(28 days)
The intended use of the Manual Wheelchair Series is to provide mobility to persons limited to a sitting position.
The Manual Wheelchair Series are manually operated, self or attendant propelled, manual, mechanical wheelchairs. Their intended function and use is to provide mobility to persons limited to a sitting position. The products may also be used as attendant propelled patient transport devices in a health care environment such as hospital, nursing homes, or extended care facilities.
The products consist primarily of a metal frame, large rear wheels with hand rims for propelling the chair, and smaller front pivoting casters for steering and turning. There is also an attendant propelled version (Model 0400), which has smaller rear wheels than the others in the series.
This is a 510(k) summary for a manual wheelchair and as such, it does not fit the typical format for studies and acceptance criteria as described in your request, which usually applies to more complex medical devices, especially those involving AI or diagnostic interpretations.
However, I can extract the relevant information regarding performance and acceptance criteria from the provided document as best as possible within the context of a mechanical device.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance for Shanghai Wheelchair Factory's Manual Wheelchair Series
The acceptance criteria for this manual wheelchair series are based on compliance with an international standard for wheelchairs.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Standard/Requirement | Device Performance/Statement of Compliance |
|---|---|---|
| Mechanical Performance | ISO Standard ISO 7176: 1993(E), "ISO Standard, Wheelchairs - Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs" (specifically Part 8) | "The Manual Wheelchair Series meet the applicable requirements specified in part 8 of the ISO Standard ISO 7176: 1993(E)" |
Note on "Power and Control Systems of Electric Wheelchairs": The document explicitly states the manual wheelchair meets requirements specified in part 8 of ISO 7176:1993(E), which is titled "Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs." This appears to be a clerical error in the submission, as a manual wheelchair does not have "power and control systems of electric wheelchairs." It is highly probable that the submission intended to reference a part of ISO 7176 (or a different ISO standard for manual wheelchairs) that covers mechanical integrity, stability, durability, or other relevant aspects for manual wheelchairs. However, based strictly on the provided text, this is the standard cited. For the purpose of this analysis, I will proceed with what is written in the document.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size used for the test set. It merely states that the "Manual Wheelchair Series" meets the requirements, implying that the tested units (likely representative samples of the different models in the series) passed the specified tests.
Data provenance (country of origin, retrospective/prospective) is also not mentioned. The testing would have been conducted by the manufacturer or a third-party testing facility.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and therefore not provided in the document. For a mechanical device like a wheelchair, "ground truth" is established through standardized physical tests (e.g., fatigue testing, static strength testing, dynamic testing, etc.) outlined in the ISO standard, not through expert consensus or interpretation of data. The results of these tests (e.g., whether a component broke, how much force was sustained, etc.) are objective measurements against specified thresholds.
4. Adjudication Method for the Test Set
This is not applicable and therefore not provided in the document. As mentioned above, mechanical testing involves objective measurements against predefined acceptance criteria from the standard, not an adjudication process by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, Effect Size of Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable to a manual wheelchair. MRMC studies are used for diagnostic or interpretive devices, often involving AI, where human performance in reading or interpreting data is being evaluated. A manual wheelchair is a mechanical mobility aid and does not involve "human readers" or "AI assistance" in its direct function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable to a manual wheelchair. Standalone performance refers to the performance of an algorithm or AI system without human intervention, which is not relevant for this device.
7. The Type of Ground Truth Used
The "ground truth" (or more accurately, the validation method) used is compliance with an international standard: ISO Standard ISO 7176: 1993(E), "ISO Standard, Wheelchairs - Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs" (specifically Part 8). The standard defines objective test methods and performance criteria.
8. Sample Size for the Training Set
This information is not applicable and therefore not provided in the document. "Training set" refers to data used to train machine learning models, which are not involved in the design or validation of a purely mechanical device like a manual wheelchair.
9. How the Ground Truth for the Training Set Was Established
This is not applicable to a manual wheelchair, as there is no "training set" in the context of mechanical device validation.
In summary, the provided 510(k) summary for the manual wheelchair primarily demonstrates substantial equivalence by stating compliance with a recognized international mechanical standard, rather than through complex clinical studies often associated with diagnostic or AI-powered devices.
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510(k) SUMMARY
Shanghai Wheelchair Factory's Manual Wheelchair Series
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
Shanghai Wheelchair Factory 80 Lane 251 Zoayang Road Shanghai, China 200062 Phone: 86-21-62542392 Fax:86-21-62168882
Contact Person:
Tracy Ma Representing Shanghai Wheelchair Factory Project Manager Vendor Development Group, Inc. 120 Ionia Street SW Grand Rapids, MI 49503
Date Prepared:
February 28, 2004
Name of Device and Name/Address of Sponsor
Manual Wheelchair Series
Vendor Development Group, Inc. 120 Ionia Street SW Grand Rapids, MI 49503 Phone: (8770 836-3673 Fax: (616) 459-9850
Common or Usual Name
Manual Wheelchair
Classification Name
Wheelchair, Mechanical
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Predicate Devices
The Shanghai Series Manual Wheelchairs are substantially equivalent to are Invacare's Model "Action Patriot" Manual Wheelchair (K930803) and Sunrise Medical's Model "Breezy 510" Manual Wheelchair (K974820)
Intended Use
The intended use of the Manual Wheelchair Series is to provide mobility to persons limited to a sitting position.
Technological Characteristics and Substantial Equivalence
A. Device Description
The Manual Wheelchair Series are manually operated, self or attendant propelled, manual, mechanical wheelchairs. Their intended function and use is to provide mobility to persons limited to a sitting position. The products may also be used as attendant propelled patient transport devices in a health care environment such as hospital, nursing homes, or extended care facilities.
The products consist primarily of a metal frame, large rear wheels with hand rims for propelling the chair, and smaller front pivoting casters for steering and turning. There is also an attendant propelled version (Model 0400), which has smaller rear wheels than the others in the series.
B. Substantial Equivalence
The Shanghai Series Manual Wheelchairs are substantially equivalent to Invacare's Model "Action Patriot" Manual Wheelchair (K930803) and Sunrise Medical' s Model "Breezy 510" Manual Wheelchair (K974820)
PERFORMANCE DATA
The Manual Wheelchair Series meet the applicable requirements specified in part 8 of the ISO Standard ISO 7176: 1993(E), "ISO Standard, Wheelchairs - Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 2004
Shanghai Wheelchair Factory C/o Ms. Tracy Ma Project Manager Vendor Development Group, Inc. 120 Ionia Street SW Grand Rapids, Michigan 49503
Re: K040561
Trade/Device Name: Manual Wheelchair Series Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: January 29, 2004 Received: March 5, 2004
Dear Ms. Ma:
This letter corrects our substantially equivalent letter of March 31, 2004 regarding the device named above. The Trade/Device Name was incorrectly listed as Shanghai Series Manual Wheelchairs. The correct Trade/Device Name is listed above.
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 (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 proiltions 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 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.
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Page 2 - Ms. Tracy Ma
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.
This letter will allow you to continue 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) 632-2011 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain,html
Sincerely vor
sincerely yours,
for Mula N. Mulkerson
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 known): K040561
- Device Name: Manual Wheelchair Series
Indications For Use:
The intended use of Shanghai Wheelchair
Factory's Manual wheelchair series
is to provide mobility to persons.
limited to a sitting position.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K040561
| Labels | Values |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | OR |
| Over-The-Counter Use |
(Optional Format 1-2-96)
APR 05 '04 11:04
301 594 2358
PAGE . 01
§ 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).