(97 days)
Not Found
No
The description details a standard powered wheelchair controlled by a joystick and a basic controller, with no mention of AI or ML capabilities.
No
The device is a powered wheelchair designed for mobility, not to treat or cure a medical condition.
No
Explanation: The "Intended Use" section clearly states that the M300 & M400 is a "powered wheelchair" for mobility, not for diagnosing any medical condition.
No
The device description clearly outlines a physical powered wheelchair with hardware components such as motors, batteries, frame, wheels, and a joystick. While it includes a controller, the device is fundamentally a piece of hardware for mobility.
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 with limited mobility. This is a physical assistance device, not a diagnostic tool.
- Device Description: The description details a powered wheelchair with components like batteries, motors, controllers, and a joystick. These are all related to physical movement and control, not the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This powered wheelchair does not fit that description.
N/A
Intended Use / Indications for Use
The intended use of the M300 & M400 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
Product codes
ITI
Device Description
M300 & M400 Powered Wheelchair is battery powered, center wheel motor driven and is controlled by the PG power wheelchair VR-2 90 amp or R-net 120 amp controller.
The user interface is a joystick.
M300 & M400 is powered by two 12VDC 60Ah, Group M34 batteries, approximate driving range on fully charged batteries is up to 25km (15,5 miles), depending on use and the terrain the chair is driven on.
The chair frame is a rived nut and welded steel construction and includes two center drive wheels with drive units (motor, gear, brake), batteries and front and rear pivoting casters.
Depending on users needs, the joystick motor control is mounted to the left or right armrest.
When the user activates the joystick, the controller receives a signal to release the brakes.
With the brakes released, the chair is allowed to move in the direction the joystick is actuated.
When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.
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)
In all instances, the M300 & M400 functioned as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
ORIGINAL, TRADITIONAL 510(K) NOTIFICATION
PERMOBIL POWERED WHEELCHAIR: M300/M400
Image /page/0/Picture/1 description: The image shows the Permobil logo. The logo is an oval shape with a black background and a white border. The word "permobil" is written in white letters in the center of the oval. The font is sans-serif and the letters are slightly rounded.
MAR - 3 2011 Attachment 11
510(k) Summary
Permobil AB Submitter Box 120 S-861 23 Timrå Sweden
+46 60 595900 Phone: +46 60 575250 Facsimile:
Jan Áström Contact Person: jan.astrom@permobil.se e-mail address:
October, 2010 Date Prepared:
Device name: M300 & M400
Classification Name:
Predicate Devices:
Powered wheelchair
Intended use:
The intended use of the M300 & M400 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
C350 ( K071650) manufactured by Permobil AB.
Description of device:
M300 & M400 Powered Wheelchair is battery powered, center wheel motor driven and is controlled by the PG power wheelchair VR-2 90 amp or R-net 120 amp controller.
The user interface is a joystick.
M300 & M400 is powered by two 12VDC 60Ah, Group M34 batteries, approximate driving range on fully charged batteries is up to 25km (15,5 miles), depending on use and the terrain the chair is driven on.
The chair frame is a rived nut and welded steel construction and includes two center drive wheels with drive units (motor, gear, brake), batteries and front and rear pivoting casters.
Depending on users needs, the joystick motor control is mounted to the left or right armrest.
When the user activates the joystick, the controller receives a signal to release the brakes.
With the brakes released, the chair is allowed to move in the direction the joystick is actuated.
When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.
1
ORIGINAL, TRADITIONAL 510(K) NOTIFICATION PERMOBIL POWERED WHEELCHAIR: M300/M400
Image /page/1/Picture/1 description: The image shows the word "permobil" in white letters on a black oval background. The oval has a white border. The letters are in lowercase, with the "o" in "permobil" being slightly smaller and raised.
Performance Data
In all instances, the M300 & M400 functioned as intended.
Substantial Equivalence
The M300 & M400 is substantially equivalent to the C350 (#K071650). The M300 & M400 has the same intended uses and similar indications, technological characteristics and principles of operation. The minor technological differences between the C350 and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the M300 & M400 is as safe and effective as the C350. Thus, the M300 & M400 is substantially equivalent.
2
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 graphic of an eagle or bird-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the graphic.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Permobil AB % Jan Astrom Box 120 S-861 23 Timra, Sweden
Re: K103477
Trade/Device Name: M300 and M400 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: January 10, 2011 Received: January 19, 2011
Dear Jan Astrom:
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
MAR - 3 2011
3
Page 2 - Jan Astrom
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.
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/ReportalProblem/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 yours,
Aj. VS. Mh
for
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment 12
INDICATION FOR USE >
510(k) number Not assigned at the writing of this submission.
M300 & M400 Device name:
Indication for Use
The intended use of the CM300/400 series of the powered wheelchair is to provide indoor and outdoor mobility to persons limited to a seating position that are capable of operating a powered wheelchair.
Prescription use
Over the counter use __
(Part 21 CFR 801 Subpart D)
(Part 21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
or
Haywood C. Gray
(División Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103477