(116 days)
The Modular Power Positioning system is appropriate for use by any individual who drives a power wheelchair and who desires or requires a change of position without having to utilize the services of an attendant. Needs for position changes include:
- All positioning benefits associated with the tilt/recline product:
Comfort: As with any individual, able-bodied or disabled, changes in position are necessary to maintain a state of comfort.
Positioning: Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position. Pressure Relief or Reduction: Individuals who wish, from time to time, to redistribute pressure from one area of the body to another, can do so by tilting and/or reclining, By changing the individual's orientation in space, pressures caused by gravity will shift. - Positioning/Versatility: Individuals are able to reach higher elevations in a seated position, increasing their range of motion and accessibility.
Motion Concepts makes no claims as to the therapeutic effectiveness of the products. Our only claims relate to the ability of the products to provide safe and reliable powered repositioning on the equipment onto which they are installed.
The Modular Power Positioning System is a seating system which is added to a power wheelchair base to provide three basic functions, power recline including shear reduction, and power elevate (or lift). Note the Modular power positioning system in itself does not include any wheelchair base components such as wheelchair frame, drive train, drive controls, wheels, brakes, batteries, suspension etc.
The Tilt unit utilizes a center of gravity shift linkage, which causes the seat frame to shift progressively forward throughout the range of tilt. This enhances the stability since the center of gravity is kept substantially in place while the user is tilting. The Tilt unit may be one of two similarly designed systems, one designed for 50° tilt, and one for 45° tilt which is integrated with the 12 inch linkage style lift.
The Recline function causes the position of the occupant's back to change by changing the position of the backrest with respect to the seat pan. The Shear Reduction works in conjunction with Recline to reduce the shear movement between the user and the backrest. The latter is accomplished by using a linkage that slides the backrest down on the back posts as the back reclines. The range of Recline is 90° to 168°.
The Elevating seat (or Lift) module allows the user to elevate the entire seat by up to 12 inches. It consists of a standard linkage style mechanism.
The maximum occupant weight for the system is up to 300 lb depending on the features of the wheelchair base and system modules selected. The Modular Power Positioning System is assembled using primarily laser-cut steel tube, machined aluminum, and mounting hardware.
The various power positioning modules may be activated via two options: using switches or through the wheelchair manufacturer's controller. Switches consist of either push button or toggle style.
Safety features include a drive lock-out which prevents the user from driving the power chair while tilted, reclined, or elevated beyond a certain pre-set limit. Electrical components are maximum 24 volts, and include a current limiter in the relay box. Stability of the Modular Power Positioning System was tested on various wheelchairs commonly used for power positioning applications. These tests were conducted to ensure the safety of the power wheelchair was not compromised by the addition of the power positioning system.
The provided document is a 510(k) premarket notification for a medical device called the "Modular Power Positioning System," which is a component added to power wheelchairs. This document focuses on demonstrating substantial equivalence to a predicate device and includes performance data from various types of testing, but it does not describe an AI/ML powered device or a study involving human readers or ground truth established by experts in the context of diagnostic performance. Therefore, many of the requested categories in your prompt are not applicable to the information contained in this document.
However, I can extract the information that is available regarding the device's acceptance criteria and the studies performed.
Here's a breakdown based on the information provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative format as would be typical for diagnostic performance (e.g., sensitivity, specificity thresholds). Instead, it lists various tests performed and implies that compliance with relevant standards and successful completion of these tests constitute meeting the acceptance criteria for safety and effectiveness.
| Performance Metric/Test Category | Reported Device Performance |
|---|---|
| Biocompatibility Testing | Performed on all skin contacting surface materials (Meshtex, Startex, Spacetex 4000U™, O-Vinyl, Style 6499 Polyester and Integral Skin foam) per ISO 10993 Part 5: Testing for in vitro cytotoxicity. |
| Electrical Safety and EMC | Complies with RESNA Section 21, Requirements and Test Methods for Electromagnetic Compatibility of Electrically Powered Wheelchairs and Scooters. |
| Software Verification and Validation | Conducted, documentation provided as recommended by FDA's Guidance. Software has a "Moderate level of Concern." |
| Mechanical Testing | Carried out to cover functional verification and device performance, established correct functionality according to relevant ANSI/RESNA standards. |
| Acoustic Testing | Not required to demonstrate device safety and effectiveness. |
| Animal Study | Not required to demonstrate the safety and effectiveness. |
| Clinical Studies | Not required to demonstrate the safety and effectiveness. |
| Stability (Full Drive - FD) | Tested with wheelchair in various positions (elevated, tilted, reclined). |
| Stability (Reduced Drive - RD) | Tested with wheelchair in various positions. |
| Power Consumption | 24 VDC / 4 Amps (improved from predicate device's 8 Amps). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any of the performance tests. The testing appears to be primarily bench testing (mechanical, electrical, software) and material biocompatibility, rather than human clinical data. The device manufacturer, Motion Concepts, is based in Concord, Ontario, Canada, suggesting the testing was likely conducted in Canada or by labs associated with the manufacturer. These would be considered prospective tests performed on the physical device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not Applicable. This device is a mechanical/electrical system, not a diagnostic AI/ML system requiring expert interpretation of medical data to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. No human adjudication of results is mentioned or relevant for the types of tests performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not Applicable. This is not an AI-powered diagnostic device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This device does not have an AI algorithm with standalone performance to evaluate in this context. While it has software, its V&V is focused on functional safety rather than diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance would be the physical and electrical properties of the device components and system as measured against engineering specifications and industry standards (e.g., ANSI/RESNA, ISO). For example:
- Biocompatibility: In vitro cytotoxicity results as per ISO 10993.
