The intended use of the LIFTKAR PT™ is to transport a wheelchair user or a person needing assistance up or down stairs by means of a battery powered, mobile lifting device. LIFTKAR PT is operated by an attendant and is used in residential and public facilities indoors and outside.

The LIFTKAR PT™ Is a wheelchair, elevator commonly known as an easy method of transporting wheelchair users of uisabled persons, ap and as a mobile stair-climber. This is done with alitting - LIFT AD PT. LIFTKAR PT™ can be used on any stairs indoors or outside.

Device Description

The LIFTKAR PT™ ADAPT is an attendant operated, battery powered lifting device that transports manual wheelchairs up or down stairs. The LIFTKAR PT is designed for indoor and outdoor use allowing mobility for the person needing assistance.

A portable stair-climber LIFTKAR PT can be dismantled into three parts, the climber unit, the battery pack and the handle. All parts are lightweight and easy to stow away.

AI/ML Overview

Acceptance Criteria and Device Performance for SANO Transportgeraete GmbH LIFTKAR PT™ Elevator Wheelchair

This document outlines the acceptance criteria and reported device performance for the LIFTKAR PT™ ADAPT, an attendant-operated, battery-powered lifting device for transporting manual wheelchairs up or down stairs, as presented in the 510(k) Summary K110495.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the LIFTKAR PT™ ADAPT are primarily based on conformity to established international standards for wheelchairs and stair-climbing devices, as well as demonstrating substantial equivalence to a predicate device. The performance data section indicates that the device meets specifications for performance criteria and intended functions, thereby satisfying the acceptance criteria.

Acceptance Criteria (Standards	Predicate Device (Scalamobil) Performance	LIFTKAR PT™ ADAPT Performance (Reported as Conforming)
ISO 7176-23:2002 Requirements and Test Methods for attendant-operated stair climbing devices	Not explicitly detailed but implied by predicate status	Conforms
ISO 7176-1:1999 Wheelchairs Determination of static stability	Not explicitly detailed	Conforms
ISO 7176-11:1999 Wheelchairs Determination of overall dimensions, mass and maneuvering space	Not explicitly detailed	Conforms
ISO 7176-6:2001 Wheelchairs Determination of maximum speed, acceleration and deceleration of electric wheelchairs	Not explicitly detailed	Conforms
ISO 7176-14:2008 Wheelchairs Power and control systems for electrically powered wheelchairs and scooters-Requirements and test methods	Not explicitly detailed	Conforms
ISO 7176-21:2009 Wheelchairs Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers	Not explicitly detailed	Conforms
ISO 7176-11:1992 Wheelchairs-Part 11 Test Dummies (Physical Medicine)	Not explicitly detailed	Conforms
ISO 7176-15:1996 Wheelchairs Requirements for Information disclosure, documentation and labeling	Not explicitly detailed	Conforms
ISO 7176-8:1998 Wheelchairs Requirements and test methods for static impact and fatigue strength	Not explicitly detailed	Conforms
EN 12184:1999 Electrically Powered Wheelchair, scooters and their chargers	Not explicitly detailed	Conforms
Comparative Metrics with Predicate Device
Minimum wheelchair width	11 inches	12.6 inches
Weight (total)	54 lbs	54.34 lbs
Safe Workload (incl. wheelchair)	308 lbs	352 lbs
Overall height	44 inches	44.49 inches
Overall width	19 inches	18.98 inches
Stair Landing minimum	36 x 36 inches	35.4 x 35.4 inches
Maximum Stair Height	10 inches w/extension	8.25 inches
Battery Type	Sealed lead gel	Sealed lead gel
Capacity with fully charged battery	300 steps	300 steps
Battery capacity	3.3 ah	5 ah
Nominal output voltage of charge	24V	24V
Charging current	1 amp	1 amp
Three main components (Handle, lifting device, battery)	Same	Same

The "Reported Device Performance" for the LIFTKAR PT™ ADAPT, as stated in the submission, is that it "conforms with the following standards" and that "The performance Data results of the testing confirm that the device meets specifications for the performance criteria and the functions it was intended for." This implies successful demonstration against the requirements within each standard.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated in the provided document. The testing reports are referenced as "BERLIN CERT Prui und Zertifizierstelle for Medizinnprodukte GmbH an der Technischen Universitat Berlin, TEST Reports in Section: 11.7-32". These reports would contain the detailed sample sizes for the various tests carried out to confirm compliance with the listed ISO and EN standards.
Data Provenance: The testing was performed by "BERLIN CERT Prui und Zertifizierstelle for Medizinnprodukte GmbH an der Technischen Universitat Berlin". This indicates the testing was conducted in Germany (Berlin). The nature of the tests (compliance with standards for mechanical devices) suggests prospective testing specifically designed to evaluate the device against these criteria, rather than retrospective analysis of existing data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. For performance testing of a mechanical device against international standards, the "ground truth" is typically established by the specified test methods within the standards themselves and evaluated by qualified testing engineers at the certification body (BERLIN CERT). There is no indication of "experts" in the sense of clinical specialists establishing a "ground truth" for a diagnostic or interpretative task.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments or when there's disagreement among human readers/experts in diagnostic studies. For objective performance testing of a mechanical device against established engineering standards, an adjudication method for the "test set" as described is not applicable or typically used. The testing is based on objective measurements and predefined acceptance criteria outlined in the standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. MRMC studies are relevant for medical imaging or diagnostic devices where human readers interpret results, and the study aims to assess the impact of AI assistance on their performance. The LIFTKAR PT™ is a mechanical mobility device; its evaluation focuses on engineering performance, safety, and substantial equivalence, not the interpretive accuracy of human readers.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

