VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001

K061743 · Maquet Cardiopulmonary, AG · DTN · Jul 21, 2006 · Cardiovascular

Device Facts

• Record ID: K061743
• Device Name: VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001
• Applicant: Maquet Cardiopulmonary, AG
• Product Code: DTN · Cardiovascular
• Decision Date: Jul 21, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Hardshell cardiotomy reservoir collects, stores, and filters blood during cardiopulmonary bypass; vacuum-tight model supports vacuum-assisted venous return and postoperative autotransfusion. Device integrates into perfusion systems; operated by perfusionists or clinicians. Safeline coating applied to internal surfaces to improve hemocompatibility. Output is processed blood returned to patient circulation. Benefits include reduced blood trauma and efficient volume replacement during and after surgery.

Clinical Evidence

Bench testing only. No clinical data provided. Testing evaluated device integrity, performance, biocompatibility, and sterility to confirm equivalence to predicate devices.

Technological Characteristics

Hardshell reservoir with Safeline coating. Mechanical filtration and collection system. No energy source or software. Biocompatible materials.

Indications for Use

Indicated for adult patients undergoing cardiopulmonary bypass procedures (up to 6 hours) requiring 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 (K982136, K003551)
• Jostra RotaFlow Centrifugal Pump with Safeline Coating (K061072)

Submission Summary (Full Text)

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K061743
MAQUET

JUL 21 2006

Special 510(k): Device Modification: Venous Hardshell Cardiotomy Reservoirs with Safeline Coating

510(k) SUMMARY

SUBMITTER:

Maquet Cardiopulmonary AG Hechinger Strasse 38 72145 Hirrlingen, Germany

Phone: [phone]

011 49 7478 921- 400

Katrin Schwenkglenks

CONTACT PERSON:

DATE PREPARED:

DEVICE TRADE NAME:

COMMON/USUAL NAME

CLASSIFICATION NAME

June 16, 2006

Fax:

Jostra Venous Hardshell Cardiotomy Reservoirs with Safeline Coating

Venous Reservoirs

Cardiopulmonary bypass blood reservoir Cardiopulmonary bypass defoamer Cardiopulmonary bypass cardiotomy suction line blood filter

### PREDICATE DEVICES OR LEGALLY MARKETED DEVICES

Jostra Venous Hardshell Cardiotomy Reservoirs (K982136, K003551) Jostra RotaFlow Centrifugal Pump with Safeline Coating (K061072)

## DEVICE DESCRIPTION/INDICATONS FOR USE STATEMENT

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

The Jostra Venous Hardshell Cardiotomy Reservoir (vacuum-tight model) is designed to collect, store and filter the blood in an extracorporeal circuit during cardiopulmonary 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 Jostra 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.

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# MAQUET

## STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The Jostra Venous Hardshell Cardiotomy Reservoirs (vacuum-tight and non-vacuum-tight model) with Safeline Coating are identical to the Jostra Venous Hardshell Cardin tygn Reservoirs with the only exception that the Venous Hardshell Cardiotomy Reservoirs with Safeline Coating have been coated with Safeline. The Safeline Coating is the same as with the Jostra RotaFlow Centrifugal Pump with Safeline Coating. Besides this difference the Venous Hardshell Cardiotomy Reservoirs with Safeline Coating are the same in design. intended use, method of operation, components, packaging, and fundamental scientific technology as compared to the uncoated Venous Hardshell Cardiotomy Reservoirs.

# DETERMINATION OF SUBSTANTIAL EQUIVALENCE

Evaluation and testing on safety and effectiveness was executed to demonstrate that the Jostra Venous Hardshell Cardiotomy Reservoirs with Safeline Coating described in this submission are substantially equivalent to the Jostra Venous Hardshell Cardiotomy Reservoirs as reservoirs and to the RotaFlow Centrifugal Pump with Safeline Coating regarding the Safeline coating.

The following areas have been tested and / or evaluated:

- Integrity -
- Performance 1
- -Biocompatibility
- -Sterility

### Conclusion

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 21 2006

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

Re: K061743

Trade Name: Venous Hardshell Cardiotomy Reservoir with Safeline Coating Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiotomy Reservoir Regulatory Class: Class II (two) Product Code: DTN Dated: June 16, 2006 Received: June 21, 2006

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,

Duna R. Holmes

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): K061743

Device Name: Venous Hardshell Cardiotomy Reservoirs with Safeline Coating _____

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

The Jostra Venous Hardshell Cardiotomy Reservoir (vacuum-tight model) is designed to collect, store and filter the blood in an extracorporeal circuit during cardiopulmonary 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 Jostra 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 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Page Lof I

(Posted November 13, 2003)

uma P. Vorland

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K061743

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