X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS

K083301 · Terumo Cardiovascular Systems Corp. · DWF · Dec 18, 2008 · Cardiovascular

Device Facts

• Record ID: K083301
• Device Name: X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS
• Applicant: Terumo Cardiovascular Systems Corp.
• Product Code: DWF · Cardiovascular
• Decision Date: Dec 18, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The X-coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. The X-coated Terumo® Dual-Stage Venous Return Cannula is indicated for use for adult single tube blood drainage from the right atrium and inferior vena cava (IVC) and delivery of the blood to the extracorporeal circuit during cardiopulmonary bypass. The X-coated Sarns™ Dual-Stage Venous Return Catheters are indicated for single tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. The Sarns ™ Malleable Venous Return Catheters are indicated for venous drainage during cardiopulmonary bypass surgery: the 24, 28, 30, 32, 34, 36 and 40 Fr. are for dual cannulation of the superior and inferior vena cava: the 40 Fr. is for single cannulation of the right atrium. The X-coated Sarns™ Malleable Dual-Stage Venous Return Catheters are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. The X-coated Sarns™ High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-coated Sarns™ Soft-Flow™ Extended Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Device Story

Cannulae and catheters used in open heart surgery; function as conduits for blood drainage and perfusion during cardiopulmonary bypass. Device inputs: blood flow from patient's venous system (superior/inferior vena cava, right atrium) or to arterial system (ascending aorta). Device transforms inputs by routing blood to/from heart-lung machine. X-coat polymer coating on blood-contacting surfaces reduces platelet adhesion. Used in OR by surgeons/perfusionists. Output: physical blood transport. Benefits: reduced platelet adhesion during extracorporeal circulation. Design includes wire reinforcement, stylets, various tip formations, luers, and connectors.

Clinical Evidence

Bench testing only. Evaluations included hemolysis, bond strength (leak, pull, flex testing), and accelerated aging/shelf life. Biocompatibility testing conducted per ISO 10993-1 for limited exposure (<24 hours) blood-contacting devices. No clinical data presented.

Technological Characteristics

Flexible tubes (straight or curved); wire-reinforced; various tip geometries (conical/angled); includes luers/connectors. Blood-contacting surfaces treated with X-coat polymer. Sterilization via Ethylene Oxide (SAL 10^-6). Materials consistent with predicate devices; biocompatibility verified per ISO 10993.

Indications for Use

Indicated for adult patients undergoing cardiopulmonary bypass surgery requiring venous drainage or aortic perfusion. Duration of use limited to 6 hours. No specific contraindications listed.

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

• Sarns™ Malleable Venous Return Catheters (K905224)
• Sarns™ High Flow Aortic Arch Cannula (K770429)
• Sarns™ Soft-Flow™ Extended Aortic Cannula (K934127)

Submission Summary (Full Text)

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K083301

# 6. 510(k) Summary

:

# DEC 1 8 2008

| | 6. 510(k) Summary | 1 |
|------|----------------------------------------------------------------------------|---|
| 6.1. | Submitter Information | 2 |
| 6.2. | Device Names, Predicate Device Names, and Predicate Device 510(k) Numbers: | 2 |
| 6.3. | Statement of Identical Intended Use(s)/Indications: | 3 |
| 6.4. | Principles of Operation and Technology: | 3 |
| 6.5. | Design and Materials: | 4 |
| 6.6. | Performance Evaluations: | 4 |
| 6.7. | Substantial Equivalence Comparison: | 4 |
| | 6.7.1. Intended Use: | 4 |
| | 6.7.2. Principles of Operation and Technology: | 4 |
| | 6.7.3. Design and Materials: | 5 |
| | 6.7.4. Substantial Equivalence Summary: | 5 |
| 6.8. | Additional Safety Information | 5 |
| 6.9. | Conclusion | 5 |

.

:

:

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6.1.

