The LIFTKAR PT™-S Is a method of transporting disabled persons, up and downstairs while seated on the stairclimber, and not in a wheelchair. This is done with a lifting mechanism. It is a battery on the bailed in the been and on a certified attendant and can be used on any stairs indoors or outside.

Device Description

The LIFTKAR PT™ S is an attendant operated, battery powered lifting device that transports a disabled person in an integrated chair up or down stairs, not in a wheelchair. The LIFTKAR PT-S is designed for indoor and outdoor use allowing mobility for the person needing assistance.

AI/ML Overview

Here's an analysis of the provided text regarding the LIFTKAR PT™-S device, focusing on acceptance criteria and study details:

This submission is for a K111858, a 510(k) premarket notification. In a 510(k), manufacturers demonstrate substantial equivalence to a legally marketed predicate device. This typically involves showing that their new device is as safe and effective as the predicate device, often through performance testing and comparison of technical specifications. It's important to understand that a 510(k) does not usually involve extensive clinical trials like a PMA (Premarket Approval) application, nor does it typically detail acceptance criteria in the same way one might for a novel, high-risk device. The "acceptance criteria" here are largely implied by demonstrating compliance with recognized standards and equivalence to the predicate.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the LIFTKAR PT™-S are not explicitly stated in a quantitative table with pass/fail thresholds. Instead, acceptance is demonstrated by conforming to relevant international standards and showing substantial equivalence in performance to its predicate device, the C-Max-U2 (K103122).

The following table summarizes the device performance of the LIFTKAR PT™-S and its comparison to the predicate, which implies the performance criteria were met if the LIFTKAR PT™-S's performance is similar to or better than the predicate and complies with the standards.

Feature / Performance Metric	Predicate Device (C-Max-U2) Performance	LIFTKAR PT™-S Performance	Implied Acceptance Criterion / Conformance
Intended Use	Transport disabled person up/down stairs	Transport disabled person up/down stairs	Functionality match
Weight (total)	78.7 lbs	67 lbs	Similar/Improved (lighter)
Safe Workload (incl. chair)	352 lbs	352 lbs persons wt.	Equivalent
Overall height	44.4 inches	44.49 inches	Equivalent
Overall width (w/o armrests)	16.9 inches	19.88 inches	Similar
Depth (footrest out)	30.9 inches	29.3 inches	Similar/Improved (less deep)
Stair Landing minimum	31.5 x 35.4 inches	31.5 x 35.4 inches	Equivalent
Maximum Stair Height	8.26 inches	8.25 inches	Equivalent
Stair Type Depth	Not specified but implied comparable	6 inches (includes winding)	Compliance with ISO 7176-23:2002
Straight stair width	Not specified but implied comparable	23.81 inches (Liftkar plus 3.93 inches)	Compliance with ISO 7176-23:2002
Winding Stair Width	Not specified but implied comparable	23.81 inches from point of stair depth of 6 inches	Compliance with ISO 7176-23:2002
Battery Type	Sealed lead acid	Sealed lead gel	Acceptable battery technology
Capacity (fully charged battery)	300 steps	300-500 steps	Similar/Improved
Speeds	8-23 steps/min (continually adjustable)	10-18 steps/min (multiple modes)	Similar operational range
Battery capacity	2x 12V 5 ah	2x 12V5 ah	Equivalent
Nominal output voltage of charge	24V	24V	Equivalent
Main components	Handle, lifting device, battery	Handle, lifting device, battery	Equivalent
Biocompatibility	Not explicitly stated for predicate	Conforms to DIN EN ISO 10993-5	Compliance with standard for safety
Stair Climbing Device Requirements	Not explicitly stated for predicate	Conforms to ISO 7176-23:2002	Compliance with standard for performance

