THREE STAGE VENOUS RETURN CANNULA, MODEL 816460

K080034 · Terumo Cardiovascular Systems Corp. · DWF · Jun 17, 2008 · Cardiovascular

Device Facts

• Record ID: K080034
• Device Name: THREE STAGE VENOUS RETURN CANNULA, MODEL 816460
• Applicant: Terumo Cardiovascular Systems Corp.
• Product Code: DWF · Cardiovascular
• Decision Date: Jun 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These cannulae are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Device Story

Three Stage Venous Return Cannula; single-tube venous drainage device for cardiopulmonary bypass surgery. Input: venous blood from right atrium/vena cava. Operation: cannula inserted into patient; connected to heart/lung machine via 3/8" tubing; blood routed to machine for oxygenation; returned to aorta via arterial cannula. Features: three drainage baskets; spring-reinforced body; obturator for insertion; depth markers for positioning. Used in OR by perfusionists/surgeons. Benefits: smaller incision site due to uniform distal diameter; reduced prime volume via 3/8" connection; maintained flow characteristics via third basket.

Clinical Evidence

Bench testing only. Performance evaluations included connector attachment, clamp test, obturator seal test, kink test, collapse test, tensile test, flow testing, and simulated use testing. No clinical data presented.

Technological Characteristics

Spring-reinforced venous cannula with three drainage baskets. 3/8" flared connection. Includes obturator. Designed for cardiopulmonary bypass. Materials and design optimized for flow characteristics and reduced prime volume. No software or electronic components.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery requiring single-tube venous drainage from the right atrium and vena cava. Indicated for up to 6 hours of use.

Regulatory Classification

Identification

A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

Predicate Devices

• Dual Stage Venous Return Cannulae (K810415)

Submission Summary (Full Text)

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Koso034

:

## SECTION 03: 510(k) SUMMARY (807.92c)

:

| | 510(k) Summary | JUN 17 2008 |
|-------------------------------|------------------------------------|-------------|
| | Submitter Information | 2 |
| | Device Name | 2 |
| | Identification of Predicate Device | 2 |
| | Device Description | 2 |
| | Intended Use | 2 |
| | Technological Characteristics | 2 - 3 |
| | Performance Evaluations | 3 |
| Conclusion for 510(K) Summary | | 3 |

:

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## Three Stage Venous Return Cannula

### Submitter Information

This Premarket Notification is submitted by:

Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor, Michigan 48103

| Contact: | Andrea N. Wallen |
|------------|---------------------------|
| Telephone: | 1-800-262-3304, Ext. 6395 |
| Fax: | 734-741-6030 |
| Date: | January 3, 2008 |

#### Device Name

Trade Name: Three Stage Venous Return Cannula Common Name: Venous Cannula Classification Name: CPB vascular catheters, cannulae, or tubing are classified as Class II devices per 21 CFR § 870.4210.

## Predicate Device

The unmodified predicate device is identified as Terumo's current line of Dual Stage Venous Return Cannulae, which fall under 510(k) # K810415.

## Device Description

The Three Stage Venous Return Cannula consists of a single tube body with a 3/8" flared end to allow for connection to the bypass circuit. These cannulae have three open areas for venous drainage. An obturator is included. Its purpose is to decrease blood loss during insertion depth markers are printed on each cannula and aid in positioning the cannula.

#### Intended Use

These cannulae are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

#### Technological Characteristics

The Three Stage Venous Return Cannula is used in open heart surgery. During open heart surgery, blood is drained into a venous cannula upstream of the heart at the superior/ inferior vena cava and right atrium. The cannula is connected to tubing that routes the blood to a heart/ lung machine where the blood is pumped and oxygenated. The blood then continues through this perfusion circuit back to

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the outlet side of the heart (the patient's aorta), where the blood re-enters the patient's circulatory system via an arterial cannulae.

There are three major differences between the modified and unmodified devices.

- . The distal portion of the three stage spring reinforced body maintains a single outside diameter to allow for a smaller incision site, whereas the dual stage cannula has a step-up in the outer diameter.
- . The (unmodified) dual stage device has a 1/2" connection site. whereas the (modified) three stage device has a 3/8" connection site which allows for a smaller blood volume to prime the bypass circuit.
- . The modified device includes a third basket which has been added to allow the smaller diameter to maintain comparable flow characteristics to the dual stage venous return cannulae.

## Performance Evaluation

Comparison studies of the performance specifications of the Three Stage Venous Return Cannula and the unmodified predicate Dual Stage Venous Return Cannula have been conducted and have shown to be substantially equivalent to the predicate (unmodified) Dual Stage Venous Return Cannula. These tests include:

- . Connector attachment
- Clamp test .
- Obturator Seal Test �
- Kink test .
- Collapse test .
- Tensile test .
- Flow Testing .
- . Simulated use test

## Conclusion

In summary, the Three Stage Venous Return Cannula performed as intended and is substantially equivalent in intended use, principles of operation, technology, design, materials, and performance to the predicate (unmodified) Dual Stage Venous Return Cannula. Any noted differences between the devices do not raise new issues of safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white and has a simple, clean design.

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

# JUN 1 7 2008

Terumo Cardiovascular Systems Corporation c/o Ms. Andrea Wallen Specialist, Regulatory Management 6200 Jackson Road Ann Arbor, MI 48103

Re: K080034

Three Stage Venous Return Cannula, Model 816460 Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheters, cannula, or tubing Regulatory Class: Class II (two) Product Code: DWF Dated: April 7, 2008 Received: April 8, 2008

Dear Ms. Wallen:

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 it may of receiver to one 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. Andrea Wallen

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/cdrb/industry/support/index.html.

Sincerely yours,

Duna R. Vachner

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: Three Stage Venous Return Cannula

#### Indications For Use:

These cannulae are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Andres N. Wallen
Andres N. Wallen

Andrea N. Wallen Regulatory Affairs Specialist Terumo Cardiovascular Systems

Prescription Use X OR

Over-The-Counter Use

(Per 21 CFR 801.109)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Holmes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K080034