(52 days)
Dual drainage venous return cannulae are indicated for venous cannulation so that extracorporeal circulation of the venous blood to a heart-lung machine may be achieved, for a duration of < 6 hours. They are also indicated for coronary bypass procedures where single tube venous drainage from the right atrium only is ordinarily contraindicated because of diminished caval return due to intra-operative manipulation of the heart. Venous return cannulae in sizes 6Fr to 18Fr can be used in pediatric patients. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin-coated blood path is desired.
Edwards venous cannulae are polymeric tubes intended to provide a means of returning deoxygenated blood from a patient to the oxygenator during cardiopulmonary bypass procedures. The cannulae are available in a range of sizes and types and in a variety of tip and hole configurations. Variants include codes with ½" to ¼" acceptance or connectors. Cannulae are reinforced by means of a stainless steel wire entirely encapsulated within the wall of the cannula to minimize the potential for cannula kinking. 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 study information based on the provided text, using the structure you requested:
While the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, it does not contain explicit "acceptance criteria" in the format of specific thresholds for a device's performance metrics (e.g., sensitivity, specificity, accuracy) like one would find for an AI/ML medical device. Instead, it discusses functional and safety testing to show comparable performance to a predicate device.
Given that limitation, I've interpreted "acceptance criteria" as the criteria for demonstrating substantial equivalence and "reported device performance" as the overall conclusion from the functional/safety testing.
Description of Acceptance Criteria and Study
The Edwards Lifesciences Venous Cannula, as described in this 510(k) summary, underwent a comparative analysis study to demonstrate substantial equivalence to its predicate device. This study focused on functional and safety performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Interpreted) | Reported Device Performance |
|---|---|
| Functional Equivalence: The proposed devices must perform in a substantially equivalent manner to the predicate device regarding intended use, fundamental scientific technology, material type, principles of operation, and functional performance. | "The functional data indicate that the proposed devices perform in a substantially equivalent manner when compared with the predicate device." |
| Safety Equivalence: The device must demonstrate comparable safety performance to the predicate device. | (Implied by the overall conclusion of substantial equivalence in conjunction with functional data, although not explicitly stated as separate "safety data" findings in the summary.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The testing described appears to be laboratory-based functional and safety testing rather than a clinical study with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the type of testing described. Functional and safety testing of a physical medical device typically involves engineering and quality assurance personnel, rather than clinical experts establishing a "ground truth" in the diagnostic sense.
4. Adjudication Method for the Test Set
This information is not applicable as the document does not describe a process requiring expert adjudication for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (especially AI/ML-based ones) to assess the impact of a device on human reader performance. The device described is a physical venous cannula.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance assessment was not done. This concept is only relevant for AI/ML algorithms. The device is a physical medical device.
7. The Type of Ground Truth Used
Given the nature of the device (a physical venous cannula) and the testing described (functional/safety), the "ground truth" would be established by engineering specifications, material science standards, and established performance criteria for such medical devices. It is not based on expert consensus, pathology, or outcomes data in the way a diagnostic device would be.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device.
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510(k) Summarv
| Submitter: | Edwards Lifesciences Research Medical, Inc. | |
|---|---|---|
| Contact Person: | Karen Jones, Senior Manager, Regulatory Affairs6864 South 300 WestMidvale, UT 84047801-565-6231 | |
| Date Prepared: | XXXXXX | OCT - 8 2009 |
| Trade Name: | Edwards Lifesciences Venous Cannula | |
| Classification Name: | Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass21 CFR Part 870.4210, Product Code DWF, Class II | |
| Predicate Device: | Edwards Lifesciences Venous Cannula |
Device Description:
Edwards venous cannulae are polymeric tubes intended to provide a means of returning deoxygenated blood from a patient to the oxygenator during cardiopulmonary bypass procedures.
The cannulae are available in a range of sizes and types and in a variety of tip and hole configurations. Variants include codes with ½" to ¼" acceptance or connectors. Cannulae are reinforced by means of a stainless steel wire entirely encapsulated within the wall of the cannula to minimize the potential for cannula kinking. The devices are provided sterile, they are non-pyrogenic and they are intended for single use only.
Intended Use:
The dual drainage venous return cannulae are indicated for venous cannulation so that extracorporeal circulation of the venous blood to a heart-lung machine may be achieved, for a duration of < 6 hours.
They are also indicated for coronary bypass procedures where single tube venous drainage from the right atrium only is ordinarily contraindicated because of diminished caval return due to intra-operative manipulation of the heart.
Venous return cannulae in sizes 6Fr to 18Fr can be used in pediatric patients.
Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin-coated blood path is desired.
Comparative Analysis:
It has been demonstrated that the proposed venous cannulae are comparable to the predicate devices in intended use and other labeling, fundamental scientific technology, material type, principles of operation and functional performance evaluations.
Functional/Safety Testing: The functional data indicate that the proposed devices perform in a substantially equivalent manner when compared with the predicate device.
Conclusion:
The venous cannulae are substantially equivalent to the cited predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Edwards Lifesciences, LLC c/o Ms. Karen Jones Senior Manager, Regulatory Affairs 6864 South 300 West Midvale, Utah 84047
OCT = 8 2009
Re: K092509
Edwards Lifesciences Venous Return Cannulae Regulation Number: 21 CFR 870.4210 Regulation Name: Catheter, Cannula and Tubing, Vascular Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DWF Dated: August 14, 2009 Received: August 17, 2009
Dear Ms. Jones:
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.
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
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Page 2 - Ms. Karen Jones
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 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.
suma R. William
Image /page/2/Picture/8 description: The image contains a handwritten symbol or signature. The symbol consists of a looping, curved line that resembles a stylized letter or abstract design. To the right of the symbol, there are two capital letters, 'B' and 'D', stacked vertically. The letters are in a simple, sans-serif font and appear to be part of the same handwritten text as the symbol.
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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Indications for Use Statement
510(k) Number (if known): ko925 09
Device Name: Edwards Lifesciences Venous Return Cannulae
Indications for Use:
- Dual drainage venous return cannulae are indicated for venous cannulation so that extracorporeal � circulation of the venous blood to a heart-lung machine may be achieved, for a duration of < 6 hours.
- . They are also indicated for coronary bypass procedures where single tube venous drainage from the right atrium only is ordinarily contraindicated because of diminished caval return due to intra-operative manipulation of the heart.
- . Venous return cannulae in sizes 6Fr to 18Fr can be used in pediatric patients.
- Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary . surgery when a heparin-coated blood path is desired.
| Prescription Use | AND/OR | Over-The-Counter Use |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (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)
sume R. V. Lume
(Division of)
Division of Cardiovascular Devices
K092504 510(k) Number_
§ 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).