The Multi-Med catheters are indicated for use in patients requiring administration of solutions, blood sampling, central venous pressure monitoring and injection of contrast media.

The Vantex central venous catheters are indicated for use in patients requiring administration of solutions, blood sampling, central venous pressure monitoring and injection of contrast media. All catheters include a soft tip to reduce the risk of vessel perforation.

Device Description

The Multi-Med Central Venous Catheters (Multi-Med CVCs) and Vantex Central Venous Catheters (Vantex CVCs) and their respective convenience kits are used with Edwards monitoring instruments. They are used in patients who require the administration of solutions, blood sampling, central venous monitoring and injection of contrast media. The Multi-Med CVCs and Vantex CVCs can be used with an uncoated stainless steel guidewire (SS guidewire) or a PTFE-coated Nitinol core guidewire (Nitinol guidewire). The guidewire is included with the Multi-Med CVCs and Vantex CVCs in convenience kits or the guidewire can be packaged as a separate component.

AI/ML Overview

The provided text describes the 510(k) summary for Multi-Med Central Venous Catheters and Vantex Central Venous Catheters. This document focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific performance acceptance criteria for a novel device through a primary study.

Therefore, much of the requested information regarding acceptance criteria, specific device performance, sample sizes for test/training sets, expert involvement, and ground truth establishment, typically found in a new device's clinical or performance study report, is not available in this submission.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the document. The submission states "Comparative Verification and validation testing was conducted to compare the performance and functionality of the Multi-Med CVCs and Vantex CVCs to the predicate devices." and "The results show that the performance functionality...is substantially equivalent to the predicate devices, and provides a marked improvement in the ease of use of the pending devices in comparison to the predicate devices." However, specific quantitative acceptance criteria and detailed performance metrics are not listed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size for Test Set: Not specified. The document mentions "bench studies" and "pre-clinical animal studies," but does not provide specific sample sizes for these tests.
Data Provenance: Not specified. The location or nature (retrospective/prospective) of the data for the bench and pre-clinical studies is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable/Not specified. This type of information is usually relevant for studies involving subjective interpretation (e.g., image analysis by radiologists). For medical devices like central venous catheters, performance is typically evaluated through objective measurements and pre-clinical/animal models, not by expert consensus on clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not specified. Adjudication methods are typically used in clinical trials or studies requiring expert review of subjective outcomes. The testing described here is primarily functional and performance-based.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This type of study (MRMC, AI assistance) is not relevant for the evaluation of central venous catheters, which are physical medical devices, not diagnostic software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is not relevant. The device is a physical catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not explicitly stated in detail. Given the nature of CVCs, "ground truth" would likely be established through:

Physical measurements against specifications (for bench testing).
Direct observation and physiological measurements in animal models (for pre-clinical studies).
Biocompatibility testing standards (for biocompatibility).

8. The sample size for the training set:

Not applicable/Not specified. This device is not an AI/ML algorithm that requires a training set. The performance testing is not based on a "training set" in that context.

9. How the ground truth for the training set was established:

Not applicable/Not specified. As there is no "training set" in the context of this device, this question is not relevant.

Summary of the Study:

The studies conducted for the Multi-Med Central Venous Catheters and Vantex Central Venous Catheters were primarily for comparative verification and validation testing to demonstrate substantial equivalence to existing predicate devices (K955839, K992532, K091709, K100739, K110167).

The testing regimen included:

Side-by-side comparative bench testing: This would involve comparing physical and functional characteristics of the new devices against the predicate devices.
Pre-clinical animal studies: These studies would evaluate the device's performance and safety in vivo in an animal model.
Biocompatibility testing: To ensure the materials used are safe for contact with the body.

The conclusion of these studies was that the Multi-Med CVCs and Vantex CVCs and the pending guidewire are substantially equivalent to the predicate devices in performance and functionality, and demonstrate a "marked improvement in the ease of use." This indicates that the device meets the regulatory threshold of substantial equivalence for its stated Indications for Use. Specific acceptance criteria or detailed raw performance data that would typically be found in a full study report are not part of this 510(k) summary.

