(52 days)
Not Found
Not Found
No
The document describes a physical medical device (venous cannulae) and its intended use and performance testing, with no mention of software, algorithms, or AI/ML technologies.
No.
This device facilitates extracorporeal circulation during surgery but does not directly treat or cure a disease or condition.
No
Explanation: The device, Edwards venous cannulae, is described as polymeric tubes used for returning deoxygenated blood to an oxygenator during cardiopulmonary bypass procedures, indicating a therapeutic or supportive function rather than a diagnostic one.
No
The device description clearly describes physical components (polymeric tubes, stainless steel wire) and their function in a surgical procedure, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. They perform tests outside the body.
- Device Description: The description clearly states that this device is a "polymeric tube intended to provide a means of returning deoxygenated blood from a patient to the oxygenator during cardiopulmonary bypass procedures." This is a device used within the body to facilitate a medical procedure.
- Intended Use: The intended use describes a surgical procedure (extracorporeal circulation, coronary bypass) where the device is used to manage blood flow during the procedure. It does not involve testing or analyzing specimens.
Therefore, based on the provided information, this device is a surgical or cardiovascular device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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
§ 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).
0
510(k) Summarv
| Submitter: | Edwards Lifesciences Research Medical, Inc. | |
|---|---|---|
| Contact Person: | Karen Jones, Senior Manager, Regulatory Affairs | |
| 6864 South 300 West | ||
| Midvale, UT 84047 | ||
| 801-565-6231 | ||
| Date Prepared: | XXXXXX | OCT - 8 2009 |
| Trade Name: | Edwards Lifesciences Venous Cannula | |
| Classification Name: | Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass | |
| 21 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 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