ThyssenKrupp Accessibility's Battery Operated Stair Lift FLOW2 is intended to mechanically transport one mobility impaired person in a fold-down seat, up and down curved stairs, indoors.

Device Description

Flow2 mono rail chairlift brings one person safely and comfortably up and down the stairs. In the meantime one saves ones energy for long outdoor walks, playing with the children or the daily tasks in house.

Flow2 is capable to swivel during the ride up and down the stairs. This unique and patented feature makes that Flow2 chairlift fits most staircases, straight, around corners and even spiral. The angle of the staircase can vary from -70 degrees up to 70 degrees.

The footrest is mounted directly to the chair. This provides a comfortable and ergonomic seating position of the user with less knee flexion.

Flow2 is easy to use by a simple and light folding operation and the intuitive to use joystick control. Features such as anti squeeze, curved armrest and safety belt provide additional safety for the user and other inhabitants of the home.

The design can be adapted to the home decor by the application of a variety of different seat fabrics and colors. Flow2 is the chairlift on the market which combines the best of 2 worlds; capable to fit on the smallest stairs while transporting the user in the most comfortable and safe way.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the ThyssenKrupp Accessibility FLOW2 stair lift:

This 510(k) summary does not contain a traditional performance study comparing the device to acceptance criteria with detailed metrics like sensitivity, specificity, accuracy, or confidence intervals. Instead, it relies on a substantial equivalence approach by comparing the FLOW2 to a predicate device (Bruno CRE-2110 Electra-Ride) and demonstrating compliance with relevant international standards.

For medical devices, especially those that are electromechanical and not diagnostic in nature, "acceptance criteria" often refer to meeting established safety and performance standards, and demonstrating that the new device is as safe and effective as a legally marketed predicate.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

For devices like a stair lift, acceptance criteria often relate to meeting specific safety standards, load capacities, speed limits, and other functional aspects. The "reported device performance" is essentially that the device meets these standards and is comparable to the predicate.

Acceptance Criteria / Standard	Reported Device Performance (FLOW2)	Predicate Device (Bruno CRE-2110 Electra-Ride)
General Safety and Performance Standards	Compliant with ASME 18.1, IEC 60601-1-2:2007 (Certified by ETL and Lift Institute)	Compliant with ASME 18.1, IEC 60601-1-2:2007
Intended Use	Mechanically transport one mobility impaired person in a fold-down seat, up and down curved stairs, indoors.	Mechanically transport one mobility impaired person in a fold-down seat, up and down stairs, indoors. (Implied for curved stairs as well given "Straight and Curved stairs" application)
Rated Load (Maximum)	275 lb (125 kg)	400 lb (181 kg)
Passengers	1	1
Power Supply	2 pieces 7AH 12 Battery	2 pieces 7AH 12 Battery
Charger	24VDC/ 2A	24VDC/ 2A
Drive Mechanism	Planetary motor with worm gear	Direct drive worm gear motor
Final Drive	Lasered rack and pinion	8dp gear rack with spur gear
Braking System	Dynamic, worm gear, el/mech brake	Dynamic, worm gear, el/mech brake
Call & Send Functionality	RF	RF
Support/Mounting	Anchored to stair thread	Anchored to stair thread
Maximum Stair Angle	70 degrees	50 degrees
Speed	0.15 m/s	0.13 m/s
Track Length (Maximum)	34 m	15 m
Safety Devices	Multiple	Multiple
Footrest Type	Folding type	Folding type
Seat Type	Folding type	Folding type
Control Mechanism	3 position switched RF unit	3 position momentary rocker switch
Construction Material	Bended round steel tube 80mm	Steel welded shape
Leveling Mechanism	Patented electronic leveling (multiple sensor controlled)	Mechanically forced
Swiveling Mechanism	Patented "en route" swiveling	End of rail

Note on Acceptance Criteria: For this type of device and submission, the primary "acceptance criteria" are the successful demonstration of substantial equivalence to a predicate device and compliance with recognized consensus standards (ASME 18.1, IEC 60601-1-2:2007). The "reported device performance" is essentially that the device meets these standards and its characteristics are within an acceptable range compared to the predicate, even where there are non-equivalent technological characteristics. The non-equivalent characteristics were discussed to show they do not raise new questions of safety or effectiveness.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable in the context of a clinical trial or performance study with a test set of data. The submission relies on engineering testing and comparison to standards and a predicate device.
Data Provenance: Not applicable for clinical data. The data provenance is from engineering and safety standard testing conducted by organizations like ETL and Lift Institute. The country of origin of the manufacturer is The Netherlands.

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)

Not applicable. This is not a diagnostic device requiring expert interpretation for ground truth establishment. Third-party testing and certification bodies (ETL, Lift Institute) verified compliance with safety and performance standards. Their "expertise" for this type of device lies in their accreditation to test against these specific standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no "test set" of clinical cases requiring adjudication. Compliance was determined by accredited testing laboratories against engineering standards.

