MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES

K041338 · Medtronic Vascular · MWS · Jul 19, 2004 · Cardiovascular

Device Facts

• Record ID: K041338
• Device Name: MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES
• Applicant: Medtronic Vascular
• Product Code: MWS · Cardiovascular
• Decision Date: Jul 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4500
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Medtronic Octopus TE Stabilizer is used to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery. It is intended to be used by trained medical professionals in operating room environments.

Device Story

Suction-based tissue stabilizer for non-arrested heart surgery; enables stabilization of epicardial surface. System components: collapsible pod assembly, rigid shaft, 5 articulating links; allows access via 12 mm thoracic port or sternotomy. Vacuum delivered to pod via disposable suction/vacuum lines; optional irrigator provides drip irrigation for site visibility. Device attaches to flexible arm and universal mounting rail on operating table. Used by surgeons in operating rooms to facilitate coronary artery procedures; provides stable surgical field; improves visibility; assists in surgical precision.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological characteristics.

Technological Characteristics

Suction-based tissue stabilizer; collapsible pod assembly; rigid shaft; 5 articulating links. Materials: reusable components. Energy source: external vacuum source. Connectivity: none. Sterilization: not specified. Software: none.

Indications for Use

Indicated for stabilization of the epicardial surface of the non-arrested heart during coronary artery surgery. For use by trained medical professionals in operating room environments.

Regulatory Classification

Identification

Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.

Predicate Devices

• Medtronic Octopus Tissue Stabilizer (K964445)
• CTS (Guidant) Vacuum Assist Stabilizer (K992833)

Reference Devices

• Medtronic Clearview Blower/Misted (K973485)

Submission Summary (Full Text)

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JUL 1 9 2004

510(k) Summary

: -

| Submitter: | Medtronic Cardiac Surgery Technologies<br>7601 Northland Drive<br>Minneapolis, MN 55428 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Scott Cundy |
| | Telephone: [phone]<br>Fax: [phone] |
| Date Prepared: | 18 May 2004 |
| Trade Name: | Medtronic Octopus® TE Stabilizer & Accessories |
| Common Name: | Cardiovascular Surgical Instrument/Heart Stabilizer |
| Equivalence to: | The Medtronic Octopus TE Stabilizer & Accessories are<br>substantially equivalent in patient population, intended use,<br>function and basic system components to the Medtronic Octopus<br>Tissue Stabilizer (K964445) and the CTS (Guidant) Vacuum<br>Assist Stabilizer (K992833). |
| | The Medtronic Octopus TE Stabilizer has an optional irrigator<br>(lavage) that is designed to provide drip irrigation for improved<br>visibility. Said irrigator has a similar surgical site cleansing<br>indication for use as existing jet lavage systems such as the<br>Medtronic Clearview Blower/Misted (K973485). |
| Description: | The non-sterile, reusable Medtronic Octopus TE Heart Stabilizing<br>System is a suction-based tissue stabilizer with a collapsible pod<br>assembly, a rigid shaft and 5 articulating links designed to enable<br>transfer into the thoracic cavity via a 12 mm thoracic port or<br>traditional sternotomy access. It is comprised of four distinct<br>elements: (1) the Medtronic Octopus TE Tissue Stabilizer, (2) the<br>Medtronic Octopus TE Suction Lines, (3) the Medtronic Octopus<br>TE Vacuum Lines, and (4) the Medtronic Octopus TE Irrigator<br>(optional). |
| | The Medtronic Octopus TE Heart Stabilizer is secured to a flexible<br>arm and universal mounting rail, which attached to the operating<br>table rail. Vacuum is delivered to the pod assembly by a<br>disposable suction line inserted through the shaft of the stabilizer<br>and a disposable vacuum line that connects the stabilizer to the<br>vacuum source. The accessories are sold separately. |
| Intended Use: | The Medtronic Octopus TE Stabilizer is used to stabilize the<br>epicardial surface of the non-arrested heart during coronary artery<br>surgery. It is intended to be used by trained medical professionals<br>in operating room environments. |
| Technological<br>Characteristics: | Comparisons between the new and predicate devices shows that<br>technological characteristics (i.e. device design and principal of<br>operation) are substantially equivalent. |
| Conclusion: | The Medtronic Octopus TE Stabilizer was found to be<br>substantially equivalent in patient population, intended use,<br>principal of operation and basic system components to the<br>predicate devices. |

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 1 9 2004

Medtronic Cardiac Surgery Technologies c/o Davis D. Cox, Ph.D. Principal Regulatory Affairs Specialist 7601 Northland Drive Minneapolis, MN 55428-1088

Re: K041338

Octopus TE Tissue Stabilizer Regulation Number: 21 CFR 870.4500 Regulation Name: Cardiovascular Surgical Instruments Regulatory Class: Class I (one) Product Code: MWS Dated: July 8, 2004 Received: July 9, 2004

Dear Dr. Cox:

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 - Davis D. Cox, Ph.D.

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]. 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Dvina R. buchanan

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): K041338

Octopus TE Tissue Stabilizer Device Name:

Indications for Use:

The Stabilizer is intended to stabilize the epicardial surface of the nonarrested heart during coronary artery surgery. It is intended to be used only by medical professionals in operating room environments.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

のお気になる。

R. Vochner

)ivision Sign-Off) ision of Cardiovascular Devices

) Number K041338