COBE SMARXT TUBING AND CONNECTORS

K981613 · Cobe Cardiovascular, Inc. · DWE · Oct 26, 1998 · Cardiovascular

Device Facts

• Record ID: K981613
• Device Name: COBE SMARXT TUBING AND CONNECTORS
• Applicant: Cobe Cardiovascular, Inc.
• Product Code: DWE · Cardiovascular
• Decision Date: Oct 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4390
• Device Class: Class 2

Intended Use

COBE® SMAR,T™ Tubing and Connectors are intended to be used in surgical procedures requiring extracorporeal support for periods of up to six hours.

Device Story

COBE® SMARxT™ Tubing and Connectors are sterile, single-use components for cardiopulmonary bypass circuits. Tubing is polyvinyl chloride (PVC) with a non-leaching, surface-modifying additive to improve blood compatibility. Connectors include straight, reducer, Y-types, luer locks, and monitor connectors. Used in surgical settings by perfusionists or surgical staff to connect oxygenators, reservoirs, and filters. Tubing is cyclically compressed in roller-type blood pumps to facilitate extracorporeal circulation. The device maintains circuit integrity and blood flow during bypass procedures. Benefits include improved blood compatibility compared to standard PVC tubing, reducing potential adverse reactions during extracorporeal support.

Clinical Evidence

Bench testing only. Performance testing included bond strength, static leak tests, rated pressure, kink resistance, tubing pump life, tubing spallation, and saturation/hematocrit connector testing. In-vitro testing demonstrated improved blood compatibility of materials containing the surface-modifying additive.

Technological Characteristics

Polyvinyl chloride (PVC) tubing and connectors. Surface-modifying additive for blood compatibility. Tubing sizes range from 0.075" ID x 0.020" wall to 5/8" ID x 1/8" wall. Single-use, sterile, non-pyrogenic. Mechanical connection via luer locks and various connector geometries.

Indications for Use

Indicated for patients undergoing surgical procedures requiring extracorporeal support for up to six hours.

Regulatory Classification

Identification

A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclically compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit.

Predicate Devices

• COBE® Tubing and Connectors

Submission Summary (Full Text)

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# OCT 26 1998

## 510(k) Summary

| SUBMITTER: | COBE Cardiovascular, Inc.<br>14401 W. 65th Way<br>Arvada, CO 80004 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Lynne Leonard<br>Phone: [phone]<br>Fax: [phone] |
| DATE PREPARED: | August 6, 1998 |
| DEVICE TRADE NAME: | COBE® SMARxT™ Tubing and Connectors |
| COMMON/USUAL NAME: | Cardiopulmonary Bypass Tubing and Connectors |
| CLASSIFICATION NAMES: | Cardiopulmonary Bypass Pump Tubing<br>Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing<br>Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting |
| PREDICATE DEVICE: | COBE® Tubing and Connectors |

### DEVICE DESCRIPTION:

The COBE® SMAR, T™ Tubing and Connectors are sterile devices with non-pyrogenic fluid pathways, for single use only, and are not to be resterilized by the user. The devices are used in connecting oxygenators, reservoirs, filters, and other cardiopulmonary bypass components into circuits used in surgical procedures requiring extracorporeal support. The tubing may also be used in roller-type cardiopulmonary bypass blood pumps. In particular, tubing sizes with a 3/32 inch wall thickness are used in the pump head of a roller-type cardiopulmonary bypass blood pump, where the tubing is cyclically compressed by the pump to cause blood to flow through the cardiopulmonary bypass circuit.

COBE® SMAR.T™ Tubing is polyvinyl chloride (PVC) tubing ranging in size from 0.075" ID x 0.020" wall to 5/8" ID x 1/8" wall. COBE® SMAR, T™ Connectors are of the following generic types: straight with or without luer port, reducer with or without luer port, Y with or without luer port, male or female luer locks, and saturation/hematocrit monitor connectors.

### INDICATIONS FOR USE

The COBE® SMAR,T™ Tubing and Connectors are intended to be used in surgical procedures requiring extracorporeal support for periods of up to six hours.

### STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The COBE® SMAR, T™ Tubing and Connectors have the same intended use as currently marketed COBE® Tubing and Connectors. The primary difference is that the COBE® SMAR, T™ Tubing and Connectors contain a non-leaching, surface modifying additive that is added to the formulation prior to fabrication to improve blood compatibility.

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Biocompatibility and performance tests were performed to demonstrate that the COBE® SMAR,T™ Tubing and Connectors are substantially equivalent to the currently marketed COBE® Tubing and Connectors.

Performance testing consisted of:

- Bond Strength Static Leak Test Rated Pressure Kink Resistance Tubing Pump Life Tubing Spallation Saturation/Hematocrit Connector Testing
In-vitro testing was performed to demonstrate improved blood compatibility of the materials containing the surface modifying additive.

These data support that the COBE® SMAR, T™ Tubing and Connectors are substantially equivalent to the currently marketed COBE® Tubing and Connectors, and that the addition of the surface-modifying material does not affect safety and effectiveness.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 26 1998

Ms. Lynne Leonard Manager, Regualtory Submissions COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, CO 80004

K981613 Re : COBE® SMARXT™ Tubing and Connectors Regulatory Class: II (Two) Product Code: DWE Dated: Auqust 7, 1998 Received: August 11, 1998

Dear Ms. Leonard:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use atvice 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the provisions 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Lynne Leonard

This letter will allow you to begin marketing your device as Inis fecter will arow you one on the motification. The FDA finding described in Your 518(A) promise of your device to a legally marketed of substantial equivalence or flassification for your device and predicate actiour device to proceed to the market.

If you desire specific advice for your device on our labeling II you desire specific advanced additionally 809.10 for in vitro regulacion (er ces), please contact the Office of Compliance at (1agnoscic devices), promally, for questions on the promotion and (Jor) Joing of your device, please contact the Office of advertising on [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your (aronsibilities under the Act may be obtained from the Division responsibilities assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html."

Sincerely yours,
Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Indications For Use

Ic 98 510(k) Number (If known): ____________________________________________________________________________________________________________________________________________________

Device Names: COBE® SMAR TTM Tubing and Connectors

Indications For Use:

COBE® SMAR T™ Tubing and Connectors are intended to be used in surgical procedures requiring extracorporeal support for periods of up to six hours.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Litte R. Loemperse
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K981613

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use __