(119 days)
No.
The device description and intended use indicate it is a passive medical device (cannula) used in surgery, with no mention of computational or AI-related functions.
Yes.
The device is used in cardiopulmonary bypass procedures to perfuse the aorta or as an arterial return cannula, which are therapeutic interventions during cardiovascular surgery.
No
The device is a cannula used for perfusion during cardiovascular surgery, not for diagnosing a condition or disease.
No
The device is a physical medical device (cannula) used in cardiovascular surgery, described with physical characteristics, materials, and mechanical testing, indicating it is hardware.
No
The device is used to perfuse the aorta or as an arterial return cannula during cardiopulmonary bypass, which is a surgical support procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The EasyFlow Aortic Cannula is intended for use in the perfusion of the aorta during cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass for up to 6 hours.
The EasyFlow Duo Cannula with guidewire is intended for use with cardiopulmonary bypass as an arterial return femoral cannula for up to 6 hours.
Product codes (comma separated list FDA assigned to the subject device)
DWF
Device Description
Easyflow & Easyflow Duo are single-use, non-toxic, non-pyrogenic fluid path devices and supplied sterile and individually packaged.
The Easyflow & Easyflow Duo are composed of the cannula and a malleable obturator inserted into the cannula to allow the placement of the cannula along the Artery.
The cannula is an open lumen PVC polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated with multiple holes at multiple stages to allow fluid flow. The clear proximal section is not reinforced to allow clamping; the proximal end terminates in a 3/8" barbed connector for standard cardiopulmonary bypass tubing
In the Easyflow Duo models the device has a 0.035" hole punched in the very distal tip of the cannula and the obturator has an approx. 0.035" internal diameter central lumen to accommodate a 0.035" guide wire used to drive the cannula along the vessel till its final placement. Once the cannula is positioned onto the vessel the surgeon removes the obturator from the cannula tubing and connects it to the arterial line.
The Easyflow is packaged as sterile stand-alone device while the Easyflow Duo is packaged into a tray containing also a Guidewire, a Needle and Vascular Dilators in order to have a kit for vascular access packaged together with the cannula.
The Easyflow & Easyflow Duo are the modified version of the disposables currently marketed as the Easyflow cannula (K060101) and the Easyflow Duo cannula (K091542). Both modified and unmodified cannulae models are recommended for use as an arterial return cannula during cardiopulmonary bypass up to six hours
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
aorta, arterial, femoral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Livanova USA Inc. has conducted extensive verification and validation testing of the Easyflow & Easyflow Duo cannula.
The devices passed all the testing in accordance with national and international standards.
Performed tests include: Visual inspection, Connector testing 180 degree pull test, Cannula clamp test, Blood pathway integrity, Flow rate and pressure drop through cannulae, Cannula kink test, Label legibility, Drainage cannula collapse resistance, Cannula integrity, Pull strength, Blood trauma characterization test, Cytotoxicity, Intracutaneous reactivity, Sensitization, Systemic Toxicity, Pyrogenicity (material mediated), Hemocompatibility (Hemolysis, Coagulation, Complement activation, Platelet and Leukocyte count assay), Genotoxicity (Mutation Assay, Mouse lymphoma).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
FDA 510(k) Clearance Letter - Easyflow Cannulae
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 27, 2025
Livanova USA Inc
Martina Carlini
RA Specialist
Sorin Group Italia S.r.l.
86, Via statale 12 Nord
Mirandola, IT 41037
Italy
Re: K250610
Trade/Device Name: Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)
Regulation Number: 21 CFR 870.4210
Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing
Regulatory Class: Class II
Product Code: DWF
Dated: February 28, 2025
Received: May 30, 2025
Dear Martina Carlini:
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.
Page 2
K250610 - Martina Carlini Page 2
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" (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 QS 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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K250610 - Martina Carlini Page 3
assistance/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).
Sincerely,
Rachel E. Neubrander -S
for 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
Enclosure
Page 4
FORM FDA 3881 (6/20) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known): K250610
Device Name: Easyflow (103-200; 103-300)
Easyflow Duo (103-210; 103-310)
Indications for Use (Describe)
The EasyFlow Aortic Cannula is intended for use in the perfusion of the aorta during cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass for up to 6 hours.
The EasyFlow Duo Cannula with guidewire is intended for use with cardiopulmonary bypass as an arterial return femoral cannula for up to 6 hours.
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
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Page 5
510(k) Summary
(in accordance with 21 CFR 807.92)
510(k) Number: K250610
I. Applicant Information
Applicant:
LIVANOVA USA INC
14401 West 65th Way
Arvada, CO 80004
Contact Person: Martina Carlini
Regulatory Affairs Specialist
Tel: +39 0535 29811
e-mail: martina.carlini@livanova.com
Application Correspondent:
SORIN GROUP ITALIA S.R.L.
