(82 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, or related concepts like DNN, image processing, or training/test sets, which are typically associated with AI/ML medical devices.
No.
The provided text only mentions "intended use" in relation to "the subject device and the predicate device" and "the produced individuals" without any specific details or claims that would classify it as a therapeutic device. There is no information describing treatment, intervention, or diagnosis.
No
The provided text only contains the heading "Intended Use / Indications for Use" followed by an incomplete sentence fragment, "The subject device and the predicate device intended use The subject device and the produced individuals." This does not provide enough information to determine if the device is diagnostic.
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, it is not possible to definitively determine if this device is an IVD (In Vitro Diagnostic).
Here's why:
- The "Intended Use / Indications for Use" section is incomplete and unclear. It mentions "The subject device and the predicate device intended use The subject device and the produced individuals." This phrasing is grammatically incorrect and doesn't provide enough detail about what the device does or measures.
- Crucially, the document states "Not Found" for many key sections that would typically describe an IVD, such as:
- Device Description
- Input Imaging Modality
- Anatomical Site
- Performance Studies
- Key Metrics
To be considered an IVD, a device typically needs to be intended for use in the examination of specimens derived from the human body (such as blood, urine, tissue, etc.) to provide information for diagnostic, monitoring, or compatibility purposes.
Without a clear description of the device's function and what it interacts with, we cannot confirm if it meets the criteria for an IVD.
In summary, the provided text is insufficient to determine the IVD status of the device. More information about the device's intended use and how it operates is required.
N/A
Intended Use / Indications for Use
The subject device and the predicate device intended use The subject device and the produced individuals.
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 features a stylized image of three human profiles facing right, arranged in a stacked, overlapping manner. The profiles are rendered in black and have a flowing, wave-like quality. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 25 1999
Mr. Dale Confer Product Design Development Manager Amigo Mobility International, Inc. 6693 Dixie Highway Bridgeport, Michigan 48722-0402
Re: K992619 Amigo Model 680000 (Amigo Excite F 350) Trade Name: Requlatory Class: II Product Code: ITI Dated: July 30, 1999 Received: August 4, 1999
Dear Mr. Confer:
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 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 requlations 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 Requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements 1 action. concerning your device in the Federal Reqister. 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.
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Page 2 - Mr. Dale Confer
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 requlation (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 ene rogaration " (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
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3A1-1
K 992679 510(k) NUMBER (IF KNOWN):
AMIGO MODEL 680000 Excite F350 DEVICE NAME:
INDICATIONS FOR USE:
The subject device and the predicate device intended use The subject device and the produced individuals.
(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) ાર
Over-The-Counter-Use
(Optional Format 1-96)
(Division Sign-Off) Division of General Restorative Dev 510(k) Number