(128 days)
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 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.
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:
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.
§ 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.