The concept of a "standalone" algorithm performance is not applicable to this device. The LIFTKAR PT™ is an attendant-operated mechanical device. Its performance is intrinsically linked to its mechanical function and its interaction with an attendant, not an independent algorithm making decisions or interpretations. The performance evaluation focuses on the mechanical and electrical integrity and functionality of the device itself.

7. The Type of Ground Truth Used

The ground truth used for the performance evaluation is based on objective engineering and safety standards (ISO and EN standards). This includes:

Predefined thresholds and specifications: e.g., maximum load capacity, battery life (number of steps), static stability, dimensions.
Standardized test methods: Procedures outlined in the ISO and EN standards for measuring these parameters.
Substantial equivalence to a predicate device: Comparisons of design, components, and performance specifications to an already legally marketed device (Scalamobil K920105).

8. The Sample Size for the Training Set

This question is not applicable to the LIFTKAR PT™ ADAPT submission. "Training set" refers to data used to train machine learning algorithms. The LIFTKAR PT™ is a mechanical device, not an AI or machine learning product. Its development and approval process do not involve training sets for algorithms.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no training set for an AI algorithm involved in the LIFTKAR PT™ ADAPT.

Summary

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MAY 2 0 2011

510(k)Summary

SANO Transportgerate GmbH LIKFTKAR PT™, Elevator Wheelchair PRODUCT CODE ING Regulation Name Wheelchair Elevator Sec. 890.3930 Class II

Submitter's Information

SANO Transportgeraete Gmbh Am Holzpoldigut 22 Lichtenberg/Linz Upper Austria 4040 Austria Telephone 43(0) 7239/510-10-10-10 Fax 43 (0_7239/510-10-14 Manfred Winkler Managing Director

Dated Prepared: 1/20/11

Name of Device and Sponsor LIFTKAR PT™ Product of SANO

Common Name

Elevator, Wheelchair

Classification Name

Class II General Controls and Special Controls. Elevator Wheelchair

Predicate Device

Scalamobil (K920105)

Intended Use

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Device Description

A portable stair-climber LIFTKAR PT can be dismantled into three parts, the climber unit, the battery pack and the handle. All parts are lightweight and easy to stow away.

Substantial Equivalence

The LIFTKAR PT™ ADAPT is substantially equivalent to the Scalamobil K920105.

The predicate device Scalamobil manufactured by Ulrich Alber was evaluated by FDA under (K920105). Like the LIFTKAR PT the Scalamobil is a fully portable stair-climbing transporter designed to permit a manual wheelchair to go up or down stairs with an attendant operating the lifting device. The benefit of an attendant operated product is they must be certified to operate these devices and they are required to inspect the product and the stairs, for safety and effectiveness, each time the device is used.

Both the LIFTKAR PT™ and the predicate device are portable wheelchair transporters that attach to wheelchairs, safely and comfortably with a minimum of backward and forward tilting. Both attach to a wheelchair via a clamp mechanism. And both use a lifting device to go up and down stairs, with the use of braked wheels.

The wheelchair is fitted with brackets, that may be attached and removed as necessary.

To attach to the wheelchair the climbing unit is simply wheeled under the chair, so that the lower bolts of the power unit lock into the lower hook brackets already mounted on the wheelchair. The attendant lifts the upper bolt component, by pressing the UP switch on the handlebar and it locks into the clamps. The attendant then inserts the two locking pins into the clamp to secure the product to the wheelchair. The quick release wheels of the wheelchair are removed and placed back on when stairs are completed.

The stair-climbing principles are identical- one set of wheels secures the wheelchair on one stair and another set of wheels reach the next step. Both use a chain mechanism.

LIFTKAR PT™ ADAPT as well as Scalamobil carry an independent power source, making it a portable device, lightweight and compact. Both products break down into 3 parts, handle, battery and climbing device. Both way approximately the same and both can carry approximately the same weights.

Both the LIFTKAR PT™ ADAPT and the Scalamobil have models that are simply connected accessories to the product.

