(42 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The MAXHEALTH Mechanical Wheelchair, K1 is 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.
The provided document describes the 510(k) summary for the MAXHEALTH Mechanical Wheelchair, K1. It states that the device's performance meets applicable requirements in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards. However, the document does not provide specific acceptance criteria or detailed results of a study proving the device meets these criteria in the format requested.
Here's what information can be extracted and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ANSI/RESNA WC vol. 1 and ISO 7176) | Reported Device Performance |
|---|---|
| Specific criteria from these standards (e.g., stability, braking, durability, static/impact strength, maneuverability, etc.) were not detailed in the provided document. | "MAXHEALTH Mechanical Wheelchair, K1 meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document only states that "Performance Testing" was conducted but doesn't mention the number of units tested.
- Data Provenance: Not specified. The country of origin of the data (where the testing was conducted) and whether it was retrospective or prospective testing are not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided. The testing relates to mechanical performance standards, not diagnostic or clinical interpretation requiring expert consensus on a "ground truth" for a test set of data. The "ground truth" in this context would be the pass/fail criteria defined by the engineering standards.
4. Adjudication method for the test set
- Not applicable and not provided. As per point 3, this type of mechanical performance testing typically relies on objective measurements against predefined thresholds, not on adjudication of subjective interpretations.
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 and not provided. This is a mechanical wheelchair and not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable and not provided. See point 5.
7. The type of ground truth used
- The "ground truth" for this device would be defined by the technical specifications and performance thresholds outlined in the ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards. These standards define acceptable levels of performance for various attributes of a wheelchair (e.g., strength, stability, braking, dimensions). The device's performance is measured against these established engineering standards.
8. The sample size for the training set
- Not applicable and not provided. This product is a mechanical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable and not provided. See point 8.
Summary of what is known:
The MAXHEALTH Mechanical Wheelchair, K1 was tested for its performance against ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards. The manufacturer claims the device "meets the applicable performance requirements" of these standards. The device's substantial equivalence was compared to the JAN MAO Wheelchair JMC612-FL318EPP (K062218).
Summary of what is missing from the provided document:
Detailed acceptance criteria (specific numerical thresholds), specific test results, sample size of tested units, testing methodology details, and any information related to AI or ground truth establishment in a clinical context are absent. The document focuses on regulatory approval through substantial equivalence rather than a detailed scientific study publication.
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Image /page/0/Picture/1 description: The image shows a logo for Maxhealth Medical Products. The logo features three stick figures with their arms raised, connected by a horizontal line. To the right of the stick figures, the text "Maxhealth" is written in a bold font, with the trademark symbol next to it. Below "Maxhealth", the text "User Friendly Medical Products" is written in a smaller font.
MAXHEALTH CORPORATION
15F-6, NO. 81. SEC 1, HSIN TAI WO RD., HSI CHIF
P.O. BOX 2-78, HSI CHIH, TAIPEI HSIEN, TAIWAN R.O.C.
TEL: 886-2-26984171(Rep.)
FAX: 886-2-26981300
886-2-26982486
510(k) SUMMARY "
MAR 0 1 2007
January 10, 2007
Submitter's Name: MAXHEALTH CORP.
15F-6, No.81, Hsin Tai Wu Rd., Sec. 1, His Chih, Taipei Hsien, Taiwan, 22101. ROC
Date summary prepared:
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
MAXHEALTH Mechanical Wheelchair, K1 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 MAXHEALTH Mechanical Wheelchair, K1 is 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:
MAXHEALTH Mechanical Wheelchair, K1 meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.
Legally marketed device for substantial equivalence comparison:
JAN MAO Wheelchair JMC612-FL318EPP (K062218 )
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its head turned to the left and wings outstretched. The eagle is composed of three thick, curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Maxhealth Corporation % Roc Chinese-Europe Industrial Research Society Jen Ke-Min No. 58, Fu-Chiun Street Hsin-Chu City China (Taiwan)
MAR 0 1 2007
Re: K070176
Trade/Device Name: MAXHEALTH Mechanical Wheelchair, K1 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: January 10, 2007 Received: January 18, 2007
Dear Jen Ke-Min:
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 - Jen Ke-Min
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 . 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
for
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the logo and contact information for Maxhealth Corporation. The logo includes a stylized graphic of three figures holding hands, along with the company name and the tagline "User Friendly Medical Products." The contact information includes the address: 15F-6, NO. 81, SEC 1, HSIN TAI WU RD., HSI CHIH, P.O. BOX 2-78, HSI CHIH, TAIPEI HSIEN, TAIWAN R.O.C., as well as the telephone and fax numbers: TEL: 886-2-2 and FAX: 886-2-2, and 886-2-2.
TEL: 886-2-26984171(Rep.)
FAX: 886-2-26981300
886-2-26982486
Indications for Use
510 (K) Number ( If Known ):
Device Name: MAXHEALTH Mechanical Wheelchair, K1
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)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative, | |
| and Neurological Devices | |
| Page 1 of 1 | |
| 510(k) Number | K070176 |
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§ 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).