(156 days)
Not Found
No
The description focuses on the mechanical and electrical components of an add-on drive system for wheelchairs and does not mention any AI or ML capabilities.
Yes
The device is 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." This clearly indicates a therapeutic intent.
No
The device is an add-on drive for wheelchairs, converting them into powered wheelchairs to increase mobility for disabled persons. It is a functional aid, not a diagnostic tool used to identify or characterize a disease or condition.
No
The device description explicitly details multiple hardware components including power wheels, battery mount, battery pack, control unit, and power supply, indicating it is a hardware device with integrated software.
Based on the provided information, the e-fix E35/E36 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is an "add-on drive for wheelchairs" to provide "a means for a disabled person to take over the propulsion of the wheelchair and increase mobility and flexibility." This describes a device used externally on a person for mobility assistance.
- Device Description: The description details mechanical and electrical components that convert a manual wheelchair into a powered one. It focuses on the physical function of propelling the wheelchair.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) from the human body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. The e-fix operates in vivo (on the body) to assist with mobility.
N/A
Intended Use / Indications for Use
The e-fix is an add-on drive for wheelchairs. The e-fix E35/E36 turns a manually propelled wheelchair into a powered wheelchair. It is 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.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
The subject device e-fix E35/E36 is an add-on drive, which converts a manual wheelchair into an electrical wheelchair.
The drive system e-fix E35/E36 includes two power wheels, a battery mount, a battery pack, a control unit, a power supply and optional devices. The wheelchair is not part of the drive system and is provided by the customer. For initial use mounting brackets are required. If the mounting brackets are fitted to the wheelchair, the power wheels, the control unit and the battery pack can be adapted. The main principle of the power wheel is that the motor unit is fixed against turning and the wheel hub is rotating. The fixing of the motor unit to the mounting brackets is realized with the wheel receiver. The wheel receiver supports the torque which the motor applies and is the interface to the wheel chair.
There are different variants of the e-fix E35 is the conventional version of the e-fix. The e-fix E36 provides a more robust drive with a higher torque. The battery pack has more capacity than the normal one. The e-fix E36 is mainly intended for heavy-weighted persons. The e-fix E35 and E36 are available with 22" or 24" wheels. The control unit is the steering device of the system. lt allows a safe and comfortable ride with the wheelchair.The battery pack is easily removable and rechargeable.
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)
Bench and non-clinical tests were performed to demonstrate substantial equivalence.
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).
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other to create a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 5, 2016
Alber Gmbh % Michael Vent Official Correspondent for Alber Gmbh Beo Medconsulting Berlin Gmbh Helmholtzstr. 2-9 Berlin, 10587 GERMANY
Re: K161241
Trade/Device Name: e-fix E35/E36 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: August 31, 2016 Received: September 7, 2016
Dear Mr. Vent:
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 device
1
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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Hoffmann -A
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
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Indications for Use
510(k) Number (if known) K161241
Device Name e-fix E35/E36
Indications for Use (Describe)
The e-fix is an add-on drive for wheelchairs. The e-fix E35/E36 turns a manually propelled wheelchair into a powered wheelchair. It is 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.
| 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)
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3
510(k) SUMMARY
Device 510k number: K161241
| Applicant: | Alber GmbH
Vor dem Weißen Stein 21
72461 Albstadt, Germany
Phone: +49 7432 2006-0
Fax: +49 7432 2006-299
Email: info@alber.de |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Michael Vent
BEO MedConsulting Berlin GmbH
Helmholtzstr. 2-9
10587 Berlin, Germany
Phone: +49 30 318 045 3
Email: m.vent@beoberlin.de |
| Device: | Proprietary: e-fix E35/E36
Common Name: add-on drive for wheelchairs
Classification Name: Powered wheelchair
Device Class: II, 21 CFR 890.3860
Classification Panel: Physical Medicine
Product Code: ITI |
Predicate Device Information:
SOLO/SOLO+
(AAT Alber Antriebstechnik GmbH)
Indications for Use:
The e-fix is an add-on drive for wheelchairs. The e-fix E35/E36 turns a manually propelled wheelchair into a powered wheelchair. It is 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 device e-fix E35/E36 is an add-on drive, which converts a manual wheelchair into an electrical wheelchair.
