(266 days)
Not Found
No
The description focuses on hardware components (catheter, manifold, guidewire) and basic physiological measurements (temperature, pressure, thermodilution). There is no mention of AI, ML, image processing, or data analysis techniques that would typically indicate the presence of such technology.
No
The device is described as a system for assessment and monitoring of cardio-respiratory function, fluid status, and vascular resistance, which are diagnostic and monitoring functions, not therapeutic ones.
Yes
The device is used to assess cardio-respiratory function, fluid status, and vascular resistance, which involves diagnosing a patient's physiological state.
No
The device description explicitly details hardware components including a femoral artery catheter, a CVC thermistor manifold, and a guidewire.
Based on the provided information, the VolumeView system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The VolumeView system is a medical device that is inserted directly into the patient's femoral artery and connected to a central venous catheter. It measures physiological parameters in vivo (within the living body), not in vitro (outside the body in a lab setting).
- The device description and intended use focus on direct patient monitoring. The system measures blood temperature and pressure, and is used for thermodilution boli injection through a CVC. These are all procedures performed directly on the patient.
Therefore, the VolumeView system is a medical device used for patient monitoring and assessment, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
KRB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
critical care patients
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Functional/Safety Testing: The VolumeView System has successfully undergone functional testing. This product has been shown to be equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
K100739
P1/1
510(k) Summary
| 510(k) Summary | ||
|---|---|---|
| Submitter: | Edwards Lifesciences LLC | |
| One Edwards Way | ||
| Irvine, CA 92614-5686 | DEC - 7 2010 | |
| Contact Person: | Patricia A. Milbank | |
| Vice 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 K072364 | ||
| Manifold: Pulsion Pulsiocath Thermodilution Catheters & | ||
| Accessories; cleared under K072364 | ||
| Guidewire: Lake Region Mfg. Guidewire, cleared under | ||
| K935170 | ||
| Device Description: | 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. | ||
| 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. | ||
| Comparative | ||
| Analysis: | The VolumeView System has been demonstrated to be as safe | |
| and effective as the predicate devices for their intended use. | ||
| Functional/Safety | ||
| Testing: | The VolumeView System has successfully undergone | |
| functional testing. This product has been shown to be | ||
| equivalent to the predicate devices. | ||
| Conclusion: | The proposed VolumeView System is substantially equivalent | |
| to the predicate devices. |
1
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.
2
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
3
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