(62 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The PRO WALKER Power Wheelchair, PL-200 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 describes a 510(k) premarket notification for a powered wheelchair, the PRO WALKER Power Wheelchair, PL-200. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with acceptance criteria based on performance metrics. Therefore, many of the requested elements are not applicable in this context.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission seeking substantial equivalence, "acceptance criteria" and "device performance" are typically framed in terms of comparison to a legally marketed predicate device, rather than specific quantitative performance goals met by the new device in a standalone study. The criteria for acceptance in this context are demonstrating that the new device is as safe and effective as the predicate.
| Feature/Criterion (Comparison to Predicate) | Reported Device Performance (PRO WALKER PL-200 vs. SINON W401) |
|---|---|
| Intended Use | Same: provide mobility to persons restricted to a seated position. |
| Batteries | Same brand, similar U1 type. |
| Control Systems | Same brand (Dynamic), different types (SHARK for new, DL for predicate). Deemed substantially equivalent as "different types" don't lead to safety concerns. |
| Chargers | Same supplier, UL certified. |
| Foldable Frame | Same. |
| Removable Armrest Type | Same. |
| Weight Limit | Same. |
| Back Upholstery Material | Same, passed resistance ignition test by SGS. |
| Cruising Range | 20-25 miles (new) vs. 20 miles (predicate). New device has longer range due to presumably larger batteries (predicate's batteries are smaller). Deemed substantially equivalent as "real range depends on practice environments" and the difference is not a safety concern. |
| Maximum Speed | 4.7 mph (new) vs. 4 mph (predicate). Deemed substantially equivalent as "do not lead any safety considerations" and "higher speed means the predicate device shall meet relevant requirements for the braking time, distance, and dynamic stability for safety considerations." |
| Appearance Dimensions (Overall dimensions, wheel size, seat dimensions) | Different. Deemed substantially equivalent as "For the regular operator, these differences for the two devices do not lead to any performance differences." |
| Safety Standards Adherence | EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Powered Wheelchairs, controller, and the chargers - requirements and test methods). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not applicable. This submission doesn't involve a clinical "test set" in the traditional sense of patient data. The performance testing is based on engineering standards and direct comparison of specifications between the new device and the predicate.
- Data provenance: Not applicable for clinical data. The performance testing refers to industry standards (e.g., ANSI / RESNA WC/Vol.2-1998) and electromagnetic compatibility standards (e.g., CISPR 11: 1990). The device manufacturer is PRO WALKER INC. located in Taiwan.
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)
Not applicable. No "ground truth" was established by experts for a clinical test set. The evaluation is based on engineering specifications and adherence to recognized standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication of expert interpretations was performed.
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/software device and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software device. The performance testing mentioned (EMC Report, ANSI/RESNA standards) are for the physical device's safety and functionality, not an algorithm's standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of device and submission, "ground truth" is established by adherence to recognized performance standards (e.g., ANSI/RESNA for wheelchairs, CISPR/EN/IEC for EMC) and by demonstrating that design differences do not raise new questions of safety or effectiveness compared to a legally marketed predicate device.
8. The sample size for the training set
Not applicable. This is not a machine learning device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth for one.
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May 11, 2004
JUL 2 0 2004
Image /page/0/Picture/2 description: The image shows the logo and contact information for Pro Walker Inc. The logo includes the company name and a stylized letter 'P' with wave-like lines inside. The contact information includes the company's address at No. 60, An Li Lane, Chang An Rd., Tachia, Taichung Hsien, TAIWAN, R.O.C., as well as their phone number (+886-4-2682-1799), fax number (+886-2682-1899), website (www.pro-walker.com.tw), and email address (pro.walker@msa.hinet.net).
દ ( 510(k) SUMMARY "
Submitter's Name: PRO WALKER INC.
No. 60, An Li Lane, Chang An Roud, Tachia, Taichung Hsine, Taiwan, 437, ROC
Date summary prepared:
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
PRO WALKER Power Wheelchair, PL-200 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 PRO WALKER Power Wheelchair, PL-200 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 the chargers - requirements and test methods)
Legally marketed device for substantial equivalence comparison:
SINON Power Wheelchair W401 (K040319)
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Image /page/1/Picture/0 description: The image shows a logo with the text "PRO WALKER" below a stylized letter "P". The "P" has a thick, bold design with a horizontal line through the upper part, creating a wave-like shape within the letter. The text "PRO WALKER" is in a simple, sans-serif font, with "PRO" above "WALKER".
. 60. An Li Lane, Chang An Rd., Tachia, Taichung Hsien. TAIWAN. R.O.C Fax: +886-2682-1899 Tel: +886-4-2682-1799 Website: www.pro-walker.com.tw E-mail : pro.walker@msa.hinet.net
C.2 COMPARISON SUMMARY
( We place the related information for the predicate device in the following pages. )
We can know from the above table that the intended use between two devices is the The batteries used are the same brand and similar U1 type. The control same. systems for the two devices are used from same brand and different types: Dynamic SHARK for the new device, and Dynamic DL for the predict device. The recharge for the two devices are also used the same supplier, and the chargers are also certified by UL. Besides, the foldable frame, removable armrest type, same weight limit, and back upholstery are the same material that also be passed the resistance ignition test by SGS.
The cruising range of the new device is 20~25 miles and 20 miles for the predicate device. This is mainly due to the fact that the batteries for the predicate devices are smaller. Certainly the real range depends on the practice environments. i.e., weight. surface, incline, and temperature. For the real life use, the two devices are substantially equivalent.
The maximum speed for the new device is 4.7 mph and 4 mph for the predicate Higher speed means the predicate device shall meet relevant requirements for the device. braking time, distance, and dynamic stability for safety considerations. The different maximum speeds do not lead any safety considerations and they are substantially equivalent in this aspect.
To sum up the mainly different of the two devices are only appearance dimensions, i.e., the overall dimensions, the size of wheels, and seat dimensions. For the regular operator, these differences for the two devices do not lead to any performance differences, and the two devices are substantially equivalent.
Based on the above the information and the analysis, we know that the subject device, the predicate device have the same intended use the same technological aspects and only minor dimensions and material differences exist. We believe that FDA can decide the subject device and the predicate device are substantially equivalent.
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
JUL 2 0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pro Walker, 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: K041336
Trade/Device Name: PRO WALKER Power Wheelchair, PL-200 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: May 24, 2004 Received: June 2, 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 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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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,
Mark A. Millman
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__________________________________________________________________________________________________________________________________________________________________________
510 (K) NUMBER ( IF KNOW ): ___TBA ___________________________________________________________________________________________________________________________________________ DEVICE NAME: PRO WALKER Power Wheelchair, PL-200 -
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 √ |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K041336 |
|---|---|
| --------------- | --------- |
§ 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).