DBT, DYNAMIC BUBBLE TRAP

K031323 · Convergenza AG · DTM · Aug 1, 2003 · Cardiovascular

Device Facts

• Record ID: K031323
• Device Name: DBT, DYNAMIC BUBBLE TRAP
• Applicant: Convergenza AG
• Product Code: DTM · Cardiovascular
• Decision Date: Aug 1, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.4260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DBT™ is indicated for use in cardiopulmonary bypass procedures for the removal of gaseous microemboli.

Device Story

The DBT™ (Dynamic Bubble Trap) is a sterile, single-use arterial filter for cardiopulmonary bypass circuits. It functions as a passive mechanical device; blood enters through 3/8-inch inlet ports into a diffuser chamber containing a three-channel spiral. This spiral induces a rotating stream, creating centripetal forces that direct gaseous microemboli toward the center of the flow line. A collection site at the distal end diverts this central flow, returning the collected microbubbles via a recirculation line. Used by clinicians in the OR during bypass, the device provides continuous, automated bubble removal without external power or software, reducing the risk of air embolism to the patient.

Clinical Evidence

Bench testing only. Testing was performed in accordance with the FDA Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions (November 29, 2000) to verify performance and minimize potential risks.

Technological Characteristics

Tubular form factor with 3/8-inch barbed inlet/outlet ports. Features an internal diffuser chamber with a three-channel spiral for centrifugal flow separation. Passive mechanical operation; no energy source required. Sterile, non-pyrogenic fluid pathway. Single-use.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass procedures requiring the removal of gaseous microemboli from the arterial line.

Regulatory Classification

Identification

A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.”

Predicate Devices

• Pall EC Plus Filter (K834380)

Submission Summary (Full Text)

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## 510(k) SUMMARY - DYNAMIC BUBBLE TRAP

| Submitter Name: | Convergenza AG |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | St. Markusgasse 16<br>FL 9490 Vaduz<br>Principality of Liechtenstein |
| Contact Person: | Christie DeWitt |
| Phone/Fax Number: | [phone] |
| Date Prepared: | April 25, 2003 |
| Device Trade Name: | DBT™, Dynamic Bubble Trap |
| Device Common Name: | Arterial Filter |
| Classification Name: | Cardiopulmonary Bypass Arterial Line Blood Filter<br>21 CFR §870.4260; Class II |
| Predicate Devices: | Pall EC Plus Filter (K834380) |
| Device Description: | The DBT™, Dynamic Bubble Trap is a sterile device with<br>a non-pyrogenic fluid pathway. It is intended for single<br>use only, in the arterial line of an extracorporeal circuit<br>during cardiopulmonary bypass procedures. It is<br>designed to remove gaseous microemboli from the<br>arterial line of a cardiopulmonary bypass circuit. |
| Intended Use: | The DBT™ is indicated for use in cardiopulmonary<br>bypass procedures for the removal of gaseous<br>microemboli. |
| Device Technological<br>Characteristics: | The DBT™ is tubular with 3/8-inch barbed inlet and<br>outlet ports. Within the tube there is a diffuser chamber<br>and a site for collecting microbubbles, which is<br>connected to the recirculation line. Inside the diffuser<br>chamber there is a tightly integrated three-channel<br>spiral. As blood passes through the spiral, it is<br>converted into a rotating stream. The resulting<br>centripetal forces direct gaseous microemboli to the<br>center of the flow line. The collection site, which is<br>situated in the center of the distal end of the tube,<br>diverts the central blood flow line and returns it together<br>with all collected microbubbles to the cardiotomy |

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Testing was performed in accordance with the Guidance Performance Data: for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions, dated November 29, 2000. The recommended special controls have been applied to minimize all identified potential risks to health. Bench testing demonstrates that the device has been designed to minimize the identified potential risks to a patient's health. Based upon the performance studies and the proposed Conclusion:

device labeling, the DBT™, Dynamic Bubble Trap, is substantially equivalent to the identified predicate devices in terms of intended use, safety, and effectiveness.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure, composed of three curved lines. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Convergenza AG c/o Ms. Christine B. DeWitt DeWitt Group International 3625 Woodlake Drive Bonita Springs, FL 34134

Re: K031323

DBT™, Dynamic Bubble Trap Regulation Number: 870.4260 Regulation Name: Cardiopulmonary Bypass Arterial Line Blood Filter Regulatory Class: Class II (two) Product Code: DTM Dated: April 24, 2003 Received: April 25, 2003

Dear Ms. DeWitt:

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.

AUG = 1 2003

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Page 2 - Ms. Christine B. DeWitt

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/dsma/dsmamain.html

Sincerely yours,

N. Robertson M.P.

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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: DBT™, Dynamic Bubble Trap _______________________________________________________________________________________________________________________________________

## Indications for Use:

The DBT™ is indicated for use in cardiopulmonary bypass procedures for the removal of gaseous microemboli.

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Concurrence of CDRH; Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="text-align:center;"> <span style="text-decoration: line-through;">X</span> OR </div> | Over-The-Counter Use |
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(Division Sign-Off)

(Optional Format 1-2-96) Division of Cardiovascular Devices

| 510(k) Number | K031323 |
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