BREATH CONTROL (BREATH ACTUATOR), SENSITOUCH BREATH CONTROL, HEAD ARRAY (SWITCH HEAD CONTROL), TRI-SWITCH HEAD ARRAY, HD

{0}------------------------------------------------ #### 13.0 510(k) SUMMARY OF SAFETY AND EFFICACY Rebecca Andersen #### 6 1998 NO Submitter: Date: # K98 3520 Names of the devices: ## QUICKIE SPECIALTY INPUT DEVICE 9/28/98 | Model<br>Number | Device Description | Performance<br>Features | Switch<br>Type | Function | |--------------------------------------|----------------------------------------------|-----------------------------------------------------------------------------------|--------------------|----------| | 139700 | Breath Control | Same | Switched Input | Actuator | | 139900 | Electronic Head Array | Same as the 3519, only<br>close proximity to sensor<br>causes activation | Switched Input | Actuator | | 139702 | Tri Switch Head Array | Same | Switched Input | Actuator | | 139703 | HD Switched Joystick | Same | Switched Input | Actuator | | 139923 | CA - 5 | Same | Switched Input | Actuator | | 139924 | Penta | 5 single switches<br>packaged in small disc.<br>Single finger control. | Switched Input | Actuator | | 139925 | Star Board Switch | 5 single switches<br>packaged in "plus"<br>arrangement. Small<br>hand control. | Switched Input | Actuator | | 139922 | Wafer Board | 5 single switches | Switched Input | Actuator | | 139706 | Mini switched Joystick | Same | Switched Input | Actuator | | 139720 | Treadle Switch | Same | Single Switch | Actuator | | 139721 | Ribbon Switch | Same | Single Switch | Actuator | | 139722 | Disc Switch | Same | Single Switch | Actuator | | 139920 | Buddy Button | Same as Disc Switch | Single Switch | Actuator | | 139921 | Micro Light | Very light touch single<br>switch | Single Switch | Actuator | | 139926 | Plate | Very light touch single<br>switch | Single Switch | Actuator | | 139927 | Grasp | Single switch activated<br>by grasping a tube | Single Switch | Actuator | | 139928 | Soft | Foam covered single<br>switch. Designed to<br>protect user from hard<br>surfaces. | Single Switch | Actuator | | 139910 | Wobble Switch | Large activation area,<br>used for gross motor<br>movements | Single Switch | Actuator | | Model<br>Number | Device Description | Performance<br>Features | Switch<br>Type | Function | | 139909<br>139907<br>139908<br>139906 | Zero Touch | Proximity switch, will<br>activate when user<br>comes close to sensor | Single Switch | Actuator | | 139704 | Proportional Head<br>Control | Same | Proportional Input | Actuator | | 139705 | Proportional Chin<br>Control / Mini Joystick | Same | Proportional Input | Actuator | | 3514 | Head Rest Mount | Same | Mount | Mount | | 2610<br>2611 | Swing Away Mount | Same | Mount | Mount | | 2615 | Bib Mount | Same | Mount | Mount | | 3395<br>3470<br>3420<br>2660 | Arm Rest Mount | Mounts the USCM to the<br>armrest. Positions<br>display | Mount | Mount | | 3205 | Midline Mount | Positions joystick in<br>middle of seat | Mount | Mount | | 3470<br>3420 | Remote Mount | Same | Mount | Mount | {1}------------------------------------------------ : {2}------------------------------------------------ # Identification of predicate devices: | PREDICATE | PREDICATE | PREDICATE | |-----------|---------------|-----------| | DEVICE | DEVICE | DEVICE | | DUFCO | QUICKIE DUFCO | INVACARE | | Predicate<br>Device Desc.<br>In Submission<br>K881463 | Predicate<br>Model #<br>In Submission<br>K881463 | Predicate<br>Current<br>Quickie Dufco<br>Description | Predicate<br>Current<br>Quickie Dufco<br>Model # | Predicate<br>Invacare<br>Model # | Predicate<br>Invacare<br>Device<br>Description | |--------------------------------------------------------|---------------------------------------------------|------------------------------------------------------|--------------------------------------------------|----------------------------------|--------------------------------------------------------| | Breath<br>Actuator | 2910 | Breath Control | 3365 | SNPM4 | Sip-N-Puff | | N/A | N/A | Electronic Head<br>Array | 3519 | ASL105C | Electronic Head<br>Array Straight<br>w/bracket | | Tri-switch<br>Head array | N/A | Tri Switch<br>Head array | 3519 | | | | Joystick<br>actuator | 2656 | HD Switched<br>Joystick | 2656 | 5020MSNP | Mini Joystick<br>w/Push<br>w/SNP/DI | | Four - To -<br>One Adaptor | 2355 | CA-5<br>Junction<br>Box | | ASL502 | 5 Switch<br>Adapter | | N/A | N/A | Penta | | | | | N/A | N/A | Star Board | | | | | Joystick<br>Actuator | 2656-X | Mini-Switched<br>Joystick | 2656 -X | 5020 | Mini Joystick<br>w/Push | | Wafer Switch<br>Actuator | 2715 | Wafer Board | 2715 | 5018 | Wafer Board | | Treadle Switch | 1474<br>Passive | Treadle<br>Switch | 1474<br>Passive | | | | Ribbon Switch | 1475<br>Passive | Ribbon<br>Switch | 1475<br>Passive | | | | N/A | N/A | Disc Switch | 3265<br>Passive | | | | N/A | N/A | Buddy Button<br>Switch | Passive | | | | N/A | N/A | Micro Light | Passive | | | | N/A | N/A | Plate | Passive | | | | N/A | N/A | Grasp | Passive | | | | Predicate<br>Device Desc.