ROWE DUAL-CHECK VALVE

K983217 · Cook, Inc. · FPA · Jan 20, 1999 · General Hospital

Device Facts

• Record ID: K983217
• Device Name: ROWE DUAL-CHECK VALVE
• Applicant: Cook, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jan 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Rowe Dual-Check Valve device is intended for use with IV cannula or extension tube sets for simultaneous or alternate administration of IV drugs and fluids. The check valve is used in conjunction with a standard Luer taper syringe.

Device Story

Rowe Dual-Check Valve is a disposable, T-fitting device containing two one-way flow valves. It connects to IV cannula or extension sets and a standard Luer taper syringe. The device allows clinicians to draw fluid from a source and infuse it into the patient. The valves are normally open, permitting gravity-driven flow in standard IV systems. It is used in clinical settings to facilitate controlled, rapid fluid or drug administration. The device simplifies the process of alternating between fluid sources and syringe-based delivery, potentially improving efficiency in intravenous therapy management.

Clinical Evidence

Bench testing only. Testing included pressure, flow, torque, and biocompatibility assessments to ensure design performance and safety for its intended use as an I.V. connector.

Technological Characteristics

Disposable T-fitting connector with two normally-open one-way valves. Compatible with standard Luer taper syringes. Designed for integration into IV cannula or extension tube sets. No electronic components or software.

Indications for Use

Indicated for use with IV cannula or extension tube sets for simultaneous or alternate administration of IV drugs and fluids in patients requiring intravenous therapy.

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

• Dual Check Valve marketed by Burron and distributed by COOK INCORPORATED (FDA DC #790062)

Submission Summary (Full Text)

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JAN 2 0 1999

K983217

510(k) Premarket Notification Rowe Dual-Check Valve COOK INCORPORATED

#### Safety and Effectiveness Information

| Submitted By: | April Lavender, RAC<br>Vice President, Regulatory Affairs<br>COOK INCORPORATED<br>925 South Curry Pike<br>P.O. Box 489<br>Bloomington, In 47402<br>[phone]<br>September 11, 1998 |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Device: | Trade Name: | Proposed Classification Name: | Rowe Dual-Check Valve |
|-------------------|-------------|-------------------------------|--------------------------------------------------------|
| | | I.V. Connector | |
| Predicate Device: | | Dual Check Valve | Marketed by Burron<br>Distributed by COOK INCORPORATED |

#### Device Description

The Rowe Dual-Check Valve is a disposable, inexpensive device that has been designed to infuse controlled volumes of fluid quickly. The Rowe Dual-Check Valve is a combination of two onc-way flow valves joined by a "T" fitting. The arrangement allows a syringe to be placed on the medial female luer-lock port. The syringe is then used to draw fluid from the source and then infuse the fluid into the body.

The Rowe Dual-Check Valve uses one-way valves that are normally open. Therefore, when the system is placed in a normal intravenous system, gravity driven flow can pass through the device.

### Indications for Use

The Rowe Dual-Check Valve is intended for use with IV cannula or extension tube sets for simultaneous or alternate administration of IV drugs and fluids. The check valve is used in conjunction with a standard Luer taper syringe.

### Substantial Equivalence

The Rowe Dual-Check Valve is similar to another COOK INCORPORATED check valve which was found substantially equivalent under FDA DC #790062. The similar indications for use and technological characteristics of the Rowe Dual-Check Valve as compared to the predicate device supports a determination of substantial equivalency.

11.1

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## 510(k) Premarket Notification Rowe Dual-Check Valve COOK INCORPORATED

# Test Data

The Rowe Dual-Check Valve was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests include:

- Pressure Test �
- � Flow Test
- � Torque Test
- � Biocompatibility

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as an I.V. connector.

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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 three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 20 1999

Ms. April Lavender, RAC Vice President, Regulatory Affairs Cook Incorporated 925 South Curry Pike P.O. Box 489 47402 Bloomington, Indiana

Re: K983217 Rowe Dual-Check Valve Trade Name: Regulatory Class: II Product Code: FPA Dated: November 2, 1998 November 4, 1998 Received:

Dear Ms. Lavender:

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. A 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 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 - Ms. Lavender

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 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 [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours

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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K983217

2

510(k) Premarket Notification Rowe Dual-Check Valve COOK INCORPORATED

510(k) Number (if known): K983217

Device Name:

:

Rowe Dual-Check Valve

Indications for Use:

The Rowe Dual-Check Valve device is intended for use with IV cannula or extension The Rowe Dual-Check Varve device administration of IV drugs and fluids. The check valve is used in conjunction with a standard Luer taper syringe.

(PLEASE 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)

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OR

Over-the-Counter Use ___________

| (Division Sign-Off) | B. Balder |
|----------------------------------------|------------------------------------------------------------|
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | 1 <span style="text-decoration:underline;">K</span> 983217 |