AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR

K132974 · Medtronic Advanced Energy, LLC · GEI · Dec 3, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K132974
• Device Name: AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR
• Applicant: Medtronic Advanced Energy, 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 Aquamantys Bipolar Sealer is a sterile, single-use bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to orthopaedic, neurosurgical, spine, endoscopic procedures [except AQM 2.3], abdominal [open abdominal for AQM 2.3] and thoracic surgery, and epidural vein sealing [3.4, 4.0 & 5.0 only] during surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Device Story

Aquamantys Bipolar Sealer is a sterile, single-use electrosurgical instrument; utilizes radio-frequency (RF) energy and saline irrigation for hemostatic sealing and coagulation of soft tissue and bone. Device features dual-electrode tip and handpiece with integrated on-off button for simultaneous RF and saline activation. System includes saline delivery line with pump tubing and drip chamber; connects to Aquamantys Pump Generator via three-pin electrical connector. Operated by surgeons in clinical settings (OR) for various surgical procedures. Output provides controlled thermal effect for tissue sealing; assists in reducing bleeding during surgery. Benefits include improved hemostasis in complex surgical fields.

Clinical Evidence

No clinical data was conducted or required to support the expanded neurosurgical indications. Evidence is based on bench testing comparing thermal zone damage on ex-vivo porcine brain tissue against the predicate device.

Technological Characteristics

Bipolar electrosurgical instrument; utilizes RF energy and saline irrigation. Features dual-electrode tip, handpiece with integrated activation button, and saline delivery line. Connects to external Aquamantys Pump Generator. Sterile, single-use device.

Indications for Use

Indicated for hemostatic sealing and coagulation of soft tissue and bone in patients undergoing orthopaedic, neurosurgical, spine, endoscopic, abdominal, or thoracic surgery, including epidural vein sealing. Contraindicated for contraceptive tubal coagulation.

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

• Codman Irrigated Bipolar Forceps (K896541)
• Aquamantys 2.3 Bipolar Sealer (K052859)
• Aquamantys EVS 4.0 Epidural Vein Sealer (K063639)
• Aquamantys Mini EVS 3.4 Epidural Vein Sealer (K063639)
• Aquamantys SBS 5.0 Sheathed Bipolar Sealer (K111732)

Submission Summary (Full Text)