.

| <b>Submitter Information</b> | |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter: · | Terumo Cardiovascular Systems Corporation<br>6200 Jackson Road,<br>Ann Arbor, MI 48103 |
| Primary Contact Name: | Junko Kurosawa,<br>Senior Associate, Regulatory Management<br>Tel: [phone], Extension 6563<br>Fax: [phone] |
| Secondary Contact Name: | Christina Thomas,<br>Manager, Regulatory Management<br>Tel: [phone], Extension 6278<br>Fax: [phone] |
| Date Prepared: | November 7, 2008 |

:

### 6.2. Device Namcs, Predicate Device Names, and Predicate Device 510(k) Numbers:

| Name of the<br>Unmodified Device | 510(k) Number of<br>Sponsor's<br>Unmodified Device | Clearance date | Name of the Modified<br>Device |
|-----------------------------------------------------------|----------------------------------------------------|----------------|-----------------------------------------------------------------------|
| Terumo® Dual-Stage<br>Venous Return<br>Cannula | | | X-coated Terumo®<br>Dual-Stage Venous<br>Return Cannula |
| Sarns™ Dual Stage<br>Venous Return<br>Catheters | | | X-coated Sarns™<br>Dual Stage Venous<br>Return Catheters |
| Sarns™ Malleable<br>Dual Stage Venous<br>Return Catheters | | | X-coated Sarns™<br>Malleable Dual Stage<br>Venous Return<br>Catheters |
| Sarns™ Malleable<br>Venous Return<br>Catheters | K905224 | 1991-02-05 | X-coated Sarns™<br>Malleable Venous<br>Return Catheters |
| Sarns™ High Flow<br>Aortic Arch Cannula | K770429 | 1977-03-16 | X-coated Sarns™<br>High Flow Aortic<br>Arch Cannula |
| Sarns™ Soft-Flow™<br>Extended Aortic<br>Cannula | K934127 | 1994-02-22 | X-coated Sarns™<br>Soft-Flow™<br>Extended Aortic<br>Cannula |

·

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These devices are substantially equivalent in intended use, materials, design, technology, principles of operation, and performance.

### 6.3. Statement of Identical Intended Use(s)/Indications:

TCVS asserts that the intended use(s)/indications for the X-coated Terumo® Dual-Stage Venous Cannula are the same intended use(s)/indications that currently exist for the unmodified Terumo® Dual-Stage Venous Cannula.

TCVS asserts that the intended use(s)/indications for the X-coated Sarns™ Dual Stage Venous Return Catheters are the same intended use(s)/indications that currently exist for the unmodified Sarns™ Dual Stage Venous Return Catheters.

TCVS asserts that the intended use(s)/indications for the X-coated Sarns™ Malleable Venous Return Catheters are the same intended use(s)/indications that currently exist for the unmodified Sarns™ Malleable Venous Return Catheters.

TCVS asserts that the intended use(s)/indications for the X-coated Sarns™ Malleable Dual Stage Venous Return Catheters are the same intended use(s)/indications that currently exist for the unmodified Sarns™ Malleable Dual Stage Venous Keturn Catheters.

TCVS asserts that the intended usc(s)/indications for the X-coated Sarns™ High How Aortic Arch Cannula are the same intended use(s)/indications that currently exist for the unmodified Sarns™ High Flow Aortic Arch Cannula.

TCVS asserts that the intended use(s)/indications for the X-coated Sarns™ Soft-Flow™ Extended Aortic Cannula are the same intended use(s)/indications that currently exist for the unmodificd Sarns™ Soft-Flow™ Extended Aortic Cannula.

These devices are indicated for up to 6 hours of use.

### 6.4. Principles of Operation and Technology:

The X-coated venous and arterial cannulae discussed in this submission are used in open heart surgery.

During open heart surgery blood is drained into a venous cannula just 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 the outlet side of the heart (the paticnt's aorta), where the blood re-enters the patient's circulatory system via the ascending aorta through an arterial cannulae. Platelets adhesion is reduced while blood travels through this circulatory path on the surface covered with X-coat polymer.

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#### 6.5. Design and Materials:

The design of cannulae and catheters is such that they meet their stated intended use, and provide an acceptable level of performance and safety to the patients. Except for the X-coat application, the design and material of the X-coated cannulae will remain the same as the unmodified cannulae. The X-coat application does not affect the cannulae design.

Venous and arterial cannulae contained in this submission are structured as straight, or slightly curved, flexible tubes which are inserted into the heart to circulate blood. Depending on the location of cannulation, size, and clinicians' preference, there is a range of design variations. These features include, but are not limited, wire reinforcement, various stylets used to help guide the cannula, tip formation (conical vs. angled), number of drainage baskets (two stage), luers, and connectors.

The generic materials for these cannulae will remain the same.

### 6.6. Performance Evaluations:

The performance of the X-coated Cannulac will rcmain the same as the unmodified cannulae. The X-coat application does not affect the functional cannulae performance. The X-coat application reduces the platelet adhesion.

The following performance evaluations of the cannulae were conducted to demonstrate its equivalence to the uncoated cannulae.

