(41 days)
Not Found
Not in text
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and intended use do not suggest any AI/ML functionality.
No
The "Intended Use / Indications for Use" explicitly states that the device "will not diagnose, treat prevent, cure or mitigate any of the population of its' intended users."
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "This device will not diagnose, treat prevent, cure or mitigate any of the population of its' intended users." This indicates it is not a diagnostic device.
No
The device is described as a "wheelchair," which is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the wheelchair is a "transport base for pediatric clients" and "will not diagnose, treat prevent, cure or mitigate any of the population of its' intended users." IVDs are specifically designed to diagnose, monitor, or screen for diseases or conditions using samples from the human body.
- Device Description: While the description is "Not Found," the intended use is the primary indicator of whether a device is an IVD.
- Other Factors: The absence of mentions of image processing, AI/ML, input imaging modality, anatomical site, and performance studies further supports that this is not an IVD. These elements are often associated with diagnostic devices, particularly those involving imaging or analysis of biological samples.
Therefore, this device, a wheelchair for pediatric transport, does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This wheelchair is designed as a transport base for pediatric clients. This device will not diagnose, treat prevent, cure or mitigate any of the population of its' intended users.
Product codes
IOR
Device Description
Not Found
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
pediatric clients
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)
Not Found
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
§ 890.3850 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
Image /page/0/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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 8 2003
Ms. Ginny S. Maloco President Freedom Designs 2241 Madera Road Simi Valley, California 93065
Re: K023574
Trade/Device Name: Gizmo Regulation Number: 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: November 6, 2002 Received: November 13, 2002
Dear Ms. Maloco:
This letter corrects our substantially equivalent letter of December 4, 2002 regarding the device referenced above. The product code was incorrectly identified as INO. The correct product code is IOR.
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 (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 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
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Page 2 - Ms. Ginny S. Maloco
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.
This letter will allow you to continue 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,
for Mark A. Milkman
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
2
K023574 510(k) Number (if known):
Device Name: __ GIZMO
Indications For Use:
This wheelchair is designed as a transport base for pediatric clients. This device will not diagnose, treat prevent, cure or mitigate any of the population of its' intended users.
Fanning
McLean
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Usc (Per 21 CFR 801.109) OR
Over-The-Counter Use /
Mark (Optional Form 1-2-96)
Division Sign-Off) Division of General, Restorative and Neurological Devices
Number K023574/