(87 days)
Not Found
No
The description focuses on mechanical and battery-powered lifting mechanisms, with no mention of AI/ML terms or functionalities.
No.
The device is described as a mobile lifting device to transport a wheelchair user up or down stairs, essentially a mobile stair-climber for mobility, not to treat or diagnose a medical condition.
No
The device is described as a mobile lifting device for transporting wheelchair users up or down stairs, which is a functional purpose, not a diagnostic one.
No
The device description clearly outlines a physical, battery-powered lifting device with mechanical components (climber unit, battery pack, handle). The performance studies also reference testing against physical standards for wheelchairs and stair-climbing devices, indicating a hardware-based device.
Based on the provided information, the LIFTKAR PT™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to transport people up and down stairs. This is a physical assistance device, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description details a mechanical lifting device. There is no mention of analyzing biological samples or performing any kind of diagnostic test.
- Lack of IVD-specific information: The document does not contain any of the typical information associated with IVD devices, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection of analytes or biomarkers
- Diagnostic claims
- Performance metrics like sensitivity, specificity, etc. (which are relevant to diagnostic accuracy)
- Relevant Standards: The standards listed (ISO 7176 series, EN 12184) are related to wheelchairs and mobility devices, not IVD devices.
The LIFTKAR PT™ is clearly a medical device, but it falls under the category of a mobility or assistive device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 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.
Product codes
ING
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
An attendant operating the device. Residential and public facilities indoors and outside.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
ISO 7176-6:2001 Wheelchairs Determination of maximum speed, acceleration and deceleration of electric wheelchairs
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
ISO 7176-15:1996 Wheelchairs Requirements for Information disclosure, documentation and labeling.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Scalamobil (K920105)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
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.
1
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.
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.
2
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
3
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
4
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
5
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
6
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