VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160

K082412 · Mapquet Cardiopulmonary AG · DTP · Nov 10, 2008 · Cardiovascular

Device Facts

• Record ID: K082412
• Device Name: VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160
• Applicant: Mapquet Cardiopulmonary AG
• Product Code: DTP · Cardiovascular
• Decision Date: Nov 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4230
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The bubble trap is intended for use in an extracorporeal circulation system during a cardiopulmonary bypass within the framework of surgical intervention. Within the specified flow rate limits, the bubble trap separates macroscopic air bubbles from the venous line, eliminating them through the deaeration line and out of the extracorporeal circulation, and by doing so supports the perfusionist's obligation to exercise due caution. The product must not be used for more than 6 hours at a time. The physician in charge of treatment must make all decisions concerning use of the venous bubble trap.

Device Story

Venous Bubble Trap (with/without Bioline coating) functions as a component in extracorporeal circulation systems during cardiopulmonary bypass. Device receives venous blood flow; utilizes physical separation principles to isolate macroscopic air bubbles from blood; vents air through a deaeration line. Operated by perfusionists in surgical settings; supports clinical decision-making by reducing air emboli risk. Single-use, sterile, non-pyrogenic; limited to 6-hour duration. Benefits patient by minimizing air-related complications during bypass.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included integrity, performance, coating stability, biocompatibility, and sterility assessments.

Technological Characteristics

Sterile, single-use, Ethylene Oxide sterilized. Features optional Bioline coating. Mechanical separation of air bubbles via deaeration line. Designed for integration into extracorporeal circulation circuits.

Indications for Use

Indicated for patients undergoing surgical intervention requiring cardiopulmonary bypass. Used within extracorporeal circulation systems to separate macroscopic air bubbles from the venous line. Contraindicated for use exceeding 6 hours.

Regulatory Classification

Identification

A cardiopulmonary bypass defoamer is a device used in conjunction with an oxygenator during cardiopulmonary bypass surgery to remove gas bubbles from the blood.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions.”

Predicate Devices

• Quadrox D Diffusion Membrane Oxygenator with Bioline Coating (K071774)
• Capiox Bubble Trap (K911632)
• Ideal Mimesys Venous Air Removal Device (K032040)
• ECC.O System with Integrated Venous Air Removal (K050890)

Submission Summary (Full Text)

{0}------------------------------------------------

KC82412

NOV 10 2008

# MAQUET

# 510 (K) Summary [as required by 21 CFR 807.92(c) ]

August 20, 2008

Submitter:

Maquet Cardiopulmonary AG Hechinger Strasse 38 72145 Hirrlingen Germany

Contact Person:

Katrin Schwenkglenks Phone: [phone] [phone] Fax: E-mail: [e-mail]

Date Prepared:

Device Trade Name:

Venous Bubble Trap with and without Bioline Coating

Cardiopulmonary bypass bubble detector

Venous Bubble Trap Common/Usual name:

Classification name:

Predicate Devices:

Quadrox D Diffusion Membrane Oxygenator with Bioline Coating, Maquet Cardiopulmonary AG (K071774). Capiox Bubble Trap, Terumo Medical Corp. (K911632), the Ideal Mimesys Venous Air Removal Device from Dideco S.r.1. as part of the Ideal Mimesys System (K032040) and

the ECC.O System with Integrated Venous Air Removal from Dideco S.r.l. (K050890) which does also contain a venous bubble trap as component.

{1}------------------------------------------------

# MAQUET

#### Device Description:

The Venous Bubble Trap is a sterile and non-pyrogenic device, for single use only and is not to be re-sterilized by the user. The device is sterilized with Ethylene Oxide.

The bubble trap is intended for use in an extracorporeal circulation system during a cardiopulmonary bypass within the framework of surgical intervention. Within the specified flow rate limits, the bubble trap separates macroscopic air bubbles from the venous line, eliminating them through the deaeration line and out of the extracorporeal circulation. The device is to be used for up to 6 hours.

#### Indications for Use:

The bubble trap is intended for use in an extracorporeal circulation system during a cardiopulmonary bypass within the framework of surgical intervention. Within the specified flow rate limits, the bubble trap separates macroscopic air bubbles from the venous line, eliminating them through the deaeration line and out of the extracorporeal circulation, and by doing so supports the perfusionist's obligation to exercise due caution. The product must not be used for more than 6 hours at a time. The physician in charge of treatment must make all decisions concerning use of the venous bubble trap.

#### Statement of Technical Comparison:

The Venous Bubble Trap with and without Bioline Coating has the same design, principals of operation, and performance as the predicate device on the market. The Bioline Coating is the same as cleared with the Quadrox D Diffusion Membrane Oxygenator with Bioline Coating.

#### Non-clinical Testing:

The following areas have been tested:

- Integrity
- Performance
- Stability of the Coating
- Biocompatibility
- Sterility

----

{2}------------------------------------------------

# MAQUET

#### Determination of Substantial Equivalence

Testing and evaluation on safety and effectiveness was executed to demonstrate that the Venous Bubble Trap with and without Bioline Coating described in this submission is substantially equivalent to the Capiox Bubble Trap from Terumo Medical Corp. as a bubble trap as well as with the Quadrox D Diffusion Membrane Oxygenator with Bioline Coating with regards to the coating.

#### Conclusion

乐

The data given demonstrate that the Venous Bubble Trap with and without Bioline Coating is substantially equivalent to the named predicate devices which currently hold market clearance.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted as a bird-like figure with intertwined snakes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 2008

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

Re: K082412

Venous Bubble Trap with and without Bioline Coating Regulation Number: 21 CFR 870.4230 Regulation Name: Cardiopulmonary bypass defoamer Regulatory Class: Class II Product Code: DTP Dated: October 17, 2008 Received: November 3, 2008

### 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.

{4}------------------------------------------------

### 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to. premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

D. Vachner

ABram D. Zuckerman, M.D. Director Division of Cardiovascular Device Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## Indications for Use

## 510(k) Number (if known): Ko82412

Device Name: Venous Bubble Trap with and without Bioline Coating __

Indications for Use:

The bubble trap is intended for use in an extracorporeal circulation system during a cardiopulmonary bypass within the framework of surgical intervention. Within the specified flow rate limits, the bubble trap separates macroscopic air bubbles from the venous line, eliminating them through the deaeration line and out of the extracorporeal circulation, and by doing so supports the perfusionist's obligation to exercise due caution.

The product must not be used for more than 6 hours at a time.

The physician in charge of treatment must make all decisions concerning use of the venous bubble trap.

Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)

D/OR Over-In

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)

unn R. V. June 1

(Division Sign-Off) Division of Cardiovascular Devices

Page *1* of *1*

510(k) Number_Ko&2 412

(Posted November 13, 2003)

……