(39 days)
The INDEPENDENCE™ iGlide™ Manual Assist Wheelchair is intended to provide mobility to persons limited to a seated position that are capable of operating a manual or power wheelchair.
The INDEPENDENCE/TM) iGLIDE(TM) Manual Assist Wheelchair is the TAILWIND Power Assist Wheelchair. With each push on the handrims, sensors and controllers calculate the difference between the effort on the handrims and the force needed to propel the chair. Electric motors supply the auxillary power needed to negotiate varying surfaces with virtually no change in effort.
The device drive consists of a gearbox with a motor controller for each side of the chair and a battery mounted underneath the chair. An on/off switch, located on the underside of the seat turns the unit on/off.
This document describes a 510(k) submission for the INDEPENDENCE™ iGLIDE™ Manual Assist Wheelchair. The key aspect of this submission is that the device is identical to a previously cleared predicate device, the TAILWIND Power Assist Wheelchair, with the only difference being the removal of a "Prescription Device Statement."
Therefore, the submission does not contain a study or data proving the device meets acceptance criteria in the traditional sense of a performance evaluation for a new or modified device. Instead, the justification for clearance relies solely on substantial equivalence to the predicate device because they are the same product.
Here's the breakdown based on your requested information, highlighting the unique nature of this submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | The INDEPENDENCE™ iGLIDE™ Manual Assist Wheelchair is identical to the TAILWIND Power Assist Wheelchair. The only change is the removal of the Prescription Device Statement. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. No new test set data was collected as the device is identical to the predicate.
- Data Provenance: Not applicable. The submission leverages the prior clearance and existing data/design of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No new ground truth establishment was required for a test set. The substantial equivalence relies on the predicate device's prior clearance.
4. Adjudication method for the test set
- Not applicable. No test set was generated or adjudicated.
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 device is a manual assist wheelchair, not an AI-assisted diagnostic or therapeutic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a manual assist wheelchair, not an algorithm.
7. The type of ground truth used
- Ground Truth: The "ground truth" in this context is the prior regulatory clearance and established safety and effectiveness of the TAILWIND Power Assist Wheelchair through its original 510(k) process. The current submission argues that since the INDEPENDENCE™ iGLIDE™ is physically the same device, its "ground truth" (safety and effectiveness) is already established.
8. The sample size for the training set
- Not applicable. There is no AI component requiring a training set for this device.
9. How the ground truth for the training set was established
- Not applicable. There is no AI component requiring a training set for this device.
Summary of the Study (or lack thereof):
The "study" in this submission is the claim of identity between the new device (INDEPENDENCE™ iGLIDE™ Manual Assist Wheelchair) and a predicate device (TAILWIND Power Assist Wheelchair). The acceptance criteria is solely based on demonstrating that these two devices are the same product. No new performance studies or clinical data are presented because the submitter argues that "Because the new and predicate devices are the same device, no new testing is needed." The FDA concurred with this assessment, granting 510(k) clearance based on substantial equivalence.
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510(k) Summary
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Independence Technology, L.L.C. 45 Technology Drive P.O.Box 4917 Warren, NJ 07059 - 4917
Contact Person
James P. O'Donnell Vice President, Regulatory Affairs Independence Technology, L.L.C. 45 Technology Drive P.O.Box 4917 Warren, NJ 07059 - 4917 908 - 412 - 2266 jodonnel(@indus.jnj.com
Date Prepared
January 22, 2003
Name of Device
INDEPENDENCE(TM) iGLIDE(TM) Manual Assist Wheelchair
Classification Name
Wheelchair, Powered
Identification of Predicate Device
TAILWIND Power Assist Wheelchair
Description of Device
The INDEPENDENCE/TM) iGLIDE(TM) Manual Assist Wheelchair is the TAILWIND Power Assist Wheelchair. With each push on the handrims, sensors and controllers calculate the difference between the effort on the handrims and the force needed to propel the chair. Electric motors supply the auxillary power needed to negotiate varying surfaces with virtually no change in effort.
The device drive consists of a gearbox with a motor controller for each side of the chair and a battery mounted underneath the chair. An on/off switch, located on the underside of the seat turns the unit on/off.
Intended Use
The INDEPENDENCE(TM) iGLIDE(TM) Manual Assist Wheelchair is intended to provide mobility to persons limited to a seated position that are capable of operating a manual or power wheelchair.
MAR 0 4 2003
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VIND Power
20F
K030250
Comparison to Predicate Device
The NOPERNDENCE (TM) Namal Asist Wirelchair is the TALL TALL TALL PALL POS PORT POS PORT POST POST OF OF OF OF
Assis Wheeldair. The only Artes the TAILWIND Power Assist Wheelchair does have the Statement.
Non-Clinical Tests Performed
Because the new and predicate devices are the same device, no new testing is needed.
Summary
The INDEPENDENCE(TM) iGLIDE(TM) Manual Assist Wheelchair is the TAILWIND Power Assist Wheelchair. The removal of the Prescription Device Statement does not raise any questions of safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 4 2003
Mr. James P. O'Donnell Vice President, Regulatory Affairs Independence Technology, L.L.C. 45 Technology Drive P.O. Box 4917 Warren, NJ 07059-4917
Re: K030250
Trade/Device Name: iGlide™ Manual Assist Wheelchair Regulation Number: 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: January 23, 2003 Received: January 24, 2003
Dear Mr. O'Donnell:
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. Iisting 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 - Mr. James P. O'Donnell
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 (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) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark M. Mellemson
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): KO30250
iglide™ Manual Assist Wheelchair Device Name:
Indications For Use:
The INDEPENDENCE™ iGlide™ Manual Assist Wheelchair is intended to provide mobility to persons limited to a seated position that are capable of operating a manua or power wheelchair.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Jivision Sign-Off Division of General, Restorative I Neurological Devices
K030250
Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Formst 1-2-96)
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).