(167 days)
Not Found
Not Found
No
The summary describes a device for warming and pressurizing IV bags, with no mention of AI, ML, image processing, or data analysis that would typically indicate AI/ML functionality.
No
The device is a warmer and pressure infusor for IV fluid bags, assisting with fluid infusion. It aids in the delivery of a therapeutic substance but does not directly treat or diagnose a disease or condition itself.
No
The device is described as an IV bag warmer and pressure infusor, designed to heat IV fluids and assist their infusion, not to diagnose medical conditions or provide diagnostic information.
No
The device description explicitly states it is a "PIV IV Bag Warmer and Pressure Infusor" designed to "hold and heat IV fluid bags" and "be inflated to increase pressure on the IV bag." These functions clearly involve physical hardware components (heating element, pressure mechanism, housing for the bag), not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to hold, heat, and pressure infuse IV fluid bags. This is a direct interaction with the patient's treatment (infusion of fluids), not an in vitro test performed on samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases
The device is a medical device used in the direct care and treatment of a patient, specifically for managing the temperature and flow of IV fluids.
N/A
Intended Use / Indications for Use
The Medical Solutions PIV IV Bag Warmer and Pressure Infusor is designed to hold and heat IV fluid bags and maintain temperatures to 980 F ( 3°F). It is also a pressure infusor designed to be inflated to increase pressure on the IV bag to assist the infusion of fluid.
Product codes
LDQ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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).
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N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized symbol. The symbol is a representation of a human figure in profile, with three figures overlapping to create a sense of depth and connection. The figures are rendered in a dark color, contrasting with the white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 1998
Medical Solutions, Incorporated C/O Mr. E.J. Smith Smith Associates P.O. Box 4343 Crofton, Maryland 21114
- Re : K981032 PIV System Trade Name: Requlatory Class: I Product Code: LDQ Dated: June 17, 1998 Received: June 19, 1998
Dear Mr. Smith:
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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ 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 inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements 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
1
Page 2 - Mr. Smith
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 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) 594-4692. 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"(21CFR 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/dsma/dsmamain.html".
Sincerely yours,
S. Dutman for
Timothy 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):
Device Name: PIV System
Classification Panel: LDQ
Indications for Use:
The Medical Solutions PIV IV Bag Warmer and Pressure Infusor is designed to hold and heat IV fluid bags and maintain temperatures to 980 F ( 3°F). It is also a pressure infusor designed to be inflated to increase pressure on the IV bag to assist the infusion of fluid.
Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 Prescription Use
or
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
Patricea Cuccurullo
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital, Infection
and General Hospital Devices
510(k) Number K981052