(32 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The SINON Power Wheelchair, SN-P401 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.
The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of medical efficacy or diagnostic performance. Instead, it details a 510(k) premarket notification for a powered wheelchair, focusing on substantial equivalence to a predicate device.
The "Performance Testing" section mentions:
- 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)
These are standards related to electromagnetic compatibility and general safety and performance for wheelchairs, not acceptance criteria for a diagnostic or AI-driven medical device. The document states that "electronic systems between two devices are the same and all passed by the UL." This implies compliance with safety standards rather than a clinical study evaluating performance metrics like sensitivity, specificity, or reader improvement.
Therefore, I cannot populate the requested table or answer most of the questions, as the information is not present in the provided text.
However, based on the limited information related to "Performance Testing" and the nature of this submission (510(k) for a powered wheelchair), a hypothetical interpretation of "acceptance criteria" for a physical device would be compliance with recognized safety and performance standards.
Here's how I would attempt to answer based on the given context, with significant caveats that the document does not provide the detail usually associated with AI/diagnostic device studies:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria (Hypothetical for a powered wheelchair) | Reported Device Performance (Based on provided text) |
|---|---|
| Compliance with EMC standards (e.g., CISPR 11, EN61000-3-2, IEC61000-3-3) | "EMC Report," "all passed by the UL" |
| Compliance with Powered Wheelchair safety and performance standards (e.g., ANSI/RESNA WC/Vol.2-1998) | "ANSI / RESNA WC/Vol.2-1998" listed as a test |
| Electronic system safety | "electronic systems between two devices are the same and all passed by the UL" |
2. Sample size used for the test set and the data provenance: Not applicable. The document refers to engineering and safety standards compliance, not data sets for clinical or algorithmic performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in the context of a powered wheelchair would be linked to engineering specifications and safety testing, not expert consensus on medical images or diagnoses.
4. Adjudication method for the test set: Not applicable.
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 a physical device, not an AI-driven diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For safety and performance standards, the "ground truth" would be the engineering specifications, test protocols, and pass/fail criteria defined by the listed standards (e.g., ANSI/RESNA, CISPR, IEC).
8. The sample size for the training set: Not applicable. This device does not use a training set in the AI sense.
9. How the ground truth for the training set was established: Not applicable.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence for a physical medical device (a powered wheelchair) through compliance with recognized safety and performance standards, rather than presenting a study evaluating diagnostic accuracy or AI performance against specific acceptance criteria.
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MAR 1 2 2004
N CORPORATION
23, Sec. 1, Mei Chuan W.Road, Taichung 403, Taiwan FAX : 886-4-23750574 TEL : 886-4-23726181
http://www.sinon.com tw E-mail servicedasinon com tw
K040320
page 1 of 2
February 2, 2004
510(k) SUMMARY "
Submitter's Name: 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-P401 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:
The SINON Power Wheelchair, SN-P401 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.
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 Power Wheelchair GP-201 (K023148)
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SINON CORPORAT 23, Sec. 1, Mei Chuan W.Road, Taichung 403, Taiwan FAX : 886-4-23750574 TEL:886-4-23726181 F .- mail service@sinon com tw http://www.sinon.com.tw
Summary for substantial equivalence comparison:
y tor succtionic systems between two devices are the same and all passed by the UL The Clections of the electronic controller, batteries and recharge. I Thus the same safety level for the two devices is assured. The major differences existing of the two Powered Wheelchairs arc the different batteries, and the overall dimension, the size of lires, 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 shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 2 2004
Sinon Corporation C/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300
Re: K040320
Trade/Device Name: SINON Power Wheelchair, SN-P401 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: February 2, 2004 Received: February 9, 2004
Dear Dr. Jen:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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 recuirements, 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 - Dr. Ke-Min Jen
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Mark A. Wilkinson
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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510 (K) NUMBER (IF KNOW): TBA K040320
DEVICE NAME: SINON Power Wheelchair, SN-P401
INDICATIONS FOR USE:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Mark N. Mikkelson
Division of General, Restorative, and Newrological Devices
KO 90320 510(k) ^'umber_
( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE )
Concurrence of CDRH, office of Device Evaluation (ODE )
OR
Prescription Use
( Per 21 CFR 801.109 )
Over - The - Counter - Use
( Optional Format 1-2-96 )
§ 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).