The TX Wheelchair Chassis is designed and manufactured by JCM Seating Solutions for the mobilization of occupants ages 2 to adult, and intended primarily for general indoor and outdoor (smooth surfaces) use. The chassis and seating system combination can also be used for transporting the occupant in a suitable motor vehicle.

Device Description

The TX Wheelchair Chassis is designed and manufactured by JCM Seating Solutions for the mobilization of both our own postural seating systems and those manufactured by other specialist seating providers, and is indicated for occupants ages 2 to adult, and intended primarily for general indoor and outdoor (smooth surfaces) use.

The chassis consist of a fabricated steel framework with two rear wheels and two front castors where both front and rear wheel sizes can be selected at point of order from a pre-determined range. The TX Wheelchair Chassis also has a "tilt in space" feature that allows for the user's position in space to be changed between -30°/+5°, which may lead to improvements in postural stability and comfort, contributing to enhanced functional activity. A push handle is provided to enable an attendant to propel the chassis and the seated occupant and under certain circumstances the product could be setup to enable the occupant to self-propel through the rear wheels themselves. The chassis and seating system combination can also be used for transporting the occupant in a suitable motor vehicle and has tie-down points to facilitate this.

AI/ML Overview

The TX Wheelchair Chassis is designed for the mobilization of individuals aged 2 to adult for general indoor and outdoor use on smooth surfaces, and can also be used for transportation in a motor vehicle.

Here’s an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Test Performed	Reported Device Performance
Static Stability	ANSI/RESNA WC-1:2009 WC Section 1	Passed
Effectiveness of Brakes	ANSI/RESNA WC-1:2009 WC Section 3	Passed
Overall Dimensions, Mass, and Turning Space	ANSI/RESNA WC-1:2009 WC Section 5	Passed
Measurement of Seating and Wheel Dimensions	ANSI/RESNA WC-1:2009 WC Section 7	Passed
Static, Impact, and Fatigue Strengths	ANSI/RESNA WC-1:2009 WC Section 8; ISO 7176-8:1998	Passed
Requirements for Information, Disclosure, Documentation, and Labeling	ANSI/RESNA WC-1:2009 WC Section 15	Passed
Application of Risk Management to Medical Devices	ISO 14971:2007	No specific performance reported, but adherence to standard implies risk management process was followed.

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

The provided summary does not explicitly state the number of individual devices tested for each standard. However, it indicates that "its device" (singular) was submitted for testing, suggesting at least one representative sample was subjected to the various tests. The testing was performed in accordance with national and international standards, implying that the data provenance is from a controlled testing environment, likely performed by a third-party testing facility. The country of origin of the device manufacturer is the United Kingdom. This was a non-clinical, retrospective study in the sense that the testing was performed on the completed device to demonstrate its compliance with established standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable. The "ground truth" for the performance criteria of a mechanical device like a wheelchair chassis is established by the defined parameters and methodologies within the recognized consensus standards (ANSI/RESNA WC-1 and ISO 7176-8). The testing engineers/technicians performing the tests are qualified to execute these standardized procedures, but they don't establish "ground truth" in the same way clinical experts do for diagnostic tests.

4. Adjudication Method for the Test Set

This information is not applicable. The device's performance against the acceptance criteria is objectively measured based on the standardized test protocols, not through expert adjudication in the context of clinical agreement or subjective assessment.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where human interpretation is involved. The TX Wheelchair Chassis is a mechanical device, and its safety and effectiveness are assessed through engineering and performance testing against established standards, not through comparative studies with human readers.

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

No, a "standalone" study in the context of an algorithm's performance was not done. This device is a mechanical product, not an AI or software algorithm. Its performance is inherent to its physical design and construction under various load and usage conditions.

7. The Type of Ground Truth Used

The ground truth used for assessing the device's performance is defined by the objective pass/fail criteria and tolerance limits established within the cited consensus standards:

ANSI/RESNA WC-1:2009, American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters)
ISO 7176-8:1998, Wheelchairs -- Part 8: Requirements and Test Methods for Static, Impact and Fatigue Strengths
ISO 14971:2007, Medical Devices -- Application of Risk Management to Medical Devices

These standards specify the conditions, procedures, and acceptable outcomes for tests related to static stability, brake effectiveness, dimensions, strength, and fatigue.

8. The Sample Size for the Training Set

This information is not applicable as this is a mechanical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as this is a mechanical device, not an AI or machine learning model that requires a training set. The design and manufacturing process would involve engineering specifications and quality controls, but not "ground truth" in the context of data for model training.

