Powered Wheelchair

K142770 · Aat Alber Antriebstechnik GmbH · ITI · Jun 9, 2015 · Physical Medicine

Device Facts

• Record ID: K142770
• Device Name: Powered Wheelchair
• Applicant: Aat Alber Antriebstechnik GmbH
• Product Code: ITI · Physical Medicine
• Decision Date: Jun 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SOLO, SOLO+ and SERVO turn a manually propelled wheelchair into a powered wheelchair. They are intended for medical purposes to provide a means for a disabled person to take over the propulsion of the wheelchair and increase mobility and flexibility.

Device Story

Power-wheelchair-conversion-kits; transform manual wheelchairs into powered units. Components: two motorized wheels, control unit, battery pack. Input: user-applied force via joystick (SOLO/SOLO+) or hand-rims (SERVO). Operation: microprocessor-controlled speed, acceleration, and deceleration; automatic safety-brake engagement upon stop; automatic power-off after 10 minutes of inactivity. User interface: joystick or hall-sensor-equipped rims. Output: powered wheel rotation. Used by patients in various settings; provides mobility assistance. Benefits: increased independence for individuals with limited manual propulsion capability. Wheels can be disengaged for manual-only use.

Clinical Evidence

Bench testing only. No clinical data. Performance verified via ISO 7176 series (stability, braking, energy consumption, speed/acceleration, mechanical strength, climatic testing, electromagnetic compatibility) and ISO 10993-5 (in vitro cytotoxicity).

Technological Characteristics

Powered add-on drive for manual wheelchairs. Components: 24V/28.8V DC motors, microprocessor control, Pb or Li-Ion battery packs. User interface: joystick or hall-sensor-equipped hand-rims. Braking: electro-magnetic spring-loaded drum brakes. Connectivity: standalone. Manufacturing: ISO 9001/13485 certified. Standards: ISO 7176 series (stability, brakes, energy, speed, strength, climate, EMC), ANSI/RESNA WC-1:2009, ISO 10993-5.

Indications for Use

Indicated for disabled persons requiring powered propulsion to increase mobility and flexibility by converting a manual wheelchair into a powered wheelchair.

Regulatory Classification

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.

Predicate Devices

• e-motion (K003449)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 9, 2015

AAT Alber Antreibstechnik GmbH c/o Ms. Stefanie D. Bankston Official Correspondent BEO MedConsulting Berlin GmbH 3001 Ferndale Drive League City, TX 77573

Re: K142770

Trade/Device Name: SOLO+, SOLO and SERVO Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: April 20, 2015 Received: April 23, 2015

Dear Ms. Bankston:

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. Isting 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 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.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Felipe Aquel -S

Carlos L. Peña, PhD, MS

for Director

Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K142770

Device Name SOLO+, SOLO and SERVO

Indications for Use (Describe)

SOLO+, SOLO and SERVO turn a manually propelled wheelchair into a powered wheelchair. They are intended for medical purposes to provide a means for a disabled person to take over the wheelchair and increase mobility and flexibility.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows a blue square with rounded corners. Inside the square, there are three white letters, "AAT", stacked vertically. The letters are bold and sans-serif. The overall design is simple and clean.

## 510(k) SUMMARY

May 09, 2015

Office of Device Evaluation U.S. Food & Drug Administration

#### Dear Madame/Sir;

In accordance with Section 510(k) of the Federal Food & Drug and Cosmetic Act, and in conformance with 21 CFR Part 807, pre-market notification is hereby made of the intention of AAT Alber Antriebstechnik GmbH to interstate commerce for commercial distribution the motorized add-on drive for wheelchairs.

| Applicant: | AAT Alber Antriebstechnik GmbH<br>Ehestetter Weg 11<br>D-72458 Albstadt-Ebingen<br>Phone: Tel. [phone]<br>Fax [phone]<br>Email: [e-mail] |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Organization Number: | 239600 |
| Contact Person: | Ms Stefanie D. Bankston / Mr Michael Vent<br>3001 Ferndale Dr<br>League City TX 77573<br>Phone: [phone]<br>Email: [e-mail] |
| Device: | a. Proprietary: SOLO, SOLO+ and SERVO<br>b. Common Name: Powered wheelchair |

-
- Classification Name: Powered wheelchair C.
- d. Device Class: II, 21 CFR 890.3860
- Classification Panel: Physical Medicine e.
- f. Product Code: ITI

#### Predicate Device Information:

We claim substantial equivalence for the subject devices SOLO, SOLO+ and SERVO in intended use, design and function to the predicate device e-motion (K003449) by Ulrich Alber GmbH.

