The proposed device, Manual Wheelchair model XSG106A, is traditional manually operated, user propelled, manual, mechanical wheelchairs. The device can be foldable easily for transport. The main frame is made of magnesium alloy frame, the materials meet the standard of ASTM B107M-2012, and which has a seat base with four-wheeled with a back cover. Upon the outside of this framework, and to the rear, are assembled two axle plates, wheels are connected to the stainless steel axle receivers via stainless steel axles. On the front end of the frame are assembled two caster housings. Caster forks are mounted to these housings via steel axles. On the frame, upon the caster, two footplates are assembled for foot holding. Two armrests are mounted on the frame for user's arm holding. Two grips mounted on the top end of the frame with a brake, and another brake is designed under the seat base.

AI/ML Overview

The provided text is a 510(k) summary for a Manual Wheelchair (Model XSG106A) and not an AI/Medical Imaging device. Therefore, the questions related to AI/Medical Imaging specific aspects such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the loop performance)," "ground truth," expertise of readers, and training/test sets are not applicable to this document.

This submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (K163352) primarily through non-clinical performance testing to relevant ISO standards for wheelchairs and biocompatibility standards.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are primarily met by demonstrating compliance with established international standards for wheelchairs and biocompatibility. The "Reported Device Performance" column essentially confirms that the proposed device complies with these standards.

Acceptance Criteria (ISO Standards for Wheelchairs & Biocompatibility)	Reported Device Performance
ISO 7176-1:2014 (Determination of static stability)	Comply with ISO 7176-1
ISO 7176-3:2012 (Effectiveness of brakes)	Comply with ISO 7176-3
ISO 7176-5:2008 (Dimensions, mass and maneuvering space)	Comply with ISO 7176-5
ISO 7176-7:1998 (Measurement of seating and wheel dimensions)	Comply with ISO 7176-7
ISO 7176-8:2014 (Static, impact and fatigue strengths)	Comply with ISO 7176-8
ISO 7176-11:2012 (Test Dummies)	Comply with ISO 7176-11
ISO 7176-13:1989 (Coefficient of friction of test surfaces)	Comply with ISO 7176-13
ISO 7176-15:1996 (Information disclosure, documentation and labeling)	Comply with ISO 7176-15
ISO 7176-16:2012 (Resistance to ignition of postural support device)	Comply with ISO 7176-16
ISO 7176-22:2014 (Set-Up Procedure)	Comply with ISO 7176-22
ISO 10993-5:2009 (Biological evaluation - In Vitro cytotoxicity)	Comply with ISO 10993-10993-1 (General compliance mentioned, likely covers both 5 & 10)
ISO 10993-10:2010 (Biological evaluation - Irritation and skin sensitization)	Comply with ISO 10993-1 (General compliance mentioned, likely covers both 5 & 10)
FDA Regulatory Requirements (Label and Labeling)	Conforms to FDA Regulatory Requirements

Study Information (as applicable to a Mechanical Wheelchair 510(k))

Sample size used for the test set and the data provenance:
- The document does not explicitly state the "sample size" of devices tested. For mechanical devices like wheelchairs, testing is typically done on a representative number of units to ensure consistency and compliance with standards.
- Data Provenance: The tests were non-clinical, conducted by the manufacturer, Jiangyin Newrise Medical Equipment Co., Ltd. The document indicates the company is based in Jiangyin City, Jiangsu Province, China. This suggests the testing was likely performed in China. The data would be considered prospective in the sense that the new device was built and then tested to these standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a mechanical device, not an AI/imaging device requiring expert interpretation for ground truth. Compliance is demonstrated through physical testing against engineering standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for human interpretation of data, typically in clinical studies or for establishing ground truth in AI. For mechanical performance testing, the results are quantitative measures against pre-defined thresholds in the ISO standards, and do not involve human adjudication in this context.
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:
- Not applicable. This is not an AI/imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is defined by the measurement criteria and performance thresholds stipulated in the referenced ISO standards (e.g., maximum deflection under load, brake effectiveness measurements, stability angles). Compliance is determined by whether the device's measured performance falls within these pre-defined (objective) engineering limits.
The sample size for the training set:
- Not applicable. This is not an AI device, so there is no training set in the machine learning sense. The "design" phase of the wheelchair could be seen as the "training" in an abstract engineering sense, where prototypes are iterated upon, but it's not a dataset size.
How the ground truth for the training set was established:
- Not applicable. As above, no AI training set.

