally marketed devices for the proposed expanded use. The studies performed (biocompatibility, human factors, general performance) support this claim by showing the device is as safe and effective as the predicates.

Summary

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KI13351

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 Company5635 Peck Road ·Arcadia, California 91006 USA
CONTACT PERSON:	Bonnie Bishop, RACVice President, Quality Assurance and RegulatoryAffairsPhone: (626) 454-2195 (direct)(626) 443-3143, extension 195Fax: (626) 443-5012E-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), CodeFMQ

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).

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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.

Optional accessories include filler cushions, torso cushions, bed support surface, incontinence pads, and travel covers.

INTENDED USE:

TECHNICAL CHARACTERISTICS:

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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.

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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

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5 10(k) Pre-Market Notification: Posey Bed 8070 (Rx Home Use/Additional Patient Environment)

K113357

Indications for Use

510(k) Number (If known):

Device Name: Posey Bed 8070 (for home use)

Indications for Use:

Prescription Use X (21 CFR 8801 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) S

/Division Sign-Off) Division of Anesthesiology, General Hospital ifection Control, Dental Devices

510(k) Number: K113357

iii

Regulation Number and Section

§ 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.