#### Intended Use:

SOLO, SOLO+ and SERVO turn a manually propelled wheelchair into a powered wheelchair. They are intended for medical purposes to provide a means for a disabled person to take over the propulsion of the wheelchair and increase mobility and flexibility.

#### Device Description:

The subject devices SOLO, SOLO+ and SERVO are power-wheelchair-conversion-kits that add powered propulsion to a manual wheelchair, thereby, turning a manual wheelchair into a powered wheelchair.

AAT Alber Antriebstechnik GmbH · Ehestetter Weg 11 · D-72458 Albstadt-Ebingen Tel. [phone] · Fax [phone] · [e-mail] · www.aat-online.de Postfach 100 560 · D-72426 Albstadt-Ebingen

Unsere Bankverbindungen Sparkasse Zollernalb · Konto 31712831 · BLZ 65351260 Swift Code: SOLADES1BAL IBAN: DE06 6535 1260 0031 7128 31

Volksbank Ebingen eG · Konto 83153004 · 65390120 LBBW · Konto 4765671 · 60050101

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows a logo with the letters "AAT" in white on a blue background. The logo is a rounded square shape. The letters are in a bold, sans-serif font. The blue background is a solid color. The logo is simple and clean.

They consist of two powered wheels (each incorporating an electrical motor) a control unit with its bracket and a battery pack. A battery charger and a bag for the battery pack are included in the delivery as well.

The powered wheels substitute the conventional manual wheels from selected wheelchairs. The battery-pack and the controller-unit can easily be attached to the wheelchair.

Speed, acceleration and deceleration are microprocessor-controlled. A preselection of the maximum speed can be done with buttons on the control unit. The wheelchair will accelerate or drive with steady speed when the joystick (SOLO and SOLO+) or the hand-rims (SERVO) are pushed into the travel-direction.

The motors will steadily reduce the driving force until the wheelchair stops if no driving-signal (deflection of the joystick or the rim) is provided. The safety-brakes lock automatically when the wheelchair stopped (SOLO, SOLO+). The manual parking brakes can also be used to prevent unintended movement.

After ten minutes of non-use the device turns off automatically. The powered wheels can be disengaged if the user wants to drive with manual propulsion, only.

Image /page/4/Figure/6 description: The image shows a SERVO Set, which includes five different components. Component 1 is a power adapter with a cord and plug. Component 2 is a pair of wheels with the word "SERVO" on the hub. The remaining components are a controller (3), a control box (4), and a metal box with a screen (5).

## SOLO+/SOLO Set

Image /page/4/Figure/8 description: The image shows five different parts of a wheelchair. The parts are labeled with numbers 1 through 5. Part 1 is the charger, part 2 is the powered wheels, part 3 is the control unit with its bracket, part 4 is the battery pack, and part 5 is the bag for the battery pack.

Unsere Hausanschrift

AAT Alber Antriebstechnik GmbH · Ehestetter Weg 11 · D-72458 Albstadt-Ebingen Tel. [phone] · Fax [phone] · [e-mail] · www.aat-online.de Postfach 100 560 · D-72426 Albstadt-Ebingen

Unsere Bankverbindungen Sparkasse Zollernalb · Konto 31712831 · BLZ 65351260 Swift Code: SOLADES1BAL IBAN: DE06 6535 1260 0031 7128 31

2

Amtsgericht Stuttgart HRB 1006 · Sitz: Albstadt · Ust ID Nr. DE 173669635 Geschäftsführer: Thomas Alber, Markus Alber

Volksbank Ebingen eG · Konto 83153004 · 65390120 LBBW · Konto 4765671 · 60050101

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image is a logo for AAT, which is displayed in a blue square with rounded corners. The letters "AAT" are written in a sans-serif font and are colored in light gray. The logo is simple and clean, with a focus on the acronym "AAT".

