The Rupiani Weely Manual Wheelchair (Weely) is a manually operated, user propelled, manual, mechanical wheelchair. It's intended function and use is to provide mobility to persons limited to a sitting position. It may also be used in as an attendant propelled transport device in a health care environment such as a hospital, nursing home or extended care facility.

The Weely consists primarily of an upper and lower frame assembly, upholstery for seating, large wheels for propelling the chair and rear swivel type pivoting casters for turning. The wheels and casters are mounted to the lower frame assembly. The wheelchair seat and back mount to the upper frame assemblies are constructed from aluminum tubing. The rear casters act as "anti-tippers and provide added stability

The lower frame is of rigid (non-folding) design. The back rest can be folded to allow for storage and transport of the chair when it is not in use. The Weely is equipped with a Varilite rigid backrest and a Varilite EVOLUTION cushion covered by SooFleece III mesh fabric provided by Ventex. The upholstery materials meet the requirements of ISO 8191-1 Part 1:Ignition Source: Smoldering Cigarette and - ISO 8191-2 Part 2: Ignition Source: Flame Match-Flame Equivalent Standard for Resistance to Ignition of Upholstered Parts.

The Weely includes a tilt mechanism which allows the seat and back of the wheelchair to be tilted. This feature is used to provide comfort to those users who may be confined to the wheelchair for extended periods of time. The tilt mechanism can also serve as an attendant aid in those situations where a patient needs to be tilted for attendant access.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "Weely Manual Wheelchair." This document focuses on demonstrating substantial equivalence to a predicate device (PDG Fuze T50 Manual Wheelchair) rather than detailing a specific study to prove the device meets acceptance criteria in the context of an AI/algorithm-driven imaging device.

Therefore, many of the requested categories (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set sample size, and how training ground truth was established) are not applicable to this document as it describes a mechanical wheelchair, not an AI or algorithm-based diagnostic or prognostic device.

However, I can extract information related to acceptance criteria (in this context, performance standards) and how the device meets them based on the provided text.

Here's the information that can be extracted:

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

Acceptance Criteria (Standard Tested)	Reported Device Performance (Weely Manual Wheelchair)
ISO 7176-1:1999 Determination of Static Stability	Tested to and meets this standard.
ISO 7176-3:2012 Determination of Effectiveness of Brakes	Tested to and meets this standard.
ISO 7176-5:2008 Determination of Overall Dimensions, Mass and Maneuvering Space	Tested to and meets this standard.
ISO 7176-7:1998 Determination of Seating and Wheel Dimensions	Tested to and meets this standard.
ISO-7176-8:1998 Requirements and Test Method for Static Impact and Fatigue Strength	Tested to and meets this standard.
ISO 7176-13:1989 Determination of Coefficients of Friction of Test Surfaces	Tested to and meets this standard.
ISO 7176-15 Requirements for Information Disclosure, Documentation and Labeling	Tested to and meets this standard.
ISO 8191-1: 1987 Furniture Assessment of the Ignitability of Upholstered Furniture (Part 1:Ignition Source: Smoldering Cigarette)	Upholstery materials meet this requirement.
ISO 8191-2: 1989 Furniture Assessment of the Ignitability of Upholstered Furniture (Part 2: Ignition Source: Flame Match-Flame Equivalent)	Upholstery materials meet this requirement.
FDA guidance document: "Guidance Document for the Preparation of Premarket Notification [(510(k)] Applications Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles"	Conforms with these requirements.
Maximum Patient Weight Capacity	Weely: 280 lbs. (Predicate: 250 lbs.). Both products are labeled with their maximum weight limit, and the difference "has no effect on safety or effectiveness."
Seat to Floor Height	Weely: 16.5" - 18.5" (Predicate: 13"-20"). "No difference. The Weely is within the same range as the Fuze."
Seat Width	Weely: 15", 17" and 19" (Predicate: 15" - 20"). "No difference. The Weely is within the same range as the Fuze."
Seat Depth	Weely: 17" - 22" (Predicate: 15"-20"). The Weely is "slightly wider due to its' higher weight limitation for which it is labeled. Chair width does not affect safety or effectiveness. It indicates that the Weely will accommodate slightly larger patients."
Overall Length	Weely: 46" with footrest (Predicate: 45" with footrest). "A one inch difference in overall length does not affect safety or effectiveness."
Tilt Range	Weely: Zero to 35 degrees (Predicate: Zero to 50 degrees). "No difference. The Weely is within the same range as the Fuze."
Front Caster	Weely: 6" (Predicate: 5",6" or 8"). "No difference. Both offer 6" diameter casters."
Large Wheel	Weely: 12", 22" or 24" (Predicate: 12", 16", 20", 22", or 24"). "No difference. The Fuze offers more sizes however the Weely sizes are with the range of the Fuze."

