VALENTINE STEEL WHEELCHAIR

• K Number: K130017
• Device Name: VALENTINE STEEL WHEELCHAIR
• Manufacturer: VALENTINE INTL. LTD.
• Date Cleared: 2014-05-28 ( 511 days)
• Product Code: IOR
• Regulation Number: 890.3850
• Type: Traditional
• Panel: Physical Medicine
• Reference & Predicate Devices: K112816
• Predicate For: K152878 , K153328

Intended Use

The device is intended for medical purpose to provide mobility to persons restricted to a sitting position.

Device Description

The Valentine Steel Wheelchair, model: 1000 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transportation and it is foldable easily. The device is consistent with the ISO 7176 series standards and uses a standard sling type back and seat, and the upholstery fabric meets the flame retardant test.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Valentine Steel Wheelchair, model 1000. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials to prove safety and effectiveness. Therefore, many of the requested categories related to clinical studies and AI performance metrics are not applicable in this context.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (a Class I mechanical wheelchair), the "acceptance criteria" are compliance with relevant international standards and equivalence to a predicate device. The device's "performance" is demonstrated by meeting these standards.

Acceptance Criteria (Applicable Standards)	Reported Device Performance
ISO 7176-1:1999 (Static Stability)	Met (Complied with)
ISO 7176-3:2012 (Brake Effectiveness)	Met (Complied with)
ISO 7176-5:2008 (Dimensions, Mass, Maneuvering)	Met (Complied with)
ISO 7176-7:1998 (Seating & Wheel Dimensions)	Met (Complied with)
ISO 7176-8:1998 (Static, Impact, Fatigue Strengths)	Met (Complied with)
ISO 7176-11:2012 (Test Dummies)	Met (Complied with)
ISO 7176-13:1989 (Coefficient of Friction)	Met (Complied with)
ISO 7176-15:1996 (Information Disclosure, Documentation, Labeling)	Met (Complied with)
ISO 7176-16:2012 (Resistance to Ignition of Upholstered Parts)	Met (Complied with)
ANSI/RESNA WC Vol. 1	Met (Complied with)
Substantial Equivalence to Predicate Device (Zhenjiang Assure Mechanical Wheelchair, model: A227, K112816)	Achieved (stated as "identical to and transferred from the predicate device" and "substantially equivalent")
Maximum Weight Bearing Capacity: 250 lbs/113.5 kgs	Device specifications state "250 lbs/113.5 kgs" (Same as predicate)

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

• Sample Size: Not applicable in the context of this 510(k) submission. Performance testing refers to standardized tests on the device itself, not clinical testing with patient samples.
• Data Provenance: Not applicable. The "study" here refers to engineering and performance testing against international standards.

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

• Number of Experts: Not applicable. Ground truth, in the sense of expert consensus on medical data, is not established for this type of device submission. The "ground truth" for compliance testing is defined by the parameters and methodologies outlined in the ISO and ANSI/RESNA standards.
• Qualifications of Experts: Not applicable. Testing would be performed by qualified personnel in test laboratories, but their qualifications are not detailed as expert medical opinion for ground truth.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no ambiguous outcome from a test set requiring adjudication in this context. Results are measured against predefined standard thresholds.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No. This is a mechanical wheelchair, not an AI-powered diagnostic or assistive device.
• Effect Size of AI Improvement: Not applicable.

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

• Standalone Performance: No. This is a mechanical device, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this device's performance is established by engineering specifications and international consensus standards (ISO 7176 series and ANSI/RESNA WC vol. 1). Compliance with these standards is the "ground truth" for safety and basic effectiveness in a 510(k) context for a mechanical device.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.

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

• Ground Truth for Training Set Establishment: Not applicable.

Summary of Device Acceptance and Study:

The Valentine Steel Wheelchair, model 1000, meets its acceptance criteria by demonstrating compliance with a comprehensive set of ISO 7176 series standards and ANSI/RESNA WC vol. 1. The "study" proving this involves performance testing conducted by the manufacturer against the specific requirements and test methods outlined in these international standards. The submission also establishes equivalence to a previously cleared predicate device, the Zhenjiang Assure Mechanical Wheelchair, model: A227 (K112816), by noting that the subject device is actually "identical to and transferred from" the predicate device and has the same intended use and technological characteristics. This approach allows the device to be cleared under a 510(k) without the need for extensive new clinical trials, as established by the FDA's substantial equivalence pathway for Class I devices.

Summary

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valentine international Lu.

詠 立 實 業有限公司 E-mail : [e-mail] http : // www.valentine-dynalife.com

Tel:[phone] Fax:[phone]

" 510(k) SUMMARY"

MAY 2 8 2014

K130017

Submitter's Name: Valentine International Ltd.

8F, No. 149, Sec. 2, Ta Tung Rd., Hsichih District, New Taipei City, 221, Taiwan, R.O.C.

Date of summary prepared: December 31, 2013

Device Name:

Valentine Steel Wheelchair, model: 1000 Proprietary Name: Mechanical Wheelchair Common or Usual Name: Classification Name: Mechanical Wheelchair, Class 1, 21 CFR 890.3850

510K contact person for all correspondence

Dr. Jen. Ke-Min Tel: [phone] Fax: [phone] Email: [e-mail]

Indications for Use:

The device is intended for medical purpose to provide mobility to persons restricted to a sitting position.

Description of the device:

The Valentine Steel Wheelchair, model: 1000 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transportation and it is foldable easily. The device is consistent with the ISO 7176 series standards and uses a standard sling type back and seat, and the upholstery fabric meets the flame retardant test.

