SINON POWER WHEELCHAIR, SN-W401 by SINON CORPORATION

The SINON Power Wheelchair, SN-W401 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the SINON Power Wheelchair, SN-W401. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria and their fulfillment in the way one might see for a diagnostic AI device.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or not present in this type of regulatory submission for a powered wheelchair. The submission relies on established engineering standards and comparison to a legally marketed equivalent device, not a performance study as typically understood for AI/diagnostic tools.

Here's a breakdown of the information available and what is not applicable:

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

Acceptance Criteria (Standard)	Reported Device Performance
EMC Report:
ANSI / RESNA WC/Vol.2-1998	Passed
CISPR 11: 1990	Passed
EN61000-3-2: 1995	Passed
IEC61000-3-3: 1995	Passed
Safety Certification:
UL certificated for electronic systems (controller, batteries, recharge)	Passed

The "acceptance criteria" here are defined by compliance with established Electromechanical Compatibility (EMC) standards and safety certifications for powered wheelchairs. The document states that the device "passed" these.

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

Not applicable in the context of this device. This is not a data-driven diagnostic device. Performance is assessed through engineering tests on the device itself.
The "test set" would be the single device or a small sample of devices manufactured for testing against the engineering standards.

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

Not applicable. Ground truth for a powered wheelchair involves meeting specific engineering and safety standards, not expert interpretation of diagnostic data. The "experts" would be the certified testing bodies (e.g., those issuing UL certification and conducting EMC tests).

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

Not applicable. Performance against engineering standards is typically binary (pass/fail) or quantitative measurement against a threshold, not subjective adjudication.

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

Not applicable. This is not an AI or diagnostic device that involves human readers.

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

Not applicable. This is a hardware device (powered wheelchair), not an algorithm. Its "standalone" performance refers to its operational capabilities as a wheelchair, which are validated through compliance with the listed engineering standards.

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

The "ground truth" for this device is defined by established international and national engineering standards for powered wheelchairs (e.g., ANSI / RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, IEC61000-3-3) and safety certifications (UL certification).

8. The sample size for the training set

Not applicable. This is not a machine learning or data-driven device.

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

Not applicable.

Additional context from the document:

Legally marketed device for substantial equivalence comparison: EPW Foldable Power Wheelchair EPW-03 (K033206)
The basis for substantial equivalence is that the electronic systems (controller, batteries, recharge) are the "same and all passed by the UL certificated" as the predicate device, ensuring the "same safety level."
Differences like battery type, overall dimensions, tire size, and weight are noted but deemed "not safety aspect" differences that would negate substantial equivalence.

Summary

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K040319

January 28, 2004

SINON CORPORATION

FEB 2 0 2004

23, Sec. 1, Mei Chuan W.Road, Taichung 403, Taiwan TEL : 086-4-23726181

FAX:886-4-23750574

F-mail service(a)sinon.com tw http://www.sinon.com tw

44 510(k) SUMMARY "

Submitter's Namc: SINON Corporation

No. 23, Sec. 1, Mei Chuan W. Road, Taichung, 403, Taiwan, ROC

Date summary prepared:

Device Name:

Proprietary Name: Common or Usual Name: Classification Name:

SINON Power Wheelchair, SN-W401 Powered Wheelchair Powered Wheelchair, Class II, 21 CFR 890.3860

Indications for Use:

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

Description of the device:

Performance Testing:

EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Powered Wheelchairs, controller, and their chargers - requirements and test methods)

Legally marketed device for substantial equivalence comparison:

EPW Foldable Power Wheelchair EPW-03 (K033206)

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SINON CORPORATION 23, Sec. 1, Mei Chuan W.Road, Taichung 403, Taiwan FAX : 886-4-23750574 TEL:886-4-23726181

http://www.sinon.com.tw F-mail.service(@sinon.com.tw

Summary for substantial equivalence comparison:

The electronic systems between two devices are the same and all passed by the UL certificated, for instance the electronic controller, batteries and recharge. Thus the same safety level for the two devices is assured. The major differences existing of the two Powered Wheelchairs are the different batteries, and the overall dimension, the size of tires, and the weight are differences between the two devices. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect.

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Image /page/2/Picture/1 description: The image is a circular seal or logo. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle. Inside the circle is a stylized emblem featuring three parallel lines that curve and flow, resembling a stylized representation of a human form or a symbol of interconnectedness.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2,0 2004

Sinon Corporation C/o Ke-Min Jen, Ph.D. ROC Chinese-European Industrial Research Society No. 58. Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300

Re: K040319

Trade/Device Name: SINON Power Wheelchair, SN-W401 Regulation Number: 21 CFR 890.3860 Regulation Namc: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: January 28, 2004 Reccived: February 9, 2004

Dear Dr. Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bected. B r (2) fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreate) to regary to regars and the Medical Device Amendments, or to commerce prior to ritar 2011 - 11:15 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 r ou may, derere, misions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it 11 your de looks o such 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 r reaso or awards 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 of 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); 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.

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Page 2 – Ke-Min Jen, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with and w yourse of substantial equivalence of your device to a legally premance notification " results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acrite for your 301) 594-4659. Also, please note the regulation entitled, Connact the Office of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micronational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

, Mark N. Milliken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_1_of _1

510 (K) NUMBER ( IF KNOW ):__ TBA DEVICE NAME: SINON Power Wheelchair, SN-W401_

INDICATIONS FOR USE:

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

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

Concurrence of CDRH, office of Device Evaluation (ODE )

Prescription Use OR Over-The-Counter-Use ✓
(Pef 21 CFR 80069) (Optional Format 1-2-96)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K040319
FI

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).