The Green OR Reprocessed Aquamantys Bipolar Sealer is a sterile, single-use bipolar electrosurgical device intended to be used in conjunction with a qualified Pump Generator for delivery of radio-frequency (RF) energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

The Green OR Reprocessed Aquamantys 2.3 Bipolar Sealer is intended for, but not limited to orthopaedic, neurosurgical, spine, thoracic, and open abdominal surgery.

The Green OR Reprocessed Aquamantys 6.0 Bipolar Sealer is intended for, but not limited to orthopaedic, spine, thoracic, and open abdominal surgery.

The Green OR Reprocessed Aquamantys 9.5 XL Bipolar Sealer is intended for, but not limited to open abdominal, orthopaedic, and thoracic surgery.

Device Description

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AI/ML Overview

This document is a 510(k) Pre-market Notification for a reprocessed medical device, the Green OR Reprocessed Aquamantys Bipolar Sealer. The submission aims to demonstrate substantial equivalence to the original, legally marketed predicate devices.

1. Table of Acceptance Criteria and the Reported Device Performance:

The document lists performance testing conducted to demonstrate substantial equivalence. These tests serve as the "acceptance criteria" for the reprocessed device to perform comparably to the original. The document states that the functional characteristics "have been evaluated and found to be equivalent to the predicate devices."

Acceptance Criteria Category	Specific Test/Property	Reported Device Performance
Functional Performance	RF Power Output	Evaluated and found equivalent to predicate devices
	Saline Flow Rate	Evaluated and found equivalent to predicate devices
Biocompatibility	Cytotoxicity	Evaluated and found equivalent to predicate devices
	Sensitization	Evaluated and found equivalent to predicate devices
	Irritation: Intracutaneous Reactivity	Evaluated and found equivalent to predicate devices
	Acute systemic toxicity	Evaluated and found equivalent to predicate devices
	Material mediated pyrogenicity	Evaluated and found equivalent to predicate devices
Sterilization Validation	Bacterial Endotoxin / LAL	Evaluated and found equivalent to predicate devices
Reprocessing Effectiveness	Cleaning	Evaluated and found equivalent to predicate devices
	Residual Protein	Evaluated and found equivalent to predicate devices
	Residual Total Organic Carbon	Evaluated and found equivalent to predicate devices
Electrical Safety	EMC and Electrical Safety (IEC 60601-2-2)	Evaluated and found equivalent to predicate devices

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

The document does not explicitly state the sample sizes used for each specific test. It broadly refers to "the functional characteristics of the subject devices have been evaluated." As this is a 510(k) for a reprocessed device, the data provenance would primarily be from laboratory testing conducted on the reprocessed units, comparing them against the specifications or performance of new, original devices (the predicates). There is no mention of clinical data or patient data (retrospective or prospective) in this summary.

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

This type of information (number and qualifications of experts) is typically associated with studies involving human interpretation or clinical outcomes, such as imaging diagnostic algorithms. For a device like a bipolar sealer undergoing functional and safety testing, the "ground truth" is established by objective engineering and laboratory standards and measurements, not expert human interpretation. Therefore, this information is not applicable or provided in this type of submission.

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

Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among human experts in cases of subjective interpretation (e.g., radiology reads). Since the described tests are objective laboratory and engineering assessments of device performance (e.g., RF power output, residual protein), such an adjudication method is not relevant or applied.

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:

An MRMC comparative effectiveness study is used to evaluate the diagnostic performance of humans, often with and without AI assistance, on a set of cases. This device (a reprocessed bipolar sealer) is a surgical tool, not a diagnostic imaging device typically associated with human "readers" or AI assistance in a diagnostic context. Therefore, an MRMC study was not conducted, and effect sizes related to human reader improvement with AI assistance are not applicable.

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

This device is not an algorithm or an AI system, but a physical electrosurgical tool. Therefore, the concept of "standalone" performance for an algorithm is not applicable. The performance testing described (RF power, saline flow, cleaning, etc.) is the "standalone" performance of the reprocessed device itself.

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

For the specific tests listed (RF Power Output, Saline Flow Rate, Biocompatibility, Sterilization, Cleaning, Electrical Safety), the ground truth is established by objective, measurable engineering specifications, industry standards (e.g., IEC 60601-2-2), and validated test methods. For example, RF power output would be measured against the manufacturer's specified output range for a new device, and residual protein levels would be measured against established acceptance limits. It would not typically involve expert consensus, pathology, or outcomes data in the usual sense for this type of device and testing.

8. The sample size for the training set:

As this is a reprocessed physical medical device and not an AI/ML algorithm, the concept of a "training set" is not applicable. The device itself is manufactured/reprocessed and then tested, not "trained."

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

Since there is no "training set" for this device, this question is not applicable.

