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. It allows a safe and comfortable ride with the wheelchair.The battery pack is easily removable and rechargeable.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called e-fix E35/E36, which is an add-on drive for wheelchairs. It outlines the device's technical specifications, indications for use, comparison to a predicate device, and conformity with standards.

However, the document does not contain the specific information requested regarding the acceptance criteria and a study proving the device meets those criteria, particularly in the context of AI/ML performance metrics, sample sizes for test/training sets, expert ground truth establishment, or multi-reader multi-case studies. This device is a powered wheelchair accessory, and the FDA submission focuses on its mechanical, electrical, and performance characteristics as a physical medical device, not an AI/ML-driven diagnostic or analytical tool.

Therefore, I cannot extract the requested information from the provided text. The document describes conformity to ISO standards for wheelchair performance and safety, but these are not the "acceptance criteria" in the sense of accuracy, sensitivity, specificity, etc., typically associated with AI/ML device evaluations. There is no mention of a "study" in the context of evaluating an AI algorithm's performance against a ground truth.

If you have a document pertaining to an AI/ML medical device, please provide that.

Summary

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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

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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)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

Device 510k number: K161241

Applicant:	Alber GmbHVor dem Weißen Stein 2172461 Albstadt, GermanyPhone: +49 7432 2006-0Fax: +49 7432 2006-299Email: info@alber.de
Contact Person:	Mr. Michael VentBEO MedConsulting Berlin GmbHHelmholtzstr. 2-910587 Berlin, GermanyPhone: +49 30 318 045 3Email: m.vent@beoberlin.de
Device:	Proprietary: e-fix E35/E36Common Name: add-on drive for wheelchairsClassification Name: Powered wheelchairDevice Class: II, 21 CFR 890.3860Classification Panel: Physical MedicineProduct Code: ITI

Predicate Device Information:

K142770

SOLO/SOLO+

(AAT Alber Antriebstechnik GmbH)

Indications for Use:

Device Description:

The subject device e-fix E35/E36 is an add-on drive, which converts a manual wheelchair into an electrical wheelchair.

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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 brakeElectromotive brakeElectromechanical brake		Manual parking brakeElectromotive brakeElectromechanical 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/backward	Joystick & push buttons		Joystick & push buttons		Same
Locks to preventunintended/unanticipatedmovement	The control unit has animmobilizer-keyIf the electrical current isturned off, the brake isengaged		The control unit has animmobilizer-keyIf the electrical current isturned off, the brake isengaged		Same
Foldablewheelchair stillfoldable?	Foldable, after detachingthe battery		Foldable, after detachingthe battery		Same
Quick ReleaseAxle	Provided		Provided		Same
Wheelsynchronization	Provided		Provided		Same
Down slopespeed regulation	Provided		Provided		Same
Regenerativebrake	Provided		Provided		Same
Performance
Range(ISO 7176-14)	Up to 10 miles(up to 13miles with theoptionally available highcapacity battery pack)		Up to 22miles	9.3 miles	Subject device has lessrange than SOLO but itdoes not adversely affectsafety or effectiveness ofthe 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 rechargesfaster, is less heavy andsuitable for morerecharges. Thedifferences have noinfluence on the safety ofthe devices
Motor	36 V; 2x110W(microprocessor controlledadaption to thepower source(Li-lon))	36V; 2x 150W(microprocessor controlledadaption to thepower source(Li-lon))	24-28.8V DC,150W(microprocessor controlledadaption to thepower source(PB or Li-Ion))	24-28.8V DC.70W(microprocessor controlledadaption to thepower source(PB or Li-Ion))	The differences in motorperformance do not affectsafety of the subjectdevice

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)

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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.

Regulation Number and Section

§ 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).