2. Sample size used for the test set and the data provenance:

Not Applicable. This document describes performance testing for a mechanical device against international standards, not a clinical study with a test set of data. The "test set" in this context refers to the physical wheelchair being tested in accordance with the listed ISO standards. No specific sample size of devices is mentioned, but typically such testing would involve one or more units of the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. Ground truth in the context of an AI/algorithm is not relevant here. The "ground truth" for a mechanical device is its adherence to engineering specifications and performance under standardized test conditions, as defined by organizations like ISO.

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

Not Applicable. Adjudication methods are for assessment of human or AI interpretation of data, which is not relevant to this mechanical device.

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 mechanical device, 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 is a mechanical device, not an algorithm.

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

Not Applicable directly in the AI/algorithm sense. For a mechanical device, the "ground truth" is established by adherence to universally accepted engineering and performance standards (e.g., ISO standards for wheelchair stability, brake effectiveness, material ignitability, etc.) validated through physical testing.

8. The sample size for the training set:

Not Applicable. This is a mechanical device; there is no "training set."

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

Not Applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a design that resembles an abstract bird or wing above them.

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

February 19, 2016

Rupiani % Edward A. Kroll President Spectre Solutions, Inc. 5905 Fawn Lane Cleveland, Ohio 44141

Re: K152827

Trade/Device Name: Weely Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: January 13, 2016 Received: January 19, 2016

Dear Edward A. Kroll:

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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements

{1}------------------------------------------------

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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Michael J. Hoffmann -A

for

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K152827

Device Name Weely Manual Wheelchair

Indications for Use (Describe)

The indications for use for the Weelchair is to provide mobility to persons limited to a sitting position.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for RUPIANI. The logo consists of a red circle above a gray circle with a white stripe, followed by the word "RUPIANI" in red, bold letters. Below the logo is the text "510(k) Premarket Notification K152827".

RUPIANI Weely Manual Wheelchair

Rupiani Weely Manual Wheelchair 510(k) Summary (Modified February 12, 2016)

l. SUBMITTER

Rupiani 74, avenue du 8 mai 1945 - 69120 Vaulx en Velin - FRANCE Tel: +33(0)4 37 45 02 54 Fax +33(0)4 37 45 02 55 Web: www.rupiani.fr Email: info@rupiani.fr

II. DEVICE

Name of Device: Weely Manual Wheelchair Common or Usual Name: Manual Wheelchair Classification Name: Wheelchair, Mechanical (21 CFR 890.3850) Regulatory Class: I Product Code: IOR

III. PREDICATE DEVICE

PDG Product Design Group Fuze T50 Manual Wheelchair (K063736)

IV. DEVICE DESCRIPTION

Device Description:

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image contains the logo for RUPANI. The logo consists of a stylized letter "i" on the left and the word "RUPIANI" on the right. The "i" is a sphere with a red dot on top and a gray stripe running through it. The word "RUPIANI" is in red and is in a bold sans-serif font.

provided by Ventex. The upholstery materials meet the requirements of ISO 8191-1 Part 1:Ignition Source: Smoldering Cigarette and - ISO 8191-2 Part 2: Ignition Source: Flame Match-Flame Equivalent Standard for Resistance to Ignition of Upholstered Parts.

Device Function

Device function is dependent solely upon the wheelchair user or caregiver. It does not function on its' own in any manner. The wheelchair user or caregiver controls motion, speed and direction by propelling themselves using the hand rims located on the rear wheels.

