(262 days)
The intended use of the Winco Model S550 Stretchair is to provide a method of transporting patients within healthcare facilities.
The Winco Model S550 Stretchair is a battery powered device designed for use in healthcare facilities. Its' intended function and use is to transport patients within the confines of the healthcare facility, where patient care is being administered. It can also be used to support the patient during examinations and other clinical activity which may take place in the facility.
The Winco Model S550 Stretchair has a powered height adjustment feature which allows patient surface to be raised and lowered for patient mounting and patient access. It also has a powered linear actuator which changes the patient surface from a sitting position to a laying (supine) position.
The patient can be transported only when in the seated position. When in the supine position, it can be used to transfer a patient to/from a bed, gurney or other patient support surface. The Winco Model S550 Stretchair is for patients weighing up to 550 Ibs. It is intended for indoor use only, by trained medical staff and health care personnel. There is no drive mechanism or power assist for moving the product from one physical location to another. This is performed manually by the medical staff. The device cannot be self-propelled by the patient.
The provided documents are a 510(k) premarket notification for a medical device (Winco Model S550 Stretchair). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than showcasing a new device's performance against specific acceptance criteria through a clinical study.
Therefore, the document does not contain the following information regarding acceptance criteria and a study proving the device meets them:
- A table of acceptance criteria and the reported device performance.
- Sample sizes used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results or effect sizes.
- Standalone performance study results for an algorithm.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
Instead, the document focuses on:
- Device Description: Details the functionality and components of the Winco Model S550 Stretchair.
- Predicate Device: Identifies the Winco Stretchair Model S999 (K110671) as the predicate.
- Comparison of Technological Characteristics: Discusses similarities and differences between the new device and the predicate, emphasizing that differences (like weight capacity and width) do not affect safety, effectiveness, or substantial equivalence.
- Performance Data (Standards Conformance): States that the Winco Model S550 Stretchair meets general safety and essential performance standards:
- IEC 60601-1 Medical Electrical Equipment Part 1: General Requirement for Safety
- IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- Conclusion: Asserts substantial equivalence based on identical technology, principle of operation, indications for use, and conformance to the same safety standards as the predicate device. The document explicitly states, "Performance testing and use of the same identical lift mechanism and linear actuator supports the safety of the Winco Model S550 Stretchair. Since the predicate was cleared in part on these data, conformance with the same requirements demonstrates that the Winco Model S550 Stretchair will perform as intended in the specified use conditions."
In summary, the provided text describes a mechanical device cleared via the 510(k) pathway, which primarily relies on demonstrating equivalence to an existing device and adherence to relevant industry standards, not on clinical performance studies with acceptance criteria in the way an AI/software device often would.
§ 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.