The "acceptance criteria" are intrinsically tied to demonstrating that the LIFTKAR PT™-S meets the requirements of the listed international standards (ISO 7176-23:2002 and DIN EN ISO 10993-5) and performs comparably to or better than the predicate device in key functional areas.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a "sample size" in terms of number of devices tested for performance. It states that "The LIFTKAR PT™-S was tested by BERLIN CERT Pruf und Zertifizierstelle for Medizinnprodukte GmbH an der Technischen Universitat Berlin." This implies that the device (likely one or a few units representative of the production model) was subjected to performance tests. The testing focuses on mechanical, electrical, and safety aspects according to standards, rather than statistical sampling from a large test set.
- Data Provenance: The testing was conducted by BERLIN CERT Pruf und Zertifizierstelle for Medizinnprodukte GmbH an der Technischen Universitat Berlin (a German testing and certification body). This is in Europe (Germany/Austria). The study is prospective in the sense that the device was manufactured and then tested according to defined protocols to assess its conformance to standards and specifications. It is not a retrospective analysis of existing data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of information (number and qualifications of experts for ground truth) is not applicable to this 510(k) submission. For a device like a powered patient transport, "ground truth" is established by direct physical measurement, engineering analysis, and evaluation against technical standards (e.g., measuring weight capacity, step height, battery life, and confirming compliance with ISO 7176-23). The "experts" involved would be the technical engineers and certifiers at BERLIN CERT, whose qualifications are implicit in the accreditation of the certification body, but not explicitly stated here (e.g., "radiologist with 10 years of experience" is for diagnostic devices).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic device evaluations where subjective interpretation plays a role and consensus among experts is needed for ground truth. For a mechanical device tested against engineering standards, the results are objective measurements and pass/fail determinations based on those standards.
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:
- No. An MRMC study is not applicable to this device. This is a powered patient transport device, not a diagnostic imaging device with AI assistance for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical mechanical/electrical apparatus, not an algorithm. Its operation inherently involves a "human-in-the-loop" (the certified attendant).
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" used for this device's performance evaluation is based on objective physical measurements and engineering assessments against recognized international standards (ISO 7176-23:2002 for requirements and test methods for attendant-operated stair climbing devices, and DIN EN ISO 10993-5 for biocompatibility/cytotoxicity testing). The device's specifications (e.g., weight capacity, maximum stair height, battery life) are the defined parameters that the tests verified.
The sample size for the training set:
- Not applicable. This device does not use an AI algorithm that requires a "training set." The training relates to the attendant who uses the device, not an algorithm.
How the ground truth for the training set was established:
- Not applicable. As there is no AI algorithm training set, this question is irrelevant. Any "training" mentioned refers to the certification of the human attendant who operates the device.

Summary

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KIII858

NOV - 4 2011

510(k)Summary

SANO Transportgerate GmbH LIKFTKAR PT™ -S, Powered Patient Transport Device PRODUCT CODE ILK Regulation Name Powered Patient Transport 890.5150 Class II

Submitter's Information

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

Dated Prepared: 08/21/11 Revised on 10.5.11

Name of Device and Sponsor LIFTKAR PT™-S Product of SANO

Common Name Integrated Seat Stairclimber

Classification Name

Powered Patient Transport

Predicate Device C-Max-U2 (AAT Alber Antriebstechnik GmbH) K103122

*Intended Use

The product is a method of transporting a disabled person up and down stairs while seated on the stairclimber and not in a wheelchair. This is done with a battery powered lifting mechanism. The LIFTKAR PT-S requires a certified attendant and can be use on any stairs indoor or outside.

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K111858

Device Description

*Attendants are trained and certified before using the device.

The portable stair-climber LIFTKAR PT-S can be dismantled into three parts, the climber unit with integrated seat, the battery pack and the handle which includes backrest and armrest. All parts are lightweight and easy to stow away.

Product	PT-S
Technical Data
Weight (total):	67 lbs
Safe Workload (incl. chair	352 lbs persons wt.
Overall height:	44.49 inches
Overall width: (w/o armrests)	19.88 inches
Depth (footrest out)	29.3 inches
*Stair Landing minimum: stairs)	31.5 x 35.4 inches (Includes landings for all types of
Maximum Stair Height	8.25 inches
*Any Stair Type Depth:	6 inches (includes winding)
*Straight stair width:	23.81 inches (includes Liftkar plus 3.93 inches)
*Winding Stair Width:	23.81 inches from point of stair depth of 6 inches

Battery

Sealed lead gel

Capacity with fully charged batter 300-500 steps

Battery capacity

2x 12V5 ah

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KI11858

Nominal output voltage of charged

24 V

Main components: Handle, lifting device, battery

*Climbing Speeds

10 steps per minute I

14 steps per minute II

III 18 steps per minute

Continuous Mode may be used, if stairs are straight, and there is no landing. Contiuous mode is 18 steps per minute. It is recommended for professional use only.

