(88 days)
Not Found
Not Found
No
The summary describes a kit of equipment for first aid during a seizure and contains no mention of AI, ML, or any related technologies or data analysis.
No
The device is described as first aid equipment for a seizure emergency and does not mention treating or curing a medical condition.
No
The device is described as "Seizure Emergency Equipment Kit" and its intended use is to "render first aid to a person who is having a seizure," which implies treatment rather than diagnosis. There is no mention of the device identifying or analyzing a medical condition.
No
The device description explicitly states "Seizure Emergency Equipment Kit," which implies the inclusion of physical equipment (hardware) in addition to any potential software components. The summary does not provide information suggesting it is solely software.
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 first aid during a seizure emergency by a caretaker. This is a direct intervention on a person, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: A "Seizure Emergency Equipment Kit" suggests a collection of tools for physical intervention or support, not for laboratory testing.
- Lack of IVD Indicators: The description lacks any mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Diagnostic testing
- Laboratory procedures
- Measuring biomarkers or other biological indicators
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is clearly outside of that scope.
N/A
Intended Use / Indications for Use
During a seizure emergency, this device is indicated for use by a caretaker to render first aid to a person who is having a seizure.
Product codes
73 KGA
Device Description
Seizure Emergency Equipment Kit
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
caretaker
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
Not Found
N/A
0
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 21 1997
Dilip J. Karnik, M.D. President Lotus Technologies, Inc. 1215 Red River Street Austin, Texas 78701
Re: K973176 Seizure Emergency Equipment Kit------------Regulatory Class: Unclassified Product Code: 73 KGA Dated: August 15, 1997 Received: August 25, 1997
Dear Dr. Karnik:
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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., stérilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS
1
Page 2 - Dilip J. Karnik, M.D.
inspections, FDA will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, the Food and Drug Administration (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 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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. 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,
Thomas J. Callahan
Thomas J. Kallahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation ------Center for Devices and Radiological Health
Enclosure
2
K973176/A'.
Page_l__of__l_
510(k) Number (if known): __ K973176
Device Name: Seizure Emergency Equipment Kit
Indications For Use:
During a seizure emergency, this device is indicated for use by a caretaker to render first aid to a person who
is having a seizure.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Christy Foreman | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, | |
| Neurological Devices | |
| 510(k) Number | K973176 |
| Prescription Use (Per 21 CFR 801.109) | |
|---|---|
| --------------------------------------- | -------------------------------------------------------------------------------------------------------------- |
OR
Over-The-Counter Use
(Optional Format 1-2-96)