Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical aspects and safety standards of a manual wheelchair, with no mention of AI or ML technologies.

Therapeutic

No.
The device is a manual wheelchair intended to provide mobility, which is an assistive device rather than a therapeutic device.

Diagnostic

No

The device description and intended use clearly state that this is a manual wheelchair designed to provide mobility, not to diagnose any medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical, mechanical device (a manual wheelchair) with various hardware components and materials. There is no mention of any software functionality.

IVD (In Vitro Diagnostic)

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, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
Device Description and Intended Use: The provided information clearly describes a Manual Wheelchair used for mobility for individuals restricted to a sitting position. It is a physical device used externally on the body for support and movement.
Lack of Biological Specimen Analysis: There is no mention of the device interacting with or analyzing any biological specimens.
Focus on Mechanical Performance: The performance studies listed focus on mechanical aspects like stability, braking, dimensions, and strength, which are relevant to a mobility aid, not an IVD.

The device described is a medical device, specifically a mobility aid, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Manual Wheelchair is to provide mobility to persons restricted to a sitting position.

Product codes

IOR

Device Description

The Aluminum Manual Wheelchair is indoor/outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat.
Main components:
Main frame, handle sleeve, back upholstery, seat upholstery, armrest, side panel, rear wheel with handle ring, rear wheel axle, legrest, footplate, front fork, front wheels, cross bar.
Main materials:
Main frame, cross bar, legrest: Aluminum, silver/blue coating
Back upholstery, seat upholstery: Cover is polyester non-woven, inside with flame resistant foam
Handle sleeve, handle sleeve, side panel, handle ring, footplate: PVC
Tire of rear wheels, front wheels, armrest pad: PU

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

Not Found

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

Usability Study:
The 15 participants read the User Manual before initial use of the device. They can understand the questions and answer them. The 15 participants can operate the device referring to the User Manual.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Tests Performed:
The following testing was performed on the "Mechanical Wheelchair SIVFH2A102" in accordance with the requirements of the design control regulations and established quality assurance procedures.
Safety and performance:
ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes
ISO 7176-5:2008 Wheelchairs - Part 5: Determination of dimensions, mass and maneuvering space
ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
ISO 7176-11:2012 Wheelchairs - Part 11: Test dummies
ISO 7176-13:1989 Wheelchairs - Part 13: Determination of friction of test surface
ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
ISO 7176-16:2012 Wheelchairs - Part 16: Resistance to ignition of postural support devices
ISO 7176-22:2014 Wheelchairs - Part 22: Set-up procedures
Biocompatibility:
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
Results for "Manual Wheelchair SIVFH2A102" met all relevant requirements in the test standards, our internal specifications, and are comparable to the predicate device.
"Mechanical Wheelchair SIVFH2A102" meets performance requirements per ISO 7176-1:2014, ISO 7176-3: 2012, ISO 7176-5:2008, ISO 7176-7:1998, ISO 7176-8:2014, ISO 7176-11:2012, 7176-13: 1989, ISO 7176-15: 1996, ISO 7176-16:2012 and ISO 7176-22:2014. It is safe and effective, and its performances meet the requirements of the pre-defined acceptance criteria and intended use.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K181795 AST Model MA012 and MS019 Rehab Wheelchair

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

May 29, 2019

Jiangsu Horizon Medical Science & Technology Co., Ltd. % Jinghua Zhou Regulation Control Manager Guangzhou Junyi Information Technology Co., Ltd. Room 215, Huaming Building, Chebei Road Guangzhou, 511660 CN

Re: K190534

Trade/Device Name: Manual Wheelchair SIVFH2A102 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: March 4, 2019 Received: March 4, 2019

Dear Jinghua Zhou:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K190534

Device Name Manual Wheelchair SIVFH2A102

Indications for Use (Describe)

The Manual Wheelchair is to provide mobility to persons restricted 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

Section 5 - 510(k) Summary

Date of Summary Preparation: February 22, 2019

1. Submitter's Identifications

Submitter's Name: Jiangsu Horizon Medical Science & Technology Co., Ltd. Address: No.1 Guanhe Road, Situ Town, Danyang City, Jiangsu Province, China, 212331 Contact Person: Cheng Gong Contact Title: QA Manager Contact E-mail Address: markgong@phoenixmedical.cn Telephone: +86-0511-86808686 Fax: +86-0511-86160891