Liftkar PT-S

Image /page/2/Picture/10 description: The image shows a stair climbing wheelchair. The wheelchair has a black seat and backrest, with armrests on either side. It has a handle at the top for pushing, and wheels at the bottom for moving. The wheelchair is designed to help people with mobility issues climb stairs.

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K11/858

Substantial Equivalence

The LIFTKAR PT™ S is substantially equivalent in intended use, design and function to the C-Max-U2 K103122 manufactured by AAT.

C-Max

Image /page/3/Picture/4 description: The image shows two different views of what appears to be a stair climbing wheelchair. The top view shows the wheelchair in its upright and functional configuration, with a seat, backrest, armrests, and wheels. The bottom view shows the wheelchair folded or collapsed, presumably for storage or transport, with the seat and backrest folded down and the frame compacted.

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్రామ 35

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KII1858

Listed Below are the similarities or differences:

Product Comparison

Weight (total):	78.7 lbs	67 lbs
Safe Workload (incl. chair)	352 lbs	352 lbs persons wt.
Overall height:	44.4 inches	44.49 inches
Overall width: (w/o armrests)	16.9 inches	19.88 inches
Depth (footrest out)	30.9 inches	29.3 inches
Stair Landing minimum:	31.5 x 35.4 inches	31.5 x 35.4 inches
Maximum Stair Height	8.26 inches	8.25 inches
Battery	Sealed lead acid	Sealed lead gel
Capacity with fully charged battery	300 steps	300-500 steps
*Speeds	8-23 steps/min	10-18 steps/min
	Continually adjustable	Continuous Mode
Battery capacity	2x 12V 5 ah	2x 12V5 ah
Nominal output voltage of charge	24V	24 V
Main components:Handle, lifting device, battery	Same	Same

C-Max-U2

PT-S

Performance Data

The LIFTKAR PT™-S was tested by BERLIN CERT Pruf und Zertifizierstelle for Medizinnprodukte GmbH an der Technischen Universitat Berlin, TEST Reports in Section: 11.7-32

LIFTKAR PT -S conforms with the following standards :

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

Biocompatibility DIN EN ISO 10993-5 Biological Evaluation and testing of Cytotoxicity

The performance Data results of the testing confirm that the device meets specifications for 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™ -S is substantially equivalent to the legally marketed device, C-Max K103122

Since the device is essentially the same as the powered patient transporter already marketed, (C-Max K103122), no effect on the safety and or effectiveness of the device is expected.

Denotes corrections made or added relating to 9.28.11 from FDA re: K111858 Liftkar PT-S (Also underlined)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. To the left of the bird symbol is text arranged in a circular pattern, spelling out "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

SANO Transportgeracte GmbH % Mobility Lifter, LLC Ms. Jeanine A. Carroccio 4028 Belleaire Lane Downers Grove, Illinois 60515

NOV - 4 2011

Re: K111858

Trade/Device Name: LIFTKAR PT™-S Regulation Number: 21 CFR 890.5150 Regulation Name: Powered patient transport Regulatory Class: II Product Code: ILK Dated: September 28, 2011 Received: October 12, 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Ms. Jeanine A. Carroccio

CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-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 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Eric Keith

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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510(k) Number: 《11858

Device Name: LIFTKAR PT™-S

Indications For Use:

Prescription Use	_______________
------------------	-----------------

AND/OR

Over-The-Counter Use___X__

(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)

sion Sign-Off

(Divisio (Division Sign of Surgical, Orthopedical Division.
and Restorative Devices

510(k) Number K111858

Regulation Number and Section

§ 890.5150 Powered patient transport.

(a)
Powered patient stairway chair lifts —(1)Identification. A powered patient stairway chair lift is a motorized lift equipped with a seat and permanently mounted in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by moving a person up and down a stairway.(2)
Classification. Class II. The stairway chair 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 American Society of Mechanical Engineers (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 chair in the event of a device failure;
(ii) Appropriate analysis and nonclinical testing must demonstrate the ability of the device, including armrests, to withstand the rated load with an appropriate factor of safety;
(iii) Appropriate restraints must be provided to prevent the user from falling from the device (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”);
(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; and
(v) Appropriate analysis and nonclinical testing must demonstrate the resistance of the device upholstery to ignition.
(b)
All other powered patient transport —(1)Identification. A powered patient transport is a motorized device intended for use in mitigating mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs (e.g., attendant-operated portable stair-climbing chairs). This generic type of device does not include motorized three-wheeled vehicles or wheelchairs.(2)
Classification. Class II.