MPS FIXED FLOW RATE SET

K982587 · Medical Product Specialists · FPA · Aug 24, 1998 · General Hospital

Device Facts

• Record ID: K982587
• Device Name: MPS FIXED FLOW RATE SET
• Applicant: Medical Product Specialists
• Product Code: FPA · General Hospital
• Decision Date: Aug 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

MPS Fixed Flow Rate Set is a gravity-driven IV administration set. Components include a bag spike, flexible drip chamber, microbore infusion tubing, and male luer-lock connector; some configurations include a 0.2 micron IV filter. Flow rate is controlled by the fluid dynamics of the fixed-diameter microbore tubing. The device is used in clinical settings for the delivery of IV fluids and drugs. It is a single-use, sterile device. Healthcare providers use the set to establish a specific, fixed flow rate for patient therapy, facilitating controlled fluid or medication administration.

Clinical Evidence

Bench testing only. Plastic component materials and bonding agents were tested per ISO 10993 Biological Testing of Medical and Dental Materials, confirming biocompatibility.

Technological Characteristics

Gravity-fed IV set; microbore infusion tubing; male luer-lock connector; optional 0.2 micron IV filter. Flow control via fixed internal diameter tubing length. Materials tested per ISO 10993. Sterile, single-use.

Indications for Use

Indicated for patients requiring continuous or intermittent infusion therapy for the administration of I.V. fluids and drugs.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• I-Flow® Fixed Flow Rate Gravity Set

Submission Summary (Full Text)

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AUG 2 4 1998

K982587

## 510(k) Summary

| 1. | Submitter: | Medical Product Specialists, Inc. (MPS)<br>499 Nibus Street, suite E<br>Brea, CA 92821<br>Tel: [phone]<br>Fax: [phone] |
|----|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact: | Dan Hyun, President<br>Medical 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 Set<br>Manufactured by I-Flow Corp., Irvine CA 92714 |
| 6. | Description: | The MPS Fixed Flow Rate Set is a family of specialized IV sets<br>designed to deliver a fluid flow at a specified rate. The MPS<br>Fixed Flow Rate Set incorporates a standard bag spike, flexible<br>drip chamber, microbore infusion tubing, and ending with a<br>standard male luer connector with luer-lock. Flow rate control<br>is established by the flow dynamics of the microbore infusion<br>tubing. Each set is provided with a spike protector, luer cap,<br>and tubing clamp. Various configurations may also include 0.2<br>micron IV filter.<br><br>Each MPS Fixed Flow Rate Set is sterilized in sealed individual<br>pouches or trays. Full labeling information is provided with<br>each MPS Fixed Flow Rate Set. Multi-unit shelf packs of<br>individual 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

- 2. For use for infusion of I.V. fluids, and drugs.
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19.11.2

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- 8. 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.

- 9. 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.

- 10. Conclusion: The MPS Fixed Flow Rate Set is substantially equivalent to the legally marketed predicate device.

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Image /page/2/Picture/2 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" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, arranged in a cascading manner.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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