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).

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).

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 contraceptive tubal coagulation (permanent female sterilization).

Device Description

The Aquamantys Bipolar Sealer is a sterile, single-use bipolar device. The device employs radio-frequency (RF) energy and saline irrigation for hemostatic sealing and coagulation. The device is equipped with a dual electrode tip. Saline and electrical lines exit the opposite end of the handpiece from the electrodes. The handpiece is equipped with an on-off button that simultaneously activates both RF and saline flow. A saline fluid delivery line is provided with the device, and includes a section of pump tubing and drip chamber or spike. The three-pin electrical connector is designed to be plugged into the Aquamantys Pump Generator.

AI/ML Overview

The provided text describes a 510(k) summary for the Aquamantys Bipolar Sealers, focusing on demonstrating substantial equivalence to a predicate device. It explicitly states that clinical studies were not required or conducted for the proposed neurosurgical expanded indications. Therefore, the information typically associated with an AI/ML device study (e.g., acceptance criteria, sample size, ground truth establishment, MRMC studies) is not present.

However, I can extract information regarding the non-clinical comparative performance data that was conducted.

Here's the breakdown of the information that can be extracted from the provided text, and the parts that state it's not applicable for this device:

Acceptance Criteria and Device Performance Study for Aquamantys® Bipolar Sealers

This document pertains to the 510(k) submission for the Aquamantys® 2.3 Bipolar Sealer, Aquamantys® EVS 4.0 Epidural Vein Sealer, Aquamantys® Mini EVS 3.4 Epidural Vein Sealer, and Aquamantys® SBS 5.0 Sheathed Bipolar Sealer. The submission aims to demonstrate substantial equivalence to a predicate device, the Codman Irrigated Bipolar Forceps.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Non-Clinical Performance	Thermal Zone Damage (comparability to predicate device)	Thermal zone damage of the Aquamantys Bipolar Sealers was comparable to the thermal zone damage of the Codman Irrigated Bipolar Forceps.

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated for the non-clinical test.
Data Provenance: Ex-vivo porcine brain tissue.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The non-clinical test involved objective measurement of thermal zone damage rather than expert interpretation of medical images.

4. Adjudication method for the test set

Not applicable. The non-clinical test involved objective measurement of thermal zone damage.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an electrosurgical instrument, not an AI-powered diagnostic or assistive tool for human readers. Clinical studies were explicitly stated as not required or conducted for the neurosurgical indications in this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used

For the non-clinical test, the "ground truth" was derived from objective measurements of thermal zone damage in ex-vivo porcine tissue, compared directly to the predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device that requires a training set.

Summary

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, :

510(k) Summary

:
:

Submitter:	Medtronic Advanced Energy180 International DrivePortsmouth, NH 03801
Contact Person:	Gabriela AnchondoPrincipal Regulatory Affairs SpecialistPhone: (904) 279-7550Fax: (603) 742-1488E-mail: gabby.anchondo@medtronic.com
Date Summary Prepared:	September 18, 2013DEC 0 3 2013
Device Trade Name:	Aquamantys® 2.3 Bipolar SealerAquamantys® EVS 4.0 Epidural Vein SealerAquamantys® Mini EVS 3.4 Epidural Vein SealerAquamantys® 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)K896541 Malis Bipolar Electrosurgical System CMC III(Medtronic Advanced Energy Aquamantys Bipolar Sealers)K052859 Aquamantys 2.3 Bipolar SealerK063639 Aquamantys EVS 4.0 Epidural Vein SealerK063639 Aquamantys Mini EVS 3.4 Epidural Vein SealerK111732 Aquamantys SBS 5.0 Sheathed Bipolar Sealer
Device Description:	The Aquamantys Bipolar Sealer is a sterile, single-use bipolar device.The device employs radio-frequency (RF) energy and saline irrigation forhemostatic sealing and coagulation. The device is equipped with a dualelectrode tip. Saline and electrical lines exit the opposite end of thehandpiece from the electrodes. The handpiece is equipped with an on-offbutton that simultaneously activates both RF and saline flow. A salinefluid delivery line is provided with the device, and includes a section ofpump tubing and drip chamber or spike. The three-pin electricalconnector is designed to be plugged into the Aquamantys PumpGenerator.
Intended Use:	The Aquamantys Bipolar Sealer is a sterile, single-use bipolarelectrosurgical device intended to be used in conjunction with theAquamantys Pump Generator for delivery of RF energy and saline forhemostatic sealing and coagulation of soft tissue and bone at theoperative 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, andepidural vein sealing [3.4, 4.0 & 5.0 only] during surgery. The device isnot intended for contraceptive tubal coagulation (permanent femalesterilization).
TechnologicalCharacteristics:	The Aquamantys Bipolar Sealers have the same technologicalcharacteristics as the Codman Irrigated Bipolar Forceps. Both devicesare bipolar electrosurgical instruments that employ radio-frequency (RF)energy and saline irrigation for hemostatic sealing and coagulation.
Non-Clinical Tests:	Comparative performance data was conducted on ex-vivo porcine braintissue. Thermal zone damage of the Aquamantys Bipolar Sealers wascomparable to the thermal zone damage of the Codman Irrigated BipolarForceps.
Clinical Tests:	Clinical studies were not required or conducted to support the proposedneurosurgical expanded indications.
Conclusion:	The indications for use, technology and performance characteristics ofthe Aquamantys Bipolar Sealers are the same as the Codman IrrigatedBipolar Forceps. Based on this, Medtronic Advanced Energy claimssubstantial equivalence to the predicate device.

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K132974 Page 2 of 2

and the control control of the control of

the country of the county of the county of

. . . . .

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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:

Device Name:

Aquamantys Epidural Vein Sealer & Aquamantys Mini Epidural Vein Sealer

Indications for Use:

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)

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

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

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.