The Aquamantys3 Generator is an electrosurgical generator with monopolar and bipolar RF outputs. It is intended to be used with specified disposables for delivery of RF energy for cutting of soft tissue and RF energy concurrent with saline for haemostatic sealing and coagulation of soft tissue and bone at the operative site during surgical procedures. The system is not intended for contraceptive tubal coagulation (permanent female sterilization).

The Aquamantys3 Bipolar Sealer is a bipolar, single use, sterile, disposable device intended for use with the Aquamantys3 Generator. The device delivers bipolar RF energy concurrent with saline for haemostatic sealing and coagulation of soft tissue and bone. 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 8.2L Bipolar Sealer with Cutting is a monopolar/bipolar, single use, sterile, disposable device intended for use with the Aquamantys3 Generator. The device delivers monopolar RF energy for cutting of soft tissue and bipolar RF energy concurrent with saline for haemostatic sealing and coagulation of soft tissue and bone. 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 Salient Surgical Aquamantys3 Pump Generator System is a general reference term used to describe use of the Salient Aquamantys3 Pump Generator together with specific, design compatible, Aquamantys3 electrosurgical instruments. The Aquamantys3 Pump Generator itself is an electrosurgical generator with, monopolar and bipolar, high frequency current outputs and an internal rotary peristaltic pump for delivery of saline. The Aquamantys3 Pump Generator is for use only with specific, design compatible Aquamantys3 electrosurgical instruments, for delivery of radio frequency (RF) energy for cutting of soft tissue and delivery of RF energy concurrent with saline for haemostatic sealing and coagulation of soft tissue and bone at the operative site. Currently included as part of the system in this 510(k) submission are the Aquamantys3 Pump Generator, and two hand-held, sterile, single use disposable electrosurgical devices that are compatible with the Aquamantys3 Pump Generator system. These disposable devices are the Aquamantys3 6.0 Bipolar Sealer and the Aquamantys3 8.2L Bipolar Sealer with Cutting.

The Aquamantys3 Pump Generator is a shelf-top unit consisting of a sheet metal housing and a front LCD control panel. The generator has a peristaltic pump located within the housing, which is capable of transferring saline through the disposable accessory device concurrent with the generator's provision of RF energy. The LCD control panel is touchscreen and serves as the user interface for power and saline settings. The Aquamantys3 Pump Generator has a receptacle in its front panel that provides for the disposable device connection to the generator's RF power and the peristaltic pump. The Aquamantys3 disposable device connection to the Aquamantys3 Pump Generator is configured as a cassette; the configuration is unique to the Aquamantys3 system and ensures only Aquamantys3 disposable devices with the cassette can be used with the Aquamantys3 Pump Generator. The generator accepts designated, commercially available, split-pad patient return electrode pads (neutral electrodes) for monopolar applications, and provides monitoring of the patient return circuit for safety purposes.

The Aquamantys3 6.0 Bipolar Sealer device is a modified disposable, that when connected to the Aquamantys3 Pump Generator, uses bipolar RF energy applied concurrently with saline to the operative site. The effect of RF energy applied concurrently with saline results in haemostatic sealing and coagulation of soft tissue and bone without charring; this result has been trademarked as Transcollation® technology by Salient Surgical Technologies. The proposed Aquamantys3 6.0 Bipolar Sealer shares the same handpiece, shaft and tip configuration as its predicate device, the Aquamantys 6.0 Bipolar Sealer. The proposed and predicate devices differ only in how they connect to their designated generators. The proposed Aquamantys3 device has a cassette to connect it to the Aquamantys3 Pump Generator, allowing the user to connect the device's saline tubing to the peristaltic pump at the same time as the device is connected electrically to the generator. The predicate Aquamantys disposable device, comparatively, has a standard three-prong plug for electrical connection to the Aquamantys Pump Generator and the user is required to manually feed the predicate's saline tubing into the peristaltic pump. The unique cassette connection helps prevent the connection of Aquamantys3 devices to other, unintended or unspecified equipment.

The Aquamantys3 8.2L Bipolar Sealer with Cutting device is a disposable that, when connected to the Aquamantys3 Pump Generator, uses monopolar RF energy for cutting, and bipolar RF energy concurrent with saline for haemostatic sealing and coagulation. The device is equipped with dual electrodes at the distal tip. Saline and electrical lines exit the opposite end (proximal end) of the device's handpiece from the distal electrodes. The device's handpiece is equipped with two activation buttons; the distal yellow button activates monopolar RF energy for cutting, and the proximal blue button simultaneously activates bipolar RF energy concurrent with saline flow for haemostatic sealing and coagulation. A saline fluid delivery line is provided with the device, which includes a spike for insertion into saline bags. The electrical connection of the device to the generator, as well as the saline tubing insertion into the generator's pump, is made via a cassette interface that is part of the disposable device. The cassette assures the unique connection of Aquamantys3 disposable devices with Aquamantys3 Pump Generators.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device called the Aquamantys®3 Pump Generator System. It details the device's description, indications for use, comparison to predicate devices, and a summary of non-clinical and clinical testing.