Via Statale 12 Nord, 86
Mirandola, MO 41047 Italy
Contact Person: Martina Carlini
Regulatory Affairs Specialist
Tel: +39 0535 29811
e-mail: martina.carlini@livanova.com
Date Prepared: June 27th 2025
II. Subject Device Identification
Device Trade Name: Easyflow (103-200; 103-300)
Easyflow Duo (103-210; 103-310)
Classification Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing
Regulation Number: 21 CFR 870.4210
Product Code: DWF
Classification: Class II
Classification Panel: Cardiovascular
Page 6
III. Predicate Device
The Easyflow & Easyflow Duo are substantially equivalent to the following cleared predicate device. Both modified and unmodified models have the same fundamental scientific technology and intended use:
Easyflow
510(k) Number: K060101
Device Trade Name: Easyflow Aortic Cannula
Classification Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing
Regulation Number: 21 CFR 870.4210
Product Code: DWF
Classification: Class II
Classification Panel: Cardiovascular
Easyflow Duo
510(k) Number: K091542
Device Trade Name: Easyflow Cannula with guidewire (Easyflow Duo)
Classification Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing
Regulation Number: 21 CFR 870.4210
Product Code: DWF
Classification: Class II
Classification Panel: Cardiovascular
IV. Device Description
Easyflow & Easyflow Duo are single-use, non-toxic, non-pyrogenic fluid path devices and supplied sterile and individually packaged.
The Easyflow & Easyflow Duo are composed of the cannula and a malleable obturator inserted into the cannula to allow the placement of the cannula along the Artery.
The cannula is an open lumen PVC polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated with multiple holes at multiple stages to allow fluid flow. The clear proximal section is not reinforced to allow clamping; the proximal end terminates in a 3/8" barbed connector for standard cardiopulmonary bypass tubing
In the Easyflow Duo models the device has a 0.035" hole punched in the very distal tip of the cannula and the obturator has an approx. 0.035" internal diameter central lumen to accommodate a 0.035" guide wire used to drive the cannula along the vessel till its final placement. Once the cannula is positioned onto the vessel the surgeon removes the obturator from the cannula tubing and connects it to the arterial line.
The Easyflow is packaged as sterile stand-alone device while the Easyflow Duo is packaged into a tray containing also a Guidewire, a Needle and Vascular Dilators in order to have a kit for vascular access packaged together with the cannula.
The Easyflow & Easyflow Duo are the modified version of the disposables currently marketed as the Easyflow cannula (K060101) and the Easyflow Duo cannula (K091542). Both modified and unmodified cannulae models are recommended for use as an arterial return cannula during cardiopulmonary bypass up to six hours
Page 7
V. Indications for Use
The EasyFlow Aortic Cannula is intended for use in the perfusion of the aorta during cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass for up to 6 hours
The EasyFlow Duo Cannula with guidewire is intended for use with cardiopulmonary bypass as an arterial return femoral cannula for up to 6 hours
VI. Summary of Technical Characteristics
The Easyflow & Easyflow Duo have the same fundamental technological characteristics, principles of operation and control mechanisms as the unmodified devices.
The PVC materials of the body, tip and suture ring/ ring stop of the Easyflow & Easyflow Duo were changed within the modified Easyflow & Easyflow Duo in order to remove the phthalates (DEHP and DnHP) used as plasticizers currently present in the device.
No other design changes have been made to the devices.
The devices are ethylene oxide sterilized and have a non-pyrogenic fluid path. They are for single use only.
VII. Non-Clinical Performance Data
Livanova USA Inc. has conducted extensive verification and validation testing of the Easyflow & Easyflow Duo cannula.
The devices passed all the testing in accordance with national and international standards.
In particular, the performed tests are the following:
| TEST CLASSIFICATION | TEST DESCRIPTION |
|---|---|
| Verification/Validation | Visual inspection |
| Verification/Validation | Connector testing 180° pull test |
| Verification/Validation | Cannula clamp test |
| Verification/Validation | Blood pathway integrity |
| Verification/Validation | Flow rate and pressure drop through cannulae |
| Verification/Validation | Cannula kink test |
| Verification/Validation | Label legibility |
| Verification/Validation | Drainage cannula collapse resistance |
| Verification/Validation | Cannula integrity |
| Verification/Validation | Pull strength |
| Verification/Validation | Blood trauma characterization test |
| Biocompatibility | Cytotoxicity |
| Biocompatibility | Intracutaneous reactivity |
| Biocompatibility | Sensitization |
| Biocompatibility | Systemic Toxicity |
| Biocompatibility | Pyrogenicity (material mediated) |
| Biocompatibility | Hemocompatibility (Hemolysis, Coagulation, Complement activation, Platelet and Leukocyte count assay) |
| Biocompatibility | Genotoxicity (Mutation Assay, Mouse lymphoma) |
Page 8
VIII. Clinical Performance Data
No clinical testing was conducted in support of the Easyflow & Easyflow Duo, as the indications for use and technical characteristics are equivalent to those of the predicate devices, which have been on the market for several years with proven safety and efficacy of use. The non-clinical testing summarized in this submission supports the substantial equivalence of the subject devices with the predicate devices when used according to their intended use.
IX. Statement of Substantial Equivalence
Based on equivalent intended use and technological the Easyflow & Easyflow Duo can be deemed to be substantially equivalent to their predicate devices:
The Easyflow & Easyflow Duo, as designed and manufactured, do not raise new questions regarding safety and effectiveness as compared to their predicate devices and are determined to be substantially equivalent to their predicate devices listed above.