Summary

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March 1, 2019

Jiangyin Newrise Medical Equipment Co., Ltd % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District Beijing, 102401 Cn

Re: K180852

Trade/Device Name: Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: January 2, 2019 Received: January 7, 2019

Dear Ray Wang:

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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 J. Pinto -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K180852

Device Name

Manual Wheelchiar

Indications for Use (Describe)

The device is intended for medical purposes 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)

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Tab #7 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K180852

1. Date of Preparation
  02/27/2019
Sponsor 2.

JIANGYIN NEWRISE MEDICAL EQUIPMENT CO., LTD.

No.97, WenXin Road, LinGang Street, JiangYin City, JiangSu Province,China 214400 Establishment Registration Number: Not yet registered or the Number Contact Person: Huang Bing Position: General Manager Tel: +86-510-86092581 Fax: +86-510-89062698 Email: Top.Brian@inewrise.cn

1. Submission Correspondent
  Mr. Ray Wang

Beijing Believe-Med Technology Service Co., Ltd.

Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401 Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang(@believe-med.com

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4. Identification of Proposed Device

Trade Name: Manual Wheelchair Common Name: Mechanical Wheelchair Model(s): XSG106A

Regulatory Information: Classification Name: Wheelchair, Mechanical Classification: I; Product Code: IOR; Regulation Number: 21 CFR 890.3850; Review Panel: Physical Medicine;

Intended Use Statement:

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

Device Description 5.

The proposed device, Manual Wheelchair model XSG106A, is traditional manually operated, user propelled, manual, mechanical wheelchairs. The device can be foldable easily for transport.

The main frame is made of magnesium alloy frame, the materials meet the standard of ASTM B107M-2012, and which has a seat base with four-wheeled with a back cover. Upon the outside of this framework, and to the rear, are assembled two axle plates, wheels are connected to the stainless steel axle receivers via stainless steel axles. On the front end of the frame are assembled two caster housings. Caster forks are mounted to these housings via steel axles. On the frame, upon the caster, two footplates are assembled for foot holding. Two armrests are mounted on the frame for user's arm holding. Two grips mounted on the top end of the frame with a brake, and another brake is designed under the seat base.

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6. Identification of Predicate Device

Predicate # 510(k) Number: K163352 Product Name: Wheelchair Manufacturer: Kunshan Hi-Fortune Health Products Co., Ltd.

Non-Clinical Test Conclusion 7.

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

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 manoeuvring 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 Coefficient of friction of test surfaces

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 device.

ISO 7176-22:2014 Wheelchairs - Part 15: Set-Up Procedure

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 skin sensitization.

1. Clinical Test Conclusion
  No Clinical Test conducted.

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9. Substantially Equivalent (SE) Comparison

Table 1 General Comparison

ITEM	Predicate Device (K163352)	Proposed Device	Remark
Product Code	IOR	IOR	SE
Regulation No.	21 CFR 890.3850	21 CFR 890.3850	SE
Class	1	1	SE
Intended Use	The device is intended for medicalpurposes to provide mobility to personsrestricted to a sitting position.	The device is intended for medicalpurposes to provide mobility to personsrestricted to a sitting position.	SE
DesignCharacteristic	Manual Operation, Four-Wheels,Foldable, Cross-Brace, Pull/Push-to-Lock,Armrest, Backrest, Footpad	Manual Operation, Four-Wheels,Foldable, Cross-Brace, Pull-to-Lock,Armrest, Backrest, Footpad	SE
OperationEnvironment	For Indoor/Outdoor use	For Indoor/Outdoor use	SE

