(9 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The PRO WALKER ML-300 Foldable Wheelchair is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.
This 510(k) premarket notification for the PRO WALKER ML-300 Foldable Wheelchair does not describe a clinical study of the device's performance against acceptance criteria in the way a diagnostic or AI-driven medical device submission would. Instead, it demonstrates substantial equivalence to a predicate device through adherence to recognized performance standards for mechanical wheelchairs.
Here's an analysis based on the provided text, focusing on how a device like this meets its "acceptance criteria":
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Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria (Performance Requirements) Reported Device Performance (Compliance) ANSI/RESNA WC Vol. 1 Wheelchair Standards Meets applicable performance requirements ISO 7176 Wheelchair Standards Meets applicable performance requirements CA Technical Bulletin CAL 117 (Flame Retardant) Upholstery fabric meets standard Intended Use: Provide mobility to persons restricted to a seated position Device intended for this purpose Weight Limit: 100 kgs Same as predicate device (100 kgs) Foldability Foldable easily, essential feature same as predicate -
Sample Size used for the test set and the data provenance:
The document does not specify a "test set" in terms of patient data or
clinical images. The "testing" refers to mechanical and material
performance evaluations of the wheelchair itself. Therefore, sample sizes
would refer to the number of wheelchairs or components tested to verify
compliance with the standards. This information is not explicitly provided,
but typically involves a limited number of units or material samples from
manufacturing for destructive and non-destructive testing per the
standards.- Data Provenance: Not applicable in the context of clinical data. The
testing would have been conducted by the manufacturer or a certified
testing lab. The submitter's address is in Taiwan.
- Data Provenance: Not applicable in the context of clinical data. The
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. "Ground truth" in this context refers to the defined
parameters and limits within the ANSI/RESNA and ISO standards for
wheelchair performance, as well as the California Technical Bulletin for
flame retardancy. These standards themselves are established by expert
committees in their respective fields (e.g., biomechanical engineers,
rehabilitation specialists for wheelchair standards; fire safety experts for
flammability standards). The submission implies that the device met these
pre-established criteria, not that new ground truth was created by experts
for this specific device's test set. -
Adjudication method:
Not applicable. There's no clinical data or expert review process
described that would require an adjudication method. Compliance with
standards is typically determined by testing results falling within
defined ranges or passing specific procedures. -
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 device is a mechanical wheelchair and does not involve AI or human "readers" interpreting data. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a mechanical wheelchair and does not
involve an algorithm. -
The type of ground truth used:
The "ground truth" for this device's performance is compliance with established international and national performance standards for wheelchairs (ANSI/RESNA WC Vol. 1 and ISO 7176) and material safety standards (California Technical Bulletin CAL 117 for flame retardance). These standards define objective, measurable criteria for safety and performance (e.g., stability, fatigue, static strength, braking effectiveness, flammability). -
The sample size for the training set:
Not applicable. This device is a mechanical wheelchair; there is no "training set" in the context of machine learning or AI. -
How the ground truth for the training set was established:
Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The PRO WALKER ML-300 Foldable Wheelchair demonstrated that it meets its acceptance criteria through performance testing against recognized national and international standards for mechanical wheelchairs and fire retardancy. The submission states, "ML-300 Foldable Wheelchair meet the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards... and the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant."
This type of submission for a Class I device typically relies on engineering and laboratory testing to assure compliance with these established standards, rather than clinical trials with human subjects. The substantial equivalence argument further reinforces that the device's design, materials, and performance characteristics are comparable to a device already deemed safe and effective (the BIOTECH B900 SUPER LIGHT Wheelchair, K020472), with any differences (like overall dimension and weight) not impacting safety aspects.
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MAY 2 8 2004
Image /page/0/Picture/2 description: The image shows a logo with the text "PRO WALKER" below a stylized letter "P". The "P" is bold and angular, with a horizontal line running through the upper portion, resembling a wave or a stylized design element. The text "PRO WALKER" is in a simple, sans-serif font, positioned directly beneath the "P" logo.
- An Li Lane, Chang An Rd., Tachia, Tai ien. TAI WAN. K. Fax: +886-2682-1899 Vebsite: www.pro-walker.com.tw E-mail : pro.walker@msa.hinet.net
510(k) SUMMARY " દ દ
Submitter's Name: PRO WALKER INC. No. 60, An Li Lane, Chang An Road, Tachia, Taichung Hsine,
Taiwan, 437, ROC.
May 12, 2004
Device Name:
Date summary prepared:
Proprietary Name:
Common or Usual Name: Classification Name:
PRO WALKER ML-300 Foldable Wheelchair Mechanical Wheelchair Mechanical Wheelchair, Class I, 21 CFR 890.3850
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 ML-300 Foldable Wheelchair is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.
Performance Testing:
ML-300 Foldable Wheelchair meet the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards as indicated in section B page 7-1~7-5.
Legally marketed device for substantial equivalence comparison: BIOTECH B900 SUPER LIGHT Wheelchair ( K020472 ).
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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" is designed with a thick, bold line and has a wave-like shape inside the upper loop. The text "PRO WALKER" is in a simple, sans-serif font and is aligned below the left side of the "P".
60, An Li Lane, Chang An Rd., Tachia, Taichung sien. TAI WAN. R.O. Tel: +886-4-2682-1799 Fax: +886-2682-1899 Website: www.pro-walker.com.tw E-mail : pro.walker@msa.hinet.net
Summary for substantial equivalence comparison:
The new device and the predicate device have the same intended use and the weight limit 100kgs between the two devices is the same. Mainframes of two devices are foldable. The overall dimensions are similar. Back upholstery material is also the same resistance ignitability fabric. - The major differences existing of the two Mechanical Wheelchairs are the different overall dimension and weight between the two devices. The overall appearance and weight 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 for 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 eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 2004
Pro Walker, Inc. C/o Dr. Kc-Min Jen ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300
Rc: K041337
Trade/Device Name: PRO WALKER ML-300 Foldable Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: May 12, 2004 Reccived: May 19, 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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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,
Mark A. Milkerer
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: PRO WALKER ML-300 Foldable Wheelchair
INDICATIONS FOR USE:
The device is intended for medical purposes to provide mobility to person 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)
Concurrence of CDRH, Office of Device Marathon (ODE)
for Mark
(Division Sign-Off)
Division of General, Ranterative,
and Neurological Devi...
510 K041337
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).