- Electrical Safety/EMC: Compliance with RESNA Section 21.
- Mechanical Performance: Functionality according to relevant ANSI/RESNA standards (e.g., static stability, dynamic stability, impact, fatigue strengths).
- Software Safety: Verification against documented requirements and risk analysis.
8. The sample size for the training set
Not Applicable. This device uses conventional engineering design, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not Applicable. No training set for an AI model is involved.
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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 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 30, 2015
Motion Concepts Dona Bhamra Senior Ouality and Regulatory Affairs Manager 84 Citation Dr. Unit #1 Concord, ON L4K 3C1 Canada
Re: K150574
Trade/Device Name: Modular Power Positioning System Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: May 19, 2015 Received: May 20, 2015
Dear Dona Bhamra:
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); medical device reporting (reporting of medical device
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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 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), 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 yours,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150574
Device Name Modular Power Positioning System
Indications for Use (Describe)
The Modular Power Positioning system is appropriate for use by any individual who drives a power wheelchair and who desires or requires a change of position without having to utilize the services of an attendant. Needs for position changes include:
- All positioning benefits associated with the tilt/recline product:
Comfort: As with any individual, able-bodied or disabled, changes in position are necessary to maintain a state of comfort.
Positioning: Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position. Pressure Relief or Reduction: Individuals who wish, from time to time, to redistribute pressure from one area of the body to another, can do so by tilting and/or reclining, By changing the individual's orientation in space, pressures caused by gravity will shift.
- Positioning/Versatility: Individuals are able to reach higher elevations in a seated position, increasing their range of motion and accessibility.
Motion Concepts makes no claims as to the therapeutic effectiveness of the products. Our only claims relate to the ability of the products to provide safe and reliable powered repositioning on the equipment onto which they are installed.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ❌ |
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510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92
I. SUBMITTER
Motion Concepts 84 Citation Drive, Unit 1 Concord, Ontario, L4K 3C1
Phone: 905-695-0134 Fax: 905-695-0138
Contact person: Dona Bhamra Date Summary Prepared: 06-May-2015
II. DEVICE
| Device Proprietary Name: | Modular Power Positioning System |
|---|---|
| Common Name: | Powered Wheelchair |
| Classification Regulation: | 21 CFR, 890.3860 |
| Product Code: | ITI |
| Classification of Device: | Class II |
PREDICATE DEVICE III.
The predicate device is TRZ CG Power Positioning System, which was cleared under K021264.
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IV. DEVICE DESCRIPTION
The Modular Power Positioning System is a seating system which is added to a power wheelchair base to provide three basic functions, power recline including shear reduction, and power elevate (or lift). Note the Modular power positioning system in itself does not include any wheelchair base components such as wheelchair frame, drive train, drive controls, wheels, brakes, batteries, suspension etc.
The Tilt unit utilizes a center of gravity shift linkage, which causes the seat frame to shift progressively forward throughout the range of tilt. This enhances the stability since the center of gravity is kept substantially in place while the user is tilting. The Tilt unit may be one of two similarly designed systems, one designed for 50° tilt, and one for 45° tilt which is integrated with the 12 inch linkage style lift.
The Recline function causes the position of the occupant's back to change by changing the position of the backrest with respect to the seat pan. The Shear Reduction works in conjunction with Recline to reduce the shear movement between the user and the backrest. The latter is accomplished by using a linkage that slides the backrest down on the back posts as the back reclines. The range of Recline is 90° to 168°.
The Elevating seat (or Lift) module allows the user to elevate the entire seat by up to 12 inches. It consists of a standard linkage style mechanism.