- . Hemolysis
- . Bond Strength
- o Leak testing
- o Pull strength testing
- o Flex testing
- Accelcrated aging / Shelf life test .

### 6.7. Substantial Equivalence Comparison:

### 6.7.1. Intended Use:

The intended use of the modified device will remain the same as the predicate device.

### 6.7.2. Principles of Operation and Technology:

The principle of operation & technology used in the modified device will remain the same as the predicate device.

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## 6.7.3. Design and Materials:

The design and materials, except for the X-coat application, will remain the same.

## 6.7.4. Substantial Equivalence Summary:

In summary, the X-coated cannulae and the uncoated cannulae are substantially equivalent in intended use, principles of operation and technology, design, and performance. Any noted differences between the devices do not raise new issues of safety and effectiveness.

### 6.8. Additional Safety Information

- . Sterilization conditions have been validated in accordance with AAMI guidelines to provide a Sterility Assurance Lovel (SAL) of 10".
- Post-stcrilization release for use will be determined in consideration of maximum . Ethylene Oxide, Ethylene Chlorohydrin and Ethylene Glycol (as appropriate) residue limits and maximum levels of patient exposure in accordance with EN ISO 10993-7 and AAMI TIR-19.
- . Biocompatibility studies were conducted using the same matcrials or combination of materials for predicate devices as recommended in the FDA General Program Mcmorandum #G95-1 (5/1/95): Use of International Standard ISO 10993: 2003, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing," [External Communicating Devices, Circulating Blood, Limited Exposure (≤ 24 hours) Contact Duration]. The blood contacting materials were found to be biocompatible.
- . Terumo has conducted material characterization studies - including physio-chemical profiles of aged and non-aged devices to demonstrate stability of the materials, and found the materials to be stable over the expiry of the product.

### 6.9. Conclusion

In summary, the X-coated cannulac are substantially equivalent in intended use, principles of operation and technology, design and performance to the uncoated cannulae.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the symbol.

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Terumo Cardiovascular Systems Corp. c/o Mr. Junka Kurosawa Senior Associate, Regulatory Management 6200 Jackson Rd. Ann Arbor, MI 48103

DEC 1 8 2008

Re: K083301

> X-coated Terumo® Dual-Stage Venous Return Cannula, X-coated Sarns™ Dual-Stage Venous Return Catheters X-coated Sams™ Malleable Venous Return Catheters, X-coated Sarns™ Malleable Dual-Stage Venous Return Catheters, X-coated Sarns™ High Flow Aortic Arch Cannula, X-coated Sarns™ Soft-Flow™ Extended Aortic Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: Class II (two) Product Code: DWF Dated: November 7, 2008 Received: November 18, 2008

Dear Mr. Kurosawa:

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

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Page 2 - Mr. Junka Kurosawa

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.

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.

R. Vahner

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): K083301

Device Name: X-coated Terumo® Dual-Stage Venous Return Cannula, X-coated Sarns™ Dual-Stage Venous Return Catheters X-coated Sarns™ Malleable Venous Return Catheters, X-coated Sarns™ Malleable Dual-Stage Venous Return Catheters, X-coated Sarns™ High Flow Aortic Arch Cannula, X-coated Sarns ™ Soft-Flow TM Extended Aortic Cannula.

### Indications For Use:

The X-coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures.

The X-coated Terumo® Dual-Stage Venous Return Cannula is indicated for use for adult single tube blood drainage from the right atrium and inferior vena cava (IVC) and delivery of the blood to the extracorporeal circuit during cardiopulmonary bypass.

The X-coated Sarns™ Dual-Stage Venous Return Catheters are indicated for single tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery.

The Sarns ™ Malleable Venous Return Catheters are indicated for venous drainage during cardiopulmonary bypass surgery: the 24, 28, 30, 32, 34, 36 and 40 Fr. are for dual cannulation of the superior and inferior vena cava: the 40 Fr. is for single cannulation of the right atrium.

The X-coated Sarns™ Malleable Dual-Stage Venous Return Catheters are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery.

The X-coated Sarns™ High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

The X-coated Sarns™ Soft-Flow™ Extended Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

These devices are indicated for up to 6 hours of use.

12-12-0

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CONFIDENTIAL

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Prescription Use X OR

Over-The-Counter Use

(Per 21 CFR 801.109)

# (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

. .

Concurrence of CDRH, Office of Device Evaluation (ODE)

une R.v.hnes

(Division Sign-Off) (Division of Cardiovascular Devices

510(k) Number_Ko8 330 |