PIV SYSTEM by MEDICAL SOLUTIONS, INC.

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.

Device Description

Not Found

AI/ML Overview

This is a Premarket Notification (510k) document for a Medical Solutions PIV System. This document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria, as typically found in clinical trial reports or validation studies.

Here's how this document relates to your request:

A table of acceptance criteria and the reported device performance: This document does not provide a table of acceptance criteria or specific reported device performance metrics in the way a study report would. It states the "Indications for Use" which specify its intended function: "designed to hold and heat IV fluid bags and maintain temperatures to 98°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." This implies the performance criteria would revolve around maintaining that temperature range and effectively increasing pressure for infusion. However, no specific data demonstrating compliance with these performance metrics is presented.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No information about a "test set" sample size or data provenance is provided. 510(k) submissions typically rely on a demonstration of "substantial equivalence" to a predicate device, which may involve bench testing and comparisons, but the specifics of such testing (including sample sizes) are not detailed in this high-level approval letter.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not pertain to studies involving expert-established ground truth for a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a "PIV IV Bag Warmer and Pressure Infusor," not an AI diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as this is a hardware device for fluid warming and infusion, not a diagnostic or AI-driven system requiring a "ground truth" in the typical sense. Performance would be based on engineering specifications and physical measurements (e.g., temperature accuracy, pressure range).
The sample size for the training set: Not applicable. The device is not an AI/machine learning system that requires a training set.
How the ground truth for the training set was established: Not applicable.

In summary: This document is an FDA 510(k) clearance letter, indicating that the device has been deemed "substantially equivalent" to a legally marketed predicate device. This regulatory clearance process does not typically involve the detailed breakdown of study design, acceptance criteria, and performance metrics as requested, which would be found in a more comprehensive clinical or validation study report if one were performed and publicly available. The information provided is sufficient for regulatory approval based on the 510(k) pathway but not for a detailed scientific study analysis.

Summary

{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

{2}------------------------------------------------

Page 1 of 1

510(k) Number (if known):

Device Name: PIV System

Classification Panel: LDQ

Indications for Use:

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

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

Regulation Number and Section

N/A