(7 days)
No
The document describes a mechanical vertical platform lift and does not mention any AI or ML components or functionalities.
No.
The device is a vertical platform lift designed to transport individuals with mobility disabilities between different levels of a building. It does not provide medical treatment, diagnosis, or rehabilitation, which are characteristics of a therapeutic device.
No
Explanation: The device is a vertical platform lift designed to transport individuals with mobility disabilities between different levels of a facility. Its function is purely for physical transport, not for diagnosing any medical conditions.
No
The device description clearly states it is an AC powered, patient transport device, which is a physical piece of equipment, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to transport people with mobility disabilities between levels. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The description clearly states it's a "patient transport device" and describes its function as moving people up and down.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information.
- Standards: The standards mentioned (ASME A18.1, CSA B44.1 / ASME 17.5) are related to lifts and electrical equipment, not medical diagnostic devices.
- Predicate Device: The predicate device (Bruno VPL 3100 Vertical Platform Lift) is also a vertical platform lift, further confirming the device's nature as a transport aid.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The VPL Series Vertical Platform Lift is intended 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 intended use of the Harmar Summit RPL/CPL Vertical Platform Lifts is to transport persons with a mobility disability, either in a wheelchair or ambulatory, up and down between levels of a residential or public facility.
Product codes
ING
Device Description
The Harmar Summit, LLC Models RPL and CPL Vertical Platform Lifts are AC powered, patient transport devices designed for use in both residential and commercial applications. Their intended function and use is 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 RPL lift is designed for residential applications and will support a maximum load of 600 lbs. The CPL lift is designed for commercial or public applications, and will support a maximum load of 750 lbs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
residential or public facility
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Residential Platform Lift (RPL) is designed to conform with the following standards;
- ASME A18.1, Section 2 Vertical Platform Lifts .
- CSA B44.1 / ASME 17.5 Elevator and Escalator Electrical Equipment .
- ASME A18.1, Section 5 -- Private Residence Vertical Platform Lifts ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Bruno VPL 3100 Vertical Platform Lift (K061514)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for "Harmar Summit". The logo features a diamond shape on the left, the word "Harmar" above the word "Summit" in a larger font, and a mountain range graphic on the right. The text below the logo is not clear enough to read.
510(k) Premarket Notification
RPL/CPL Vertical Platform Lifts
JUL - 1 2009
510(k) SUMMARY
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
Summit Harmar, LLC 2075 47th Street Sarasota, Florida 34234 Phone: (941) 351-2776 Fax: (941) 684-1115
Kevin Kaminski Contact Person: Director, Global Sourcing and Logistics
Date Prepared: June 22, 2009
Name of Device
RPL/CPL Vertical Platform Lift
Common or Usual Name
Wheelchair Elevator
Classification Name
Wheelchair Elevator
Predicate Device
Bruno VPL 3100 Vertical Platform Lift (K061514)
Intended Use
The VPL Series Vertical Platform Lift is intended to transport persons with a mobility disability, either in a wheelchair or ambulatory, up and down between levels of a residential or public facility.
Device Description
The Harmar Summit, LLC Models RPL and CPL Vertical Platform Lifts are AC powered, patient transport devices designed for use in both residential and commercial applications. Their intended function and use is to transport persons with a mobility
1
Image /page/1/Picture/0 description: The image shows the logo for Harmar Summit. The logo includes a diamond shape on the left, the words "Harmar Summit" in bold black letters, and a mountain graphic above the word "Summit". Below the logo, the words "510(k) Premarket Notification" are printed in a smaller font.
RPL/CPL Vertical Platform Lifts
disability, either in a wheelchair or ambulatory, up and down between levels of a residential or public facility.
The RPL lift is designed for residential applications and will support a maximum load of 600 lbs. The CPL lift is designed for commercial or public applications, and will support a maximum load of 750 lbs.
Substantial Equivalence
The Summit Harmar RPL/CPL Vertical Platform Lifts are substantially equivalent to the Bruno VPL 3100 Vertical Platform Lift (K061514).
Performance Data
The Residential Platform Lift (RPL) is designed to conform with the following standards;
- ASME A18.1, Section 2 Vertical Platform Lifts .
- CSA B44.1 / ASME 17.5 Elevator and Escalator Electrical Equipment .
- ASME A18.1, Section 5 -- Private Residence Vertical Platform Lifts ●
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wings, representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Public Health Service-
JUL -- 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Harmar Summit, LLC % Mr. Kevin Kaminski 2075 47" Street Sarasota, Florida 34234
Re: K091881
Trade/Device Name: Harmar Summit RPL/CPL Vertical Platform Lifts Regulation Number: 21 CFR 890.3930 Regulation Name: Wheelchair elevator Regulatory Class: II Product Code: ING Dated: June 24, 2009 Received: June 24, 2009
Dear Mr. Kaminski:
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.
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Kevin Kaminski
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
incerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): TBD
Device Name: Harmar Summit RPL/CPL Vertical Platform Lifts
Indications for Use:
The intended use of the Harmar Summit RPL/CPL Vertical Platform Lifts is to 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 X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF 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 K091881