(19 days)
Not Found
No
The description focuses on basic powered mobility features and manual controls, with no mention of AI/ML terms or functionalities.
No.
Explanation: A therapeutic device is used to treat or cure a disease or condition. This device is a powered scooter intended to provide mobility, which is an assistive device, not a therapeutic one.
No
The device description states its purpose is to provide mobility, and the intended use indicates it's for persons restricted to a seated position. There is no mention of it being used to diagnose any medical condition or gather diagnostic information.
No
The device description clearly describes a physical, battery-operated powered scooter with hardware components like wheels, a seat, hand controls, and a battery charger. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as providing mobility to persons restricted to a seated position. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The description details a powered scooter for mobility, not equipment used for analyzing biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or any other components typically associated with IVD devices.
- Performance Studies: The performance studies listed are related to electrical and safety standards for powered scooters, not diagnostic performance metrics.
In summary, the device's purpose and description align with a mobility aid, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Product codes (comma separated list FDA assigned to the subject device)
INI
Device Description
The A&I Scooter SC-301 is an indoor / outdoor Powered Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the Scooter 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing:
EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Powered Scooters, controller, and their chargers requirements and test methods)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).
0
WELL SUCCESS BIOTECH. INC
6F, No.70, Zi You Road, Hsinchu City, 300, Taiwan. R.O.C. TEL:886-3-5357667 FAX : 886-3-5357669 E-mail:i5357667@yahoo.com.tw
MAY 2 5 2004
દ ત્ 510(k) SUMMARY "
Submitter's Name: WELL SUCCESS Biotech. Inc.
6F, No.70, Zi You Road, Hsinchu City, 300, Taiwan, R.O.C.
Date summary prepared:
Device Name:
Proprietary Name:
Common or Usual Name: Classification Name:
May 1, 2004
A&I Scooter, SC-301 ( Trade name: A&I, A&E, J&C ) Electrical Scooter Motorized 3-Wheeled Vehicle, Class II, 21 CFR 890.3800
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 A&I Scooter SC-301 is an indoor / outdoor Powered Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the Scooter 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 Scooters, controller, and their chargers requirements and test methods)
Legally marketed device for substantial equivalence comparison: WU's 3-Wheeled Neo Scooter, WT-T3D (K032488)
1
C.2 COMPARISON SUMMARY
( We place the related information for the predicate device in the following pages, including the visual appearance, 510k information on the FDA website, and the comparison and summary table. )
The intended uses, back upholstery, maximum speed, and warranty period between the new device SC-301 and the predicate device WT-T3D are all the same. Especially the electronic systems between two devices are the same suppliers and all passed by the UL certificated including the batteries and recharge, and the electronic controllers between the two devices are also passed by the UL certificated. Besides, the back upholstery is the same material, and also passed the resistance ignition test by SGS. Thus the same safety level for the two devices is assured.
The major difference existing for new device is more agile and easy to fold for storage or transportation and the predicate device is for general use. So the sizes and visual appearance among them have differences, and there is no safety level difference.
To sum up, 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.
Based on the above the information and the analysis, we know that the subject device and the predicate devices have the same intended use, the same technological aspects and only minor dimensions or data differences exist. We believe that FDA can decide the subject device and the predicate device are substantially equivalent.
2
WELL SUCCESS BIOTECH. INC.
6F, No.70, Zi You Road, Hsinchu City, 300, Taiwan, R.O.C. TEL:886-3-5357667 FAX:886-3-5357669 E-mail:j5357667@yahoo.com.tw
Summary for substantial cquivalence comparison:
The electronic systems between the two devices are all passed by the UI, certificated, including the elcctronic controllers, the batteries and recharge. Besides, the two devices are the same maximum speed and back upholstery. Thus the same safety level for the two devices is assured. The major differences existing of the two Powered Scooters are the different overall dimension and weight between the two The overall appearance and weight differences are not safety aspect. devices. So the new device is substantially equivalent to the predicate devices in this aspect.
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3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an emblem that features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
MAY 25 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Well Success Biotech, Inc. C/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300
Re: K041187
Trade/Device Name: A & I Scooter, SC-301 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: May 1, 2004 Received: May 6, 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 Codc 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); 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.
4
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 yours,
L. Mark A. Milburn
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
5
of Page l
510 (K) NUMBER ( IF KNOW ):___TBA
DEVICE NAME: A&I Scooter, SC-301
INDICATIONS FOR USE:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Prescription Use __
AND/OR
Over-The-Counter Use
V
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mach N Millan
for (Division Sign-Off
Division of General, Restorative, and Neurological Devices
510(k) aber K04 1187