VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5

K100739 · Edwards Lifesciences, LLC · KRB · Dec 7, 2010 · Cardiovascular

Device Facts

• Record ID: K100739
• Device Name: VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5
• Applicant: Edwards Lifesciences, LLC
• Product Code: KRB · Cardiovascular
• Decision Date: Dec 7, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1915
• Device Class: Class 2

Intended Use

The VolumeView system is indicated for use in critical care patients in which cardio-respiratory function, fluid status, and vascular resistance need constant and/or intermittent assessment. The femoral arterial catheter is indicated for femoral artery insertion.

Device Story

VolumeView System comprises 4 or 5 French, 16 or 20 cm, two-lumen femoral artery catheter, CVC thermistor manifold, and PTFE-coated nitinol guidewire. Catheter includes thermistor for blood temperature measurement and lumen for pressure monitoring. Manifold facilitates injection of thermodilution boli through central venous catheter. Used in critical care settings by clinicians for hemodynamic monitoring. Provides data for assessment of cardio-respiratory function, fluid status, and vascular resistance. Output used by healthcare providers to guide clinical decision-making regarding patient fluid management and cardiovascular support.

Clinical Evidence

Bench testing only.

Technological Characteristics

Two-lumen femoral artery catheter (4 or 5 French, 16 or 20 cm); CVC thermistor manifold; PTFE-coated nitinol guidewire. Sensing via thermistor for blood temperature and pressure monitoring lumen. Class II device.

Indications for Use

Indicated for critical care patients requiring constant or intermittent assessment of cardio-respiratory function, fluid status, and vascular resistance. Femoral arterial catheter indicated for femoral artery insertion.

Regulatory Classification

Identification

A thermodilution probe is a device that monitors cardiac output by use of thermodilution techniques; this device is commonly attached to a catheter that may have one or more probes.

Predicate Devices

• Pulsion Pulsiocath Thermodilution Catheters & Accessories (K072364)
• Lake Region Mfg. Guidewire (K935170)

Submission Summary (Full Text)

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K100739
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## 510(k) Summary

| 510(k) Summary | | |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Submitter: | Edwards Lifesciences LLC<br>One Edwards Way<br>Irvine, CA 92614-5686 | DEC - 7 2010 |
| Contact Person: | Patricia A. Milbank<br>Vice President, RA/CA | |
| Date Prepared: | November 29, 2010 | |
| Trade name: | VolumeView System | |
| Classification Name: | Probe, Thermodilution (21 CFR 870.1915)<br>Catheter Guidewire (21 CFR 870.1330) | |
| Predicate Devices: | Catheter: Pulsion Pulsiocath Thermodilution Catheters &<br>Accessories; cleared under K072364<br>Manifold: Pulsion Pulsiocath Thermodilution Catheters &<br>Accessories; cleared under K072364<br>Guidewire: Lake Region Mfg. Guidewire, cleared under<br>K935170 | |
| Device Description: | The VolumeView System consists of a 4 or 5 French, 16 or 20<br>cm, two lumen femoral artery catheter and a CVC thermistor<br>manifold. One catheter lumen has a thermistor for making<br>blood temperature measurements, and the other is used for<br>pressure monitoring. | |
| | The manifold is used for injecting thermodilution boli through<br>a central venous catheter. | |
| | The guidewire is a PTFE-coated nitinol guidewire. | |
| Intended Use: | The VolumeView system is indicated for use in critical care<br>patients in which cardio-respiratory function, fluid status, and<br>vascular resistance need constant and/or intermittent<br>assessment. The femoral arterial catheter is indicated for<br>femoral artery insertion. | |
| Comparative<br>Analysis: | The VolumeView System has been demonstrated to be as safe<br>and effective as the predicate devices for their intended use. | |
| Functional/Safety<br>Testing: | The VolumeView System has successfully undergone<br>functional testing. This product has been shown to be<br>equivalent to the predicate devices. | |
| Conclusion: | The proposed VolumeView System is substantially equivalent<br>to the predicate devices. | |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The bird is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged around the circumference of the circle.

## Public Health Service

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

Edwards Lifesciences, LLC c/o Ms. Patricia Milbank, J.D. Vice President, RA/CA, Critical Care One Edwards Way Irvine, CA 92614

DEC - 7 2010

Re: K100739

Trade/Device Name: VolumeView System Regulatory Number: 21 CFR 870.1915 Regulation Name: Thermodilution Probe Regulatory Class: II (two) Product Code: KRB Dated: November 19, 2010 Received: November 22, 2010

Dear Ms: Milbank:

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.

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. Patricia Milbank, J.D.

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 tollofre no [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcestoYour/Industry/default.htm.

Sincerely yours.

Duna R. Vahner

A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number (if known): 长い0739

Device Name: VolumeView System

Indications for Use:

DEC - 7 2010

The VolumeView system is indicated for use in critical care patients in which cardio-respiratory function, fluid status, and vascular resistance need constant and/or intermittent assessment. The femoral arterial catheter is indicated for femoral artery insertion.

Prescription Use ___X___ (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dung D. Vu. Anmer

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K100739