CENTRIMAG RETURN CANNULA KIT

K110980 · Levitronix, LLC · DWF · Jun 20, 2011 · Cardiovascular

Device Facts

• Record ID: K110980
• Device Name: CENTRIMAG RETURN CANNULA KIT
• Applicant: Levitronix, LLC
• Product Code: DWF · Cardiovascular
• Decision Date: Jun 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CentriMag Return Cannula is indicated for use as an arterial return cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.

Device Story

The CentriMag Return Cannula Kit is a sterile, single-use, disposable arterial return cannula designed for use within extracorporeal bypass circuits. The kit includes a PVC cannula, obturator, hemostasis seal, cap, porous plug, needle with sheath, guidewire assembly, and various stabilizer rings and tips. The device is intended for short-term extracorporeal circulatory support (up to six hours). It functions as a vascular access component to facilitate blood return during bypass procedures. It is used in clinical settings by healthcare professionals. The device provides a physical conduit for blood flow; it does not involve electronic processing, software, or automated decision-making.

Clinical Evidence

No clinical data was performed for this device. Substantial equivalence was demonstrated through bench testing, including physical testing, sterilization validation, biocompatibility, shelf life, transportation, in vitro hemolysis, and flow versus pressure drop testing.

Technological Characteristics

Materials: Polyvinyl Chloride (PVC). Components: Cannula, obturator, hemostasis seal, cap, porous plug, needle with sheath, guidewire assembly, stabilizer rings, and tip stabilizers. Principle: Passive vascular access/conduit for extracorporeal circulation. Sterilization: Sterile, single-use. Connectivity: None. Software: None.

Indications for Use

Indicated for use as an arterial return cannula in extracorporeal bypass circuits for circulatory support 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

• Medtronic EOPA™ Elongate one-piece Arterial Cannula and Guidewire (K031037)

Submission Summary (Full Text)

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K110980

JUN 2 0 2011

# 510(k) Summary - Levitronix CentriMag Return Cannula Kit

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations, Part 807, and in particular §807.92.

### A. Application Information

B.

Date Prepared: April 6, 2011 Submitter's Name & Address: Levitronix LLC 45 First Avenue Waltham, MA 02451 Contact Person: Lydia Sakakeeny, Ph.D. Regulatory Affairs Specialist Ph: [phone] Fax: [phone] e-mail: [e-mail] Device Information Trade or Proprietary Name: CentriMag Return Cannula Kit Common or Usual Name: CentriMag Return Cannula Kit Classification Name: Catheter, cannula and tubing, vascular, cardiopulmonary bypass (DWF, 870.4210), Class II Performance Standard: Performance standards do not currently exist for these devices. None are established under section 514 of the Food, Drug and Cosmetic Act.

#### ். Legally Marketed Predicate Device

| Levitronix Device | Predicate | Predicate 510(k) |
|------------------------------|---------------------------------------------------------------------------------------------------|------------------|
| CentriMag Return Cannula Kit | Medtronic EOPA™ Elongate<br>one-piece Arterial Cannula<br>and Guidewire (Medtronic<br>EOPA 77722) | K031037 |

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## D. Device Description

## CentriMag Return Cannula Kit

The CentriMag Return Cannula Kit consists of a sterile, single-use, disposable, noncoated, Polyvinyl Chloride (PVC) Cannula and the following accessories:

- A) One Obturator (or Introducer)
- в) One Hemostasis Seal
- c) One Cap
- D) One Porous Plug
- E) One Needle with Sheath
- F) One Guidewire Assembly
- G) Two Stabilizer Rings Medium
- H) Two Stabilizer Rings Small
- 1) Two Tip Stabilizers

### E. Intended Use

The CentriMag Return Cannula is indicated for use as an arterial return cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.

### F. Comparison to Predicate Device

The CentriMag Return Cannula Kit has an indication for use, design features, and functional characteristics which are substantially equivalent to the predicate device. The device raises no new safety or effectiveness issues.

#### G. Summary of Performance Data

The CentriMag Return Cannula Kit has successfully undergone functional testing demonstrating substantial equivalence to the predicate device. The following functional testing was performed. All met pre-established acceptance criteria.

- Physical Testing .
- Sterilization Validation .
- Biocompatibility .
- Shelf Life Studies �
- . Transportation
- . Hemolysis (in vitro)
- . Flow versus Pressure Drop

#### H. Clinical Performance

Clinical testing was not performed for the CentriMag Return Cannula Kit.

### l. Conclusion

The Levitronix CentriMag Return Cannula Kit is substantially equivalent to the Medtronic EOPA™ Elongate one-piece Arterial Cannula and Guidewire (K031037).

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

Levitronix LLC c/o Lydia Sakakeeny, Ph.D. Regulatory Affairs Specialist 45 First Avenue Waltham, MA 02451

JUN 2 0 2011

K110980 Re: CENTRIMAG® Return Cannula Kit Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheters, cannula, or tubing Regulatory Class: Class II (two) Product Code: DWF Dated: April 6, 2011 Received: April 7, 2011

Dear Dr. Sakakeeny:

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 10 eommer of the ride 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your be subject to such 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.

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Page 2 - Lydia Sakakeeny, Ph.D.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be davised that I Dri 3 losaanes or our device complies with other requirements of the Act that I DA has made a colorminations administered by other Federal agencies. You must of any I cucral statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sense and CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (22) regions 531-542 of the Act); 21 CFR 1000-1050. production control provisions (Setians (Seting your device as described in your Section 510(k) I mis icher with anow you to begin maniening of substantial equivalence of your device to a legally premarket notification: "The PDF Internation for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific at not to: 700 - 0200 276-0120. Also, please note the regulation entitled, Conact the Office of Compilance in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your respended Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Brian D. Zuckerman, M.D.

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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# Indications for Use Statement

Applicant:

Levitronix LLC

KITO980

510(k) Number (if known):

Device Name:

CentriMag Return Cannula Kit

# Indications for Use:

The CentriMag Return Cannula is indicated for use as an arterial return cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiov 510(k) Number