(177 days)
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.
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.
The Permobil M300 & M400 powered wheelchairs were assessed for substantial equivalence to the predicate device Permobil C350 (K071650). The performance data indicates that the M300 & M400 functioned as intended in all instances based on various ISO and RESNA standards.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" but lists various characteristics and their values for both the new device and the predicate device, implying these are the performance metrics against which substantial equivalence is judged. The "reported device performance" are the values for the M300 & M400.
| Characteristic | Acceptance Criteria (Predicate Permobil C350) | Reported Device Performance (Permobil M300 & M400) |
|---|---|---|
| Intended use | Provide indoor/outdoor mobility to persons restricted to a sitting position, capable of operating a powered wheelchair | Same |
| Type of base | Rear wheel driven | Mid wheel driven |
| Caster wheel dimension | 210x65 | 200x50 |
| Drive wheel dimension | 3.00-8 | 3.00-8 |
| Adjustable Anti-Tip Wheels | Anti tip device mounted in the rear, R100/32-2-v/4" | The front and rear castor wheels function as Anti-tip devices. |
| Overall dimension, l/w/h | 1065/625/1110 (42"/24½"/43¾") | 1256/620/1260 (49½"/24½"/49½") |
| Weight incl. batteries | 142 kg (313 lbs) (incl. PS-Seat and seat elevator) | 155 kg (342 lbs) (incl. PS-Seat and seat elevator, seat tilt) |
| Weight bearing capacity | 136 kg (300 lb) | 136 kg (300 lb) |
| Maximum speed | Up to 10 km/h (6.2 mph) | Up to 12 km/h (7.5 mph) |
| Brake system | Multiple brake system: 1. Electronic braking by drive motors. 2. Magnetic parking brakes that automatically stops the chair in case of power failure. | Same |
| Ground clearance/Obstacle-climbing | 70 mm/60 mm (2¾" /2⅓") | 77mm/70mm (3"/2¾") |
| Turning Radius | 954 mm (37") | 800mm (31.5") |
| Driving range | Up to 25 km (16 miles) | Up to 25 km (16 miles) |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample size for a "test set" in the context of human subjects or a specific data set. The performance testing was based on compliance with various international and national standards for wheelchairs (ISO and RESNA). These standards typically involve testing a representative sample of the devices. The data provenance is derived from the testing conducted by Permobil AB, based in Timrå, Sweden. The testing described is likely prospective, as it's part of the premarket notification for a new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided in the document. The device is a powered wheelchair; its performance is evaluated against engineering and safety standards, not against "ground truth" established by medical experts in diagnosing conditions.
4. Adjudication method for the test set:
This information is not applicable and not provided in the document. As mentioned above, the evaluation is against established engineering and safety standards, not expert consensus requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable and not provided in the document. The device is a powered wheelchair; it is not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided in the document. The device is a physical powered wheelchair, not an algorithm.
7. The type of ground truth used:
The "ground truth" in this context is the fulfillment of requirements outlined in the specified international and national standards (ISO 7176 series and RESNA WC-1/WC-2). These standards define objective performance thresholds and test methodologies for characteristics like climatic resistance, power and control systems, electromagnetic compatibility, weight bearing capacity, speed, braking, etc.
8. The sample size for the training set:
This information is not applicable and not provided in the document. The development of a powered wheelchair does not typically involve a "training set" in the way that machine learning algorithms do. The design and engineering process is iterative, based on established mechanical and electrical engineering principles, and validated through testing against standards.
9. How the ground truth for the training set was established:
This information is not applicable and not provided in the document for the reasons stated in point 8.
{0}------------------------------------------------
ORIGINAL, TRADITIONAL 510(K) NOTIFICATION PERMOBIL POWERED WHEELCHAIR: M300/M400
Image /page/0/Picture/2 description: The image shows the word "permobil" in white letters inside of a black oval. The word "permobil" is written in a sans-serif font, with the letters being bolded. The oval is outlined in white, and the background is black. The image is a logo for the company Permobil.
APR 1 7 2013
Attachment 11
11
510(k) Summary
Permobil AB Submitter
Box 120 S-861 23 Timrå Sweden
+46 60 595900 Phone: +46 60 575250 Facsimile:
Contact Person: Jan Åström jan.astrom@permobil.se e-mail address:
Date Prepared: April 2013
M300 & M400 Device name:
Classification Name:
Powered wheelchair (21 CFR 890.3860. Product Code ITI)
Predicate Devices:
C350 ( K071650) manufactured by Permobil AB.
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.
