NOVAPORT ONE VASCULAR ACCESS CANNULA

K112565 · Novalung GmbH · DWF · Dec 6, 2011 · Cardiovascular

Device Facts

• Record ID: K112565
• Device Name: NOVAPORT ONE VASCULAR ACCESS CANNULA
• Applicant: Novalung GmbH
• Product Code: DWF · Cardiovascular
• Decision Date: Dec 6, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The NovaPort® One Vascular Access cannula with its associated Introducer Kit is a percutaneous cannula intended to be used to cannulate blood vessels in patients requiring extracorporeal support such as cardiopulmonary bypass. The application of NovaPort® One cannula is limited to < 6 hours.

Device Story

NovaPort® One is a wire-reinforced, thin-walled polyurethane femoral cannula with an integrated introducer kit; used for percutaneous vessel cannulation during extracorporeal support (e.g., cardiopulmonary bypass). Features a beveled tip and insertion depth marks for positioning. All blood-contacting surfaces are treated with Novalung Coating—a bioactive, non-thrombogenic surface consisting of high molecular weight heparin from pig mucosa bound to immobilized polypeptides. Device is single-use, sterile, and non-pyrogenic. Operated by clinicians in a surgical or clinical setting to facilitate connection to extracorporeal equipment. Provides vascular access for blood perfusion; limited to short-term use (< 6 hours).

Clinical Evidence

Bench testing only. Testing included pressure/burst, simulated use, kink resistance, tensile strength, flow characteristics, hemolysis, biocompatibility, and coating validation.

Technological Characteristics

Polyurethane wire-reinforced cannula; beveled tip; Novalung heparin-based bioactive coating. Available in 13F, 17F, 19F, 21F diameters; 90 mm length. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for patients requiring extracorporeal support, such as cardiopulmonary bypass, for cannulation of blood vessels. Use is limited to < 6 hours.

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

• Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit (K052524)
• One Piece Pediatric Arterial Cannula 7000 Models (K024069)

Reference Devices

• Bioline coating (K102532)
• Novalung sLA (K072362)

Submission Summary (Full Text)

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

K112565

# TRADITIONAL 510(K)

510(k) Summary

For the Novalung® GmbH NovaPort® One Vascular Access DEC - 6 2011

# SUBMITTER/510(k) HOLDER: I.

Novalung® GmbH Zukunftspark 1 D-74076 Heilbronn, Germany Telephone: [phone] - 0 Telefax: [phone] - 299 FDA Establishment Registration Number: 3004569487

#### II. CONTACT PERSON

Leann Christman, MEd Telephone: [phone] ext. 232 Fax: [phone] Email: [e-mail]

#### III. DEVICE NAME

Proprietary Trade Name: NovaPort® One Vascular Access Common/Usual Name: Percutaneous Cannula and Introducer Set

#### DEVICE CLASS: IV.

Class II

#### CLASSIFICATION NAME: V.

Cardiopulmonary bypass vascular catheter, cannula, or tubing Classification regulation: Sec. 870.4210

#### PRODUCT CODES: VI.

DWF

#### VII. PREDICATE DEVICES

K052524, Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit K024069. One Piece Pediatric Arterial Cannula 7000 Models

## PRODUCT DESCRIPTION VIII.

The NovaPort® One Vascular Access cannula with Novalung coating are a wire reinforced, thin walled femoral cannula made of polyurethane. A cone without wire reinforcement allows clamping and serves as transition to a connector. The beveled tip is not a separate piece and is part of the whole cannula body. The NovaPort® one cannulas are inserted percutaneously into

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

vessels. Insertion depth marks aid in positioning the cannula. They have a beveled tip that is made as part of the PVC body.

The Cannula is intended to be used to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal equipment. The cannula introducer is intended to facilitate proper insertion and placement of the appropriate sized cannula within the vessel for cardiopulmonary bypass.

