Explorer Mini

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION". February 27, 2020 Permobil AB Ivan Fernandez Director of Regulatory Compliance Box 120 S-861 23 Timra, Sweden Re: K190682 Trade/Device Name: Explorer Mini Regulation Number: 21 CFR 890.3900 Regulation Name: Standup Wheelchair Regulatory Class: Class II Product Code: IPL Dated: January 28, 2020 Received: January 28, 2020 ## Dear Ivan Fernandez: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Heather Dean, Ph.D. Acting Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K190682 Device Name Explorer Mini Indications for Use (Describe) The Explorer Mini is a pediatric powered wheelchair with the intention to provide mobility to pediatric users weighing up to 35 pounds and maximum length of up to 39 inches tall, between 12-36 months of age, who position themselves in a sitting position in the wheelchair and have the capacity to operate a joy stick hand control. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| | <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> 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 - K190682 | Submitter | Permobil AB<br>Box 120<br>S-861 23 Timrå<br>Sweden | |---------------------------------|--------------------------------------------------------------------------------------------------| | Phone:<br>Facsimile: | +46 60 595900<br>+46 60 575250 | | Contact Person: | Ivan Fernandez, Director of Regulatory Compliance | | Email Address: | ivan.fernandez@permobil.com | | Telephone number: | 800-736-0925 | | Date Prepared: | February, 2020 | | Trade Name: | Explorer Mini | | Common/<br>Classification Name: | Wheelchair, Standup,<br>Standup Wheelchair | | Product Code: | IPL<br>21CFR 380.3900 | | Predicate Device: | WHEELCHAIR MODEL STS<br>Innovative Products Inc<br>071390<br>Product code: IPL<br>21CFR 380.3900 | ## Description of the Explorer Mini This submission covers the Explorer Mini device. ### Indication for use: The Explorer Mini is a pediatric powered wheelchair with the intention to provide mobility to pediatric users weighing up to 35 pounds and maximum length of up to 39 inches tall, between 12-36 months of age, who position themselves in a sitting position in the wheelchair and have the capacity to operate a joy stick hand control. {4}------------------------------------------------ ### General Description: The Explorer Mini is designed for children with mobility impairments that will never walk, inefficient mobility or lose the ability to walk efficiently, need mobility assistance in early childhood. The Explorer Mini is intended for children weighing up to 35 pounds versus the Wheelchair Model STS (K071390) which is intended for users weighing up to 150 pounds. The Explorer Mini is designed specifically for the pediatric users. This is a limit in indications for use to the larger population of the predicate device that includes children and young adults. Clinical and non-clinical performance testing has demonstrated this difference does not affectiveness of the device when used as labeled. ### Use environment: Explorer Mini is intended to be used in everyday life, in safe environments where the child is. Typical environments are at the clinical training site, at home, at preschool, at friends and extended family. The design of the device is small and compact, making it possible for the child to drive the device in these environments. Like any other infant or toddler at play, Explorer Mini is intended to be used under supervision by an adult, and it is the care-givers responsibility to ensure that the surrounding environment is safe and appropriate for the child to drive. ### Principle of operation: Explorer Mini includes a base to which the wheels and casters are attached. An adjustable height, vertical column is attached to the base. The driver control (joystick) is integrated at the top of the column and the seating system is attached to the column. The Explorer Mini speed and direction are controlled via a control system comprising a power module and joystick. The Explorer Mini has the appearance of a "ride on toy" and weighs between 60% and 90% less than typical power chairs available to this population today. Both appearance and weight are factors critical to acceptance by the intended user population. Explorer Mini seat is configured with a permanent 360degree support assembly positioned around the upper torso for added user safety and stability. This assembly supports both sitting and standing. An adjustable-position saddle shaped seat is used for sitting. The saddle shape allows for 'straddle' standing or alternately the seat can be removed to open the area for full active standing. The 360degree support assembly adjusts to accommodate and support standing while driving. The Explorer Mini is powered by two 5 Amp. batteries providing an approximate driving range up to 4.6 miles. The