AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER

K123201 · Medtronic Advanced Energy, LLC · GEI · Jan 10, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K123201
• Device Name: AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER
• Applicant: Medtronic Advanced Energy, LLC
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 10, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer is a single use, sterile, bipolar device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of radio-frequency (RF) energy and saline for blunt dissection and for haemostatic sealing and coagulation of soft tissue at the operative site. It is intended for, but not limited to, abdominal, and thoracic surgery, endoscopic, laparoscopic, and thoracoscopic procedures. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Device Story

Aquamantys Endo DBS 8.7 is a handheld, disposable, bipolar electrosurgical wand. Used with Aquamantys Pump Generator; delivers bipolar RF energy concurrent with saline flow to operative site. Operated by surgeons in OR settings (abdominal/thoracic/laparoscopic/endoscopic/thoracoscopic). Blue activation button on handpiece triggers RF and saline delivery. Saline facilitates blunt dissection and hemostatic sealing/coagulation of soft tissue. Device connects to generator via three-pronged connector; includes drip chamber/spike for saline bag. Benefits include controlled tissue dissection and reduced bleeding during surgery.

Clinical Evidence

No clinical data provided. Substantial equivalence established via bench performance testing, including visual inspection, static/dynamic cable pulls, saline tube pulls, air leak/flow testing, hipot testing, saline flow testing, shaft deflection/pull, electrode pull, continuity, biocompatibility assessment, animal tissue testing, and electrical safety.

Technological Characteristics

Single-use, sterile, bipolar electrosurgical device. Features stainless steel shaft, clamshell tip housing, and dual electrodes. Connects to Aquamantys Pump Generator for RF energy and peristaltic saline delivery. Activation via handpiece button. Biocompatible materials used. Bench testing verified mechanical and electrical integrity.

Indications for Use

Indicated for blunt dissection and hemostatic sealing/coagulation of soft tissue in abdominal, thoracic, endoscopic, laparoscopic, and thoracoscopic surgical procedures. 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

• Aquamantys Double Cone Bipolar Sealer (K101057)
• Monopolar Floating Ball (K010662)

Submission Summary (Full Text)

{0}------------------------------------------------

## K123201

### 510(k) Summary

;

## JAN 1 0 2013

| Submitter: | Medtronic Advanced Energy<br>180 International Drive<br>Portsmouth, NH 03801<br>USA |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tara N. Turney, RAC<br>Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | October 11th, 2012 |
| Trade Name: | Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer |
| Common Name: | Electrosurgical accessory |
| Classification<br>Name: | Electrosurgical Cutting and Coagulation Device and<br>Accessories |
| Predicate Device: | Aquamantys Double Cone Bipolar Sealer<br>(K101057)<br><br>Monopolar Floating Ball<br>(K010662) |
| Device<br>Description: | The Aquamantys Endo DBS 8.7 device is a handheld "wand-<br>like" disposable that, when connected to the Aquamantys<br>Pump Generator, uses bipolar radio-frequency energy<br>concurrent with saline for hemostatic sealing and coagulation.<br>The device is equipped with dual electrodes at the distal tip.<br>Saline and electrical lines enter from the opposite end<br>(proximal end) of the device's hand piece from the distal<br>electrodes. The device's hand piece is equipped with a blue<br>button that activates bipolar RF energy concurrent with saline<br>flow for blunt dissection and for hemostatic sealing and<br>coagulation. The long, stainless steel shaft allows for the<br>device to be used in laparoscopic, endoscopic and<br>thoracoscopic procedures. A saline fluid delivery line is<br>provided with the device, which includes a drip<br>chamber/spike for insertion into saline bags. The proposed<br>device connects to the Aquamantys Pump Generator using a<br>three-pronged connector. |

·

:

{1}------------------------------------------------

200 8 : V Statement of Intended Use:

Summary of

Technological

Characteristics:

The Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer is a single use, sterile. bipolar device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of radio-frequency (RF) energy and saline for blunt dissection and for haemostatic sealing and coagulation of soft tissue at the operative site. It is intended for. but not limited to, abdominal, and thoracic surgery, endoscopic, laparoscopic, and thoracoscopic procedures.

The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

The Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer applies the same fundamental scientific technology as the existing Medtronic Advanced Energy Aquamantys devices. The device's hand piece is equipped with a blue activation buttons that activates bipolar RF energy concurrent with saline flow for blunt dissection and for hemostatic sealing and coagulation. The device is designed to connect to the Aquamantys Pump Generator, providing connection to both RF power and the peristaltic pump for saline flow. The main differences between the proposed and predicate devices are as follows:

- . Tip Configuration
- o Clamshell tip housing with saline exit
- o Smaller electrodes
- Shaft Material
- o Stainless steel

The Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer has undergone bench performance testing to verify and validate the performance features and specifications. The testing included:

- visual, .
.

- static cable pulls, .
- dynamic cable pulls, .
- static saline tube pulls, .
- air leak and flow, .
- . hipot testing.
- . saline flow testing,
- . shaft deflection/pull.
- electrode pull. .
- continuity .
- biocompatibility assessment, .

Summary of Nonclinical Data:

{2}------------------------------------------------

- animal tissue testing, and .
- electrical safety

.

r

·

| Summary of | Clinical testing was not required to establish substantial |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Data: | equivalence between the proposed and predicate devices. |
| Conclusion from<br>Data: | Medtronic Advanced Energy has demonstrated that the<br>Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer is<br>substantially equivalent to the predicate devices based upon<br>indications for use, design, test results and fundamental<br>scientific technology. |

:

:

.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

#### 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, LLC % Ms. Janet Kwiatkowski Regulatory Affairs Manager 180 International Drive Portsmouth, New Hampshire 03801

January 10, 2013

Re: K123201

Trade/Device Name: Aquamantys Endo DBS 8.7 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories. Regulatory Class: Class II Product Code: GEI · Dated: October 11, 2012 Received: October 12, 2012

Dear Ms. Kwiatkowski:

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. Please note: CDRH does 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{4}------------------------------------------------

Page 2 - Ms. Janet Kwiatkowski

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

### Indications for Use

510(k) Number (if known): K123201

ﻟﻤﺴﺎﺑﻘﺎ ﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ

ﻤﺤﺴ

Aquamantys Endo DBS 8.7 Device Name:

Indications for Use:

The Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer is a single use, sterile, bipolar device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of radio-frequency (RF) energy and saline for blunt dissection and for haemostatic sealing and coagulation of soft tissue at the operative site. It is intended for, but not limited to, abdominal, and thoracic surgery, endoscopic, laparoscopic, and thoracoscopic procedures.

The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Prescription Use X (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)

Dwight Yen 2013.01.08 14:40:12 -05'00'

(Division Sign-Off)

Division of Surgical Devices

510(k) Number ____K123201_

Page 1 of _

Medtronic Advanced Energy Aquamantys Endo DBS 8.7 Traditional 510(k)

28