## Comparison to legally marketed device (Substantial Equivalence):

The SOLO, SOLO+ and SERVO are essentially equivalent in intended use, design and function with the e-motion by Ulrich Alber GmbH (K003449). However, there are some minor differences discussed below.

| | Subject devices<br>SOLO / SOLO+ / SERVO | Predicate device<br>e-motion<br>(K003449) |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Technical data | | |
| Wheels | 24" | 22" / 24" |
| Weight | 22.9kg/22,9kg/24,8kg | 22 kg |
| Max. user weight | 160kg/200kg/150kg | 130 kg |
| Total weight approved | 210kg/250kg/200kg | 180 kg |
| Braking technologies | Electro-magnetic spring loaded drum brakes. | same |
| Speed, acceleration,<br>deceleration | Preselected max-speed, microprocessor-controlled<br>speed, acceleration and deceleration. The user controls<br>these parameter with the joystick or rim-propulsion. | same |
| User Interface | Joystick (SOLO, SOLO+) / rim with hall-sensor (SERVO) | same as SERVO |
| Driving force | Approx. 10N to push or pull the joystick or rim. Rim-<br>sensor-sensitivity is adjustable. | same as SERVO |
| Forward/backward<br>movement | Joystick (SOLO, SOLO+)/ rim with hall-sensor (SERVO) | same as SERVO |
| Locks to prevent<br>unintended /<br>unanticipated<br>movement | manual parking brake (SERVO)<br>SOLO, SOLO+ have an electro-magnetic spring loaded<br>drum brakes in addition | same as SERVO |
| Foldable wheelchair still<br>foldable? | Foldable, after detaching the battery | same |
| Performance | | |
| Range<br>(ISO 7176-14) | up to 22mil / 9.3mil / 34mil | up to 15.5 mil |
| Speed:<br>forward/backward | 3.8 mil/h / 1.9 mil/h | same |
| Electrical data | | |
| battery | 28,8V, 16Ah(Pb)<br>24V, 8,5 Ah(Li-Ion) | 25,2V, 6,0 Ah (Li-Ion) |
| motor | 24-28,8V; DC, 150W/70W (microprocessor controlled<br>adaption to the power source (PB or LI-Ion)) | 25,2V; DC; 60W |

## The Chart summarizes technical similarities and differences:

#### Differences:

| Differences | Discussion |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Wheel size | The subject and the predicate devices are available with 24-inch wheels. The<br>predicate device is also available with smaller 22-inch wheels. Some user may<br>choose smaller wheels to reach the floor with their feet for foot-propulsion or<br>simply because they feel a 24-inch wheelchair is too large. However, the<br>wheel-size has no influence on the safety of the powered propulsion. |
| Weight differences | The weight differences occur from design details. The subject devices are able<br>to carry a higher max. load while the basic material is the same. Therefore, the<br>design is reinforced, more rigged and consequently a bit heavier. The weight<br>differences have no negative influence on the safety of the subject devices. |
| Max. user weight | The subject devices are designed to carry a higher user-weight. This is actually<br>an advantage. It lowers the risk of unintended overloading the wheelchair. All<br>mechanical and driving characteristics are well approved to ensure a safe use<br>under the max. load. The differences have no negative influence on the safety. |

#### Unsere Hausanschrift

AAT Alber Antriebstechnik GmbH · Ehestetter Weg 11 · D-72458 Albstadt-Ebingen Tel. [phone] · Fax [phone] · [e-mail] · www.aat-online.de Postfach 100 560 · D-72426 Albstadt-Ebingen

ట

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image is a square logo with a blue background and white text. The text "AAT" is prominently displayed in the lower portion of the logo. The upper-right corner of the logo has a rounded edge, giving it a modern and clean appearance.

