(65 days)
The Genesis Vertical Platform Lift is intended to mechanically transport persons with a mobility disability, either in a wheelchair or ambulatory, up and down between levels of a residential or public facility.
The Genesis Vertical Platform Lift is designed to transport persons with a mobility disability, either in a wheelchair or ambulatory, up and down between levels of a residential or public facility. It can be located within with its own integrated shaftway enclosure, located within a building shaftway or be unenclosed other than guarding around the platform area. It is designed for both indoor and outdoor locations. The Genesis has a capacity of 750 lbs to accommodate a person in a wheelchair and an attendant. The lifting height is up to 14 feet. It is available with a chain hydraulic drive system or an acme screw drive system. Backup systems are available for emergency operation and evacuation. All controls are low-voltage constant pressure. Use may be restricted to authorized persons with key switches located on the control panels. The Genesis is built in accordance with ASME A17.5 Electrical Code for Elevating Devices and the ASME A18.1 Safety Standard for Platform Lifts and Stairway Chairlifts.
This is a premarket notification for a Class II medical device, specifically a "Wheelchair elevator" or "Vertical Platform Lift." The submission aims to demonstrate substantial equivalence to a predicate device, not necessarily to prove the device meets specific acceptance criteria based on performance studies in the way one might for diagnostic or AI-driven devices.
Therefore, many of the requested categories for a study proving acceptance criteria are not directly applicable to this type of submission. This document describes the device's function and its adherence to established safety standards, which serves as the basis for its equivalence.
Here's a breakdown of the available information in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, the "acceptance criteria" are compliance with relevant safety standards and technical specifications, and the "reported device performance" is its adherence to these.
| Acceptance Criteria (Compliance with Standards/Specifications) | Reported Device Performance (Adherence/Features) |
|---|---|
| Mechanical Capacity Standard: Accommodate a person in a wheelchair and an attendant. | Capacity of 750 lbs. |
| Lifting Height Standard: Support typical residential/public facility needs. | Lifting height up to 14 feet. |
| Drive Systems: Offer reliable and safe transport mechanisms. | Available with chain hydraulic drive system or acme screw drive system. |
| Emergency Operation: Provide safety in case of power failure or malfunction. | Backup systems available for emergency operation and evacuation. |
| Control System Standard: Ensure safe and user-friendly operation. | All controls are low-voltage constant pressure. Use may be restricted to authorized persons with key switches located on the control panels. |
| Electrical Safety Standard: Compliance with electrical codes for elevating devices. | Built in accordance with ASME A17.5 Electrical Code for Elevating Devices. |
| Platform Lifts and Stairway Chairlifts Safety Standard: Compliance with specific safety standards for this type of equipment. | Built in accordance with ASME A18.1 Safety Standard for Platform Lifts and Stairway Chairlifts. |
| Intended Use: Mechanically transport persons with mobility disability. | Functions to transport persons with mobility disability, either in a wheelchair or ambulatory, up and down between levels of a residential or public facility. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a mechanical device, and a "test set" in the context of diagnostic or AI performance studies is not relevant here. The "testing" refers to the device's design and manufacturing to meet the specified engineering and safety standards. There is no mention of a specific clinical or performance test set with human subjects or data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. "Ground truth" as defined for diagnostic or AI studies (e.g., expert consensus on medical images) does not apply to this device. The "truth" is whether the device meets the engineering and safety specifications, which would be verified through engineering tests, inspections, and adherence to codes, not expert consensus on performance data in the same way.
4. Adjudication Method for the Test Set
Not applicable. See reasoning for #2 and #3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This type of study is for evaluating human performance, often with or without AI assistance, especially in diagnostic fields. It is not relevant for a mechanical device like a vertical platform lift.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This refers to the performance of an algorithm or AI system. This device is purely mechanical with electrical controls, not an AI or algorithm-driven system.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance is its compliance with established engineering and safety standards (ASME A17.5 and ASME A18.1) and its technical specifications (e.g., capacity, lifting height, control types, drive systems). This is verified through engineering design, manufacturing processes, and potentially physical testing against those standards. It does not involve expert consensus, pathology, or outcomes data in the typical medical device sense.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an algorithm or AI-driven system that requires data for machine learning.
9. How the Ground Truth for the Training Set was Established
Not applicable. See reasoning for #8.
§ 890.3930 Wheelchair elevator.
(a)
Permanently mounted wheelchair platform lift —(1)Identification. A permanently mounted wheelchair platform lift is a motorized vertical or inclined platform lift device permanently installed in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a guided platform to move a person from one level to another, with or without a wheelchair.(2)
Classification. Class II. The permanently mounted wheelchair platform lift 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:(i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate that the safety controls are adequate to prevent a free fall of the platform in the event of a device failure;
(ii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the device to withstand the rated load with an appropriate factor of safety;
(iii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the enclosures to prevent the user from falling from the device; and
(iv) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests,” and ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must validate electromagnetic compatibility and electrical safety.
(b)
Portable wheelchair elevators —(1)Identification. A portable wheelchair elevator is a motorized lift device that is not permanently mounted in one location and that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a means to move a person, with or without a wheelchair, from one level to another (e.g., portable platform lifts, attendant-operated stair climbing devices for wheelchairs).(2)
Classification. Class II.