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.

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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Posey Bed 8040 and Posey Bed 8060," an enclosed bed canopy system. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a performance study with detailed acceptance criteria and results against those criteria. As such, much of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set size) is not present in the provided text.

Here's an analysis of what can be extracted:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria:
- Substantial equivalence to the Posey Bed 8070 (K103817) and Soma Safe Enclosure (K963701) in terms of safety and intended use.
- Suitability for intended use based on biocompatibility, human factors, and performance testing.
- Compatibility with hospital beds meeting specific dimensions (Length ≤ 96" and does not retract < 76"; Width ≤ 36"; Bed platform height for 8040: 13-22 inches, for 8060: 16-25 inches).
- Operational limits (e.g., head of bed angle ≤ 70°) must be observed.
- Minimization of patient entrapment (e.g., side rails down, mattress compartment preventing movement).
- Intended for patients 46-300 pounds and at least 46 inches tall.
- Fabric, mesh, and zippers are the same as predicate devices.
Reported Device Performance:
- The document states: "Results of biocompatibility (ISO 10993), human factors, and performance testing have established that the Posey Bed 8040/8060 is suitable for the intended use indicated and is substantially equivalent to the Posey Bed 8070 and the Soma Safe Enclosure."
- The FDA concurred with the substantial equivalence conclusion.

Table:

Acceptance Criteria	Reported Device Performance
Substantial equivalence to predicate devices (Posey Bed 8070 and Soma Safe Enclosure) regarding safety, intended use, and materials (fabrics, mesh, zippers).	"A comparison of device features demonstrates that the Posey Bed 8040/8060 when attached to a compatible hospital bed is substantially equivalent to the currently marketed Posey Bed 8070. The three Posey Bed devices (Models 8040, 8060 and 8070) utilize the same fabrics, mesh, and zippers and are framed, enclosed canopies. The Posey Bed 8040/8060 is also substantially equivalent to the Soma Safe Enclosure..." "Results of biocompatibility (ISO 10993), human factors, and performance testing have established that the Posey Bed 8040/8060 is suitable for the intended use indicated and is substantially equivalent to the Posey Bed 8070 and the Soma Safe Enclosure." FDA decision: "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..."
Suitability for intended use after biocompatibility, human factors, and performance testing.	"Results of biocompatibility (ISO 10993), human factors, and performance testing have established that the Posey Bed 8040/8060 is suitable for the intended use indicated..."
Compatibility with hospital beds: Length ≤ 96" (and not retracting < 76"), Width ≤ 36", and specific height ranges (Posey Bed 8040: 13-22 inches; Posey Bed 8060: 16-25 inches).	The document describes these as "hospital bed compatibility guidelines" that "must be observed". Performance confirmed suitability with internal testing.
Minimization of patient entrapment (e.g., side rails kept down, mattress compartment to prevent mattress movement and crawling under).	"The Posey Bed 8040/8060 requires that the hospital bed side rails be kept in the 'down' position. The canopy contains a specialized compartment for the mattress that helps 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." Performance confirmed suitability with internal testing.
Intended use for patients at least 46 inches tall, weighing between 46 and 300 pounds, at extreme risk of injury from a fall or unassisted bed exit, as a less restrictive alternative to physical restraints, and prescribed by a licensed physician.	The Indications for Use section clearly states these parameters. Performance confirmed suitability with internal testing.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "performance testing" and "human factors testing" were conducted, but does not specify any sample sizes, data provenance, or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document states: "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."
No specific number or qualifications of "caregivers" (experts) are provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No adjudication method is described for any testing mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC or comparative effectiveness study is mentioned. The device is a physical bed canopy, not an AI or diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. The device is a physical bed canopy.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For "performance testing" related to safety, compatibility, and entrapment, the "ground truth" would likely be based on engineering standards, biomechanical principles, and direct observation of the device's physical interactions and function.
For "human factors testing," "ground truth" would be established through observation and feedback from caregivers regarding usability and effectiveness of training/instructions.
The document does not detail the specific methodology for establishing this "ground truth."

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that uses a "training set."

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device that uses a "training set."

Summary of what is present and what is missing:

The provided 510(k) summary primarily focuses on demonstrating substantial equivalence through comparison of features, materials, and a blanket statement about internal testing (biocompatibility, human factors, performance). It does not provide the granular detail of a clinical or performance study that would elaborate on specific quantitative acceptance criteria or detailed results to meet those criteria. Many of the questions are not applicable due to the nature of the device (a physical restraint system, not a diagnostic or AI tool).

Summary

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510(k) Pre-Market Notification: Posey Bed 8040 and Posey Bed 8060

K 113355

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.

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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 < 76"
. Width of bed frame must be ≤ 36"
The height of the bed platform (deck of the . bed) from the floormust be able to adjust between:
- For Posey Bed 8040 -13 and 22 inches
- For Posey Bed 8060-16 and 25 inches

Depending on the features of the bed, operational limits must also be observed when a Posey Bed canopy is in use as described in the User Manual. For example, the head of bed angle can only be raised to ≤ 70°.

The Posey Bed 8040/8060 requires that the hospital bed side rails be kept in the "down" position. The canopy contains a specialized compartment for the mattress that helps 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.

Accessories that are specifically for use with the Posey Bed 8040/8060 include travel covers, universal bed straps, , and a pediatric canopy cover and skirt for a more child-friendly appearance. General bed accessories that can be used with the Posey Bed 8040/8060 or any other Posey Bed or hospital bed are filler cushions, a torso cushion, a support surface, an incontinence pad, and headboard/footboard pads ..

The Posey Bed 8040/8060 is an A-Frame bed canopy system. When attached to a compatible hospital bed (not included) the 8040/8060 is

INTENDED USE:

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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.

A comparison of device features demonstrates that the Posey Bed 8040/8060 when attached to a compatible hospital bed is substantially equivalent to the currently marketed Posey Bed 8070. The three Posey Bed devices (Models 8040, 8060 and 8070) utilize the same fabrics, mesh, and zippers and are framed, enclosed canopies. The Posey Bed 8040/8060 is also substantially equivalent to the Soma Safe Enclosure which was originally manufactured by Nova Technologies, Inc. (Bristol, Connecticut) and is now manufactured by Vivax Medical Corp (Torrington, Connecticut).

Results of biocompatibility (ISO 10993), human factors, and performance testing have established that the Posey Bed 8040/8060 is suitable for the intended use indicated and is substantially equivalent to the Posey Bed 8070 and 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.

TECHNICAL CHARACTERISTICS:

PERFORMANCE TESTING:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem of an eagle.

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

MAY - 2 2012

Re: K113355

Trade/Device Name: Posey Bed 8040 and Posey Bed 8060 Regulation Number: 21 CFR 880.6760 Regulation Name: Protective Restraint Regulatory Class: I Product Code: OYS Dated: April 19, 2012 Received: April 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 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/Safetv/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. Ansin

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

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Indications for Use

K 11.2355

510(k) Number (If known):

Device Name: Posey Bed 8040 and Posey Bed 8060

Indications for Use:

Prescription Use X (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)

evaluation (ODE)

5/1/2012

(Division'Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

CONFIDENTIAL

510(k) Number: .

510(k) Number: K113355

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.