(28 days)
The Wheelchair Mover is intended to push various types of manual wheelchairs up to 24 inches wide on dry, surfaced walkways indoors. Maximum patient plus wheelchair load capacity is 550 pounds.
The Wheelchair Mover is a motorized device that attaches to, and then pushes, various types of manual wheelchairs. The Wheelchair Mover is intended to push various types of manual wheelchairs up to 24 inches wide on dry, surfaced walkways indoors. Maximum patient plus wheelchair load capacity is 550 pounds. The Wheelchair Mover helps caregivers move people seated in manual wheelchairs. It is particularly useful to help move heavy manual wheelchairs up ramps, but can be used in many circumstances to make it easier to move an occupied manual wheelchair. A self-contained battery powers the Wheelchair Mover. It rolls on three wheels. The front, central one is the drive wheel that provides motive force. The Wheelchair Mover has attachment jaws that connect to the rear of the lower frame of manual wheelchairs. The person operating the Wheelchair Mover stands behind the Wheelchair Mover. The operator uses a steering handlebar and various hand-operated controls to direct the movement of the Wheelchair Mover and attached manual wheelchair with its occupant.
The provided text describes the "Dane Technologies Wheelchair Mover" and references "Functional and Safety Testing" to relevant consensus standards. However, it does not provide specific acceptance criteria or detailed study results in the format requested.
The document states: "The Dane Technologies WheelChair Mover has been tested to the relevant consensus standards for powered wheelchairs (21 CFR 890.3860, ProCode ITI) and has met the required performance criteria and functioned as intended." This is a general statement of compliance, not a detailed breakdown of acceptance criteria and performance.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's what can be inferred or stated based on the given text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with relevant consensus standards for powered wheelchairs (21 CFR 890.3860, ProCode ITI) | "Met the required performance criteria and functioned as intended." (No specific metrics or thresholds provided in the text) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The text only mentions "Functional and Safety Testing" without details on sample size or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. This type of information is usually relevant for studies involving diagnostic image analysis or expert review, which is not the nature of the device described (a motorized wheelchair mover). Ground truth for functional and safety testing would typically involve engineering specifications and objective measurements, not expert consensus in the diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication methods are typically used in clinical trial settings or for establishing ground truth in expert-reviewed data, neither of which is described for this device's testing.
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/Not provided. This device is a physical product (a wheelchair mover), not an AI diagnostic tool that human readers would use. Therefore, an MRMC study is irrelevant to its purpose and testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This device is a mechanical system with an operator, not an algorithm. Standalone performance tests would apply to its mechanical and electrical functions, which are generically stated as being compliant with standards but not detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Inferred: For "Functional and Safety Testing," the ground truth would likely be based on engineering specifications, objective measurements, and compliance with the specified consensus standards (21 CFR 890.3860, ProCode ITI). The text does not elaborate further.
8. The sample size for the training set
- Not applicable/Not provided. This is a physical device, and the concept of a "training set" is generally used for machine learning models, not for traditional engineering product testing.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As above, the concept of a "training set" and its ground truth is not relevant in the context described for this device's testing.
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Section 5 -510(k) Summary
Image /page/0/Picture/2 description: The image shows the logo for Dane Technologies. The logo is inside of an oval shape. The words "DANE TECHNOLOGIES" are stacked on top of each other in the center of the oval. There is a trademark symbol in the bottom right corner of the oval.
Date Prepared: November 12, 2007
- Dane Technologies, Inc. Submitter: 7105 Northland Terrace Brooklyn Park, MN 55428
- Contact: Oliver Pittenger Director Continuous Improvement Dane Technologies, Inc. 7105 Northland Terrace Brooklyn Park, MN 55428 Phone: 763-746-4423, FAX: 763-559-9221 Email: oliverp@danetechnologies.com
Trade Name of Device: Dane Technologies Wheelchair Mover
Classification: Wheelchair, Powered Wheelchair - 21 CFR 890.3860
Product Code: ITI
Predicate Device: Invacare, Model Storm TDX Power Wheelchair (K023589)
Device Description: The Wheelchair Mover is a motorized device that attaches to, and then pushes, various types of manual wheelchairs. The Wheelchair Mover is intended to push various types of manual wheelchairs up to 24 inches wide on dry, surfaced walkways indoors. Maximum patient plus wheelchair load capacity is 550 pounds.
