(15 days)
The LEVO C3 power wheelchair with optional seating and standing position function may be of interest for any individuals who needs a power wheelchair and cannot stand up on their own such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc.. The LEVO C3 power wheelchair is a product which changes people's position in/from seating or/to standing but also any position in between. The product provides high indoor and outdoor mobility.
The LEVO C with optional seating and standing position function is center wheel driven, battery powered, motor driven power wheelchair and is controlled by the PG Drives Technology's power wheelchair controller "VR2". The joystick is integrated in the controller. The wheelchair is powered by two 12V/55Ah or two 12V/72Ah batteries with a theoretical driving range of 25km (55Ah), 35km (72Ah). The electrical positioning change is integrated in an electrical center wheel drive power wheelchair that performs high indoor and outdoor mobility in any optional possible position. For security, the speed is reduced to half speed as soon as the patient is not in the sitting position.
This document primarily describes a 510(k) submission for a medical device, the LEVO C3 power wheelchair. It focuses on demonstrating substantial equivalence to predicate devices and adherence to regulatory standards, rather than presenting a study with specific acceptance criteria and performance metrics in the typical sense of algorithm or diagnostic device evaluation.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly available or applicable in this type of regulatory document.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide a table of quantitative acceptance criteria and reported device performance in terms of accuracy, sensitivity, specificity, etc., as one would find for a diagnostic algorithm. Instead, the "acceptance criteria" are compliance with established safety and performance standards for power wheelchairs, and the "reported performance" is that the device meets these standards and is substantially equivalent to predicate devices.
| Acceptance Criteria (Inferred from regulatory context) | Reported Device Performance (Inferred) |
|---|---|
| Compliance with ISO, EN, and ANSI/RESNA standards for power wheelchairs. | The LEVO C3 has been tested after the latest ISO, EN and ANSI/RESNA standards. |
| Substantial equivalence to predicate devices (LEVO combi, LEVO comfort II, Permobil C350 PS) in technological characteristics, safety, and effectiveness. | The LEVO C3 has in substantial the same technological characteristics and the same safety and effectiveness as the predicate device(s). Minor changes do not raise new questions of safety and effectiveness. |
| Speed reduction to half speed when not in sitting position for security. | For security, the speed is reduced to half speed as soon as the patient is not in the sitting position. |
| Ability to change people's position in/from seating or/to standing and any intermediate position. | The product changes people's position in/from seating or/to standing but also any position in between. |
| Provides high indoor and outdoor mobility on surfaces like tar, grass and gravel. | Provides high indoor and outdoor mobility on surfaces like tar, grass and gravel. |
| Not allowed to drive in standing position on uneven ground. | It is not allowed to drive in standing position on uneven ground. |
| Low shearing design to prevent shearing forces or dislocations during changing positions. | The whole body support system is equipped with the latest low shearing design to prevent shearing forces or dislocations during changing positions. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document describes compliance with standards and equivalence to predicate devices, which typically involves engineering testing and comparative analysis, not a clinical "test set" in the sense of human subject data for an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. "Ground truth" in this context would likely refer to the established specifications and performance expectations outlined in the relevant ISO, EN, and ANSI/RESNA standards, rather than expert consensus on medical images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The "test set" described is a regulatory and engineering compliance process, not a clinical study requiring adjudication of expert interpretations.
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
Not applicable. This is a physical medical device (power wheelchair), not an AI-assisted diagnostic or interpretative tool. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is implicit in the international and national standards (ISO, EN, ANSI/RESNA) that govern the safety and performance of power wheelchairs. These standards define the acceptable range of physical, mechanical, and electrical characteristics, as well as safety features.
8. The sample size for the training set
Not applicable. This document describes a physical medical device, not an AI algorithm requiring a training set. The design of the LEVO C3 is based on "experience from the past" and previous models (LEVO combi, LEVO comfort II), which can be considered an analogous "training" or experience base for the engineering design, but not a data set in the AI sense.
9. How the ground truth for the training set was established
Not applicable in the AI sense. The "ground truth" for the engineering design and development came from "Experience from the past has shown" and "Experience from the past has shown that the centre wheel driven power wheel chair has the most compact and efficient manoeuvrability capability with some limitations...". This refers to empirical knowledge gained from previous product development and market use of their own and competitor's wheelchairs.
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Image /page/0/Picture/0 description: The image shows the logo for LEVO, which is described as "THE EXPERTS IN STANDING." Below the logo is a handwritten number, 6083017. The logo is in black ink, and the handwritten number is also in black ink. The image is a close-up of the logo and the number.
