(9 days)
The RTm and Oval wheelchairs are intended to provide mobility to persons limited to a seated position that are capable of operating a manual wheelchair.
The RTm and Oval wheelchairs are mechanical wheelchairs.
The provided document is a 510(k) summary for a medical device, specifically the RTm and Oval manual wheelchairs. This type of document is for regulatory submission and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report of performance against specific acceptance criteria for AI/software-as-a-medical-device (SaMD).
Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs for performance, sample sizes for test and training sets, expert qualifications, and adjudication methods (which are standard for SaMD validation) are not applicable to this document. This submission pertains to a physical, mechanical device, not an algorithm or AI product.
Here's an analysis based on the provided text, addressing what can be inferred or explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table of numerical acceptance criteria with corresponding device performance values as would be expected for an AI/SaMD product. Instead, the acceptance criteria are implicitly defined by compliance with established international and national standards for manual wheelchairs, and the performance is reported as successful passage of these tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Compliance with ISO 7176-5 Determination of Overall Dimensions, Mass, and Turning Space | Successfully passed testing to voluntary standards, including ISO 7176-5. |
| Compliance with ISO 7176-15 Requirements for information disclosure, documentation, and labeling | Successfully passed testing to voluntary standards, including ISO 7176-15. |
| Compliance with ISO 7176-16 Resistance to ignition of upholstered parts requirements and test methods | Successfully passed testing to voluntary standards, including ISO 7176-16. |
| Compliance with ISO 7176-1 Determination of Static Stability | Successfully passed testing to voluntary standards, including ISO 7176-1. |
| Compliance with ANSI/RESNA WC Volume 1-1998 Section 93 Maximum Overall Dimensions | Successfully passed testing to voluntary standards, including ANSI/RESNA WC Vol 1-1998 Section 93. |
| Substantial equivalence to predicate device (Sunrise Medical Model Quickie GT Manual Wheelchair) | "This device has a similar intended use and technological characteristics as the predicate device. The device and the predicate device are both mechanical wheelchairs. Comparisons demonstrate substantial equivalence." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document states, "Where applicable a 100 kg dumm / (plus 12.4 kg) as specified in ISO 7176 -11 was used." This refers to a test dummy used for physical testing, not a "test set" of data or patient cases in the context of AI/SaMD. The number of physical units tested is not explicitly stated, but typically for such evaluations, a representative sample of manufactured devices would be tested, or a prototype.
- Data Provenance: Not applicable in the context of an AI/SaMD. The "data" here comes from physical tests of the wheelchair itself, not from patient records or imaging.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. This is not a study requiring expert readers to establish ground truth for a diagnostic or prognostic task. The "ground truth" for the performance of the physical wheelchair is determined by the physical properties of the wheelchair and its behavior under standardized testing conditions.
4. Adjudication Method for the Test Set:
Not applicable. There is no "adjudication method" in the sense of resolving discrepancies between expert opinions, as this is not an interpretive diagnostic study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This is not an AI/SaMD. Therefore, no MRMC study, human reader improvement with AI, or effect size is discussed.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
Not applicable. This is a physical device, not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for compliance of the RTm and Oval wheelchairs is established through physical testing against recognized industry standards. For example, the static stability of the wheelchair (a performance characteristic) is evaluated according to the procedures outlined in ISO 7176-1. The successful completion of these tests serves as the "ground truth" for compliance with the standards.
8. Sample Size for the Training Set:
Not applicable. This is a physical device. There is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, this is a physical device, not an AI/ML system requiring a training set with established ground truth.
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Confidential Document 510(k) Summary (as required by 21 CFR 807.92(c))
Manufacturer Name and Address
APR - 9 2008
NEXT Mobility LLC 7444 Haggerty Road Canton, MI 48187 Phone (734) 207-3405 Fax (734) 207-2642
Contact Person
Joseph Azary Regulatory Consultant 543 Long Hill Avenue Shelton, CT 06484 Phone (203) 944-9320 Fax (203) 944-9317
Prepared By:
Chris White Joseph Azary
Date Prepared
Revised March 25, 2008
Name of Device
-
- RTM 2) Oval
Classification Name
Wheelchair, Mechanical
Identification of Predicate Device
Sunrise Medical Model Quickie GT Manual Wheelchair (K850536)
Description of the Device Intended Use
The RTm and Oval wheelchairs are intended to provide mobility to persons limited to a seated position that are :apable of operating a manual wheelchair.
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Comparison to Predicate Device
This device has a similar intended use and technological charaçteristics as the predicate device. The device and the predicate device are both mechanical wheelchairs. Compari ons demonstrate substantial equivalence.
Non-Clinical Tests Performed
All applicable tests were voluntarily conducted in accordance with the following standards:
ISO 7176-5 Determination of Overall Dimensions, Mass, and Turning Space
ISO 7176-15 Requirements for inf >rmation disclosure, documentation, and labeling
ISO 7176-16 Resistance to ignition of upholstered parts requirements and test methods.
ISO 7176-1 Determination of Stat c Stability
ANSI/RESNA WC Volume 1-1998 Section 93 Maximum Overall Dimensions
Where applicable a 100 kg dumm / (plus 12.4 kg) as specified in ISO 7176 -11 was used.
Technological Characteristics
The device has been subjected to and successfully passed testing to voluntary standards.
Summary
We believe the subject devices ar : substantially equivalent to the predicate devices.
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black and white, and the text is also in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 9 2008
NEXT Mobility, LLC c/o Underwriters Laboratories, Inc. Mr. Jeff D. Rongero 12 Laboratory Drive Research Triangle Park, NC 27709
Re: K080880 Trade/Device Name: RTm and Oval Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: March 27, 2008 Received: March 31, 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 for area waren in 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 r ou may, dierelove, maines 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 If your device is elassined tootrols. Existing major regulations affecting your device can may be subject to back academans, 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 r lease of advised that I Dr Fristantly or our device complies with other requirements of the Act that I DT has Intade a actives and regulations administered by other Federal agencies. You must or any i catal battator and a weeks including, but not limited to: registration and listing (21 Configity with an the Fice of requirements, on the source requirements as set Cr K I at 607), nooning (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (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 the reporting 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 N. Millikan
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: 1) RTm 2) Oval
Indications For Use:
The RTm and Oval wheelchairs are intended to provide r lobility 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-C )NTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office ( f Device Evaluation (ODE)
Wilke Ogl. Gormxn
(Division (Division of General, Restorat Division rological Devices
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510(k) Number K080880
§ 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).