The Wheelchair Mover helps caregivers move people seated in manual wheelchairs. It is particularly useful to help move heavy manual wheelchairs up ramps, but can be used in many circumstances to make it easier to move an occupied manual wheelchair.
A self-contained battery powers the Wheelchair Mover. It rolls on three wheels. The front, central one is the drive wheel that provides motive force. The Wheelchair Mover has attachment jaws that connect to the rear of the lower frame of manual wheelchairs. The person operating the Wheelchair Mover stands behind the Wheelchair Mover. The operator uses a steering handlebar and various hand-operated controls to direct the movement of the Wheelchair Mover and attached manual wheelchair with its occupant.
JAN 28 2008
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Intended Use: "The Wheelchair Mover is intended to push various types of manual wheelchairs up to 24 inches wide on dry, surfaced walkways indoors. Maximum patient plus wheelchair load capacity is 550 pounds."
This differs from the predicate primarily in that the predicate device is directed by the occupant; while the Wheelchair Mover is directed by a caregiver and must be attached to a manual wheelchair.
Functional and Safety Testing: The Dane Technologies WheelChair Mover has been tested to the relevant consensus standards for powered wheelchairs (21 CFR 890.3860, ProCode ITI) and has met the required performance criteria and functioned as intended.
Substantial Equivalence: In response to a request for a 513(g) determination, FDA sent a letter dated March 16, 2007 indicating that the Wheelchair Mover should be categorized as a "Wheelchair, Powered" [21 CFR 890.3860, ProCode ITI]. The Wheelchair Mover is substantially equivalent in that it is a self-contained, battery driven, device controlled by a user. It is different in that it is used to assist caregivers with the transport of patients in manual, non-powered wheelchairs from location to location. Steering, speed, and direction are under the control of the caregiver, not the patient. See details below.
| Feature | Wheelchair Mover | Predicate Device |
|---|---|---|
| Wheel Configuration | 3 wheels, with forward, central drive wheel | 6 wheels (two being anti-tip), with two rear drive wheels |
| Operator | Trained operator | Chair occupant |
| Mechanism to attach to manual wheelchair | Hand-operated jaws and hitch plus foot pedals to move jaws either to left or right | Not available, not applicable |
| Steering mechanism | Steering bar | Hand operated joystick |
| Brake mechanism | Controller operated; regenerative braking | Controller operated; regenerative braking |
| Speed control | Thumb control levers | Hand operated joystick |
| Reverse throttle control | Yes | Hand operated joystick |
| Forward throttle control | Yes | Hand operated joystick |
| Hand-operated horn | Yes | No |
| Rabbit/turtle switch to set two ranges of speed | Variable speed, 2 range | Operator can set a maximum speed limit |
| Power source | Self-contained battery | Self-contained battery |
| Charge cord | Yes | Yes |
| Anti-static wire | Yes | Yes |
| Power control and emergency off | Yes | No |
| Control Status LED | Yes | Yes |
| Back-away button | Yes | No |
| Battery level Indicator | Yes | Yes |
| On/Off switch | Yes | Yes |
| Environment | Indoors | Outdoor/Indoor |
Conclusion: The Wheelchair Mover is substantially equivalent to the predicate,
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized caduceus symbol on the right. To the left of the caduceus is text arranged in a circular pattern that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".
JAN 28 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Dane Technologies c/o InterTek Testing Services Mr. Daniel W. Lehtonen 2307 East Aurora Road Twinsburg, OH 44087
K073701 Trade/Device Name: Dane Technologies Wheelchair Mover Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: January 11, 2008 Received: January 14, 2008
Dear Mr. Lehtonen:
Re:
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 – Mr. Daniel W. Lehtonen
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 vours.
Mark M. Miller
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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Section 4 - Indications for Use Statement
Device Name: Dane Technologies Wheelchair Mover
Indications for use:
The Wheelchair Mover is intended to push various types of manual wheelchairs up to 24 inches wide on dry, surfaced walkways indoors. Maximum patient plus wheelchair load capacity is 550 pounds.
Prescription Use (Part 21 CFR 801 Subpart D AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millheim
(Division Sign-cill) Division of General. Restorative, and Neurological Devices
510(k) Number
Dane Technologies Wheelchair Mover 510(k) 12
§ 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).