MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN

K113565 · Edwards Lifesciences, LLC · FOZ · May 18, 2012 · General Hospital

Device Facts

• Record ID: K113565
• Device Name: MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN
• Applicant: Edwards Lifesciences, LLC
• Product Code: FOZ · General Hospital
• Decision Date: May 18, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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. 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 Story

Multi-Med and Vantex Central Venous Catheters (CVCs) are intravascular devices used for fluid administration, blood sampling, pressure monitoring, and contrast media injection. Devices are used in clinical settings by healthcare professionals. Catheters feature soft tips to minimize vessel perforation risk. They are compatible with stainless steel or PTFE-coated Nitinol core guidewires. The device facilitates central venous access; output is clinical data (pressure monitoring) or therapeutic delivery (fluids/contrast). Benefit includes safe, reliable venous access for critical care monitoring and therapy.

Clinical Evidence

Bench testing and pre-clinical animal studies were conducted to verify performance and functionality. Biocompatibility testing was performed. No human clinical trial data was required or presented for this 510(k) submission.

Technological Characteristics

Intravascular catheter (21 CFR 880.5200). Features include multi-lumen configurations and soft tips. Compatible with stainless steel or PTFE-coated Nitinol core guidewires. Materials are consistent with previously cleared predicate devices. No software or electronic components.

Indications for Use

Indicated for patients requiring administration of solutions, blood sampling, central venous pressure monitoring, and injection of contrast media.

Regulatory Classification

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.

Predicate Devices

• Multi-Med Multi-Lumen CVCs (K955839)
• Vantex CVCs with Oligon Material (K992532)
• Multi-Med CVCs and Vantex CVCs (K091709)
• VolumeView System (K100739)
• PreSep Oligon Oximetry Catheters (K110167)

Submission Summary (Full Text)

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K113565

# 510(k) Summary

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MAY 1 8 2012

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| | 510(k) Summary | | MAY 1 |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-------|
| Submitter: | Edwards Lifesciences LLC<br>One Edwards Way<br>Irvine, CA 92614-5686 | | |
| Contact Person: | Marguerite Thomlinson, JD, BSME<br>Director of Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] | | |
| Date Prepared: | November 30, 2011 | | |
| Trade Name: | Multi-Med Central Venous Catheters .<br>Vantex Central Venous Catheters | | |
| Classification Name: | Intravascular Catheter (21 CFR Part 880.5200) | | |
| Product Class/<br>Product Code: | Class II/FOZ | | |
| Predicate Devices: | K955839: Multi-Med Multi-Lumen CVCs<br>K992532: Vantex CVCs with Oligon Material<br>K091709: Multi-Med CVCs and Vantex CVCs<br>K100739: VolumeView System<br>K110167: PreSep Oligon Oximetry Catheters | | |
| Device Description: | The Multi-Med Central Venous Catheters (Multi-Med CVCs) and<br>Vantex Central Venous Catheters (Vantex CVCs) and their respective<br>convenience kits are used with Edwards monitoring instruments. They<br>are used in patients who require the administration of solutions, blood<br>sampling, central venous monitoring and injection of contrast media.<br>The Multi-Med CVCs and Vantex CVCs can be used with an uncoated<br>stainless steel guidewire (SS guidewire) or a PTFE-coated Nitinol core<br>guidewire (Nitinol guidewire). The guidewire is included with the<br>Multi-Med CVCs and Vantex CVCs in convenience kits or the<br>guidewire 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.

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.

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.

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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 [phone] or [phone] 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.

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.

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