Stellar LEAP

{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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 27, 2017 Pdg Product Design Group, Inc % Georgiann Keyport Senior Partner Canopy Medical LLC 1160 Vierling Drive Shakopee, Minnesota 55379 Re: K163432 Trade/Device Name: Stellar LEAP Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: May 29, 2017 Received: June 2, 2017 Dear Georgiann Keyport: 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) K163432 Device Name Stellar LEAP Indications for Use (Describe) The Stellar LEAP Manual Tilt Wheelchair is intended to provide mobility to persons restricted to a seated 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}------------------------------------------------ # 510(K) SUMMARY - K163432 ## Date Prepared: June 26th, 2017 | 510(k) Submitter | Contact | |---------------------------------|--------------------------------------------------| | PDG Product Design Group Inc. | Contact: | | 103-318 East Kent Ave. South | Torr Brown, Chief Engineer | | Vancouver, CA-BC CANADA V5X 4N6 | Tel: 604-323-9220; Fax: 604-323-9097 | | | Email: tbrown@pdgmobility.com | | General Information | | | Trade Name | Stellar LEAP | | Common Name | Manual Tilt Wheelchair | | Classification | Mechanical wheelchair (21 CFR 890.3850; Class I) | | Information | ProCode: IOR; Panel: Physical Medicine | | Predicate Device(s) | The Stellar Tilt (K990557) | | Reference Device (s) | PDG Elevation Manual Wheelchair (K140023) | #### 1.1 Device Description The Stellar LEAP manual tilt wheelchair is an indoor / outdoor, manually operated, Tilt-in-Space wheelchair. Its intended function and use is to provide mobility to persons ages 16 and up (adolescents and adults). The Stellar LEAP manual tilt wheelchair consists of metal frame architecture with a backrest, seat, and rear wheels, which allow for occupant or attendant propelling of the device. Smaller caster wheels are also mounted on the front of the frame to facilitate steering and turning. The Stellar LEAP consists of three (3) metal frame subassemblies: a lower frame, upper seat frame, and sub-frame assembly. The manual Tilt-in-Space operation is achieved using a gas strut mechanism connected between the upper seat frame and sub-frame. The Stellar LEAP Manual Tilt Wheelchair is available in a standard configuration, which allows 20° Tilt-in-Space (posterior) tilt, with a maximum weight capacity of 250 lbs. PDG offers optional features / options to be added to the Stellar LEAP wheelchair, including the two below features: - Stellar LEAP Anterior Tilt Feature (0° 30°): Functional reach extension & transfer . assist - Stellar LEAP Dynamic Recline Backrest Tilt Feature: 30° range of dynamic recline for the backrest combined with the anterior tilt {4}------------------------------------------------ Other available options / accessories to complete the Stellar LEAP configuration include: seat width / depth / height, armrests, casters, frog leg suspension forks, rear wheel / tire, hand rim, wheel locks, anti-tippers, back post style, back options, back upholstery, headrest, tilt control, recline control, front rigging, foot plates, footrest / leg rest accessories, position straps, IV pole, 02 holder. #### 1.2 Intended Use / Indications The Stellar LEAP wheelchair is intended to provide mobility to persons restricted to a seated position. The Indications for Use statement for the Stellar LEAP is identical to the predicate device, the Stellar Tilt. Both the subject and predicate devices have the same intended use for providing mobility to persons restricted to a seated position. #### 1.3 Substantial Equivalence Comparison The Stellar LEAP and predicate Stellar Tilt wheelchairs have the same basic design, principle of use and intended use / indications. The subject and predicate devices share similar dimensions, weight, and both offer posterior Tilt-in-Space capability. The overall dimensions, seat width, seat depth, and adjustable seat to floor height for both the subject and predicate wheelchairs are very similar. The subject, predicate and reference device differ in their frame design, materials of construction, and tilt features, however the overall function of the wheelchairs are similar. The predicate device does not include the anterior tilt feature, thus the reference device K140023 has been included in the comparison below. | Comparison of Technological characteristics with the Predicate Device and Reference<br>Device. | | | | | |------------------------------------------------------------------------------------------------|-------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------| | | Subject Device<br>Stellar LEAP | Predicate Device<br>Stellar Tilt<br>(As cleared under<br>K990557) | Reference<br>Device<br>Elevation<br>(As cleared under<br>K140023) | | | Characteristic | Dimension/Weight | Dimension/Weight | Dimension /<br>Weight | | | Seat width | 14" - 22" | 14" - 22" | 12" - 19" | | | Seat depth | 16" - 22" | 16" - 22" | 14" - 20" | | | Seat to Floor Height<br>(adjustable) | 13" - 18" | 14" - 20" | 18" - 21" | | | Posterior Tilt | 0° to 20° | 45° | 15°±5°<br>(depending on set<br>up) | | | Comparison of Technological characteristics with the Predicate Device and Reference<br>Device. | | | | | | | Subject Device | Predicate Device | Reference Device | | | | Stellar