Summary

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April 7, 2022

Green OR, LLC. % Aaron Rogers Director of Regulatory and Quality Pathway LLC 8779 Cottonwood Ave. Suite 105 Santee, California 92071

Re: K211203

Trade/Device Name: Green OR Reprocessed Aquamantys Bipolar Sealer Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: NUJ Dated: March 7, 2022 Received: March 8, 2022

Dear Aaron Rogers:

We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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K211203 - Aaron Rogers

Reprocessed Single-Use Device Models Included in Submission:
OM	Model Number	Device Name/Description
OEM	Model Number	Device Name/Description
Medtronic	23-113-1	Aquamantys 2.3 Bipolar Sealer
Medtronic	23-112-1	Aquamantys 6.0 Bipolar Sealer
Medtronic	23-313-1	Aquamantys 9.5 XL Bipolar Sealer

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Indications for Use

510(k) Number (if known) K211203

Device Name

Green OR Reprocessed Aquamantys 2.3 Bipolar Sealer, Green OR Reprocessed Aquamantys 6.0 Bipolar Sealer, Green OR Reprocessed Aquamantys 9.5 XL Bipolar Sealer

Indications for Use (Describe)

The Green OR Reprocessed Aquamantys 2.3 Bipolar Sealer is intended for, but not limited to orthopaedic, neurosurgical, spine, thoracic, and open abdominal surgery.

The Green OR Reprocessed Aquamantys 6.0 Bipolar Sealer is intended for, but not limited to orthopaedic, spine, thoracic, and open abdominal surgery.

The Green OR Reprocessed Aquamantys 9.5 XL Bipolar Sealer is intended for, but not limited to open abdominal, orthopaedic, and thoracic surgery.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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K211203

Image /page/4/Picture/2 description: The image shows the logo for GreenOR. The word "Green" is written in green font, and the letters "OR" are written in blue font. A green and blue circular arrow surrounds the word "Green" and connects to the letters "OR".

Reprocessed Aquamantys Bipolar Sealers

K211203 Summary

SUBMITTER	Green OR, LLC.John Zehren4200 Dahlberg Drive #300Golden Valley, MN 55422
CONTACT	Aaron RogersPathway, LLC.8779 Cottonwood Ave. #105Santee, CA 92071619-415-0103 x704arogers@pathwaynpi.com
DATE PREPARED	April 6, 2022
DEVICE NAME	Green OR Reprocessed Aquamantys Bipolar Sealer
CLASSIFICATION	Electrosurgical cutting and coagulation device and accessoriesRegulation: 21 CFR 878.4400Device Class: Class IIProduct Code: NUJ
	PredicateManufacturer	Device Name	510(k)
PREDICATEDEVICE	Medtronic	Aquamantys 2.3 Bipolar Sealer	K132974
	Medtronic	Aquamantys 9.5 XL Bipolar Sealer	K120537
	Medtronic	Aquamantys 6.0 Bipolar Sealer	K111285
REFERENCEDEVICE	No reference devices were used in this submission.
	with an on-off button that simultaneously activates both RF and salineflow. A saline fluid delivery line is provided with the device, andincludes a section of pump tubing and a drip chamber or spike. Thethree-pin electrical connector is designed to be plugged into aqualified Pump Generator. The generator is not included in the scopeof the study and will not be reprocessed.
	The Green OR Reprocessed Aquamantys Bipolar Sealer is a sterile,single-use bipolar electrosurgical device intended to be used inconjunction with a qualified Pump Generator for delivery of RF energyand saline for hemostatic sealing and coagulation of soft tissue andbone at the operative site. The device is not intended forcontraceptive tubal coagulation (permanent female sterilization).
INTENDED USE	The Green OR Reprocessed Aquamantys 2.3 Bipolar Sealer isintended for, but not limited to orthopaedic, neurosurgical, spine,thoracic, and open abdominal surgery.
	The Green OR Reprocessed Aquamantys 6.0 Bipolar Sealer isintended for, but not limited to orthopaedic, spine, thoracic, and openabdominal surgery.
	The Green OR Reprocessed Aquamantys 9.5 XL Bipolar Sealer isintended for, but not limited to, open abdominal, orthopaedic, andthoracic surgery.
TECHNOLOGICALCHARACTERISTICS	The technological characteristics and the fundamental scientifictechnology of the subject devices are identical to the predicatedevice. The subject devices are a reprocessed version of thepredicate. The predicate devices were used to support intended use,technological characteristics, and functional performancespecifications.
	The functional characteristics of the subject devices have beenevaluated and found to be equivalent to the predicate devices basedon the following tests:
PERFORMANCETESTING	Sterilization Validation Biocompatibility Cytotoxicity Sensitization Irritation: Intracutaneous Reactivity Acute systemic toxicity Material mediated pyrogenicity Bacterial Endotoxin / LAL EMC and Electrical Safety IEC 60601-2-2 Functional Performance RF Power Output Saline Flow Rate

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	• Cleaning
	• Residual Protein
	• Residual Total Organic Carbon
CONCLUSION	Based on comparisons of the indications for use, intended use, technological characteristics, and performance data to the predicate devices, the Green OR Reprocessed Aquamantys Bipolar Sealer is substantially equivalent to the predicate devices.

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.