Thoratec CentriMag Drainage (Venous) Cannula Kit

K152190 · Thoratec Corporation · DWF · Sep 18, 2015 · Cardiovascular

Device Facts

• Record ID: K152190
• Device Name: Thoratec CentriMag Drainage (Venous) Cannula Kit
• Applicant: Thoratec Corporation
• Product Code: DWF · Cardiovascular
• Decision Date: Sep 18, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CentriMag Cannulae are designed to serve as conduits to transport blood between the heart and the extracorporeal blood pump. The Cannulae are intended for use for circulatory support during cardiac surgery for cardiopulmonary surgical procedures for up to six hours.

Device Story

The Thoratec CentriMag Drainage (Venous) Cannula Kit is a sterile, single-use, disposable device designed to transport blood between the heart and the Thoratec CentriMag Extracorporeal Blood Pumping System. Used during cardiac surgery, the cannula acts as a conduit for extracorporeal circulatory support. The kit includes the cannula body, a 3/8-inch barbed connector, apical sewing ring with umbilical tape, handle, cap, support cuff, and suture rings. The device is placed surgically by a physician. The modification improves the connection reliability between the connector and the cannula body. The device facilitates blood flow to the extracorporeal pump, supporting the patient's circulatory system during surgical procedures.

Clinical Evidence

No clinical data. Substantial equivalence was demonstrated through bench testing, including flex, tensile strength, chemical resistance, pressure, and suture ring security/deformation tests. Materials were evaluated for chemical characterization and biocompatibility. Testing included 2x sterilized, accelerated-aged devices simulating 1-year real-time, and 30-day heated saline soak.

Technological Characteristics

Sterile, single-use, disposable venous cannula kit. Components include cannula body, barbed connector, apical sewing ring, and support cuff. Mechanical design features improved connector-to-cannula body interface. Biocompatible materials. No electronic or software components.

Indications for Use

Indicated for use with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours during cardiac surgery.

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

• Thoratec CentriMag Drainage Cannula Kit (K110983)

Reference Devices

• Thoratec CentriMag Extracorporeal Blood Pumping System (K020271)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three overlapping profiles facing right, with flowing lines suggesting movement or connection. The profiles are rendered in a single color, creating a unified and recognizable emblem.

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

Thoratec Corporation Lori DonDiego Senior Manager, Regulatory Affairs 6035 Stoneridge Drive Pleasanton, VA 94588

Re: K152190

Trade/Device Name: Thoratec CentriMag Drainage (Venous) Cannula Kit Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Vascular Catheter, Cannula, or Tubing Regulatory Class: Class II Product Code: DWF Dated: August 31, 2015 Received: September 2, 2015

Dear Ms. DonDiego:

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 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

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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.

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 yours.

M.A. Willehemen

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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# 4.0 Indications for Use Statement

| Applicant: | Thoratec Corporation |
|---------------------------|---------------------------------------------------|
| 510(k) Number (if known): | K152190 |
| Device Name: | Thoratec CentriMag® Drainage (Venous) Cannula Kit |

# Indications for Use:

The CentriMag Drainage (Venous) Cannula is indicated for use 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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# 5.0 510(k) Summary

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: | July 31, 2015 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Name & Address: | Thoratec Corporation<br>6035 Stoneridge Drive<br>Pleasanton, CA 94588<br>Establishment Registration No.: 2916596<br>Owner / Operator No.: 9045196 |
| Contact Person: | Lori DonDiego<br>Sr. Manager, Regulatory Affairs<br><br>Ph: 925-734-6921<br>Fax: [phone]<br><br>Thoratec Corporation<br>6035 Stoneridge Drive<br>Pleasanton, CA 94588 |
| Device Information | |
| Trade or Proprietary Name: | CentriMag Drainage (Venous) Cannula Kit |
| Common or Usual Name: | Cardiopulmonary bypass cannula |
| Classification Name: | Cardiovascular bypass vascular catheter,<br>cannula, or tubing (DWF, 21 CFR –<br>870.4210), Class II |
| Performance Standard: | Performance standards do not currently |

Performance standards do not currently exist for these devices. None established under section 514 of the Food, Drug and Cosmetic Act.

## C. Legally Marketed Predicate Device

Thoratec CentriMag Drainage Cannula Kit (K110983)

B.

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## Device Description D.

The Thoratec CentriMag® Drainage (Venous) Cannula Kit consists of the drainage (venous) cannula and several accessories used in the surgical placement procedure. The cannula and all kit its accessories are sterile, singleuse, disposable devices. The cannula kit is designed for use with the Thoratec CentriMag® Extracorporeal Blood Pumping System (K020271).

The Drainage Cannula Kit includes the following accessories:

| QTY | Kit Component |
|-----|----------------------------------------|
| 1 | Drainage (Venous) Cannula Body |
| 1 | Connector, 3/8-inch, barbed |
| 1 | Apical Sewing Ring with Umbilical Tape |
| 1 | Apical Sewing Ring Handle |
| 1 | Cap (with Umbilical Tape) |
| 1 | Apical Support Cuff |
| 4 | Suture Rings (large) |
| 4 | Suture Rings (medium) |

# E. Intended Use

The CentriMag Cannulae are designed to serve as conduits to transport blood between the heart and the extracorporeal blood pump. The Cannulae are intended for use for circulatory support during cardiac surgery for cardiopulmonary surgical procedures for up to six hours.

# ட் Technological Characteristics

The technological characteristics of the modified CentriMag Drainage (Venous) Cannula Kit are the same as the predicate device.

# G. Comparison to Predicate Device

The modified CentriMag Drainage (Venous) Cannula Kit has the same indication for use, technological characteristics, and performance attributes which essentially renders the modified device equivalent to the predicate device. Moreover, the new device raises no new questions concerning safety or effectiveness. The modification improves upon the reliability of the connection between the connector and the cannula body.

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## Summary of Performance Data H.

The modified CentriMag Drainage (Venous) Cannula Kit has successfully undergone performance testing to demonstrate substantial equivalence to the predicate device.

The following performance and functional verification tests have been conducted on the redesigned cannula with successful results:

- Flex Test ●
- Tensile Strength Test ●
- Chemical Resistance Test ●
- Pressure Test ●
- Suture Ring and Apical Sewing Ring Security and Deformation Test
- Dimensional Verification Examination ●
- Cannula Body Material Examination ●

All testing employed devices that were exposed to 2x sterilized, acceleratedaging to simulate a real-time equivalent of 1-year, and heated saline soak for 30days.

Additional verification involved materials evaluation for chemical characterization and biocompatibility to address raw material supplier changes. Lastly, a reduced confirmatory microbiological performance qualification revalidation) was conducted.

The risk management methods used to assess the design modifications to the CentriMag Drainage (Venous) Cannula were a Risk Analysis and a Failure Modes and Effects Analysis (FMEA).

## l. Clinical Performance

Clinical testing was not performed.

## J. Conclusion

The redesigned CentriMag Drainage (Venous) Cannula Kit is substantially equivalent to the current CentriMag Drainage Cannula Kit (K110983).