(258 days)
The Future Mobility Healthcare Inc. Capella wheelchair is intended to provide mobility to persons limited to a sitting position.
Dynamic tilt in space mechanical wheelchair which offers adjustability to redistribute the body weight for optimal positioning. The tilting is operated by the care-giver in the back handles of the chair. The Capella/Capella 45 can accommodate different size occupants. The seat width and depth can be ordered in several sizes. The Capella/Capella 45 is constructed of a rigid, aluminum frame with anti-tippers and the ability to tilt and manual recline. Depending on the seat depths, it has a capacity to support a human weight of 350lbs (250lbs Capella45). One gas spring is used to lift an ddecline the seat and back to the tilting positions in the Capella 45. And the Capella uses two gas springs. The gas spring(s) are connected by cables to levers on the push bar so that they can be locked and unlocked by the caregiver.
The provided text is a 510(k) summary for a mechanical wheelchair, not a medical imaging or AI-powered diagnostic device. Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, ground truth for training set) are not applicable to this type of device submission.
The acceptance criteria for this device, a mechanical wheelchair, are primarily based on ensuring its safety and effectiveness through compliance with recognized standards and comparison to a predicate device.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The device (Future Mobility Healthcare Inc. Capella/Capella 45) demonstrates substantial equivalence to the predicate device (PDG Inc. Fuze T20) by meeting or exceeding similar performance characteristics and conforming to relevant safety standards.
| ITEM | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Capella/Capella 45) |
|---|---|---|
| Indications for Use | Providing mobility to persons limited to a sitting position. | Providing mobility to persons limited to a sitting position. |
| Product Description | Dynamic tilt-in-space mechanical wheelchair, rigid aluminum frame, anti-tippers, tilt and manual recline, gas spring(s) for tilt operation controlled by caregiver levers. Accommodates different size occupants. | Dynamic tilt-in-space mechanical wheelchair, rigid aluminum frame, anti-tippers, tilt and manual recline, gas spring(s) for tilt operation controlled by caregiver levers. Accommodates different size occupants. Capella uses two gas springs, Capella 45 uses one. |
| Intended surface for operation | All surfaces except rough surfaces. | All surfaces except rough surfaces. |
| Safety Characteristics | Spring return push-to-lock wheel lock, anti-tippers, rigid body frame for resistance to fatigue, shear, and impact forces. | Spring return push-to-lock wheel lock, anti-tippers, rigid body frame for resistance to fatigue, shear, and impact forces. Designed and tested according to ANSI/RESNA WC/Vol.1, with satisfactory results. |
| Overall Function & Physical Characs. | Rigid, aluminum frame, anti-tippers, tilt and manual recline. Capacity: 250 lbs. | Rigid, aluminum frame, anti-tippers, tilt and manual recline. Capacity: 350 lbs (Capella), 250 lbs (Capella 45). |
| Tilt | 20 degrees. | 17 degrees (Capella), 44 degrees (Capella 45). (Static stability test performed to ensure no stability problems). |
| Fixed Recline | 0 to 30 degrees. | -7 to +21 degrees (28 degrees). (Standard chair resting state is +7 deg recline). |
| Seat Width | 13-20 inches. | 16-24 inches. (Test results satisfactory, no impact on safety/effectiveness). |
| Seat Depth | 15-20 inches. | 15-20 inches. (Test results satisfactory, no impact on safety). |
| Seat-to-floor height | 13-20 inches (front). | 13-19 inches (front). (Comparable, no bearing on safety/effectiveness). |
| Adjustable arm heights | 10-14 inches. | 9.5-14 inches. (No impact on effectiveness/safety). |
| Front Riggings | 70 and 90 degrees. | 60, 70, 80, 90 degrees. (No impact on safety/effectiveness). |
| Back Post Heights | 20 and 25 inches. | 19 and 24 inches. (No impact on safety/effectiveness). |
| Rear Wheel Sizes | 12, 16, 20, 22, 24 inches. | 16, 20, 22, 24 inches. (Each size evaluated for stability and strength with satisfactory results). |
| Caster Sizes | 5, 6, or 8 inches. | 5, 6, 7, or 8 inches. (Each size evaluated by Future Mobility, no impact on safety). |
| Chair Width | For 12 and 16" rear wheels: seat width is +9.5"; for 20, 22, 24" rear wheels: seat width is +10.75". | Seat width +10.75 inches. (Safety evaluated to be satisfactory, no impact to effectiveness). |
| Chair Length (no riggings) | 28 inches. | 31 inches. (No impact on safety/effectiveness). |
| Overall Length | 42 inches. | 45 inches. (No impact on safety/effectiveness). |
| Maximum Human Support Weight | 250 lbs. | 350 lbs (Capella), 250 lbs (Capella 45). (All chairs passed safety, stability, fatigue, and strength tests). |
| Flammability Standards (Materials) | Meets California Technical Bulletin CAL177 standard for flame retardant. | Meets California Technical Bulletin CAL 177 standard for flame retardant for backrests and seat cushions. (No impact on safety and effectiveness). |
| Prescription use or over-the-counter | Over the counter. | Over the counter. (No impact to safety and effectiveness). |
| Gas Spring Configuration | Single center-positioned locking gas spring. | Capella: Two locking gas springs in tandem parallel configuration. Capella 45: Single center-positioned locking gas spring. (No impact to safety and effectiveness). |
| Compliance with Standards (Overall) | Implied compliance to relevant medical device standards for mechanical wheelchairs (as K063736 was cleared). | Developed in accordance with ISO 7176, parts 1, 5, 7, 8, 11, 13, and 15. All results are satisfactory and meet the standards indicated from ANSI/RESNA WC/Vol.1. Passed safety, stability, fatigue, and strength tests. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is an engineering and performance testing study conducted against harmonized standards. The submission states:
- "The Capella/Capella45 has been designed and tested according to the ANSI/RESNA WC/Vol.1. All results are satisfactory and meet the standards indicated from ANSI/RESNA WC/Vol.1"
- "All chairs passed safety, stability, fatigue and strength tests."
