(29 days)
Not Found
No
The description focuses on hardware interfaces and basic control logic, with no mention of AI or ML concepts.
No.
The device acts as an input method for controlling a power wheelchair and related systems, rather than directly treating a medical condition or restoring a bodily function.
No
This device is an alternate input device designed to allow individuals with severe physical disabilities to operate a power wheelchair, seating system, and environmental control unit, not to diagnose a medical condition.
No
The device description explicitly mentions physical components like "alternate actuators (input devices)", "breath tube interface, which contained a pressure transducer", "single switch scanner module", "display boxes", "connectors (DB15, DB9)", and "interface modules". The testing section also includes "Pull Out Strength" and "Insertion Force" tests, which are related to physical hardware. While software is likely involved in processing signals, the device is clearly not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide individuals with severe physical disabilities the ability to operate a power wheelchair, power seating system, and environmental control unit. This is a functional assistance device, not a diagnostic tool.
- Device Description: The description details how the device acts as an input mechanism for controlling external equipment (wheelchair, seating, environmental controls). It describes the physical interface and how it translates user input into signals for these systems. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on biological sample analysis.
The device is clearly designed to provide control and independence for individuals with physical disabilities, which falls under the category of assistive technology or medical devices for mobility and control, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing:
Pull Out Strength - Pass
Insertion Force - Pass
Pin Activity Compatibility - Pass
Safety:
An analysis of complaints against Quickie chairs was completed and charted. This analysis was supported by a literature search which was conducted by a 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).
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
Number | Device Description | Performance
Features | Switch
Type | Function |
|--------------------------------------|----------------------------------------------|-----------------------------------------------------------------------------------|--------------------|----------|
| 139700 | Breath Control | Same | Switched Input | Actuator |
| 139900 | Electronic Head Array | Same as the 3519, only
close proximity to sensor
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
packaged in small disc.
Single finger control. | Switched Input | Actuator |
| 139925 | Star Board Switch | 5 single switches
packaged in "plus"
arrangement. Small
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
switch | Single Switch | Actuator |
| 139926 | Plate | Very light touch single
switch | Single Switch | Actuator |
| 139927 | Grasp | Single switch activated
by grasping a tube | Single Switch | Actuator |
| 139928 | Soft | Foam covered single
switch. Designed to
protect user from hard
surfaces. | Single Switch | Actuator |
| 139910 | Wobble Switch | Large activation area,
used for gross motor
movements | Single Switch | Actuator |
| Model
Number | Device Description | Performance
Features | Switch
Type | Function |
| 139909
139907
139908
139906 | Zero Touch | Proximity switch, will
activate when user
comes close to sensor | Single Switch | Actuator |
| 139704 | Proportional Head
Control | Same | Proportional Input | Actuator |
| 139705 | Proportional Chin
Control / Mini Joystick | Same | Proportional Input | Actuator |
| 3514 | Head Rest Mount | Same | Mount | Mount |
| 2610
2611 | Swing Away Mount | Same | Mount | Mount |
| 2615 | Bib Mount | Same | Mount | Mount |
| 3395
3470
3420
2660 | Arm Rest Mount | Mounts the USCM to the
armrest. Positions
display | Mount | Mount |
| 3205 | Midline Mount | Positions joystick in
middle of seat | Mount | Mount |
| 3470
3420 | Remote Mount | Same | Mount | Mount |
1
:
2
Identification of predicate devices:
| PREDICATE | PREDICATE | PREDICATE |
|---|---|---|
| DEVICE | DEVICE | DEVICE |
| DUFCO | QUICKIE DUFCO | INVACARE |
| Predicate
Device Desc.
In Submission
K881463 | Predicate
Model #
In Submission
K881463 | Predicate
Current
Quickie Dufco
Description | Predicate
Current
Quickie Dufco
Model # | Predicate
Invacare
Model # | Predicate
Invacare
Device
Description |
|--------------------------------------------------------|---------------------------------------------------|------------------------------------------------------|--------------------------------------------------|----------------------------------|--------------------------------------------------------|
| Breath
Actuator | 2910 | Breath Control | 3365 | SNPM4 | Sip-N-Puff |
| N/A | N/A | Electronic Head
Array | 3519 | ASL105C | Electronic Head
Array Straight
w/bracket |
| Tri-switch
Head array | N/A | Tri Switch
Head array | 3519 | | |
| Joystick
actuator | 2656 | HD Switched
Joystick | 2656 | 5020MSNP | Mini Joystick
w/Push
w/SNP/DI |
| Four - To -
One Adaptor | 2355 | CA-5
Junction
Box | | ASL502 | 5 Switch
Adapter |
| N/A | N/A | Penta | | | |
| N/A | N/A | Star Board | | | |
| Joystick
Actuator | 2656-X | Mini-Switched
Joystick | 2656 -X | 5020 | Mini Joystick
w/Push |
| Wafer Switch
Actuator | 2715 | Wafer Board | 2715 | 5018 | Wafer Board |
| Treadle Switch | 1474
Passive | Treadle
Switch | 1474
Passive | | |
| Ribbon Switch | 1475
Passive | Ribbon
Switch | 1475
Passive | | |
| N/A | N/A | Disc Switch | 3265
Passive | | |
| N/A | N/A | Buddy Button
Switch | Passive | | |
| N/A | N/A | Micro Light | Passive | | |
| N/A | N/A | Plate | Passive | | |
| N/A | N/A | Grasp | Passive | | |
| Predicate
Device Desc.
In Sub-mission
K881463 | Predicate
Model #
In Sub-mission
K881463 | Predicate
Current
Quickie Dufco
Description | Predicate
Current
Quickie Dufco
Model # | Predicate
Invacare
Model # | Predicate
Invacare
Device
Description |
| N/A | N/A | Soft | Passive | 5830M4 | Soft Switch
Package
w/SNP/DI/
Display /Adapte |
| N/A | N/A | Wobble Switch | Passive | | |
| N/A | N/A | Zero Touch | Active | | |
| N/A | N/A | Proportional
Head Control | 3500 | 1500M4 | RIM Head
Control w/Adj.
Slide tube |
| Joystick
Actuator
(with chincup
option) | 2651 | Proportional chin
control / Mini -
Joystick | 2651
3185 | 1558M4 | Compact
Joystick with
Display |
| Actuator/Switc
hed Output | 2620 | Switched Output
Controller | 3329
3340
3350
3630
3660 | | |
| N/A | N/A | Head Rest
Mount
Or Swing Away
Mount | 3514 & 15 | RIMHW | RIM Hardware
For 1500M4 |
| Swing Away
Mount | 2610 & 11 | Swing-away mount | 2610 & 11 | | |
| Breath Tube
Kit | 2422 | Breath Control
Mount | 2422 | PKG32666 | Sip-N-Puff, 16"
Fixed |
| Bib Kit | 2615 | Bib Mount | 2615
3390 | PKG32669 | Complete Bib
Assembly |
| Armrest
Mount | 2660 | Armrest Mount | 3395
3470
3420
2660 | 1679 | Arm Attach
Hdwr For
1555M4 |
| N/A | N/A | Mid-line mount | 3205 | JCMM4 | |
| N/A | N/A | Remote Mount or
Chair Back Clamp | 3470
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