However, the document does not contain specific acceptance criteria or quantitative performance data in the way a clinical study report with predefined endpoints and statistical analysis would. Instead, it states that the device was found to be "substantially equivalent" to predicate devices based on non-clinical performance testing.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be extracted from this document directly. I will provide the information that is available and explicitly state when information is not present.

Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria. Instead, it relies on demonstrating equivalence to predicate devices. The reported device performance is qualitative: "the tissue effect of the Aquamantys3 system was comparable to the predicate devices for both monopolar RF for cutting and bipolar RF concurrent with saline for haemostatic sealing and coagulation (Transcollation® technology) applications."

Acceptance Criteria (Quantitative)	Reported Device Performance (Quantitative)
Not specified in the document.	Not specified in the document.
Qualitative Acceptance: The tissue effect and general performance of the Aquamantys3 Pump Generator with its disposable devices (Aquamantys3 6.0 Bipolar Sealer and Aquamantys3 8.2L Bipolar Sealer with Cutting) must be comparable to predicate devices for relevant applications.	Reported Performance: The tissue effect of the Aquamantys3 system was comparable to the predicate devices for both monopolar RF for cutting and bipolar RF concurrent with saline for haemostatic sealing and coagulation (Transcollation® technology) applications.

Study Details

Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated as a number of subjects or samples. The testing involved "in-vivo animal (porcine) studies" and "related verification bench tests."
- Data provenance: "in-vivo animal (porcine) studies" and "related verification bench tests." Country of origin is not specified, but the applicant is Salient Surgical Technologies, Inc., based in Portsmouth, NH, USA. The studies are prospective in nature, as they were conducted to evaluate a new device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: The document states that "In-vivo animal study participants included surgeons, circulating nurses and Salient Surgical Technologies' personnel." A specific number of experts or their roles in establishing "ground truth" (e.g., assessing tissue effect outcomes) is not quantified.
- Qualifications of experts: Only general roles are given (surgeons, circulating nurses). Specific qualifications (e.g., years of experience, board certification) are not detailed.
Adjudication method for the test set:
- Not specified. The document only mentions that animal study participants included surgeons, nurses, and company personnel, but how their observations or assessments were adjudicated to determine "comparability" is not described.
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:
- No, this type of study was not conducted. This document describes a medical device (electrosurgical system), not an AI-assisted diagnostic tool or system that would typically involve human "readers" or AI assistance in interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The device is a surgical instrument and generator system, not an algorithm. Its performance inherently involves human operation.
The type of ground truth used:
- The "ground truth" was implicitly established by the observed "tissue effect" and "general performance" in the in-vivo animal studies and bench tests, assessed for comparability against predicate devices. This would likely involve visual assessment by surgeons, potentially histological analysis of tissue, and objective measurements from bench tests. The document does not explicitly state a definitive "ground truth" method like pathology or specific outcome measures, but rather "comparable tissue effect."
The sample size for the training set:
- Not applicable/Not provided. This device is not an AI/ML algorithm that requires a training set. The "testing" referred to is for device validation and verification.
How the ground truth for the training set was established:
- Not applicable. No training set for an AI/ML algorithm was used.

Summary

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K 111 285
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510(k) Summary for the Salient Surgical Technologies, Inc. Aquamantys 3 Pump Generator System, Aquamantys 3 6.0 Bipolar Sealer and Aquamantys 3 8.2L Bipolar Sealer with Cutting As Required by 21 CFR 807.87(k)

1. SPONSOR/510(K) HOLDER

Salient Surgical Technologies, Inc. 180 International Drive Portsmouth, NH 03801

Phone:	603-742-1515
Fax:	603-742-5943
Contact:	Rita M. Calnan

May 5, 2011 Date Prepared:

2. DEVICE NAME

Proprietary Name:	Aquamantys®3 Pump Generator System, which includes theAquamantys®3 Pump Generator, Aquamantys®3 6.0 BipolarSealer and Aquamantys®3 8.2L Bipolar Sealer with Cutting
Common/Usual Name:	Electrosurgical Generator and accessory
Classification Name:	Electrosurgical cutting and coagulation device and accessories

3. PREDICATE DEVICES

Salient Surgical (formerly TissueLink) Aquamantys Pump Generator System . (includes Aquamantys Pump Generator, Aquamantys 6.0 Bipolar Sealer and Aquamantys 2.3 Bipolar Sealer), K052859
ValleyLab ForceFX Electrosurgical Generator, K944602 .
ValleyLab E2516 Electrosurgical Pencil, K813071 .

