SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM

K012763 · Cobe Cardiovascular, Inc. · DRT · Nov 15, 2001 · Cardiovascular

Device Facts

• Record ID: K012763
• Device Name: SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
• Applicant: Cobe Cardiovascular, Inc.
• Product Code: DRT · Cardiovascular
• Decision Date: Nov 15, 2001
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sorin Biomedica SMAR T® BCD Vanguard™ Surface Modified Blood Cardioplegia System is intended to mix, cool, warm, and deliver oxygenated blood and cardioplegic solution for periods up to 6 hours. The device allows monitoring of temperature and pressure, traps bubbles, and removes air. Blood and cardioplegic solution are delivered to the patient by a 100% occlusive roller pump, through the extension line and appropriate cannula.

Device Story

Cardioplegia heat exchanger with integral bubble trap; used during cardiopulmonary bypass. Inputs: oxygenated blood and cardioplegic solution. Device mixes, cools, or warms fluids; traps bubbles; removes air via hydrophobic membrane; monitors temperature and pressure via integrated ports. Output: temperature-controlled, air-free cardioplegic solution delivered to patient via 100% occlusive roller pump and cannula. Used in surgical settings by perfusionists/surgeons. Surface-modifying material added to blood contact assembly to improve blood compatibility. Pressure relief valve prevents over-pressurization. Benefits: maintains myocardial protection during surgery; reduces blood trauma.

Clinical Evidence

Bench testing only. In-vitro studies performed: stability of surface-modifying material, elution, blood compatibility, heat exchanger efficiency, priming volume, blood pathway pressure drop, blood pathway integrity, ease of prime, blood trauma (platelet depletion, white blood cell depletion, plasma free hemoglobin generation), and connection integrity.

Technological Characteristics

Cardiopulmonary bypass heat exchanger. Features hydrophobic membrane, one-way valve, pressure relief valve, filter screen, temperature monitoring port, and pressure monitoring port. Includes surface-modifying material on blood contact surfaces to enhance biocompatibility. Single-use, nonpyrogenic fluid pathways. Operates with 100% occlusive roller pump.

Indications for Use

Indicated for patients requiring extracorporeal circulation during surgical procedures where mixing, cooling, warming, and delivery of oxygenated blood and cardioplegic solution are necessary for up to 6 hours.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

• SORIN Biomedica BCD Vanguard™ Blood Cardioplegia System

Submission Summary (Full Text)

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510(k) Pre-Market Notification: SMAR,T® BCD Vanguard™ Blood Cardioplegia System COBE Cardiovascular, Inc.

NOV 1 5 2001

K012763

### 510(k) Summary

| SUBMITTER: | COBE Cardiovascular, Inc. |
|------------|---------------------------|
| | 14401 W. 65th Way |
| | Arvada, CO 80004 |

Lynne Leonard CONTACT PERSON: Phone:[phone] Fax: [phone]

August 16, 2001 DATE PREPARED:

SORIN Biomedica SMARŢT® BCD Vanguard™ DEVICE TRADE NAME: Surface Modified Blood Cardioplegia System

COMMON/USUAL NAME: Cardioplegia Heat Exchanger

CLASSIFICATION NAME: Cardiopulmonary Bypass Heat Exchanger

SORIN Biomedica BCD Vanguard™ PREDICATE DEVICE: Blood Cardioplegia System

DEVICE DESCRIPTION AND INTENDED USE:

The SMAR T BCD Vanguard is a cardioplegia heat exchanger with integral bubble trap, r he only സ്റ്റ് ഇയ varigurations connected to the heat exchanger available with various tudifying material has been added to the primary blood contact assembly. 71 Junate mostlying to improve the blood compatibility of the device. The sundocs of the mout oxehanger seide, is for single use only, and has nonpyrogenic fluid pathways.

