MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900

K040385 · Quest Medical, Inc. · FPA · Apr 7, 2004 · General Hospital

Device Facts

• Record ID: K040385
• Device Name: MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900
• Applicant: Quest Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Apr 7, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

For administration of intravenous fluids to a patient's vascular system utilizing needleless components and an I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. The needleless safety feature may aid in the prevention of needlestick injury.

Device Story

Sterile, single-use, non-pyrogenic intravenous fluid administration set; 85-inch (216 cm) length. Features multiport IV manifold with integrated back check valves, pre-attached needleless injection sites, drip chamber, and roller clamps. Used in clinical settings for simultaneous delivery of multiple IV fluids. Operates via gravity, syringe, or infusion pump. Needleless design reduces risk of needlestick injury to healthcare providers. Device facilitates controlled fluid delivery to patient vascular system.

Clinical Evidence

Bench testing only. Laboratory design verification testing performed in accordance with FDA guidance for Intravascular Administration Sets demonstrated acceptable performance.

Technological Characteristics

Sterile, single-use, non-pyrogenic IV administration set. Components include multiport manifold, integrated back check valves, needleless injection sites, drip chamber, and roller clamps. 85-inch (216 cm) length. Mechanical fluid delivery system.

Indications for Use

Indicated for patients requiring intravenous fluid administration via gravity, syringe, or infusion pump, utilizing needleless components for multiple simultaneous therapies.

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

• Baxter Continu-Flo Solution Set, 2C8930 (K003225)

Submission Summary (Full Text)

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K040385

APR - 7 2004

## Section 11

510(k) Summary of Safety and Effectiveness

#### SUBMITTER INFORMATION: 1.

Submitter's Name: Address:

Telephone: Fax Number: Contact Person: Date Prepared:

- DEVICE INFORMATION: 2. Proprietary Name: Common/Usual Names: Classification:
Quest Medical, Inc. One Allentown Parkway Allen, Texas 75002 972-390-9800 972-390-2881 Kathryn J. Thompson 1 April 2004

Multiport® Manifold I.V. Set with Swabable Valves Intravascular Administration Sets, I.V. Sets Class 11, 21 CFR 880.5440

Baxter Continu-Flo Solution Set, 2C8930, K003225

PREDICATE DEVICE:

- DEVICE DESCRIPTION: ന്
Sterile single use, non-pyrogenic intravenous fluid administration set: 85 in. (216 cm) long, multiport IV manifold with integrated back check valves, pre-attached needleless injection sites, drip chamber, roller clamps.

- INTENDED USE: 4.
For administration of intravenous fluids to a patient's vascular system utilizing needleless components and an I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump.

### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF NEW DEVICE TO ട്. PREDICATE DEVICE:

The technological characteristics of the Multiport IV Set do not differ significantly from the currently marketed Baxter Continu-Flo set. The devices use the same fundamental scientific technology and have the same intended use.

#### NON-CLINICAL TEST CONCLUSIONS: 6.

.The results of laboratory testing (design verification) using the FDA guidance for Intravascular Administration Sets demonstrate acceptable performance of the device.

Replaces pages 28, 29, and 30

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its back, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is in black and white.

Public Health Service

APR - 7 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Quest Medical. Incorporated C/O Mr. Jeremi Peck Responsible Third Party Official Underwriters Laboratories Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

Re: K040385

Trade/Device Name: Multiport® Manifold I.V. Set 3 with Swabable Valves Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: March 16, 2004 Received: March 23, 2004

Dear Mr. Peck:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -- Mr. Peck

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

for,

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K040385

## SECTION 5 INDICATIONS FOR USE STATEMENT

| 510(k) Number: | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Multiport® Manifold I.V. Set with Swabable Valves |
| Indications for Use: | For administration of intravenous fluids to a patient's vascular<br>system utilizing needleless components and an I.V. manifold<br>for multiple simultaneous intravenous therapy via gravity,<br>syringe, or infusion pump.<br>The needleless safety feature may aid in the prevention of<br>needlestick injury. |

(Please do not write below this line-continue on another page if needed)

# CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Prescription Use_ V (Per 21 CFR 801.109)

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OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Anesthoology
Infection Control, Dental Devices

510(k) Number: K040385