| Total weight | The total weight of the subject devices is consequently higher because of the<br>higher product-weight and max. user-weight. The differences have no negative<br>influence on the safety. |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Theoretical driving<br>range | The theoretical driving distance from our subject devices differ from the<br>predicate device because of different weight capacities and the possibility to<br>choose different batteries. This difference has no influence on the safety of the<br>devices. It only has an influence on the comfort of the devices. The user is free<br>to choose the configuration that suits his habits the best. The user is able to<br>easily reset the wheels to manual propulsion at any time if the batteries run out<br>of energy. |
| Battery capacity | The user of the SOLO, SOLO+ and SERVO can choose between Pb-batteries<br>and Li-lon batteries. Both battery types are approved and have their<br>advantages. While the Pb-battery is cheaper and has a higher capacity, the Li-<br>lon battery is faster recharged, less heavy and suitable for more recharges.<br>The user should choose the configuration that suits his habits the best. The<br>differences have no influence on the safety of the devices. |
| Battery technology | The predicate device is available with Li-Ion battery, only. The subject devices<br>are also available with Pb-batteries. Both battery types are approved and have<br>their advantages. While the Pb-battery is cheaper and has a higher capacity,<br>the Li-Ion battery is faster recharged, less heavy and suitable for more<br>recharges. The user should choose the configuration that suits his habits the<br>best. The differences have no influence on the safety of the devices. |
| Motor | While the material and design is similar, the electrical data differ. The motor-<br>characteristics may have little influence on driving characteristics but they don't<br>result it any safety differences. |
| User Interface | The SOLO and SOLO+ have a Joystick to steer the wheelchair. User with a<br>limited capability to use the rim can steer the wheelchair like a classical<br>powered wheelchair with a joystick. This opportunity has no negative influence<br>on the safety of the device. It expands the range of users. |

## Performance Standards:

To demonstrate substantial equivalence we performed non-clinical tests according recognized standards:

- To demonstrate the static stability (tilt-over-value) we performed non-clinical tests according to ISO 7176-1: Determination of static stability.
- . To demonstrate the dynamic stability (tilt-over-value while driving) we performed nonclinical tests according to ISO 7176-2: Determination of dynamic stability.
- . To demonstrate effectiveness of the device's brakes we performed non-clinical tests according to ISO 7176-3: Determination of effectiveness of brakes.
- . To demonstrate effectiveness of the power system we performed non-clinical tests according to ISO 7176-4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance.
- . To demonstrate safety related to speed, acceleration and deceleration we performed non-clinical tests according to ISO 7176-6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs.
- To ensure comparability with other test results all measurements were made in conformity . with ISO 7176-7 and ANSI / RESNA WC-1:2009 section 7: method of measurement of seating and wheel dimensions
- . To demonstrate mechanical strength and durability, non-clinical tests were performed according to ISO 7176-8 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatique strengths.
- To demonstrate safe use and performance under different climations, non-clinical tests were performed according to ISO 7176-9 Wheelchairs - Part 9: Climatic tests for electric wheelchairs

Unsere Hausanschrift

AAT Alber Antriebstechnik GmbH · Ehestetter Weg 11 · D-72458 Albstadt-Ebingen Tel. [phone] · Fax [phone] · [e-mail] · www.aat-online.de Postfach 100 560 · D-72426 Albstadt-Ebingen

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image is a logo for AAT, which is a blue square with rounded corners. The letters "AAT" are written in white in the bottom left corner of the square. The logo is simple and clean, and the blue and white colors give it a professional look.

- . To ensure comparability with other test results all load tests were performed in conformity with ISO 7176-11 Wheelchairs - Part 11: Test Dummies
- . To ensure comparability with other test results all driving and braking tests were performed in conformity with ISO 7176-13 Wheelchairs – Part 13 Determination Of Coefficient Of Friction Of Test Surfaces
- . To demonstrate electrical safety, software-validation and performance, non-clinical tests were performed according to ISO 7176-14 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters -Requirements and test methods
- . To demonstrate electromagnetic compatibility, non-clinical tests were performed according to ANSI/RESNA wc/ vol.2 and ISO 7176-21 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
- . To demonstrate the device's biocompatibility, we performed non-clinical tests according to ISO 10993-5: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity

### Quality Assurance and Manufacturing Controls:

AAT Alber Antriebstechnik GmbH operates to an established and certified quality management system according to ISO 9001, and ISO 13485 requirements.

#### Conclusion:

The subject devices, SOLO, SOLO+ and SERVO, are as safe, as effective and perform as well as the predicate device.

Sincerely,

## AAT Alber Antriebstechnik GmbH

Stefanie D. Bankston / p.p. Michael Vent Official Correspondent for AAT Alber Antriebstechnik

5