All surfaces of the NovaPort® One which come into contact with blood are protected with the Novalung Coating. This coating is a bioactive, stable, biocompatible and non-thrombogenic surface. This coating consists of high molecular weight heparin from pig mucosa bound covalently and ionically to immobilized polypeptides.

NovaPort® one cannula is available in insertion lengths of 90 mm and with outer diameters of 13 F, 17 F, 19 F and 21 F. All are supplied sterile with Novalung coated, non-pyrogenic, and are single use.

## IX. INDICATIONS OF USE

ﮯ ﻣﻌﻤ ﮨ

The NovaPort® One Vascular Access cannula with its associated Introducer Kit is a Novalung coated percutaneous cannula intended to be used to cannulate blood vessels in patients requiring extracorporeal support such as cardiopulmonary bypass. The application of NovaPort® One cannula is limited to limited to < 6 hours.

# TECHNOLOGICAL CHARACTERISITICS AND SUBSTANTIAL EQUIVALENCE X.

The NovaPort® One Vascular Access are identical to the predicate devices in terms of intended use, indications for use, levels of attachmental scientific technology, materials and surgical technique. Based on the information provided herein, the subject NovaPort® One Vascular Access have been demonstrated to be substantially equivalent to the previously cleared Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit (K052524) and the One Piece Pediatric Arterial Cannula 7000 Models. Please refer to the Table 10-1 for a comparison of the predicates and subject Novaport regarding substantial equivalence.

Further on the indications for use of the Novalung coating of the Novaport One cannula with Novalung coating is the same as with the Bioline coating (K102532) and Novalung sLA (K072362).

#### PERFORMANCE TESTING XI.

The NovaPort® One Vascular Access was subjected to numerous tests and comparisons to the predicate device: testing included pressure/burst, simulated use, kink resistance, tensile strength, flow characteristics, hemolysis, biocompatibility, and validation testing to coating.

# SUMMARY AND CONCLUSIONS XII.

Novalung GmbH makes the claim that the NovaPort® One Vascular Access is substantially equivalent to the cited predicates in terms of intended use, indications for use, fundamental technology, design characteristics, generic materials of construction, and operational characteristics. As shown in Table 10-1 and the discussion above, the differences between the NovaPort® One Vascular Access and cited predicates are minor and raise no new issues of

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

safety or effectiveness. In addition, comparative testing included in this 510(k) premarket notification demonstrates that the NovaPort® One Vascular Access has performance substantially equivalent to Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit (K052524) and the One Piece Pediatric Arterial Cannula 7000 Models (K024069). The Novaport One meets design specifications.

ﻬﻢ ﺷﻬﺪ ﺑﺎﻟﻘﺮﻥ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟ

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

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three curved lines that resemble a person embracing another person.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

Novalung® GmbH c/o Ms. Leann Christman MC3, Inc. 3550 West Liberty, Suite 3 Ann Arbor, MI 48103

JAN 12 2012

K112565 Re:

NovaPort® One Vascular Access and Introducer Kit Regulation Number: 21 CFR 870.4210 Regulation Name: Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass Regulatory Class: Class II Product Code: DWF Dated: November 4, 2011 Received: November 8, 2011

Dear Ms. Christman:

This letter corrects our substantially equivalent letter of December 6, 2011

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 (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general anorols 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 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. Leann Christman

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

W

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

Enclosure

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

# INDICATIONS FOR USE

510(k) Number (if known): K112565

Device Name: NovaPort® One Vascular Access

Indications for Use:

The NovaPort® One Vascular Access cannula with its associated Introducer Kit is a percutaneous cannula intended to be used to cannulate blood vessels in patients requiring extracorporeal support such as cardiopulmonary bypass. The application of NovaPort® One cannula is limited to < 6 hours.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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)

.f.hilehem

(Division Sign-Off) Division of Cardiovascular Device

Page 1 of 1

510(k) Number K 112565

Novalung® GmbH, Traditional 510(k) NovaPort® One Vascular Access

· September 1, 2011

Confidential Page 4-1