(56 days)
Not Found
No
The device description and intended use focus on the physical components and function of arterial and aortic perfusion cannulae for cardiopulmonary bypass. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
These devices are "therapeutic" because they are intended to deliver oxygenated blood to the patient during cardiopulmonary bypass procedures, which is a treatment for a medical condition.
No
These devices are surgical tools (cannulae) used for delivering blood during cardiopulmonary bypass procedures, not for diagnosing conditions.
No
The device description clearly details physical components such as cannulae, tubing connectors, vent plugs, introducers, guidewires, and a hemostasis valve. These are all hardware components, indicating the device is not software-only.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens from the human body. The descriptions clearly state that these devices are cannulae intended for perfusion of the aorta and arteries during cardiopulmonary bypass procedures. They are used to deliver oxygenated blood directly into the patient's circulatory system.
- The intended use is for direct patient intervention. The devices are inserted into the patient's body for therapeutic purposes (delivering blood), not for analyzing biological samples outside the body.
- The device descriptions focus on physical characteristics and function within the circulatory system. They describe the materials, sizes, tips, connectors, and how they facilitate blood flow and insertion into blood vessels. There is no mention of analyzing blood or other bodily fluids.
Therefore, these devices fall under the category of medical devices used for surgical procedures, specifically cardiopulmonary bypass, and are not IVDs.
N/A
Intended Use / Indications for Use
EZ Glide Aortic Perfusion Cannulae:
Aortic perfusion cannulae are intended for perfusion of the aorta during short-term (≤6 hours) cardiopulmonary bypass procedures.
Aortic perfusion cannulae may be used in pediatric or adult populations based on the flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates.
OptiSite Arterial Perfusion Cannulae:
The Edwards Lifesciences arterial perfusion cannulae are indicated for arterial perfusion in the extracorporeal circuit for
§ 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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 5, 2024
Edwards Lifesciences Peter Lindwall Director, Regulatory Affairs 1 Edwards Way Irvine. California 92614
Re: K233895
Trade/Device Name: EZ Glide Aortic Perfusion Cannulae (EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18. OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B); Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, Or Tubing Regulatory Class: Class II Product Code: DWF Dated: December 7, 2023 Received: December 11, 2023
Dear Peter Lindwall:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Nicole M. Gillette -S
Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K233895
Device Name OptiSite Arterial Perfusion Cannulae
Indications for Use (Describe) OptiSite Arterial Perfusion Cannulae:
The Edwards Lifesciences arterial perfusion cannulae are indicated for arterial perfusion in the extracorporeal circuit for Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K233895
Device Name EndoReturn Arterial Cannulae
Indications for Use (Describe) EndoReturn Arterial Cannulae:
The EndoReturn arterial cannula are indicated for patients undergoing cardiopulmonary bypass. They are intended to deliver oxygenated blood for cardiopulmonary bypass during surgery.
The EndoReturn arterial cannula with hemostasis valve also allows the hemostatic introduction and removal of vascular catheters such as the EndoClamp aortic catheter.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known) K233895
Device Name EZ Glide Aortic Perfusion Cannulae
Indications for Use (Describe) EZ Glide Aortic Perfusion Cannulae:
Aortic perfusion cannulae are intended for perfusion of the aorta during short-term (≤6 hours) cardiopulmonary bypass procedures.
Aortic perfusion cannulae may be used in pediatric or adult populations based on the flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
K233895 510(k) Summary, revised 01-30-2024
| Contact Details | ||
|---|---|---|
| Applicant Name | Edwards Lifesciences | |
| Applicant Address | 1 Edwards Way Irvine CA 92614 United States | |
| Applicant Contact Telephone | 949-701-8980 | |
| Applicant Contact | Mr. Peter Lindwall | |
| Applicant Contact Email | peter_lindwall@edwards.com | |
| Device Name | ||
| Device Trade Name | EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); | |
| OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); | ||
| EndoReturn Arterial Cannulae (ER21B and ER23B) | ||
| Common Name | Cardiopulmonary bypass vascular catheter, cannula, or tubing | |
| Classification Name | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | |
| Regulation Number | 870.4210 | |
| Product Code | DWF | |
| Legally Marketed Predicate Devices | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K123370 | EZ Glide Aortic Perfusion Cannulae | DWF |
| K073559 | OptiSite Arterial Perfusion Cannulae | DWF |
| K971291 | EndoReturn Arterial Cannulae | DWF |
| Device Description Summary |
EZ Glide Aortic Perfusion Cannulae, General Description & Operation of Action
Note: There is no change to the general description or operation of the device from the predicate EZ Glide Aortic Perfusion Cannulae device. There is no change to the design or manufacturing of the device from the predicate EZ Glide Aortic Perfusion Cannulae Device. The EZ Glide Aortic Perfusion Cannulae device deliver oxygenated blood from the cardiopulmonary bypass pump directly into the aorta. The cannulae terminate in a 3/8" (9.5mm) barbed tubing connector and a vent plug. Cannulae are wire-reinforced and include a dispersion tip in either a straight or curved configuration. EZ Glide Aortic Cannulae are available in sizes 21 French (Fr) and 24 French (Fr). The EZ Glide Aortic Cannulae are packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Note that there are no accessories packaged with the EZ Glide Aortic Perfusion Cannulae.
