VASCUTEK CANNULA GRAFT, MODEL CGS2008S

K081560 · Vascutek, Ltd. · DWF · Feb 10, 2009 · Cardiovascular

Device Facts

• Record ID: K081560
• Device Name: VASCUTEK CANNULA GRAFT, MODEL CGS2008S
• Applicant: Vascutek, Ltd.
• Product Code: DWF · Cardiovascular
• Decision Date: Feb 10, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended to be used in axillary arterial perfusion during cardiopulmonary bypass procedures. These devices are indicated for up to 6 hours of use.

Device Story

The Vascutek Cannula Graft is a vascular cannula designed for axillary arterial perfusion during cardiopulmonary bypass. It functions by connecting the patient to a cardiopulmonary bypass machine to maintain circulation and oxygenation. The device is a hybrid assembly combining a Terumo Soft-Flow® Aortic Cannula tip with a Vascutek SEALPTFE Wrap graft, bonded using medical-grade adhesive. This modification replaces the standard PVC cannula tip with a softer ePTFE graft material to reduce potential tissue trauma during vessel attachment. The device is used in hospital operating theaters by qualified surgeons. It is provided sterile for single use. The output is the return of oxygenated blood to the patient's circulatory system. Clinical benefit includes reduced trauma at the cannulation site compared to traditional rigid cannula tips.

Clinical Evidence

Bench testing only. Testing included tensile strength and leak testing of the attachment site between the cannula and the graft. Results showed the attachment strength exceeded that of the predicate Terumo Soft-Flow® Cannula. No leakage was observed. Performance was verified after 2 years of accelerated aging.

Technological Characteristics

Materials: PVC (cannula) and gelatin-sealed ePTFE (graft) bonded with medical-grade adhesive. Dimensions: ~50 cm length, 8 mm diameter. Energy source: None (passive). Connectivity: None. Sterilization: Ethylene oxide. Single-use. Class II device.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass procedures requiring axillary arterial perfusion. Intended for use up to 6 hours. Prescription use only.

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

• Terumo Soft-Flow® Cannula (K934127)
• Vascutek SEALPTFE Wrap graft (K041528)

Submission Summary (Full Text)

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K081560

## 510(k) SUMMARY

FEB 1 0 2009

# VASCUTEK CANNULA GRAFT

# Date prepared: 20th of May 2008 Revised: 10th February 2009

## Page 1 of 4

| Common/Usual Name : | Cardiopulmonary bypass vascular catheter, cannula, or tubing | | | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| Proprietary Name(s) : | Vascutek Cannula Graft (Model Number: CGS2008S) | | | |
| Classification Name : | Catheter, Cannula and Tubing, Vascular, Cardiopulmonary<br>Bypass | | | |
| Classification : | The Food and Drug Administration has classified these devices<br>as Class II devices under classification 21 CFR 870.4210.<br>Classification, DWF. | | | |
| Applicant and :<br>510(k) submitter | Karen Kelso<br>Regulatory Affairs Manager<br>Vascutek Ltd.<br>Newmains Avenue<br>Inchinnan Industrial Estate<br>Renfrewshire, Scotland<br>PA4 9RR, United Kingdom | | | |
| | Phone: [phone]<br>Fax: [phone] | | | |

## Device Predicates:

| Predicate Device<br>Name | Common Name | Classification | FDA Clearance<br>Date | 510(k) |
|---------------------------------|-----------------------------------------------------------------------|----------------|------------------------|---------|
| Terumo Soft-Flow®<br>Cannula | Cardiopulmonary<br>bypass vascular<br>catheter, cannula,<br>or tubing | Class II DWF | 22nd February<br>1994 | K934127 |
| Vascutek SEALPTFE<br>Wrap graft | Vascular graft,<br>prosthesis | Class II DSY | 14th September<br>2004 | K041528 |

## Device Description:

The Vascutek Cannula Graft is a modified device design. It is a combination of a Terumo Soft-Flow® Aortic Cannula (K934127) and a Vascutek SEALPTFE Wrap graft (K041528). It is intended for use in perfusion during cardiopulmonary bypass procedures. The reason for the modification is summarised as follows. Direct introduction of a cannula tip into a patient's blood vessel may cause tissue trauma during attachment of the patient to a Replacement of the cannula tip with a softer, cardiopulmonary bypass machine

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SEALPTFE Wrap vascular graft, maybe less traumatic and be preferred by some surgeons. This is the design rationale for the Vascutek Cannula Graft.

There are no new materials used in the Vascutek Cannula Graft, other than the use of medical grade adhesive to create the bond between the Terumo Soft-Flow® Cannula (K934127) and Vascuteks SEALPTFE Wrap graft (K041528). Both predicate devices use materials with an extensive history of use in cardiovascular and other medical applications and have been thoroughly tested historically for their respective 510(k) clearances. All materials used in the manufacture of the Vascutek Cannula Graft are biocompatible and non-toxic.

The physical properties of the combined predicate devices i.e. the Terumo Soft-Flow® Aortic Cannula (K934127) and the Vascutek SEALPTFE Wrap graft (K041528) remain unchanged and the point of attachment of the component devices has been tested and shown to be suitable for the intended use.

The Vascutek Cannula Graft is a finished product, provided sterile for single use only.

The overall length of the Vascutek Cannula Graft is approximately 50 cm and the cannula and graft portions are both 8 mm in diameter. The Vascutek Cannula Graft is only available in a single model i.e. a CGS2008S.

