(11 days)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
The AVANTICARE Mechanical Wheelchair, MS-8000 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The dcvice can bc disassembled for transport and it is foldable easily. The device uses a standard sling type back and scat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.
The provided document is a 510(k) premarket notification for a mechanical wheelchair (LERADO, AVANTICARE Mechanical Wheelchair, MS-8000). The document primarily focuses on establishing substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and study information, based solely on the provided text:
Acceptance Criteria and Device Performance (LERADO, AVANTICARE Mechanical Wheelchair, MS-8000)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | To provide mobility to persons restricted to a sitting position. |
| Applicable Performance Standards | Meets applicable performance requirements as specified in ANSI/RESNA WC vol. I and ISO 7176 Wheelchair Standards. |
| Flame Retardancy | Upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant. |
| Weight Limit | 100 kgs (same as predicate device). |
| Foldability | Can be disassembled for transport and is easily foldable. Mainframe is foldable (same as predicate device). |
| Overall Dimensions | Similar to predicate device (with some differences noted, not impacting safety). |
| Upholstery Material | Back upholstery material is the same resistance-ignitability fabric as the predicate device. |
| Seat Heights | Small difference compared to predicate device, but not leading to any safety hazard. |
| Hanger and Rear Axle Designs | Same as predicate device. |
| Caster Sizes | Different from predicate device; predicate device's caster size is smaller and moves more easily. |
| Overall Appearance | Differences exist between the new device and predicate device, but these are noted as "not safety aspect." |
| Weight and Size | Larger than predicate device, intended to make the user feel more comfortable during transport. |
| Optional Accessories | Same as predicate device, offering users the same choice of needed accessories. |
Study Information:
-
Sample size used for the test set and the data provenance:
The document does not specify a separate "test set" in the context of an AI/algorithm-based device. The performance testing refers to meeting established industry standards (ANSI/RESNA WC vol. I and ISO 7176 Wheelchair Standards) rather than a study on a specific dataset of patient outcomes or expert interpretations. The device itself is a physical product (mechanical wheelchair). Therefore, data provenance is not applicable in the typical sense of medical imaging or diagnostic algorithms. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a mechanical device, not a diagnostic or prognostic algorithm that requires expert ground truth establishment for a test set. Acceptance criteria are based on engineering standards and design comparisons. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as there is no test set requiring expert adjudication for ground truth. -
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. The device is a mechanical wheelchair and does not involve AI assistance or human readers. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a mechanical device, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For a mechanical wheelchair, the "ground truth" for performance is established by adherence to recognized engineering and safety standards (ANSI/RESNA WC vol. I and ISO 7176 Wheelchair Standards) and by direct comparison of physical and functional attributes to a legally marketed predicate device. The information provided about "Upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant" is also a type of regulatory-defined ground truth for a specific material property. -
The sample size for the training set:
Not applicable. This is a mechanical device, not an algorithm that requires a training set. -
How the ground truth for the training set was established:
Not applicable, as there is no training set.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APK 1 8 2005
Lerado Oversea Ltd. TWN Branch (BVI) C/o Dr. Ke-Min Jen ROC Chinese-European Industrial No. 58, Fu- Chiun Street Hsin-Chu City China (Taiwan) ROC 300
Re: K050290
Trade/Device Name: Lerado, Avanticare Mechanical Wheelchair, MS-8000 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: February 4, 2005 Received: February 7,2005
Dear Dr. Ke-Min Jen:
This letter corrects our substantially equivalent letter of February 18, 2005 regarding the trade name of the device. The error on the first letter was that we had Ms-800 instead of MS-8000.
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 (OS) 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 (240) 276-0120 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/industry/support/index.html.
Sincerely yours,
Stipt Rhodes
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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Indications for Use
The for the county of the state the state the starter of the states
COYPET 510 (K) Number ( If Known ):
Device Name: LERADO. AVANTICARE Mechanical Wheelchair, MS-8000
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,
in Neurological Devices
| (k) Number | K050290 | Page 1 of 1 |
|---|---|---|
| ------------ | --------- | ------------- |
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Image /page/3/Picture/0 description: The image shows a logo for Lerado Group. The logo consists of the word "LERADO" in bold, sans-serif font, with a triangular shape in place of the "A". Below the word "LERADO" are the words "LERADO" and "GROUP" on either side of a horizontal line. Below that is the Chinese translation of the company name.
LERADO OVERSEA LTD. TWN BRANCH(BVI No 22. Kuang Fu Road, Chia Tai Industrial Tai Pao City. ia Yi Hsien, Taiwan. ROC Fax: 886-5-2379672 886-5-2475570 http:// www.lerado.com edwardI @mail.lerado.com
66 510(k) SUMMARY "
Submitter's Name: Lerado Oversea Ltd. Twn Branch (BVI) No. 22, Kuang Fu Road, Chia Tai Industrial,Tai Pao City, Chia Yi Hsien, 612, Taiwan, ROC.
Date summary prepared:
February 4,2005
Device Name:
Proprietary Name:
LERADO, AVANTICARE Mechanical Wheelchair, MS-8000 Mechanical Wheelchair Common or Usual Name: Classification Name: 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 AVANTICARE Mechanical Wheelchair, MS-8000 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The dcvice can bc disassembled for transport and it is foldable easily. The device uses a standard sling type back and scat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.
Performance Testing:
AVANTICARE Mechanical Wheelchair, MS-8000 mect the applicable performance requirements as specified in ANSI/RESNA WC vol. I and ISO 7176 Wheelchair Standards.
Legally marketed device for substantial equivalence comparison:
PRO WALKER ML-300 Foldable Wheelchair ( K041337 )
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Image /page/4/Picture/0 description: The image shows the logo for Lerado Group. The logo consists of the word "LERADO" in large, bold letters, with a triangle in place of the "A". Below the word "LERADO" is the text "LERADO GROUP" in smaller letters. Below that is Chinese text.
LERADO OVERSEA LTD. TWN BRANCH(BVI) 22, Kuang Fu Road, Chia Tai Industrial Tai Pao City, ia Yi Hsien, Taiwan, ROC 886-5-2475520 Fax 886-5-2379672 E-mail edwardL@mail lerado corn http // www.lerado com
C.2 COMPARISON SUMMARY
( We place the related information for the predicate device in the following pages.)
From the above comparison table that the intended use and the weight limit 100kgs between the two devices are the same. Mainframes of two devices are foldable. The overall dimensions are similar. Back upholstery material is also the same resistance -ignitability fabric and also meets the California Technical Bulletin CAL 117 standard for flame retardant. The major differences existing are the overall dimension, and the size of tires 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.
The seat heights between the new device and the predicate device have small difference, not leading to any safety hazard. The hanger and rear axle designs are same. The caster sizes are different. The predicate device's caster size is smaller and it can move more easily than the larger ones can. The weight and size of the new device is larger and the user can feel more comfortable to transport it. At last the optional accessories for the two devices are the same, thus the users have the same adversity to choose the needed accessories to accommodate their needs.
Based on the above the information and the analysis, we know that the new device and the predicate device have the same technological aspects and the same intended use, except for tiny appearance differences. We believe that FDA can decide the subject device and the predicate device are substantially equivalent.
§ 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).