The Merits Model P322 Powered Wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

Device Description

Model P322 Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the PG power wheelchair VR-2 50amp controller. The user interface is a joystick. P322 is powered by two 12 VDC 34ah (U1) batteries. The batteries are charged by 4A off-board charger connect with 3-pin Microphone Connector to charging socket on joystick. The approximate driving range on fully charged batteries is up to 28km (18mi). The chair frame is a rived nut and welded steel construction and includes two front drive wheels with drive units (including motor, gear, brake), batteries and rear pivoting casters. Depending on users needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the wheelchair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.

The upholstery of the device complies with EN 1021-1/-2:2006: Furniture: Assessment of the ignitability of upholstered furniture: Ignition source: Smouldering cigarette/ Match flame equivalent

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

AI/ML Overview

The document describes a 510(k) premarket notification for the Merits Model P322 Powered Wheelchair. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel efficacy. Therefore, the "acceptance criteria" discussed are primarily related to meeting established performance standards for powered wheelchairs, and the "study" is a series of non-clinical tests to show compliance with these standards.

Here's the information requested, based on the provided text:

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

Acceptance Criteria Category	Specific Standard/Test	Description/Purpose (Acceptance Criteria)	Reported Device Performance
Stability	ISO 7176-1:1999	Determination of Static Stability	Meets specifications
	ISO 7176-2:2001	Determination of Dynamic Stability of electric wheelchairs	Meets specifications
Braking	ISO 7176-3:2003	Determination of effectiveness of brakes	Meets specifications
Range/Power	ISO 7176-4:2008	Energy consumption for determination of theoretical distance range	Up to 28km (18mi) on fully charged batteries; Meets specifications
Dimensions/Maneuvering	ISO 7176-5:2008	Determination of overall dimensions, mass and maneuvering space	Meets specifications
Acceleration/Deceleration	ISO 7176-6:2001	Determination of maximum acceleration and deceleration of electric wheelchairs	Meets specifications
Seating/Wheel Dimensions	ISO 7176-7:1998	Method of Measurement of Seating and Wheel Dimensions	Meets specifications
Strength/Durability	ISO 7176-8:1998	Requirements and test methods for static, impact and fatigue strengths	Meets specifications
Environmental	ISO 7176-9:2009	Climatic tests for wheelchairs	Meets specifications
Obstacle Climbing	ISO 7176-10:2008	Determination of obstacle-climbing ability of electrically power wheelchairs	Meets specifications
Test Dummies	ISO 7176-11:1992	Test dummies (Standard for test methodology)	N/A (Standard for test design)
Friction Coefficient	ISO 7176-13:1989	Determination of coefficient of friction of test surfaces	Meets specifications
Control Systems	ISO 7176-14:2008	Power control systems for electrically powered wheelchairs and scooters - Requirements and test methods	Meets specifications
Information/Labeling	ISO 7176-15:1996	Requirements for Information Disclosure, Documentation and Labeling	Meets specifications
Electrical Safety	IEC 60601-1:1988	General requirements for safety	Meets specifications
EMC	IEC 60601-1-2:2007	Electromagnetic Compatibility Requirements and Tests	Meets specifications
Risk Management	ISO 14971:2007	Application of risk management to medical devices	Meets specifications
Upholstery Ignitability	EN 1021-1:2006	Ignition source: Smouldering cigarette	Complies
	EN 1021-2:2006	Ignition source: Match flame equivalent	Complies

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

The document describes non-clinical testing of the Merits Model P322 Powered Wheelchair. This type of testing typically involves one or more physical units of the device being subjected to standardized tests in a laboratory setting. There is no specific sample size mentioned (e.g., "N=X wheelchairs tested"), nor is there information about data provenance in terms of country of origin or retrospective/prospective nature, as these concepts usually apply to clinical studies with human subjects or real-world data. The tests are prospective in the sense that they are performed on the device to demonstrate compliance.

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 section is not applicable to this type of device and submission. The "ground truth" for the performance tests of a powered wheelchair is defined by the technical specifications and requirements of the ISO, IEC, and EN standards listed. The "experts" involved would be the engineers and technicians performing the tests, qualified in understanding and executing these specific technical standards. Their qualifications are not detailed in the submission, as it's assumed they are competent to perform the standard tests.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices, to resolve disagreements among human readers or experts on ground truth determination. For engineering performance tests, the outcome is typically an objective measurement against a defined standard.

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. MRMC studies are relevant for diagnostic devices (often AI-assisted) where human interpretation of medical images or data is involved. This submission is for a powered wheelchair, which does not involve human readers interpreting AI outputs.

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

This is not applicable. A powered wheelchair is a physical device, not an algorithm. The "standalone performance" refers to the device's ability to meet the specified performance metrics (e.g., stability, braking, range) on its own, which is precisely what the non-clinical tests demonstrate.

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

The "ground truth" for the Merits Model P322 Powered Wheelchair's performance is established by international and national engineering and safety standards (ISO, IEC, EN). Compliance with these standards serves as the objective measure of the device's technical performance and safety. There is no expert consensus, pathology, or outcomes data used as ground truth in this context.

