(29 days)
Not Found
No
The device description and performance studies focus on the physical components and basic functional testing of a catheter for pressure monitoring, with no mention of AI or ML.
No.
The device is used to monitor central vascular pressures, which is a diagnostic function, not a therapeutic one. It does not treat or cure a condition.
Yes
The device is used to obtain continuous central vascular pressures via the left atrium, which provides information about the patient's physiological state. This information is used by healthcare professionals to monitor and manage the patient during and/or after cardiac surgery, thus aiding in diagnosis or guiding a treatment plan.
No
The device description clearly outlines physical components (catheter, stopcock, stylet, suture anchor) and performance studies focus on physical properties and biocompatibility, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "obtain continuous central vascular pressures via the left atrium during and/or after cardiac surgery." This describes a device used in vivo (within the body) for monitoring physiological parameters.
- Device Description: The description details a catheter, stopcock, stylet, and suture anchor, all components of a device designed for insertion into the body.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) outside of the body. IVDs are specifically designed for testing these types of samples in vitro.
Therefore, this device falls under the category of an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Left Atrial Pressure Monitoring Catheters are intended to be used solely in conjunction with a standard hemodynamic pressure monitoring system to obtain continuous central vascular pressures via the left atrium during and/or after cardiac surgery.
Product codes
DQO
Device Description
The Edwards Lifesciences Left Atrial Pressure Monitoring Catheters consist of a radiopaque catheter bonded to a 3-way stopcock. Each catheter is marked at 1, 2, 3, and 4 centimeters for reference and is fitted over a pencil point stainless steel stylet. The proximal end of the stylet terminates in a male luer lock hub which is engaged by the proximal female port of the stopcock. Each catheter is provided with a moveable suture anchor. The devices are provided sterile, they are non-pyrogenic and they are intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
left atrium
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 functional data indicate that the Left Atrial Pressure Monitoring Catheter performs in a substantially equivalent manner when compared with the predicate device. The following functional tests were performed. All data met pre-established acceptance criteria.
- Biocompatibility Per ISO 10993 .
- Hemocompatibility Hemolysis Assay and clotting time coagulation assay. .
- Stopcock Handle Rotation Torque Tensile test of the stem/core and the stopcock housing. .
- Stopcock Handle Leak Testing -- Inspection for defects after exposure to dynamic water flow . and manipulation of the stopcock stem/core.
- Stopcock Flow Redirection Testing Inspection of proper liquid directional flow as indicated . on stopcock lever.
- Stopcock Leakage Testing for Pressure Decay within the stopcock stem/core. .
- Stopcock Visual Inspection ~ Evaluated for component damage and discoloration. .
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
510(k) Summary
110103 p 1/2
| Submitter: | Edwards Lifesciences® LLC | |
|---|---|---|
| Contact Person: | Spencer Walker, Regulatory Affairs Associate II | |
| 12050 Lone Peak Pkwy | ||
| Draper, UT 84020 | ||
| (801) 565-6100 | FEB 11 201 | |
| Date Prepared: | January 11, 2011 | |
| Trade Name: | Edwards Lifesciences® Left Atrial Pressure Monitoring Catheter - (LAP) | |
| Classification Name: | Catheter Intravascular Diagnostic | |
| 21 CFR Part 870.1200, Product Code DQO, Class II | ||
| Predicate Device: | K852197: Research Medical, Inc. LAP-CATH Left Atrial Pressure | |
| Monitoring Catheter |
Device Description:
The Edwards Lifesciences Left Atrial Pressure Monitoring Catheters consist of a radiopaque catheter bonded to a 3-way stopcock. Each catheter is marked at 1, 2, 3, and 4 centimeters for reference and is fitted over a pencil point stainless steel stylet. The proximal end of the stylet terminates in a male luer lock hub which is engaged by the proximal female port of the stopcock. Each catheter is provided with a moveable suture anchor. The devices are provided sterile, they are non-pyrogenic and they are intended for single use only.
Intended Use:
The Left Atrial Pressure Monitoring Catheters are intended to be used solely in conjunction with a standard hemodynamic pressure monitoring system to obtain continuous central vascular pressures via the left atrium during and/or after cardiac surgery.
Comparative Analysis:
lt has been demonstrated that the Left Atrial Pressure Monitoring Catheter is comparable to the predicate device in intended use and other labeling, fundamental scientific technology, material types, principles of operation and functional performance evaluations. The stopcock material change has been fully assessed within the Edwards Risk Management and Design Controls systems. All necessary verification steps met pre-determined acceptance criteria. No new issues of safety or efficacy have been raised and the performance data demonstrate equivalence.
Functional/Safety Testing
The functional data indicate that the Left Atrial Pressure Monitoring Catheter performs in a substantially equivalent manner when compared with the predicate device. The following functional tests were performed. All data met pre-established acceptance criteria.
- Biocompatibility Per ISO 10993 .
- Hemocompatibility Hemolysis Assay and clotting time coagulation assay. .
- Stopcock Handle Rotation Torque Tensile test of the stem/core and the stopcock housing. .
- Stopcock Handle Leak Testing -- Inspection for defects after exposure to dynamic water flow . and manipulation of the stopcock stem/core.
1
K110103 p 2/2
- Stopcock Flow Redirection Testing Inspection of proper liquid directional flow as indicated . on stopcock lever.
- Stopcock Leakage Testing for Pressure Decay within the stopcock stem/core. .
- Stopcock Visual Inspection ~ Evaluated for component damage and discoloration. .
Conclusion:
The Left Atrial Pressure Monitoring Catheter is substantially equivalent to the cited predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Edwards Lifesciences. LLC C/O Mr. Spencer Walker, Regulatory Affairs Associate II Cardiac Surgery Systems 12050 Lone Peak Pkwy Draper, UT 84020
FEB 1 1 201
Re: K110103
Trade/Device Name: Edwards Lifesciences Left Atrial Pressure Monitoring Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DQO Dated: January 12, 2011 Received: January 13, 2011
Dear Mr. Walker:
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.
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 or any I edelar states and requirements, including, but not limited to: registration and listing (21
3
Page 2 - Mr. Spencer Walker
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
W.M.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use
Indications for Use
510(k) Number (if known): Known): K | O/
Edwards Lifesciences Left Atrial Pressure Monitoring Catheter Device Name:
The Left Atrial Pressure Monitoring Catheters are intended to be used solely in conjunction with a standard hemodynamic pressure monitoring system to obtain continuous central vascular pressures via the left atrium during and/or after cardiac surgery.
Prescription Use × (Per 21 CFR 801.109)
OR Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
(Concurrence of CDRH, Office Of Device Evaluation (ODE)
Division of Cardiovascular Devices
510(k) Number K110103
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used, or disclosed without written permission from Edwards Lifesciences, LLC.
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