LEAP | Stellar Tilt<br>(As cleared under K990557) | Elevation<br>(As cleared under K140023) | | | Back angle (non-dynamic adjustable) | 90°, 98°, 106°, 114°, 122° | 90°, 98°, 106°, 114°, 122° | N/A | | | Option / Accessory: Back angle -dynamic or Dynamic Recline Backrest | Range of 30°, @ neutral (90°- 120°) | Range of 30° | Range of 30°, @ neutral (90°- 120°) | | | Option / Accessory: Anterior Tilt | 30° (max) | N/A | 25°±10°<br>(depending on set up) | | | Back height | 20" or 25" or 31" | 25" or 31"<br>(seat width +9.5") | 9.4"-14.6" | | | Overall width | 12" and<br>16" rear<br>wheels | (seat width +9.5") | N/A | | | | 20",<br>22", 24"<br>rear<br>wheels | (seat width +10.5") | 25" rear wheels | | | | (seat width +10.5") | | Min 23.1"<br>Max 27.1" | | | Overall length (without front rigging) | 30" – 37" | 30" – 37" | With Legrest<br>(32"-24.5") | | | Weight capacity | 250 lbs. | 250 lbs. | 250 lbs. | | | Chair weight,<br>ISO7176-5 Part 8 | 8.9 | 83 lbs. (37.8kg) | 75 lbs. (34.2kg) | 26.5 lbs. (12.0 kg) | | Static stability downhill<br>ISO7176-1 Part 8 | 8.2 | Tipping<br>commences at<br>greater than 10.5° | Tipping<br>commences at<br>greater than 11.0° | Tipping<br>commences at<br>greater than 10° | | | 8.4 | Tipping<br>commences at<br>greater than 10° | Tipping<br>commences at<br>greater than 11.0° | Tipping<br>commences at<br>greater than 10° | | Static stability uphill | 9.3 | Tipping<br>commences at 7.8° | Tipping<br>commences at 7.8° | Tipping<br>commences at | | | Subject Device | Predicate Device | Reference Device | | | | Stellar LEAP | Stellar Tilt<br>(As cleared under K990557) | Elevation<br>(As cleared under K140023) | | | ISO7176-1 Part 9 | 9.5 | Tipping commences at 8.2° | onto anti-tips | greater than 5.4° | | Static stability<br>sideways<br>ISO7176-1 Part<br>10.2, 10.3 | 10.2 | Tipping commences at<br>greater than 10° | Tipping commences at<br>greater than 12° | Tipping commences at<br>greater than 10° | | | 10.3 | Tipping commences at<br>greater than 10° | Tipping commences at<br>greater than 12° | Tipping commences at<br>greater than 10° | | Static stability<br>anti-tip<br>ISO7176-1 Part 11 | 11.2 | Tipping commences at<br>greater than 10° | Tipping commences at<br>greater than 14.0° | Tipping commences at<br>greater than 10° | | | 11.3 | Tipping commences at<br>greater than 17° | Tipping commences at<br>greater than 14.0° | Tipping commences at<br>greater than 10° | | | 11.4 | N/A | Tipping commences at<br>greater than 14.0° | N/A | | Minimum turning<br>radius<br>ISO7176-5 Part 8 | 8.13 | 830mm | 815 mm | 515mm | {5}------------------------------------------------ {6}------------------------------------------------ #### 1.4 Performance Data The Stellar LEAP has been evaluated through ISO 14971-compliant risk analysis and nonclinical testing performed in accordance with the below wheelchair standards: - . ISO 7176 – Part 1 – Determination of static stability - ISO 7176 – Part 3 – Determination of effectiveness of brakes - ISO 7176 Part 5 Determination of overall dimensions, mass and turning space • - ISO 7176 Part 7 Measurement of seating and wheel dimensions. . {7}------------------------------------------------ - ISO 7176 Part 8 Requirements and test methods for static impact and fatigue ● strengths - ISO 7176 - Part 11 - Test dummies - ISO 7176 - Part 13 - Determination of coefficient of friction of test surfaces. - . ISO 7176 - Part 15 - Requirements for information disclosure, documentation and, labeling. - ISO 7176 - Part 16 - Resistance to ignition of postural support devices - . ISO 7176 - Part 19 - Wheeled mobility devices for use as seat in motor vehicles Results of the above ISO evaluations demonstrated that the Stellar LEAP meets the requirements of ISO 7176- 1, 3, 5, 7, 8, 11, 13, 15, 16, and 19. Furthermore, a biocompatibility assessment was carried out for the Stellar LEAP by identifying the patient contacting materials and conducting a biomaterial evaluation in accordance with: - ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and ● testing within a risk management process (2010) - FDA Guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (June 16, 2016) #### 1.5 Conclusions The Stellar LEAP has substantially equivalent indications and principle of operation to the currently marketed Stellar Tilt. While there are design differences in the frame configuration. materials of construction, joining methods and tilt features, the Stellar LEAP has been evaluated through ISO 14971 - Application of risk management to medical devices and design verification and validation (DV&V) testing was carried out and showed the Stellar LEAP performed compliant to ISO 7176-1, 3. 5. 7. 8. 11. 13. 15. 16 and 19. The subject device has the same intended use, principles of operation, and technological characteristics to the predicate device. Furthermore, similar to the reference device, Elevation, the Stellar LEAP utilizes gas struts to provide anterior tilting function capability. Additionally, the biocompatibility assessment of the Stellar LEAP was carried out in consideration of the safe history of use of these patient contacting materials with other marketed PDG wheelchairs. Thus the Stellar LEAP raises no new questions of safety or effectiveness compared to the predicate device and is, therefore, substantially equivalent. - End of 510(k) Summary -