Table 2 Performance Comparison

ITEM	Predicate Device (K163352)	Proposed Device	Remark
OverallDimensions	Length: 1137 mm (44.8")	Length: 1030 mm	Analysis
	Width: 680 mm (26.8")	Width: 640 mm
	Height: 880 mm (34.6")	Height: 930 mm
Rear Wheel	Size: 559 mm (22")	Size: 610 mm	Analysis
	Tire Type: Rubber	Tire Type: PU Solid Material
	Rim Diameter/Material: 510.7 mm(20.1")/Steel Composite	Rim Diameter/Material: 534 mm/SteelComposite
Wheel Lock	Pull-to-Lock, Push-to-Lock	Pull-to-Lock	SE
Ground Clearance	64 mm (2.5")	150 mm	Analysis
Min. TurningDiameter	1915.2 mm (75.4")	1700 mm	Analysis
	Armrest	Arm pad: Paded
Height-Adjustable: No		Height-Adjustable: No	SE
Seat Dimensions	Depth: 420 mm (16.5")	Depth: 460 mm	Analysis
	Height: 470 mm (18.5")	Height: 420 mm
	Width: 410 mm (16.1")	Width: 410 mm
Casters	Size: 152 mm (6")	Size: 200 mm	Analysis
	Tire Type: PU	Tire Type: PVC Solid Material
Weight ofwheelchair	11.07kg	18kg	Analysis
	Weight Capabity	100kg

Difference Analysis:

a. Overall Dimensions, the proposed device has minor different overall dimensions with predicate device, this specification is only affects the appearance of the device, it could not affects the safety and effectiveness of proposed device. All performances of proposed device are meet the design

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specification and been conducted into performance test, so the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.

Rear Wheel, the proposed device has different rear wheel size and materials with predicate device, b. this specification is only affects the appearance of the device, it could not affects the safety and effectiveness of proposed device. All performances of proposed device are meet the design specification and been conducted into performance test, so the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.
Ground Clearance, the proposed device has more ground clearance than predicate device, which is C. meet the design specification and has better trafficability characteristic than predicate device, and it also been conducted into performance test, so the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.
Min. Turning Diameter, the proposed device has smaller min. turning diameter than predicate device, d. which is meet the design specification and has better flexibility than predicate device, and it also been conducted into performance test, so the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.
Seat Dimensions, the proposed device has different seat dimensions with predicate device, this e. specification is only affects the appearance of the device, it could not affects the safety and effectiveness of proposed device. All performances of proposed device are meet the design specification and been conducted into performance test, so the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.
f. Casters, the proposed device has different caster size and materials with predicate device, this specification is only affects the appearance of the device, it could not affects the safety and effectiveness of proposed device. All performances of proposed device are meet the design specification and been conducted into performance test, so the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.
Weight of wheelchair, the proposed device has different weight of wheelchair with predicate device, g. this different is caused by different framework design, but it could not affects the safety and effectiveness of proposed device. All performances of proposed device are meet the design specification and been conducted into performance test, so the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.

ITEM	Predicate Device (K163352)	Proposed Device	Remark
Performance Test	Comply with ISO7176-1/-3/-5/-7/-8/-11/-13/-15/-16/-22	Comply with ISO7176-1/-3/-5/-7/-8/-11/-13/-15/-16/-22	SE
Biocompatibility	Comply with ISO 10993-1	Comply with ISO 10993-1	SE
Label andLabeling	Conforms to FDA RegulatoryRequirements	Conforms to FDA RegulatoryRequirements	SE

		Table 3 Safety Comparison

The proposed device is substantially equivalent to the predicate device. Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.

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10. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.

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).