MEDLINE VESSEL CANNULA

K111147 · Medline Industries, Inc. · DWF · Jul 19, 2011 · Cardiovascular

Device Facts

• Record ID: K111147
• Device Name: MEDLINE VESSEL CANNULA
• Applicant: Medline Industries, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Jul 19, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2

Intended Use

Medline Vessel Cannulae are intended for use in conjunction with cardiopulmonary bypass surgery or in vascular surgery to perfuse a vein graft or to help check for leaks in a harvested vein which will be used for a graft.

Device Story

Medline Vessel Cannula is a sterile, single-use, disposable device used during cardiopulmonary bypass or vascular surgery. The device consists of a 2-inch flexible, kink-resistant body featuring a one-way valve and a soft blunt tip, terminating in a female luer. It is operated by clinicians to perfuse vein grafts or to facilitate leak testing in harvested veins. The device provides a physical conduit for fluid delivery to ensure graft integrity prior to implantation, aiding in surgical preparation and patient safety.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 (sensitization, irritation, cytotoxicity, intramuscular implant, acute/subchronic systemic toxicity, pyrogen, hemolysis, complement activation). Functional performance testing conducted per ISO/ASTM standards (appearance, dimensions, flow direction, tensile strength, leakage).

Technological Characteristics

Flexible, kink-resistant body with one-way valve and female luer; 2-inch length; soft blunt tip. Materials meet ISO 10993 biocompatibility standards. Single-use, sterile, non-pyrogenic. No software or electronic components.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass or vascular surgery requiring vein graft perfusion or leak testing of harvested veins.

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

• DLP Vessel Cannulae (Medtronic) (K810820)

Submission Summary (Full Text)

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# 510(k) Summary

K 11147 JUL 1 9 2011

## Summary Preparation Date

July 1, 2011

# Submitter / 510(k) Sponsor

Medline Industries, Inc. One Medline Place Mundelein, IL 60060

#### Contact Person

Matt Clausen Regulatory Affairs Specialist Phone: [phone] Fax: [phone]

# Device Name / Classification

Device Name: Vessel Cannula Proprietary Name: Medline Vessel Cannula Common Name: Vessel Cannulae Classification Name: Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass under 21 CFR 870.4210

# Predicate Device

DLP Vessel Cannulae (Medtronic), K810820

#### Device Description

Medline's Vessel Cannula are to be supplied as sterile, non-pyrogenic, single use, disposable devices. They are visually transparent and consist of a flexible, kink resistant body with a one way valve. This vessel cannula is 2 inches in length and terminates with a female luer and a soft blunt tip.

#### Indications for Use

Medline Vessel Cannulae are intended for use in conjunction with cardiopulmonary bypass surgery or in vascular surgery to perfuse a vein graft or to help check for leaks in a harvested vein which will be used for a graft.

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# Summary of Technological Characteristics

Information included in this submission demonstrates that there are no significant differences in technological characteristics between Medline's Vessel Cannula and the cited predicate device.

## Summary of Non-Clinical Testing

Biocompatibility testing of the Medline Vessel Cannula demonstrated that it meets the requirements of guidelines presented in the ISO 10993 Testing Standard. Below is a listing of the specific testing performed.

- 1. Sensitization
- 2. Irritation
- 3. Cytotoxicity
- 4. Intramuscular Implant
- న్. Acute Systemic Toxicity
- 6. Subchronic Systemic Toxicity
- 7. Pyrogen
- 8. Hemolysis (direct contact method)
- 9. Hemolysis (extract method)
- 10. Complement Activation

Functional performance testing of the Medline Vessel Cannula demonstrated device effectiveness in accordance with relevant ISO/ASTM test methods. Below is a listing of the specific testing performed.

- Appearance 1.
- 2. Dimensions
- 3. Direction of Flow
- Tensile Strength 4.
- 5. Leakage

# Conclusion

In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline Vessel Cannula is safe, effective and substantially equivalent as described herein.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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 depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

Medline Industries, Inc. c/o Mr. Matt Clausen Regulatory Affairs Specialist One Medline Place Mundelein, IL 60060

JUL 19 2011

Re: K11147 Medline Vessel Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheters, cannula, or tubing Regulatory Class: Class II (two) Product Code: DWF Dated: April 21, 2011 Received: April 25, 2011

Dear Mr. Clausen:

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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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. D. Zuckerman, M.D.

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): K11147

Device Name:

# Medline Vessel Cannula

Indications For Use:

Medline Vessel Cannulae are intended for use in conjunction with cardiopulmonary bypass surgery or in vascular surgery to perfuse a vein graft or to help check for leaks in a harvested vein which will be used for a graft.

Prescription Use X (Part 21 CFR 801 Subpart D) OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

Division of Cardiovascular Devices

510(k) Number K111147