The MPS Gravity Flow Control Set is intended only for a gravity infusion of I.V. fluids and drugs. The MPS Gravity Flow Control Set maintains a pre-selected flow rate for I.V. fluids and drugs to a patient.

Device Description

The MPS Gravity Flow Control Set is a family of specialized IV sets designed to deliver a fluid flow at a specified rate. The MPS Gravity Flow Control Sets will be available in both primar I.V. sets and extension sets. It incorporates a standard bag spike, flexible drip chamber, PVC tubing, Clamp and ending with a standard male luer lock. Various flow rates are established by rotating the barrel to vary the position of the accurate slot in the barrel relative to the oppositely disbursed inlet and outlet. Each MPS Gravity Flow Control Set is sterilized in sealed individual pouches or trays. Full labeling information is provided with each MPS Gravity Flow Control Set. Multi-unit shelf packs of individual pouches or trays are provided for convenience.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and supporting studies.

Based on the provided text, it appears this is a 510(k) summary for a medical device that does not involve AI or machine learning. The device, "MPS Gravity Flow Control Set," is essentially an IV set accessory designed to control fluid flow rates via a mechanical rotary device. Therefore, many of the typical questions for AI/ML device studies, such as ground truth establishment with experts, MRMC studies, and standalone algorithm performance, are not applicable.

The core of this submission is demonstrating substantial equivalence to a legally marketed predicate device, primarily through technological comparison and material biocompatibility testing.

Here's a breakdown of the requested information, adjusted to reflect the nature of the device:

1. A table of acceptance criteria and the reported device performance

Since this is a non-AI/ML device submission focusing on substantial equivalence, the "acceptance criteria" are not framed in terms of AI performance metrics (like sensitivity, specificity, AUC). Instead, they revolve around demonstrating that the device is safe and performs comparably to the predicate.

Acceptance Criterion (Implicit)	Reported Device Performance
Material Biocompatibility and Safety	Plastic component materials and bonding agents have been tested per ISO 10993 Biological Testing of Medical and Dental Materials. Testing indicates that materials are safe and biocompatible.
Functional Equivalence to Predicate Device (Flow Control)	"The MPS Gravity Flow Control Set is a family of specialized IV sets designed to deliver a fluid flow at a specified rate." "There are no technological differences between the Master Medical STAT-2 set and the MPS Gravity Flow Control Set. Both devices control gravity flow rates by rotating the barrel to vary the position of the accurate slot in the barrel relative to the oppositely disbursed inlet and outlet." "The MPS Gravity Flow Control Set maintains a pre-selected flow rate for I.V. fluids and drugs to a patient."
Intended Use Equivalence to Predicate Device	Intended Use for gravity infusion of I.V. fluids and drugs, setting and maintaining pre-selected flow rates, single-use. This matches, or is substantially equivalent to, the implied intended use of the predicate. Prohibited uses (pressure infusion, blood, enteral solution) are also stated.
Sterility	"Each MPS Gravity Flow Control Set is sterilized in sealed individual pouches or trays." (Implied to meet sterility standards, though no specific test results are detailed in this summary).
Substantial Equivalence (Overall)	"The MPS Gravity Flow Control Set is substantially equivalent to the legally marketed predicate device."

Study that proves the device meets the acceptance criteria:

The primary "study" is a combination of:

Nonclinical Test Summary: This specifically addresses the biocompatibility and safety of materials.
Technological Comparison Analysis: This is an argumentative comparison establishing that the device's design and mechanism for flow control are identical to the predicate device, K871753 and K852254, marketed by ConMed Corporation (originally Master Medical Corporation).

Additional Information (where applicable for this non-AI/ML device):

2. Sample size used for the test set and the data provenance: Not applicable. There isn't a "test set" in the sense of clinical data or images. The "testing" involved material testing per ISO 10993, for which sample sizes are not specified in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML is not relevant here. The "ground truth" for material safety relies on established ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. 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. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For biocompatibility, the ground truth is established by the standards outlined in ISO 10993. For functional performance, the "ground truth" is the established function of the predicate device.
8. The sample size for the training set: Not applicable. There is no training set for this type of device.
9. How the ground truth for the training set was established: Not applicable.

