ANGIOTECH CVC

K073520 · Angiotech Pharmaceuticals, Inc. · FOZ · Apr 11, 2008 · General Hospital

Device Facts

• Record ID: K073520
• Device Name: ANGIOTECH CVC
• Applicant: Angiotech Pharmaceuticals, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Apr 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

The multiple-lumen catheter permits venous access to the central circulation. The Angiotech antimicrobial surface is intended to help provide protection against bacterial colonization on the catheter surface and it may help reduce catheter-related infections. The catheter is not intended to be used as a treatment for existing infections, nor is it indicated for longer than 30 days use.

Device Story

Angiotech CVC is a 7-French, triple-lumen, polyurethane central venous catheter; features MEDI-COAT antimicrobial surface containing 5-fluorouracil (5-FU) to prevent bacterial colonization. Used in clinical settings (e.g., ICU) by healthcare providers for central venous access. Device provides physical access to central circulation while antimicrobial coating reduces risk of catheter-related bloodstream infections. Clinical decision-making supported by reduced infection risk profile. Benefits include protection against bacterial colonization on catheter surface.

Clinical Evidence

Prospective, randomized clinical trial in adult ICU patients compared Angiotech CVC to predicate device. Primary endpoint: prevention of bacterial colonization on catheters. Results showed Angiotech CVC was effective and non-inferior. Catheter-related bloodstream infection rate was 0% for Angiotech CVC group vs. 2 cases in predicate group. Catheter insertion site infection rates were low and comparable. No adverse effects reported.

Technological Characteristics

7-French, triple-lumen, polyurethane catheter. Antimicrobial surface (MEDI-COAT) contains 48.8 µg/cm of 5-fluorouracil. Complies with ISO 10555-1 (sterile, single-use intravascular catheters) and ISO 10555-3 (central venous catheters).

Indications for Use

Indicated for patients requiring short-term (up to 30 days) venous access to the central circulation. Not indicated for treatment of existing infections.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• ARROWg+ard Blue Central Venous Catheter (K993691)
• ARROWg+ard Blue Central Venous Catheter (K900263)

Submission Summary (Full Text)

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KO 73520 page 2 of 2

Section 5 - 510(k) Summary

| Technological<br>characteristics: | The proposed device has the same technological characteristics as the<br>predicate device(s) with difference being the use of 5-FU to prevent<br>bacterial colonization. |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance tests: | The product meets all the requirements of ISO 10555-1 (Sterile,<br>single use intravascular catheters) and ISO10555-3 (Sterile,<br>central venous catheters)<br>The following were performed to demonstrate substantial<br>equivalence catheter stiffness catheter elongation catheter flexural fatigue tolerance priming volume: distal lumen priming volume: medial lumen priming volume: proximal lumen distal lumen flow rate medial lumen flow rate proximal lumen flow rate clinical evaluation |
| Assessment of non-<br>clinical performance<br>data: | The Angiotech CVC has undergone testing to that provides<br>assurance of safety and effectiveness for its intended use. Testing<br>included both <i>in vitro</i> and <i>in vivo</i> biocompatibility, <i>in vitro</i> zone<br>of inhibition, <i>in vitro</i> minimal inhibitory concentration, <i>in vitro</i><br>minimal bactericidal concentration, mechanical and physical<br>testing, and drug release testing. |
| Assessment of clinical<br>performance data: | The Angiotech® CVC was evaluated in a prospective,<br>randomized clinical trial as compared to the predicate device.<br>Angiotech Catheter insertions in adult patients in an ICU setting<br>proved that the Angiotech CVC was effective and non-inferior<br>when compared to the predicate device for prevention of bacterial<br>colonization on catheters. The comparability of the two devices<br>was further supported by the low rate of catheter-related<br>bloodstream infection, which occurred in none of the Angiotech<br>CVC group and two in the predicate device group. The rates of<br>catheter insertion site infections were low and comparable in the<br>two groups. No adverse effects have been associated with the<br>clinical use of Angiotech CVC. The results of the clinical trial<br>support the intended use of the Angiotech CVC. |
| Conclusion: | The results of non-clinical and clinical testing demonstrate that<br>the device is as safe and effective as the legally marketed<br>predicate device(s). |

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K073520 page 1 of 2

## Section 5 - 510(k) Summary

In accordance with 212 CFR 807.87, the following 510(k) summary has been prepared per 21 CFR 8107.92

| Submitter | Angiotech BioCoatings Corp<br>336 Summit Point Drive<br>Henrietta, NY 14467 USA |
|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant Contact: | Trudy D. Estridge, Ph.D.<br>Director of Regulatory Affairs<br>Angiotech<br>Dulles Gateway Center<br>13921 Park Center Road, Suite 100<br>Herndon, VA 20171 USA<br>Voice: 703-796-8927<br>Fax: [phone]<br>Email: [e-mail] |
| Date summary<br>prepared: | December 13, 2007 |
| Device trade name: | Angiotech® CVC |
| Device Common<br>Name: | Central Venous Catheter (CVC) |
| Device classification: | Catheter, intravascular, therapeutic, short-term less than 30 days.<br>Product Code FOZ, 21 CFR 880.5200, Class II |
| Legally marketed<br>devices to which the<br>device is substantially<br>equivalent: | ARROWg+ard Blue® Central Venous Catheter<br>K993691 and K900263 |
| Description of the<br>device: | The Angiotech® CVC Multi-lumen Central Venous Catheter with<br>MEDI-COATTM Antimicrobial Surface is a 7-French, polyurethane<br>triple lumen, 15 or 20-cm catheter with a MEDI-COAT containing 48.8<br>µg/cm of 5-fluorouracil. |
| Intended use of the<br>device: | The multiple-lumen catheter permits venous access to the central<br>circulation. The Angiotech antimicrobial surface is intended to help<br>provide protection against bacterial colonization on the catheter surface<br>and it may help reduce catheter-related infections. The catheter is not<br>intended to be used as a treatment for existing infections, nor is it<br>indicated for longer than 30 days use. |

## Angiotech CVC 510(k) Summary

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Public Health Service

APR 1 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Trudy D. Estridge, Ph.D. Director of Regulatory Affairs Angiotech Pharmaceuticals, Incorporated Dulles Gateway Center 13921 Park Center Road, Suite 100 Herndon, Virginia 20171

Re: K073520

Trade/Device Name: Angiotech CVC Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: March 28, 2008 Received: March 28, 2008

Dear Dr. Estridge:

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 - Dr. Estridge

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,

Chiu-Lin, Ph.D.

Chiu Lin, Ph,D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section 4 - Indications for Use Statement

510k number if known:

K073520

Device Name:

Angiotech CVC

Indications for Use:

The multiple-lumen catheter permits venous access to the central circulation. The Angiotech antimicrobial surface is intended to help provide protection against bacterial colonization on the catheter surface and it may help reduce catheterrelated infections. The catheter is not intended to be used as a treatment for existing infections, nor is it indicated for longer than 30 days 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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Concurrence of CDRH, Office of Device Evaluation (ODE)

Charles Brown Jr for ADW
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K073520

Section 4 Page 1 of 1