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 a stylized font, enclosed within an oval shape. The word is in lowercase letters and appears to be a logo or brand name. The background of the oval is dark, while the word "permobil" is in a lighter color, creating a contrast that makes it stand out. The overall design is simple and recognizable.
Performance Data
Testing was performed in accordance with the following standards:
- ISO 7176-9:2001 Wheelchairs - Part 9: Climatic tests for electrical wheelchairs
- ISO 7176-11:1992 Wheelchairs Part 11: Test Dummies .
- ISO 7176-13:1989 Wheelchairs Part 13: Determination of coefficient of friction of ● test surfaces
- . ISO 7176-14 2008 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters. Requirements and test methods
- 1SO 7176-21:2009 Wheelchairs Part 21: Requirements and test methods for ● electromagnetic compatibility
- RESNA WC-1:2009 Wheelchairs Volume 1: Requirements and Test Methods for ● Wheelchairs (including Scooters)
- RESNA WC-2:2009 Wheelchairs -- Volume 2: Additional Requirements for . Wheelchairs (including Scooters) with Electrical Systems
In all instances, the M300 & M400 functioned as intended.
Substantial Equivalence
The Permobil M300 and M400 wheelchairs are substantially equivalent to the cleared predicate device, the Permobil C350, as outlined in the following table:
| Characteristic | Permobil M300 & M400 | Permobil C350 (K071650) |
|---|---|---|
| Intended use | To provide indoor and outdoormobility to persons restricted to asitting position that are capable ofoperating a powered wheelchair | To provide indoor and outdoormobility to persons restricted to asitting position that are capable ofoperating a powered wheelchair |
| Type of base | Mid wheel driven | Rear wheel driven |
| Caster wheel dimension | 200x50 | 210x65 |
| Drive wheel dimension | 3.00-8 | 3.00-8 |
| Adjustable Anti-Tip Wheels | The front and rear castor wheelsfunction as Anti-tip devices. | Anti tip device mounted in the rear,R100/32-2-v/4" |
| Over all dimension, 1/w/h in | 1256/620/1260 (49'/2"/24'/2"/49'/2") | 1065/625/1110 (42"/24 Y2'/43 'h") |
| Weight incl. batteries | 155kg (342 lbs)(incl. PS-Seat andseat elevator, seat tilt) | 142 kg (313 lbs)(incl. PS-Seat and seatelevator) |
| Weight bearing capacity | 136 kg (300 lb) | 136 kg (300 lb) |
| Maximum speed | Up to 12 km/h (7,5 mph) | Up to 10 km/h (6,2 mph) |
| Brake system | Multiple brake system: | Multiple brake system: |
| 1. Electronic braking bydrive motors. | 1. Electronic braking bydrive motors. | |
| 2. Magnetic parking brakes thatautomatically stops the chair in case ofpower failure. | 2. Magnetic parking brakes thatautomatically stops the chair in case ofpower failure. | |
| Ground clearance/Obstacle-climbing | 77mm/70mm (372 3/4") | 70 mm/60 mm (2 34" /2 1/3") |
| Turning Radius | 800mm (31,5") | 954 mm (37") |
| Driving range | Up to 25 km (16 miles) | Up to 25 km (16 miles) |
The M300 & M400 are substantially equivalent to the C350 (#K071650). The M300 & M400 has the same intended uses and similar indications, technological characteristics and
{2}------------------------------------------------
ORIGINAL, TRADITIONAL 510(K) NOTIFICATION PERMOBIL POWERED WHEELCHAIR: M300/M400
Image /page/2/Picture/1 description: The image shows the Permobil logo. The logo is in black and white and features the word "Permobil" in a stylized font. The word is inside of an oval shape. The logo is simple and recognizable.
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 are substantially equivalent.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, with three figures representing health, services, and human aspects. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
April 17,2013
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Permobil C/O Michael Heyl Hogan Lovells USP Columbia Square 555 Thirteenth Street, NW Washington DC, 20004
Re: K123290
Trade/Device Name: M300/M400 powered wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: March 14, 2012 Received: March 14, 2013
Dear Mr. Heyl:
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
{4}------------------------------------------------
Page 2 - Mr. Michael Heyl
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known): K123290
Device Name: M300 & M400
Indications For Use:
The intended use of the M300 & M400 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 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joyce M. Whang -S
| (Division Sign Off) | |
|---|---|
| Division of Neurological and Physical Medicine | |
| Devices (DNPMD) | |
| 510(k) Number | K123290 |
Page 1 of 1
§ 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).