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.

Device Description

The IKON 40 is a foldable, ultra-lightweight and fully adjustable manual wheelchair.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for a manual wheelchair (IKON 40). It details the device's characteristics and compares it to a predicate device to establish substantial equivalence.

Based on the provided text, the device in question is a manual wheelchair, not an AI/imaging device. Therefore, a discussion of "AI performance metrics, ground truth, experts, and training/test sets" is not applicable.

The document focuses on substantiating the equivalence of the IKON 40 Manual Wheelchair to a legally marketed predicate device (MyOn HC™ Manual Wheelchair) through non-clinical performance testing and technical characteristic comparison, rather than AI-driven diagnostic or assistive capabilities.

Here's a breakdown of the relevant information provided:

Acceptance Criteria and Device Performance (for a Manual Wheelchair)

The acceptance criteria for a mechanical wheelchair are typically demonstrated through compliance with established industry standards for safety, durability, and functionality. The "reported device performance" is the successful completion and compliance with these standards.

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Acceptance Criteria (Standard Compliance)	Reported Device Performance (Met/Compliant)
ANSI / RESNA - ISO 7176-1:2014 (Static stability)	Met
ANSI / RESNA ISO 7176-3:2012 (Effectiveness of brakes)	Met
ANSI / RESNA - ISO 7176-5:2008 (Dimensions, mass, maneuvering space)	Met
ANSI / RESNA - ISO 7176-7:1998 (Seating and wheel dimensions)	Met
ANSI / RESNA - ISO 7176-8:2014 (Static, impact, fatigue strengths)	Met
ANSI / RESNA - ISO 7176-11 (Test Dummies)	Met
ANSI / RESNA – ISO 7176-13 (Coefficient of friction)	Met
ANSI / RESNA - ISO 7176-15:1996 (Information disclosure, documentation, labeling)	Met
ANSI / RESNA WC/Volume 1 2009, Section16 (Resistance to Ignition of Upholstered Parts)	Met
CAL117:2013, Section 1 (Flammability Testing)	Met
ISO 8191-1:1987 & 8191-2:1988 (Flammability Testing)	Met

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is described under "Performance Testing Data: Non-Clinical Testing" on page 6 of the document.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify a "sample size" in terms of number of units tested. For mechanical devices undergoing standard compliance testing, it's typically a specific number of prototypes or production units (e.g., 1-3 units of each configuration) to demonstrate compliance with the specified test methods. The document states "Testing was performed by a non-clinical laboratory on the IKON 40."
Data Provenance: The testing was non-clinical laboratory testing. The document does not specify a country of origin for the testing itself, but the manufacturer (Broda Seating) is based in Kitchener, ON, Canada. The testing involves physical and mechanical evaluations of the wheelchair's various components and overall structure against predefined standards. This is inherently prospective testing, as it's performed specifically for the purpose of this submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This question is not applicable as the device is a manual wheelchair, not an AI/imaging device. "Ground truth" in this context is established by the test standards themselves and objective measurements/observations during physical testing, not expert consensus on images.

4. Adjudication Method for the Test Set:

This question is not applicable as the device is a manual wheelchair. Adjudication methods like 2+1 or 3+1 are used for human review of data, typically in AI or clinical studies. For mechanical testing, the results are objectively measured against the specified standard's pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

This question is not applicable as the device is a manual wheelchair. MRMC studies are relevant for evaluating the impact of AI on human reader performance in diagnostic tasks.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This question is not applicable as the device is a manual wheelchair. "Standalone performance" refers to the performance of an algorithm without human intervention, which is not relevant here.

7. The Type of Ground Truth Used:

The "ground truth" for a mechanical device like a wheelchair is established by the international and national performance standards themselves (e.g., ANSI / RESNA ISO 7176 series, CAL117). These standards define the test methods and the acceptable ranges or pass/fail criteria for static stability, brake effectiveness, dimensions, strengths, flammability, etc. The "truth" is whether the device physically meets these empirically defined and externally validated criteria.

8. The Sample Size for the Training Set:

This question is not applicable as the device is a manual wheelchair and does not involve AI or machine learning algorithms that require a "training set."

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable as there is no training set for a manual wheelchair.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K190550

Device Name IKON 40 Manual Wheelchair

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date Prepared (revised): June 28,2019

K190550

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)

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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 andanti-tippers)	34 lbs.	34 lbs.
Front seat height	16"	16"
Backrest height	16.5"	16.5"
Legrests	*Swing AwayElevating	Swing AwayElevating
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 HeightFixed Non-Adjustable	*Flip Back Adjustable HeightFixed Non-Adjustable
Armrest height range	9"- 11" Adjustable	9"- 11" Adjustable
Rear wheel	*22", 24" Spoke22", 24" Composite Mag	*22", 24" Spoke22", 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.

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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 devicethat is intended to be used to providemobility to persons ages 12 and over(adolescents and adults) with a weightcapacity of 300 lbs. The device is to be usedas a means of mobility for persons limited toa sitting position.	The MyOn HC™ Manual Wheelchair isintended to provide mobility to personsover 12 years of age (adolescents andadults) with a weight capacity of 220 & 290lbs. depending on the seat width. Thedevice is indicated to provide mobility topersons restricted to a sitting position.
Cross brace bars	1 x 1 Aluminum Folding Frame	1 x 1 Aluminum Folding Frame2 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 AwayElevating	Swing AwayElevating
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 HeightFixed Non-Adjustable	Flip Back Adjustable HeightT Arm Adjustable Height
Armrest height range	9"- 11" Adjustable	9"- 11" Adjustable
Rear wheel	22", 24" Spoke22", 24" Composite Mag	24", 25", 26" - Spoke20", 22", 24" - Composite Mag20", 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. 1Section 1,3,5,7,8,15 &16	ANSI / RESNA Wheelchair Standard Vol. 1Section 1,3,5,7,8,15 &16
Standards — FR	CAL 117 / ISO 8191	CAL 117 / ISO 8191

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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.

Regulation Number and Section

§ 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).