MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE

K140165 · Medtronic, Inc. · DWF · May 20, 2014 · Cardiovascular

Device Facts

• Record ID: K140165
• Device Name: MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE
• Applicant: Medtronic, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: May 20, 2014
• 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

Multi-Stage Venous Cannula product family (MC2 Two-Stage, OVAL MC2, Thin Wall Two-Stage, MC2X Three-Stage) facilitates venous drainage during cardiopulmonary bypass surgery. Device consists of wire-wound PVC body, side ports in distal tip, and ported atrial basket. Cannula inserted into right atrium and inferior vena cava; provides drainage path for blood to bypass machine. Used in surgical setting by medical professionals. Insertion depth marks assist in positioning. Sterile, non-pyrogenic, disposable device.

Clinical Evidence

Bench testing only. Performance testing included kink/bend, collapse under negative pressure, and tensile strength/pull. Biocompatibility testing performed per EN ISO 10993-1.

Technological Characteristics

Wire-wound PVC body; stainless steel components; side ports in distal tip; ported atrial basket; 3/8 inch to 1/2 inch connection site; 38.7cm length; sterile, non-pyrogenic, disposable. Biocompatibility per EN ISO 10993-1.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery requiring venous drainage via the right atrium and inferior vena cava simultaneously for a duration of six hours or less.

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

• MC2X Multi-Stage Venous Cannula (K052372)
• DLP Single Stage Venous Cannula (K120988)

Submission Summary (Full Text)

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510(k) Summary

K140165

MAY 2 0 2014

Date Prepared:

Submitter:

Medtronic, Inc. Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428

January 17, 2014

Establishment Registration Number: 2184009

Contact Person:

Jacqueline A. Hauge Senior Regulatory Affairs Specialist Medtronic Perfusion Systems Phone: [phone].367.8360 Fax: Email: [e-mail]

Alternate Contact: Susan C. Fidler Senior Regulatory Affairs Manager Medtronic Perfusion Systems Phone: [phone] Fax: [phone] Email: [e-mail]

## Device Name and Classification

| Trade Name: | MC2™ Two-Stage Venous Cannula<br>OVAL MC2™ Two-Stage Venous Cannula<br>Thin Wall Two-Stage Venous Cannula<br>MC2X™ Three-Stage Venous Cannula |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula, or tubing |
| Regulation Number: | 870.4210 |
| Product Code: | DWF |
| Product Classification: | Class II |

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## Predicate Devices

1

MC2XTM Multi-Stage Venous Cannula K052372 DLPTM Single Stage Venous Cannula K120988

## Device Description

The Multi-Stage Venous Cannula product family includes the MC2" Two-Stage Venous Cannula, OVAL MC2™ Two-Stage Venous Cannula, Thin Wall Two-Stage Venous Cannula, and MC2X " Three-Stage Venous Cannula configurations. All Multi-Stage Venous Cannula configurations feature a wire wound polyvinyl chloride (PVC) body with side ports in the distal tip, a ported atrial basket, and a % inch (0.95cm) - ½ inch (1.27cm) connection site. The overall length of each cannula is approximately 15% inch (38.7cm). Insertion depth marks are provided to aid in positioning of the cannula during the surgical procedure. These cannulae are sterile, non-pyrogenic, disposable medical devices.

## 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.

## Comparison to Predicate Devices

A comparison of the modified Multi-Stage Venous Cannula product to the currently marketed predicate products (K052372 and K120988) indicates the following similarities:

- Same intended use .
- . Same technological characteristics
- 에 Same operating principle
- l Same design features
- . Same base materials (Polyvinyl Chloride (PVC), Stainless Steel)
- I Same shelf life

## Summary of Performance and Biological Testing

Medtronic conducted the following performance testing for the modified Multi-Stage Venous Cannula product:

. Kink / Bend . Collapse under negative pressure · Tensile strength / Pull Additionally, biocompatibility testing was performed in accordance with EN ISO 10993-1 Biological evaluation of medical devices –Part 1: Evaluation and testing within a risk management process. Performance and biological tests confirm that the modified Multi-Stage Venous Cannula product met pre-determined acceptance criteria and is substantially equivalent to the predicate device.

## Conclusion

Medtronic has demonstrated that the modifications made to the Multi-Stage Venous Cannula product family described in this submission result in a substantially equivalent device because the fundamental scientific principle, operating principle, design features and intended use are unchanged from the predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

#### May 20, 2014

Medtronic, Inc. Medtronic Perfusion Systems Jacqueline A. Hauge Senior Regulatory Affairs Specialist 7611 Northland Drive Minneapolis, MN 55428

Re: K140165

Trade/Device Name: MC2TM Two-Stage Venous Cannula OVAL MC2™ Two-Stage Venous Cannula Thin Wall Two-Stage Venous Cannula MC2XTM 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: February 17, 2014 Received: February 19, 2014

Dear Ms. Hauge:

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. 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.

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 - Jacqueline A. Hauge

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

.ポイ

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

M

for 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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|-----------------------------------------|--------------|
| Food and Drug Administration | |
| Indications for Use | Form Appro |
| | Expiration C |
| | See PRA S |

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### 510(k) Number (if known).

### K140165

Device Name MC27M Two-Stage Venous Cannula

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## Indications for Use (Describe)

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2017 11:12:12

Type of Use (Select one or both, as applicable) 1 80 - 60 [2] Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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