base provides the propulsion which is derived from two (left and right) front mounted gear-motor wheel assemblies supported by two rear mounted 360degree swiveling casters. Also incorporated in the base are the batteries and control module. When the user activates the joystick, the controller receives a signal to move the device in the direction the joystick is pointed. Simultaneously, the controller directs the gear-motors to respond appropriately. When the user releases the joystick, the chair decelerates to a stop. The inherent gear ratio holds the device in place like a park brake. {5}------------------------------------------------ #### Predicate comparison of major technical features: The Explorer Mini is substantially equivalent to WHEELCHAIR MODEL STS (Innovative Products Inc., K071390, product code: IPL). The Explorer Mini has similar intended use and indications, technological characteristics, and principles of operation. The differences between the Explorer Mini and the predicate device are: - The total weight of the of the device is considerably less at 40 pounds. This make the Explorer Mini easier to handle for secondary users. - The speed of the Explorer Mini is 1.5mph while the Wheelchair Model STS (K071390) has a speed of up to 5mph. The speed is set to correlate to the speed a child within the intended age has when or running slowly. The low speed also ensures that the caregiver can keep up with child. This ensures that Explorer Mini has a safer speed for the pediatric end user as well as care giver. The minor technological differences between Explorer Mini and its Predicate device Wheelchair Model STS raise no new issues of safety or effectiveness. Performance data demonstrates that the Explorer Mini is as safe and effective as the Wheelchair Model STS. Thus, the Explorer Mini is substantially equivalent. Table 1 provides a comparison of the predicate device (Wheelchair Model STS) and the Explorer Mini in order to demonstrate substantial equivalence. | Feature | Predicate Device: | Subject Device: | Comparison | |---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Wheelchair Model STS | Explorer Mini | | | 510(k) number | K071390 | K190682 | N/A | | Intended Use | The intended use of the model<br>STS pediatric powered<br>wheelchair is to provide<br>mobility to children and<br>young adults, weighting up to<br>150 pounds, with the ability to<br>place themselves in a sitting<br>position in the wheelchair and<br>have the capacity to operate a<br>standard joy stick hand<br>control. | The Explorer Mini is<br>a pediatric powered<br>wheelchair with the<br>intention to provide<br>mobility to pediatric<br>users weighing up to<br>35 pounds and<br>maximum length of<br>up to 39 inches tall,<br>between 12-36<br>months of age, who<br>position themselves<br>in a sitting position in<br>the wheelchair and<br>have the capacity to<br>operate a joy stick | Permobil has designed<br>the Explorer Mini<br>specifically for the<br>pediatric users<br>weighing up to 35<br>pounds and<br>maximum length of<br>up to 39 inches tall,<br>between 12-36<br>months of age, which<br>is a narrower scope of<br>the predicate device.<br>The predicate device<br>has a broader target<br>group "…provide<br>mobility to children | | | | | weighting up to 150<br>pounds...”. Several of<br>the functions in the<br>Explorer Mini are<br>designed to be<br>appropriate for the<br>young target group,<br>such as the lower<br>speed, seating area,<br>table area, etc. | | Product code | IPL 890.3900 | IPL 890.3900 | Identical | | User age ranges<br>and maximum<br>weight<br>capacities | Children or young adults<br>weight up to 150 lbs. | 12-36 months -35lbs<br>(16kg) or 39”<br>(100cm) | Differences is that<br>STS does specify<br>upper weight limit but<br>does not specify<br>intended user age<br>population. The<br>intended user of<br>Explorer Mini is<br>described by a lower<br>age limit and a<br>maximum weight and<br>physical size limit.<br>Regardless of user<br>weight or age, no new<br>or increased risks are<br>identified. The<br>Explorer Mini has<br>been subjected to all<br>applicable ISO 7176<br>series tests | | Device<br>description | STS includes a base to which<br>the wheels and casters are<br>attached with the option of<br>attaching a seat or standing<br>frame. | Explorer Mini<br>powered wheelchair<br>includes a base to<br>which wheels and<br>casters are attached<br>with the option of<br>utilizing the seat or<br>configuring the<br>system for standing | Functionally<br>Equivalent | | | When the joystick is activated<br>a signal is directed through the<br>power module to the gear<br>motors which propel the chair | When the joystick is<br>activated a signal is<br>directed through the<br>power module to the<br>gear motors which<br>propel the chair | Identical | | | & control both speed and direction | control both speed and direction | | | | STS uses a