CENTRIMAG DRAINAGE CANNULA KIT

K110983 · Levitronix, LLC · DWF · Jun 20, 2011 · Cardiovascular

Device Facts

• Record ID: K110983
• Device Name: CENTRIMAG DRAINAGE 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

Indications for Use

The CentriMag Drainage Cannula is intended to be used as a venous drainage cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.

Device Story

The CentriMag Drainage Cannula Kit is a sterile, single-use, disposable venous drainage cannula designed for use within extracorporeal bypass circuits. The kit includes a PVC cannula and various accessories, including a cap, apical sewing ring handle, apical sewing ring, apical support cuff, and stabilizer rings. The device is intended for short-term extracorporeal circulatory support, specifically for periods up to six hours. It functions as a conduit for venous blood drainage during bypass procedures. The device is intended for clinical use by healthcare professionals in settings where extracorporeal circulatory support is required.

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

The device is constructed from Poly Vinyl Chloride (PVC). It is a sterile, single-use, disposable cannula. It functions as a passive venous drainage conduit in an extracorporeal bypass circuit. No software or electronic components are involved.

Indications for Use

Indicated for use as a venous drainage cannula within an extracorporeal bypass circuit for circulatory support for durations 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

• Edwards Lifesciences Venous Drainage Cannula (K870109)

Submission Summary (Full Text)

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# K110983

## 510(k) Summary – Levitronix CentriMag Drainage Cannula Kit

JUN 2 0 2011

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

#### C. Legally Marketed Predicate Device

| Levitronix Device | Predicate | Predicate 510(k) |
|--------------------------------|-------------------------------------------------|------------------|
| CentriMag Drainage Cannula Kit | Edwards Lifesciences<br>Venous Drainage Cannula | K8701091 |

^{1 510}k originally issued to Research Medical, Inc.

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#### D. Device Description

### CentriMag Drainage Cannula Kit

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

- A) One Cap with Tape
B) One Apical Sewing Ring Handle

C) One Apical Sewing Ring

D) One Apical Support Cuff

E) Two Stabilizer Rings - Large

F) Two Stabilizer Rings - Medium

#### ய் Intended Use

The CentriMag Drainage Cannula is intended to be used as a venous drainage cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.

#### F. Comparison to Predicate Device

The CentriMag Drainage Cannula Kit has indications 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 Drainage 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 .

#### ાન. Clinical Performance

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

#### l. Conclusion

The Levitronix CentriMag Drainage Cannula Kit is substantially equivalent to the Edwards Lifesciences Venous Drainage Cannula (K870109).

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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

Re: K110983

CENTRIMAG® Drainage.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 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincefely yours,

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

510(k) Number (if known):

Device Name:

CentriMag Drainage Cannula Kit

110983

### Indications for Use:

The CentriMag Drainage Cannula is intended to be used as a venous drainage 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)

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