(29 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test Performed | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993 | Met pre-established acceptance criteria |
| Hemocompatibility | Hemolysis Assay and clotting time coagulation assay | Met pre-established acceptance criteria |
| Stopcock Handle Rotation Torque | Tensile test of the stem/core and the stopcock housing | Met pre-established acceptance criteria |
| Stopcock Handle Leak Testing | Inspection for defects after exposure to dynamic water flow and manipulation of the stopcock stem/core | Met pre-established acceptance criteria |
| Stopcock Flow Redirection Testing | Inspection of proper liquid directional flow as indicated on stopcock lever | Met pre-established acceptance criteria |
| Stopcock Leakage Testing | Pressure Decay within the stopcock stem/core | Met pre-established acceptance criteria |
| Stopcock Visual Inspection | Evaluated for component damage and discoloration | Met pre-established acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each functional/safety test (e.g., number of catheters tested for biocompatibility, leak testing, etc.). It mentions that the "performance data demonstrate equivalence" to the predicate device and that "all necessary verification steps met pre-determined acceptance criteria."
The data provenance is not explicitly stated in terms of country of origin but is related to the manufacturing and testing by Edwards Lifesciences, LLC. The studies appear to be prospective in nature, as they involve testing the newly developed device against pre-established criteria.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This type of information (number and qualifications of experts for ground truth) is only relevant for studies where human interpretation or judgment is part of the "ground truth" (e.g., image analysis, clinical diagnosis). The described tests are functional and safety tests of a physical medical device, not a diagnostic algorithm, so there is no mention of experts establishing a "ground truth" in this context. The acceptance criteria are based on quantitative measurements and industry standards (e.g., ISO 10993).
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or studies involving expert consensus for ground truth. Since the reported studies are functional and safety tests of a physical device, this concept does not apply. The acceptance criteria are objective and predefined.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic imaging or other decision-support AI systems where human readers interpret cases. The described studies are for a physical catheter device. The comparative analysis mentions that "it 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," but this refers to the overall substantial equivalence, not an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
No, a standalone study (in the context of an algorithm's performance) was not done. This device is a physical medical instrument, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the functional and safety tests was based on objective, quantifiable measurements and adherence to established industry standards (e.g., ISO 10993 for biocompatibility) and predefined specifications for mechanical and performance characteristics (e.g., torque, leak rates, flow redirection).
8. The Sample Size for the Training Set
This concept of a "training set" is applicable to machine learning or AI models. Since the device is a physical catheter, there is no training set in the AI sense. The design and manufacturing processes are validated through engineering and quality control, not by training an algorithm on a dataset.
9. How the Ground Truth for the Training Set was Established
As there is no training set for an AI model, this question is not applicable. The "ground truth" for ensuring the device's design and manufacturing quality relies on validation against engineering specifications, material properties, and relevant standards.
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510(k) Summary
110103 p 1/2
| Submitter: | Edwards Lifesciences® LLC | |
|---|---|---|
| Contact Person: | Spencer Walker, Regulatory Affairs Associate II12050 Lone Peak PkwyDraper, 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 Diagnostic21 CFR Part 870.1200, Product Code DQO, Class II | |
| Predicate Device: | K852197: Research Medical, Inc. LAP-CATH Left Atrial PressureMonitoring 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.
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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.
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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
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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
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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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§ 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).