(61 days)
The product will be used by the patient to assist in navigating a specific set of stairs. This is a self-contained product that is mounted to the tread of a staircase. A trained dealer will install the unit, test it and teach the end user how to operate it. The typical user is someone who has limited function of their knees, hips or ankles and/or has trouble bending these joints. Other users include rehabilitated stroke victims, those inflicted with MS, arthritis, heart disease, and those who cannot handle the exertion of walking up and down stairs. The unit may be recommended by doctors or physical therapists, for those who are recuperating but a large number of users acquire a stairway elevator just because it eases the burden of climbing stairs, improving their quality of life. For those who are wheelchair bound, it requires that they be able to transfer and is usually an option only if the physical limitations of the residence prohibits a vertical elevator.
The B.07 is a stairway chairlift designed to carry a rated load of 300 lb. directly up and down a set of stairs in a residence or public setting. The B.07 is designed to travel a maximum 32 feet at a rated speed of 18 feet per minute. Safety switches installed on the B.07 stop the carriage when it reaches the top or bottom of the stairway. The footrest incorporates obstruction sensors, which will stop the carriage if an obstacle is encountered on the stairs. The B.07's simple design allows for easy operation, quick installation and reliability. Its rail is made of extruded aluminum and hides the drive components and the traveling cable. It is a vertical mount rail that attaches to the tread so wear marks cannot develop on its outer surface due to the internal rolling system. The angle is fully adjustable for staircases of 25 to 45 degrees. The seat and footrest height are adjustable for both short and tall people. The chair can be swiveled at the top and bottom landing for easy and safe access to the seat. The stairlift can be transformed from a left hand to a right hand side on the site of installation within minutes. The device uses a roller chain drive system with an aluminum rail that allows for modifying the length of travel without having a weld. For safety, the B.07 is equipped with a safety brake, an obstruction sensor, a swiveled seat detector and a final limit switch. The chair lift can also be folded in the up position as to facilitate access to the staircase.
The provided 510(k) summary for the B.07 Stairway Chairlift does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of medical efficacy or diagnostic performance.
This document describes a stairway chairlift, which is a mechanical device for patient transport, not a diagnostic or AI-powered medical device that would have performance metrics like sensitivity, specificity, or agreement with expert readers. The 510(k) process for such a device focuses on demonstrating substantial equivalence to a predicate device, primarily concerning its design, intended use, and safety features.
Therefore, I cannot provide answers to the requested points, as they are not applicable to the type of device and the information presented in this 510(k) summary. The document focuses on:
- Subject Device Description: Mechanical features, load capacity, speed, safety mechanisms (obstruction sensors, safety brake, limit switch).
- Intended Use: Assisting patients with limited mobility to navigate stairs.
- Product Comparison: Substantial equivalence to another stairway chairlift (Bruno Electra-Ride K921648).
There is no mention of an algorithm, AI, human readers, ground truth consensus, or effect sizes related to diagnostic improvement.
§ 890.5150 Powered patient transport.
(a)
Powered patient stairway chair lifts —(1)Identification. A powered patient stairway chair lift is a motorized lift equipped with a seat and permanently mounted in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by moving a person up and down a stairway.(2)
Classification. Class II. The stairway chair 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 American Society of Mechanical Engineers (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 chair in the event of a device failure;
(ii) Appropriate analysis and nonclinical testing must demonstrate the ability of the device, including armrests, to withstand the rated load with an appropriate factor of safety;
(iii) Appropriate restraints must be provided to prevent the user from falling from the device (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”);
(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; and
(v) Appropriate analysis and nonclinical testing must demonstrate the resistance of the device upholstery to ignition.
(b)
All other powered patient transport —(1)Identification. A powered patient transport is a motorized device intended for use in mitigating mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs (e.g., attendant-operated portable stair-climbing chairs). This generic type of device does not include motorized three-wheeled vehicles or wheelchairs.(2)
Classification. Class II.