Scientific Concepts

There are no complex scientific concepts related to the Weely manual wheelchair. It is a simple, basic, manually operated mobility device.

Significant Physical and Performance Characteristics:

Design:

The Weely manual wheelchair consists primarily of an upper and lower frame assembly, upholstery for seating, large wheels for propelling the chair and rear swivel type pivoting casters for turning. The rear casters also serve as an "anti-tipper" system which minimizes the potential for the chair to tip over backwards. The wheels and casters are mounted to the lower frame assembly. The wheelchair seat and back mount to the upper frame assembly. Both frame assemblies are constructed from aluminum tubing.

The Weely features a tilt mechanism which allows the seat and back of the wheelchair to be tilted. This feature is used to provide comfort to those users who may be confined to the wheelchair for extended periods of time. The tilt mechanism can also serve as an attendant aid in those situations where a patient needs to be tilted for attendant access.

Materials:

Materials used are:

. Aluminum frame, support members, wheels and components
Steel fasteners and components
Rubber and Polyurethane tires
. Fabric covered foam upholstery

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image contains the logo for RUPANI. The logo consists of a stylized letter "i" with a red dot on top, followed by the word "RUPIANI" in red, bold letters. The logo is set against a white background.

Physical Properties:

The Weely manual wheelchair consists primarily of an aluminum frame assembly, a back rest frame, seat and back rest upholstery, large rear wheels with hand rims for self-propelling the chairs and front and rear swivel pivoting casters for turning.

V. INDICATIONS FOR USE

The indications for Use for the Weely Manual Wheelchair are to provide mobility to persons limited to a sitting position. This identical to the predicate device.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The technology and principle of operation for the Weely and the Fuze T50 are identical. They both consist of aluminum frames with a seat and large wheels with hand rims for propelling the device. Smaller, pivotinq type casters are mounted on the front of the chairs for steering and turning.

Device function is dependent solely upon the wheelchair user or the caregiver. They do not function on their own in any manner. The wheelchair user or caregiver controls motion, speed and direction by propelling the wheelchair.

If both rear wheels are propelled at the same time, the chair will move forward in a straight direction. If only the left rear wheel is propelled the chair will turn to the right. If only the right rear wheel is propelled the chair will turn to the left.

The tilt feature is manually operated and is activated by two release levers located at the rear of the wheelchair. It utilizes standard gas springs for maintaining the static position of the chair. The tilt angle is adjusted by squeezing the levers inward simultaneously until the desired tilt angle has been reached. Once any of the two levers are released, the chair will remain at the angle chosen.

Discussion of Similarities and Differences:

The Weely manual wheelchair is substantially equivalent to the predicate PDG Fuze T50 wheelchair (K063736) in technology, function, performance and materials. It has the same indications for use which is to provide mobility for persons restricted in a sitting position.

The frame width, depth and the back cane heights vary slightly between the devices, but since these are only used to better fit the device to the user's needs, these slight differences do not cause any concerns for the safety and effectiveness of the weight limit differs slightly as the maximum patient weight for the Weely is 280 lbs. where the predicate is 250 lbs. This difference has no effect on safety or effectiveness and both devices are clearly labeled with maximum patient weight capacity.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Rupiani. The logo consists of a red sphere above a gray sphere with a white line running through it on the left side. To the right of the sphere is the word "RUPIANI" in red, bold letters.

With regard to accessories and add-ons, both devices offer the same types of armrests, backrests, hangers and footplates. These accessories are made of the exact same materials for both devices and thus do not raise any questions for the safety and effectiveness of the Weely wheelchairs.