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

No MRMC study was done. This device is a mechanical stair lift, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a mechanical device with human users, not an algorithm. Its operation involves human interaction (joystick control) for its intended function. The "standalone" performance would be its mechanical and electrical function independent of a specific user, verified by engineering tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this submission is established by compliance with international consensus safety and performance standards (ASME 18.1, IEC 60601-1-2:2007) as verified by accredited testing bodies (ETL, Lift Institute). For mechanical devices, this often involves physical load testing, endurance testing, electrical safety testing, and functional assessments without human subjects.

8. The sample size for the training set

Not applicable. There is no AI component or "training set" for this device.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Summary

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K121561
PAGE 1 OF 3

OCT 2 6 2012

510(k) SUMMARY as required by section 807.92(c)

Submitted by:	ThyssenKrupp Accessibility BVVan Utrechtweg 992921 LN Krimpen aan den IjsselThe Netherlands
Contact:	Arnold van der HeidenMail: avanderheiden@tkacc.nlTel: +31 180 530900Fax: +31 180 530901
Date prepared:	05/21/2012
Trade Names:	FLOW2/ SWING
Common Device Name:	Battery Operated Stair Lift for Curved Stairs
Regulation Number	890.5150
Class	II
Product Code:	ILK
Submission	K121561
Predicate Device:	Stair Lift BRUNO Independent Living Aids INCK970927CFR 890.5150

Promotional Product Description

The footrest is mounted directly to the chair. This provides a comfortable and ergonomic seating position of the user with less knee flexion.

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Intended Use

. ThyssenKrupp Accessibilty's Battery Operated Stair Lift is intended to mechanically transport one mobility impaired person in a fold-down seat, up and down curved stairs, indoors.

Product Comparison Tables

Equivalent Technological Characteristics

	Bruno CRE-2110 Electra-Ride	ThyssenKrupp Accessibility Flow2
Standards	ASME 18.1, IEC 60601-1-2:2007	ASME 18.1, IEC 60601-1-2:2007
Application	Straight and Curved stairs	Straight and Curved stairs
Rated Load	400 lb (181 kg) maximum	275 lb (125 kg) maximum
Passengers	1	1
Power	2 pieces 7AH 12 Battery	2 pieces 7AH 12 Battery
Charger	24VDC/ 2A	24VDC/ 2A
Drive	Direct drive worm gear motor	Planetary motor with worm gear
Final Drive	8dp gear rack with spur gear	Lasered rack and pinion
Braking	Dynamic, worm gear, el/mech brake	Dynamic, worm gear, el/mech brake
Call & Send	RF	RF
Supports	Anchored to stair thread	Anchored to stair thread
Angle	50 degrees	70 degrees
Speed	0.13 m/s	0.15 m/s
Track length	15 m	34 m
Location	Designed to contour of stairway	Designed to contour of stairway
Safety devices	Multiple	Multiple
Footrest	Folding type	Folding type
Seat	Folding type	Folding type

Non Equivalent Technological Characteristics

	Bruno CRE-2110 Electra-Ride	ThyssenKrupp Accessibility Flow2
Control	3 position momentary rocker switch	3 position switched RF unit
Construction	Steel welded shape	Bended round steel tube 80mm
Leveling	Mechanically forced	Patented electronic leveling
Swiveling	End of rail	Patented "en route" swiveling

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Product Comparison Discussion

Bruno's Electra Ride and ThyssenKrupp Accessibility's Flow2 show substantial equivalence on most standard features and characteristics.

Both products follow the contour of the stairway by a customer specific design, the . only difference in this aspect is that Bruno applies a steel welded shape while ThyssenKrupp uses a bended round steel tube.
Both products provide levelling of the chair during the ride, the only difference in this . aspect is that the Bruno chair is forced mechanically in horizontal position while ThyssenKrupp applies a patented multiple sensor controlled electronic levelling system
Both products provide swivelling of the chair for easy getting on and off the chair, the . only difference in this aspect is that ThyssenKrupp provides patented "en route" swivelling to allow installation at narrow staircases

ThyssenKrupp Accessibility's Flow2 mainly shows non equivalence with Bruno's Electra Ride on electronic control. The system - electronics included - is certified by ETL and Lift Institute as stated by the ETL Listing Report and Lift Institute Type Approval, based on international stair lift standards.

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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 stylized eagle with three stripes forming its body and wing. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

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

Thyssenkrupp Accessibility B.V. % Mr. Arnold Heiden Technical Advisor Van Utrechtweg 99 Krimpen aan den lissel Zuid-Holland, Netherlands 2921 LN

Re: K121561

Trade/Device Name: FLOW2 Regulation Number: 21 CFR 890.5150 Regulation Name: Powered patient transport Regulatory Class: Class II Product Code: ILK Dated: October 23, 2012 Received: October 25, 2012

OCT 26 2012

Dear Mr. Heiden:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Mr. Arnold Heiden

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/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,

Mark H. Milliman

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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Indications for Use

510(k) Number (if known): _ K121561

Device Name: FLOW2

Indications for Use:

ThyssenKrupp Accessibility's Battery Operated Stair Lift FLOW2 is intended to mechanically transport one mobility impaired person in a fold-down seat, up and down curved stairs, indoors.

NO Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use YES AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

and the same of the same of the same and the many of the many of the many comments of the many of the many of the many of the many of the many of the many of the many of the

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K121561

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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.