(115 days)
The Stryker Powered Wheeled Stretcher is an electromechanical stretcher that provides a method of transporting patients within healthcare facilities. The stretcher may be used for minor procedures and short-term stay, typical of existing stretcher applications.
The drive-assist Big Wheel provides the healthcare caregiver greater maneuverability in steering and moving the stretcher with significantly less force.
The Stryker Powered Wheeled Stretcher is a powered patient transport device with a motorized drive-assist fifth wheel. This stretcher is a motorized device to be used to transport patients with the many contract, and patient securement straps. The stretcher will have a motorized drive-assist fifth wheel that will assist the caregiver in maneuvering the stretcher. Only the caregiver, not the patient, will have controls to adjust patient positioning. As with the predicate device, the stretcher of this submission will be a movable, caster mounted stretcher. In addition, as with the predicate stretcher, the lift system provides both support and height and life surface to the patient surface. The stretcher is designed to meet UL and IEC stability requirements.
The provided text is a 510(k) premarket notification for the Stryker Powered Wheeled Stretcher. It focuses on demonstrating substantial equivalence to a predicate device and outlines general safety and performance characteristics, but it does not contain specific acceptance criteria, study data, or detailed performance results in the format requested.
Therefore, the following information is not present in the provided document:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set, data provenance, number of experts, and adjudication methods for ground truth establishment.
- Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone performance studies.
- Specific type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set and how its ground truth was established.
What the document does provide in relation to performance and testing is:
- General Statement about Testing: "Significant safety and performance characteristics are tested to ensure compliance with specifications. After testing is complete, the test reports become part of the Device Master Record."
- Risk Management: "A review of risks and hazards of the product was conducted. This included complaints, recalls, and medical device reports analyses. Also, a review was also conducted to identify other device reports and performance hazards by a cross-functional team... A verification and validation plan has been developed to ensure these hazards have been considered and their occurrence minimized."
- Compliance with Voluntary Standards: The device will comply with several voluntary standards related to medical electrical equipment safety and electromagnetic compatibility (IEC 601-1-1, IEC 601-1-2, UL 2601-1, CAN/CSA-C22.2 No. 601.1-M90). These standards typically involve specific tests and acceptance criteria, but the document does not elaborate on the specific results from those tests.
In summary, this document is a regulatory submission for substantial equivalence based on safety characteristics and compliance with general standards, rather than a detailed clinical or performance study report with explicit acceptance criteria and results for the device's functional performance.
§ 890.3690 Powered wheeled stretcher.
(a)
Identification. A powered wheeled stretcher is a battery-powered table with wheels that is intended for medical purposes for use by patients who are unable to propel themselves independently and who must maintain a prone or supine position for prolonged periods because of skin ulcers or contractures (muscle contractions).(b)
Classification. Class II (performance standards). The powered wheeled stretcher is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9, and the following conditions for exemption:(1) Appropriate analysis and nonclinical testing must demonstrate that the safety controls are adequate to ensure safe use of the device and prevent user falls from the device in the event of a device failure;
(2) Appropriate analysis and nonclinical testing must demonstrate the ability of the device to withstand the rated user weight load with an appropriate factor of safety;
(3) Appropriate analysis and nonclinical testing must demonstrate the longevity of the device to withstand external forces applied to the device and provide the user with an expected service life of the device;
(4) Appropriate analysis and nonclinical testing must demonstrate proper environments of use and storage of the device to maximize the longevity of the device;
(5) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate electromagnetic compatibility and electrical safety;
(6) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate that the skin-contacting components of the device are biocompatible;
(7) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate the software life cycle and that all processes, activities, and tasks are implemented and documented;
(8) Appropriate analysis and nonclinical testing must validate that the device components are found to be nonflammable;
(9) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate that the battery in the device performs as intended over the anticipated service life of the device;
(10) Adequate labeling is provided to the user to document proper use and maintenance of the device to ensure safe use of the device in the intended use environment; and
(11) Appropriate risk assessment including, but not limited to, evaluating the dimensional limits of the gaps in hospital beds, and mitigation strategy to reduce entrapment.