2. Correspondent's Identifications

Correspondent's Name: Guangzhou Junyi Information Technology Co., Ltd. Address: Room 215, Huaming Building, Chebei Road, Guangzhou, P.R. China ZIP Code: 511660 Contact Person: Jinghua Zhou Contact Title: Regulation Control Manager Contact E-mail Address: admanzhou@126.com Telephone: +86-20-82329549 Fax: +86-20-82329549

3. Name of the Device

Device Classification Name: Wheelchair, Mechanical Product Name: Mechanical Wheelchair Trade Name: Manual Wheelchair SIVFH2A102 Model: SIVFH2A102 Classification Panel: Physical Medicine Regulation Number: 21 CFR 890.3850 Product Code: IOR Device Classification: Class I

4. The Predicate Devices

K181795 AST Model MA012 and MS019 Rehab Wheelchair

5. Device Description

The Aluminum Manual Wheelchair is indoor/outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat.

4

Main components:

Main frame, handle sleeve, back upholstery, seat upholstery, armrest, side panel, rear wheel with handle ring, rear wheel axle, legrest, footplate, front fork, front wheels, cross bar.

Main materials:

Main frame, cross bar, legrest: Aluminum, silver/blue coating

Back upholstery, seat upholstery: Cover is polyester non-woven, inside with flame resistant foam

Handle sleeve, handle sleeve, side panel, handle ring, footplate: PVC

Tire of rear wheels, front wheels, armrest pad: PU

6. Intended Use of Device

The Manual Wheelchair is to provide mobility to persons restricted to a sitting position.

7. Summary of Substantial Equivalence

	Proposed Device	Predicate device	Comparison
510k Number	K190534	K181795	-----
Product Code	IOR	IOR	Same
Proprietary Name	Manual Wheelchair
SIVFH2A102	AST Model MA012
and MS019 Rehab
Wheelchair	-----
Model	SIVFH2A102	MA012 and MS019	-----
Manufacturer	Jiangsu Horizon
Medical Science &
Technology Co., Ltd.	Sichuan AST
Medical Equipment
Co., Ltd.	-----
Indications for Use	The Manual
Wheelchair is to
provide mobility to
persons restricted to
a sitting position.	The AST Model
MA012 and MS019
Rehab Wheelchairs
are to provide
mobility to persons
limited to a sitting
position.	Same
Type of Use	Over-the-counter	Over-the-counter	Same
Basic Design	The Aluminum
Manual Wheelchair
is indoor/outdoor
wheelchair that has a
base with
four-wheeled with a	The AST Model
MA012 and MS019
Rehab Wheelchair
are manual
wheelchairs.
They have adjustable	Similar
The structure
and materials
of main frame
of the proposed
device and
	seat. The device can	armrests, and	predicate
	be disassembled for	multiple
position. The casters	device are
	transport and it is	are 6"/7"/8" PU	same, only
	foldable easily. The	wheels with height	individual
	device uses a	adjustable forks and	materials are
	standard sling type	the rear wheels are	different, such
	back and seat.	20"/22"/24"*1-3/8"	as back
	Aluminum frame	polyurethane	upholstery and
	with silver/blue	(MA012 and	seat upholstery,
	coating and folding	MS019).	etc.
	backrest	Aluminum frame	The differences
	Flip back armrest	with liquid coated	do not raise
	PU pad	and folding backrest	safety and
	Detachable and	Flip-up and	effectiveness
	elevating footrest	detachable armrest	of the proposed
	Front caster PU tires	PU pad	device.
	and detachable rear	Detachable footrest
	wheel PU tires	Front casters PU
	Polyester non-woven	tires and quick
	cover of back	release rear wheel
	upholstery and seat	PU tires
	upholstery	Nylon cushion
	Main frame, cross
	bar, legrest:	AST Model MA012	Similar
	Aluminum,	Rehab Wheelchair:	The Main
	silver/blue coating	Aluminum frame	structural
	Back upholstery, seat	with liquid coated	materials and
	upholstery: Cover is	and folding backrest	wheels
	polyester	Flip-up and	materials are
	non-woven, inside	detachable armrest	same.
Materials	with flame resistant	PU pad	The differences
	foam
Handle sleeve,	Detachable footrest	do not raise
	handle sleeve, side	Front casters PU	safety and
	panel, handle ring,	tires and quick	effectiveness
	footplate: PVC	release rear wheel	of the proposed
	Tire of rear wheels,	PU tires	device.
	front wheels, armrest	Nylon cushion
	pad: PU
	Main frame, handle	AST Model MA012	Same
	sleeve, back	Rehab Wheelchair:	Although the
Components	upholstery, seat	Main frame, handle	expressions are
	upholstery, armrest	sleeve, back	different, the
	pad, armrest, side	upholstery, seat	main
	wheel panel, rear	upholstery, armrest	components
		with handle ring, pad, rear wheel axle, legrest, footplate, brake, front fork, front wheels, cross bar.	armrest, side panel, front casters, rear wheel, legrest, footplate, brake, front fork, cross-brace.	are same.
Control Mode		Mechanical	Mechanical	Same
	Length	1030mm	Model MA012:
1173mm(±1mm)	Similar
The two physical
Dimension	Width	660mm	Model MA012:
645mm (±1mm)	dimensions are different. The difference does
	Height	930mm	Model MA012:
892mm (±1mm)	not affect the effectiveness and safety.
Net weight		30.2 lbs/13.7kg	Model MA012:
17.2kg/38lbs	Similar
The proposed device is heavier than the predicate device.
Weight capacity		275 lbs/125kg	Model MA012:
300lbs/136kg	Similar
Weight capacity of the proposed device is less than the predicate device.
Seat width		460mm(18")	Model MA012:
16"(406mm)
18"(457mm)
20"(508mm)	Similar
Different seat sizes do not
Seat height		510mm(20")	Model MA012:
19.7"(500mm)	raises the safety and
Seat depth		425mm(16.7")	Model MA012:
16"-20"
(406mm-508mm)	effectiveness of the device.
Frame type		foldable	foldable	Same
Cross-brace configuration		18"	14", 16", 18", 20" or 22"	Same

