(44 days)
The intended use of the Winco Stretchair is to provide a method of transporting patients within healthcare facilities.
The Winco Mfg., LLC 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 Stretchair can support a patient in either a supine (laying) position or seated position. The Stretchair model S300 is for patients weighing up to 300 lbs, the S675 is for patients weighing up to 675 lbs, and the S999 is for patients weighing up to 1000 lbs.
The product includes a battery powered linear actuator to lower the backrest and raise the footrest simultaneously. It also includes a hydraulic unit for vertical height adjustment.
This is a submission for a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with acceptance criteria based on performance metrics. Therefore, many of the requested categories for AI/algorithm performance studies are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety Standards | Meets the requirements of UL 60601-1 and CAN/CSA C 22.2 Electrical Safety Standards. |
| Flame Retardancy | Upholstery meets the requirements of CAL 117 for Flame Retardancy. |
| Substantial Equivalence | Found substantially equivalent to TransMotion Medical, Inc. Power Drive Chair Model TMM6 (K091043). |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a medical device submission for a physical product (a stretcher), not an AI/algorithm-based device. Performance was assessed against electrical safety and flame retardancy standards, not through clinical data sets.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a medical device submission for a physical product. "Ground truth" in the context of AI/algorithm performance is not relevant here. Compliance with standards is typically verified by certified testing laboratories and regulatory bodies.
4. Adjudication Method for the Test Set
Not applicable. The evaluation was based on compliance with established safety and material standards, not on expert consensus or adjudication of a test set in the AI sense.
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
Not applicable. This device is a powered wheeled stretcher, not an AI or imaging diagnostic tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical product; there is no algorithm or standalone performance to evaluate in this context.
7. The Type of Ground Truth Used
The "ground truth" in this context is the fulfillment of requirements outlined in recognized safety and material standards:
- UL 60601-1 and CAN/CSA C 22.2 Electrical Safety Standards
- CAL 117 for Flame Retardancy
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device submission.
§ 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.