(123 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the mechanical aspects and safety standards of a manual wheelchair. There is no mention of AI, ML, or any computational processing related to the device's function.
No.
The device is a manual wheelchair, intended to provide mobility to persons with limitations, but it does not claim any therapeutic effect or treatment of a medical condition.
No
Explanation: The "MyOn HC™ Manual Wheelchair" is described as a device providing mobility to persons with limitations in movement. Its intended use and description solely focus on physical support and transportation, not on diagnosing any medical condition or disease.
No
The device description clearly states it is a "foldable, manually operated fully adjustable lightweight wheelchair" and describes physical components like a frame, folding mechanism, and riggings. The performance studies also focus on physical testing of the wheelchair's structure and materials.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a manual wheelchair intended to provide mobility to individuals with limitations. It is a physical device used externally by the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
The device is a mobility aid, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The MyOn HC™ Manual Wheelchair is intended to provide mobility to persons ages 12 and up (adolescents and adults) with a weight capacity of 220 & 290 lbs. depending on the seat width. The device is indicated to provide mobility to persons limited to a sitting position.
Product codes
IOR
Device Description
This Traditional [510(k)] submission is being supplied to the U.S. FDA to obtain authorization to market the MyOn HC™ Manual Wheelchair. The MyOn HC™ Manual Wheelchair is a foldable, manually operated fully adjustable lightweight wheelchair. It is indicated to provide mobility to persons which have limitations in mobility. It provides support and mobility to users that are seated in the wheelchair, for limited time up to permanent, full day usage. The design incorporates a horizontal folding mechanism connected to a left & right side frame on which many adjustments can be made to meet the individual user needs. The frame can be either equipped with swing in or swing out, detachable, riggings with an angle of 70°, 80° or the frame which has a fixed 80° front. It allows 5" of center of gravity (CG) adjustments and stepless backrest angle adjustments from -15° to + 15° which can be achieved whist the user is seated in the wheelchair. The subject device intended use is to provide mobility to persons ages 12 and up (adolescents and adults) with a weight capacity of 220 & 2901bs depending on the seat width. There is no prior submission for the subject device.
The associated accessories include:
- Posture belt .
- Tipper aid
- Air pump .
- Passive illumination ●
- . Cane holder
- . Luggage carrier
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
ages 12 and up (adolescents and adults)
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)
Non-Clinical Test:
Non-clinical laboratory testing was performed on the subject MyOn HCTM Manual Wheelchair to determine substantial equivalence. The following testing was performed:
- ANSI / RESNA WC/Volume 2 2009, Section 1: Determination of Static Stability .
- ANSI / RESNA WC/Volume 1 2009, Section 5: Determination of Dimensions, Mass ● and Maneuvering Space
- ANSI / RESNA WC/Volume 1 2009, Section 7: Measurement of Seating and Wheel ● Dimensions
- ANSI / RESNA WC/Volume 1 2009. Section 8: Static. Impact And Fatigue Strengths ● Tests
- ANSI / RESNA WC/Volume 1 2009, Section15: Requirements for Information . Disclosure, Documentation and Labeling
- ANSI / RESNA WC/Volume 1 2009, Section16: Resistance to Ignition of Upholstered ● Parts
- CAL117:2013, Section 1: Flammability Testing ●
- ISO 8191-1:1987 & 8191-2:1988: Flammability Testing ●
Testing demonstrated that the subject MyOn HC™M Manual Wheelchair is substantially equivalent to the marketed predicate device.
Animal Study:
Animal testing was not required for this submission.
Clinical Testing:
Clinical testing was not required for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Action Patriot Manual Wheelchair (K930803)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 5, 2016
Invacare Corporation Elijah Wreh Regulatory Affairs Manager (Pre-Market) One Invacare Way Elyria, Ohio 44035
Re: K152536
Trade/Device Name: MyOn HCTM Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: December 4, 2015 Received: December 7, 2015
Dear Elijah Wreh:
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 and Part 809); medical device reporting (reporting of medical 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
1
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 and Part 809), 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.