Summary

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K113565

510(k) Summary

MAY 1 8 2012

	510(k) Summary		MAY 1
Submitter:	Edwards Lifesciences LLCOne Edwards WayIrvine, CA 92614-5686
Contact Person:	Marguerite Thomlinson, JD, BSMEDirector of Regulatory AffairsPhone: (949) 756-4386Fax: (949) 809-5676
Date Prepared:	November 30, 2011
Trade Name:	Multi-Med Central Venous Catheters .Vantex Central Venous Catheters
Classification Name:	Intravascular Catheter (21 CFR Part 880.5200)
Product Class/Product Code:	Class II/FOZ
Predicate Devices:	K955839: Multi-Med Multi-Lumen CVCsK992532: Vantex CVCs with Oligon MaterialK091709: Multi-Med CVCs and Vantex CVCsK100739: VolumeView SystemK110167: PreSep Oligon Oximetry Catheters
Device Description:	The Multi-Med Central Venous Catheters (Multi-Med CVCs) andVantex Central Venous Catheters (Vantex CVCs) and their respectiveconvenience kits are used with Edwards monitoring instruments. Theyare used in patients who require the administration of solutions, bloodsampling, central venous monitoring and injection of contrast media.The Multi-Med CVCs and Vantex CVCs can be used with an uncoatedstainless steel guidewire (SS guidewire) or a PTFE-coated Nitinol coreguidewire (Nitinol guidewire). The guidewire is included with theMulti-Med CVCs and Vantex CVCs in convenience kits or theguidewire can be packaged as a separate component.

· .

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Indications for Use:

The Multi-Med catheters are indicated for use in patients requiring administration of solutions, blood sampling, central venous pressure monitoring and injection of contrast media.

Comparative Verification and validation testing was conducted to compare the Analysis: performance and functionality of the Multi-Med CVCs and Vantex CVCs to the predicate devices. This testing regimen included side-byside comparative bench and pre-clinical performance testing of the pending and predicate devices. The results show that the performance functionality of the Multi-Med CVCs and Vantex CVCs and the pending guidewire is substantially equivalent to the predicate devices, and provides a marked improvement in the ease of use of the pending devices in comparison to the predicate devices. Thus, the Multi-Med CVCs and Vantex CVCs have been demonstrated to be safe and effective and substantially equivalent to the predicate devices for their intended use.

Functional/ Safety Testing:

The Multi-Med CVCs and Vantex CVCs have successfully undergone functional and performance testing, including bench studies, pre-clinical animal studies and biocompatibility testing. Multi-Med CVCs and Vantex CVCs have been shown to be safe and effective and substantially equivalent to the cited predicate devices for their intended use.

Conclusion:

The Multi-Med CVCs and Vantex CVCs are safe and effective and are substantially equivalent to the cited predicate devices.

Page 27 of 520 Nov. 30. 2011

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three horizontal bars running through the body of the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY 1 8 2012

Ms. Marguerite Thomlinson, JD, BSME Director of Regulatory Affairs Edwards Lifesciences, LLC One Edwards Way Irvine, California 92614-5686

Re: K113565

Trade/Device Name: Multi-Med Central Venous Catheters, Vantex Central Venous Catheters Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: April 16, 2012 Received: April 18, 2012

Dear Ms. Thomlinson:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Ms. Thomlinson

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Avant

Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use

510(k) Number (if known): K 113565

Device Name:

Multi-Med Central Venous Catheters Vantex Central Venous Catheters

Indications for Use:

The Multi-Med catheters are indicated for use in patients requiring administration of solutions, blood sampling, central venous pressure monitoring and injection of contrast media.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L.L. for RZC May 16, 2012

Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number:

Special 510k: Edwards Multi-Med/Vantex

Page 29 of 520 Nov. 30, 2011

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).