The heat exchanger assembly (heat exchanger with bubble trap) contains a hydrophobic membrane, a one-way valve, a pressure relief valve, a filter screen, a nyarophobio monitoring port and a pressure monitoring port. The housing is designed such that air entering the device rises to the membrane and is vented to the atmosphere. The one-way valve keeps air from entering the device. The pressure relief valve is designed to relieve excess pressure in the event of outlet line clamping, and has tubing attached to it to vent the solution to the cardiotomy reservoir. The temperature monitoring port is used to measure the temperature of the blood cardioplegia mixture, and the pressure monitoring line is connected to either a pressure manometer or a transducer to measure pressure.

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#### INDICATIONS FOR USE

The SMAR, T® BCD Vanguard™ Surface Modified Blood Cardioplegia System is intended to mix, cool, warm, and deliver oxygenated blood and cardioplegic solution for intended to mix, 600, warm, and avice also allows monitoring of temperature and penous of up to ox hes, and removes air. Blood and cardioplegic solution are pressure, traps bubbloo, and rene 100% occlusive roller pump, through the extension line and appropriate cannula.

# STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The SMAR T® BCD Vanguard™ Surface Modified Blood Cardioplegia System has the The OMARY I - BOD Vanguard - Sanaco Vanguard™ Blood Cardioplegia System. The Same intended use as the OOTIN - BCD Vanguard" contains a surface-modifying two uction in that 17 the Stibility; and 2) SMAR, T Surface Modified Tubing and matehal to improve blood compatibled for various tubing and connectors within the circuit configurations. Otherwise, materials, components, design, sterilization and manufacturing processes for the two devices are the same.

Biocompatibility testing and in-vitro testing were performed to demonstrate that the Dioompanbilly tooling and Surface Modified Blood Cardioplegia System is substantially equivalent to the currently marketed BCD Vanguard™ Blood Cardioplegia System.

In-vitro testing consisted of:

- 1. Stability testing, surface-modifying material
- Surface-modifying material elution 2
- Surface-modifying material blood compatibility 3.
- Heat exchanger efficiency 4.
- Priming volume 5.
- Blood pathway pressure drop 6.
- 7. Blood pathway integrity
- Ease of prime 8.
- Blood trauma (including platelet depletion, white blood cell depletion, and 9. plasma free hemoglobin generation)
- 10. Connection integrity

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized graphic of three wavy lines, resembling an abstract human figure or a bird in flight. The logo is black and white.

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

## NOV 1 5 2001

Mr. Lynne Leonard Sr. Regulatory Affairs Manager COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, CO 80004-3599

Re: K012763

Trade Name: Sorin Biomedica SMAR T BCD Vanguard Surface Modified Blood Cardioplegia System Regulation Number: 21 CFR 870.4240 Regulation Name: Cardiopulmonary bypass heat exchanger. Regulatory Class: Class II (two) Product Code: DRT Dated: August 16, 2001 Received: August 17, 2001

Dear Mr. Leonard:

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 - Mr. Lynne Leonard

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

James F. Dillard III

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## NOV 1 5 2001

Indications For Use

510(k) Number (If known):

K012763

Sorin Biomedica SMAR T® BCD Vanguard™ Surface Modified Blood Cardioplegia System Device Name:

Indications For Use:

The Sorin Biomedica SMAR T® BCD Vanguard" Surface Modified Blood Cardioplegia System is The Sorin Biomedica SMAR, I - BCD Vanguard blood and cardioplegic solution for periods up
intended to mix, cool, warm, and deliver oxygenated blood areas bubbles, and removes intended to mix, cool, warm, and deliver oxygenator bround transmont of the bubbles, and removes
to 6 hours. The device allows monitoring of temperature, a 100% occursive ro to 6 hours. The device anows momoring of temporature and processor of 100% occlusive roller pump,
air. Blood and cardioplegic solution are delivered to the patient by a 100 an . Drood and extension line and appropriate cannula.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Re
510(k) Number 2012763

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________