OptiSite Arterial Perfusion Cannulae, General Description & Operation of Action
Note: There is no change to the general description or operation of the device from the predicate OptiSite Arterial Perfusion Cannulae device. There is no change to the design or manufacturing of the device from the predicate OptiSite Arterial Perfusion Cannulae Device.
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The OptiSite Arterial Perfusion Cannulae device is indicated for arterial perfusion in the extracorporeal circuit for less than 6 hours. Cannulation site selection is left to the discretion of the surgeon and may include the femoral artery or the aortic arch.
The Edwards Lifesciences Arterial Perfusion Cannulae have smoothly rounded tips to facilitate atraumatic insertion. The proximal ends of the cannula are designed to accept 3/8" (9.5mm) tubing.
Introducers are provided with some arterial cannula codes. Introducers are designed for use with 0.038" (0.96 mm) quidewires. Each introducer is provided with a removable vented luer cap. Leave the vented cap in place to allow venting of the cannula for use without a guidewire. Remove the cap to allow cannula use with a guidewire. The OptiSite Arterial Perfusion Cannulae are packaged sterile and non-pyrogenic in a sealed, peel-type pouch,
EndoReturn Arterial Cannulae, General Description & Operation of Action
Note: There is no change to the general description or operation of the device from the predicate EndoReturn Arterial Cannulae device. There is no change to the design or manufacturing of the device from the predicate EndoReturn Arterial Cannulae Device. The EndoReturn Arterial Cannulae devices are flexible plastic tubes intended to provide a means of perfusing arterial blood returning to the patient from the oxygenator through the extracorporeal circuit during cardiopulmonary bypass procedures. The cannulae are placed either through the femoral artery or directly into the aorta to return oxygenated blood from the CPB circuit and to hemostatically introduce Edwards intra-aortic occlusion catheters. Each device is packaged sterile and non-pyrogenic in a sealed, peel-type pouch and are intended and labeled for single use only.
The Endo Return Arterial Cannulae with the hemostasis valve are made with a wirereinforced cannula shaft which provides kink resistance and flexibility, and include the following kit components:
- Introducer
- Guidewire (0.038" (0.097mm) x 100 cm) J-tip ●
- Connector hub ●
The tapered atraumatic tip aids in insertion and advancement into the femoral artery. The non-wire-reinforced clamp site(s), a 3/8 in. barbed connector, and a hemostasis valve allows passage of catheters such as the Edwards IntraClude intra-aortic occlusion device. The introducers accept a 0.038 in. (0.97 mm) guidewire and are marked to simplify assembly. A connector hub secures and immobilizes the introducer within the cannula for easier, oneperson insertion of the cannula/introducer assembly. A lubricious coating, (SlipCoat™) is applied to the surface of the EndoReturn arterial cannula shafts. This coating is intended to provide a lubricious surface effective for the duration of the intended use of the cannula, thereby easing the insertion of the cannula into the artery, and the aortic occlusion catheters through the cannula. The EndoReturn Arterial Cannulae are packaged sterile and nonpyrogenic in a sealed, peel-type pouch.
Intended Use/Indications for Use
EZ Glide Aortic Perfusion Cannulae:
Aortic perfusion cannulae are intended for perfusion of the aorta during short-term (≤6 hours) cardiopulmonary bypass procedures.
Aortic perfusion cannulae may be used in pediatric or adult populations based on the flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates.
7
OptiSite Arterial Perfusion Cannulae:
The Edwards Lifesciences arterial perfusion cannulae are indicated for arterial perfusion in the extracorporeal circuit for