The LEVO comfort II stand-up power wheelchair may be of interest for any individuals who needs a power wheelchair and can not stand up on their own such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc..

Intended use: The LEVO comfort II stand-up power wheelchair is a product which changes people's position from sitting to Standing to sitting but also any position in between. The product provides indoor and outdoor mobility.

Device Description

The LEVO comfort II power wheelchair is centre wheel driven, battery powered, motor driven and is controlled by the PG Drives Technology's power wheelchair controller "VSI" The Joystick is integrated in the Controller. The wheelchair is powered by: two 12V/26Ah, two 12V/40Ah or four 12V/26Ah batteries with a theoretical driving range of 14km (26Ah), 20km (40Ah) or 28km (56Ah) on the fully charged batteries.

The wheelchair consists of the following basic sub-sections:

Base with two direct-drive units with integrated parking brakes, two 12V/26Ah, two 12V/40Ah or four 12V/26Ah, two 14"x2%" rear wheels and two 8"x2" front wheels.
PG Drives Technology's power wheelchair controller . "VSI"
Seating System including stand-up mechanisms and actuator.

The base is of welded steel construction and includes the base frame, front castor wheels, rear driving wheels with drive unit (motor/gear/brakes) and batteries. The motor Controller is mounted to the left or right armrest, depending on the user's needs.

AI/ML Overview

The LEVO comfort II is a stand-up power wheelchair. The provided text indicates that the device's safety and effectiveness were established primarily through substantial equivalence to predicate devices, namely the LEVO mobil LCM (K 963817) and Quickie Freestyle (K 031289). No specific acceptance criteria with quantifiable metrics or a detailed study evaluating the device against such criteria are explicitly provided in the furnished document.

The document states: "The LEVO comfort II was basically developed on experience of the LEVO mobil LCM. However being able to provide additional outdoor mobility as well as further improvements in the geometric for an excellent biomechanical response to the user's body. The only modifications are simply colour and design changes. So the LEVO comfort II has in substantial the same technological characteristics and the same safety and effectiveness as the predicate device(s) and the minor changes declared in the Submission do not raise new questions of safety and effectiveness." This implies that the device is considered safe and effective because its core design and performance are substantially similar to previously cleared devices, with only minor aesthetic and functional improvements that do not introduce new safety or effectiveness concerns.

Therefore, many of the specific details requested in the prompt, such as

a table of acceptance criteria and reported device performance,
sample sizes for test sets,
details of experts and adjudication methods,
MRMC studies,
standalone performance studies,
ground truth types,
training set sample sizes, and
ground truth establishment for training sets,
are not present in the provided 510(k) summary. These types of detailed studies are typical for novel devices or those with significant changes that might impact safety or effectiveness. For devices demonstrating substantial equivalence to existing products with minor modifications, such extensive testing might not be required or documented in the summary.

The only performance-related detail mentioned is a "theoretical driving range of 14km (26Ah), 20km (40Ah) or 28km (56Ah) on the fully charged batteries," which describes a characteristic rather than a performance target against a predefined criterion.

Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate devices for safety and effectiveness	"has in substantial the same technological characteristics and the same safety and effectiveness as the predicate device(s)"
Ability to change users' position from sitting to standing and vice versa	Explicitly stated as a function of the device
Indoor and outdoor mobility	Explicitly stated as a function of the device
Driving range (theoretical)	14km (26Ah), 20km (40Ah), 28km (56Ah)
No new questions of safety and effectiveness raised by modifications	"the minor changes declared in the Submission do not raise new questions of safety and effectiveness."

Study Information (Based on provided text):

Sample size used for the test set and the data provenance: Not explicitly stated. The determination of safety and effectiveness appears to be based on a comparison to predicate devices, rather than a new standalone test set for empirical performance evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed clinical efficacy or safety studies with expert ground truth establishment are not mentioned for this submission. The "ground truth" for substantial equivalence is derived from the established safety and effectiveness of the predicate devices.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as detailed testing requiring adjudication is not described.
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: Not applicable. This device is a physical medical device (power wheelchair), not an AI/software-based diagnostic or assistive system that would involve human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device.
The type of ground truth used: Substantial equivalence to predicate devices (LEVO mobil LCM and Quickie Freestyle). The safety and effectiveness of these predicate devices serve as the "ground truth."
The sample size for the training set: Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-based device.
How the ground truth for the training set was established: Not applicable.

Summary

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KOS1387

JUN 1 0 2005

510(k) Summary of Safety and Effectiveness

LEVO comfort II

Submitter:	LEVO AGP.O. Box 1272Anglikerstrasse 20CH-5610 Wohlen, Switzerland
Phone:	+41 56-6184411
Fax:	+41 56-6184410
Contact Person:	Mr. Markus Burger, Head of R&DMr. Thomas Raeber, Managing Director
E-Mail-Address:	m.burger@levo.ch raeber@levo.ch
Device Name:	LEVO comfort II
Classification Name:	Electrical Power Wheelchair, Stand-up
Identification ofPredicate Devices:	LEVO mobil LCM (K 963817)Quickie Freestyle (K 031289)
Intended Use:	The LEVO comfort II stand-up power wheelchair is a productwhich changes people's position from sitting to Standing andStanding to sitting but also any position in between. Theproduct provides indoor and outdoor mobility.
Description ofthe Device:	The LEVO comfort II power wheelchair is centre wheeldriven, battery powered, motor driven and is controlled by thePG Drives Technology's power wheelchair controller "VSI"The Joystick is integrated in the Controller.The wheelchair is powered by: two 12V/26Ah, two12V/40Ah or four 12V/26Ah batteries with a theoreticaldriving range of 14km (26Ah), 20km (40Ah) or 28km(56Ah) on the fully charged batteries.

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KOSIJ87

The wheelchair consists of the following basic sub-sections:

Base with two direct-drive units with integrated parking brakes, two 12V/26Ah, two 12V/40Ah or four 12V/26Ah, two 14"x2%" rear wheels and two 8"x2" front wheels.
PG Drives Technology's power wheelchair controller . "VSI"
Seating System including stand-up mechanisms and ● actuator.

Safety and Effectiveness:

The LEVO comfort II was basically developed on experience of the LEVO mobil LCM. However being able to provide additional outdoor mobility as well as further improvements in the geometric for an excellent biomechanical response to the user's body. The only modifications are simply colour and design changes. So the LEVO comfort II has in substantial the same technological characteristics and the same safety and effectiveness as the predicate device(s) and the minor changes declared in the Submission do not raise new questions of safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circle around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 2005

Levo AG C/o Mr. Stefan Priess TUV America, Inc. 1775 Old Highway 8 New Brighton, Minnesota 55112

Re: K051387

Trade/Device Name: LEVO comfort II Regulation Number: 21 CFR 890.3900 Regulation Name: Standup Wheelchair Regulatory Class: II Product Code: IPL Dated: May 25, 2005 Received: May 27, 2005

Dear Mr. Preiss:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Stefan Priess

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Miriam C. Provost, Ph.D.

Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): not known

Device Name: LEVO comfort II

The LEVO comfort II stand-up power wheelchair may be of interest for Indications for Use: any individuals who needs a power wheelchair and can not stand up on their own such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc..

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number_K051387

Regulation Number and Section

§ 890.3900 Standup wheelchair.

(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).