(190 days)
Not Found
Not Found
No
The summary describes a fluid warmer and contains no mention of AI or ML.
Yes
The device is described as warming intravenous fluids, which is a therapeutic intervention aimed at maintaining or improving a patient's physiological state during fluid administration.
No
Explanation: The device's intended use is to warm intravenous fluids, which is a therapeutic or supportive function, not a diagnostic one. It does not gather information about a patient's health condition.
No
The device description "HOT SHOT™ FLUID WARMER IV FLUIDS" and the intended use "Warm intravenous fluids" strongly indicate a hardware device designed to physically warm fluids, not a software-only application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Warm intravenous fluids." This describes a physical process applied to a substance before it enters the body, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The description "HOT SHOT™ FLUID WARMER IV FLUIDS" further reinforces that it's a device for warming fluids, not for performing diagnostic tests.
- Lack of IVD Characteristics: The provided information lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information about a patient's health status
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely to warm fluids for administration.
N/A
Intended Use / Indications for Use
Warm intravenous fluids.
Product codes
LDQ
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
N/A
0
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal features the department's logo, which consists of a stylized caduceus with three intertwined snakes and a bowl. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 2000
Mr. Bert Hudson Vice President Shotwell & Carr, Inc. 3535 Firewheel Drive, Suite A Flower Mound, Texas 75028-2628
K992258 Re : Hot Shot™ Fluid Warmer IV Fluids Trade Name: Unclassified Regulatory Class: Product Code: LDQ Dated: July 2, 1999 Received: July 6, 1999
Dear Mr. Hudson:
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 Requlations, Title 21, Parts 800 to 895. पुर substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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
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Page 2 - Mr. Hudson
obligation you might have under sections 531 through 542 of obilgation 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 findinq 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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,
othy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) number (if known): Unknown; not yet assigned by FDA.
Device name: HOT SHOT™ FLUID WARMER IV FLUIDS
Indications for use of the device:
Warm intravenous fluids.
(Please do not write below this line. Continue on another page if needed.)
Concurrence of CBER, Office of Device Evaluation (ODE)
Prescription Use / or Over-the-Counter Use
(Per 21 CFR 801.109) (Optional format 1-2-96)
Rebecca Cucente
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K992258
Imt2.12