Winner Transfer Wheelchair

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, overlaid with three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 11, 2017 Winner Sg Pte Ltd % Diane Horwitz, Ph.D., RAC Regulatory Consultant Eminence Clinical Research, Inc. 1880 Office Club Pointe. Suite 1360 Colorado Springs, Colorado 80920 Re: K162328 Trade/Device Name: Winner Transfer Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: April 10, 2017 Received: April 12, 2017 Dear Dr. Horwitz: 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 as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the {1}------------------------------------------------ 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 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. # Michael J. Hoffmann -S 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) K162328 Device Name Winner Transfer Wheelchair Indications for Use (Describe) The Winner Transfer Wheelchair is a manually operated wheelchair that is intended for medical purposes to provide mobility to persons restricted 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}------------------------------------------------ #### 1. Submission Sponsor Winner SG Pte Ltd Michael Pang, Managing Director 14 Little Road #07-01 Tropical Industrial Building Singapore 536987 Email: michael@winner-wheelchair.com.sg Phone: +65 93635453 Owner/Operator Number: 10047779 #### 2. Submission Correspondent Eminence Clinical Research, Inc. Diane Horwitz, Ph.D., RAC 1880 Office Club Pointe Suite 1360 Colorado Springs, CO 80920 Email: dhorwitz@ecr-inc.com #### 3. Initial Importer and US Agent Prius Healthcare USA, LLC Matthew Farrell 4029 Tampa Rd suite 4000c Oldsmar, FL 34677 Phone: 813 8545464 ext. 304 Fax: 813 8545442 Email: mfarrell@priushcusa.com Registration number: 3008546725 Owner/Operator number: 10034069 #### 4. Date Prepared May 9, 2017 #### 5. Device Identification Winner Transfer Wheelchair Trade/Proprietary Name: Common/Usual Name: Mechanical Wheelchair Mechanical Wheelchair Classification Name: Classification Regulation: 890.3850 Product Code: IOR Device Class: Class I Physical Medicine Classification Panel: {4}------------------------------------------------ ### 6. Legally Marketed Predicate Device(s) Breezy Elegance Manual Folding Wheelchair, K133855, Sunrise Medical LLC #### 7. Device Description The Winner Transfer Wheelchair is a manual wheelchair used by individuals for whom walking is difficult or impossible and who need assistance in transport. The Winner Transfer Wheelchair is propelled manually by the user propelling the wheels or being pushed by an assistant. The Winner Transfer Wheelchair has the standard attributes of the predicate wheelchair, such as an aluminum frame with flip away, height adjustable and retractable armrests, an adjustable upholstered tension back and flip down back, and a swing away and removable footrest. The Winner Transfer Wheelchair has an accessory, the Kingfisher 125T Retractable Kit, which can be attached to either the left side or the right side of the Winner Transfer Wheelchair. The Retractable Kit serves to allow the rear wheel to be retracted (moved back in a linear motion), thereby opening the side distance in front of the wheel to permit easier lateral transfer. Whereas in most wheelchairs, the rear wheel is obstructing placement of a Transfer Board which is often used during lateral transfer. When the rear wheel is retracted using the Kingfisher 125T Retractable Kit, it is easier for the user to positioning the transfer board. The base wheelchair can be fitted with a left or right retractable kit. #### 8. Indication for Use Statement The Winner Transfer Wheelchair is a manually operated wheelchair that is intended for medical purposes to provide mobility to persons restricted to a sitting position. #### 9. Substantial Equivalence Discussion The following table compares the Winner Transfer Wheelchair to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence. {5}------------------------------------------------ ## Table 1. Comparison of Characteristics | Manufacturer | Predicate Device<br>Breezy Elegance Manual<br>Folding Wheelchair<br>(K133855)<br>Sunrise Medical | Subject Device<br>Winner Transfer Wheelchair<br>K162328<br>Winner SG G Pte Ltd/<br>A & I Industries | Same or Different<br>(Reason that difference does<br>not impact safety or<br>effectiveness) | |--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | IOR | IOR | Same | | Regulation Number | 890.3850 | 890.3850 | Same | | Regulation Name | Mechanical Wheelchair | Mechanical Wheelchair | Same | | Intended Use /<br>Indications for Use<br>Statement | Breezy Elegance Folding<br>Manual Wheelchairs are<br>manually operated devices<br>with wheels that are intended<br>for medical purposes to<br>provide mobility to persons<br>restricted to a sitting position. | The Winner Transfer Wheelchair is a<br>manually operated wheelchair that<br>is intended for medical purposes to<br>provide mobility to persons<br>restricted to a sitting position. | Similar Intended Use and<br>Indications for Use. Both<br>devices have the same general<br>purpose and both devices are<br>used for subjects with similar<br>mobility with one additional<br>functionality. | | Use Environment | Healthcare Setting or Home;<br>inside or outside | Healthcare Setting or Home; inside<br>or outside | Same | | Patients | Individuals who cannot walk<br>for long distances | Individuals who cannot walk for long<br>distances | Same | | Movement from<br>Wheelchair to Bed or<br>Other