← Product Code [DWF](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF) · K110983 # CENTRIMAG DRAINAGE CANNULA KIT (K110983) _Levitronix, LLC · DWF · Jun 20, 2011 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K110983 ## Device Facts - **Applicant:** Levitronix, LLC - **Product Code:** [DWF](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF.md) - **Decision Date:** Jun 20, 2011 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.4210 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## 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. ## 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. ## Regulatory 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](/device/K870109.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # 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 | | | | | | | | | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|--------------------------------|-----------------------------|--------------------------------------------------------|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------| | |
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: (781) 466-6553
Fax: (781) 622-5090
e-mail: Isakakeeny@levitronix-us.com
| 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: (781) 466-6553
Fax: (781) 622-5090
e-mail: Isakakeeny@levitronix-us.com | | | | 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: (781) 466-6553
Fax: (781) 622-5090
e-mail: Isakakeeny@levitronix-us.com | | | | | | | | | | B. | Device Information | | | | | | | | | | |
Trade or Proprietary Name:CentriMag Drainage Cannula Kit
Common or Usual Name:CentriMag Drainage 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.
| Trade or Proprietary Name: | CentriMag Drainage Cannula Kit | Common or Usual Name: | CentriMag Drainage 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. | | Trade or Proprietary Name: | CentriMag Drainage Cannula Kit | | | | | | | | | | Common or Usual Name: | CentriMag Drainage 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. | | | | | | | | | #### C. Legally Marketed Predicate Device | Levitronix Device | Predicate | Predicate 510(k) | |--------------------------------|-------------------------------------------------|------------------| | CentriMag Drainage Cannula Kit | Edwards Lifesciences
Venous Drainage Cannula | K8701091 | 1 510k originally issued to Research Medical, Inc. {1}------------------------------------------------ #### 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). {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized, curved lines. 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. {3}------------------------------------------------ ## 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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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 {4}------------------------------------------------ ### 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) --- Division Sidn-Off --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K110983](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWF/K110983) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com