Table 1 Comparison to Predicate Device

5

6

7

| Back style | Fixed | Model
MS019:
Fixed
Model
MA012:
Adjustable | predicate
device include
with that of
proposed
device.
Same
Back style of
proposed
device is same
as predicate
device model
MS019. |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Anti-tippers | Optional | Optional | Same |
| Wheel
construction | Quick release | Model
MA012:
Quick release
Model
MS019:
Fixed | Same
Wheel
construction of
proposed
device is same
as predicate
device model
MA012. |
| Tires | Front: 8"
Rear: 24" | Front: 6",7",8"
Rear: 20",22",24" | Same
The tires sizes
of proposed
device
are
included
to
those
of
predicate
device. |
| Armrest | Flip back armrest | Model
MA012:
Height
Adjustable
desk length armrest,
Flip back
Model
MS019:
Fixed or adjustable
height; desk or full
length; removable | Similar
The height
of
armrest
of
proposed
device can not
be adjustable. |
| Foot rest | Optional/
swing
away | Optional/
swing
away | Same |
| Rear Axle Position | Single | Multiple | Similar
The rear axle
of proposed
device has only
one size. |
| Frame
Construction | Foldable frame | Foldable frame | Same |
| Frame Material | Aluminum | Model MA012:
Aluminum
Model MS019: Steel | Same
The frame
material of
proposed
device is same
as predicate
device model
MA012. |
| Safety Feature | Manual Wheel Lock | Manual Wheel Lock | Same |
| Standard | ISO7176-1
ISO7176-3
ISO7176-5
ISO7176-7
ISO7176-8
ISO7176-11
ISO7176-13
ISO7176-15
ISO7176-16
ISO7176-22
ISO10993-1
ISO10993-5
ISO10993-10 | ISO7176-1
ISO7176-3
ISO7176-5
ISO7176-7
ISO7176-8
ISO7176-11
ISO7176-13
ISO7176-15
ISO7176-16
ISO7176-22
ISO10993-1
ISO10993-5
ISO10993-10 | Same |

8

8. Substantial Equivalence discussion:

Our device and the predicate device are almost identical in terms of all areas described in the above table (Table 1). There are some minor differences with the predicate device don't affect the safety or effectiveness of the subject device.