The maximum weight bearing capacity of the device is 250 lbs/113.5 kgs. The following surfaces are recommended not to operate on:

• Sand surface
• Wet or icy surface .
• Road maintenance hole metal cover ●
• Multiple steps.
• Escalators. ( Use the elevator.)
• Steep incline over 10 degrees.
• . Ground clearance over 60 mm / 2.3"
• Curb climbing ability over 20 mm / 0.8"

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立實業有限公司 ફંગ્રે E-mail : [e-mail] http : // www.valentine-dynalife.com

Legally marketed device for substantial equivalence comparison:

Zhenjiang Assure Mechanical Wheelchair, model: A227 (K112816)

Performance Testing:

Valentine Steel Wheelchair, model: 1000 meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.

Technological Characteristics Summary:

To ensure the safety and effectiveness of the following ISO standards were complied with:

• ISO7176-1:1999, Wheelchairs - Part 1: Determination of Static Stability.
• ISO7176-3: 2012, Wheelchairs Part 3: Determination of effectiveness of brakes. .
• ISO7176-5: 2008, Wheelchairs Part 5: Determination of overall dimensions, ● mass and maneuvering space.
• ISO7176-7: 1998, Wheelchairs Part 7: Measurement of seating and wheel . dimensions.
• . ISO7176-8: 1998, Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths.
• . ISO7176-11:2012, Wheelchairs - Part 11: Test dummies.
• ISO7176-13:1989, Wheelchairs Part 13: Determination of coefficient of friction ● of test surfaces.
• ISO7176-15:1996, Wheelchairs Part 15: Requirements for information disclosure, . documentation and labelling.
• ISO7176-16:2012, Wheelchairs Part 16: Resistance to ignition of upholstered ● parts. Requirements and test methods.

Discussion of Clinical Testing Performed:

NA

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valentine · international · Ltd. 詠 立 實 業 有 限 公 司 E-mail : [e-mail] http : // www.valentine-dynalife.com

Tel:[phone] Fax:[phone]

Comparison Table between the subject device and predicate device:
ITEMS	PREDICATE DEVICE	SUBJECT DEVICE
BRAND NAME	Zhenjiang Assure	Valentine
MANUFACTURER	Zhenjiang Assure MedicalEquipment Co., Ltd.	ValentineInternational Ltd.
MODEL NO	Mechanical Wheelchair, A227	Steel Wheelchair,model 1000
510K NO	K112816	K130017
INTENDED USE	The device is intended for medicalpurposes to provide mobility topersons restricted to a sittingposition.	Same
OPERATING	Indoor / outdoor wheelchair	Same
TECHNOLOGICALCHARACTERISTICS	According to ISO7176-1/-3/-5/-7/-8/-11/-13/-15/-16series standards	Same
FRAMESeat widthCross braceSeat heightBackrest heightReclining backrestSeat slingFrame colors	18"YES20"un-adjustablefixedpadded nylonBlue	Same
ARMRESTArm padFlip backHeight-adjustable	PaddedYES, detachablePre-installed armrests	Same
HANGERSSwing-awayElevating leg restArticulating leg restFootplate styleHeel loopFootrest angle	YESYESYESPaddedNo10~150	Same
REAR AXLEOffset axleQuick-release axle	YESYES	Same

D3

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valentine international Luc.

詠 立實業有限公司

E-mail : [e-mail] http : // www.valentine-dynalife.com

Tel:[phone] Fax:[phone]

ITEMS	PREDICATE DEVICE	SUBJECT DEVICE
REAR WHEELSizeTire typeHandrim material	24"PU solid materialSteel composite	Same
CASTERSSizeTire type	8"PU solid material	Same
WHEEL LOCK	Pull-to-Lock	Same
WEIGHT CAPACITY	250 lbs/113.5 kgs	Same
WEIGHT OF CHAIR	40 lbs / 18.2 kgs	Same
WARRANTY	12 months for the main parts(The chair side frames areguaranteed for 5 years from the dateof purchase. )	Same
ACCESSORIESAnti-tipperRear stepperFold down pushhandleSafety belt	YESYESYESOptional	NOYESYESOptional

※ Actually, the subject device is identical to and transferred from the predicate device.

Substantial equivalence comparison discussion:

Actually, the subject device is identical to and transferred from the predicate device. From the above comparison table the intended uses between the subject device: Valentine Steel Wheelchair, model: 1000 and the predicate device: Zhenjiang Assure Mechanical Wheelchair, model: A227 (K112816) are the same. Mainframes of two devices are foldable. There are similar removable desk-length armrest and same swing-away detachable elevating footrest. Besides, back upholstery material is also the same resistance-ignitability fabric and also meets the requirements for flame retardant. The differences in the overall appearance do not raise any safety or effectiveness aspect. Thus the subject device is substantially equivalent to the predicate device.

D4

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

May 28, 2014

Valentine International, Limited Dr. Jen. Ke-Min 8F, No. 149, Sec. 2, Ta Tung Rd., Hsichih District - New Taipei City 221 Taiwan. R.O.C.

Re: K130017

Trade/Device Name: Valentine Steel Wheelchair, model: 1000 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: April 6, 2014 Received: April 15, 2014

Dear Dr. Jen, Ke-Min:

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 or any I 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 (reporting of medical

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Page 2 - Dr. Jen. Ke-Min

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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/ReportaProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Felipe Aquel -S

Carlos Peña, PhD, MS for 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) K130017

Device Name

Valentine Steel Wheelchair, model: 1000

Indications for Use (Describe)

The device is intended for medical purpose 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)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

ം Date: 2014.05.28 17:26:40

-04'00'

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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).