(58 days)
Not Found
Not Found
No
The summary does not contain any keywords or descriptions related to AI or ML technology.
No
The device's intended use is to provide an optional means of mobility for physically challenged people, which sounds like an assistive device rather than one that treats or cures a medical condition.
No
The "Intended Use / Indications for Use" states that the device is "To provide an optional means of mobility for physically challenged people," which describes a assistive mobility device, not a diagnostic one.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To provide an optional means of mobility for physically challenged people." This clearly describes a device used on a person for a physical function (mobility), not a device used in vitro (outside the body) to examine specimens like blood, tissue, or urine for diagnostic purposes.
- Lack of IVD Indicators: The description lacks any mention of:
- Analyzing biological samples.
- Providing diagnostic information.
- Using reagents or laboratory procedures.
- Any of the typical components or functions associated with IVD devices.
Therefore, based solely on the provided text, this device falls outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
To provide an optional means of mobility for physically challenged people.
Product codes
INI
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
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).
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 a stylized image of an eagle or bird-like figure with three wing-like shapes, suggesting movement or flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 2000 FEB
Mr. Chris Tinsley President Pillar Technology, Inc. 1101 Illinois P.O. Box 187 Neodesha, Kansas 66757
Re: K994127
Trade Name: Glory Regulatory Class: II Product Code: INI Dated: December 6, 1999 Received: December 7, 1999
Dear Mr. Tinsley:
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 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 (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.
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
1
Page 2 - Mr. Chris Tinsley
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) 594-4595. 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,
Mark Melkerss
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________ K994127
Device Name: Glory
Indications for Use:
To provide an optional means of mobility for physically challenged people.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOFHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Over-The-Counter Use OR (Per 21 CFR 801.109) sion of General Restorative Devices 510(k) Number
(Optional Format 1-2-96)