(14 days)
The Millenium II wheelchairs are intended to provide mobility to persons limited to a seated position that are capable of operating a manual wheelchair.
The Millenium II wheelchairs are intended to provide mobility to persons limited to a seated position that are capable of operating a manual wheelchair.
The provided text describes the 510(k) summary for the MILLENIUM II mechanical wheelchair. This document focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and performance standards rather than clinical performance or AI algorithm validation. Therefore, many of the requested categories for AI/clinical study evaluation are not applicable.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ISO 7176, Part 1 | Voluntarily conducted |
| ISO 7176, Part 5 | Voluntarily conducted |
| ISO 7176, Part 15 | Voluntarily conducted |
| ISO 7176, Part 16 | Voluntarily conducted |
| ISO 7176, Part 93 | Voluntarily conducted |
| ISO 7176, Part 3 | To be completed pre-launch |
| ISO 7176, Part 8 | To be completed pre-launch |
2. Sample size used for the test set and the data provenance
The document indicates testing was performed on the device ("a 100 kg dummy (plus 12.4 kg) as specified in ISO 7176 - 11 was used"). This suggests a single device may have been tested using a standardized dummy setup.
Data Provenance: The tests are "Non-Clinical Tests," implying they were conducted in a laboratory or engineering setting by the manufacturer (NEXT Mobility LLC). There is no information on country of origin of the data beyond the manufacturer's location in Canton, MI, USA. The testing is for mechanical performance and safety, not involving human subjects or clinical data in the traditional sense. It's likely considered prospective testing of the device prototypes or production samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for mechanical wheelchair testing is established by adherence to specified parameters within international standards (ISO 7176 series), not by expert human interpretation.
4. Adjudication method for the test set
Not applicable. The testing involves standardized mechanical performance tests, which yield objective measurements against defined criteria. It does not involve human interpretation requiring adjudication.
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 a mechanical wheelchair, not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical wheelchair, not an AI algorithm.
7. The type of ground truth used
The ground truth used for mechanical wheelchair testing is defined by the objective performance criteria and methodologies outlined in the ISO 7176 standards. This includes measures of strength, stability, durability, and other physical characteristics, with pass/fail criteria typically specified by the standard. The "ground truth" is adherence to these engineering standards.
8. The sample size for the training set
Not applicable. This is a mechanical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a mechanical device, not an AI model.
In summary, the provided document is a 510(k) premarket notification for a mechanical wheelchair, which relies on demonstrating compliance with recognized international performance standards (ISO 7176) and substantial equivalence to a predicate device. It does not involve AI or clinical studies in the typical sense that would necessitate the detailed categories requested for human-AI interaction or algorithm validation.
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KO 81665
JUN 2 7 2008
510(k) Summary (as required by 21 CFR 807.92(c))
Manufacturer Name and Address
NEXT Mobility LLC 7444 Haqqerty Road Canton, MI 48187 Phone (734) 207-3405 Fax (734) 207-2642
Contact Person / Requiatory Correspondent
Joseph Azarv Orchid Design 80 Shelton Technology Center Shelton, CT 06484 Phone: (203) 922-0105 Fax: (203) 922-0130 Email: jazary@erols.com or joseph.azary@orchid-orthopedics.com
Date Prepared
March 14, 2008 [Revised on June 26, 2008]
Name of Device MILLENIUM II
Classification Name
Wheelchair, Mechanical
Identification of Predicate Device
Invacare Tracer K935398
Description of the Device Intended Use
The Millenium II wheelchairs are intended to provide mobility to persons limited to a seated position that are capable of operating a manual wheelchair.
Comparison to Predicate Device
This device has a similar intended use and technological characteristics as the predicate device. The main differences are the Millenium offers additional seat widths, axle to accommodate a travel wheel (the travel wheel is not part of this submission), and the wheel locks are push to lock only. The device and predicate device are both mechanical wheelchairs.
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Non-Clinical Tests Performed
All applicable tests were voluntarily conducted in accordance with ISO 7176, including Parts 1, 5, 15, 16, and 93. Where applicable a 100 kg dummy (plus 12.4 kg) as specified in ISO 7176 - 11 was used.
Testing to parts 3 and 8 will be completed prior to product launch and commercialization.
Summary
In conclusion we believe the subject device is a low risk device that complies with internationally recognized standards and substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NEXT Mobility, LLC % Underwriters Laboratories, Inc. Mr. Jeff D. Rongero 12 Laboratory Drive Research Triangle, NC 27709
Re: K081665 Trade/Device Name: Millenium II Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: June 12, 2008 Received: June 13, 2008
Dear Mr. Rongero:
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.
JUN 2 7 2008
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 - Mr. Jeff D. Rongero
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millman
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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Indications for Use
510(k) Number (if known):
Device Name: Millenium II
Indications For Use:
The Millenium wheelchairs are intended to provide mobility to persons limited to a seated position that are capable of operating a manual wheelchair.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (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 Sigui-Off) Page 1 of 1 Division of General, Restorative, and Neurological Devices
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510(k) Number
§ 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).