The maximum occupant weight for the system is up to 300 lb depending on the features of the wheelchair base and system modules selected. The Modular Power Positioning System is assembled using primarily laser-cut steel tube, machined aluminum, and mounting hardware.
The various power positioning modules may be activated via two options: using switches or through the wheelchair manufacturer's controller. Switches consist of either push button or toggle style.
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Safety features include a drive lock-out which prevents the user from driving the power chair while tilted, reclined, or elevated beyond a certain pre-set limit. Electrical components are maximum 24 volts, and include a current limiter in the relay box. Stability of the Modular Power Positioning System was tested on various wheelchairs commonly used for power positioning applications. These tests were conducted to ensure the safety of the power wheelchair was not compromised by the addition of the power positioning system.
V. INDICATIONS FOR USE
The Modular Power Positioning system is appropriate for use by any individual who drives a power wheelchair and who desires or requires a change of position without having to utilize the services of an attendant. Needs for position changes include:
- All positioning benefits associated with the tilt/recline product:
Comfort -- as with any individual - able-bodied or disabled - changes in position are necessary to maintain a state of comfort.
Positioning - Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position.
Pressure Relief or Reduction - Individuals who wish, from time to time, to redistribute pressure from one area of the body to another, can do so by tilting and/or reclining. By changing the individual's orientation in space, pressures caused by gravity will shift.
- Positioning/Versatility - individuals are able to reach higher elevations in a seated position, increasing their range of motion and accessibility.
Motion Concepts makes no claims as to the therapeutic effectiveness of the products. Our only claims relate to the ability of the products to provide safe and reliable powered repositioning on the equipment onto which they are installed
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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Modular Power Positioning System is substantially equivalent to the TRZ-CG with power elevating seat, tilt and recline.
Both the Modular Power Positioning System and the TRZ-CG are seating systems which are added to power wheelchairs to provide three basic functions, Power Tilt, Power Recline including Shear Reduction, and a Power Elevating Seat, with target populations of people with limited mobility such as quadriplegics. Both systems are generally fabricated from the same materials with similar mechanical operation. Both have similar safety features and meet the same standards.
The most significant difference between the Modular Power Positioning System the predicate device is that the predicate device uses a 7" tower style actuator for lift, whereas the proposed device uses a 12" linkage style mechanism. This increase in lift will have an impact on the stability of the wheelchair, however testing has shown that the resulting stability is still within the accepted range. In addition, the Modular Power Positioning System provides a maximum tilt angle of 50 degrees, whereas the predicate device provides 55 degrees. 50 degrees is an industry standard, and adequate for the intended use of the Modular Power Positioning System. This difference in maximum tilt angle does not adversely affect the safety or effectiveness of the system.
In addition to the drive lock out (DLO) system of the original system which is used to disable the wheelchair drive system when the seating system reaches a factory pre-set position, the new system also includes a second trigger which enables the reduced drive (RD) feature standard on most wheelchairs. This system allows the user to drive at a maximum of 25 to 30% speed when the seating system reaches a second, lower factory pre-set position. The system stability was tested for both driving modes, Full Drive (FD) and Reduced Drive (RD). For testing details see Bench Testing, Section 18 below.
Due to the improved mechanical efficiency of the Tilt, Recline, and Lift linkages, the new system uses less electrical power ( 24 VDC / 4 Amps) than the predicate device (24 VDC / 8 Amps) and does adversely affect the safety or effectiveness of the device.
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The Modular Power Positioning System includes a seat depth range of 15-22 compared to predicate which offers 16-24 inches, and a back height range of 18-30 inches compared to predicate which offers 18-26 inches. These new ranges are more effective in meeting user needs, and stability testing has shown the safety would not be adversely affected.
VII. PERFORMANCE DATA
The following performance data has been provided in support of the substantial equivalence determination.
Biocompatibility Testing ●
Bio-Compatibility was evaluated for all surface materials where prolonged skin contact may occur. Cytotoxicity testing per ISO 10993 Part 5: Testing for in vitro cytotoxicity was performed on all skin contacting surface materials such as Meshtex, Startex, Spacetex 4000U™, O-Vinyl, Style 6499 Polyester and Integral Skin foam.
. Electrical Safety and electromagnetic compatibility (EMC)
Electromagnetic Compatibility has been conducted on the Modular power positioning system. The system complies with RESNA Section 21, Requirements and Test Methods for Electromagnetic Compatibility of Electrically Powered Wheelchairs and Scooters.
