(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.
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JAN - 7 2004
K033469 Genesis Vertical Platform Lift
3. Summary
..
| Common Device Name: | Elevator, Wheelchair |
|---|---|
| Trade Name: | Genesis Vertical Platform Lift |
| Predicate Device: | V-1504 Vertical Platform Lift (K960739) asmanufactured by Services Industriels Savaria Inc. |
| See the attached product literature. | |
| Device Description: | The Genesis Vertical Platform Lift is designed totransport persons with a mobility disability, either in awheelchair or ambulatory, up and down betweenlevels of a residential or public facility. |
| It can be located within with its own integratedshaftway enclosure, located within a buildingshaftway or be unenclosed other than guardingaround the platform area. It is designed for bothindoor and outdoor locations. | |
| The Genesis has a capacity of 750 lbs toaccommodate a person in a wheelchair and anattendant. The lifting height is up to 14 feet. It isavailable with a chain hydraulic drive system or anacme screw drive system. Backup systems areavailable for emergency operation and evacuation. | |
| All controls are low-voltage constant pressure. Usemay be restricted to authorized persons with keyswitches located on the control panels. | |
| The Genesis is built in accordance with ASME A17.5Electrical Code for Elevating Devices and the ASMEA18.1 Safety Standard for Platform Lifts andStairway Chairlifts. | |
| See the attached product literature. | |
| Intended Use: | The Genesis Vertical Platform Lift is intended tomechanically transport persons with a mobilitydisability, either in a wheelchair or ambulatory, upand down between levels of a residential or publicfacility. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 7 2004
Mr. Norm Cooper Director of Marketing and Customer Relations Garaventa Accessibility 7505 -134A Street Surrey, British Columbia V3W 7B3
Rc: K033469
Trade/Device Name: Genesis Vertical Platform Lift Regulation Number: 21 CFR 890.3930 Regulation Name: Wheelchair elevator Regulatory Class: II Product Code: ING Dated: December 4, 2003 Received: December 5, 2003
Dear Mr. Cooper:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enatiment date of the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de rices that have teen that do not require approval of a premarket approval application (PMA). and Cosmeter for (110) warket the device, subject to the general controls provisions of the Act. The 1 ou may, dierely mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it rryour device to such additional controls. Existing major regulations affecting your device can hay be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean r rease oc acvised that 1991 one and that your device complies with other requirements of the Act that 1 27 the altern and regulations administered by other Federal agencies. You must or any I edotal statutes and states requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Orth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Norm Cooper
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and h your your finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please n you a the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Mark N Millburn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications For Use
510(k) Number: K033469
Genesis Vertical Platform Lift Device Name:
Elevator, Wheelchair
Indications for Use:
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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mullum
Revision Sign-Off
§ 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.