HLM TUBING SET WITH SOFTLINE COATING

K090533 · Maquet Cardiopulmonary, AG · DWF · Dec 18, 2009 · Cardiovascular

Device Facts

• Record ID: K090533
• Device Name: HLM TUBING SET WITH SOFTLINE COATING
• Applicant: Maquet Cardiopulmonary, AG
• Product Code: DWF · Cardiovascular
• Decision Date: Dec 18, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4210
• Device Class: Class 2

Intended Use

The HLM Tubing Sets with Softline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Softline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Softline Coating is to connect the patient to the heart-lung machine and its components. The HLM Tubing Sets with Softline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours.

Device Story

HLM Tubing Sets with Softline Coating function as components in extracorporeal perfusion circulation systems. The device connects patients to heart-lung machines for blood oxygenation and carbon dioxide removal during open heart surgery. The tubing features a Softline surface coating designed to improve physical surface properties for extracorporeal circulation. The device is intended for single use, with a maximum utilization period of six hours. It is operated by clinical staff in surgical settings. The device provides a physical conduit for blood flow; it does not involve electronic processing, software, or automated decision-making.

Clinical Evidence

Bench testing only. No clinical data presented.

Technological Characteristics

Extracorporeal tubing set for cardiopulmonary bypass. Features Softline surface coating. Single-use, sterile or non-sterile. Restricted to 6-hour duration. Mechanical component; no energy source, software, or algorithm.

Indications for Use

Indicated for use in extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less in patients undergoing open heart 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

• HLM Tubing Set with Bioline coating (K080592)
• Quadrox-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating (K082117)

Submission Summary (Full Text)

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K090533

#### Special 510(k) Device Modification HLM Tubing Set with Softline Coating

| 510(k) SUMMARY | DEC 1 8 2009 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | Maquet Cardiopulmonary AG<br>Hechinger Strasse 38<br>72145 Hirrlingen, Germany |
| CONTACT PERSON: | Dr. Ingrid Richter<br>Phone: [phone]<br>Fax: [phone] |
| DATE PREPARED: | February 24, 2009 |
| DEVICE TRADE NAME: | HLM Tubing Sets with Softline Coating |
| COMMON/USUAL NAME | Custom Tubing Pack |
| CLASSIFICATION NAME | Cardiopulmonary Bypass Vascular<br>Catheter, Cannula, or Tubing;<br>Cardiopulmonary Bypass Adaptor,<br>Stopcock, Manifold, or Fitting;<br>Cardiopulmonary Bypass Pump Tubing. |

### PREDICATE DEVICES OR LEGALLY MARKETED DEVICES

HLM Tubing Set with Bioline coating (K080592)

Quadrox-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating (K082117)

## DEVICE DESCRIPTION / INDICATONS FOR USE STATEMENT

The HLM Tubing Sets with Softline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Tubing sets that are sold sterile are not to be re-sterilized by the user.

In open heart surgery the HLM Tubing Sets with Softline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Softline Coating is to connect the patient to the heart-lung machine and its components. The HLM Tubing Sets with Softline Coating are therefore a

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component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours.

The Softline Coating improves the physical surface properties of products for the extracorporeal circulation system.

#### STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The HLM Tubing Set - Softline Coated has the same intended use, design, principals of operation, and performance as the HLM Tubing Set with Bioline Coating. The only difference is the application of the Softline Coating instead of the Bioline coating to the set components.

#### DETERMINATION OF SUBSTANTIAL EQUIVALENCE

Evaluation on safety and effectiveness was executed to demonstrate that the HLM-Tubing Set with Softline Coating described in this submission is substantially equivalent to the HLM-Tubing Set with Bioline Coating (K080592) as a custom tubing pack and to the Quadrox-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating (K082117) with regards to the Softline Coating.

The following areas have been evaluated:

- Integrity
- Performance
- Biocompatibility
- Sterility

#### CONCLUSION

The data given demonstrate that the HLM-Tubing Set with Softline Coating is substantially equivalent to the named predicate devices which hold currently market clearance.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Maquet Cardiopulmonary AG c/o Dr. Ingrid Richter Regulatory Affairs Manager Hechinger Strasse 38 72145 Hirringen Germany

DEC 1 8 2009

Re: K090533

HLM Tubing Set with Softline Coating Regulation Number: 21 CFR 870.4210 Regulation Name: Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DWF Dated: November 23, 2009 Received: November 25, 2009

Dear Dr. Richter:

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 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 - Dr. Ingrid Richter

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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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# Indications for Use

510(k) Number (if known): _Ko905333_

Device Name: HLM Tubing Set with Softline Coating

Indications for Use:

. .

The HLM Tubing Sets with Softline Coating are designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less.

Over-The-Counter Use Prescription Use × AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Sign-Off |
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| Division of Cardiovascular Devices | |
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| 510(k) Number | k090533 |

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(Posted November 13, 2003)