- "Each wheel size has been evaluated by Future Mobility for stability and strength with satisfactory results."
- "Each caster size has been evaluated by Future Mobility."
- The conclusion explicitly states: "Future Mobility Healtheare Capella Dynamic Tilt mechanical wheelchair was developed in accordance with ISO 7176, parts 1, 5, 7, 8, 11, 13, and 15. It is the conclusion that the Future Mobility HealthCare Capella wheelchair is safe and effective, as well as substantially equivalent to the legally marketed device identified as the predicate devices."
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a number of devices. It refers to "All chairs" and "Each wheel size" and "Each caster size," implying that representative samples of the manufactured devices and their components were tested. For a mechanical device of this nature, testing protocols usually involve a predefined number of units or components to demonstrate reliability and meet engineering standards.
- Data Provenance: Not explicitly stated, but the testing would have been conducted by Future Mobility Healthcare Inc. or a contracted testing facility, likely in the country of origin (Canada, based on the submitter's address). This is a prospective evaluation of the newly designed device's performance against established physical standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. "Ground truth" in the context of mechanical device testing typically refers to the objective physical measurements and performance metrics defined by the specific engineering standards (ANSI/RESNA WC/Vol.1, ISO 7176 parts). Experts are involved in setting these standards and designing the tests, but not in establishing "ground truth" for individual test results in the same way as in a diagnostic study.
4. Adjudication method for the test set
- Not applicable. Performance is measured against objective, quantitative engineering specifications, not subjective interpretation requiring adjudication.
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 or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI or diagnostic device. Performance is inherently "standalone" in that the wheelchair's mechanical properties are tested independently of a human user, though it's designed for human interaction.
7. The type of ground truth used
- Engineering Standards / Objective Performance Metrics: The "ground truth" is defined by the objective pass/fail criteria and quantitative limits set forth in the referenced international and national standards: ANSI/RESNA WC/Vol.1 and ISO 7176 (parts 1, 5, 7, 8, 11, 13, and 15). These standards cover aspects like static stability, strength, fatigue, dimensions, and material properties.
8. The sample size for the training set
- Not applicable. This is a mechanical device, not an AI model requiring a training set. The "design and development" process would involve iterative prototyping and testing, but not in the sense of a machine learning training set.
9. How the ground truth for the training set was established
- Not applicable. No training set is used for this type of device.
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Future Mobility Healthcare Inc. FDA Submittal - 510(k) CAPELLA .