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# 510(k) Summary

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| Submitter: | Medtronic Advanced Energy<br>180 International Drive<br>Portsmouth, NH 03801 |
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| Contact Person: | Gabriela Anchondo<br>Principal Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Summary Prepared: | September 18, 2013<br>DEC 0 3 2013 |
| Device Trade Name: | Aquamantys® 2.3 Bipolar Sealer<br>Aquamantys® EVS 4.0 Epidural Vein Sealer<br>Aquamantys® Mini EVS 3.4 Epidural Vein Sealer<br>Aquamantys® SBS 5.0 Sheathed Bipolar Sealer |
| Common Name: | Electrosurgical Instrument |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Predicate Device: | (Codman Irrigated Bipolar Forceps)<br>K896541 Malis Bipolar Electrosurgical System CMC III<br>(Medtronic Advanced Energy Aquamantys Bipolar Sealers)<br>K052859 Aquamantys 2.3 Bipolar Sealer<br>K063639 Aquamantys EVS 4.0 Epidural Vein Sealer<br>K063639 Aquamantys Mini EVS 3.4 Epidural Vein Sealer<br>K111732 Aquamantys SBS 5.0 Sheathed Bipolar Sealer |
| Device Description: | The Aquamantys Bipolar Sealer is a sterile, single-use bipolar device.<br>The device employs radio-frequency (RF) energy and saline irrigation for<br>hemostatic sealing and coagulation. The device is equipped with a dual<br>electrode tip. Saline and electrical lines exit the opposite end of the<br>handpiece from the electrodes. The handpiece is equipped with an on-off<br>button that simultaneously activates both RF and saline flow. A saline<br>fluid delivery line is provided with the device, and includes a section of<br>pump tubing and drip chamber or spike. The three-pin electrical<br>connector is designed to be plugged into the Aquamantys Pump<br>Generator. |
| Intended Use: | The Aquamantys Bipolar Sealer is a sterile, single-use bipolar<br>electrosurgical device intended to be used in conjunction with the<br>Aquamantys Pump Generator for delivery of RF energy and saline for<br>hemostatic sealing and coagulation of soft tissue and bone at the<br>operative site. It is intended for, but not limited to orthopaedic,<br>neurosurgical, spine, endoscopic procedures [except AQM 2.3],<br>abdominal [open abdominal for AQM 2.3] and thoracic surgery, and<br>epidural vein sealing [3.4, 4.0 & 5.0 only] during surgery. The device is<br>not intended for contraceptive tubal coagulation (permanent female<br>sterilization). |
| Technological<br>Characteristics: | The Aquamantys Bipolar Sealers have the same technological<br>characteristics as the Codman Irrigated Bipolar Forceps. Both devices<br>are bipolar electrosurgical instruments that employ radio-frequency (RF)<br>energy and saline irrigation for hemostatic sealing and coagulation. |
| Non-Clinical Tests: | Comparative performance data was conducted on ex-vivo porcine brain<br>tissue. Thermal zone damage of the Aquamantys Bipolar Sealers was<br>comparable to the thermal zone damage of the Codman Irrigated Bipolar<br>Forceps. |
| Clinical Tests: | Clinical studies were not required or conducted to support the proposed<br>neurosurgical expanded indications. |
| Conclusion: | The indications for use, technology and performance characteristics of<br>the Aquamantys Bipolar Sealers are the same as the Codman Irrigated<br>Bipolar Forceps. Based on this, Medtronic Advanced Energy claims<br>substantial equivalence to the predicate device. |

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers.

#### 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

Medtronic Advanced Energy Ms. Gabriela Anchondo Senior Regulatory Affairs Specialist 180 International Drive Portsmouth, New Hampshire 03801

December 3, 2013

Re: K132974

Trade/Device Name: Aquamantys 2.3 Bipolar Sealer, Aquamantys EVS 4.0 Epidural Vein Sealer, Aquamantys Mini EVS 3.4 Epidural Vein Scaler, Aquamantys SBS 5.0 Sheathed Bipolar Scaler Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 15, 2013 Received: November 18, 2013

Dear Ms. Anchondo:

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 10 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. 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 either 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 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); medical device reporting (reporting of medical

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Page 2 - Ms. Gabriela Anchondo

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (21CFR 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Radiological Health

# Joshua C. Nipper -S

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

Enclosure

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#### Indications for Use

510(k) Number (if known): K132974

#### Device Name:

Aquamantys 2.3 Bipolar Sealer

#### Indications for Use:

The Aquamantys 2.3 Bipolar Sealer is a sterile, single-use, bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to orthopaedic, neurosurgical, spine, thoracic, and open abdominal surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

### Device Name:

Aquamantys Epidural Vein Sealer & Aquamantys Mini Epidural Vein Sealer

#### Indications for Use:

The Aquamantys Epidural Vein Sealer is a sterile, single-use bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to orthopaedic, neurosurgical, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein sealing during surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

#### Device Name:

Aquamantys SBS 5.0 Sheathed Bipolar Sealer

#### Indications for Use:

The Aquamantys SBS 5.0 Sheathed Bipolar Sealer is a sterile, single-use bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to orthopaedic, neurosurgical, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein sealing during surgery. The device is not intended for contraceplive tubal coagulation (permanent female sterilization).

Prescription Use × (Per 21 CFR 801 Subpart D) AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Lona H. Chen -A .

upped by Long H. Chen A.
Only Severament Bunlands
BurProple, Loo Long H. Chen A. 12-12-12-19200 JEC. 100. 1. 1-1100164054
Cizts: 2013.0 1.22 14-1 F. 19-05 DC

for BSA

(Division Sign-off) Division of Surgical Devices 510(k) Number_K132974