(163 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description points to a standard battery-powered mobility device.
No
The device is a battery-powered wheeled device to assist mobility impaired individuals, which is a mobility aid rather than a therapeutic device.
No
The device is described as a "battery powere wheeled device" to help "mobility impaired individual to move about." This functionality points to a rehabilitation or assistive device, not one used for diagnosis. There is no mention of identifying, detecting, or measuring a medical condition or disease.
No
The intended use describes a "battery powered wheeled device," which is clearly a hardware component, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a "battery powered wheeled device" for assisting "permanently mobility impaired individual to move about". This is a physical mobility aid, not a diagnostic test performed on samples from the human body.
- Device Description: While "Not Found", the intended use is the primary indicator.
- Mentions image processing, AI, DNN, or ML: These are often associated with IVDs that analyze images or data for diagnostic purposes, and they are not mentioned here.
- Input Imaging Modality, Anatomical Site: These are "Not Applicable", further indicating it's not a device that interacts with the body for diagnostic purposes.
- Performance Studies and Key Metrics: The absence of these details, which are crucial for demonstrating the analytical and clinical performance of an IVD, also supports that it's not an IVD.
- Predicate Device: The listed predicate device (K990484 Independence 324) is likely a similar mobility device, not an IVD.
In summary, the description points to a medical device for mobility assistance, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
the temp permanently mobility impaired individual to move about in doors, and out through the use of a battery powere wheeled device. Weight capacity individual not to exceed 250 l
Product codes
ITI
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 (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
§ 890.3860 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
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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 25 1999
Mr. Charles B. Walker, Jr. Sales and Marketing Manager Eagle Parts and Products, Inc. 1811 Wilkinson Road Augusta, Georgia 30904
Re: K990122 Independence 624 Trade Name: K990484 Independence 324 Trade Name: Requlatory Class: II Product Code: ITI Dated: Undated Received: April 30, 1999
Dear Mr. Walker:
We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, 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 aqainst misbranding and adulteration.
If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does
1
Page 2 - Mr. Charles B. Walker, Jr.
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 requlations.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, 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
Enclosures
2
K990122/A'
FDA/CDPH/ODE/D
3 23 PM *99
Page
NUMBER (IF KNOWN): K990122 EPENDENCE 624
INDICATIONS FOR USE:
the temp permanently mobility impaired individual to move about in doors, and out through the use of a battery powere wheeled device. Weight capacity individual not to exceed 250 l
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED .
oncurrence of CDRH, Office of Device Evaluation (
Prescription Us (Per 21 CFR 801. OR
-The-Counter Optional Format
Division Sign-Out
Division of General Restorative Devices
510(k) Number
K4