motor lock system<br>for park brakes. A park brake<br>for safety is attached to each<br>gear-motor which is activated<br>when the chair comes to a stop | A park brake is<br>provided by the gear<br>ratio which is<br>designed to prevent<br>movement when no<br>signal is detected. | Functionally<br>Equivalent | | Total width | 24" | 19" | Functionally<br>Equivalent | | Total length | 32" | 25" | Functionally<br>Equivalent | | Total height | 35" (to backrest) | Minimum: 28.7"<br>Maximum 36.6" | Functionally<br>Equivalent | | Turning<br>diameter | 50" | 42.5" | Functionally<br>Equivalent | | Speed Range | 0-5 mph | 0-1.5 mph | Appropriate for the<br>intended user group | | Driving range | 25 miles | 3.4 miles | Appropriate for the<br>intended user group | | Brake distance-<br>Normal<br>operation<br>(Horizontal-<br>Forward-Max<br>speed) | Information regarding the<br>braking distance for the STS<br>is not available in the labeling | Minimum braking<br>distance from<br>maximum speed<br>11.8" | The lower speed of the<br>Explorer Mini and the<br>gear ratio which is<br>designed to prevent<br>movement when no<br>signal is detected, and<br>thereby ensuring that | | Time to brake | Information regarding the<br>braking distance for the STS<br>has not been found. The STS<br>User Manual states:<br>The STS is equipped with two<br>powerful brake systems.<br>• Regenerative – uses<br>electricity to rapidly<br>slow the vehicle when<br>the joystick returns to<br>the center/stop<br>position.<br>• Disc park brake –<br>activates mechanically<br>after regenerative<br>braking slows the | A park brake is<br>provided by the gear<br>ratio which is<br>designed to prevent<br>movement when no<br>signal is detected.<br>When the user<br>releases the joystick,<br>the chair immediately<br>decelerates to a stop. | the Explorer Mini<br>stops immediately<br>make the Explorer<br>Mini safer than the<br>STS in regard to<br>braking distance | | | or when power is<br>removed from the<br>system for any reason<br>The STS uses a motor lock<br>system for park brakes. A park<br>brake for safety is attached to<br>each gear-motor which is<br>activated when the chair<br>comes to a stop. | | | | Operating<br>surface &<br>environment | The STS is designed to<br>operate both indoors and<br>outdoors. It maneuvers on all<br>terrains except soft sand. | Explorer Mini is<br>designed for indoor<br>use and limited<br>outdoor use on firm,<br>flat and dry surfaces | Explorer Mini is<br>intended to be used on<br>safer<br>surfaces/surroundings.<br>Even though the<br>Explorer Mini is<br>designed for limited<br>outdoor use it has<br>been subjected to the<br>same stability test<br>requirements as an<br>outdoor chair. | | Manageable<br>gradient | 5° | 6° | Functionally<br>Equivalent | | Max. curb height<br>Obstacle<br>Climbing Ability | 2.5" | 1.0" | Appropriate for the<br>intended use<br>environment | | Max. chair<br>weight | 160 lbs. | 52 lbs. | Appropriate for the<br>intended user group | | Frame material,<br>frame tube size | The STS is constructed<br>primarily of steel tubing. The<br>base has a steel frame with a<br>molded Plastic Overlay. The<br>seat and standing frame are<br>constructed of steel tubing. A<br>version of the standing system<br>uses a wooden backboard. | The Explorer Mini<br>base is constructed<br>with a steel frame<br>with molded Plastic<br>Overlays. The tower<br>is constructed with<br>aluminum extrusions<br>while the seat and<br>table are a<br>combination of<br>aluminum and steel<br>components with<br>molded plastic<br>overlays. The back<br>and lateral arms are<br>molded plastic | There are differences<br>in the materials used<br>but both products are<br>appropriately<br>constructed for the<br>intended user and the<br>intended use<br>environment and has<br>been tested according<br>to the requirements<br>and to ensure safety of<br>the device. The<br>Explorer Mini has<br>been tested per ISO<br>7176 test<br>requirements. No new<br>risk identified. Both | | | | | Mini are appropriately<br>constructed for the<br>intended use | | Controller | Controller 24V PG | Controller 24V PG nVR2 | Functionally Equivalent | | Joystick mounting | Left or right mounted | Central mounted | Functionally Equivalent | | Batteries | 2 x 28 AH Gel cell batteries | 2 x 12 V AGM lead-acid batteries in series | Functionally Equivalent | | Stand-up feature | Power to go from sit to stand | Manual adjustment to go from sit to stand | Functionally Equivalent | #### Table 1 Comparison to predicate device {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the word "permobil" in blue font. The font is sans-serif and the letters are all lowercase. The word is slightly italicized, and the "o" is smaller than the other letters. The background is white. ## Non-Clinical Testing: The Explorer Mini has been tested according to ISO 7176 evaluates the strength, stability (static and dynamic), and