The Zhenjiang Assure Mechanical Wheelchair,model:K1 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 is consistent with the ISO 7176 series standards and uses a standard sling type back and seat, the upholstery fabric meets the flame retardant test.

AI/ML Overview

The provided text is a 510(k) summary for the Zhenjiang Assure Mechanical Wheelchair, Model:K1. This document focuses on demonstrating substantial equivalence to a predicate device and does not involve AI/ML technology or associated performance metrics like sensitivity, specificity, or AUC. Therefore, a table of acceptance criteria and reported device performance related to those metrics, along with details about studies involving test sets, ground truth establishment, expert adjudication, or MRMC studies, cannot be extracted from this text.

The document describes non-clinical performance testing against established ISO standards for wheelchairs to demonstrate safety and effectiveness.

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

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria and reported device performance in the context of AI/ML metrics (e.g., sensitivity, specificity, AUC). Instead, it lists the international standards to which the device conforms for non-clinical performance. The "reported device performance" is essentially that the device is "compatible as requirement of" these ISO standards.

No.	Standards Development Organization (SDO), Designation Number-Year, and Title	Device Performance
1	ISO 7176-1:2014 Wheelchairs-Part 1: Determination of static stability.	Compatible as requirement of ISO 7176-1:2014
2	ISO 7176-3:2012 Wheelchairs-Part 3: Determination of effectiveness of brakes	Compatible as requirement of ISO 7176-3:2012
3	ISO 7176-5:2008 Wheelchairs-Part 5:Determination of overall dimensions, mass and maneuvering space	Compatible as requirement of ISO 7176-5:2008
4	ISO 7176-11:2012 Wheelchairs-Part 11: Test dummies	Compatible as requirement of ISO 7176-11:2012
5	ISO 7176-13:1989 Wheelchairs-Part 13:Determination of coefficient of friction of test surfaces	Compatible as requirement of ISO 7176-13:1989
6	ISO 7176-15:1996 Wheelchairs-Part 15:Requirements for information disclosure, documentation and labelling.	Compatible as requirement of ISO 7176-15:1996
7	ISO 7176-16:2012 Wheelchairs-Part 16:Resistance to ignition of upholstered parts, Requirements and test methods	Compatible as requirement of ISO 7176-16:2012

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and therefore not provided, as the studies are physical performance tests for a mechanical wheelchair, not data-driven AI/ML studies. The testing is based on risk assessment utilizing Failure Mode Effect Analysis (FMEA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and therefore not provided. The "ground truth" for a mechanical wheelchair's performance is determined by its adherence to specified engineering and safety standards (e.g., ISO 7176 series), which are validated through physical testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and therefore not provided, as there is no expert adjudication of subjective assessments. The methods for verifying compliance with ISO standards are typically standardized testing procedures.

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

This information is not applicable and therefore not provided. The submission is for a mechanical wheelchair, which does not involve human readers or AI assistance in its function or evaluation.

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

This information is not applicable and therefore not provided. The device is a mechanical wheelchair and does not involve algorithms or AI.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance is compliance with the technical specifications and safety requirements outlined in the referenced ISO 7176 series standards. These are empirically verifiable through physical testing.

8. The sample size for the training set

This information is not applicable and therefore not provided, as this is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable and therefore not provided, as this is not an AI/ML device that requires a training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 5, 2023

Zhenjiang Assure Medical Equipment Co.,Ltd. Eric Shi QA & QC Manager No.297, Chuqiao road, Zhenjiang city, Jiangsu province China

Re: K231320

Trade/Device Name: Zhenjiang Assure Mechanical Wheelchair, Model:K1 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I, reserved Product Code: IOR Dated: May 5, 2023 Received: May 8, 2023

Dear Eric Shi:

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.

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

{1}------------------------------------------------

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Tushar Bansal -S

Tushar Bansal, PhD Acting 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K231320

Device Name

Zhenjiang Assure Mechanical Wheelchair,model:K1

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)

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}------------------------------------------------

510k Summary

As per 21 CFR 807.92

1.Submitter Information

Company Name:Zhenjiang Assure Medical Equipment Co.,Ltd.

Address: No.297, Chuqiao road, Zhenjiang city, Jiangsu province,China.

Phone:+86-18621771627

Contact Person (including title):Eric Shi (QA&QC Manager)

E-mail:eric-shi@isosh.com

Subject Device Information

� Type of 510(k) submission:Special
� Common Name:Mechanical Wheelchair
� Proprietary Name:Zhenjiang Assure Mechanical Wheelchair,model:K1
Regulation Name:Wheelchair, Mechanical �
� Product Code:IOR
� Regulation Number:890.3850
� Regulation Class:1

2.Predicate Device Information

� Sponsor:Zhenjiang Assure Medical Equipment Co., Ltd
� Common Name: Mechanical Wheelchair
� Proprietary Name:Zhenjiang Assure Mechanical Wheelchair, model:A227
� Regulation Name:Wheelchair, Mechanical
510(k) number:K112816 �
� Product Code:IOR
� Regulation Number:890.3850
� Regulation Class:1

3.Device Description

The Zhenjiang Assure Mechanical Wheelchair,model:K1 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 can be disassembled for transport and it is foldable easily. The device is

{4}------------------------------------------------

consistent with the ISO 7176 series standards and uses a standard sling type back and seat, the

upholstery fabric meets the flame retardant test.