510(k) Summary of Safety and Effectiveness
| Submitter: | LEVO AGP.O. Box 1272Anglikerstrasse 20CH-5610 Wohlen, Switzerland | OCT 24 2008 |
|---|---|---|
| Phone:Fax: | +41 56-6184411+41 56-6184410 | |
| Contact Person: | Mr. Thomas Nietlisbach, Construction EngineerMr. Thomas Raeber, CEO | |
| E-Mail-Address: | t.nietlisbach@levo.cht.raeber@levo.ch | |
| Device Name: | LEVO C3 |
Classification Name: Electrical Power Wheelchair, Stand-up
Identification of
Predicate Devices: LEVO combi (K 030893) LEVO comfort II (K 051387) Permobil C350 PS (K 071650)
The LEVO C3 power wheelchair is a product which Intended Use: changes people's position in/from seating or/to standing but also any position in between. The product provides high indoor and outdoor mobility on surfaces like tar, grass and gravel. However, it is not allowed to drive in standing position on uneven ground.
Device Description: The LEVO C with optional seating and standing position function is center wheel driven, battery powered, motor driven power wheelchair and is controlled by the PG Drives Technology's power wheelchair controller "VR2". The joystick is integrated in the controller. The wheelchair is powered by two 12V/55Ah or two 12V/72Ah batteries with a theoretical driving range of 25km (55Ah), 35km (72Ah).
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Image /page/1/Picture/0 description: The image shows the logo for LEVO.ot, with the tagline "THE EXPERTS IN STANDING" underneath. The logo is in a simple, sans-serif font, with the "ot" portion of the name being smaller and slightly raised. There is a small plus sign to the right of the logo.
The LEVO C power wheelchair is a product which changes people's position in/from seating or/to standing but also any position in between.
The electrical positioning change is integrated in an electrical center wheel drive power wheelchair that performs high indoor and outdoor mobility in any optional possible position. For security, the speed is reduced to half speed as soon as the patient is not in the sitting position.
Components: The LEVO C3 power wheelchair consists of three basic sub-sections. These are the base with drive units, the PG Drives Technology's VR2-Control System, and the body supporting system including the mechanisms with actuators to change positions.
The base of the LEVO C3 includes the frame, four direct-drive units with integrated parking brakes, two 12V/55Ah or two 12V/72Ah batteries, two 2.80/2.50-4" straight front and two 3.00-8" center driving wheels as well as two 7X1¾" twin rear castor wheels. The base also includes a vehicle tie-down kit.
PG Drives Technology's VR2-Control System includes the power module, the integrated actuator module and the controller with integrated joystick.
The body supporting system includes the seat support, the back support, armrests and leg rests and the mechanisms with actuators to change positions. This optional position change mechanism allows people to switch into/from seating or/to standing but also any position in between including tilt in space. The whole body support system is equipped with the latest low shearing design to prevent shearing forces or dislocations during changing positions.
Safety and Effectiveness: The LEVO C3 was developed on experience of the LEVO combi, LEVO comfort II and all other powered wheelchairs previously developed and produced by LEVO AG since 1975. Experience from the past has shown that the centre wheel driven power wheel chair has the most compact and efficient manoeuvrability capability with some limitations when it comes up to obstacles and steep ramps. A front wheel driven power chair offers this best capability while the user is in standing. The new power wheelchair LEVO C has been developed as a combination of both and uses in regards of the power motors as well as the controller the same technology as already used and proved in the market. The seating and positioning components are also built up based on experience and became specificans on known stressed components. The whole new power chair with its inbuilt new technologies for improvements in effectiveness and safeties, in many regards shows similarities to the above mentioned products, but also has
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Image /page/2/Picture/0 description: The image shows the logo for LEVO.d, with the tagline "THE EXPERTS IN STANDING" underneath. The logo is in a bold, sans-serif font, and the tagline is in a smaller, lighter font. There is a small cross symbol to the right of the logo.
been tested after the latest ISO, EN and ANSI/RESNA standards as listed in this documentation.
So the LEVO C³ 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/3/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with stylized wings and body. The symbol is black and the text is in a simple, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
LEVO AG % TÜV SÜD America, Inc. Mr. Stefan Preiss 1775 Old Highway 8 / Suite 104 New Brighton, Minnesota 55112-1891
OCT 2 4 2008
Re: K083017 Trade/Device Name: LEVO C Standup Wheelchair Regulation Number: 21 CFR 890.3900 Regulation Name: Standup wheelchair. Regulatory Class: Class II Product Code: IPL Dated: October 7, 2008 Received: October 9, 2008
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
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Page 2 - Mr. Stefan Preiss
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark M. Mulhern
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the logo for LEVO.ot, with the tagline "THE EXPERTS IN STANDING" underneath. The logo is in a simple, sans-serif font, with the "O" in LEVO being a perfect circle. The tagline is in a smaller font and is centered below the logo.
Statement of Indication for Use
not known 510(k) Number:
Proprietary Name LEVO C3 of the new Device:
The LEVO C3 power wheelchair with optional seating and Indications for Use: standing position function may be of interest for any individuals who needs a power wheelchair and cannot stand up on their own such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc..
The LEVO C3 power wheelchair is a product which changes Intended use: people's position in/from seating or/to standing but also any position in between. The product provides high indoor and outdoor mobility.
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)
Mark A. Mulkern
(Division Sign-C Division of General, Restorative, and Neurologi
510(k) Number
K08 3017
§ 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).