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Product Comparison

PT-Adapt 160

Scalamobil

Minimum wheelchair width	12.6 inches	11 inches
Weight (total):	54.34 lbs	54 lbs
Safe Workload (incl. wheelchair)	352 lbs	308 lbs
Overall height:	44.49 inches	44 inches
Overall width:	18.98 inches	19 inches
Stair Landing minimum:	35.4 x 35.4 inches	36 x 36 inches
Maximum Stair Height	8.25 inches	10 inches w/extension
Battery	Sealed lead gel	Sealed lead gel
Capacity with fully charged battery	300 steps	300 steps
Battery capacity	5 ah	3.3 ah
Nominal output voltage of charge	24V	24 V
Charging current	1 amp	1 amp
Three main components:Handle, lifting device, battery	Same	Same

Performance Data

The LIFTKAR PT™ ADAPT was tested by BERLIN CERT Prui und Zertifizierstelle for The LIFT KARPT - ADAF I was tested by DERIAN GENES - Serlin, TEST Reports in Section:
Medizinnprodukte GmbH an der Technischen Universitat Berlin, TEST Reports in Section: 11.7-32

LIFTKAR PT ADAPT conforms with the following standards :

ISO 7176-23:2002 Requirements and Test Methods for attendant - operated stair climbing devices

ISO 7176-1:1999 Wheelchairs Determination of static stability

ISO 7176-111999 Wheelchairs Determination of overall dimensions, mass and maneuvering space

space
ISO 7176-6:2001 Wheelchairs Determination of maximum speed, acceleration and deceleration of electric wheelchairs

deceleration of clectric whoses and on the time to to electric wheelchairs

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ISO 7176-14:2008 Wheelchairs Power and control systems for electrically powered wheelchairs and scooters-Requirements and test methods

ISO 7176-21:2009 Wheelchairs Requirements and test methods for electromagnetic 100 / 27 oility of electrically powered wheelchairs and scooters, and battery chargers ISO 7176-11:1992 Wheelchairs-Part 11 Test Dummies (Physical Medicine) Date of Standard 1992

Standard 1772
ISO 7176-15:1996 Wheelchairs Requirements for Information disclosure, documentation and labeling.

and fabelling?
ISO 7176-8:1998 Wheelchairs Requirements and test methods for static impact and fatigue strength

EN 12184:1999 Electrically Powered Wheelchair, scooters and their chargers.

The performance Data results of the testing confirm that the device meets specifications for rne performance criteria and the functions it was intended for. And is substantially equivalent to the predicate device.

Conclusion

Based on the design, performance specifications, testing, and intended use, the LIFTKAR PT™ is substantially equivalent to the legally marketed device, Scalamobil (K920105).

Since the device is essentially the same as the elevator, wheelchair stair-climbing device already marketed, (Scalamobil K920105), no effect on the safety and or effectiveness of the device is expected.

4.6

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Image /page/4/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.

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

MAY 2 0 2011

Sano Transportgeraete GmbH % Ingegnoso Technologies, LLC Ms. Jeanine A. Carroccio 4028 Belleaire Lane Downers Grove, Illinois 60515

Re: K110495

Trade/Device Name: LIFTKAR PT™ Regulation Number: 21 CFR 890.3930 Regulation Name: Wheelchair elevator Regulatory Class: Class II Product Code: ING Dated: January 20, 2011 Received: February 22, 2011

Dear Ms. Carroccio:

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

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Page 2 - Ms. Jeanine A. Carroccio

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 (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Aliz Bin nok

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE

510(k) Number:

Device Name: LIFTKAR PT™

Indications For Use:

The LIFTKAR PT™ Is a wheelchair, elevator commonly known as an easy method of transporting I he LIF I KAR I I " Is a whicelehan, crovates - This is done with alitting - LIFT AD PT wheelchair users of uisabled persons, ap and as a mobile stair-climber. LIFTKAR PT™ can be used on any stairs indoors or outside.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D)

(Please do not write below this line-continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

(Divjsion Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110495

Regulation Number and Section

§ 890.3930 Wheelchair elevator.

(a)
Permanently mounted wheelchair platform lift —(1)Identification. A permanently mounted wheelchair platform lift is a motorized vertical or inclined platform lift device permanently installed in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a guided platform to move a person from one level to another, with or without a wheelchair.(2)
Classification. Class II. The permanently mounted wheelchair platform lift is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9 and the following conditions for exemption:(i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate that the safety controls are adequate to prevent a free fall of the platform in the event of a device failure;
(ii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the device to withstand the rated load with an appropriate factor of safety;
(iii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the enclosures to prevent the user from falling from the device; and
(iv) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests,” and ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must validate electromagnetic compatibility and electrical safety.
(b)
Portable wheelchair elevators —(1)Identification. A portable wheelchair elevator is a motorized lift device that is not permanently mounted in one location and that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a means to move a person, with or without a wheelchair, from one level to another (e.g., portable platform lifts, attendant-operated stair climbing devices for wheelchairs).(2)
Classification. Class II.