(9 days)
Not Found
No
The device description explicitly states it is a "mechanical wheelchair" and there are no mentions of AI, ML, image processing, or any data-driven performance metrics typically associated with AI/ML devices. The performance studies focus on mechanical standards.
No.
The device is a manual wheelchair, which provides mobility rather than treating a medical condition or restoring a bodily function.
No
The device description clearly states "The RTm and Oval wheelchairs are mechanical wheelchairs," and their intended use is "to provide mobility to persons limited to a seated position." There is no indication that these wheelchairs are used to diagnose medical conditions or diseases.
No
The device description explicitly states that the RTm and Oval wheelchairs are "mechanical wheelchairs," indicating they are hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to individuals using a manual wheelchair. This is a mechanical function for physical support and movement, not for diagnosing a condition or analyzing biological samples.
- Device Description: The device is described as a "mechanical wheelchair." This further reinforces its nature as a physical aid, not an in vitro diagnostic tool.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), chemical reactions, or diagnostic purposes.
- Performance Studies: The performance studies focus on mechanical aspects like stability, dimensions, and resistance to ignition, which are relevant to a wheelchair but not to an IVD.
- Predicate Device: The predicate device is another manual wheelchair, which is consistent with the device being a mobility aid.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This description clearly indicates a device for physical mobility.
N/A
Intended Use / Indications for Use
The RTm and Oval wheelchairs are intended to provide mobility to persons limited to a seated position that are capable of operating a manual wheelchair.
Product codes
IOR
Device Description
Not Found
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
Non-Clinical Tests Performed: All applicable tests were voluntarily conducted in accordance with the following standards: ISO 7176-5 Determination of Overall Dimensions, Mass, and Turning Space; ISO 7176-15 Requirements for information disclosure, documentation, and labeling; ISO 7176-16 Resistance to ignition of upholstered parts requirements and test methods; ISO 7176-1 Determination of Static Stability; ANSI/RESNA WC Volume 1-1998 Section 93 Maximum Overall Dimensions. Where applicable a 100 kg dummy (plus 12.4 kg) as specified in ISO 7176 -11 was used.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).
0
Confidential Document 510(k) Summary (as required by 21 CFR 807.92(c))
Manufacturer Name and Address
APR - 9 2008
NEXT Mobility LLC 7444 Haggerty Road Canton, MI 48187 Phone (734) 207-3405 Fax (734) 207-2642
Contact Person
Joseph Azary Regulatory Consultant 543 Long Hill Avenue Shelton, CT 06484 Phone (203) 944-9320 Fax (203) 944-9317
Prepared By:
Chris White Joseph Azary
Date Prepared
Revised March 25, 2008
Name of Device
-
- RTM 2) Oval
Classification Name
Wheelchair, Mechanical
Identification of Predicate Device
Sunrise Medical Model Quickie GT Manual Wheelchair (K850536)
Description of the Device Intended Use
The RTm and Oval wheelchairs are intended to provide mobility to persons limited to a seated position that are :apable of operating a manual wheelchair.
1
Comparison to Predicate Device
This device has a similar intended use and technological charaçteristics as the predicate device. The device and the predicate device are both mechanical wheelchairs. Compari ons demonstrate substantial equivalence.
Non-Clinical Tests Performed
All applicable tests were voluntarily conducted in accordance with the following standards:
ISO 7176-5 Determination of Overall Dimensions, Mass, and Turning Space
ISO 7176-15 Requirements for inf >rmation disclosure, documentation, and labeling
ISO 7176-16 Resistance to ignition of upholstered parts requirements and test methods.
ISO 7176-1 Determination of Stat c Stability
ANSI/RESNA WC Volume 1-1998 Section 93 Maximum Overall Dimensions
Where applicable a 100 kg dumm / (plus 12.4 kg) as specified in ISO 7176 -11 was used.
Technological Characteristics
The device has been subjected to and successfully passed testing to voluntary standards.
Summary
We believe the subject devices ar : substantially equivalent to the predicate devices.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black and white, and the text is also in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 9 2008
NEXT Mobility, LLC c/o Underwriters Laboratories, Inc. Mr. Jeff D. Rongero 12 Laboratory Drive Research Triangle Park, NC 27709
Re: K080880 Trade/Device Name: RTm and Oval Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: March 27, 2008 Received: March 31, 2008
Dear Mr. Rongero:
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 area waren in 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 r ou may, dierelove, maines 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 If your device is elassined tootrols. Existing major regulations affecting your device can may be subject to back academans, 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 r lease of advised that I Dr Fristantly or our device complies with other requirements of the Act that I DT has Intade a actives and regulations administered by other Federal agencies. You must or any i catal battator and a weeks including, but not limited to: registration and listing (21 Configity with an the Fice of requirements, on the source requirements as set Cr K I at 607), nooning (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Jeff D. Rongero
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millikan
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: 1) RTm 2) Oval
Indications For Use:
The RTm and Oval wheelchairs are intended to provide r lobility to persons limited to a seated position that are capable of operating a manual wheelchair.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-C )NTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office ( f Device Evaluation (ODE)
Wilke Ogl. Gormxn
(Division (Division of General, Restorat Division rological Devices
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510(k) Number K080880