(131 days)
The Bella Elevator, LLC vertical Platform lift models RL, UL, SL, EL, EPL are 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.
The Bella Elevator, LLC vertical platform lift models RL, UL, SL, EPL are 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. The model EL and EPL are located within with their own integrated enclosure. The model SL is located within a hoistway. The UL model is unenclosed, other than guarding around the platform area. The RL model is unenclosed and intended for applications found in a residence. These models are designed for both indoor and outdoor applications. Each referenced model has a capacity of 750 lbs to accommodate a person in a wheelchair and an attendant. The lifts are 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 switch located on control panels.
The provided text is a 510(k) summary for a medical device (Vertical Platform Lifts) and related FDA correspondence. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically associated with AI/software medical device submissions (e.g., performance metrics like sensitivity, specificity, AUC).
The documentation focuses on the device description, intended use, and its compliance with established national safety standards for physical devices. Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving their fulfillment as per your prompt's structure, which is designed for AI/software-based devices.
The "Performance Data" section in the document states: "The Bella Elevator, LLC Vertical Platform Lift models RL, UL, SL, EL, and ELP fully comply with the applicable sections of the following National Safety Standards:
- ASME A18.1- Safety Standard for Platform Lifts and Stairway Chairlifts
- ASME 17.5- Electrical Code for Elevating Devices"
This indicates that the "acceptance criteria" for this physical device are the requirements of these safety standards, and the "study" proving compliance is likely a series of engineering tests and demonstrations showing the device adheres to these standards. However, the document does not elaborate on specific metrics, sample sizes, ground truth, or expert involvement as requested for AI/software evaluation.
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Image /page/0/Picture/0 description: The image shows a logo for Bella Elevator. The logo is in an oval shape with a decorative border. The words "BELLA" and "ELEVATOR" are stacked on top of each other in the center of the oval.
Bella Elevator, LLC 8915 N. Pioneer Rd Peoria, IL 61615 Phone: (309)-689-8090 Fax: (309) 689-8091
510K Summary
Contact Person:
Rick Crane, President
Date: October 3, 2011
Re: 510K Summary
Name of Device:
RL, UL, SL, EL, and EPL Vertical Platform Lifts
Common or Unusual name:
Wheelchair Elevator or Vertical Platform Conveyance (VPC)
Classification Name:
នេះនោះទេរជារមទេរជាក្រការក្រោយមានការប្រកួតប្រកួតប្រកួតប្រកួតប្រកួតប្រកួតប្រកួតប្រកួតប្រកួតប្រកួតប្រកួតប្រកួតប្រកួតប្រកួតប្រកួតប្រកួតប្រកួតប្រកួ
Wheelchair Elevator (CFR 890.3930)
Predicate Device:
Bruno VPL 3100 Vertical Platform Lift (K061514)
Summit Harmar RPL/CPL Vertical Platform Lift (K091881)
Savaria, Inc V-1504 Vertical Platform Lift (K960739)
Garaventa Genesis Platform Lift (K033469)
8915 N. PIONEER ROAD, SUITE A PEORIA, IL 61615 PH: (309) 689-8090 FAX: (309) 689-8091 FEB 2 2 2012
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K) Summary Cont'd:
Intended Use:
ine Bella Elevator, LLC vertical platform lift models RL, UL, SL, EL, EPL are designed to transport persons with a mobility idisability, either in a wheelchair or ambulatory, up and down between levels of a residential or public facility.
Device Description:
The Bella Elevator, LLC vertical platform lift models RL, UL, SL, EPL are designed to transport persons with a TIN Bena Divines, ELC veracal placed or ambulatory, up and down between levels of a residential or public facility.
The model EL and EPL are located within with their own integrated enclosure. The model SL is located within a I he model Du and LL a to roo The UL model is unenclosed, other than guarding around the platform area. The RL producing ouring blank were applications found in a residence. These models are designed for both indoor and outdoor applications.
Each referenced model has a capacity of 750 bs to accommodate a person in a wheelchair and an attendant. The Ladd released model has a capacity of 700 low ith a chain hydraulic drive system or an acme screw drive 'ystem. 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 switch located on control panels.
Performance Data:
The Bella Elevator, LLC Vertical Platform Lift models RL, UL, SL, EL, and ELP fully comply with the applicable sections of the following National Safety Standards:
ASME A18.1- Safety Standard for Platform Lifts and Stairway Chairlifts
ASME 17.5- Electrical Code for Elevating Devices
8915 N. PIONEER ROAD, SUITE A PEORIA, IL 61615 PH: (309) 689-8090 FAX: (309) 689-8091
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle faces right and is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 22 2012
Bella Elevator, LLC % Mr. Rick Crane President 8915 North Pioneer Road Peoria, Illinois 61615
Re: K113065
Trade/Device Name: Vertical Platform Lifts Models RL, UL, SL, EL, and EPL Regulation Number: 21 CFR 890.3930 Regulation Name: Wheelchair elevator Regulatory Class: II Product Code: ING Dated: February 8, 2012 Received: February 15, 2012
Dear Mr. Crane:
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 commerce prior to May 28, 1976, 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, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR,Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth 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. Rick Crane
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you active oper.fils aartersOffices/CDRH/CDRHOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please the Comer 101 Do recess and ng by reference to premarket notification" (21CFR Part nove the regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the rou may oouall only generers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Millikan
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K11 3065 RL, UL, Models Device Name: Ver tical Platform Indications For Use: જીવની ડે
The Bella Elevator, LLC vertical Platform lift m
RL, UL, SL, EL, EPL are designed to transport persons
with a mobility disability leither 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 (21 CFR 801 Subpart C)
Counter Use
01 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K113065
§ 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.