(266 days)
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.
The VolumeView System consists of a 4 or 5 French, 16 or 20 cm, two lumen femoral artery catheter and a CVC thermistor manifold. One catheter lumen has a thermistor for making blood temperature measurements, and the other is used for pressure monitoring. The manifold is used for injecting thermodilution boli through a central venous catheter. The guidewire is a PTFE-coated nitinol guidewire.
The provided text is a 510(k) Summary for the Edwards Lifesciences VolumeView System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain specific details about acceptance criteria, a study proving the device meets those criteria, or information on aspects like sample sizes, ground truth establishment, or expert involvement in a study.
The 510(k) summary only states:
- "The VolumeView System has been demonstrated to be as safe and effective as the predicate devices for their intended use."
- "The VolumeView System has successfully undergone functional testing. This product has been shown to be equivalent to the predicate devices."
These statements indicate that some form of testing was performed to demonstrate substantial equivalence, but the details required for your request are not present in this summary.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, rather than a detailed study report with specific performance metrics and methodologies.
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K100739
P1/1
510(k) Summary
| 510(k) Summary | ||
|---|---|---|
| Submitter: | Edwards Lifesciences LLCOne Edwards WayIrvine, CA 92614-5686 | DEC - 7 2010 |
| Contact Person: | Patricia A. MilbankVice President, RA/CA | |
| Date Prepared: | November 29, 2010 | |
| Trade name: | VolumeView System | |
| Classification Name: | Probe, Thermodilution (21 CFR 870.1915)Catheter Guidewire (21 CFR 870.1330) | |
| Predicate Devices: | Catheter: Pulsion Pulsiocath Thermodilution Catheters &Accessories; cleared under K072364Manifold: Pulsion Pulsiocath Thermodilution Catheters &Accessories; cleared under K072364Guidewire: Lake Region Mfg. Guidewire, cleared underK935170 | |
| Device Description: | The VolumeView System consists of a 4 or 5 French, 16 or 20cm, two lumen femoral artery catheter and a CVC thermistormanifold. One catheter lumen has a thermistor for makingblood temperature measurements, and the other is used forpressure monitoring. | |
| The manifold is used for injecting thermodilution boli througha central venous catheter. | ||
| The guidewire is a PTFE-coated nitinol guidewire. | ||
| Intended Use: | The VolumeView system is indicated for use in critical carepatients in which cardio-respiratory function, fluid status, andvascular resistance need constant and/or intermittentassessment. The femoral arterial catheter is indicated forfemoral artery insertion. | |
| ComparativeAnalysis: | The VolumeView System has been demonstrated to be as safeand effective as the predicate devices for their intended use. | |
| Functional/SafetyTesting: | The VolumeView System has successfully undergonefunctional testing. This product has been shown to beequivalent to the predicate devices. | |
| Conclusion: | The proposed VolumeView System is substantially equivalentto the predicate devices. |
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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 (800) 638-2041 or (301) 796-7100 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
§ 870.1915 Thermodilution probe.
(a)
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.(b)
Classification. Class II (performance standards).