(101 days)
The device is a motorized device intended for medical purposes to assist in transfer of a patient to and from beds, chairs, treatment facilities, wheelchairs or transport vehicles.
The HoverTech International Transformer is a battery powered patient transport device with a motorized drive to aid the caregiver in maneuvering the device while transporting patients within care facilities. Its intended function and use is to transport patients to various areas within the patient care facility and may contain supports for fluid infusion equipment. It can also be used to support the patient in a seated or supine position during examinations, physical therapy and other clinical activities within the patient care facility. The adjustability of the Transformer allows for better patient access by caregivers and also provides for enhanced patient comfort.
The provided text describes a 510(k) summary for the HoverTech International® Transformer, a battery-powered patient transport device. However, it does not contain the specific information required to answer your request about acceptance criteria and a study proving the device meets them.
Here's why and what information is missing:
- Acceptance Criteria and Reported Device Performance: The document states that "Safety Testing and performance characteristics have been conducted and successfully completed in order to ensure compliance with specifications." However, it does not list what those specific specifications or acceptance criteria are, nor does it provide the results or reported performance of the device against them. It only mentions compliance with voluntary standards like IEC and UL for safety and biocompatibility. These are general standards, not specific performance metrics for this particular device.
- Sample Size, Ground Truth, Adjudication, MRMC, Standalone Studies, Training Set: All of these data points are typical for studies evaluating diagnostic or predictive algorithms/devices, especially in fields like medical imaging. Since the HoverTech International® Transformer is a physical patient transport device (a powered wheeled stretcher), these types of studies (MRMC, standalone algorithm performance, training/test sets for AI, ground truth establishment by experts/pathology) are not applicable to this device's regulatory submission as described.
Summary of missing information:
- Table of acceptance criteria and reported device performance: Not provided. The document generally states "compliance with specifications" and "safety testing," but no specific metrics or results are reported.
- Sample size used for the test set and data provenance: Not applicable in the context of this physical device.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable.
- Adjudication method: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance study: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What is present in the document is a declaration of compliance with general safety and electrical standards:
- Voluntary Standards the device will comply with:
- IEC 60601-1 (General Requirements for Safety)
- IEC 60601-1-2 (Electromagnetic Compatibility)
- IEC 60601-2-38 (Safety of Electrically Operated Hospital Beds - applicable parts only for loading and pinch points)
- UL 2601-1 (Standard for Medical Electrical Equipment)
- CAN/CSA C22.2 No. 601.1-M90 (Standard for Medical Equipment)
- ISO 10993-5 (Biocompatibility - In Vitro cytotoxicity)
- ISO 10933-10 (Biocompatibility - irritation and sensitization, delayed type hypersensitivity)
The document concludes that the device is "substantially equivalent" to a predicate device (Transmotion Medical Model TMM6 Power Drive Chair) based on "intended use, basic technology, and performance characteristics." The "performance characteristics" are implied to be met through the safety testing and compliance with the listed voluntary standards, but no specific performance data is disclosed in this summary.
§ 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.