(172 days)
Not Found
No
The description focuses on mechanical features and standard wheelchair functionality. There is no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is a wheelchair chassis designed for mobilization and transport, not for directly treating or diagnosing a medical condition. While it can improve postural stability and comfort, this is a supportive function rather than a therapeutic one.
No
The device is a wheelchair chassis designed for mobilization and transport, not for diagnosing medical conditions.
No
The device description clearly outlines a physical wheelchair chassis made of fabricated steel with wheels and castors, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text clearly describes a wheelchair chassis designed for the mobilization and transportation of individuals. It is a mechanical device used externally on the body.
- Intended Use: The intended use is for mobility and transportation, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to sample collection, analysis, or diagnostic testing.
Therefore, based on the provided information, the TX Wheelchair Chassis is a mobility aid, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
IOR
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.
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
2 to adult
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)
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)
- WC Section 1 Static Stability (Results: Passed)
- WC Section 3 Determination of the Effectiveness of Brakes (Results: Passed)
- WC Section 5 Overall Dimensions, Mass, and Turning Space (Results: Passed)
- WC Section 7 Measurement of Seating and Wheel Dimensions (Results: Passed)
- WC Section 8 Static, Impact, and Fatigue Strength Dimensions (Results: Passed)
- 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.
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
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
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
1
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.
7. Indication for Use
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.
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 Seating
Solutions | Substantial
Equivalence
Comparison |
|---------------------|---------------------------|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name | Multi Frame
Wheelchair | TX Wheelchair
Chassis | - |
| 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 subject
chassis is made
from tubular steel
and the predicate
chassis is made
from tubular
aluminum, these
differences are |
| Table 5-A – Comparison of Characteristics |
|---|
| Multi Frame Wheelchair vs. TX Wheelchair Chassis |
2
| | | | insignificant as both
the subject and
predicate device
passed performance
testing in
accordance with
FDA recognized
consensus
standards for
mechanical
wheelchairs to
prove their safety
and 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 subject
and predicate
chassis are offered
in several different
models/frame sizes
based on their
overall width. The
slight difference in
size does not affect
the intended use of
these devices. |
| Front Wheel Options
(diameter) | 180 mm | 150/200 mm | The subject chassis
is offered with front
wheels (castors) in
two different sizes,
while the predicate
chassis is offered
with front wheels in
only one size. The
slight difference in
sizes does not affect
the intended use of
these devices. |
| Rear Wheel Options
(diameter) | 320/560 mm | 300/400/600 mm | The subject chassis
is offered with rear
wheels in three
different sizes,
while the predicate
chassis is offered
with rear wheels in
two different sizes.
The slight difference
in sizes does not
affect the intended
use of these
devices |
| Chassis Weight | | | |
| | Size 1/Size 2/Size 3
(320 mm)
= 13 kg
Size 1/Size 2/Size 3
(560 mm)
= 14 kg | TX 30
(300/400/600 mm)
= 16-17 kg
TX 35
(300/400/600 mm)
= 17-18 kg | While the subject
chassis is made
from tubular steel
and the predicate
chassis is made
from tubular
aluminum, these
differences are
considered to be
insignificant in their
overall operation by
either the user or
the user's assistant,
as both the subject
and predicate
devices passed
performance testing
in accordance with
FDA recognized
consensus
standards for
mechanical
wheelchairs to
prove their safety
and effectiveness. |
| Max. Chassis Load
(user/seat/accessories) | 100 kg
(220 lbs) | 110 kg
(243 lbs) | While the subject
chassis is made
from tubular steel
and can handle a
slightly larger
maximum load
capacity when
compared to the
predicate chassis
that is made from
tubular aluminum,
these differences
are insignificant as
both the subject
and predicate
devices passed
performance testing
in accordance with
FDA recognized
consensus
standards for
mechanical
wheelchairs to |
| | | | prove their safety
and effectiveness. |
| Tilt/Prone Seat Angle | 0-30°/35°/40° | -30°/+5° | Both the subject
and predicate
chassis are offered
with the ability of
their postural
seating system (an
accessory offered
with the chassis by
their manufacturer)
to be tilted back. In
the case of the
subject device, the
amount of rearward
tilt is set at -30°,
while in the case of
the predicate device
the amount of
rearward tilt can be
positioned to -
30°/35°/40°
depending on how
the seating system
is mounted to the
frame. While the
predicate device
also has the ability
to tilt forward +5°.
The slight difference
in forward and rear
tilt options between
the subject and
predicate devices
does not affect their
overall intended
use. |
| Age of Occupant | Children | 2-adult | The subject chassis
is designed for
occupants ages 2 -
adult (18) up to 243
lbs in weight, while
the predicate
chassis is designed
for children up to
220 lbs in weight. |
| User Environment | General indoor and
outdoor use | General indoor and
outdoor use | Both the subject
and predicate
chassis 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 which
the postural seating
system is attached. |
| Foot Support | Yes | Yes | Both the subject
and predicate
chassis are offered
with a frame
mounted foot
support (rest) for
the occupant to rest
their feet on when
using the device. |
| Transport Tie-Down
Fittings | Yes | Yes | Both the subject
and predicate
chassis are offered
with a WTORS
(Wheelchair Tie
Down and Restraint
Systems) fittings
that allow the
chassis/seating
system/occupant to
be safely secured
(tied down) during
transport. |
| Indications for Use | The Multi Frame's
intended function
and use is to
provide mobility to
children limited to a
sitting position. The
Wheelchair consists
primarily of an
aluminum frame,
large rear wheels
with hand rims for
propelling the
wheelchair or
smaller rear wheels
for attendant-only
use, and smaller
front pivoting
casters for steering
and turning. | 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. | Some minor
differences
between the subject
and predicate
device are:
•The frame of the
subject chassis is
made of steel, while
the frame of the
predicate chassis is
made from
aluminum.
•Both the subject
and predicate
chassis are offered
in several frame
sizes.
•Both the subject
and predicate
chassis are offered
with different
options for their
rear wheel
diameter while the |
| | | subject chassis is
offered with front
wheels in two size
diameters, and the
predicate device is
offered in only one
size.
•Both the subject
and predicate
chassis allow for the
occupant to be
tilted back to a
prone position. | |
| | | | |
| | | | |
3
4
5
・
6
.
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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)
8
- 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
9
Solutions, is therefore determined to be substantially equivalent to the predicate device manufactured by Snug Seat, Inc., previously cleared under K100084.
10
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
11
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
12
Indications for Use
510(k) Number (if known): K131336
Device Name:_TX Wheelchair Chassis
Indications For Use:
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.
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
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