Surface | Lateral transfer using transfer<br>board for assistance | Lateral transfer using transfer board<br>for assistance<br>Easier process due to Kingfisher<br>Retractable Kit accessory | Similar but easier transfer with<br>wheel retracted with the<br>Subject Device | | DIMENSIONS, WEIGHT AND WEIGHT LIMITATION | | | | | Front Seat to Floor<br>Height | 17 in. (43 cm) expandable to<br>20 in. (51 cm) | 19.7 in. (500 mm) | Similar | | Front Wheel<br>Diameters | 8 in. x 1.3 in. | 7.9 in. x 2 in. (200 mm x 50 mm) | Similar | | Rear Wheel<br>Diameters | 24 in. x 1 in. (61 cm x 2.5 cm) | 24 in. x 1 in. (61 cm x 2.5 cm) | Same | | Seat Width | 16 in. or 18 in. (41 cm or 46<br>cm) | 17.7 in. (450 mm) | Similar | | User Weight Limit | 275 lbs. (125 kg) | 275 lbs. (125 kg) | Same | | Chair Weight | 32 lbs. (16 kg) | 39.7 lb. to 52.9 lb. (18 kg to 24 kg),<br>including accessories (retractable<br>wheel(s)) | The retractable wheel<br>accessory weighs 8.4 lb. (3.8<br>kg) | | Backrest Angle | 80° | 75° | Similar angle; allows for<br>comfortable seating of user | | MATERIAL | | | | | Frame Material | Aluminum | Aluminum | Same | | Upholstery | Polyurethane Foam<br>with Nylon Cover | Polyurethane Foam<br>with Nylon Cover | Same | | Hand Rims | Aluminum Tubing | Aluminum | Same | | Manufacturer | Predicate Device<br>Breezy Elegance Manual<br>Folding Wheelchair<br>(K133855)<br>Sunrise Medical | Subject Device<br>Winner Transfer Wheelchair<br>K162328<br>Winner SG G Pte Ltd/<br>A & I Industries | Same or Different<br>(Reason that difference does<br>not impact safety or<br>effectiveness) | | FEATURES | | | | | Foldable | Yes | Yes | Same | | Legrests and<br>Footplates | Adjustable and removable. | Adjustable and removable. | Same | | Retractable Rear<br>Wheels | Non-retractable | Yes | Difference does not raise<br>safety or effectiveness<br>concerns based on the ISO<br>testing: 7176-1, 7176-8 | {6}------------------------------------------------ #### 10. Non-Clinical Performance Data Mechanical Wheelchairs (21 CFR 890.3850, Product Code IOR) have the following applicable guidance document on which this submission was based: - Guidance Document for the Preparation of Premarket Notification [510k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles, July 26, 1995. Recognized consensus standards for Product Code IOR, Mechanical Wheelchairs, have been used in the design and testing of the device. The Winner Transfer Wheelchair with the Kingfisher 125T accessory were tested to and comply with the following listed recognized consensus standards. - ISO 7176-1:2014 Determination of Static Stability ● - ISO 7176-3:2012 - Determination of Effectiveness of Brakes - ISO 7176-5:2008 - Determination of Dimensions, mass and maneuvering space - ISO 7176-7:1998 Measurement of Seating and Wheel Dimensions ● - . ISO 7176-11:2012 – Test Dummies - . BS EN 12183:2014 – Manual Wheelchairs – Requirements and Test Method, with Normative References to the following to demonstrate individual aspects of safety, effectiveness, and substantial equivalence of the Winner Transfer Wheelchair: - EN 1021-2: 2006, Furniture Assessment of the ignitability of upholstered o furniture - Part 2: Ignition source match flame equivalent and ISO 8191-2. - ISO 7176-8: 1998, Wheelchairs Part 8: Requirements and test methods for static, o impact and fatigue strengths - ISO 7176-13: 1989, Wheelchairs Part 13: Determination of coefficient of friction o of test surfaces - ISO 7176-15: 1996, Wheelchairs Part 15: Requirements for information o disclosure, documentation and labelling - ISO7176-16: 2012 (Annex A) Resistance to ignition of postural support devices O - ISO 7176-22: 2000, Wheelchairs Part 22: Set-up procedures O {7}------------------------------------------------ As part of demonstrating safety and effectiveness of Winner Transfer Wheelchair and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Winner SG Pte Ltd completed performance tests per the International Standards above. The Winner Transfer Wheelchair meets all the requirements for overall design and confirms that the output meets the design inputs and specifications. The Winner Transfer Wheelchair passed all testing stated above as shown by the acceptable results obtained. ## 11. Clinical Performance Data There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device. ## 12. Statement of Substantial Equivalence By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Technological improvements may add new features, however base technological characteristics should be equivalent and no new questions should be raised regarding its safety and effectiveness. The Winner Transfer Wheelchair device shares the same base indications for use, device operation, overall technical and functional capabilities as the predicate device, and both the Winner Transfer Wheelchair with the Kingfisher 125T Retractable Kit as well as the predicate device meet product specifications and international performance standards. The addition of the Kingfisher 125T Retractable kit does not present any new issues around safety during wheelchair use, as the wheels are not retracted while the wheelchair is being driven. The Winner Transfer Wheelchair is identical in design and function to the predicate device for the all basic expected modes of operation and use and only differs with the addition of the retractable wheel. As all items are identical with only the added convenience functionality it is concluded that the Winner Transfer Wheelchair is substantially equivalent to the predicate device.