(36 days)
Edwards Lifesciences Femoral Access Cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (≤ 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Femoral access cannulae may be used in pediatric populations or adult populations based on flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
The Edwards Femoral Access Venous and Arterial Cannulae with/out Duraflo® coating are wire-reinforced thin-wall polyurethane or PVC cannulae. The wire reinforcement is intended to prevent kinking during use. The clear proximal section of the cannula is unreinforced for clamping and terminates in either a barbed connector for 1/4" or 3/8" tubing connection. The cannulae are available on various sizes and lengths. Each cannula is furnished with one, or in some cases two, dilator(s). In the case of cannulae supplied with two dilators, one is solid and the other is hollow. The hollow dilator will pass over guidewires up to 0.038" (0.97 mm) in diameter. The guidewire, when used, facilitates percutaneous insertion under direct visualization. The cannulae tips are tapered for easy insertion. Some cannulae feature incremental depth markings to aid in proper placement and positioning. Some versions have, as an additional aid to placement, the clear tip section of the cannula contain two radiopaque barium stripes for visualization. Edwards Femoral Access Cannulae are intended to provide a means of draining the blood flow (venous), or perfusing blood into the body (arterial) of a patient during cardiopulmonary bypass procedures. Each Edwards Lifesciences device is packaged sterile and non-pyrogenic in a sealed, peel-type pouch.
Here's an analysis of the provided text regarding the Edwards Lifesciences® Femoral Access Venous and Arterial Cannulae, focusing on acceptance criteria and study details.
Based solely on the provided 510(k) summary, the document does not contain the detailed study information typically associated with establishing device performance against specific acceptance criteria. The 510(k) summary explicitly states that the basis for the submission is the addition of contraindications to the Instructions for Use, and that no physical changes are being made to the devices. It claims substantial equivalence to previously cleared predicates without providing new performance data for this submission.
Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets them cannot be extracted from this document because such a study is not detailed here.
Here's a breakdown of what can be inferred or explicitly stated from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this 510(k) summary, as no new performance data is presented. | Not specified in this 510(k) summary. |
| Assumed to meet previously established safety and efficacy criteria for predicate devices. | The document states: "The Femoral Access Arterial and Venous Cannulae met all predetermined acceptance criteria to confirm safety and efficacy." However, the criteria themselves and the data supporting this are not provided in this summary. |
Explanation: The 510(k) summary, in this instance, is focused on a labeling change (adding contraindications) rather than demonstrating new performance. It relies on the prior clearance of its predicate devices to assert that the device "met all predetermined acceptance criteria." The specific criteria and the data proving performance against them are not included in this document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in this 510(k) summary.
- Data Provenance: Not specified in this 510(k) summary.
- Retrospective/Prospective: Not specified in this 510(k) summary.
Explanation: Since no new performance studies are detailed, this information is not available in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified in this 510(k) summary, as no new clinical or performance studies requiring expert ground truth establishment are detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified in this 510(k) summary.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a physical medical device (cannulae), not an AI/software-based diagnostic tool that would typically involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not specified in this 510(k) summary. For a physical device like a cannula, "ground truth" would typically relate to mechanical properties, biocompatibility, flow rates, and successful implantation/function in in vitro or in vivo studies, data which are not presented here.
8. The sample size for the training set
- Not applicable/Not specified in this 510(k) summary, as no AI model or complex algorithm requiring a training set is discussed.
9. How the ground truth for the training set was established
- Not applicable/Not specified in this 510(k) summary.
Summary of Findings from the Provided Text:
The provided 510(k) summary (K140208) is a submission primarily focused on labeling changes (adding contraindications) for existing, previously cleared devices. It explicitly states that "No physical changes are being made to these devices" and that the "design of the device remains unchanged." The basis for clearance is substantial equivalence to predicate devices (K123298 and K123303), which would have had their own studies (mechanical, biocompatibility, etc.) for initial clearance. This particular document does not present any new acceptance criteria or new data from studies to prove device performance. It simply asserts that the device "met all predetermined acceptance criteria" based on its equivalence and prior clearances.
