MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula
Device Facts
| Record ID | K251258 |
|---|---|
| Device Name | MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula |
| Applicant | Medtronic, Inc. |
| Product Code | DWF · Cardiovascular |
| Decision Date | Jun 20, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4210 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
This cannula is intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery up to six hours or less.
Device Story
MC2™ Two-Stage and MC2X™ Three-Stage Venous Cannulae are single-use, wire-wound PVC devices used during cardiopulmonary bypass surgery. Cannulae feature side ports in the distal tip and a ported atrial basket for venous drainage. Insertion depth marks assist clinicians in positioning. Devices are inserted into the right atrium and inferior vena cava to facilitate blood drainage to the bypass circuit. Operation is manual; performed by surgeons or perfusionists in an OR setting. Output is the physical drainage of venous blood. Benefits include effective venous return during bypass procedures. Modification involves a change in cannula body material formulation.
Clinical Evidence
No clinical data. Evidence consists of pre-clinical bench testing, including functional performance (occluder removal, vacuum collapse, kink, pressure integrity, tensile strength), blood trauma (hemolysis, plasma-free hemoglobin, cell reduction), and comprehensive biocompatibility testing (cytotoxicity, sensitization, irritation, pyrogenicity, systemic toxicity, complement activation, PTT). Testing was performed on both accelerated and real-time aged samples to confirm shelf-life stability.
Technological Characteristics
Wire-wound PVC body; ported atrial basket; 3/8-inch to 1/2-inch connection site; ~15.25 inch length. Sterilized via ethylene oxide. Single-use. Material formulation change implemented compared to predicate.
Indications for Use
Indicated for patients undergoing cardiopulmonary bypass surgery requiring venous drainage via the right atrium and inferior vena cava for up to six hours.
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
- MC2™ Two-Stage Venous Cannula, MC2X™ Three-Stage Venous Cannula (K140165)
Related Devices
- K140165 — MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE · Medtronic, Inc. · May 20, 2014
- K052372 — MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C · Medtronic Perfusion Systems · Sep 22, 2005
- K031776 — MC2X MULTI-STAGE VENOUS CANNULA · Medtronic Perfusion Systems · Jul 25, 2003
- K253671 — Dual Stage Venous Cannulae · Sorin Group Italia S.R.L. · Jan 30, 2026
- K080034 — THREE STAGE VENOUS RETURN CANNULA, MODEL 816460 · Terumo Cardiovascular Systems Corp. · Jun 17, 2008
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
June 20, 2025
Medtronic, Inc
Stephen Beier
Senior Principal Regulatory Affairs Specialist
8200 Coral Sea Street NE
Mounds View, Minnesota 55112
Re: K251258
Trade/Device Name: MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula
Regulation Number: 21 CFR 870.4210
Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, Or Tubing
Regulatory Class: Class II
Product Code: DWF
Dated: April 23, 2025
Received: April 23, 2025
Dear Stephen Beier:
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}
K251258 - Stephen Beier
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}
K251258 - Stephen Beier
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
{3}
FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740
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) K251258 | |
| Device Name MC2™ Two-Stage Venous Cannula MC2X™ Three-Stage Venous Cannula | |
| Indications for Use (Describe) This cannula is intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery up to six hours or less. | |
| 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}
Pre-market Notification 510(k) K251258
# 510(k) Summary of Safety and Effectiveness
Date Prepared: June 20, 2025
Applicant: Medtronic, Inc.