Elements ofComparison	Subject Device: K231320	Predicate Device: K112816	Comment
Proprietary Name	Zhenjiang Assure MechanicalWheelchair,model:K1	Zhenjiang Assure MechanicalWheelchair, model:A227	N/A
General Comparison
510(k) Number	K231320	K112816	N/A
Regulation Name	Wheelchair, Mechanical	Wheelchair, Mechanical	Same
Regulation Number	890.3850	890.3850	Same
Product Code	IOR	IOR	Same
Indications for Use	The device is intended formedical purpose to providemobility to persons restrictedto a sitting position.	The device is intended for medicalpurpose to provide mobility topersons restricted to a sittingposition.	Same
Model	K1	A227
Over-The-CounterUse	Yes	Yes
Where used	Indoor/outdoor	Indoor/outdoor	Same
Target population	The elderly and disabled	The elderly and disabled	Same
Frame Material	high-quality SPCC steel pipe	high-quality SPCC steel pipe	Same
Framework	foldable	foldable	Same
Casters	8"	5" ~ 8"
Rear wheel	24"	12 1/2" ~ 22"	Note 1
Seat length	16"~18"	10~17"
Seat height	19.5"	21"
Elements ofComparison	Subject Device	Predicate Device	Comment
Seat width	16"~20"	10"~18"
Max loading	136 kg/300 lbs	100 kg/220 lbs
Materials	high-quality SPCC steel pipe	high-quality SPCC steel pipe	Same
Components ofMechanicalWheelchair	Handle	Handle	Note 2
	Footplate	Footplate
	Backrest	Backrest
	Armrest	Armrest
	Front caster	Front caster
	Front fork	Front fork
	Rear wheel	Rear wheel
Handle size	103*34mm	103*34mm	Same
Footplate size	197*161mm	197*161mm	Same
Backrest size	16"~20"	16"~20"	Same
Armrest size	10.12" x 2.2" x 1.42"	10.12" x 2.2" x 1.42"	Same
Front caster size	8"*1.25"	8"*1"	Same
Rear wheel size	24"*1"	24"*1"	Same
Handle size	103*34mm	103*34mm	Same
Performance	compatible as requirement ofISO7176-1:1999,ISO7176-3:2003,ISO7176-5:2008,ISO71766-11:1992,ISO7176-13:1989,ISO7176-15:1996,ISO7176-16:1997	compatible as requirement ofISO7176-1:1999,ISO7176-3:2003,ISO7176-5:2008,ISO7176-11:1992,ISO7176-13:1989,ISO7176-15:1996,ISO7176-16:1997	Same

4.Summary of Comparison and Technological Characteristics

{5}------------------------------------------------

Note 1: The K1 is a new specification for predicate device.The parameters of Casters,Rear

wheel,Seat length,Seat height,Seat width and Max loading differ from those of predicate devices.

{6}------------------------------------------------

Note 2: The K1 is a new specification for predicate device.The K1 is also composed of Handle,Footplate,Backrest,Armrest,Front caster,Front fork and Rear wheel.The design of front fork is differ from those of predicate devices.

6.Summary of Verification and Validation

The manufacturer has performed non-clinical performance testing based on its risk assessment utilizing Failure Mode Effect Analysis (FMEA).

Following Quality System processes,required testing was conducted to validate the cumulative modifications made to the subject devices.

Performance test

No.	FDArecognitionnumber	Standards Development Organization (SDO), DesignationNumber-Year, and Title
1	16-195	ISO 7176-1:2014 Wheelchairs-Part 1: Determination of static stability.
2	16-192	ISO 7176-3:2012 Wheelchairs-Part 3: Determination of effectiveness ofbrakes
3	16-163	ISO 7176-5:2008 Wheelchairs-Part 5:Determination of overalldimensions, mass and maneuvering space
4	16-190	ISO 7176-11:2012 Wheelchairs-Part 11: Test dummies
5	16-25	ISO 7176-13:1989 Wheelchairs-Part 13:Determination of coefficient offriction of test surfaces
6	16-27	ISO 7176-15:1996 Wheelchairs-Part 15:Requirements for informationdisclosure, documentation and labelling.
7	16-191	ISO 7176-16:2012 Wheelchairs-Part 16:Resistance to ignition ofupholstered parts, Requirements and test methods

7.Conclusion

The conclusions drawn from the nonclinical and clinical tests demonstrate that the device is as safe,

as effective, and performs as well as the legally marketed predicate device

8.Prepared Date

6 May 2023

{7}------------------------------------------------

Regulation Number and Section

N/A