K130788
510(k) Summary
Submitted by:
Future Mobility HealthCare Inc. 3223 Orlando Drive Mississauga. ON, L4V IC5 Tel. (1-888-737-4011)
DEC 0 5 2013
Contact:
Mr. Abdul Panchbhaya Toll Free: 1-888-737-4011. Local: 905-671-1661 asif?@futuremobility.ca
Date: Sept., 2013
Trade Name: Capella Dynamic Tilting, and Capella 45 variant, mechanical wheelchair
Common Name: Manual Wheelchair
Classification Name: Wheelchair. Mechanical
Regulation Number: 890.3850
Predicate Devices: PDG Inc. Fuze T20
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Future I
Future Mobility Healthcare Inc. FDA Submittal - 510(k) CAPELLA
Table of Comparison to Legally Marketed devices and effect of differences on safety and effectiveness . ·
| ITEM | Legally marketed:PDG Inc. Fuze T20 | Future MobilityHealthcare.Inc.Capella/Capella 45 | Impact on safety andeffectiveness |
|---|---|---|---|
| Indications for use | The PDG Fuze T20 isindicated for providingmobility to personslimited to a sittingposition. | The Capella/Capella45 is indicated forproviding mobility toperson limited to asitting position. | The indicated use fordevices is identical. |
| Manufacturer | PDG Product DesignInc. | Future MobilityHealthcare Inc. | n/a |
| K Number | K063736 | K130788 | n/a |
| Product Code: | IOR | IOR | n/a |
| FDA Product Class | 1 | 1 | n/a |
| Product Description | Dynamic tilt in spacemechanical wheelchairwhich offersadjustability toredistribute the bodyweight for optimalpositioning. The tiltingis operated by thecare-giver in the backhandles of the chair.The Fuze T20 canaccommodate differentsize occupants. Theseat width and depthcan be ordered inseveral sizes. | Dynamic tilt in spacemechanical wheelchairwhich offersadjustability toredistribute the bodyweight for optimalpositioning. The tiltingis operated by thecare-giver in the backhandles of the chair.The Capella/Capella45 can accommodatedifferent sizeoccupants. The seatwidth and depth can beordered in severalsizes. | All devices aredesigned with similarfunctions and theCapella/Capella 45 hasno features that impactthe safety andeffectiveness of thepredicate devices. |
| Intended surface forthe operation | To be operated on allsurfaces except roughsurfaces | To be operated on allsurfaces except roughsurfaces | Unites are intended forsame surface ofoperation |
| Safety Characteristics | Spring return push tolock wheel lock, anti-tippers | Spring return push tolock wheel lock, anti-tippers | All have the safetyrequirements for amechanicalwheelchair. Thisincludes anti-tipper |
| fixtures, wheel lockingmechanism and a rigidbody frame forresistance to fatigue,shear, as well asimpact forces. TheCapella/Capella45 hasbeen designed andtested according to theANSI/RESNAWC/Vol.1. All resultsare satisfactory andmeet the standardsindicated fromANSI/RESNAWC/Vol.1 | |||
| Performance /Function | |||
| Overall function andphysical characteristics | The Fuze T20 isconstructed of a rigid,aluminum frame withanti-tippers and theability to tilt andmanual recline.Depending on the seatdepths, it has acapacity to support ahuman weight of250lbs. One gas springis used to lift anddecline the seat andback to the tiltingpositions. The gasspring is connected bycables to levers on thepush bar so that it canbe locked andunlocked by thecaregiver. | The Capella/Capella45 is constructed of arigid, aluminum framewith anti-tippers andthe ability to tilt andmanual recline.Depending on the seatdepths, it has acapacity to support ahuman weight of350lbs (250lbsCapella45). One gasspring is used to lift anddecline the seat andback to the tiltingpositions in theCapella 45. And theCapella uses two gassprings. The gasspring(s) areconnected by cables tolevers on the push barso that they can belocked and unlocked | The Capella has thesame overall functionand physicalcharacteristics of amechanical tilt inspace wheelchair. Ituses two gas cylindersto tilt the user with thecontrols located on thestroller bars. TheCapella 45 similarlyuses just one gascylinder. |
| Tilt | 20 deg | by the caregiver.17deg Capella. 44 degCapella 45 | All devices have tiltcapability. The restingstate for the staticstability test has beenperformed on all toindicate that the tiltdoes not create anystability problems. |
| Fixed recline | 0 to 30 degrees | -7 to +21 degrees (28degrees) | All devices havesimilar degree of fixedrecline capability of upto 30 deg. And 28 deg.Respectively. Thestandard chair restingstate is at +7 degrecline. |
| Seat width | 13-20" | 16-24" | No impact on safetyand effectiveness. Testresults are satisfactory. |
| Seat depth | 15-20" | 15-20" | Seat depth is similarand no impact tosafety. Test results aresatisfactory. |
| Seat-to-floor height | 13-20" (front) | 13-19" (front) | Wheelchairs arecomparable in heightand the differenceshould not have abearing on safety andeffectiveness. |
| Adjustable arm heights | 10 to 14" | 9.5 to 14" | This does not have animpact oneffectiveness norsafety. |
| Front riggings | 70 and 90 deg | 60.70.80.90 deg | No impact on safetyand effectiveness |
| Back post heights | 20 and 25" | 19" and 24" | No impact on safetyand effectiveness |
| Rear wheel sizes | 12.16.20.22.24 | 16,20.22.24 | Various sizes areoffered depending onend users preference.Each wheel size has |
| been evaluated byFuture Mobility forstability and strengthwith satisfactoryresults | |||
| Caster Sizes | 5.6. or 8" | 5.6.7. or 8" | Various sizes areoffered depending onend users preference.No impact on safety aseach caster size hasbeen evaluated byFuture Mobility. |
