EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL

K014054 · Edwards Lifesciences, LLC · DQO · Mar 8, 2002 · Cardiovascular

Device Facts

• Record ID: K014054
• Device Name: EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL
• Applicant: Edwards Lifesciences, LLC
• Product Code: DQO · Cardiovascular
• Decision Date: Mar 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The Edwards Lifesciences Swan-Ganz Monitoring Catheter with Oligon™ material is indicated for the assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring. Secondary indications are for sampling blood and infusing solutions.

Device Story

Intravascular diagnostic catheter; dual-lumen body tube; distal lumen monitors pulmonary artery/wedge pressures, samples venous blood, and infuses solutions; second lumen inflates distal latex balloon to facilitate catheter flotation into pulmonary artery. Operated by clinicians in clinical settings. Balloon inflated via 3 cc syringe connected to inflation valve. Provides real-time pressure monitoring to assist hemodynamic assessment and clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only; functional integrity and performance testing performed. Biocompatibility testing conducted per ISO 10993-1 and FDA G95-1.

Technological Characteristics

Dual-lumen catheter with Oligon™ material; latex balloon; ethylene oxide sterilization; packaged in Tyvek-sealed tray. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for patients requiring hemodynamic assessment via direct intracardiac and pulmonary artery pressure monitoring, blood sampling, or solution infusion.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Swan-Ganz Monitoring Catheter
• Baxter Healthcare Vantex™ Central Venous Catheters with Oligon™ material

Submission Summary (Full Text)

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KOI 40 54
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## 510(k) Summary, Safety and Effectiveness

| Submitter: | Edwards Lifesciences LLC<br>One Edwards Way<br>Irvine, California 92614 USA |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Contact: | Jason Smith<br>Phone: [phone]<br>Fax: [phone] |
| Device Trade Name: | Edwards Lifesciences Swan-Ganz Monitoring<br>Catheter with Oligon™ material |
| Common Name: | Intravascular Diagnostic Catheter |
| Classification: | Class II (Reference 21 CFR 870.1200) |
| Predicate or Legally<br>Marketed Device: | Swan-Ganz Monitoring Catheter<br>Baxter Healthcare Vantex™ Central Venous<br>Catheters with Oligon™ material |
| Date prepared: | December 7, 2001 |

#### Device Description:

The Edwards Lifesciences Swan-Ganz Monitoring Catheter with Oligon™ material is used to monitor right heart pressures, sample mixed venous blood, and infuse solutions. The catheters are composed of a dual lumen body tube. The distal lumen terminates at the tip and is used to monitor pulmonary artery and wedge pressures. The distal lumen may also be used to sample venous blood and infuse solutions. The second lumen is used only to inflate the latex balloon which can be found at the distal end of the catheter. The function of the balloon is to enable the catheter to float down the bloodstream into the pulmonary artery. The balloon is inflated with a 3 cc syringe, which is connected to the inflation valve at the inflation lumen hub. The device will be packaged in a tray sealed with a tyvek lid and sterilized using 100% ethylene oxide.

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K014054
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#### Indications for Use:

The Edwards Lifesciences Swan-Ganz Monitoring Catheter with Oligon™ material is indicated for the assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring. Secondary indications are for sampling blood and infusing solutions.

### Technology Comparison:

The Edwards Lifesciences Swan-Ganz Monitoring Catheter with Oligon™ material is 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 Edwards Lifesciences Swan-Ganz Monitoring Catheter with Oligon™ material to evaluate the integrity and performance of the device. Based upon the results of this testing, Edwards Lifesciences has determined that the Edwards Lifesciences Swan-Ganz Monitoring Catheter with Oligon™ material is safe and effective and is acceptable in design and construction for its intended use.

#### Test Summary, In-vivo:

Clinical testing was not performed on the subject device because the intended use and indications are the same as the predicate devices. Furthermore, the Edwards Lifesciences Swan-Ganz Monitoring Catheter with Oligon™ material exhibited comparable design characteristics to the predicate devices in the in vitro testing, thus clinical testing was not performed.

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KO14054
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### Test Summary, Biocompatibility:

Biocompatibility testing was performed on the Edwards Lifesciences Swan-Ganz Monitoring Catheter with Oligon™ material 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 Edwards Lifesciences Swan-Ganz Monitoring Catheter with Oligon™ material was found to be biocompatible and nontoxic and acceptable for its intended use.

# Rationale for Substantial Equivalence Determination:

The battery of non-clinical tests discussed above demonstrates that the Edwards Lifesciences Swan-Ganz Monitoring Catheter with Oligon™ material exhibit comparable mechanical and functional characteristics to the predicate devices in addition to being biocompatible and chemically acceptable. Based upon those characteristics, the Edwards Lifesciences Swan-Ganz Monitoring Catheter with Oligon™ material is substantially equivalent to the predicate devices in safety and effectiveness in addition to being intended for the same uses.

Aran Smith 12/7/01

Jason Smith Senior Regulatory Affairs Specialist Edwards Lifesciences

Date

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 8 2007

Mr. Jason Smith Senior Regulatory Affairs Specialist Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614-5686

K014054 Re:

Swan-Ganz Monitoring Catheter with Oligon Material Regulation Number: 870.1200 Regulation Name: Diagnostic intravascular catheter. Regulatory Class: II (two) Product Code: 74 DQO Dated: December 7, 2001 Received: December 10, 2001

Dear Mr. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Bochon 9 rotes process is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the encrosure) to regard date of the Medical Device Amendments, or to devices that productions of 1770, the onloadinen using the Federal Food, Drug, and Cosmetic Ilave bech recassified in accordinos i of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, market the device, sabject to annual registration, listing of devices, good controls provisions or also ing, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be may be subject to saon adaltions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reast be advised that 1 27 is toualite to bur device complies with other requirements of the Act or that I Driver a doceminations administered by other Federal agencies. You must on a possible ally i edelul statutes and regulating, but not limited to: registration and listing (21 CFR Part 807); an the Ave 3 requirements) increases and manufacturing practice requirements as set forth in the quality labeling (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Jason Smith

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in yourse by a finding of substantial equivalence of your device to a legally promatics notification - 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 11 you desire specific acres 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF 1 5 8 4 586. Additionally, for questions on the promotion and advertising of Compination at (301) 59 - 1 the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Bram Zuckerman, M.D.

ram Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Edwards Lifesciences Swan-Ganz Monitoring Catheter with Oligon™ material

K01 4054

Indications For Use:

The Edwards Lifesciences Swan-Ganz Monitoring Catheter with Oligon™ material is indicated for the assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring. Secondary indications are for sampling blood and infusing solutions.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

510(k) Numbe

(Optional Format 1-2-96)