MPS FIXED FLOW RATE SET by MEDICAL PRODUCT SPECIALISTS

The MPS Fixed Flow Rate Set is a family of specialized IV sets designed to deliver a fluid flow at a specified rate. The MPS Fixed Flow Rate Set incorporates a standard bag spike, flexible drip chamber, microbore infusion tubing, and ending with a standard male luer connector with luer-lock. Flow rate control is established by the flow dynamics of the microbore infusion tubing. Each set is provided with a spike protector, luer cap, and tubing clamp. Various configurations may also include 0.2 micron IV filter.

Each MPS Fixed Flow Rate Set is sterilized in sealed individual pouches or trays. Full labeling information is provided with each MPS Fixed Flow Rate Set. Multi-unit shelf packs of individual pouches or trays are provided for convenience.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a medical device called the "MPS Fixed Flow Rate Set." This documentation focuses on establishing substantial equivalence to a predicate device, as opposed to proving performance against specific acceptance criteria through a clinical study with detailed statistical analysis.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in the provided document.

The document primarily focuses on:

Device Description and Intended Use: The MPS Fixed Flow Rate Set is a family of specialized IV sets designed to deliver fluid at a specified rate, incorporating standard components and controlling flow via microbore tubing. It's intended for single use in continuous or intermittent infusion therapy for I.V. fluids and drugs.
Technological Comparison to Predicate Device: The core of the submission is to demonstrate substantial equivalence to the I-Flow® Fixed Flow Rate Gravity Set. The submission explicitly states, "There are no technological differences between the I-Flow Fixed Rate Gravity Set and the MPS Fixed Flow Rate Set. Both devices control gravity flow rates by varying the length of fixed internal diameter microbore tubing."
Nonclinical Test Summary: Mentions that plastic components and bonding agents were tested per ISO 10993 for biocompatibility and safety.

Given these points, here is a breakdown of what can and cannot be answered from the provided text:

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

Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., flow rate accuracy within X%, duration of flow within Y%). The acceptance criterion for this 510(k) submission is "substantial equivalence" to the predicate device.
Reported Device Performance: No specific quantitative performance data is provided for the MPS Fixed Flow Rate Set beyond the statement that "Flow rate control is established by the flow dynamics of the microbore infusion tubing." The document relies on the equivalence to the predicate device, which presumably has its own established performance characteristics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable/not provided. This was a substantial equivalence submission, not a performance study with a 'test set' in the traditional sense of evaluating an algorithm. Nonclinical tests (biocompatibility) are mentioned, but sample sizes for those are not given.
Data Provenance: Not applicable/not provided. The nonclinical tests are internal to the manufacturer (Medical Product Specialists, Inc., Brea, CA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There was no 'ground truth' established by experts for a test set in the context of this 510(k) for this device type.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No such adjudication was performed for device performance.

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 device is an intravenous fluid delivery set, not an AI-assisted diagnostic or therapeutic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. No ground truth in this sense was used. The basis for approval is substantial equivalence to a legally marketed predicate device.

8. The sample size for the training set

Not applicable. There is no 'training set' as this device does not involve machine learning or AI.

9. How the ground truth for the training set was established

Not applicable.

Summary of Device Acceptance/Proof:

The "acceptance criteria" for the MPS Fixed Flow Rate Set, in the context of this 510(k) submission, was demonstrating substantial equivalence to the predicate device, the I-Flow® Fixed Flow Rate Gravity Set.

The "study that proves the device meets the acceptance criteria" in this case is the 510(k) submission itself, which presents:

A clear description of the device and its intended use.
A direct comparison of technological characteristics to the predicate device, explicitly stating "There are no technological differences." Both devices utilize the same principle of controlling gravity flow rates by varying the length of fixed internal diameter microbore tubing.
A summary of nonclinical biocompatibility testing (per ISO 10993).

The FDA's review of this submission led to the determination that the device is substantially equivalent to the legally marketed predicate device, thus allowing it to be marketed. This regulatory process acknowledges that if a new device is sufficiently similar to an already approved one, it does not need to undergo the same rigorous, full-scale clinical trials required for novel devices.

Summary

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AUG 2 4 1998

K982587

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:	June 29, 1998
4.	Device trade name:	MPS Fixed Flow Rate Set
	Common name:	Intravenous (I.V.) Sets Accessory
5.	Predicate device:	I-Flow® Fixed Flow Rate Gravity SetManufactured by I-Flow Corp., Irvine CA 92714
6.	Description:	The MPS Fixed Flow Rate Set is a family of specialized IV setsdesigned to deliver a fluid flow at a specified rate. The MPSFixed Flow Rate Set incorporates a standard bag spike, flexibledrip chamber, microbore infusion tubing, and ending with astandard male luer connector with luer-lock. Flow rate controlis established by the flow dynamics of the microbore infusiontubing. Each set is provided with a spike protector, luer cap,and tubing clamp. Various configurations may also include 0.2micron IV filter.Each MPS Fixed Flow Rate Set is sterilized in sealed individualpouches or trays. Full labeling information is provided witheach MPS Fixed Flow Rate Set. Multi-unit shelf packs ofindividual pouches or trays are provided for convenience.

7. Intended Use:

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The MPS Fixed Flow Rate Set is intended for single use in continuous or 1. intermittent infusion therapy.
ਮ ਪਲਾਂ ਨੇ ਕਿਹਾ ਹ
1. For use for infusion of I.V. fluids, and drugs.
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19.11.2

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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 I-Flow Fixed Flow Rate Gravity Set.

There are no technological differences between the I-Flow Fixed Rate Gravity Set and the MPS Fixed Flow Rate Set. Both devices control gravity flow rates by varying the length of fixed internal diameter microbore tubing.

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 Fixed Flow Rate Set is substantially equivalent to the legally marketed predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 1998

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

Re : K982587 Trade Name: MPS Fixed Flow Rate Set Requlatory Class: II Product Code: FPA Dated: June 29, 1998 Received: July 24, 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 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 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 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 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 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 requlation 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. Dutton 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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K 982587

PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT

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

510(k) Number: K982587

MPS Fixed Flow Rate Set Device Name:

Indications For Use:

The MPS Fixed Flow Rate Set is intended for single use in continuous or 1. intermittent infusion therapy.
For use for infusion of I.V. fluids and drugs. 2.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

Viola Hubbard L. Pat Cricente

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number 长 9 82587

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.