HARVESTING CANNULA

K132743 · Maquet Cardiovascular, LLC · GEI · Dec 3, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K132743
• Device Name: HARVESTING CANNULA
• Applicant: Maquet Cardiovascular, LLC
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 3, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VASOVIEW System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.

Device Story

Harvesting Cannula is a multi-lumen surgical instrument used in minimally invasive endoscopic vessel harvesting. Device features four lumens housing an endoscope, C-Ring, distal lens washer tube, and a VASOVIEW Harvesting Tool. Physician operates the device to perform blunt dissection of tissue and vessels; harvesting tool enables cutting and coagulation of vessel branches. C-Ring slider on handle controls C-Ring retraction and distal lens washing. Device provides visualization and mechanical access for surgeons during arterial bypass procedures. Benefits include reduced surgical trauma via minimally invasive approach compared to open surgery.

Clinical Evidence

Bench testing only. In-vitro performance and shelf-life testing demonstrated that the functionality and performance characteristics of the Harvesting Cannula are comparable to the currently marketed predicate device.

Technological Characteristics

Four-lumen cannula design; includes endoscope, C-Ring, lens washer, and harvesting tool ports. Mechanical actuation via C-Ring slider. Materials and sterilization processes are identical to the predicate device. Class II electrosurgical accessory (Product Code GEI).

Indications for Use

Indicated for patients undergoing endoscopic surgery for arterial bypass, including coronary artery bypass grafting (CABG) and peripheral artery bypass. Used for blunt dissection of blood vessels (saphenous vein, radial artery), ducts, and other structures in extremities, extraperitoneal, subcutaneous, and thoracic spaces.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Guidant VasoView HemoPro Endoscopic Vessel Harvesting System (K052274)

Submission Summary (Full Text)

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# K132743

## Harvesting Cannula

# 510(k) Summary

# Prepared in accordance with 21 CFR Part 807.92

| 510(k) Number: | KXXXXXX K132743 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | 30 August 2013 |
| Device Owner: | MAQUET Cardiovascular LLC<br>45 Barbour Pond Drive<br>Wayne, New Jersey 07470 |
| Contact Personnel: | Mark Dinger |
| Title: | Regulatory Affairs Specialist II |
| Email: | [e-mail] |
| Phone: | 973-709-7691 |
| | Fax: [phone] |
| Trade Name: | Harvesting Cannula |
| Device Generic Name: | Harvesting Cannula |
| Classification: | According to 21 CFR 878.4400 of the Federal Food, Drug<br>and Cosmetic Act, the device classification is Class II,<br>Product code GEI. |
| Predicate Device: | K052274 Guidant VasoView HemoPro Endoscopic Vessel<br>Harvesting System (SE: 21 September 2005) |
| Device Description: | The Harvesting Cannula has four lumens which house the<br>Endoscope, C-Ring, distal lens washer tube and<br>VASOVIEW Harvesting Tool for cutting and sealing of<br>vessel branches. The C-Ring with the built in distal lens<br>washer is independently controlled by a C-Ring Slider on<br>the handle of the Harvesting Cannula. The C-Ring retracts<br>the vessel and washes the distal tip of the Endoscope. The<br>Harvesting Tool can be inserted, removed, rotated,<br>extended, and retracted from the main Harvesting Cannula<br>through the Tool Adapter Port. |

