(38 days)
The V-1504 Vertical Platform Lift is intended to mechanically transport an individual in a wheelchair directly between floors in a private residence or public facility.
The V-1504 Vertical Platform Lift is a a lift designed to carry a maximum of one wheelchair and two individuals (500 lb. capacity; 750 lb. optional) directly up and down between floors in a residential or public facility. It is designed for use both inside and outdoors and can be operated either enclosed or unenclosed. The V-1504 is driven by a 2:1 chain hydraulic system, consisting of two #50 high quality roller chains, a cylinder and pump powered by an electric (1.5 hp) motor. The breaking load and stress factor of each chain is 6200 lbs. The lift can be controlled from either end at a key-controlled station or from an on-board panel. All of the controls are of low voltage, incorporate continuous pressure directional buttons, and comply with U.S. ANSI/UL standard 508. The maximum lifting height is 23 feet, and the platform travels at a speed of 25 ft/min. The lift also provides for battery-powered lowering in emergency situations. The platform is constructed of ASTM A366 steel tubing and has an anti-skid surface. The enclosure is made of plexiglass and 0.100" steel tube.
The provided text describes a vertical platform lift (Savaria V-1504) and its comparison to a predicate device. However, it does not contain information about acceptance criteria for a device performance study, nor does it describe such a study.
The document is a 510(k) summary, which is a premarket submission made to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. This type of submission typically focuses on design, function, and intended use comparison rather than extensive performance studies with acceptance criteria in the way a clinical or algorithm performance study would.
Therefore, I cannot provide the requested information, particularly items 1 through 9, because the provided text does not contain a description of a study with acceptance criteria to "prove the device meets the acceptance criteria." The document discusses the device's technical specifications and compares them to a predicate device to establish substantial equivalence.
§ 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.