Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)

K250610 · Sorin Group Italia S.R.L. · DWF · Jun 27, 2025 · Cardiovascular

Device Facts

• Record ID: K250610
• Device Name: Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)
• Applicant: Sorin Group Italia S.R.L.
• Product Code: DWF · Cardiovascular
• Decision Date: Jun 27, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Easyflow and Easyflow Duo are single-use, sterile, non-pyrogenic cannulae for arterial return during cardiopulmonary bypass. Devices consist of PVC polymer tubes with wire-reinforced distal sections and perforated tips for fluid flow. Easyflow Duo includes a guidewire, needle, and vascular dilators for femoral access; a malleable obturator facilitates vessel placement. During surgery, the surgeon inserts the cannula into the artery, removes the obturator, and connects the proximal 3/8" barbed connector to the arterial line of the bypass circuit. The device facilitates blood flow from the bypass machine to the patient. Modifications from predicate devices include the removal of phthalate plasticizers (DEHP and DnHP) from the PVC material. Devices are intended for use by surgeons in clinical settings.

Clinical Evidence

No clinical testing was conducted. Substantial equivalence is supported by non-clinical performance data, including verification/validation testing (visual inspection, pull strength, kink test, flow rate/pressure drop, blood pathway integrity) and comprehensive biocompatibility testing (cytotoxicity, sensitization, systemic toxicity, hemocompatibility, genotoxicity).

Technological Characteristics

Materials: PVC polymer (phthalate-free). Design: Open lumen tube with wire-reinforced distal sections and multiple perforations. Connectivity: 3/8" barbed connector. Sterilization: Ethylene oxide. Single-use. No electronic or software components.

Indications for Use

Indicated for patients undergoing cardiovascular surgery requiring extracorporeal cardiopulmonary bypass for up to 6 hours. EasyFlow Aortic Cannula is for aortic perfusion; EasyFlow Duo is for arterial return via femoral access.

Regulatory Classification

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.

Predicate Devices

• Easyflow Aortic Cannula (K060101)
• Easyflow Cannula with guidewire (Easyflow Duo) (K091542)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

{1}

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-

{2}

K250610 - Martina Carlini
Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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

{3}

FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services [phone]
EF

| 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 Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "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}

LivaNova
Health innovation that matters

# 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: [phone]
e-mail: [e-mail]

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: [phone]
e-mail: [e-mail]

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

Special 510(k) – Easyflow & Easyflow Duo cannulae

{5}

LivaNova
Health innovation that matters

## 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

Special 510(k) – Easyflow & Easyflow Duo cannulae

{6}

LivaNova
Health innovation that matters

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) |

Special 510(k) – Easyflow & Easyflow Duo cannulae

{7}

LivaNova
Health innovation that matters

## 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 unmodified Easyflow & Easyflow Duo, cleared under K060101 and K091542 respectively;

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.

Special 510(k) – Easyflow & Easyflow Duo cannulae