(293 days)
The TotalCare® Bed System is intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy. The TotalCare® Bed System is intended to provide a patient support to be used in health care environments. The TotalCare® Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare® Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.
The TotalCare® Bed System, dependent upon model, is capable of supporting patient populations up to 500 lbs.
The TotalCare® Modular Therapy (Bed) System is a control unit (GUI) and frame which can house several therapeutic surfaces. The system can articulate to provide different positions for treatment, sleeping, up-in-bed, and other physician recommended positions. The Graphical Caregiver Interface/ Graphical User Interface can be set for alarms such as patient egress and head-of-bed angle.
The Hill-Rom TotalCare® Modular Therapy (Bed) System is a medical bed designed to provide patient support and therapy.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Source | Reported Device Performance |
|---|---|---|
| Functional, Performance, Safety, and Efficacy | Hill-Rom's verification and validation based on international standards | Meets functional, performance, safety, and efficacy specifications and requirements in compliance with listed international standards. |
| Compliance with International Standards | IEC 60601-1 (General Safety) | Compliant |
| IEC 60601-1-2 (EMC Requirements) | Compliant | |
| IEC 60601-1-4 (Programmable Electrical Medical Systems) | Compliant | |
| IEC 60601-2-38 (Safety of Electrically Operated Hospital Beds) | Compliant | |
| Substantial Equivalence to Predicate Devices | FDA's 510(k) review process | Determined to be substantially equivalent to legally marketed predicate devices. |
| Intended Use | Device Description and Indications for Use | Functions as a patient support system in healthcare environments; treats/prevents pulmonary/immobility complications, pressure ulcers; provides Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy; supports patients up to 500 lbs. |
2. Sample Size for Test Set and Data Provenance
The provided summary does not mention any specific sample sizes for a test set related to clinical performance or algorithm evaluation. Instead, it explicitly states:
- "Clinical testing was not required for determination of substantial equivalence."
- "A literature review was compiled of articles related to safe patient handling and benefits of therapy surfaces and beds of this type for patients experiencing prolonged immobility."
This indicates that the device's acceptance was primarily based on non-clinical performance and substantial equivalence to predicate devices, without a dedicated clinical test set for this specific submission.
3. Number of Experts and Qualifications for Ground Truth
Given that "Clinical testing was not required," there is no mention of experts used to establish ground truth for a test set in the context of this 510(k) summary. The evaluation relied on compliance with engineering standards and comparison to existing products.
4. Adjudication Method for the Test Set
As there was no clinical test set requiring human assessment, no adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done as clinical testing was not required. The device is a medical bed, not an AI-assisted diagnostic tool for which such studies are typically performed.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study was done as the device is a medical bed and not an algorithm-based system requiring such evaluation. The evaluation focused on the physical device's compliance with safety and performance standards.
7. Type of Ground Truth Used
The "ground truth" for the device's acceptance was:
- Compliance with international engineering and safety standards: This forms the basis for the non-clinical performance summary (e.g., IEC 60601 series).
- Substantial equivalence to predicate devices: This involves comparing the new device's technological characteristics and intended use to existing, legally marketed similar devices, rather than a clinical ground truth like pathology or outcome data.
8. Sample Size for the Training Set
Since there are no indications of a machine learning or AI algorithm being developed or deployed within this device, there is no mention of a training set sample size.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a training set, the question of how its ground truth was established is not applicable.
In Summary:
The Hill-Rom TotalCare® Modular Therapy (Bed) System's acceptance was based on non-clinical performance validation against established international safety and performance standards, and demonstrating substantial equivalence to predicate medical beds. Clinical testing was not deemed necessary for this 510(k) submission, and therefore, typical metrics associated with AI device evaluation (like test set size, expert ground truth, MRMC studies, or training sets) are not present in this documentation.
§ 890.5170 Powered flotation therapy bed.
(a)
Identification. A powered flotation therapy bed is a device that is equipped with a mattress that contains a large volume of constantly moving water, air, mud, or sand. It is intended for medical purposes to treat or prevent a patient's bedsores, to treat severe or extensive burns, or to aid circulation. The mattress may be electrically heated.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.