(223 days)
Not Found
No
The description focuses on the mechanical and electrical components of a powered wheelchair and explicitly states that AI, DNN, or ML were not found in the document.
No
The device is a powered wheelchair for transportation, not for treating or diagnosing medical conditions.
No
Explanation: The device is an electric wheelchair designed for transportation, not for diagnosing medical conditions. It does not collect or analyze any physiological data for diagnostic purposes.
No
The device description clearly outlines a physical, powered wheelchair with hardware components like wheels, a seat, armrests, footrests, hand controls, and a battery charger. It is not solely software.
Based on the provided information, the Walk on Wheels HS-3500 Electric Aisle Wheelchair is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide transportation for disabled or elderly individuals. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The description details a powered wheelchair with components for mobility and passenger comfort. There is no mention of reagents, assays, or any components used for analyzing biological specimens.
- Lack of IVD Indicators: The document explicitly states "Not Found" for mentions of image processing, AI/DNN/ML, input imaging modality, anatomical site, indicated patient age range, training/test set descriptions, and key metrics like sensitivity, specificity, PPV, NPV, etc. These are common elements found in submissions for diagnostic devices.
- Performance Studies: The performance studies focus on mechanical and electrical safety and compliance with wheelchair standards (ANSI/RESNA, ISO). They do not involve clinical trials related to diagnostic accuracy or performance on biological samples.
In summary, the Walk on Wheels HS-3500 is a mobility aid, not a device used to diagnose diseases or conditions by examining samples from the human body.
N/A
Intended Use / Indications for Use
The Walk on Wheels HS-3500 Electric Aisle Wheelchair is an indoor/outdoor powered wheelchair that provides transportation for a disabled or elderly person on/off an airplane or within the airport terminal. It is also suited for use in other narrow constrained spaces. It is not intended to be used during flight.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
The Walk on Wheels HD-3500 Electric Aisle Wheelchair is a power wheelchair designed to transport elderly or disabled persons on/off an airplane. It has a base with four wheels, a padded seat with adjustable armrests and seatbelt, adjustable/removable foot rests with a leg band, and hand controls located at the back of the wheelchair allowing an attendant to control the chair. It can be disassembled for transport and is provided with an off-board battery charger.
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
Not Found
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)
Non-Clinical Testing: Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995 were conducted and the results are included in the submission. All testing was successful. EMC testing was performed, and the HS-3500 and its battery charger passed the EMC testing. Applicable ANSI/RESNA WC-1 and WC-2 standards and ISO 7176 standards were used for performance testing. The HS-3500 complies with the cited standards.
Clinical Testing: Not included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).
0
Walk on Wheels HS-3500 Electric Aisle Wheelchair, K120405 Response to Deficiency Letter dated August 2, 2012
Sept. 10, 2012
1 9 2012
Attachment 2
510(k) SUMMARY
1. Contact Information
Submitter's name: Walk on Wheels Australia Pty, Ltd. 260 Leitchs Road Brendale, Queensland 4500 Australia Contact Person: Sheila Ramerman, RAC SJR Associates
Date prepared:
September 4, 2012
2. Device name:
Trade name: Walk on Wheels HS-3500 Electric Aisle Wheelchair Common name: Powered wheelchair Classification name: Wheelchair, powered. ITI
3. Legally Marketed Predicate Device:
HEARTWAY Attendant-Controlled Power Chair, TC1, K071006
4. Device Description:
The Walk on Wheels HD-3500 Electric Aisle Wheelchair is a power wheelchair designed to transport elderly or disabled persons on/off an airplane. It has a base with four wheels, a padded seat with adjustable armrests and seatbelt, adjustable/removable foot rests with a leg band, and hand controls located at the back of the wheelchair allowing an attendant to control the chair. It can be disassembled for transport and is provided with an off-board battery charger.
5. Intended Use/Indications for Use:
The Walk on Wheels HS-3500 Electric Aisle Wheelchair is an indoor/outdoor powered wheelchair that provides transportation for a disabled or elderly person on/off an airplane or within the airport terminal. It is also suited for use in other narrow constrained spaces. It is not intended to be used during flight.
6. Substantial Equivalence Comparison:
The device features of the Walk on Wheels HS-3500 and the HEARTWAY TC1 are very similar. Both are attendant controlled and battery powered. Off-board battery chargers are provided with both powered wheelchairs. Both can be disassembled for transport. The target population is similar and the use parameters are similar.
1
K120405
PAGE 2 OF 2
Walk on Wheels HS-3500 Electric Aisle Wheelchair, K120405 Response to Deficiency Letter dated August 2, 2012
Sept. 10, 2012
Page 9
7. Non-Clinical Testing
Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995 were conducted and the results are included in the submission. All testing was successful.
EMC testing was performed, and the HS-3500 and its battery charger passed the EMC testing.
Applicable ANSI/RESNA WC-1 and WC-2 standards and ISO 7176 standards were used for performance testing. The HS-3500 complies with the cited standards.
8. Clinical Testing
Clinical testing is not included in this submission.
9. Conclusions
The non-clinical testing demonstrates that the HS-3500 Electric Aisle Wheelchair performs as designed and intended. Comparison of specifications with the predicate device demonstrates that any differences in specifications or technology do not raise new questions of safety or effectiveness. The HS-3500 Electric Aisle Wheelchair is substantially equivalent to the predicate device in design, function, and indications for use/intended use.
2
Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. The text is in all capital letters and is evenly spaced around the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Walk on Wheels Australia Party, Limited % SJR Associates Ms. Sheila Ramerman, RAC Principal Consultant 927 Throne Drive Eugene, Oregon 97402
1 9 2012
Re: K120405
Trade/Device Name: Walk on Wheels HS-3500 Electric Aisle Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: September 10, 2012 Received: September 12, 2012
Dear Ms. Ramerman:
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
3
Page 2 - Ms. Sheila Ramerman. RAC
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.
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/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 Division of Small Manufacturers, 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 vours.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment 1
Indications for Use
510(k) Number (if known):
Device Name: Walk on Wheels HS-3500 Electric Aisle Wheelchair
Indications for Use:
The Walk on Wheels HS-3500 Electric Aisle Wheelchair is an indoor/outdoor powered wheelchair that provides transportation for a disabled or elderly person on/off an airplane or within the airport terminal. It is also suited for use in other narrow constrained spaces. It is not intended to be used during flight.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
. Page 27
(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 Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120405