(61 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 device description is very basic and suggests a simple mobility aid.
No
The device is described as a "Mini Shopper" intended to provide mobility, which suggests it is a mobility aid rather than a device used for treating disease or injury.
No
The device is described as a "Mini Shopper" intended to provide mobility, which suggests it is a mobility aid rather than a tool for diagnosis. There is no mention of medical conditions or diagnostic procedures in the provided information.
No
The summary describes a physical device ("TE-787N Mini Shopper") intended for mobility, not a software application.
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 physical assistance, not a device used in vitro (outside the body) to examine specimens for diagnostic purposes.
- Device Description: "TE-787N Mini Shopper" suggests a mobility aid, consistent with the intended use.
- Lack of IVD Indicators: The document explicitly states "Not Found" for all fields related to imaging, AI/ML, anatomical sites, patient age, user/setting, training/test data, performance studies, and key metrics. These are all common elements of IVD device descriptions.
In summary, the intended use and device description point to a mobility device, which falls outside the scope of In Vitro Diagnostics.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three overlapping profiles of human faces.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 7 2007
Shoprider International, Inc. % Pillar Technology, Inc. Mr. Chris Tinsley, President P.O. Box 187 Neodesha, KS 66757
Re: K013927 Trade/Device Name: TE-787N Mini Shopper Regulation Number: 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: November 19, 2001 Received: November 28, 2001
Dear Mr. Tinsley:
This letter corrects our substantially equivalent letter of January 28, 2002.
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 - Mr. Chris Tinsley
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 (240) 276- 0120 or view their Internet address http://www.fda.gov/cdrh/organiz.html#OC for OC organization structure. 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N Melkman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Mini Shopper Device Name: TE-787N__
Indications for Use:
Indications for Use.
To provide an optional means of mobility for physically challenged people.
(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
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
(k) Number. K013927 (Optional Format 1-2-96)