8. The sample size for the training set

This is not applicable. This device is a physical product (a powered wheelchair) and does not involve AI or machine learning, which rely on training data sets.

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

This is not applicable, as there is no training set for this device.

Summary

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K122357

JAN

9 2013

510(k) SUMMARY

Merits Health Products Co., LTD. 510(k) Premarket Notification

Submitter:

Merits Health Products Co., LTD. No.18, Jingke Rd., Nantun Dist. Taichung City 40852, Taiwan (R.O.C.)

Contact Person:

Vincent Chen Merits Health Products Co., LTD. No.18, Jingke Rd., Nantun Dist., Taichung City 40852, Taiwan (R.O.C.) Phone: +886-4-23594985 ext.200 Fax: +886-4-23503962

Date Prepared:

July 30, 2012

Proprietary Name:

Merits Model P322 Powered Wheelchair .

Common name:

Powered Wheelchair

Classification name:

Powered Wheelchair

Comparison to Predicate Devices:

This submission indicates the Substantial Equivalence of Merits Model P322 FWD Powered Wheelchair with the predicate Hoveround Teknique FWD mk4 Power Chair (K090108). P322 has the same intended uses and similar indications, technological characteristics and principles of operation with predicate device.

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Device Description

The upholstery of the device complies with EN 1021-1/-2:2006: Furniture: Assessment of the ignitability of upholstered furniture: Ignition source: Smouldering cigarette/ Match flame equivalent

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

The Merits Model P322 is substantially equivalent to Hoveround Teknique FWD mk4 Power Chair (K090108). Both products are battery power, motorized designed for use with powered wheelchairs. Performance characteristics and drive mechanisms are similar and all have the same intended function and use which is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair. Additional, they are all constructed from the same basic materials, have the same basic operational principles and all use DC batteries as their source of power.

Although there are some minor differences between P322 and its predicate device. But they raise no new issues of safety or effectiveness. Performance data demonstrate that P322 is safe. The non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do no raise any new questions of safety or effectiveness.

Intended Use

The Merits Model P322 Powered Wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

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Discussion of Non-clinical Tests Performed for Determinations of Substantial equivalence are as follows:

ISO 7176-1:1999 Determination of Static Stability

ISO 7176-2:2001 Determination of Dynamic Stability of electric wheelchairs

ISO 7176-3:2003 Determination of effectiveness of brakes

Energy consumption of electric wheelchairs and scooters for ISO 7176-4:2008 determination of theoretical distance range

Determination of overall dimensions, mass and maneuvering ISO 7176-5:2008 space
of speed. Determination maximum acceleration and ISO 7176-6:2001 deceleration of electric wheelchairs
ISO 7176-7:1998 Method of Measurement of Seating and Wheel Dimensions
Requirements and test methods for static, impact and fatigue ISO 7176-8:1998 strengths

ISO 7176-9:2009 Climatic tests for wheelchairs

Determination of obstacle-climbing ability of electrically power ISO 7176-10:2008 wheelchairs

ISO 7176-11:1992 Test dummies

ISO 7176-13:1989 Determination of coefficient of friction of test surfaces

ISO 7176-14:2008 Power control systems for electrically powered and wheelchairs and scooter- Requirements and test methods.

Requirements for Information Disclosure, Documentation and ISO 7176-15:1996 Labeling
Medical electrical equipment Part 1: General requirements for IEC 60601-1:1988 safety
IEC 60601-1-2:2007 Electromagnetic Compatibility Requirements and Tests
Medical devices -- Application of risk management to medical ISO 14971:2007 devices
Furniture Assessment of the ignitability of upholstered EN 1021-1:2006 furniture : Ignition source: Smouldering cigarette

Furniture Assessment of the ignitability of upholstered EN 1021-2:2006 furniture : Ignition source: Match flame equivalent

The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device.

Conclusions

According to comparison table, the differences on weight capacity, function of elevate, recline and dimension of width do not deleteriously affect the safety and effectiveness of the device.

So based on the design, performance specifications and testing and intended use, the Merits Model P322 Powered Wheelchair is substantially equivalent to Hoveround Teknique FWD mk4 Power Chair (K090108).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Merits Health Products CO., LTD Mr. Vincent Chen No. 18 Jingke Road Nantun Dist Taichung China (Taiwan) 40852

JAN
9 2013

Re: 510(k) Number: K122357

Trade/Device Name: Merits Model P322 Powered Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: December 21, 2012 Received: December 26, 2012

Dear Mr.Chen:

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 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 (reporting of medical

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Page 2 - Mr. Vincent Chen

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joyce M. Whang

for Victor Krauthamer, Ph.D. Acting 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 STATEMENT

510(k) File Number:

Device Name: Merits Model P322 Powered Wheelchair

Indications for Use: The Merits Model P322 Powered Wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

Prescription Use_ V (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Brian D.Pullin -S

Division of Neurological and Physical Medicine Devices 510(k) Number: 1122357

Regulation Number and Section

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).