durability of the powered wheelchair. Tests are performed on the whole wheelchair to determine the performance, safety, and effectiveness of the device. All performed testing revealed that the Explorer Mini successfully passed all requirements and was found to be substantially equivalent to the predicate device mentioned in this submission. The predicate device, the STS device, was tested according to FDA Recognized standards. The Explorer Mini was tested to the current recognized standards; ISO 7176 Series. | Recognized standard | Standard name | Outcome | |----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| | ISO 7176-1:2014<br>[ANSI/RESNA WC-1/1] | Wheelchairs - Part 1: Determination of static stability | Pass | | ISO 7176-2:2001<br>[ANSI/RESNA WC-1/1] | Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs | Pass | | ISO 7176-3:2012<br>[ANSI/RESNA WC-2/3] | Wheelchairs - Part 3: Determination of effectiveness of brakes | Pass | | ISO 7176-4:2008<br>[ANSI/RESNA WC-2/4] | Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range | Pass | | ISO 7176-5:2008<br>[ANSI/RESNA WC-1/5] | Wheelchairs - Part 5: Determination of overall dimensions, mass and maneuvering space | Pass | | ISO 7176-6:2001<br>[ANSI/RESNA WC-2/6] | Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs | Pass | | ISO 7176-7:1998<br>[ANSI/RESNA WC-<br>1/7] | Wheelchairs - Part 7: Measurement of seating and<br>wheel dimensions | Pass | | ISO 7176-8:2014<br>[ANSI/RESNA WC-<br>1/8] | Wheelchairs - Part 8: Requirements and test<br>methods for static, impact and fatigue strengths | Partial<br>conformance<br>provided<br>alternative<br>evidence to fulfill<br>requirement | | ISO 7176-9:2009<br>[ANSI/RESNA WC-<br>2/9] | Wheelchairs - Part 9: Climatic tests for electric<br>wheelchairs | Pass | | ISO 7176-11:2012 | Wheelchairs - Part 11: Test dummies | N/A - This<br>standard sets<br>requirements for<br>testing | | ISO 7176-10:2008<br>[ANSI/RESNA WC-<br>2/10] | Wheelchairs - Part 10: Determination of obstacle-<br>climbing ability of electrically powered<br>wheelchairs | Pass | | ISO 7176-13:1989 | Wheelchairs - Part 13: Determination of<br>coefficient of friction of test surfaces | N/A - This<br>standard sets<br>requirements for<br>testing | | ISO 7176-14:2008<br>[ANSI/RESNA WC-<br>2/14] | Wheelchairs - Part 14: Power and control systems<br>for electrically powered wheelchairs and scooters -<br>Requirements and test methods | Pass | | ISO 7176-15:1996<br>[ANSI/RESNA WC-<br>1/15] | Wheelchairs - Part 15: Requirements for<br>information disclosure, documentation and<br>labeling | Pass | | ISO 7176-16:2012<br>[ANSI/RESNA WC-<br>1/16] | Wheelchairs - Part 16: Resistance to ignition of<br>postural support devices | Pass | | ISO 7176-21:2009<br>[ANSI/RESNA WC-<br>2/21] | Wheelchairs - Part 21: Requirements and test<br>methods for electromagnetic compatibility of<br>electrically powered wheelchairs and scooters, and<br>battery chargers | Pass | | ISO 7176-25:2013 | Wheelchairs - Part 25: Batteries and chargers for<br>powered wheelchairs | Partial<br>conformance<br>provided<br>alternative<br>evidence to fulfill<br>requirement | | RESNA WC-1:2009<br>Section 20 | Determination of the Performance of Stand-up<br>Type Wheelchairs | Pass | | ISO 10993-1 | Biological evaluation of medical devices | Pass | Table 2 List of recognized standards to which the Explorer Mini complies {10}------------------------------------------------ {11}------------------------------------------------ Image /page/11/Picture/1 description: The image shows the word "permobil" in a sans-serif font. The word is written in all lowercase letters and is a dark blue color. The letters are closely spaced together, giving the word a compact appearance. ## Clinical Testing: The device is designed to provide the compensatory motor skills that work in concert with the sensory skills to bring about postural control, upper extremity stability in this young population where several developmental milestones remain to be met. A usability study was performed on 33 children with mobility impairments justifying a need for a device as the Explorer Mini. A label comprehension study of the User's manual was performed on 15 physiotherapists/occupational therapists and 15 parents. The human factor validation testing revealed that the Explorer Mini is a safe and effective medical device for the intended user, and all studied use-related risks were deemed acceptable. ### Conclusions: The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as the legally marketed device. The Explorer Mini and Predicate device, Wheelchair Model STS are substantially equivalent. Explorer Mini has the same general intended use and similar indications, principles of operation, and similar technological characteristics as the previously cleared WHEELCHAIR MODEL STS; Innovative Products Inc - K071390 ● - Product code: IPL - 21CFR 380.3900