The drive system e-fix E35/E36 includes two power wheels, a battery mount, a battery pack, a control unit, a power supply and optional devices. The wheelchair is not part of the drive system and is provided by the customer. For initial use mounting brackets are required. If the mounting brackets are fitted to the wheelchair, the power wheels, the control unit and the battery pack can be adapted. The main principle of the power wheel is that the motor unit is fixed against turning and the wheel hub is rotating. The fixing of the motor unit to the mounting brackets is realized with the wheel receiver. The wheel receiver supports the torque which the motor applies and is the interface to the wheel chair.
There are different variants of the e-fix E35 is the conventional version of the e-fix. The e-fix E36 provides a more robust drive with a higher torque. The battery pack has more capacity than the normal one. The e-fix E36 is mainly intended for heavy-weighted persons. The e-fix E35 and E36 are available with 22" or 24" wheels. The control unit is the steering device of the system.
4
lt allows a safe and comfortable ride with the wheelchair.The battery pack is easily removable and rechargeable.
| K161241 (Subject device) | K142770 (Predicate device) | Rationale | |||
|---|---|---|---|---|---|
| Technical Data | |||||
| E35 | E36 | SOLO | SOLO+ | ||
| Indications for Use | The e-fix is an add-on drive for wheelchairs. The e-fix E35/E36 turns a manually propelled wheelchair into a powered wheelchair. It is 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. | The e-fix is an add-on drive for wheelchairs. The e-fix E35/E36 turns a manually propelled wheelchair into a powered wheelchair. It is 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. | 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 | 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 | N/A |
| Wheel size (in.) | 22" or 24" | 22" or 24" | 24" | 24" | Some users may choose smaller wheels to reach the floor with their feet for foot propulsion. The wheel size has no influence on the safety of the powered propulsion |
| Weight (Set) | 18.9 kg | 18.9 kg | 22.9 kg | 22.9 kg | The subject device is lighter due to the battery weight. However, it is has no negative influence on the safety of the device |
| Max. user weight | 120 kg | 160 kg | 160 kg | 200 kg | The subject device has a lower user weight capacity and has no negative influence on the safety of the device |
| Total weight approved | 170 kg | 210 kg | 210 kg | 250 kg | The subject device has a lower weight because of lower product and user weight. It has no negative influence on the safety of the device |
| Braking technologies | Manual parking brake | ||||
| Electromotive brake | |||||
| Electromechanical brake | Manual parking brake | ||||
| Electromotive brake | |||||
| Electromechanical brake | Same | ||||
| Speed, acceleration, deceleration | Preselected max-speed, microprocessor-controlled speed, acceleration and deceleration. The user controls these parameter with the joystick. | Preselected max-speed, microprocessor-controlled speed, acceleration and deceleration. The user controls these parameter with the joystick. | Same | ||
| Forward/backwar | |||||
| d | Joystick & push buttons | Joystick & push buttons | Same | ||
| Locks to prevent | |||||
| unintended/ | |||||
| unanticipated | |||||
| movement | The control unit has an | ||||
| immobilizer-key | |||||
| If the electrical current is | |||||
| turned off, the brake is | |||||
| engaged | The control unit has an | ||||
| immobilizer-key | |||||
| If the electrical current is | |||||
| turned off, the brake is | |||||
| engaged | Same | ||||
| Foldable | |||||
| wheelchair still | |||||
| foldable? | Foldable, after detaching | ||||
| the battery | Foldable, after detaching | ||||
| the battery | Same | ||||
| Quick Release | |||||
