MW18 manual wheelchair is a mechanical which is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bring the two sides together. The manual wheelchair incorporates a foldable frame, a seat, two footrests and four wheels. The larger rear wheels have push-rims of slightly smaller diameter projecting just beyond the user to manoeuvre the chair by pushing them on without requiring them to grasp the tyres. The manual wheelchairs have brakes that bear on the tyres of there are two push handles at the upper rear of the frame to allow for manual propulsion by a second person, e.g. caregiver. The wheelchair can support users of up to 120kg.

Main Components:

Main frame, back upholstery, seat upholstery, handgrip, armrest, front wheel, hand rim, crossbar, footrest, skirt guard, brake, anti-tipper (optional)

The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.

AI/ML Overview

The provided FDA 510(k) summary is for a Manual Wheelchair (MW18), a Class I, reserved medical device. This type of device does not typically involve AI components or require the complex statistical studies, multi-reader multi-case studies, and expert ground truth establishment that are common for AI/ML-driven diagnostic devices.

Instead, the acceptance criteria for a manual wheelchair primarily focus on functional performance, safety, and compliance with established industry standards. The study proving the device meets these criteria is a series of non-clinical performance tests conducted in accordance with international standards for wheelchairs.

Here's the breakdown of the information requested, based on the provided document:

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

The document lists the ISO standards that the device complies with, which effectively serve as the acceptance criteria. The "reported device performance" is the statement of compliance with these standards.

Acceptance Criteria (ISO Standard & Description)	Reported Device Performance
ISO 7176-1:2014: Wheelchairs - Part 1: Determination of static stability	Complies with the standard
ISO 7176-3:2012: Wheelchairs - Part 3: Determination of effectiveness of brakes	Complies with the standard
ISO 7176-5:2008: Wheelchairs - Part 5: Determination of dimensions, mass and maneuvering space	Complies with the standard
ISO 7176-7:1998: Wheelchairs - Part 7: Measurement of seating and wheel dimensions	Complies with the standard
ISO 7176-8:2014: Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strength	Complies with the standard
ISO 7176-11:2012: Wheelchairs -- Part 11: Test dummies	Complies with the standard (used for testing)
ISO 7176-13:1989: Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces.	Complies with the standard
ISO 7176-15:1996: Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling.	Complies with the standard
ISO 16840-10:2021: Wheelchair seating - Part 10: Resistance to ignition of postural support devices	Complies with the standard
ISO 7176-22: 2014: Wheelchairs - Part 22: Set-up procedures	Complies with the standard (used for testing)
ISO 10993-5: Biological evaluations of medical devices -- Part 5: Tests for In Vitro cytotoxicity	Complies with the standard (for biocompatibility)
ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	Complies with the standard (for biocompatibility)
ISO 10993-23: Biological evaluation of medical devices - Part 23: Tests for irritation	Complies with the standard (for biocompatibility, though noted "not applicable" seemingly by mistake for this standard as well as others in the provided text as the biocompatibility tests were conducted)

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of patient data, as this is a mechanical device. The "test set" refers to the physical units of the Manual Wheelchair (MW18) that were subjected to the non-clinical tests. The document does not explicitly state the number of sample units used for these tests. Data provenance is not applicable in the context of patient data as it's not an AI/ML device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this device. "Ground truth" in the context of AI/ML performance is not relevant for a mechanical manual wheelchair. The "truth" is established by the ability of the device to meet the defined performance specifications and safety standards through physical testing.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical image interpretation, not for mechanical device testing. Compliance with standards is typically assessed by conformity to predefined pass/fail criteria for each test.

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 is not applicable. An MRMC study is designed for evaluating the performance of diagnostic algorithms, often with human readers in the loop. This device is a manual wheelchair, not a diagnostic AI tool.

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

This is not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device is the compliance with established international performance and safety standards (ISO standards) for manual wheelchairs. This is determined through objective, quantifiable physical tests, rather than expert consensus, pathology, or outcomes data in the way it's understood for diagnostic devices.

8. The sample size for the training set

This is not applicable. There is no "training set" for a mechanical device like a manual wheelchair.

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

This is not applicable. There is no "training set" or "ground truth for a training set" for this type of device.

Summary

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July 11, 2024

Lichtmega Technology CO., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Co. Ltd. 14th Floor, 1500# Century Avenue Shanghai, Shanghai 200122 China

Re: K241460

Trade/Device Name: Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I, reserved Product Code: IOR Dated: May 23, 2024 Received: May 23, 2024

Dear Ivy 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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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

for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241460

Device Name

Manual Wheelchair

Indications for Use (Describe)

The Manual Wheelchair is to provide mobility to persons limited 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."

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510(k) Summary
Contact Details			Prepared on: 2024-06-0521 CFR 807.92(a)(1)
Applicant Name	Lichtmega Technology CO., Ltd.
Applicant Address	#101, No. 200, Cangjing Road, Songjiang District Shanghai ShanghaiChina
Applicant Contact Telephone	+86-021-5789862
Applicant Contact	Mr. Hyman Zhu
Applicant Contact Email	Hyman@lichtmega.com
Correspondent Name	Shanghai Sungo Management Consulting Co. Ltd.
Correspondent Address	14th Floor, 1500# Century Avenue Shanghai Shanghai 200122China
Correspondent Contact Telephone	+86-21-58817802
Correspondent Contact	Ms. Ivy Wang
Correspondent Contact Email	haiyu.wang@sungoglobal.com
Device Name			21 CFR 807.92(a)(2)
Device Trade Name	Manual Wheelchair (MW18)
Common Name	Mechanical wheelchair
Classification Name	Wheelchair, Mechanical
Regulation Number	890.3850
Product Code(s)	IOR
Legally Marketed Predicate Devices			21 CFR 807.92(a)(3)
Predicate #		Predicate Trade Name (Primary Predicate is listed first)	Product Code
K201461		Manual Wheelchair	IOR
Device Description Summary			21 CFR 807.92(a)(4)

Main Components:

Main frame, back upholstery, seat upholstery, handgrip, armrest, front wheel, hand rim, crossbar, footrest, skirt guard, brake,

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anti-tipper (optional)

The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.

Intended Use/Indications for Use

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

Indications for Use Comparison

The proposed device has same indications for use to the predicate device. Minor difference on dimension and specifications do not affect the safety and effectiveness of the proposed device.

Technological Comparison

The proposed device is same in working principle, indications for use, technological characteristics, and is composed of the same or similar components as the predicate device. The product proposed under this premarket notification has the same or similar performance characteristics and conform to the same. Differences between the subject wheelchair and predicate devices did not raise any new concerns regarding safety and effectiveness.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Non-clinical tests were conducted to verify that the subject device met all design specifications and provided support of the substantial equivalence determination. 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 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 strength 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 16840-10:2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method ISO 7176-22: 2014 Wheelchairs - Part 22: Set-up procedures Bio-Compatibility tests were conducted to verify that the safety requirements, and the following standards were complied: ISO10993-5 Biological evaluations of medical devices --- Part 5: Tests for In Vitro cytotoxicity

ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

ISO 10993-23 Biological evaluation of medical devices - Part 23: Tests for irritation

not applicable

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K201461.

21 CFR 807.92(a)(5)

and specifications do not

21 CFR 807,92(a)(6)

21 CFR 807.92(a)(5)

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).