# Intended Use:

The intended use of the Vascutek Cannula Graft is:

"This device is intended to be used in axillary arterial perfusion during cardiopulmonary bypass procedures. These devices are indicated for up to 6 hours of use".

This intended use is substantially equivalent to the intended use of the Terumo Soft-Flow® Aortic Cannula predicate device, K934127 i.e. arterial perfusion during cardiopulmonary bypass.

# Principles of Operation and Technology:

Cardiopulmonary bypass temporarily takes over the function of the heart and lungs when patients are undergoing surgery. Cardiopulmonary bypass maintains the circulation of blood and the oxygen content of the patient's body. Cardiopulmonary bypass consists of two main functional units, the pump and the oxygenator, which removes oxygen deprived blood from a patient's body and replaces it with oxygen-rich blood through a series of tubes. Arterial cannulae are commonly used to enable connection of the patient to a cardiopulmonary bypass machine.

## Performance:

Studies were undertaken, specifically to address the attachment site of the Terumo Soft-Flow® Cannula (K934127) and the Vascutek SEALPTFE Wrap graft (K041528). Testing consisted of tensile strength and leak testing. Results demonstrated that the strength of the attachment of the two combined devices was greater than the tensile strength of the

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predicate Terumo Soft-Flow® Cannula itself (K934127). No leakage was observed demonstrating equivalence to both predicate devices. These results were also demonstrated after 2 years accelerated ageing of the Vascutek Cannula Graft.

#### Substantial Equivalence:

The Vascutek Cannula Graft is substantially equivalent in intended use, design and materials, performance, principles of operation and technology to the predicate devices, which are summarised below. This is shown comprehensively in Table 2, Section 10 of this pre-market notification.

#### Intended Use:

Vascutek's Cannula Graft and the Terumo Soft-Flow® Cannula predicate device (K934127) share the same intended use, i.e. both are indicated for arterial perfusion during bypass surgery for up to 6 hours.

The Vascutek Cannula Graft and both predicate devices are intended for prescription use only.

#### Design and Materials:

The design of the Vascutek Cannula Graft is the same as the predicate devices i.e. it is a combination of a Terumo Soft-Flow® Cannula and a Vascutek SEALPTFE Wrap graft. The only difference is the replacement of the PVC tip of the Terumo Soft-Flow® Cannula (K934127) with a Vascutek SEALPTFE Wrap graft (K041528). As stated previously, the replacement of the cannula tip with a softer, SEALPTFE Wrap vascular graft, maybe less traumatic and be preferred by some surgeons.

The materials of the Vascutek Cannula Graft are the same as the predicate devices i.e. PVC (Terumo Soft-Flow® Cannula) and gelatin sealed ePTFE (Vascutek SEALPTFE Wrap graft).

There are therefore no new materials other than the medical grade adhesive used at the point of attachment, which has undergone comprehensive biocompatibility testing, which demonstrates that it is biocompatible and non-toxic.

#### Performance:

Studies on the performance of the attachment site demonstrated that the strength of the attachment of the two combined devices was greater than the predicate Terumo Soft-Flow® Cannula itself (K934127). No leakage was observed demonstrating equivalence to both predicate devices. These results were also demonstrated after 2 years accelerated ageing of the Vascutek Cannula Graft.

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## Principles of Operation and Technology:

Both the Vascutek Cannula Graft and the predicate Terumo Soft-Flow® Cannula (K934127) are used in open heart surgery to return oxygenated blood to the patient.

The Vascutek Cannula Graft and both predicate devices are intended only for use in hospital operating theatres by suitably qualified surgeons.

The Vascutek Cannula Graft and both predicate devices are provided sterile by ethylene oxide for single use only.

## Addition Information:

Vascutek Cannula Grafts are packaged using the same materials as those used for Vascuteks other vascular graft products and the Vascutek SEALPTFE Wrap graff predicate device (K041528).

Vascutek has conducted testing on aged and non-aged Vascutek Cannula Grafts to demonstrate stability of the materials and found the Vascutek Cannula Graft to be stable over the expiry of the product i.e. 2 years.

## Substantial Equivalence Summary:

In summary, the Vascutek Cannula Graft is substantially equivalent in intended use, design and materials, performance, principles of operation and technology to the predicate devices

#### Conclusion:

In conclusion, the Vascutek Cannula Graft is substantially equivalent to the predicate devices in commercial distribution and results of non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate devices.

Karari Kebo

Signature

Signature

10-2-09
Date

ব

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the left side of the logo.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 2009

Vascutek Ltd. c/o Ms. Karen Kelso Regulatory Affairs Manager Newmains Avenue Inchinnan Industrial Estate Renfrewshire, Scotland PA4 9RR, United Kingdom

Re: K081560

> Vascutek Cannula Graft Regulation Number: 21 CFR 870.4210 Regulation Name: Catheter, Cannula and Tubing Vascular, Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DWF Dated: January 19, 2009 Received: January 22, 2009

# Dear Ms. Kelso:

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. Karen Kelso

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 (OS) 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,

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): Koll 1360

Device Name:

Vascutek Cannula Graft

Indications for Use:

This device is intended to be used in axillary arterial perfusion during cardiopulmonary bypass procedures. These devices 好 -are indicated for up to 6 hours of use.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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Conqurrence of CDRH, Office of Device Evaluation (ODE) and and the comments of the states of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comm (Division Sign Off) Page __ Division of Caralovasoural Devices 510(k) Number 6081560

(Posted November 13, 2003)