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 Description

The Aquamantys Endo DBS 8.7 device is a handheld "wand-like" disposable that, when connected to the Aquamantys Pump Generator, uses bipolar radio-frequency energy concurrent with saline for hemostatic sealing and coagulation. The device is equipped with dual electrodes at the distal tip. Saline and electrical lines enter from the opposite end (proximal end) of the device's hand piece from the distal electrodes. The device's hand piece is equipped with a blue button that activates bipolar RF energy concurrent with saline flow for blunt dissection and for hemostatic sealing and coagulation. The long, stainless steel shaft allows for the device to be used in laparoscopic, endoscopic and thoracoscopic procedures. A saline fluid delivery line is provided with the device, which includes a drip chamber/spike for insertion into saline bags. The proposed device connects to the Aquamantys Pump Generator using a three-pronged connector.

AI/ML Overview

This document describes the Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer, a device intended for surgical hemostasis and coagulation. The provided text, a 510(k) summary, outlines the device's characteristics and the studies performed to demonstrate its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists several bench performance tests conducted to verify and validate the Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer. However, specific quantitative acceptance criteria or detailed performance results (e.g., pass/fail thresholds, numerical outcomes) for each test are not explicitly stated in the provided text. The summary only broadly confirms that the device "has undergone bench performance testing to verify and validate the performance features and specifications."

Acceptance Criteria (Implied)	Reported Device Performance
Visual integrity and proper assembly	Testing performed and results verified.
Cable strength against static pulls	Testing performed and results validated.
Cable durability against dynamic pulls	Testing performed and results validated.
Saline tube strength against static pulls	Testing performed and results validated.
Air leak integrity and proper fluid flow	Testing performed and results validated.
Hipot (High Potential) testing for electrical safety	Testing performed and results validated.
Consistent and adequate saline flow	Testing performed and results validated.
Shaft deflection and pull resistance	Testing performed and results validated.
Electrode pull resistance	Testing performed and results validated.
Electrical continuity	Testing performed and results validated.
Biocompatibility	Assessment performed.
Performance on animal tissue (hemostatic sealing, coagulation)	Testing performed.
Electrical safety standards adherence	Testing performed.

2. Sample Size Used for the Test Set and Data Provenance:

The document states that the device "has undergone bench performance testing" and "animal tissue testing." However, the exact sample size used for these test sets and the data provenance (e.g., country of origin, retrospective or prospective) are not specified in this 510(k) summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The summary does not mention using experts to establish ground truth for the test set. The testing described appears to be primarily engineering and physical performance testing, and animal tissue testing, rather than human-expert-reviewed clinical or image-based evaluations.

4. Adjudication Method for the Test Set:

Given that expert-established ground truth is not mentioned, an adjudication method is not applicable and not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it discussed in the document. The submission explicitly states: "Clinical testing was not required to establish substantial equivalence between the proposed and predicate devices." This device is a surgical instrument, not an AI or diagnostic imaging device that would typically undergo MRMC studies.

6. Standalone Performance Study:

A standalone performance study (algorithm only without human-in-the-loop) was not applicable and not performed. The device is a surgical instrument and not an AI algorithm. The performance testing conducted was on the device itself (bench and animal tissue).

7. Type of Ground Truth Used:

For the bench performance tests, the "ground truth" would be established by engineering specifications and validated test methods. For the animal tissue testing, the "ground truth" for hemostatic sealing and coagulation would be assessed through direct observation and measurement of the tissue response during and after device application. The document does not specify if these assessments were quantitative or qualitative, or who performed them.

8. Sample Size for the Training Set:

The concept of a "training set" is not applicable as this is a physical medical device (electrosurgical accessory), not an AI algorithm requiring training data.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable as there is no training set mentioned for this device.

Summary

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

K123201

510(k) Summary

;

JAN 1 0 2013

Submitter:	Medtronic Advanced Energy180 International DrivePortsmouth, NH 03801USA
Contact Person:	Tara N. Turney, RACSenior Regulatory Affairs SpecialistPhone: 603-742-5445Fax: 603-742-1488Email: tara.n.turney@medtronic.com
Date Prepared:	October 11th, 2012
Trade Name:	Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer
Common Name:	Electrosurgical accessory
ClassificationName:	Electrosurgical Cutting and Coagulation Device andAccessories
Predicate Device:	Aquamantys Double Cone Bipolar Sealer(K101057)Monopolar Floating Ball(K010662)
DeviceDescription:	The Aquamantys Endo DBS 8.7 device is a handheld "wand-like" disposable that, when connected to the AquamantysPump Generator, uses bipolar radio-frequency energyconcurrent with saline for hemostatic sealing and coagulation.The device is equipped with dual electrodes at the distal tip.Saline and electrical lines enter from the opposite end(proximal end) of the device's hand piece from the distalelectrodes. The device's hand piece is equipped with a bluebutton that activates bipolar RF energy concurrent with salineflow for blunt dissection and for hemostatic sealing andcoagulation. The long, stainless steel shaft allows for thedevice to be used in laparoscopic, endoscopic andthoracoscopic procedures. A saline fluid delivery line isprovided with the device, which includes a dripchamber/spike for insertion into saline bags. The proposeddevice connects to the Aquamantys Pump Generator using athree-pronged connector.

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

200 8 : V Statement of Intended Use:

Summary of

Technological

Characteristics:

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

Summary of	Clinical testing was not required to establish substantial
Clinical Data:	equivalence between the proposed and predicate devices.
Conclusion fromData:	Medtronic Advanced Energy has demonstrated that theAquamantys Endo DBS 8.7 Dissecting Bipolar Sealer issubstantially equivalent to the predicate devices based uponindications for use, design, test results and fundamentalscientific 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 (800) 638-2041 or (301) 796-7100 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)

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.