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510(k) Summary
| Submitter: | Edwards Lifesciences® LLC |
|---|---|
| Contact Person: | Lindsay Martin, Regulatory Affairs Associate III12050 Lone Peak PkwyDraper, UT 84020(801) 565-5388 |
| Date Prepared: | January 24, 2014 |
| Trade Name: Cannulae | Edwards Lifesciences® Femoral Access Venous and Arterial |
| Classification Name: | Cardiopulmonary bypass vascular catheter, cannula or tubing Class II (21 CFR §870.4210), Product Code DWF |
| Predicate Devices: | K123298: Femoral Access Arterial CannuulaeK123303: Femoral Access Venous Cannulae |
Device Description:
The Edwards Femoral Access Venous and Arterial Cannulae with/out Duraflo® coating are wire-reinforced thin-wall polyurethane or PVC cannulae. The wire reinforcement is intended to prevent kinking during use. The clear proximal section of the cannula is unreinforced for clamping and terminates in either a barbed connector for 1/4" or 3/8" tubing connection.
The cannulae are available on various sizes and lengths. Each cannula is furnished with one, or in some cases two, dilator(s). In the case of cannulae supplied with two dilators, one is solid and the other is hollow. The hollow dilator will pass over guidewires up to 0.038" (0.97 mm) in diameter. The guidewire, when used, facilitates percutaneous insertion under direct visualization. The cannulae tips are tapered for easy insertion.
Some cannulae feature incremental depth markings to aid in proper placement and positioning. Some versions have, as an additional aid to placement, the clear tip section of the cannula
MAR - 5 2014
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contain two radiopaque barium stripes for visualization. Edwards Femoral Access Cannulae are intended to provide a means of draining the blood flow (venous), or perfusing blood into the body (arterial) of a patient during cardiopulmonary bypass procedures. Each Edwards Lifesciences device is packaged sterile and non-pyrogenic in a sealed, peel-type pouch.
Intended Use:
Intended for femoral venous and arterial access during cardiopulmonary bypass (CPB).
Indications For Use:
Edwards Lifesciences Femoral Access Cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (≤ 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Femoral access cannulae may be used in pediatic populations or adult populations based on flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
Comparative Analysis:
The basis for this submission is the addition of contraindications to the instructions for use of the Indications for Use statement. No physical changes are being made to these devices. The subject devices have the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate devices.
Summary of Changes:
The basis for this 510(k) submission is to address potential off label usage by adding contraindications to the Instructions for Use for the Femoral Access Arterial and Venous Cannulae labeling cleared under the previous 510(k) submissions (K123298 and K123303). The design of the device remains unchanged. No physical changes are being made to these devices. The subject devices have the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate devices. New contraindications are
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K140208, 510(k) Summary
being added to mitigate consumer risk for potential off-label use of the Femoral Access Arterial and Venous Cannulae.
Conclusion:
The Femoral Access Arterial and Venous Cannulae are substantially equivalent to the cited predicate device(s). Additionally, the Femoral Access Arterial and Venous Cannulae met all predetermined acceptance criteria to confirm safety and efficacy.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing service to the nation. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Public Health Service
March 5, 2014
Edwards Lifesciences, LLC. % Lindsay Martin Associate III, Regulatory Affairs 12050 Lone Peak Pkwy Draper, UT 84020 US
Re: K140208
Trade/Device Name: Fem-Flex II Femoral Arterial Cannula Fem-Flex Femoral Arterial Cannula Femoral Access Cannula with Duraflo™ coating Fem-Flex II Femoral Venous Cannula Femoral Venous Cannulae FemTrak Femoral Venous Cannula Femoral Access Cannula with Duraflo™ coating Regulation Number: 21 CFR 870.4210 Regulation Name: Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass Regulatory Class: Class II Product Code: DWF Dated: January 29, 2014 Received: February 3, 2014
Dear Ms. Martin,
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.
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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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
. A. Zilleham
for 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): K140208
Edwards Lifesciences Femoral Access Venous and Arterial Cannulae Device Name:
Caution: Federal law (U. S. A.) restricts this device to sale by, or on the order of, a physician.
Edwards Lifesciences Femoral Access Cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (≤ 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician.
Femoral access cannulae may be used in pediatric populations or adult populations based on flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates.
Extracomoreal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
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)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
M.A. Stillman
Page B-2
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).