. Software Verification and Validation Testing
Software verification and validation testing have been conducted and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device is considered to have a "Moderate level of Concern" because "prior to mitigation of hazards, a failure of the Software Device could result in Minor Injury, either to a patient or to a user of the device."
. Mechanical and acoustic testing
Mechanical testing of the Modular Power Positioning System was carried out to cover functional verification and device performance. Testing established correct
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functionality according to the relevant ANSI/RESNA standards. No acoustic testing was required to demonstrate device safety and effectiveness of the subject device.
. Animal Study
Animal performance testing was not required to demonstrate the safety and effectiveness of the subject device.
Clinical Studies .
Clinical testing was not required to demonstrate the safety and effectiveness of the subject device.
| Modular Power Positioning System (SubjectDevice) | TRZ CG (PredicateDevice) | |
|---|---|---|
| Indicationsfor Use | - All positioning benefits associated with thetilt/recline product — comfort, repositioning,pressure relief- Positioning/Versatility — Individuals are able toreach higher levels, increasing their range of motionand accessibility | Same |
| TargetPopulation | - Quadriplegics- persons with ALS, MS, spinal muscular atrophy, andany other disability which causes the individual torequire a power wheelchair and not be able to reach anelevated position or shift his/her weight | Same |
| Design | -mechanism includes a seat which tilts, reclines, andelevates- tilt, recline, and elevating seat utilize linear actuators | Same except elevatingfunction utilizes towerstyle actuator. |
| seat widthrange | 16 to 24 inches | 16 to 24 inches |
| seat depthrange | 15 to 22 inches | 16 to 24 inches |
| back height | 18 to 30 inches | 18 to 26 inches |
| Modular Power Positioning System (SubjectDevice) | TRZ CG (PredicateDevice) | |
| range | ||
| Materials | - steel tube and plate, aluminum, powder-coated | Same |
| Motor type | Linear actuator,gear reduction screw type | Linear actuator,gear reduction screwtype |
| Energy | 24 VDC Wheelchair Batteries | Same |
| Used | 4 Amps | 8 Amps |
| Performance- Tilt | 50° | 55° |
| Performance- Recline | 168° | 168° |
| Lift(ElevatingSeat) | 12 inches | 7 inches |
| MechanicalSafety | - wheelchair remains stable with fully elevated, tilted,and reclined seat — center-of-gravity shift furtherenhances stability- drive lock-out prevents user from driving power chairwhile tilted beyond a pre-set limit- tilt limit is available | Same |
| Where Used | - private residences- chronic-care facilities- indoors, outdoors | Same |
| ElectricalSafety | - electrical components are 24 volts maximum- current limit built into relay box | Same |
| StabilitySafety | - includes DLO (drive lock out) trigger- includes RD (reduced drive) trigger | Includes DLO only |
| StandardsMet | - RESNA, see details below | Same |
Predicate Device Comparison Table
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- . ANSI/RESNA WC-1:2009 Section 1: Determination of Static Stability
- . ANSI/RESNA WC-2:2009 Section 2: Determination of Dynamic Stability
- ANSI/RESNA WC-1:2009 Section 8: Requirements and Test Methods for Static, Impact . and Fatigue Strengths
- ANSI/RESNA WC-2:2009 Section 9: Climatic Tests .
- . ANSI/RESNA WC-1:2009 Section 11: Test Dummies
- ANSI/RESNA WC-1:2009 Section 13: Determination of Coefficient Friction of Test . Surfaces
- . ANSI/RESNA WC-1:2009 Section 14: Power and Control Systems Requirements and Test Methods
- ANSI/RESNA WC-1:2009 Section 15: Requirements for Information Disclosure, . Documentation and Labeling
- ANSI/RESNA WC-1:2009 Section 16 Resistance to Ignition of Upholstered Parts, or . EN12184:2014 section 8.10 Resistance to Ignition
- ANSI/RESNA WC-2:2009 Section 21: Requirements and Test Methods for . Electromagnetic Compatibility of Electrically Powered Wheelchairs and Motorized Scooters
- . ISO 10993:2009 Biological Evaluation of Medical Devices
- EN 1021-1/-2:2006: Testing of Ignitability For Upholstered Furniture . California Technical Bulletin 117-2013: Requirements For Testing The Smolder Resistance Of Materials Used In Upholstered Furniture
Conclusions
The Modular Power Positioning System has the same intended use and similar technological characteristics as the TRZ CG Power Positioning Device, K021264. The non-clinical testing and the predicate device comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety and effectiveness. Thus the Modular Power Positioning System is substantially equivalent to the predicate device, has passed all the necessary testing and is considered to be safe for user operation.
§ 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).