<br>In Sub-mission<br>K881463 | Predicate<br>Model #<br>In Sub-mission<br>K881463 | Predicate<br>Current<br>Quickie Dufco<br>Description | Predicate<br>Current<br>Quickie Dufco<br>Model # | Predicate<br>Invacare<br>Model # | Predicate<br>Invacare<br>Device<br>Description | | N/A | N/A | Soft | Passive | 5830M4 | Soft Switch<br>Package<br>w/SNP/DI/<br>Display /Adapte | | N/A | N/A | Wobble Switch | Passive | | | | N/A | N/A | Zero Touch | Active | | | | N/A | N/A | Proportional<br>Head Control | 3500 | 1500M4 | RIM Head<br>Control w/Adj.<br>Slide tube | | Joystick<br>Actuator<br>(with chincup<br>option) | 2651 | Proportional chin<br>control / Mini -<br>Joystick | 2651<br>3185 | 1558M4 | Compact<br>Joystick with<br>Display | | Actuator/Switc<br>hed Output | 2620 | Switched Output<br>Controller | 3329<br>3340<br>3350<br>3630<br>3660 | | | | N/A | N/A | Head Rest<br>Mount<br>Or Swing Away<br>Mount | 3514 & 15 | RIMHW | RIM Hardware<br>For 1500M4 | | Swing Away<br>Mount | 2610 & 11 | Swing-away mount | 2610 & 11 | | | | Breath Tube<br>Kit | 2422 | Breath Control<br>Mount | 2422 | PKG32666 | Sip-N-Puff, 16"<br>Fixed | | Bib Kit | 2615 | Bib Mount | 2615<br>3390 | PKG32669 | Complete Bib<br>Assembly | | Armrest<br>Mount | 2660 | Armrest Mount | 3395<br>3470<br>3420<br>2660 | 1679 | Arm Attach<br>Hdwr For<br>1555M4 | | N/A | N/A | Mid-line mount | 3205 | JCMM4 | | | N/A | N/A | Remote Mount or<br>Chair Back Clamp | 3470<br>3420 | | | {3}------------------------------------------------ {4}------------------------------------------------ ## Description of the device: Alternate actuators (input devices) are designed to provide those with severe physical disabilities the independence to operate a power wheelchair, a power seating system, and an environmental control unit using a device other than the standard joystick. A variety of alternate input actuators are currently available on the market as many power wheelchair users require some form of input control other than a joystick. In prior submissions, several alternate input devices (specialty controls) and their interface modules were employed in addition to the main wheelchair controller. These included the breath tube interface, which contained a pressure transducer, a single switch scanner module and a display. Other specialty control functions also required independent display boxes and / or displays. However Quickie's new controllers, that are intended to interface with specialty input devices, have incorporated these functions into the Controller/ USCM (Universal Specialty Control Module). This greatly simplifies the wheelchair's configuration as it eliminates the need for additional dedicated interface boxes and displays to be mounted on the chair. As with the devices currently marketed by Quickie, the alternate actuator is used to signal both the speed and direction of the power chair, as well as the selection of various operating modes which are then controlled by the wheelchair controller/USCM. Examples of the various modes that can be controlled are: maximum speed, drive profile (e.g. indoor/outdoor), latched driving, powered seating systems and environmental controls systems. The method of selection for both drive control and mode is dependent upon the type of alternate input actuator. Two basic types of input actuators exist: proportional and switched. Both types are compatible with Quickie's controller/USCM. When using alternate input actuators, the wheelchair controller will enter a sleep state if the actuator has not sent a signal for a specified period of time. This helps to extend the life of the chair batteries, and reduces the likelihood of unintentional movement. The primary change being addressed is the modification of one of the standard connectors used to interface with the Quickie Controllers that have a Universal Specialty Control Unit (USCM). Two of the three connections that were made to the old Multi-mode remain the same. Some devices used a breath tube that activated a pressure transducer that translated the air pressure to electrical signals. This connection remains unchanged. Some devices used a single jack connector to transfer