BAXTER HEMOSTASIS VALVE INTRODUCERS

K981909 · Baxter Edwards · DYB · Nov 24, 1998 · Cardiovascular

Device Facts

• Record ID: K981909
• Device Name: BAXTER HEMOSTASIS VALVE INTRODUCERS
• Applicant: Baxter Edwards
• Product Code: DYB · Cardiovascular
• Decision Date: Nov 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Baxter Healthcare Hemostasis Valve Introducers are indicated for use in patients requiring access of the venous system and to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter). Single Lumen Introducers: The Baxter Healthcare Single Lumen Hemostasis Valve Introducers are indicated for use in patients requiring access of the venous system and to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter). Multiple Lumen Access Products: The Baxter Healthcare Multiple Lumen Access Products are indicated for use in patients requiring access of the venous system, to facilitate catheter insertion (e.g., pulmonary artery or infusion catheter) and central venous pressure monitoring.

Device Story

Percutaneous sheath introducer system; facilitates venous access and catheter insertion. Device components: housing body with integrated hemostasis valve, sheath, side port/extension tube, and dilator. Valve provides seal around catheter and prevents backflow. Optional AMC Thromboshield coating. Used in clinical settings by healthcare professionals. Device provides physical access path for catheters; enables central venous pressure monitoring in multi-lumen models. Benefits include vessel access and backflow prevention during catheterization.

Clinical Evidence

No clinical data. Substantial equivalence supported by in-vitro functional testing and biocompatibility testing per ISO 10993-1-1994.

Technological Characteristics

Percutaneous sheath introducer; includes housing, sheath, side port, and dilator. Features hemostasis valve for backflow prevention. Optional AMC Thromboshield coating. Sterilized via 100% ethylene oxide. Packaged in tray with Tyvek lid. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for patients requiring venous system access and catheter insertion (e.g., pulmonary artery or infusion catheters); multiple lumen versions also indicated for central venous pressure monitoring.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Baxter Healthcare Intro-Flex® Percutaneous Sheath Introducer
• Cook Critical Care Intro Deuce Hemostasis Valve set
• Bard Access Systems Peel-Apart Percutaneous Introducer Kit

Submission Summary (Full Text)

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K981909

# 510(k) Summary, Safety and Effectiveness

| Submitter: | Baxter Healthcare Corporation<br>CardioVascular Group<br>Critical Care<br>17221 Red Hill Avenue<br>Irvine, California 92614 USA |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Scott Beggins<br>Phone: [phone]<br>Fax: [phone] |
| Device Trade Name: | Baxter Hemostasis Valve Introducers |
| Common Name: | Percutaneous Sheath Introducer |
| Classification: | Class II (Reference 21 CFR 870.1340) |
| Predicate or Legally<br>Marketed Device: | Baxter Healthcare Intro-Flex® Percutaneous Sheath<br>Introducer, Cook Critical Care Intro Deuce<br>Hemostasis Valve set and Bard Access Systems<br>Peel-Apart Percutaneous Introducer Kit |
| Date prepared: | May 29, 1998 |

## Device Description:

The Baxter Hemostasis Valve Introducers are used to access the venous system and to facilitate catheter insertion. The introducers are composed of a housing body to which a sheath is attached distally and a side port/extension tube is connected proximally. A valve is located in the housing body to provide a seal around a catheter when inserted through the Introducer and to prevent backflow when no catheter is present. A dilator is provided with the Introducer to ease insertion of the device into the vessel. The Baxter Hemostasis Valve Introducers are provided with and without AMC Thromboshield™ which is used on Baxter's catheters and introducer products. The device will be packaged in a tray sealed with a tyvek lid and sterilized using 100% ethylene oxide.

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### Indications for Use:

The Baxter Healthcare Hemostasis Valve Introducers are indicated for use in patients requiring access of the venous system and to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter).

### Technology Comparison

The Baxter Hemostasis Valve Introducers are technologically comparable to the predicate devices in construction and physical specifications. Furthermore, design, manufacturing, and sterilization procedures are representative of current industry practices.

### Test Summary, In-vitro

Functional testing was performed on the Baxter Hemostasis Valve Introducers to evaluate the integrity and performance of the device. Based upon the results of this testing, the Baxter CardioVascular Group, Edwards Critical-Care has determined that the Baxter Hemostasis Valve Introducers are safe and effective and are acceptable in design and construction for its intended use.

#### Test Summary, In-vivo

Clinical testing was not performed on the subject catheter because the intended use and indications are the same as the predicate devices. Furthermore, the Baxter Hemostasis Valve Introducers exhibited comparable design characteristics to the predicate devices in the in vitro testing, thus clinical testing was not performed.

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## Test Summary, Biocompatibility:

Biocompatability testing was performed on the Baxter Hemostasis Valve Introducers in accordance with the requirements specified in International Standards Organization (ISO) 10993-1-1994 Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests and the FDA General Program Memorandum No. G95-1. The Baxter Hemostasis Valve Introducers were found to be biocompatable and nontoxic and acceptable for its intended use.

#### Rational for Substantial Equivalence Determinations:

The battery of non-clinical tests discussed above demonstrates that the Baxter Hemostasis Valve Introducers exhibits comparable mechanical and functional specifications to the predicate devices in addition to being biocompatible and chemically acceptable. Based upon those characteristics, the Baxter Hemostasis Valve is substantially equivalent to the predicate devices in safety and effectiveness in addition to being intended for the same uses.

Scott Beyer 5/29/98

Scott Beggins Date Senior Manager, gulatory Affairs CardioVascular Group Baxter Healthcare Corporation

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or a stylized human figure.

Food and Drug Administration Rockville MD 20857

# NOV 24 1000

Mr. Scott Beggins Senior Manager, Regulatory Affairs Baxter Edwards 17221 Red Hill Ave. Irvine, CA 92614-5686

Re: K981909 Trade Name: Baxter Hemostasis Valve Introducers Regulatory Class: II Product Code: DYB Dated: September 4, 1998 Received: September 8, 1998

Dear Mr. Beggins:

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 A substantially equivalent determination assumes compliance with 895. 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation

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Page 2 - Mr. Scott Beggins

you might have under sections 531 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 [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,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number (if known): K981909

Device Name: Baxter Hemostasis Valve Introducers

Indications For Use:

Single Lumen Introducers: The Baxter Healthcare Single Lumen Hemostasis Valve Introducers are indicated for use in patients requiring access of the venous system and to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter). Multiple Lumen Access Products: The Baxter Healthcare Multiple Lumen Access Products are indicated for use in patients requiring access of the venous system, to facilitate catheter insertion (e.g., pulmonary

artery or infusion catheter) and central venous pressure monitoring.

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Concurrence of CDRH, Office OF Device Evaluation (ODE)

A. Doyal Youtt for TJCallahan

Division of Cardiovascular, Respiratory, and Neurological D 510(k) Number