Medtronic Perfusion Systems
7611 Northland Drive
Minneapolis, MN 55428
Establish Registration Number: 2184009
Contact Person: Stephen Beier, RAC
Senior Principal Regulatory Affairs Specialist
Email: stephen.beier2@medtronic.com
Diane Howell (Alternate)
Regulatory Affairs Manager
Email: diane.d.howell@medtronic.com
Trade Name: MC2™ Two-Stage Venous Cannula
MC2X™ Three-Stage Venous Cannula
Device Name: Catheter, cannula and tubing, vascular, cardiopulmonary bypass
Regulation Description: Cardiopulmonary bypass vascular catheter, cannula, or tubing
Classification: Class II
Regulation Number: 21 CFR 870.4210
Product Code: DWF
Predicate Device: MC2™ Two-Stage Venous Cannula, MC2X™ Three-Stage Venous Cannula (K140165)
## Device Description:
The MC2™ Two-Stage Venous Cannula and MC2X™ Three-Stage Venous Cannula models feature wire wound polyvinyl chloride (PVC) bodies with side ports in the distal tip, a ported atrial basket drainage site located along the length of the cannula body, and a 3/8-inch (0.95 cm) to 1/2-inch (1.27 cm) connection site. The overall length of each cannula body is approximately 15¼ inch (38.7 cm). Insertion depth marks are provided to aid in positioning of the cannula. Each cannula is nonpyrogenic, is intended for single use, and has been sterilized using ethylene oxide.
{5}
Pre-market Notification 510(k) K251258
## Indications for Use:
This cannula is intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery up to six hours or less.
## Substantial Equivalence:
The design, principles of operation, and fundamental scientific technology of the modified MC2™ Two-Stage Venous Cannula and MC2X™ Three-Stage Venous Cannula models were found to be substantially equivalent to the predicate device, MC2™ Two-Stage Venous Cannula and MC2X™ Three-Stage Venous Cannula, previously cleared in K140165.
## Comparison to Predicate:
A comparison of the MC2™ Two-Stage Venous Cannula and MC2X™ Three-Stage Venous Cannula to the predicate device indicates the following similarities:
- Same intended use
- Equivalent labeling
- Equivalent technological characteristics
- Same operating principle
- Same design features
- Same sterilization requirements, methods, and parameters
- Same shelf-life
- Same packaging materials and configuration
- Similar materials of construction
The following device modification was made to the predicate device:
- Cannula body material formulation change
## Summary of Performance Data
Pre-clinical bench testing was used to verify the performance characteristics of this device with the material formulation change. Testing was also conducted on aged samples to confirm that the changed cannula body material did not have an impact on cannula shelf life. Testing was conducted under both accelerated as well as real time conditions. Design outputs demonstrated conformance to the design input requirements defined in the testing protocol.
{6}
Pre-market Notification 510(k) K251258
The following tests, including functional performance testing, blood trauma testing, and biocompatibility testing, were conducted to support the material formulation change.
| Performance Testing |
| --- |
| Occluder Removal Testing, Vacuum Collapse Testing, Ink Adhesion Testing, Kink Under Bend Testing, Pressure Integrity Testing, Clamp Leak Rate and Clamp Site Drainage Testing, and Tensile Strength Testing (including Body-to-Connector Bond Strength and Strength of Bonds within Cannula Body) |
| Blood Trauma Testing |
| Plasma-free Hemoglobin Testing, White Blood Cell Reduction and Platelet Reduction Testing, and Hemolysis Testing |
| Biocompatibility Testing |
| Chemical Characterization and Toxicological Risk Assessment, Cytotoxicity Testing, Sensitization Testing, Intracutaneous Irritation Testing, In Vitro Skin Irritation Assay Testing, Material Mediated Pyrogenicity Testing, Acute Systemic Toxicity Testing, Hemolysis Assay Testing – Direct Contact and Extract Method, Complement Activation Assay Testing, Partial Thromboplastin Time (PTT) Testing, and Platelet and Leukocyte Count Testing |
Conclusion:
The data included in this submission are sufficient to demonstrate that the modified MC2™ Two-Stage Venous Cannula and MC2X™ Three-Stage Venous Cannula are substantially equivalent to the predicate device, MC2™ Two-Stage Venous Cannula and MC2X™ Three-Stage Venous Cannula (K140165) and does not raise new questions of safety or effectiveness.
