CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING

K993189 · Terumo Corp. · DWE · Mar 1, 2000 · Cardiovascular

Device Facts

• Record ID: K993189
• Device Name: CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING
• Applicant: Terumo Corp.
• Product Code: DWE · Cardiovascular
• Decision Date: Mar 1, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cardiopulmonary Bypass Pump Tubing is intended to provide a conduit for extracorporeal blood flow through a roller pump during cardiopulmonary bypass procedures. The tubing is intended for use in procedures lasting up to 6-hours in duration.

Device Story

Cardiopulmonary bypass pump tubing serves as a conduit for extracorporeal blood flow within a roller pump system. Used during cardiopulmonary bypass procedures by clinical staff in surgical settings. Facilitates blood circulation outside the body during surgery; supports procedures up to 6 hours. Device provides physical pathway for blood transport; ensures compatibility with standard roller pump mechanisms.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cardiopulmonary bypass pump tubing designed for use with roller pumps. Material properties and dimensions specified for extracorporeal blood flow compatibility. Non-implantable, single-use conduit.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass procedures requiring extracorporeal blood flow via a roller pump for durations up to 6 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.

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 2 9 2002

Terumo Medical Corporation c/o Mr. Gary A. Courtney 125 Blue Ball Road Elkton, MD 21921

Re: K993189

Cardiopulmonary Bypass Pump Tubing Regulation Number: 21 CFR 870.4390 Regulation Name: Cardiopulmonary Bypass Pump Tubing Regulatory Class: Class II (two) Product Code: DWE Dated: January 17, 2000 Received: January 19, 2000

Dear Mr. Courtney:

This letter corrects our substantially equivalent letter of March 1, 2000 regarding the incorrect Indications for Use.

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). 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 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. Gary A. Courtney

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 continue 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 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]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.gov/cdrb/dsma/dsmamain.html.

Sincercly yours,

Datel
Bram D. Zuckerman, M.D.

Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number (if known): K993189

#### Device Name: Cardiopulmonary Bypass Pump Tubing

### Indications For Use:

The Cardiopulmonary Bypass Pump Tubing is intended to provide a conduit for extracorporeal blood flow through a roller pump during cardiopulmonary bypass procedures.

The tubing is intended for use in procedures lasting up to 6-hours in duration.

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

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respilatory Devices
510(k) Number
K993189

OR

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

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