The Aquamantys3 BSC 9.1S is a monopolar/bipolar, single use, sterile, disposable device intended for use with the Aquamantys3 Pump Generator. The device delivers bipolar RF energy concurrent with saline for haemostatic sealing and coagulation of soft tissue and bone and monopolar RF energy for cutting of soft tissue. It is intended for, but not limited to, orthopaedic, spine, thoracic, and open abdominal surgery.

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

Device Description

The proposed Aquamantys3 BSC 9.1S is a sterile, single-use hemostatic sealing and cutting device. The device employs bipolar radiofrequency (RF) energy and saline for hemostatic sealing and coagulation, and monopolar radio-frequency (RF) energy for cutting. The device is equipped with a dual electrode tip with saline orifices on both sides of the inner electrode at its distal end. Saline and RF energy are supplied to the device from lines on the proximal end of the hand piece. The cassette provides the electrical connection and saline fluid delivery from the Aquamantys3 Generator. The hand piece is equipped with an on-off Transcollation® Sealing Saline button that simultaneously activates both bioolar RF and saline flow for hemostatic sealing using both electrodes. The hand piece is equipped with an on-off Cut button that activates the monopolar RF energy for cutting on a single electrode.

AI/ML Overview

The provided text describes a medical device, the Aquamantys3 BSC 9.1S, and its substantial equivalence determination based on nonclinical data. Clinical data was not required for this determination. Therefore, several of the requested sections regarding the study design and ground truth establishment (items 2, 3, 4, 5, 6, 7, 8, 9) are not applicable as no clinical study was performed.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission notes that the device underwent "bench performance testing to verify and validate the performance features and specifications." While specific quantitative acceptance criteria are not explicitly detailed in the provided text, the list below represents the types of tests performed to ensure the device met its intended performance characteristics. The reported device performance is that it successfully met the requirements of these tests, leading to a substantial equivalence determination.

Acceptance Criteria Category (Implied)	Reported Device Performance
Mechanical Integrity & Durability
Static Cable Pulls	Passed testing to ensure cable integrity.
Dynamic Cable Pulls	Passed testing for cable resilience under movement.
Static Saline Tube Pulls	Passed testing for saline tube integrity.
Cassette Separation	Passed testing to ensure appropriate cassette function and attachment.
Shaft Deflection/Pull	Passed testing for shaft flexibility and strength.
Electrode Pull	Passed testing to ensure electrode secureness.
Functional Performance
Visual Inspection	Device met visual quality standards.
Air Leak and Flow	Passed testing for air tightness and proper flow characteristics.
Hipot Testing (Dielectric Withstand)	Passed electrical safety testing.
Saline Flow Testing	Passed testing for accurate and consistent saline delivery.
Continuity (Electrical)	Passed testing to ensure proper electrical pathways.
Animal Tissue Testing	Device demonstrated expected hemostatic sealing, coagulation, and cutting performance on animal tissue.
Electrical Safety	Device met electrical safety standards.
Biocompatibility
Biocompatibility Assessment	Device materials were assessed and found to be biocompatible for intended use.

Summary of the Study Proving Acceptance Criteria:

The study that proved the device met its acceptance criteria was a series of nonclinical bench performance tests. These tests were conducted to "verify and validate the performance features and specifications" of the Aquamantys3 BSC 9.1S. The purpose of these tests was to demonstrate the device's substantial equivalence to a legally marketed predicate device (Aquamantys3 8.2L Bipolar Sealer with Cutting K111285) rather than to establish clinical efficacy or safety from human clinical trials.

The specific tests performed included: visual inspections, static and dynamic cable pulls, static saline tube pulls, air leak and flow tests, hipot testing, saline flow testing, cassette separation, shaft deflection/pull, electrode pull, continuity tests, biocompatibility assessment, animal tissue testing, and electrical safety tests. The conclusion drawn from these tests was that the Aquamantys3 BSC 9.1S is substantially equivalent to the predicate device based on its design, test results, and fundamental scientific technology.

Detailed Information (as requested by enumeration, with N/A where not applicable from the given text):

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

Test Set Sample Size: Not specified in the provided text for each individual bench test. Bench tests typically involve a relevant number of device units to ensure consistency and reliability of results, but specific numbers are not given.
Data Provenance: The tests were "bench performance testing," implying they were conducted in a laboratory or engineering environment by the manufacturer (Medtronic Advanced Energy). There is no mention of country of origin of the data in a geographical sense, or if it was retrospective or prospective, as these terms typically apply to clinical studies.

