MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM

K012898 · Cobe Cardiovascular, Inc. · DTR · Sep 17, 2001 · Cardiovascular

Device Facts

• Record ID: K012898
• Device Name: MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM
• Applicant: Cobe Cardiovascular, Inc.
• Product Code: DTR · Cardiovascular
• Decision Date: Sep 17, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4240
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CSC14 Blood Cardioplegia System is intended to mix, cool, warm, and deliver oxygenated blood and cardioplegic solution for periods of up to six hours. The device also allows monitoring of temperature and pressure, traps bubbles, and allows for air removal. Blood and cardioplegic solution are delivered to the patient by a 100% occlusive roller pump through the extension line and appropriate cannula.

Device Story

The CSC14 Blood Cardioplegia System is a sterile, single-use heat exchanger used during cardiopulmonary bypass. It receives oxygenated blood and cardioplegic solution, which it mixes, cools, or warms before delivery to the patient. The device features an integral bubble trap for air removal and ports for monitoring temperature and pressure. It is operated by a perfusionist or clinician in a clinical setting, utilizing a 100% occlusive roller pump to drive the fluid through extension lines and a cannula. The device assists in maintaining myocardial protection during surgery by precisely controlling the temperature and composition of the cardioplegic solution delivered to the heart.

Clinical Evidence

Bench testing only. In-vitro studies evaluated heat exchanger efficiency, pressure drop, priming volume, device integrity, connection integrity, sterile barrier integrity, and blood trauma to demonstrate equivalence to the predicate device.

Technological Characteristics

Sterile, single-use heat exchanger with integral bubble trap and tubing. Fluid pathways are non-pyrogenic. Operates via heat exchange principle for blood/cardioplegic solution temperature control. No software or electronic components described.

Indications for Use

Indicated for mixing, cooling, warming, and delivering oxygenated blood and cardioplegic solution to patients during cardiopulmonary bypass procedures for up to 6 hours.

Regulatory Classification

Identification

A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.

Predicate Devices

• SORIN BCD Vanguard Blood Cardioplegia System (K934847)

Submission Summary (Full Text)

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Special 510(k)-Device Modification: CSC14 Blood Cardioplegia System

K012898

19

# SEP 1 7 2001

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

510(k) Summary

14401 W. 65th Wav Arvada, CO 80004

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

DATE PREPARED: August 27, 2001

DEVICE TRADE NAME: CSC14 Blood Cardioplegia System

COMMON/USUAL NAME: Cardioplegia Heat Exchanger

CLASSIFICATION NAME: Cardiopulmonary Bypass Blood Heat Exchanger

#### PREDICATE DEVICE: SORIN BCD Vanguard Blood Cardioplegia System, #K934847

### DEVICE DESCRIPTION:

The CSC14 Blood Cardioplegia System is a sterile device with non-pvrogenic fluid pathways. for single use only, and is not to be resterilized by the user. The device is a heat exchanger with integral bubble trap and various tubing configurations.

### INDICATIONS FOR USE

The CSC14 Blood Cardioplegia System is intended to mix, cool, warm, and deliver oxygenated blood and cardioplegic solution for up to 6 hours. The device also allows monitoring of temperature and pressure, traps bubbles, and allows for air removal. Blood and cardioplegic solution are delivered to the patient by a 100% occlusive roller pump through the extension line and appropriate cannula.

### STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The CSC14 Blood Cardioplegia System is identical to the SORIN BCD Vanguard Blood Cardioplegia System (K934847) in intended use, method of operation, and fundamental scientific technology. The two devices differ in the geometry and features of the integral bubble trap.

### TESTING TO DETERMINE SUBSTANTIAL EQUIVALENCE

In-vitro tests were performed to demonstrate that the CSC14 Blood Cardioplegia System described in this submission is substantially equivalent to the SORIN CSC 14 Blood Cardioplegia System (K934847). In-vitro testing consisted of heat exchanger efficiency, pressure drop, priming volume, device integrity, connections integrity, sterile barrier integrity, and blood trauma.

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Image /page/1/Picture/1 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 a stylized image of three birds in flight, arranged in a stacked formation.

Public Health Service

SEP 1 7 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lynne Leonard Sr. Regulatory Affairs Manager COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, CO 8004-3599

Re: K012898

> CSC14 Blood Cardioplegia System Regulation Number: 21 CFR 870.4240 Regulation Name: Cardiopulmonary Bypass Heat Exchangers Regulatory Class: II Product Code: DTR Dated: August 28, 2001 Received: August 29, 2001

Dear Ms. 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.

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

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Page 2 - Ms. Lynne Leonard

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quanty by became (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) I mis letter will and w you'll finding of substantial equivalence of your device to a legally prematicate 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 If you desire specific ad 100 for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Far 8586. Additionally, for questions on the promotion and advertising of Compliance at [phone]. I fine of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation entitled, "Thisolanang oresponsibilities under the Act may be obtained from the Outcr general miormation on your respational 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,

signature

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

Enclosure

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#### Indications For Use

510(k) Number (If known): KOL2898

CSC14 Blood Cardioplegia System Device Name:

Indications For Use:

The CSC14 Blood Cardioplegia System is intended to mix, cool, warm, and deliver oxygenated blood and cardioplegic solution for periods of up to six hours. The device also allows monitoring of temperature and pressure, traps bubbles, and allows for air removal. Blood and cardioplegic solution are delivered to the patient by a 100% occlusive roller pump through the extension line and appropriate cannula.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Cardiovascular & Respiratory Devices 510(k) Number Loud 9 K

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

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