VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING

K090690 · Maquet Cardiopulmonary, AG · DTN · Dec 23, 2009 · Cardiovascular

Device Facts

• Record ID: K090690
• Device Name: VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING
• Applicant: Maquet Cardiopulmonary, AG
• Product Code: DTN · Cardiovascular
• Decision Date: Dec 23, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Venous Softbag Reservoirs are indicated for use in extracorporeal circuits during cardiopulmonary bypass procedures in the field of open-heart-surgery. The utilization period of this device is restricted to six hours. Blood contact longer than 6 hours is not recommended. Application and use of the softbag reservoir is in the sole responsibility of the respective physician.

Device Story

Venous Softbag Reservoir serves as a blood container within extracorporeal circuits during cardiopulmonary bypass surgery. Device consists of welded plastic foils sandwiching tubes and a polyester mesh for air removal. Used in clinical settings by medical professionals; provides temporary blood storage during bypass. Benefits patient by facilitating extracorporeal circulation. Delivered sterile for single use.

Clinical Evidence

Bench testing only. Evaluation included integrity, performance, biocompatibility, and sterility testing to demonstrate equivalence to predicate devices.

Technological Characteristics

Materials: plastic foils, polyester mesh. Design: welded foil bag with integrated tubing. Function: blood reservoir for cardiopulmonary bypass. Sterilization: sterile, single-use. Coating: Softline coating.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass procedures during open-heart surgery. Restricted to 6 hours of use.

Regulatory Classification

Identification

A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.

Special Controls

*Classification.* Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Jostra Venous Softbag Reservoirs with and without Safeline Coating (K070605)
• Adult Quadrox-i Microporous Membrane Oxygenator with and without integrated Arterial Filter (082117)

Submission Summary (Full Text)

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K090690

DEC 2 3 2009

# MAQUET

### 510(k) Summary

[as required by 21 CFR 807.92(c)]

| Submitter | MAQUET Cardiopulmonary AG<br>Hechinger Strasse 38<br>72145 Hirrlingen<br>Germany | |
|----------------|----------------------------------------------------------------------------------|--|
| Contact Person | Katrin Schwenkglenks | |

Katrin Schwenkglenks Phone: [phone] Fax: [phone]

Venous Reservoir Bag

Date Prepared March 12, 2009

Device Trade Name

Common/Usual Name

Classification Names

Reservoir, Blood, Cardiopulmonary Bypass (CFR 870.4400, product code : DTN)

Venous Softbag Reservoirs with Softline Coating

Legally Marketed Devices Jostra Venous Softbag Reservoirs with and without Safeline Coating (K070605), Adult Quadrox-i Microporous Membrane Oxygenator with and without integrated Arterial Filter (082117).

#### Device Description

The Venous Softbag Reservoir is used in extracorporeal circuits during cardiopulmonary bypass surgery and serves as container for a certain blood volume. It consists of plastic foils which are welded together and between which tubes of different diameters and a polyester mesh are sandwiched. The polyester mesh serves for an improved air removal. Application duration: The utilization period of this device is restricted to six hours. The softbag reservoir is delivered sterile and is determined for single use only.

The group of Venous Softbag Reservoirs consists of a variety of models which differ in size (filling volume) and in the port sizes. The filling volumes of the reservoirs range from 650 ml to 1900 ml depending on the model and the ports are either 3/8" or ½" in size.

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## MAQUET

#### Statement of Indications for Use

The Venous Softbag Reservoirs are indicated for use in extracorporeal circuits during cardiopulmonary bypass procedures in the field of open-heartsurgery. The utilization period of this device is restricted to six hours. Blood contact longer than 6 hours is not recommended. Application and use of the softbag reservoir is in the sole responsibility of the respective physician.

#### Statement of Technical Comparison

The Venous Softbag Reservoirs with Softline Coating are identical to the Jostra Venous Softbag Reservoirs with Safeline Coating with the only exception that the Venous Softbag Reservoirs with Softline Coating have been coated with Softline Coating instead of Safeline Coating. However, the Softline Coating is the same as with the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating. Besides this difference the Venous Softbag Reservoirs with Softline Coating are the same in design, intended use, method of operation, components, packaging, and fundamental scientific technology as compared to the Venous Softbag Reservoirs with Safeline Coating.

#### Determination of Substantial Equivalence

Evaluation and testing on safety and effectiveness was executed to demonstrate that the Venous Softbag Reservoirs with Softline Coating described in this submission are substantially equivalent to the Jostra Venous Softbag Reservoirs with Safeline Coating as reservoirs and to the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating regarding the Softline Coating and the pre-assembled combination of the reservoir with the oxygenator.

The following areas have been tested and / or evaluated:

- Integrity -
- Performance .
- Biocompatibility ・
- Sterility -

#### Conclusion

The data given demonstrate that the Venous Softbag Reservoirs with Softline Coating are 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" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure with three wing-like shapes.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Maquet Cardiopulmonary AG c/o Ms. Katrin Schwenkglenks Hechinger Strasse 38 72145 Hirrlingen Germany

DEC 2 3 2009

Re: K090690

> Maquet Venous Softbag Reservoirs with Softline Coating Regulation Number: 21 CFR 870.4400 Regulation Name: Reservoir, Blood, Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DTN Dated: November 23, 2009 Received: November 25, 2009

Dear Mr. Schwenkglenks:

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 - Ms. Katrin Schwenkglenks

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/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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

W.M.

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): _ Kogo 690 Device Name: Venous Softbag Reservoir with Softline Coating __

Indications for Use:

The Venous Softbag Reservoirs are indicated for use in extracorporeal circuits during cardiopulmonary bypass procedures in the field of open-heart-surgery. The utilization period of this device is restricted to six hours. Blood contact longer than 6 hours is not recommended. Application and use of the softbag reservoir is in the sole responsibility of the respective physician.

| Prescription Use (Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use (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)

| (Division Sign-Off) | |
|------------------------------------|---------|
| Division of Cardiovascular Devices | |
| 510(k) Number | K090690 |
| Page | 1 of 1 |

(Posted November 13, 2003)