VII. PERFORMANCE DATA

The Weely Manual Wheelchairs have been tested to the following standards;

ISO 7176-1:1999 Determination of Static Stability
ISO 7176-3:2012 Determination of Effectiveness of Brakes
ISO 7176-5:2008 Determination of Overall Dimensions, Mass and Maneuvering
Space
ISO 7176-7:1998 Determination of Seating and Wheel Dimensions
ISO-7176-8:1998 Requirements and Test Method for Static Impact and Fatique Strength
ISO 7176-13:1989 Determination of Coefficients of Friction of Test Surfaces
ISO 7176-15 Requirements for Information Disclosure, Documentation and Labeling
ISO 8191-1: 1987 Furniture Assessment of the Iqnitability of Upholstered Furniture (Part 1:Ignition Source: Smoldering Cigarette)
ISO 8191-2: 1989 Furniture Assessment of the Ignitability of Upholstered Furniture (Part 2: Ignition Source: Flame Match-Flame Equivalent)

The performance data published by PDG Product Design Group states that PDG Wheelchairs are tested to ISO Standards. Test reports are published on the PDG web site but cannot be reproduced without permission.

The Fuze T50 510(k) Summary states that the Fuze T50 has been tested to and meets the requirements of ISO 7176 Determination of Static Stability. Further, manual wheelchairs are subject to the 1995 FDA quidance document entitled: "Guidance Document for the Preparation of Premarket Notification [(510(k)] Applications Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles."

This quidance includes various safety and performance requirements that the Fuze T50 would have to have met or addressed prior to being cleared by FDA. Meeting these requirements also serves as a basis for substantial equivalence of the Weely to its' predicate.

VIII. CONCLUSIONS:

Based on the above discussion, Rupiani believes that the Weely wheelchair is substantially equivalent to the PDG Fuze T50 (K063736). While there are some differences between the Weely and its predicate, these differences are minor and do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness.

Performance testing and compliance with FDA guidance for manual wheelchairs supports the safety of the Weely manual wheelchairs. Since the predicate device was cleared based in part on

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image features the logo for RUPIANI, with a stylized icon to the left and the company name in bold, red letters to the right. The icon consists of a gray sphere with a curved, dark gray line running through it, topped with a red dot. A thin, red line runs along the bottom edge of the logo, providing a subtle border.

510(k) Premarket Notification K152827

these data, conformance with the same requirements demonstrate that the Weely will perform as intended in the specified use conditions.

Further, technology, principle of operation and indications for use between Weely and the Fuze T50. This demonstrates that they perform comparably to the predicate device that is currently marketed for the same intended use. Therefore, the Weely manual wheelchairs are substantially equivalent to the Fuze T50 device.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image contains the word "RUPIANI" in red, bold letters. To the left of the word is a logo that features a red dot above a gray circle with a white design inside. The logo and word are on a white background. There is a red line at the bottom of the image.

510(k) Premarket Notification K152827

RUPIANI Weely Manual Wheelchair

Feature/Specification	Fuze T50	RupianiWeely	Discussion of Differences
510(k) Accession Number	K063736	TBD	NA
Clearance Date	January 17, 2007	TBD	NA
Intended Use	To provide mobility topersons limited to aseated position	Same	No difference
Seat to Floor Height	13"-20"	16.5" -18.5"	No difference. The Weely is within the same range asthe Fuze.
Seat Width	15" - 20"	15", 17"and 19"	No difference. The Weely is within the same range asthe Fuze
Seat Depth	15"-20"	17" - 22"	The Weely is slightly wider due to its' higher weightlimitation for which it is labeled. Chair width does notaffect safety or effectiveness. It indicates that the Weelywill accommodate slightly larger patients.
Overall Length	45" with footrest	46" withfootrest	A one inch difference in overall length does not affectsafety or effectiveness.
User Weight Limit	250 lbs.	280 lbs.	This has no effect on safety or effectiveness. Bothproducts are labeled with their maximum weight limit.
Tilt Feature	Yes	Yes	No difference. Both have the tilt feature.
Tilt Range	Zero to 50 degrees.	Zero to 35degrees	No difference. The Weely is within the same range asthe Fuze
Frame Material	Aluminum	Same	No difference
Frame Type	Rigid lower frame withfolding backrest	Same	No difference
Front Caster	5",6" or 8"	6"	No difference. Both offer 6" diameter casters
Large Wheel	12", 16", 20", 22", or24"	12", 22" or24"	No difference. The Fuze offers more sizes however theWeely sizes are with the range of the Fuze.

Weely Manual Wheelchair Technological Comparison to Predicate Device

Regulation Number and Section

§ 890.3850 Mechanical wheelchair.

(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).