Michael J. Hoffmann -A
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152536
Device Name MyOn HCTM Manual Wheelchair
Indications for Use (Describe)
The MyOn HC™ Manual Wheelchair is intended to provide mobility to persons ages 12 and up (adolescents and adults) with a weight capacity of 220 & 290 lbs. depending on the seat width. The device is indicated to provide mobility to persons limited to a sitting position.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| SUBMITTER: | Invacare Corporation
One Invacare Way
Elyria, OH 44035 |
|-----------------------|--------------------------------------------------------------------------------------------------|
| | Phone: (440) 329-6840
Email: ewreh@invacare.com |
| CONTACT PERSON: | Elijah N. Wreh
Regulatory Affairs Manager (Pre-Market) |
| Date Prepared: | January 5, 2016 |
| DEVICE | |
| Name of Device: | MyOn HCTM Manual Wheelchair |
| Common or Usual Name: | Wheelchair, mechanical |
| Classification Name: | Mechanical wheelchair 21 CFR §890.3850 |
| Regulatory Class: | I |
| Product Code: | IOR: Wheelchair, mechanical |
| PREDICATE DEVICE: | Action Patriot Manual Wheelchair (K930803)
No reference devices were used in this submission. |
DEVICE DESCRIPTION
This Traditional [510(k)] submission is being supplied to the U.S. FDA to obtain authorization to market the MyOn HC™ Manual Wheelchair. The MyOn HC™ Manual Wheelchair is a foldable, manually operated fully adjustable lightweight wheelchair. It is indicated to provide mobility to persons which have limitations in mobility. It provides support and mobility to users that are seated in the wheelchair, for limited time up to permanent, full day usage. The design incorporates a horizontal folding mechanism connected to a left & right side frame on which many adjustments can be made to meet the individual user needs. The frame can be either equipped with swing in or swing out, detachable, riggings with an angle of 70°, 80° or the frame which has a fixed 80° front. It allows 5" of center of gravity (CG) adjustments and stepless backrest angle adjustments from -15° to + 15° which can be achieved whist the user is seated in the wheelchair. The subject device intended use is to provide mobility to persons ages 12 and up
4
(adolescents and adults) with a weight capacity of 220 & 2901bs depending on the seat width. There is no prior submission for the subject device.
The associated accessories include:
- Posture belt .
- Tipper aid
- Air pump .
- Passive illumination ●
- . Cane holder
- . Luggage carrier
INDICATIONS FOR USE
The MyOn HC™ Manual Wheelchair is intended to provide mobility to persons ages 12 and up (adolescents and adults) with a weight capacity of 220 & 290 lbs. depending on the seat width. The device is indicated to provide mobility to persons limited to a sitting position.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The device comparison showed that the subject device is substantially equivalent in intended use, design and operational principles to the previously cleared Action Patriot Manual Wheelchair (K930803). The subject device is substantially equivalent to the predicate device in regards to intended use, design, materials, and operational principles to provide mobility to persons limited to a sitting position.
5
Design Characteristics Comparison
| Design | Action Patriot Manual Wheelchair
Predicate Device
(K930803) | MyOn HCTM Manual Wheelchair
Subject Device
Pending Submission |
|---------------------------|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Weight Limit | 250Ibs | 220 & 290lbs* |
| Cross-brace Configuration | X-design | Folds lengthwise and backwards* |
| Seat Width | 14"-20" | 12"-21" * |
| Seat Depth | 16"& 18" | 14"-20" *
14"-16" adjustable*
16"-18" adjustable* |
| Back Style | Fixed or adjustable | Fixed or adjustable |
| Back Angle
Adjustment | -5 to +20 degrees in 5 degree increments | -15 to +15 degrees* |
| Back Height | 15-19", 16", 20" | 12"-20" |
| Arm Types | Flip-back arm rests | Flip-back arm rests, adjustable, desk length |
| Anti-Tippers | Optional | Optional |
| Wheel Locks | Push-to-Lock, Pull-to-Lock, Hill Holder | Push-to-Lock, Pull-to-Lock |
| Rear Wheel
Sizes | 20", 22", 24" | 22"-25" * |
| Caster Sizes | 6", 8" | 4"-7" * |
| Front
riggings | 60° straight
70° straight | Pivot inwards and outwards
70° straight
80° straight*
90° straight*
Elevate 0-80°* |
PERFORMANCE DATA
Non-Clinical Test
Non-clinical laboratory testing was performed on the subject MyOn HCTM Manual Wheelchair to
determine substantial equivalence. The following testing was performed:
- ANSI / RESNA WC/Volume 2 2009, Section 1: Determination of Static Stability .
- ANSI / RESNA WC/Volume 1 2009, Section 5: Determination of Dimensions, Mass ● and Maneuvering Space
- ANSI / RESNA WC/Volume 1 2009, Section 7: Measurement of Seating and Wheel ● Dimensions
- ANSI / RESNA WC/Volume 1 2009. Section 8: Static. Impact And Fatigue Strengths ● Tests
- ANSI / RESNA WC/Volume 1 2009, Section15: Requirements for Information . Disclosure, Documentation and Labeling
- ANSI / RESNA WC/Volume 1 2009, Section16: Resistance to Ignition of Upholstered ● Parts
- CAL117:2013, Section 1: Flammability Testing ●
- ISO 8191-1:1987 & 8191-2:1988: Flammability Testing ●
6
Testing demonstrated that the subject MyOn HC™M Manual Wheelchair is substantially equivalent to the marketed predicate device.
Animal Study
Animal testing was not required for this submission.
Clinical Testing
Clinical testing was not required for this submission.
CONCLUSIONS
The subject device has the same intended use and similar technological characteristics as the predicate device. The non-clinical laboratory data support the safety of the subject MyOn HC™ Manual Wheelchair and demonstrate that the subject device should perform as intended in the specified use conditions. Therefore, the subject MyOn HCTM Manual Wheelchair is substantially equivalent to the predicate device identified throughout this submission.