DEC 0-3 2013

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| Indications for Use: | The VASOVIEW System is indicated for use in minimally<br>invasive surgery allowing access for vessel harvesting, and<br>is primarily indicated for patients undergoing endoscopic<br>surgery for arterial bypass. It is indicated for cutting tissue<br>and controlling bleeding through coagulation, and for<br>patients requiring blunt dissection of tissue including<br>dissection of blood vessels, dissection of blood vessels of<br>the extremities, dissection of ducts and other structures in<br>the extraperitoneal or subcutaneous extremity and thoracic<br>space. Extremity procedures include tissue<br>dissection/vessel harvesting along the saphenous vein for<br>use in coronary artery bypass grafting and peripheral artery<br>bypass or the radial artery for use in coronary artery bypass<br>grafting. Thoracoscopic procedures include exposure and<br>dissection of structures external to the parietal pleura,<br>including nerves, blood vessels and other tissues of the<br>chest wall. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | The Proposed Harvesting Cannula and the predicate<br>devices have the following similarities:<br>the same intended use, the same operating principles, same labeling, incorporates the same basic design, sterilized using the same materials and processes, same materials, has same packaging. The Proposed Harvesting Cannula and the predicate<br>devices have the following differences:<br>C-Ring Tube – Addition of a rib to the C-Ring Tube<br>as well as tube length change (to accommodate for<br>the C-Ring Tube Rib design). Blunt Tip – C-ring tube channel revision. Scope Wash Tube – Scope Wash Tube length<br>changed (to accommodate for new C-Ring Tube<br>Rib design). This difference is not considered a technological difference<br>and is substantially equivalent to the predicate devices. |
| Safety and<br>Performance: | MAQUET Cardiovascular's development process required<br>that the following activities be completed during the<br>development of the Harvesting Cannula: |
| | • Performance testing<br>• Shelf life testing |
| | The results of the in-vitro tests conducted demonstrate that<br>the functionality and performance characteristics of the<br>device are comparable to the currently marketed Harvesting<br>Cannula. |
| Conclusion: | Based upon the information submitted in this Traditional<br>510(k) premarket notification, MAQUET's Harvesting<br>Cannula is substantially equivalent to the currently<br>marketed Harvesting Cannula. The Harvesting Cannula is<br>similar to the predicate devices in the intended use and the<br>fundamental scientific technology of the device. The design<br>verification and validation testing established that the<br>Harvesting Cannula is substantially equivalent as the<br>predicate device. |

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The text is in all caps and is relatively small compared to the caduceus symbol.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

MAQUET Cardiovascular LLC Mr. Mark Dinger Regulatory Affairs Specialist II 45 Barbour Pond Drive Wayne, New Jersey 07470

December 3, 2013

Re: K132743

Trade/Device Name: Harvesting Cannula Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 27. 2013 Received: September 30, 2013

Dear Mr. Dinger:

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 for use stated on the May 28. 1976. the cnactment 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 rou may : merels provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA). it may be subject to 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.

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 that I DA has into a and regulations administered by other Federal agencies. You must or any rederal states and the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Mark Dinger

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Joshua C. Nipper -S

For

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

### 510(k) Number (if known) K132743

Device Name Harvesting Cannula

#### Indications for Use (Describe)

The VASOVIEW System is indicated for use in minimally invesive surgery allowing access for vessel harvesting, and is primerily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting bleeding through coagulation, and for patients requiring blunt dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperity and theracies pace. Extremity procedures include tissection/vessel harvesting along the saphencus vein for use in coronary artery bypass grafting and perioteral artery bypass or the radial artery for use in coronary artery bypass grafting. Thorecossipic procedures include exposure and dissection of structures external to the parietal pleases and other tissues of the chest wall.

Type of Use (Select one or both, as applicable)

🇿 Prescription Use (Parl 21 CFR 801 Subpart D)

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

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

| FOR FDA USE ONLY | |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
| Long H. Chen A | for BSA |
| (Division Sign-off)<br>Division of Surgical Devices | 510(k) Number: K132743 |
| | <div style="font-size: 8px;">Digitally signed by Long H. Chen - A</div> <div style="font-size: 8px;">DN: c=US, o=U.S. Government, ou=HHS,</div> <div style="font-size: 8px;">ou=FDA, ou=People, cn=Long H. Chen - A</div> <div style="font-size: 8px;">0.9.2342.19200300.100.1.1=1300366056</div> <div style="font-size: 8px;">Date: 2013.12.02 08:44:22 -05'00'</div> |
| FORM FDA 3881 (9/13) | Page 1 of 2 |