| Chair width | For 12 and 16" rearwheels seat width is+9.5" for 20.22.24"rear wheels seat widthis +10.75" | Seat width +10.75" | Does not have anyimpact toeffectiveness. Safetyhas been evaluated tobe satisfactory |
| Chair length | 28" no riggings | 31" no riggings | No impact on safetyand effectiveness |
| Overall length | 42" | 45" | No impact on safetyand effectiveness |
| Maximum humansupport weight | 250lbs | 350lbs (Capella)250lbs (Capella45) | All chairs passedsafety, stability.fatigue and strengthtests. |
| Overall function andphysical characteristics | The Fuze T20 isconstructed of a rigidaluminum frame withanti-tippers and theability to tilt andmanual recline. It has acapacity to support ahuman weight of250lbs | The Capella (andCapella45) isconstructed of a rigidaluminum frame withanti-tippers and theability to tilt andmanual recline. It has acapacity to support ahuman weight of350lbs (250lbs Capella45) | All have the sameoverall function andphysical characteristicsof a mechanical tilt inspace wheelchair. |
| Materials | Fuze T20 materialmeet the CaliforniaTechnical BulletinCAL177 standard forflame retardant. | The material used onthe Capella/Capella45back rests and seatcushions meet theCalifornia TechnicalBulletin CAL 177 | Both wheelchairs meetthe flammabilitystandards of CAL 177.No impact on safetyand effectiveness. |
| standard for flameretardant. | |||
| Prescription use orover the counter | Over the counter | Over the counter | No impact to safetyand effectiveness |
| Gas spring | The Fuze T20 utilizesa single centrepositioned locking gasspring to operate thelift and decline of theseat. | The Capella utilizestwo locking gassprings in tandemparallel configurationto operate the lift anddecline of the seat. TheCapella 45 utilizes asingle centrepositioned locking gasspring to operate thelift and decline of theseat. | No impact to thesafety andeffectiveness. |
.
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Image /page/2/Picture/0 description: The image shows the logo for Future Mobility Healthcare Inc. The logo is in black and white and features a stylized wheelchair graphic above the word "Mobility". The text is slightly distorted, giving it a textured appearance.
Future Mobility Healtheare Inc. FDA Submittal - 510(k) CAPELLA
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Future Mobility Healthcare Inc. FDA Submittal - 510(k) CAPELLA
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Image /page/4/Picture/0 description: The image shows the logo for Future Mobility Healthcare Inc. The logo is in black and white and features a stylized wheelchair above the word "Mobility". The text is in a blocky, slightly distressed font, giving it a unique and somewhat vintage appearance.
Future Mobility Healthcare Inc. FDA Submittal - 510(k) CAPELLA
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Future Mobility Healthcare Inc.
FIDA Submittal - 510(k) CAPELLA ・
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Image /page/6/Picture/0 description: The image shows the logo for Future Mobility Healthcare Inc. The logo features the words "Future Mobility" in a bold, sans-serif font, with a stylized wheelchair graphic incorporated into the word "Mobility". Below this, the words "Healthcare Inc." are printed in a similar font, completing the company name.
Future Mobility Healthcare Inc. FDA Submittal - 510(k) CAPELLA
The rationale of declaring the Future Mobility Healthcare Capella wheelchair is substantially equivalent to the above predicate devices is based on the following:
- Same Indications for use: providing mobility to persons limited to a sitting position.
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Similar kev design technical characteristics- the Fuze T20 and Capella are mechanical wheelchairs which have technical similarities.
- The Fuze T20 and Capella Dynamic tilt, and Capella 45. wheelehairs are manually operated, self propelled mechanical wheelchairs, and may also be used as attendant propelled transport devices. They consist of aluminum frames for use by patients weighing up to 250 lbs and 350 lbs. respectively.
Conclusion:
Future Mobility Healtheare Capella Dynamic Tilt mechanical wheelchair was developed in accordance with ISO 7176. parts 1. 5. 7. 8. 11. 13. and 15. It is the conclusion that the Future Mobility HealthCare Capella wheelchair is safe and effective, as well as substantially equivalent to the legally marketed device identified as the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hamoshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 5, 2013
Future Mobility Healthcare c/o Abdulsamad Panchbhaya, President and CEO 3223 Orlando Drive Mississauga, ON L4V IC5
Re: K130788
Trade/Device Name: Capella Dynamic Tilt and Capella 45 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: October 18, 2013 Received: October 18, 2013
Dear Abdulsamad Panchbhaya:
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
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Page 2 - Abdulsamad Panchbhaya
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/forYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting 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): K130788
Device Name: Capella Dynamic Tilt and Capella 45
Indications For Use:
The Future Mobility Healthcare Inc. Capella wheelchair is intended to provide mobility to persons limited to a sitting position.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use × (21 CFR 807 Subpart C)
(Please do not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Joyce M. Whang -S
Page 1 of _ 1
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).