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 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.

AI/ML Overview

The provided text describes the 510(k) summary for the "Edwards Lifesciences Swan-Ganz Monitoring Catheter with Oligon™ material". This is a traditional medical device submission, not an AI/ML medical device, and therefore the standard acceptance criteria and study designs for AI/ML devices, such as those involving image analysis, multi-reader multi-case studies, or algorithm-only performance, do not apply.

Here's an analysis based on the provided text, adapted for a non-AI/ML medical device:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, acceptance criteria are generally met through comparability to a predicate device and established performance standards, rather than specific numerical metrics for "performance" as one would expect with an AI/ML diagnostic.

Acceptance Criteria Category	Specific Criteria (Implicitly based on Predicate)	Reported Device Performance
Functional Integrity	- Maintain physical structure and integrity.	"Functional testing was performed... to evaluate the integrity and performance of the device."
	- Proper balloon inflation mechanism.	(Implied to be successful, no specific details provided).
	- Accurate pressure monitoring capability.	(Implied to be successful, no specific details provided).
	- Capability for blood sampling and fluid infusion.	(Implied to be successful, no specific details provided).
Biocompatibility	- Nontoxic and biologically compatible with human tissue per ISO 10993-1-1994.	"The Edwards Lifesciences Swan-Ganz Monitoring Catheter with Oligon™ material was found to be biocompatible and nontoxic and acceptable for its intended use."
Material Equivalence	- Oligon™ material performs comparably to predicate.	"The Edwards Lifesciences Swan-Ganz Monitoring Catheter with Oligon™ material is technologically comparable to the predicate devices in construction and physical specifications."
Sterilization	- Effective sterilization using 100% ethylene oxide.	"The device will be... sterilized using 100% ethylene oxide." (Implied to be effective and acceptable).
"Safe and Effective"	- Overall safety and effectiveness for intended use, comparable to predicate.	"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."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The functional and biocompatibility testing involved physical samples of the device, but the number of units tested is not detailed in this summary.
Data Provenance: The "Test Summary, In-vitro" and "Test Summary, Bi-ocompatability" indicate internal laboratory testing conducted by Edwards Lifesciences LLC. The summary does not provide country of origin for the data (beyond the submitter's location in Irvine, California, USA) nor if it was retrospective or prospective, though device testing is typically prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts & Qualifications: Not applicable in the context of this device and the provided submission. "Ground truth" for a physical medical device typically refers to established engineering standards, material science principles, and biological safety guidelines (e.g., ISO standards), rather than expert consensus on diagnostic images. Biocompatibility testing follows standardized protocols evaluated by qualified toxicologists or biologists, but specific details of expert roles are not in a 510(k) summary.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Adjudication methods like "2+1" or "3+1" are relevant for expert review of diagnostic findings (e.g., in radiological studies). This device undergoes lab-based functional and biocompatibility testing against defined specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is specific to diagnostic aids, particularly those involving human interpretation of medical images or data, often with AI assistance. This device is a catheter, not an AI diagnostic.
Effect Size of Human Readers: Not applicable.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: No, a standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not done. This concept applies to AI/ML algorithms, not physical medical devices like a catheter.

7. Type of Ground Truth Used

Type of Ground Truth: For the functional testing, the "ground truth" would be established engineering specifications and performance benchmarks for intravascular catheters (e.g., pressure sensor accuracy, balloon inflation volume, material strength). For biocompatibility, the ground truth is defined by international standards (ISO 10993-1-1994) which outline acceptable biological responses to medical devices. There's no pathology or outcomes data used as "ground truth" for the pre-market evaluation described.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device does not involve an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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

Submitter:	Edwards Lifesciences LLCOne Edwards WayIrvine, California 92614 USA
Contact:	Jason SmithPhone: 949-250-2662Fax: 949-250-3579
Device Trade Name:	Edwards Lifesciences Swan-Ganz MonitoringCatheter with Oligon™ material
Common Name:	Intravascular Diagnostic Catheter
Classification:	Class II (Reference 21 CFR 870.1200)
Predicate or LegallyMarketed Device:	Swan-Ganz Monitoring CatheterBaxter Healthcare Vantex™ Central VenousCatheters with Oligon™ material
Date prepared:	December 7, 2001

Device Description:

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K014054
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Indications for Use:

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 (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

510(k) Numbe

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
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.(b)
Classification. Class II (performance standards).