signal. This connection also remains unchanged. The third type of connector employed by the prior Multi-mode device was a DB15 connector. The Controller/ USCM, which replaces the Multi-mode, translates the same signals using a DB9 connector. The DB9 was selected for the Controller/USCM because it has developed across the specialty input device industry as the standard connector. The DB-9 is used by many companies making specialty input devices including Switch-it, Tash, and ASL. {5}------------------------------------------------ Warnings, cautions and contraindications are in the user's manual. ### COMPARISON OF DEVICE CHARACTERISTICS TO PREDICATE(S): #### Testing: | Pull Out Strength | Pass | |----------------------------|------| | Insertion Force | Pass | | Pin Activity Compatibility | Pass | #### Safety: An analysis of complaints against Quickie chairs was completed and charted. See Chart # 1 in This analysis was supported by a literature search which was conducted by a this section. third party to determine the number of complaints, MDR's and recalls that have been reported to the FDA concerning wheelchairs in general. This information was summarized, and presented in a Management Review report dated 2/20/97. The analysis demonstrated common issues across all manufacturers product lines, and varying levels approximately comparable to relative market share. #### Efficacy Articles are being provided on the use and efficacy of mechanical reclining wheelchairs. See Appendix D. #### 510(k) number: Not assigned at the writing of this summary #### Conclusion: There are no new issues of safety or efficacy. The indications for use are the same, the technological characteristics are the same, and the performance characteristics are the same for both the modified and predicate devices. {6}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 6 1998 Ms. Rebecca Andersen Vice President, Quality and Regulatory Affairs Sunrise Medical, Inc. Mobility Products Division 7477A East Dry Creek Parkway Longmont, Colorado 80503 Re : K983520 Trade Names: Breath Control, Model # 139700 Head Array, Model # 139900 Tri-switch Head Array, Model # 139702 Heavy Duty Switched Joystick, Model # 139703 CA-5 Junction Box, Model # 139923 Penta Switch, Model # 139924 4 Zero Touch Switch without Lap Tray, Model # 139907 5 Zero Touch Switch without Lap Tray, Model # 139908 5 Zero Touch Switch with Lap Tray, Model # 139906 Mini-Switched Joystick, Model # 139706 Wafer Board, Model # 139922 Star Board, Model # 139925 Treadle Switch, Model # 139720 Ribbon Switch, Model # 139721 Disc Switch, Model # 139722 Buddy Button Switch, Model # 139920 Micro Light Switch, Model # 139921 Plate, Model # 139926 Grasp, Model # 139927 Soft, Model # 139928 Wobble Switch, Model # 139910 Zero Touch, Model # 139909 Proportional Head Control, Model # 139704 Proportional Chin Control/Mini Joystick, Model # 139705 Head Control Mount, Model # 3514 Swing-away mount, Model # 3514-x Bib Mount, Model # 2615 Armrest Mount, Model # 2660 Mid-line Mount, Model # 3205 Regulatory Class: II Product Code: ITI Dated: September 28, 1998 Received: October 8, 1998 Dear Ms. Andersen: We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to devices {7}------------------------------------------------ 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). You may, therefore, market the devices, 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 aqainst misbranding and adulteration. If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major requlations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to beqin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market. If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other gener Other general information on your responsibilities under the Act may be {8}------------------------------------------------ Page 3 - Page 2 - Ms. Rebecca Andersen obtained from the Division of Small Manufacturers Assistance obtained Trom the Division of 6.0.2.2041 or (301) 443-6597 or at at fes corr free namber (s://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ CONFIDENTIAL ### 12.2 Indications for Use Alternate input devices are designed to provide those with sever physical disabilities the independence to operate a power wheelchair, a power seating system, and an environmental control unit from a single actuating device. 510(k) number: Not assigned as of this time Device name: Input Actuators and Mounts Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription use (per 21 CFR801.109) [X] Over-the-counter use bocollfo Sign-Off f General Restorative Device 510(k) Number