(43 days)
Not Found
Vigilance Continuous Cardiac Output/Oximetry/Continuous End Diastolic Volume (CCO/SvO2/CEDV) Monitor, 3M CDI Blood Parameter Monitoring System 500, Central Venous Oximetry Probe Catheter and Probe, Multi-Med Multi-Lumen Central Venous Catheter, Edslab Dual Lumen Regional Saturation Oximetry Catheter
No
The description focuses on microprocessor-based calculations of spectral data and does not mention AI or ML.
No
The device is used for monitoring hemodynamic parameters, oxygen saturation, and hemoglobin, not for treating a condition or disease.
Yes
The device measures parameters (oxygen saturation, hemoglobin) in human blood to monitor hemodynamic status, which is used for diagnosis and management of patient conditions.
No
The device description explicitly states the system is comprised of a system console, laptop computer, optical module, and Edwards oximetry catheter, indicating it includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The key is that the testing is done outside of the body.
- Device Function: The EW200 System and Edwards oximetry catheters measure oxygen saturation and hemoglobin directly within the bloodstream of the patient. The light is transmitted into the blood and reflected back, allowing for continuous monitoring in vivo.
- Lack of Sample Handling: There is no mention of collecting a sample (like drawing blood) and then analyzing it with the device. The measurement is happening in real-time within the patient's circulatory system.
Therefore, while the device measures parameters in human blood, it does so in vivo rather than in vitro.
N/A
Intended Use / Indications for Use
The EW200 System is indicated for use in patients requiring monitoring of hemodynamic parameters, including oxygen saturation and hemoglobin.
The PreSep catheter is indicated for hemodynamic monitoring through oxygen saturation measurement and hemoglobin measurement.
Product codes
DXG, DQE
Device Description
The EW200 System is a microprocessor-based instrument that, when connected to an Edwards oximetry catheter, provides continuous measurement of oxygen saturation (SO2) and hemoglobin (HGB)/hematocrit (HCT) levels in human blood. The system is comprised of a system console, laptop computer, optical module and Edwards oximetry catheter. The system console emits light that is transmitted into the blood stream through the optical module that connects to the oximetry catheter. The light is reflected back through the catheter to the system console and the spectral data is used to calculate SO2 and HGB.
The PreSep Oximetry catheter is a catheter that is used with Edwards oximetry monitors to measure oxygen saturation and also provides the means for measuring hemoglobin with the EW200 System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The EW200 System and PreSep catheter have successfully undergone functional testing. In addition, the EW200 System was also subjected to electrical safety testing. These products have been shown to be equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Vigilance Continuous Cardiac Output/Oximetry/Continuous End Diastolic Volume (CCO/SvO2/CEDV) Monitor, 3M CDI Blood Parameter Monitoring System 500, Central Venous Oximetry Probe Catheter and Probe, Multi-Med Multi-Lumen Central Venous Catheter, Edslab Dual Lumen Regional Saturation Oximetry Catheter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1435 Single-function, preprogrammed diagnostic computer.
(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).
0
APR 2 5 2006
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
510(k) Summary
| Submitter: | Edwards Lifesciences LLC
One Edwards Way
Irvine, CA 92614-5686 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Paula A. Torrianni, Director, Regulatory Affairs |
| Date Prepared: | October 28, 2005 |
| Trade name: | EW200 System (Oxygen Saturation and Hemoglobin
Monitoring System) |
| | PreSep Oximetry Catheter |
| Classification
Name: | Single-Function, Preprogrammed Diagnostic Computer
(21 CFR 870.1435) |
| | Catheter, Oximeter, Fiberoptic (21CFR870.1230) |
| Predicate
Devices: | Vigilance Continuous Cardiac Output/Oximetry/Continuous
End Diastolic Volume (CCO/SvO2/CEDV) Monitor |
| | 3M CDI Blood Parameter Monitoring System 500 |
| | Central Venous Oximetry Probe Catheter and Probe |
| | Multi-Med Multi-Lumen Central Venous Catheter |
| | Edslab Dual Lumen Regional Saturation Oximetry Catheter |
| Device
Description: | The EW200 System is a microprocessor-based instrument
that, when connected to an Edwards oximetry catheter,
provides continuous measurement of oxygen saturation
(SO2) and hemoglobin (HGB)/hematocrit (HCT) levels in
human blood. The system is comprised of a system
console, laptop computer, optical module and Edwards
oximetry catheter. The system console emits light that is
transmitted into the blood stream through the optical module
that connects to the oximetry catheter. The light is reflected
back through the catheter to the system console and the
spectral data is used to calculate SO2 and HGB. |
| | The PreSep Oximetry catheter is a catheter that is used with
Edwards oximetry monitors to measure oxygen saturation
and also provides the means for measuring hemoglobin with
the EW200 System. |
| | |
| Intended Use: | The EW200 System is indicated for use in patients requiring
monitoring of hemodynamic parameters, including oxygen
saturation and hemoglobin.
The PreSep catheter is indicated for hemodynamic
monitoring through oxygen saturation measurement and
hemoglobin measurement. |
| Comparative
Analysis: | The EW200 System and PreSep catheter have been
demonstrated to be as safe and effective as the predicate
devices for their intended use. |
| Functional/Safety
Testing: | The EW200 System and PreSep catheter have successfully
undergone functional testing. In addition, the EW200
System was also subjected to electrical safety testing.
These products have been shown to be equivalent to the
predicate devices. |
| Conclusion: | The EW200 System and PreSep catheter are substantially
equivalent to the predicate devices. |
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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings, formed by three curved lines. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the bird. The text is in all capital letters and is evenly spaced around the circle.
MAY 1 5 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Edwards Lifesciences, LLC c/o Ms. Laura Danielson TUV Product Service America 1775 Old Highway 8NW, Suite 104 New Brighton, MN 55112
Re: K060660
Trade/Device Name: EW200 System and PreSep Oximetry Catheter Regulation Number: 21 CFR §870 and 21 CFR §870.1230 Regulation Name: Single-Function, Preprogrammed Diagnostic Computer, and Catheter, Oximeter, Fiberoptic Regulatory Class: Class II (two) Product Code: DXG and DQE Dated: April 25, 2006 Received: April 25, 2006
Dear Ms. Danielson:
This letter corrects our substantially equivalent letter of April 25, 2006.
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 (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.
3
Page 2 - Ms. Laura Danielson
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.
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bfremman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Edwards Lifesciences LLC 510(k) Notification for the EW200 System and PreSep Catheter
1666660 510(k) Number (if known):
EW200 System and PreSep Oximetry Catheter Device Name:
Indications for Use:
The EW200 System is indicated for use in patients requiring monitoring of hemodynamic parameters, including oxygen saturation and hemoglobin.
The PreSep Oximetry catheter is indicated for hemodynamic monitoring through oxygen saturation measurement and hemoglobin measurement.
Edwards oximetry catheters are indicated for oxygen saturation and hemoglobin measurement.
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)
B. Simmons
n of Cardlovascular Devices 510(k) Number Ko
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