(52 days)
No
The device description and performance studies focus on mechanical features and standard wheelchair testing, with no mention of AI or ML.
No.
A wheelchair provides mobility for physically impaired individuals but does not directly treat or cure a disease or condition; therefore, it is considered a medical device but not a therapeutic device.
No
Explanation: The device description and intended use clearly indicate that this is a manual wheelchair providing mobility, not a device designed for diagnosis or detection of medical conditions.
No
The device description clearly outlines a physical wheelchair with hardware components like a frame, wheels, seat, and backrest. It does not describe software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Wheelchair mobility... for the physically impaired." This describes a device used to assist with physical movement and mobility, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a mechanical device for transportation and support, not a device that performs tests on biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic information
Therefore, this device falls under the category of a medical device for mobility assistance, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Wheelchair mobility, either self-propelled or propelled by an attendant, for the physically impaired.
Product codes
IOR
Device Description
The wheelchair is a standard lightweight manual folding chair that provides mobility based on an individual user's needs and capabilities. Since it has the same intended use as typical wheelchairs, its features are also comparable. A sling seat and backrest are affixed to a sturdy frame that is supported by two large rear wheels and two forward swivel caster wheels. The two side frames are connected by a horizontal cross brace, rather than a vertical cross brace, that can assume a folded configuration. The wheelchair accommodates removable armrests, detachable footrests, rear anti-tippers, push handles, and wheel locks.
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 A/RT chair has a horizontal cross brace, rather than the typical vertical cross brace of most folding wheelchairs. This new feature has been tested for Design Validation/Verification and has performed acceptably. The results of the ANSI/RESNA two-drum test and subject evaluations support a determination of "substantially equivalent" for the ActivX wheelchair.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Quickie2 (K890050)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
JAN 28
JAN 28 8 1999
510(K) - APRT - ActivX Wheelchair
1984367
VI. 510(K) SUMMARY
| Submitter: | Adorno/Rogers Technology, Inc.
PO Box 160337
Austin, TX 78716
512-474-7267
Fax: 512-476-6460 |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Paul Gibb |
| Date of Preparation: | December 3, 1998 |
| Common Name:
Proprietary Name:
Predicate Device: | Mechanical Folding Wheelchair (per 21 CFR section 890.3850)
ActivX
Quickie2 (K890050) |
| Intended Use: | Wheelchair mobility, either self-propelled or propelled by an
attendant, for the physically impaired. |
| Device Description: | The wheelchair is a standard lightweight manual folding chair that
provides mobility based on an individual user's needs and capabilities.
Since it has the same intended use as typical wheelchairs, its features
are also comparable. A sling seat and backrest are affixed to a sturdy
frame that is supported by two large rear wheels and two forward
swivel caster wheels. The two side frames are connected by a
horizontal cross brace, rather than a vertical cross brace, that can
assume a folded configuration. The wheelchair accommodates
removable armrests, detachable footrests, rear anti-tippers, push
handles, and wheel locks. |
| Comparison With
Predicate Device: | The ActivX wheelchair and the predicate device have an identical
intended use and are identical with respect to the way the user
propels and maneuvers the chair. The dimensions, construction
materials, and standard features/options of the two chairs are
substantially equivalent. The only difference between the A/RT
chair and the predicate device is in the way the chairs are opened and
folded. The A/RT chair has a horizontal cross brace, rather than the
typical vertical cross brace of most folding wheelchairs. This new
feature has been tested for Design Validation/Verification and has
performed acceptably. The results of the ANSI/RESNA two-drum
test and subject evaluations support a determination of "substantially
equivalent" for the ActivX wheelchair. |
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
JAN 28 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Paul Gibb Vice President and Chief Operating Officer Adorno/Rogers Technology, Inc. P.O. Box 160337 Austin, Texas 78716
K984367 Re: Trade Name: ActivX Regulatory Class: I Product Code: IOR December 3, 1998 Dated: Received: December 7, 1998
Dear Mr. Gibb:
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 controls provisions The general controls provisions of the Act of the Act. include reguirements 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ 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. Paul Gibb
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
510(k) NUMBER (IF KNOWN): K984367 Mechanical Folding Wheelchair - ActivX DEVICE NAME:
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
INDICATIONS FOR USE:
Intended Use:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
... — - .
Wheelchair mobility, either self-propelled or propelled by an attendant, for the physically impaired.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K984367