Summary

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K131336

510(k) Summary for TX Wheelchair Chassis

1. Submission Sponsor

JCM Seating Solutions Ltd 15-18 Maxwell Road Woodston Industrial Estate Peterborough Cambridgeshire PE2 7HU United Kingdom Phone: 44 1733 405830 Fax: 44 1733 405838 Contact: Wayne Killick, Operations Director Website: www.jcmseating.co.uk

OCT 2 8 2013

2. Submission Correspondent

Emergo Group 816 Congress Avenue Suite 1400 Austin, TX 78701 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Stuart R. Goldman, Senior Consultant, RA/QA Email: project.management@emergogroup.com

3. Date Prepared

March 19, 2013

4. Device Identification

Trade/Proprietary Name: TX Wheelchair Chassis Common/Usual Name: Wheelchair Classification Name: Wheelchair, Mechanical Classification Regulation: 890.3850 Product Code: IOR Device Class: Class I Physical Medicine Classification Panel:

5. Predicate Device

Multi Frame Wheelchair (K100084)

6. Device Description

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ages 2 to adult, and intended primarily for general indoor and outdoor (smooth surfaces) use.

7. Indication for Use

8. Substantial Equivalence Discussion

The following table compares the TX Wheelchair Chassis to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

Device Manufacturer	Snug Seat	JCM SeatingSolutions	SubstantialEquivalenceComparison
Device Trade Name	Multi FrameWheelchair	TX WheelchairChassis	-
FDA 510(k)	K100084	Pending	-
FDA Product Code	IOR	IOR	IOR
FDA Regulation	§ 890.3850	§ 890.3850	§ 890.3850
Frame Construction	Tubular aluminum	Tubular steel	While the subjectchassis is madefrom tubular steeland the predicatechassis is madefrom tubularaluminum, thesedifferences are

Table 5-A – Comparison of Characteristics
Multi Frame Wheelchair vs. TX Wheelchair Chassis

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			insignificant as boththe subject andpredicate devicepassed performancetesting inaccordance withFDA recognizedconsensusstandards formechanicalwheelchairs toprove their safetyand effectiveness.
Frame Models/Sizes(overall width)	Size 1/Size 2/Size 3(590/640/690 mm)	TX 30/TX 35(550/620 mm)	Both the subjectand predicatechassis are offeredin several differentmodels/frame sizesbased on theiroverall width. Theslight difference insize does not affectthe intended use ofthese devices.
Front Wheel Options(diameter)	180 mm	150/200 mm	The subject chassisis offered with frontwheels (castors) intwo different sizes,while the predicatechassis is offeredwith front wheels inonly one size. Theslight difference insizes does not affectthe intended use ofthese devices.
Rear Wheel Options(diameter)	320/560 mm	300/400/600 mm	The subject chassisis offered with rearwheels in threedifferent sizes,while the predicatechassis is offeredwith rear wheels intwo different sizes.The slight differencein sizes does notaffect the intendeduse of thesedevices
Chassis Weight
	Size 1/Size 2/Size 3(320 mm)= 13 kgSize 1/Size 2/Size 3(560 mm)= 14 kg	TX 30(300/400/600 mm)= 16-17 kgTX 35(300/400/600 mm)= 17-18 kg	While the subjectchassis is madefrom tubular steeland the predicatechassis is madefrom tubularaluminum, thesedifferences areconsidered to beinsignificant in theiroverall operation byeither the user orthe user's assistant,as both the subjectand predicatedevices passedperformance testingin accordance withFDA recognizedconsensusstandards formechanicalwheelchairs toprove their safetyand effectiveness.
Max. Chassis Load(user/seat/accessories)	100 kg(220 lbs)	110 kg(243 lbs)	While the subjectchassis is madefrom tubular steeland can handle aslightly largermaximum loadcapacity whencompared to thepredicate chassisthat is made fromtubular aluminum,these differencesare insignificant asboth the subjectand predicatedevices passedperformance testingin accordance withFDA recognizedconsensusstandards formechanicalwheelchairs to
			prove their safetyand effectiveness.
Tilt/Prone Seat Angle	0-30°/35°/40°	-30°/+5°	Both the subjectand predicatechassis are offeredwith the ability oftheir posturalseating system (anaccessory offeredwith the chassis bytheir manufacturer)to be tilted back. Inthe case of thesubject device, theamount of rearwardtilt is set at -30°,while in the case ofthe predicate devicethe amount ofrearward tilt can bepositioned to -30°/35°/40°depending on howthe seating systemis mounted to theframe. While thepredicate devicealso has the abilityto tilt forward +5°.The slight differencein forward and reartilt options betweenthe subject andpredicate devicesdoes not affect theiroverall intendeduse.
Age of Occupant	Children	2-adult	The subject chassisis designed foroccupants ages 2 -adult (18) up to 243lbs in weight, whilethe predicatechassis is designedfor children up to220 lbs in weight.
User Environment	General indoor andoutdoor use	General indoor andoutdoor use	Both the subjectand predicatechassis are designed
			for general indoor and outdoor use under normal environmental conditions.
Parking Brakes	Yes	Yes	Both the subject and predicate chassis are offered with a hand operated barking system that engages the rear wheels and can be adjusted to accommodate the different size rear wheel options that each model of device is offered in.
Hand (Drum) Brakes	Yes	Yes	Both the subject and predicate chassis are offered with drum brakes that can be operated by the occupant's assistant, and these brake levers are mounted (one on each side) of the device's push brace that is attached to the chassis frame.
Anti-Tip Mechanism	Yes	Yes	Both the subject and predicate chassis are offered with an anti-tip mechanism by way of a frame mounted anti-tip bar that is attached to the rear of the chassis that can be rotated to either engage or disengage into position.
Seat Plate	Yes	Yes	Both the subject and predicate chassis are offered with an interface
			(seat) plate to whichthe postural seatingsystem is attached.
Foot Support	Yes	Yes	Both the subjectand predicatechassis are offeredwith a framemounted footsupport (rest) forthe occupant to resttheir feet on whenusing the device.
Transport Tie-DownFittings	Yes	Yes	Both the subjectand predicatechassis are offeredwith a WTORS(Wheelchair TieDown and RestraintSystems) fittingsthat allow thechassis/seatingsystem/occupant tobe safely secured(tied down) duringtransport.
Indications for Use	The Multi Frame'sintended functionand use is toprovide mobility tochildren limited to asitting position. TheWheelchair consistsprimarily of analuminum frame,large rear wheelswith hand rims forpropelling thewheelchair orsmaller rear wheelsfor attendant-onlyuse, and smallerfront pivotingcasters for steeringand turning.	The TX WheelchairChassis is designedand manufacturedby JCM SeatingSolutions for themobilization ofoccupants ages 2 toadult, and intendedprimarily for generalindoor and outdoor(smooth surfaces)use. The chassis andseating systemcombination canalso be used fortransporting theoccupant in asuitable motorvehicle.	Some minordifferencesbetween the subjectand predicatedevice are:•The frame of thesubject chassis ismade of steel, whilethe frame of thepredicate chassis ismade fromaluminum.•Both the subjectand predicatechassis are offeredin several framesizes.•Both the subjectand predicatechassis are offeredwith differentoptions for theirrear wheeldiameter while the
		subject chassis isoffered with frontwheels in two sizediameters, and thepredicate device isoffered in only onesize.•Both the subjectand predicatechassis allow for theoccupant to betilted back to aprone position.

