JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING

K070605 · Maquet Cardiopulmonary, AG · DTN · Jan 4, 2008 · Cardiovascular

Device Facts

• Record ID: K070605
• Device Name: JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING
• Applicant: Maquet Cardiopulmonary, AG
• Product Code: DTN · Cardiovascular
• Decision Date: Jan 4, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4400
• Device Class: Class 2

Intended Use

The Jostra 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 functions as a blood container within extracorporeal circuits during cardiopulmonary bypass surgery. Device consists of welded plastic foils containing integrated tubing and a polyester mesh for air removal. Available in various filling volumes (650 ml to 1900 ml) and port sizes (3/8" or 1/2"). Optional Safeline coating available. Used in clinical settings (OR) by physicians; device is sterile and single-use. Provides temporary blood storage and air management during bypass; supports clinical decision-making by maintaining circuit integrity and patient safety during cardiac procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included integrity, performance, stability of the coating, biocompatibility, and sterility to demonstrate substantial equivalence.

Technological Characteristics

Plastic foil construction with integrated tubing and polyester mesh for air removal. Available with or without Safeline coating. Filling volumes 650-1900 ml; port sizes 3/8" or 1/2". Sterile, single-use. No energy source or software.

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

• BMR 1900 Soft-Shell Venous Reservoir, Cobe Cardiovascular Inc. (K050111)
• MVR 800 Collapsible Venous Reservoir Bag, Medtronic Inc. (K920774)
• RotaFlow Centrifugal Pump with Safeline Coating (K061072)

Submission Summary (Full Text)

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JAN - 4 2008

# K070605 MAQUET

## 510 (K) Summary Jas required by 21 CFR 807.92(c) 1

| Submitter: | Maquet Cardiopulmonary AG<br>Hechinger Strasse 38<br>72145 Hirrlingen<br>Germany |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Katrin Schwenkglenks<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared:<br>Device Trade Name: | February 28, 2007<br>Jostra Venous Softbag Reservoirs with and without<br>Safeline Coating |
| Common/Usual Name: | Venous Reservoir Bag |
| Classification Names: | Reservoir, Blood, Cardiopulmonary Bypass<br>(21 CFR 870.4400, product code: DTN) |
| Predicate Devices: | BMR 1900 Soft-Shell Venous Reservoir, Cobe<br>Cardiovascular Inc. (K050111),<br>MVR 800 Collapsible Venous Reservoir Bag,<br>Medtronic Inc. (K920774)<br>RotaFlow Centrifugal Pump with Safeline Coating<br>(K061072) |

### 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.

### Statement of Indications for Use

The Jostra 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.

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## MAQUET

### Statement of Technical Characteristics Comparison

Maquet Cardiopulmonary AG has compared indications for use, design, specifications, performance characteristics and safety of the Jostra Venous Softbag Reservoirs with and without Safeline Coating and of the predicate devices.

In-vitro testing on safety and effectiveness was executed to demonstrate that the Jostra Venous Softbag Reservoirs with and without Safeline Coating described in this submission are substantially equivalent to the named predicate devices.

The following areas have been tested:

- Integrity .
- Performance -
- Stability of the coating -
- Biocompatibility ・
- -Sterility

### Conclusion

The Jostra Venous Softbag Reservoirs with and without Safeline Coating are substantially equivalent to the named predicate devices that currently hold market clearance.

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Public Health Service

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JAN - 4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K070605

Jostra Venous Softbag Reservoirs with and without Safeline Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary bypass blood reservoir Regulatory Class: Class II (two) Product Code: DTN Dated: December 20, 2007 Received: December 26, 2007

Dear Ms. 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 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.

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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); 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 begin 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours.

Bfommamourh

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): Ko 70605

Device Name: Jostra Venous Softbag Reservoir with and without Safeline Coating

Indications for Use:

The Jostra 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 Over-The-Counter Use X 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)

Bhammana

San-Off second Cardiovascular De

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(Posted November 13, 2003)