| Axle | Provided | Provided | Same | ||
| Wheel | |||||
| synchronization | Provided | Provided | Same | ||
| Down slope | |||||
| speed regulation | Provided | Provided | Same | ||
| Regenerative | |||||
| brake | Provided | Provided | Same | ||
| Performance | |||||
| Range | |||||
| (ISO 7176-14) | Up to 10 miles | ||||
| (up to 13miles with the | |||||
| optionally available high | |||||
| capacity battery pack) | Up to 22 | ||||
| miles | 9.3 miles | Subject device has less | |||
| range than SOLO but it | |||||
| does not adversely affect | |||||
| safety or effectiveness of | |||||
| the subject device | |||||
| Speed: | |||||
| Forward/backward | 3.7 mph/2.6 mph | 3.8 mph/1.9 mph | Similar | ||
| Electrical data | |||||
| Battery | 36 V (Li-lon 10S3P) | 28.8V: | |||
| 16Ah(Pb) | 24V: | ||||
| 8.5Ah(Li-Ion) | Li ion battery recharges | ||||
| faster, is less heavy and | |||||
| suitable for more | |||||
| recharges. The | |||||
| differences have no | |||||
| influence on the safety of | |||||
| the devices | |||||
| Motor | 36 V; 2x | ||||
| 110W | |||||
| (microprocesso | |||||
| r controlled | |||||
| adaption to the | |||||
| power source | |||||
| (Li-lon)) | 36V; 2x 150W | ||||
| (microprocesso | |||||
| r controlled | |||||
| adaption to the | |||||
| power source | |||||
| (Li-lon)) | 24-28.8V DC, | ||||
| 150W | |||||
| (microprocesso | |||||
| r controlled | |||||
| adaption to the | |||||
| power source | |||||
| (PB or Li-Ion)) | 24-28.8V DC. | ||||
| 70W | |||||
| (microprocesso | |||||
| r controlled | |||||
| adaption to the | |||||
| power source | |||||
| (PB or Li-Ion)) | The differences in motor | ||||
| performance do not affect | |||||
| safety of the subject | |||||
| device |
Comparison to predicate device:
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The device is in conformity with Standards and Guidance Documents:
Guidance Document for the Preparation of PreMarket Notification 510k Applications for Mechanical and Powered Wheelchairs and Motorized Three-wheeled vehicles
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
ISO 7176-1:2014, wheelchairs - part 1: determination of static stability. (Physical Medicine)
6
ISO 7176-2:2001, wheelchairs - part 2: determination of dynamic stability of electric wheelchairs. (Physical Medicine)
ISO 7176-3:2012, wheelchairs - part 3: determination of effectiveness of brakes. (Physical Medicine)
ISO 7176-4:2008, wheelchairs - part 4: energy consumption of electric wheelchairs and scooters for determination of theoretical distance range. (Physical Medicine)
ISO 7176-6:2001, wheelchairs - part 6: determination of maximum speed, acceleration and deceleration of electric wheelchairs. (Physical Medicine)
ISO 7176-8:2014, Wheelchairs Part 8: Requirements and test methods for static, impact and fatique strengths
ISO 7176-9:2009, wheelchairs - part 9: climatic tests for electric wheelchairs. (Physical Medicine)
ISO 7176-10:2008, wheelchairs - part 10: determination of obstacle-climbing ability of electrically powered wheelchairs. (Physical Medicine)
ISO 7176-14:2014, wheelchairs - part 14: power and control systems for electrically powered wheelchairs and scooters - requirements and test methods. (Physical Medicine)
ISO 7176-15:1996, wheelchairs - part 15: requirements for information disclosure, documentation and labeling. (Physical Medicine)
ISO 7176-21:2009, wheelchairs - part 21: requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers. (Physical Medicine)
ISO 10993-5:2009, biological evaluation of medical devices -- part 5: tests for in vitro cytotoxicity. (Biocompatibility)
Quality Assurance and Manufacturing Controls:
Alber GmbH operates to certified quality managementsystem according to EN ISO 13485.
Conclusion:
Conclusions drawn from the performance, bench and non-clinical tests demonstrate that the subject device substantially equivalent to the predicate device.