(372 days)
Not Found
Not Found
No
The 510(k) summary does not mention AI, ML, or any related technologies. The description focuses on the device's function as a powered wheelchair and its equivalence to existing devices.
No.
A powered wheelchair, while for medical purposes, primarily provides mobility assistance rather than directly treating or diagnosing a disease or condition.
No
The description states the device is intended for "medical purposes to provide mobility," which points to a therapeutic or assistive function, not a diagnostic one. There is no mention of the device being used to identify or analyze diseases or conditions.
No
The device description explicitly states it is a "Powered Wheelchair," which is a hardware device. The summary focuses on performance studies related to the physical wheelchair, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to persons restricted to a sitting position. This is a physical function, not a diagnostic test performed on samples from the human body.
- Device Description: It's a powered wheelchair, a device for physical assistance.
- Lack of IVD Characteristics: The document explicitly states "Not Found" for key characteristics associated with IVDs, such as:
- Image processing
- AI, DNN, or ML (often used in analyzing diagnostic data)
- Input Imaging Modality
- Anatomical Site (IVDs often target specific sites for sample collection)
- Description of training/test sets and performance studies (while performance studies are mentioned, they are related to the physical function and safety of the wheelchair, not diagnostic accuracy).
IVDs are used to examine specimens from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition. The Theradyne Rover Express™ Powered Wheelchair does not perform this function.
N/A
Intended Use / Indications for Use
The Theradyne Rover Express™ Powered Wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Product codes
ITI
Device Description
The Theradyne Rover Express™ Powered Wheelchair.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Theradyne Rover Express™ Powered Wheelchair was examined and tested as provided in FDA's Guidance Documents, except for any deviations noted in the Declaration of Conformity and Summary Report. The results of examination and testing were successful, and did not raise any issues of safety and effectiveness of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
AUG 12 699
K 98>774
A. 510(K) Summary
510(K) SUMMARY
| SUBMITTER: | Theradyne Healthcare Products, a Division of Kurt Manufacturing Company. |
|---|---|
| CONTACT PERSON: | Phil Schlangen 1325 Quincy Street, Northeast Minneapolis, MN 55413 |
| DATE PREPARED: | July 19, 1999 |
| TRADE NAME: | Theradyne Rover Express™ Powered Wheelchair |
| CLASSIFICATION NAME AND NUMBER PRODUCT CODE: | Wheelchair, Powered Class II, 21 CFR 890.3860, Code: ITI |
| PREDICATE DEVICE(S): | The Theradyne Rover Express™ Powered Wheelchair is substantially equivalent to previously marketed powered wheelchairs, as demonstrated by its conformance to FDA recognized consensus standards and FDA's guidance documents. |
| DEVICE DESCRIPTION: | The Theradyne Rover Express™ Powered Wheelchair. |
| INTENDED USE: | The Theradyne Rover Express™ Powered Wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position. |
| FUNCTIONAL & SAFETY TESTING: | The Theradyne Rover Express™ Powered Wheelchair was examined and tested as provided in FDA's Guidance Documents, except for any deviations noted in the Declaration of Conformity and Summary Report. The results of examination and testing were successful, and did not raise any issues of safety and effectiveness of the device. |
| CONCLUSION: | The Theradyne Rover Express™ Wheelchair is substantially equivalent to previously marketed powered wheelchairs as demonstrated by its conformance to FDA recognized consensus standards and FDA's Guidance Documents. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 12 1999
Mr. Phil Schlangen Kurt Manufacturing Company Theradyne Healthcare Products 1325 Ouincy Street NE Minneapolis, Minnesota 55413
Re: K982724
Trade Name: Theradyne Rover Express Powered Wheelchair Regulatory Class: II Product Code: ITI Dated: July 20, 1999 Received: July 21, 1999
Dear Mr. Schlangen:
We have reviewed your Section 510(k) notification of intent to market the device referenced above, and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Phil Schlangen
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Page
510(k) Number (if known):
Device Name: Theradyne Rover Express™ Powered Wheelchair
Indications for Use:
The Theradyne Rover Express™ Powered Wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Concurrence of CDRH, Office of Device Evaluation (ODE)
biotte
Division Sign-Off) Division of General Restorative D 510(k) Number
Over-the-Counter Use
Abbreviated 510(k) Premarket Notification - Theradyne Rover™ Powered Wheelchair August 3, 1998