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9. Non-Clinical Performance Data

As part of demonstrating the safety and effectiveness of its TX Wheelchair Chassis and in showing substantial equivalence to the predicate device, JCM Seating Solutions submitted its device for extensive performance testing in accordance with the following FDA guidance document and recognized consensus standards shown below.

. Guidance Document for the Preparation of Premarket Notification [510k]] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles
ANSI/RESNA WC-1:2009, American National Standard for Wheelchairs -. Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters)

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o WC Section 1 Static Stability (Results: Passed)
o WC Section 3 Determination of the Effectiveness of Brakes (Results: Passed)
o WC Section 5 Overall Dimensions, Mass, and Turning Space (Results: Passed)
o WC Section 7 Measurement of Seating and Wheel Dimensions (Results: Passed)
O WC Section 8 Static, Impact, and Fatigue Strength Dimensions (Results: Passed)
o WC Section 15 Requirements for Information, Disclosure, Documentation, and Labeling (Results: Passed)
. ISO 7176-8:1998, Wheelchairs -- Part 8: Requirements and Test Methods for Static, Impact and Fatigue Strengths (Results: Passed)
ISO 14971: 2007, Medical Devices -- Application of Risk Management to . Medical Devices

The TX Wheelchair Chassis passed all the testing in accordance with national and international standards stated above as shown by the acceptable results obtained.

10. Clinical Testing

There was no clinical testing required to support the TX Wheelchair as the indications for use is equivalent to the predicate device. Mechanical wheelchairs, including the predicate device, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared device, or has the same intended use and different technological characteristics, but it can be demonstrated that the new device is substantially equivalent to the predicate device, and that the new device does not raise any questions regarding its safety and effectiveness when compared to the predicate device.

It has been shown in this 510(k) submission that the differences between the TX Wheelchair Chassis and the Multi Frame Wheelchair do not raise any questions regarding its safety and effectiveness when used as indicated. Furthermore, the TX Wheelchair Chassis has undergone extensive performance testing in accordance with the applicable sections of ANSI/RESNA WC-1 and ISO 7176-8 to demonstrate its safety. The TX Wheelchair Chassis, as designed and manufactured by JCM Seating

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Solutions, is therefore determined to be substantially equivalent to the predicate device manufactured by Snug Seat, Inc., previously cleared under K100084.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 28, 2013

JCM Seating Solutions. Ltd c/o Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K131336

Trade/Device Name: TX Wheelchair Chassis Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: September 30, 2013 Received: October 1, 2013

Dear Mr. Job:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Mark Job

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/ResourcesforYou/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/ReportalProblem/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.

v.ru.207/MedicalDevices/ResourcesforIndustry/ucm400142.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): K131336

Device Name:_TX Wheelchair Chassis

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 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

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).