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

Number of Experts: Not applicable. For bench performance testing of this nature, "experts" in the context of clinical ground truth (e.g., radiologists) are not typically involved in establishing the "ground truth" of mechanical, electrical, or functional performance. Engineering and quality control personnel within the manufacturer's R&D are responsible for conducting and evaluating these tests against predefined specifications.
Qualifications of Experts: Not applicable for establishing clinical ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic imaging, to resolve discrepancies among expert readers. For bench testing, test results are typically compared against predefined engineering specifications and criteria (e.g., pass/fail), often with established quality control and review processes rather than expert adjudication in the clinical sense.

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:

MRMC Study: No. The provided text explicitly states, "Clinical testing was not required to establish substantial equivalence between the proposed and predicate devices." Therefore, no MRMC study, or any clinical study involving human readers or AI assistance, was performed according to this submission.
Effect Size with AI: Not applicable.

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

Standalone Performance: No. The device is a physical electrosurgical device, not an algorithm or AI system. Therefore, the concept of "standalone algorithm only" performance does not apply.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Type of Ground Truth: For the nonclinical bench testing, the "ground truth" was established based on engineering specifications, design requirements, and performance standards for the device's mechanical, electrical, and functional characteristics. For animal tissue testing, the "ground truth" would be the observed physical effects (hemostatic sealing, coagulation, cutting) consistent with the device's intended mechanism of action.

8. The sample size for the training set:

Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set. The term "training set" is relevant for machine learning models, not for traditional medical devices like this electrosurgical accessory.

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

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Summary

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< 121290

510(k) Summary

Submitter:

Medtronic Advanced Energy 180 International Drive Portsmouth, NH 03801 USA

Contact Person:

Date Prepared:

April 27th, 2012.

Trade Name:

Common Name:

Classification Name:

Predicate Device:

Device Description:

Statement of Intended Use: JUN 2 5

Tara N. Turney, RAC Senior Regulatory Affairs Specialist Phone: 603-742-5445 Fax: 603-742-1488 Email: tara.n.turney@medtronic.com

April 27th, 2012 ·

Aquamantys3 BSC 9.1S

Electrosurgical accessory

Electrosurgical Cutting and Coagulation Device and Accessories

Aquamantys3 8.2L Bipolar Sealer with Cutting K11285, cleared September 9th, 2011

The Aquamantys3 BSC 9.1S is a monopolar/bipolar, single use, sterile, disposable device intended for use with the Aquamantys3 Pump Generator. The device delivers bipolar

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K121290

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RF energy concurrent with saline for haemostatic sealing and coagulation of soft tissue and bone and monopolar RF energy for cutting of soft tissue. It is intended for, but not limited to. orthopaedic, spine, thoracic, and open abdominal surgery.

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

The Aquamantys3 BSC 9.1S applies the same fundamental scientific technology as the existing Medtronic Advanced Energy Bipolar Sealers, with the addition of monopolar RF energy applied without saline, as is seen in the predicate Medtronic Advanced Energy Aquamantys3 8.2L Bipolar Sealer with Cutting (K111285). The device's hand piece is equipped with two activation buttons; the distal vellow button activates monopolar RF energy for cutting, and the proximal blue button activates bipolar RF energy concurrent with saline flow for hemostatic sealing and coagulation. The cord of the Aquamantys3 BSC 9.1S terminates in a cassette that is designed to uniquely insert into the Aquamantys3 Pump Generator, providing simultaneous connection to both RF power and the peristaltic pump. The main differences between the proposed and predicate devices are as follows:

. Tip Configuration
Hand piece design, including: .
- Ergonomic feel o
  - Improved look and design O
  - Materials o
Overall length of device
Malleable shaft

Summary of Nonclinical Data:

Summary of

Technological

Characteristics:

に

The Aquamantys3 BSC 9.1S 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,
cassette separation,
shaft deflection/pull,

80

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electrode pull,
continuity
biocompatibility assessment,
animal tissue testing, and
electrical safety .

Summary of Clinical Data:

ﺘﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟ

Conclusion from Data:

Clinical testing was not required to establish substantial equivalence between the proposed and predicate devices.

Medtronic Advanced Energy has demonstrated that the Aquamantys3 BSC 9.1S is substantially equivalent to the predicate device based upon indications for use, design, test results and fundamental scientific technology.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the bird symbol.

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

JUN 2 5 2012

Medtronic Incorporated % Ms. Tara Turney, RAC Regulatory Affairs Specialist 180 International Drive Portsmouth, New Hampshire 03801

Re: K121290

Trade/Device Name: Aquamantys3 BSC 9.1S Regulation Number: CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: April 27, 2012 Received: April 30, 2012

Dear Ms. Turney:

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

.
.

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Page 2 - Ms. Tara Turney

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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,
E.W. Keith

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

Enclosure

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K121290 Indications for Use

510(k) Number (if known):

Device Name:

Aquamantys3 BSC 9.1S

Indications for Use:

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)

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(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number	K121290
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Medtronic Advanced EnergyAquamantys3 BSC 9.1STraditional 510(k)	Confidential
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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.