(118 days)
Not Found
No
The summary describes a manual wheelchair with no mention of AI or ML capabilities.
No
The device is described as a manual wheelchair for mobility, not to treat or diagnose a medical condition.
No
Explanation: The device is described as a manual wheelchair intended for mobility, not for diagnosing any medical conditions.
No
The device description clearly states it is a "manual wheelchair device" and a "foldable, ultra-lightweight and fully adjustable manual wheelchair," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to individuals with limited mobility. This is a physical function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a manual wheelchair, a physical aid for mobility.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The standard IKON 40 is a manual wheelchair device that is intended to be used to provide mobility to persons ages 12 and over (adolescents and adults) with a weight capacity of 300 lbs. The device is to be used as a means of mobility for persons limited to a sitting position.
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
The IKON 40 is a foldable, ultra-lightweight and fully adjustable manual wheelchair.
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 over (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 Testing: Testing was performed by a non-clinical laboratory on the IKON 40 to determine substantial equivalence based on the following standards:
- ANSI / RESNA - ISO 7176-1:2014 Wheelchairs - Section 1: Determination of static stability
- ANSI / RESNA ISO 7176-3:2012 Wheelchairs Section 3: Determination of effectiveness of brakes
- ANSI / RESNA - ISO 7176-5:2008 Wheelchairs - Section 5: Determination of dimensions, mass and maneuvering space
- ANSI / RESNA - ISO 7176-7:1998 Wheelchairs — Section 7: Measurement of seating and wheel dimensions
- ANSI / RESNA - ISO 7176-8:2014 Wheelchairs - Section 8: Requirements and test methods for static, impact and fatigue strengths
- ANSI / RESNA - ISO 7176-11 Wheelchairs- Section 11: Test Dummies
- ANSI / RESNA – ISO 7176-13 Wheelchairs- Section 13: Determination of coefficient of friction
- ANSI / RESNA - ISO 7176-15:1996 Wheelchairs — Section 15: Requirements for information disclosure, documentation and labelling
- 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
Key results: Non-clinical laboratory test results support the subject device and demonstrate the IKON 40 should perform as intended in the specified use conditions.
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): 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
§ 890.3850 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
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July 1, 2019
Broda Seating (Broda LP) Jeremy Ballard Product Manager 560 Bingemans Centre Drive Kitchener, ON, N2B3X9 CA
Re: K190550
Trade/Device Name: IKON 40 Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: March 28, 2019 Received: March 28, 2019
Dear Jeremy Ballard:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Vivek Pinto, Ph.D. Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190550
Device Name IKON 40 Manual Wheelchair
Indications for Use (Describe)
The standard IKON 40 is a manual wheelchair device that is intended to be used to provide mobility to persons ages 12 and over (adolescents and adults) with a weight capacity of 300 lbs. The device is to be used as a means of mobility for 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
Date Prepared (revised): June 28,2019
Submitter:
Broda Seating (Broda LP)
560 Bingemans Centre Drive
Kitchener, ON, N2B3X9
Registration Number 8043392
Phone: 844-552-7632
Fax: 844-442-7632
Device:
Device Trade Name: IKON 40 Manual Wheelchair Common or Usual Name: Folding Ultra-Lightweight, Manual Wheelchair Classification Name: Mechanical Wheelchair 21 CFR §890.3850 Regulatory Class: I Product Code IOR: Wheelchair, mechanical
Predicate Device:
MyOn HC™ Manual Wheelchair (K152536); manufactured by Invacare®
(1525712)
4
Device Description:
Technical Specifications (* Standard Configuration):
The IKON 40 is a foldable, ultra-lightweight and fully adjustable manual wheelchair.
| Specification | IKON 40 | |
|---|---|---|
| Cross bar | *1 x 1 | 2 x 1 |
| Seat widths | 16", *18" | 20", 22" |
| Seat depths | 16"- 22" Adjustable | 16"- 22" Adjustable |
| Seat height | 14", 15", 16", 17", 18", 19" | |
| Adjustable | 14", 15", 16", 17", 18", 19" | |
| Adjustable | ||
| Max user weight | 300 lbs. | 300 lbs. |
| Chair length | 40" | 40" |
| Chair width | 26" | 26" |
| Length (no legrests) | 30" | 30" |
| Folded height | 34.5" | 34.5" |
| Folded width | 13.5" | 13.5" |
| Total weight (Including legrests, armrests and | ||
| anti-tippers) | 34 lbs. | 34 lbs. |
| Front seat height | 16" | 16" |
| Backrest height | 16.5" | 16.5" |
| Legrests | *Swing Away | |
| Elevating | Swing Away | |
| Elevating | ||
| Legrest range | 13.5"- 19" Adjustable | 13.5"- 19" Adjustable |
| Legrest angle (°) | 70° | 70° |
| Footrests | Flip Up and Angle Adjustable | Flip Up and Angle Adjustable |
| Armrests | *Flip Back Adjustable Height | |
| Fixed Non-Adjustable | *Flip Back Adjustable Height | |
| Fixed Non-Adjustable | ||
| Armrest height range | 9"- 11" Adjustable | 9"- 11" Adjustable |
| Rear wheel | *22", 24" Spoke | |
| 22", 24" Composite Mag | *22", 24" Spoke | |
| 22", 24" Composite Mag | ||
| Front wheel | 5", 6", *7", 8" Castors | 5", 6", *7", 8" Castors |
Indications for Use:
The standard IKON 40 is a manual wheelchair device that is intended to brovide mobility to persons ages 12 and over (adolescents and adults) with a weight capacity of 300 lbs. The device is a means of mobility for persons limited to a sitting position.