The following table (Table 2) shows similarities and differences of the performance between our device and the predicate device. Tests were conducted following the recommended procedures outlined in the respective consensus standards, and results for "Manual Wheelchair SIVFH2A102" met all relevant requirements in the test standards, our internal specifications, and are comparable to the predicate device.

Description	Proposed Device	Predicate device
Static stability	Meets ISO 7176-1:2014	Meets ISO 7176-1:2014
Effectiveness of brakes	Meets ISO 7176-3:2012	Meets ISO 7176-3:2012
Dimensions, mass and
maneuvering space	Meets ISO 7176-5:2008	Meets ISO 7176-5:2008
Seating and wheel
dimensions	Meets ISO 7176-7:1998	Meets ISO 7176-7:1998

Table 2: Comparison of Performance Testing

9

| Static, impact, and fatigue

strengths	Meets ISO 7176-8:2014	Meets ISO 7176-8:2014
Information disclosure,
documentation and
Labeling	Meets ISO 7176-15:1996	Meets ISO 7176-15:1996
Resistance to ignition	Meets ISO 7176-16:2012	Meets ISO 7176-16:2012

Jiangsu Horizon Medical Science & Technology Co., Ltd.

The tests were performed following the general requirements outlined in ISO 7176-11:2012, ISO 7176-13:1989, ISO 7176-22:2014.

A brief discussion of the non-clinical testing data that was submitted, referenced or relied on to demonstrate that the Proposed Device is safe and effective, and whose performance meets the requirements of its user-defined acceptance criteria and intended uses:

"Mechanical Wheelchair SIVFH2A102" meets performance requirements per ISO 7176-1:2014, ISO 7176-3: 2012, ISO 7176-5:2008, ISO 7176-7:1998, ISO 7176-8:2014, ISO 7176-11:2012, 7176-13: 1989, ISO 7176-15: 1996, ISO 7176-16:2012 and ISO 7176-22:2014. It is safe and effective, and its performances meet the requirements of the pre-defined acceptance criteria and intended use.

A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence.

According to the non-clinical test results, the proposed devices are as safe, as effective and perform as well as the predicate device. So the proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device.

9. Non-Clinical Tests Performed:

The following testing was performed on the "Mechanical Wheelchair SIVFH2A102" in accordance with the requirements of the design control regulations and established quality assurance procedures.

Safety and performance:

ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability

ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes

ISO 7176-5:2008 Wheelchairs - Part 5: Determination of dimensions, mass and maneuvering space

ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions

ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths

ISO 7176-11:2012 Wheelchairs - Part 11: Test dummies

ISO 7176-13:1989 Wheelchairs - Part 13: Determination of friction of test surface

ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling

ISO 7176-16:2012 Wheelchairs - Part 16: Resistance to ignition of postural support

10

devices

ISO 7176-22:2014 Wheelchairs - Part 22: Set-up procedures

Biocompatibility:

ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity

10. Usability Study:

The 15 participants read the User Manual before initial use of the device. They can understand the questions and answer them. The 15 participants can operate the device referring to the User Manual.

Based on the verification & validation testing records provided, we concluded that the Manual Wheelchair, Model SIVFH2A102 is considered to meet the usability requirement as defined in the verification & validation test report.

These non-clinical tests demonstrate that the labeling for the Manual Wheelchair, Model SIVFH2A102, manufactured by Jiangsu Horizon Medical Science & Technology Co., Ltd. and also distributed by US-Distributors is comprehensive, was well understood by a variety of "patients", and provided sufficient information for safe and proper use of the device.

11. Conclusion:

Based on the comparison of the proposed device of SIVFH2A102 is determined to be Substantially Equivalent (SE) to the predicate device of AST Model MA012 and MS019 Rehab Wheelchair, in respect of safety and effectiveness.