VENOUS HARDSHELL CARDIOTOMY RESERVIORS

K090534 · Maquet Cardiopulmonary, AG · DTN · Dec 23, 2009 · Cardiovascular

Device Facts

• Record ID: K090534
• Device Name: VENOUS HARDSHELL CARDIOTOMY RESERVIORS
• 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 Hardshell Cardiotomy Reservoir, non-vacuum-tight, is designed to collect, store and filter the blood in an extracorporeal circuit during cardopulmonary bypass procedures up to six hours in adult surgery. It can be integrated into almost all perfusion systems. The Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated. The Venous Hardshell Cardiotomy Reservoir, vacuum-tight model, is designed to collect, store and filter the blood in an extracorporeal circuit during cardopulmonary bypass procedures with or without vacuum assisted venous return up to six hours in adult surgery. It can be integrated into almost all perfusion systems. The Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated. This reservoir is also designed to be used postoperatively as a drainage and autotransfusion reservoir (e.g. for chest drainage) to return autologous blood shed from the chest to the patient for volume replacement.

Device Story

Venous Hardshell Cardiotomy Reservoir collects, stores, and filters blood in extracorporeal circuits during cardiopulmonary bypass; vacuum-tight model supports vacuum-assisted venous return and postoperative autotransfusion. Device integrates into perfusion systems; operated by perfusionists or clinicians in surgical/clinical settings. Features integrated filters and defoamer; utilizes Softline coating to improve biocompatibility. Output is processed blood returned to patient circulation. Benefits include effective blood management, filtration of debris, and autologous blood recovery, reducing need for donor blood.

Clinical Evidence

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

Technological Characteristics

Hardshell reservoir with integrated filters and defoamer; available in vacuum-tight and non-vacuum-tight models. Features Softline coating for biocompatibility. Designed for integration into extracorporeal perfusion circuits.

Indications for Use

Indicated for adult patients undergoing cardiopulmonary bypass procedures (up to 6 hours) for blood collection, storage, and filtration. Vacuum-tight model also indicated for postoperative drainage and autotransfusion of shed chest blood for volume replacement.

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 Hardshell Cardiotomy Reservoirs with Safeline Coating (K061743)
• QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating (K082117)

Submission Summary (Full Text)

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K090534

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 | DEC 23 2005 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person | Frank Moehrke<br>Phone: [phone]<br>Fax: [phone] | |
| Date Prepared | February 25, 2009 | |
| Device Trade Name | Venous Hardshell Cardiotomy Reservoirs<br>with Softline Coating | |
| Common/Usual Name | Venous Hardshell Reservoir | |
| Classification Names | Cardiopulmonary bypass blood reservoir<br>(21 CFR 870.4400 – Product Code: DTN)<br>Cardiopulmonary bypass defoamer<br>(21 CFR 870.4230 - Product Code: DTP)<br>Cardiopulmonary bypass cardiotomy suction line<br>blood filter<br>(21 CFR 870.4270 - Product Code: JOD) | |
| Legally Marketed Devices | Jostra Venous Hardshell Cardiotomy Reservoirs<br>with Safeline Coating (K061743),<br>- QUADROX-i Adult microporous membrane<br>Oxygenator with and without integrated<br>Arterial Filter with Softline Coating (K082117) | |

#### Device Description

The Venous Hardshell Cardiotomy Reservoir is a reservoir with integrated filters and a defoamer. It is designed to be open or vacuum-tight. It may be marketed both as single product and as pre-assembled combination with the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating (K082117).

#### Indications for Use

The Venous Hardshell Cardiotomy Reservoir, non-vacuum-tight, is designed to collect, store and filter the blood in an extracorporeal circuit during cardopulmonary bypass procedures up to six hours in adult surgery. It can be integrated into almost all perfusion systems. The Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated.

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# MAQUET

The Venous Hardshell Cardiotomy Reservoir, vacuum-tight model, is designed to collect, store and filter the blood in an extracorporeal circuit during cardopulmonary bypass procedures with or without vacuum assisted venous return up to six hours in adult surgery. It can be integrated into almost all perfusion systems. The Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated. This reservoir is also designed to be used postoperatively as a drainage and autotransfusion reservoir (e.g. for chest drainage) to return autologous blood shed from the chest to the patient for volume replacement.

#### Statement of Technical Comparison

The Venous Hardshell Cardiotomy Reservoirs (vacuum-tight and nonvacuum-tight model) with Softline Coating are identical to the Jostra Venous Hardshell Cardiotomy Reservoirs with Safeline Coating with the only exception that the Venous Hardshell Cardiotomy 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 Hardshell Cardiotomy 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 Hardshell Cardiotomy Reservoirs with Safeline Coating.

#### Determination of Substantial Equivalence

Evaluation and testing on safety and effectiveness was executed to demonstrate that the Venous Hardshell Cardiotomy Reservoirs with Softline Coating described in this submission are substantially equivalent to the Jostra Venous Hardshell Cardiotomy 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 -
- Biocompatibilitv -
- Sterility .

#### Conclusion

The data given demonstrate that the Venous Hardshell Cardiotomy Reservoirs (vacuum-tight and non-vacuum-tight model) with Softline Coating are substantially equivalent to the named predicate devices which hold currently market clearance.

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

Maquet Cardiopulmonary AG c/o Mr. Frank Moehrke Regulatory Affairs Manager Hechinger Strasse 38 72145 Hirringen Germany

#### DEC 2 3 2009

Re: K090534

> Maquet Venous Hardshell Cardiotomy 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. Moehrke:

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 - Mr. Frank Mochrke

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,
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): Ko90534

Device Name:

#### Venous Hardshell Cardiotomy Reservoirs with Softline Coating

Indications for Use:

The Venous Hardshell Cardiotomy Reservoir, non-vacuum-tight, is designed to collect, store and filter the blood in an extracorporeal circuit during cardopulmonary bypass procedures up to six hours in adult surgery. It can be integrated into almost all perfusion systems. The Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated.

The Venous Hardshell Cardiotomy Reservoir, vacuum-tight model, is designed to collect, store and filter the blood in an extracorporeal circuit during cardopulmonary bypass procedures with or without vacuum assisted venous return up to six hours in adult surgery. It can be integrated into almost all perfusion systems. The Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated. This reservoir is also designed to be used postoperatively as a drainage and autotransfusion reservoir (e.g. for chest drainage) to return autologous blood shed from the chest to the patient for volume replacement.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|--------------------------|
| | AND/OR |
| | Over-The-C<br>(21 CFR 80 |

Counter Use 01 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 4090534

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**DEC 2 3 2009**