5
Technological Characteristics Comparison to the Predicate Device:
The following device characteristics comparison demonstrates that the IKON 40 is substantially equivalent in design, construction, operational uses and functionality for persons limited to a sitting position as the previously cleared MyOn HC™ Manual Wheelchair (K152536).
| Characteristics | IKON 40 | MyOn HC™ (K152536) |
|---|---|---|
| Indications for Use | ||
| (IFU) | The IKON 40 is a manual wheelchair device | |
| that is intended to be used to provide | ||
| mobility to persons ages 12 and over | ||
| (adolescents and adults) with a weight | ||
| capacity of 300 lbs. The device is to be used | ||
| as a means of mobility for persons limited to | ||
| a sitting position. | The MyOn HC™ Manual Wheelchair is | |
| intended to provide mobility to persons | ||
| over 12 years of age (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 restricted to a sitting position. | ||
| Cross brace bars | 1 x 1 Aluminum Folding Frame | 1 x 1 Aluminum Folding Frame |
| 2 x 1 Aluminum Folding Frame | ||
| Folding Method | Collapsible Cross-Brace | Collapsible Cross-Brace |
| Warranty | Lifetime on Frame | Lifetime on Frame |
| Seat widths | 16", 18", 20", 22" | 15", 16", 17", 18",19", 20", 22", 24" |
| Seat depths | 16"- 22" | |
| Adjustable | 16"- 20" | |
| Adjustable | ||
| Max user weight | 300 lbs. (1 x 1) | |
| 300 lbs. (2 x 1) | 275 lbs. (1 x 1) | |
| 350 lbs. (2 x 1) | ||
| Wheelchair weight | ||
| (Including legrests, | ||
| armrests and anti- | ||
| tippers) | 34 lbs. | 31 lbs. |
| Seat height | 14", 15", 16", 17", 18", 19" | |
| Adjustable | 14", 15", 16", 17", 18",19", 20" Adjustable | |
| Legrests | Swing Away | |
| Elevating | Swing Away | |
| Elevating | ||
| Legrest range | 13.5"- 19" Adjustable | 13.25"- 18.25" Adjustable |
| Legrest angle (°) | 70° | 70°, 80°, 90° |
| Footrests | Flip Up and Angle Adjustable | Flip Up and Angle Adjustable |
| Armrests | Flip Back Adjustable Height | |
| Fixed Non-Adjustable | Flip Back Adjustable Height | |
| T Arm Adjustable Height | ||
| Armrest height range | 9"- 11" Adjustable | 9"- 11" Adjustable |
| Rear wheel | 22", 24" Spoke | |
| 22", 24" Composite Mag | 24", 25", 26" - Spoke | |
| 20", 22", 24" - Composite Mag | ||
| 20", 24", 25", 26" - Performance | ||
| Front wheel | 5", 6", 7", 8" Castors | 5", 6", 8" Castors |
| Anti-tippers | Yes, Optional | Yes, Optional |
| Standards - Strength, | ||
| Stability and Durability | ANSI / RESNA Wheelchair Standard Vol. 1 | |
| Section 1,3,5,7,8,15 &16 | ANSI / RESNA Wheelchair Standard Vol. 1 | |
| Section 1,3,5,7,8,15 &16 | ||
| Standards — FR | CAL 117 / ISO 8191 | CAL 117 / ISO 8191 |
6
Performance Testing Data:
Non-Clinical Testing:
Testing was performed by a non-clinical laboratory on the IKON 40 to determine substantial equivalence:
- ANSI / RESNA - ISO 7176-1:2014 Wheelchairs - Section 1: Determination of static stability
- ANSI / RESNA ISO 7176-3:2012 Wheelchairs Section 3: Determination of effectiveness of brakes ●
- ANSI / RESNA - ISO 7176-5:2008 Wheelchairs - Section 5: Determination of dimensions, mass and maneuvering space
- ANSI / RESNA - ISO 7176-7:1998 Wheelchairs — Section 7: Measurement of seating and wheel dimensions
- ANSI / RESNA - ISO 7176-8:2014 Wheelchairs - Section 8: Requirements and test methods for static, impact and fatigue strengths
- ANSI / RESNA - ISO 7176-11 Wheelchairs- Section 11: Test Dummies
- ANSI / RESNA – ISO 7176-13 Wheelchairs- Section 13: Determination of coefficient of friction
- ANSI / RESNA - ISO 7176-15:1996 Wheelchairs — Section 15: Requirements for information disclosure, documentation and labelling
- 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
Animal Study:
Animal testing was not required for this submission
Clinical Testing:
Clinical testing was not required for this submission
Conclusions:
The IKON 40, this 510(k) subject device, has the same intended use, safety and similar technological characteristics as the predicate device, the MyOn HC™. Non-clinical laboratory test results support the subject device and demonstrate the IKON 40 should perform as intended in the specified use conditions. Broda has determined that therefore, the IKON 40 Manual Wheelchair is substantially equivalent to the predicate device, MyOn HC™, identified above throughout this document.