Summary

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JAN 20 1999

K983926

510(k) Summary

1.	Submitter:	Medical Product Specialists, Inc. (MPS)499 Nibus Street, suite EBrea, CA 92821Tel: 714-257-0470Fax: 714-257-0513
2.	Contact:	Dan Hyun, PresidentMedical Products Specialists
3.	Date prepared:	November 2, 1998
4.	Device trade name:	MPS Gravity Flow Control Set
	Common name:	Intravenous (I.V.) Sets Accessory
5.	Predicate device:	Master Medical CorporationMarketed by ConMed Corp.310 Broad St. Utica, NY 13051K871753 and K852254
6.	Description:	The MPS Gravity Flow Control Set is a family of specialized IVsets designed to deliver a fluid flow at a specified rate. TheMPS Gravity Flow Control Sets will be available in both primarI.V. sets and extension sets. It incorporates a standard bagspike, flexible drip chamber, PVC tubing, Clamp and endingwith a standard male luer lock. Various flow rates areestablished by rotating the barrel to vary the position of theaccurate slot in the barrel relative to the oppositely disbursedinlet and outlet.Each MPS Gravity Flow Control Set is sterilized in sealedindividual pouches or trays. Full labeling information isprovided with each MPS Gravity Flow Control Set. Multi-unitshelf packs of individual pouches or trays are provided forconvenience.

7. Intended Use:

1. The MPS Gravity Flow Control Set is intended only for a gravity infusion of I.V. fluids and drugs.
1. The MPS Gravity Flow Control Set incorporates a rotary device to set and maintain a pre-selected flow rate for I.V. fluids and drugs to a patient.
3 The MPS Gravity Flow Control Set is intended for single use in the I.V. infusion. Change per CDC guidelines or per hospital protocol.

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1. Do not use the MPS Gravity Flow Control set with a pressure infusion device.
Do not administer blood, blood product or enteral solution. 5.
1. Technological comparison to predicate device:

The technological characteristics are intended to be substantially equivalent (in materials, design, and intended use) to the devices currently marketed as the ConMed Corporation STAT-2 (original 510(k) was issued to Master Medical Corp.)

There are no technological differences between the Master Medical STAT-2 set and the MPS Gravity Flow Control Set. Both devices control gravity flow rates by rotating the barrel to vary the position of the accurate slot in the barrel relative to the oppositely disbursed inlet and outlet.

1. Nonclinical test summary:
  Plastic component materials and bonding agents have been tested per ISO 10993 Biological Testing of Medical and Dental Materials. Testing indicates that materials are safe and biocompatible.
1. Conclusion: The MPS Gravity Flow Control Set is substantially equivalent to the legally marketed predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 20 1999

Mr. Dan Hyun President Medical Products Specialists, Incorporated 499 Nibus Street, Suite E Brea, California 92821

K983926 Re : MPS Gravity Flow Control Set Trade Name: Regulatory Class: II Product Code: FPA Dated: November 2, 1998 Received: November 5, 1998

Dear Mr. Hyun:

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 The general controls controls provisions of the Act. provisions of the Act include requirements for annual reqistration, 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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

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Page 2 - Mr. Hyun

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 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" (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/dsmamaifi.html".

Sincerely yours

Timothy A. Ulatowski

Ulatowski Timo Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K983926

REVISED

PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT

(As required by ODE for all 510(k) received after Jan. 1, 1996.)

K983926 510(k) Number: MPS Gravity Flow Control Set Device Name:

Indications For Use:

The MPS Gravity Flow Control Set is intended only for a gravity 1. infusion of I.V. fluids and drugs.
The MPS Gravity Flow Control Set maintains a pre-selected flow 2. rate for I.V. fluids and drugs to a patient.

(Do not write below this line. Continue on another page if needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) 25 (Division of Dental, Infection of Dentale, and General Hospital, Infection
S100->>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> 510(k) Number _ K98

prescription Use
(Per 21 CFR 801.109) ✓

over-the-counter Use _

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.