BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT

K052524 · Medtronic Perfusion Systems · DWF · Nov 22, 2005 · Cardiovascular

Device Facts

• Record ID: K052524
• Device Name: BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT
• Applicant: Medtronic Perfusion Systems
• Product Code: DWF · Cardiovascular
• Decision Date: Nov 22, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The percutaneous cannula is for use by trained physicians only, to cannulate vessels, perfuse vessels or organs in a patient for cardiopulmonary bypass circulation. Standard surgical or percutaneous insertion techniques can be employed. This product is intended for use up to six hours or less.

Device Story

Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit consists of wire-wound, flexible venous cannula with multiple side holes and introducer; features improved introducer-to-cannula tip transition and 3/8" barbed connector. Used by trained physicians in clinical settings for cardiopulmonary bypass; facilitates vessel cannulation and organ perfusion. Insertion depth marks assist in positioning. Available in 19 Fr, 21 Fr, and 25 Fr sizes; offered in Carmeda coated or uncoated versions. Device is sterile, non-pyrogenic, and disposable for single-use, short-term (≤6 hours) applications. Provides access for extracorporeal equipment connection.

Clinical Evidence

No clinical data. Substantial equivalence established through bench testing and design validation.

Technological Characteristics

Wire-wound cannula body with basket-type side holes; 30.125-inch length; 19, 21, 25 Fr sizes; Carmeda coated or uncoated options; 3/8" barbed connector; sterile, non-pyrogenic, single-use disposable.

Indications for Use

Indicated for patients requiring cardiopulmonary bypass circulation; for use by trained physicians to cannulate vessels or perfuse organs; intended for short-term use (6 hours or less).

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 Femoral Cannula and Introducer (K884129)

Submission Summary (Full Text)

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

NOV 2 2 2005

K052524

# 510(k) Summary

| Date Prepared: | September 7, 2005 |
|----------------|-------------------|
|----------------|-------------------|

Submitter:

Medtronic Perfusion Systems 7611 Northland Boulevard Brooklyn Park, MN 55428

Contact Person:

Bruce Backlund Senior Regulatory Affairs Specialist

Phone: [phone] [phone] Fax:

.

# Device Name and Classification:

| Trade Name: | Bio-Medicus Multi-Stage Venous Femoral Percutaneous<br>Kit |
|--------------------|------------------------------------------------------------|
| Common Name: | Percutaneous Cannula and Introducer Set |
| Classification: | Class II |
| Predicate Devices: | Bio-Medicus Femoral Cannula and Introducer<br>K884129 |

And Children Children Children

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

#### Device Description

The Biomedicus Femoral Cannula and Introducer Set include the new Bio-Medicus Femoral Venous Cannula and Introducer. The Cannula are one piece, wire wound bodies with basket type holes. Insertion depth marks aid in positioning the Cannula. All are supplied sterile, and non-pyrogenic and are single use.

This new Biomedicus Femoral Venous Cannula and Introducer Set consists of a longer flexible cannula with multiple side holes, a longer introducer, an improved introducer to cannula tip transition and 3/8" barbed connector.

The cannulae are available in 19 Fr, 21 Fr and 25 Fr sizes.

The Cannula are 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.

The overall product length is approximately 30.125 inches. The device is sterile, nonpvrogenic and disposable, and is intended for short-term single use.

The product will be available in both Carmeda coated and uncoated versions.

#### Indications for Use

The percutaneous cannula is for use by trained physicians only, to cannulate vessels, perfuse vessels or organs in a patient for cardiopulmonary bypass circulation. Standard surgical or percutaneous insertion techniques can be employed.

This product is intended for use up to six hours or less.

#### Comparison to Predicate Device

The predicate device 510(k) K884129 was cleared on December 21, 1988. This 510(k) was for various sizes and shapes of Cannula.

This Cannula was indicated as intended 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.

A copy of the original IFU as provided in the 510(k) is included in Appendix A.

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

# Summary of Performance Data

Validation testing was used to establish the performance characteristic of the modifications of this device from the previously marketed device.

### Conclusion

Medtronic Perfusion Systems has demonstrated that the Bio-Medicus Femoral Venous Cannula and Introducer is substantially equivalent to the predicate devices based upon design, test results, and indications for use.

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" written around it. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, with flowing lines above them.

Public Health Service

NOV 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Perfusion Systems c/o Mr. Bruce Backlund Senior Regulatory Affairs Specialist 7611 Northland Drive N Brooklyn Park, MN 55428

Re: K052524

Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, and Tubing Regulatory Class: Class II (Two) Product Code: DWF Dated: October 28, 2005 Received: October 31, 2005

Dear Mr. Backlund:

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.

{4}------------------------------------------------

Page 2 - Mr. Bruce Backlund

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.

Dmne R. Wagner

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): Koss252A

# Device Name: Bio-Medicus Multistage Venous Femoral Percutaneous Kit

Indications for Use:

The percutaneous cannula is for use by trained physicians only, to cannulate vessels, perfuse vessels or organs in a patient for cardiopulmonary bypass circulation. Standard surgical or percutaneous insertion techniques can be employed.

This product is intended for use up to six hours or less

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)

R. Vorhuer

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K c52524

Page | of |

ੰ

(Posted November 13, 2003)