MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE

K994171 · Medtronic Cardiac Surgical Products · DWF · Apr 27, 2000 · Cardiovascular

Device Facts

• Record ID: K994171
• Device Name: MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE
• Applicant: Medtronic Cardiac Surgical Products
• Product Code: DWF · Cardiovascular
• Decision Date: Apr 27, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These devices are intended for the perfusion of anticoagulated arterial blood to an ischemic area of the heart.

Device Story

The Medtronic AortoCoronary Shunt is a cardiovascular cannula system used during beating heart coronary artery bypass graft (CABG) surgery. The device consists of an aortic root cannula assembly, a Y-tubing connector, and arteriotomy cannulae (2mm, 3mm, 4mm). The surgeon assembles these components intraoperatively. The device functions by diverting oxygenated, arterial blood from the patient's aorta directly into one or two coronary arteries. This provides perfusion to ischemic myocardial tissue during the surgical procedure. The device is used in the operating room by cardiac surgeons. By maintaining blood flow to the heart muscle during the procedure, the shunt helps prevent myocardial ischemia and supports cardiac function.

Clinical Evidence

No clinical data. Evidence is based on non-clinical bench testing. Biocompatibility testing (ISO 10993-1) included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, and hemocompatibility, all yielding negative results. Mechanical performance testing included tensile strength, hydrostatic burst pressure, fluid flow resistance, and resistance to kinking/clamping. Results confirmed the device delivers blood at flow rates exceeding those normally observed in target coronary arteries.

Technological Characteristics

The device is a cardiovascular cannula system constructed from flexible medical-grade materials. It is designed for limited contact (<24 hours) with circulating blood. The system includes an aortic root cannula, Y-tubing connector, and arteriotomy cannulae. It operates via passive fluid pressure head to deliver blood. Biocompatibility is verified per ISO 10993-1. The device is non-electronic and does not utilize software or algorithms.

Indications for Use

Indicated for perfusion of anticoagulated arterial blood from the aorta to coronary vessels to supply an ischemic area of the heart during beating heart CABG procedures.

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

• Medtronic DLP Aortic Root Cannula (K994171)
• Medtronic DLP Y-Type Coronary Perfusion Adapter (K994171)
• Medtronic DLP Coronary Cannula (K994171)

Submission Summary (Full Text)

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APR 2 7 2000

Medtronic c Surgical Products 620 Watson, S.W. Grand Rapids, MI 49504 U.S.A. Phone [phone]
FAX [phone]

## 510(k) Summary [As Required by 21 CFR 807.92]

| Submitter: | James Balun<br>Medtronic Cardiac Surgical Products<br>620 Watson, S.W.<br>Grand Rapids, Michigan 49504 |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number: | [phone] |
| FAX Number: | [phone] |
| Date Summary Prepared: | December 7, 1999 |
| Trade Name of Device: | Medtronic AortoCoronary Shunt and separately packaged Arteriotomy Cannulae |
| Common Name of Device: | Cardiovascular cannula and tubing |
| Classification Name of Device: | "Cardiopulmonary bypass vascular cannula and tubing",<br>Class II at 21 CFR 870.4210 |
| Predicate Substantially Equivalent Devices: | Medtronic DLP Aortic Root Cannula<br>Class II at 21 CFR 870.4210<br>Medtronic DLP Y-Type Coronary Perfusion Adapter<br>Class II at 21 CFR 870.4210<br>Medtronic DLP Coronary Cannula<br>Class II at 21 CFR 870.4210 |
| Description of Device: | The Medtronic AortoCoronary Shunt includes an Aortic Root Cannula<br>Assembly, a Y-Tubing Connector Assembly and a set of Arteriotomy Cannulae<br>(2 mm, 3 mm and 4 mm sizes). The Arteriotomy Cannula Assemblies are also<br>available separately for user convenience. The user assembles the components<br>into the final product configuration immediately prior to use. The assembled<br>device diverts oxygenated, arterial blood from the patient's aorta directly to one<br>or two coronary arteries, thereby providing perfusion of an ischemic area of the<br>heart during cardiac surgical procedures |
| Intended Use of Device: | These devices are intended for the perfusion of anticoagulated arterial blood<br>to an ischemic area of the heart. |

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## Comparison to Predicate Devices:

The Aortic Root Cannula Assembly used in the new Medtronic AortoCoronary Shunt is identical to the predicate Medtronic DLP 10014 Aortic Root Cannula except for the substitution of a more flexible material that is used to fabricate the cannula body. The Y-Tubing Connector Assembly used in the new Medtronic AortoCoronary Shunt is very similar to the predicate Medtronic DLP 10004 Y-Type Coronary Perfusion Adapter except for material substitutions. which permit increased flexibility of this assembly as well. Finally the Arteriotomy Cannula Assemblies used in the new Medtronic AortoCoronary Shunt are substantially equivalent to the predicate Medtronic DLP 30010 and 30012 Coronary Cannula in that both the new and predicate devices are intended to deliver protective fluid (blood or cardioplegia solution) to myocardial tissue via direct cannulation of the coronary arteries.

## Summary of Non-Clinical Performance Data:

Material biocompatibility testing was conducted in accordance with the ISO 10993-1 standard. Under this standard the AortoCoronary Shunt and Arteriotomy Cannulae are categorized as externally communicating devices in contact with circulating blood for a limited (<24 hour) contact duration. The battery of biocompatibility tests performed yielded negative (non-toxic) results in Cytotoxicity (MEM Elution Method), Sensitization (Guinea Pig Maximization Method), Intracutaneous Reactivity (in rabbits), Acute Systemic Toxicity (in mice), Genotoxicity (Ames Salmonella tvphimurium / Escherichia coli Mutation Reversion Method) and Hemocompatibility (material-mediated Hemolysis and Thrombogenicity) assessments.

Tensile and hydrostatic burst testing were performed on all segments of the fully assembled AortoCoronary Shunt. These tests vielded acceptable results. Resistance to fluid flow, determined by measuring the rate of flow from the end of the device as a function of the fluid pressure head at the inlet of the device, was assessed as well. This parameter was evaluated for both the Arteriotomy Cannulae alone as well as for the fully assembled AortoCoronary Shunt. These tests demonstrated that the product is capable of delivering blood to target coronary arteries at flow rates that are higher than are normally observed in those coronary arteries. Finally the resistance of the product to kinking and damage due to clamping the sections of tubing was assessed. This testing vielded acceptable results as well.

## Conclusions of Non-Clinical Tests:

The results of the non-clinical tests summarized above support an assertion that the Medtronic AortoCoronary Shunt and Arteriotomy Cannulae are as safe and effective as the three predicate legally marketed medical devices itemized above.

Section 2

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2000

Mr. James Balun Principal Product Regulations Manager Medtronic Cardiac Surgical Products 620 Watson SW 49504 Grand Rapids, MI

Re: K994171/S1 Medtronic AortoCoronary Shunt and Arteriotomy Cannulae Requlatory Class: II Product Code: DWF March 27, 2000 Dated: Received: March 28, 2000

Dear Mr. Balun:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. James Balun

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Bura L. Lymperle

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K994171 5 10(k) Number (if known):

Medtronic AortoCoronary Shunt and separately packaged Arteriotomy Cannulae Device Name:

Indications For Use:

These devices are intended for the perfusion of anticoagulated arterial blood from the aorta to coronary vessels to supply an ischemic area of the heart during beating heart CABG procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Betri L. Guspiz C
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________ K gal 417

Prescription Use (Per 21 CFR 801.109)

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OR

Over-The-Counter Use

(Optional Format 1-2-96)