4. DEVICE DESCRIPTION

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frequency current outputs and an internal rotary peristaltic pump for delivery of saline. The Aquamantys3 Pump Generator is for use only with specific, design compatible Aquamantys3 electrosurgical instruments, for delivery of radio frequency (RF) energy for cutting of soft tissue and delivery of RF energy concurrent with saline for haemostatic sealing and coagulation of soft tissue and bone at the operative site. Currently included as part of the system in this 510(k) submission are the Aquamantys3 Pump Generator, and two hand-held, sterile, single use disposable electrosurgical devices that are compatible with the Aquamantys3 Pump Generator system. These disposable devices are the Aquamantys3 6.0 Bipolar Sealer and the Aquamantys3 8.2L Bipolar Sealer with Cutting.

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connection of Aquamantys3 devices to other, unintended or unspecified equipment.

5. INDICATION FOR USE/INTENDED USE

Aquamantys3 Generator:

Aquamantys3 6.0 Bipolar Sealer:

Aquamantys3 8.2L Bipolar Sealer with Cutting:

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for, but not limited to, orthopaedic, spine, thoracic, and open abdominal surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE/S

The Aquamantys3. Pump Generator applies the same fundamental technology as the predicate Aquamantys Pump Generator (previously cleared under K052859) in that it delivers bipolar RF energy with saline to provide haemostatic sealing and coagulation of soft tissue and bone at the operative site. The proposed generator is additionally similar to the predicate Valleylab ForceFX Generator (previously cleared under K944602) in that it delivers monopolar RF energy, in addition to bipolar RF energy, for cutting and coagulation during surgery.

The modified single-use disposable accessory device, the Aquamantys3 6.0 Bipolar Sealer, is similar to the Aquamantys 6.0 Bipolar Sealer such that both devices provide concurrent delivery of bipolar RF energy with saline. The two devices share identical handpiece, shaft and tip configurations and differ only in regard to how they connect to their respective, designated generators. The cord of the predicate Aquamantys 6.0 terminates in a standard three-prong electrical connector and has saline tubing that is manually loaded as an additional step into the peristaltic pump. The cord of the proposed Aquamantys3 6.0 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 Aquamantys3 8.2L Bipolar Sealer with Cutting applies the same fundamental scientific technology as the existing Salient Surgical Bipolar Sealers, with the addition of monopolar RF energy applied without saline, similar to a standard monopolar electrosurgical pencil, such as Valleylab's E2516 (K813071). The device's handpiece is equipped with two activation buttons; the distal yellow button activates monopolar RF energy for cutting, and the proximal blue button simultaneously activates bipolar RF energy concurrent with saline flow for haemostatic sealing and coagulation. The cord of the Aquamantys3 8.2L 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.

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7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

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The tissue effect and general performance of the Aquamantys3 Pump Generator was evaluated with each of the proposed disposable devices, the Aquamantys3 6.0 Bipolar Sealer and the Aquamantys3 8.2L Bipolar Sealer with Cutting, in in-vivo animal (porcine) studies and related verification bench tests. These verification and validation activities demonstrated the tissue effect of the Aquamantys3 system was comparable to the predicate devices for both monopolar RF for cutting and bipolar RF concurrent with saline for haemostatic sealing and coagulation (Transcollation® technology) applications. In-vivo animal study participants included surgeons, circulating nurses and Salient Surgical Technologies' personnel.

8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

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

9. SUMMARY OF OTHER INFORMATION

No other testing was required to establish substantial equivalence between the proposed and predicate devices.

10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS

Testing performed, including in-vivo animal, verification and validation testing, indicates the Aquamantys3 Pump Generator, the Aquamantys3 6.0 Bipolar Sealer and the Aquamantys3 8.2L Bipolar Sealer with Cutting are substantially equivalent to the predicate devices. The proposed devices do not introduce considerations for safety and efficacy different from the considerations of their predicate devices.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three lines representing its wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a sans-serif font.

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

Salient Surgical Technologies, Inc. % Ms. Rita M. Calnan 180 International Drive Portsmouth, New Hampshire 03801

SEP - 9 2011

Re: K111285

Trade/Device Name: Aquamantys®3 Pump Generator System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: August 29, 2011 Received: August 31, 2011

Dear Ms. Calnan:

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

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Page 2 - Ms. Rita M. Calnan

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 331-542 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/Reportal?roblem/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

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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KIII285

Indications for Use

510(k) Number (if known): 《《III 285

Device Name: Aquamantys®3 Pump Generator System

Indications for Use:

The Aquamantys3 Pump Generator

Aquamantys3 6.0 Bipolar Sealer:

Aquamantys3 8.2L. Bipolar Sealer with Cutting:

The Aquamantys3 8.2L Bipolar Sealer with Cutting is a monopolar/bipolar, single use, sterile, disposable device intended for use with the Aquamantys3 Generator. The device delivers monopolar RF energy for cutting of soft tissue and bipolar RF energy concurrent with saline for haemostatic sealing and coaqulation of soft tissue and bone. 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).

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)

Neil R. Podell (44c) for man

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

510(k) Number K111285

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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.