The Aquamantys™ Minimally Invasive Sealer (MIS) FLEX and Aquamantys™ Minimally Invasive Sealer (MIS) Flex Mini are sterile, single-use bipolar electrosurgical devices 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. They are intended for, but not limited to orthopaedic, neurosurgical, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein sealing during surgery. These devices are not intended for contraceptive tubal coagulation (permanent female sterilization).

Device Description

MIS FLEX and MIS FLEX Mini are single-use, disposable, bipolar devices. The MIS FLEX and MIS FLEX Mini employ radio-frequency (RF) energy and saline irrigation (termed Transcollation Technology™) for hemostatic sealing and coagulation. The devices are equipped with dual electrode tips while 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 either of the FDA cleared AEX (K143175) or Aquamantys (K052859) Pump Generators. The MIS FLEX devices feature a fully malleable shaft, altered saline delivery and dual ports for saline delivery (two for each electrode). The distal end of the device features small, rounded electrode geometry. The MIS FLEX and MIS FLEX Mini differ by the length of the shaft. The MIS FLEX is designed for transsphenoidal and MIS Spine procedures while the MIS FLEX Mini is designed for craniotomies with application in posterial cervical and other spinal procedures.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific acceptance criteria in the manner typically seen for performance claims like accuracy, sensitivity, or specificity. This document is a 510(k) summary for a premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than proving novel performance against acceptance criteria.

However, based on the information provided, I can infer the "acceptance criteria" were primarily related to safety, electrical performance, biocompatibility, and functional access. The "study" refers to the non-clinical testing performed to demonstrate these aspects.

Here's an interpretation based on the document's content:

1. Table of Acceptance Criteria (Inferred) and Reported Device Performance

Acceptance Criteria Category (Inferred)	Specific Standard (Inferred)	Reported Device Performance
Biocompatibility	ISO-10993-1, -4, -5, -10, -11	Met requirements (Biocompatibility evaluation conducted, testing included in-vitro cytotoxicity, acute system toxicity, irritation/intracutaneous reactivity, sensitization, pyrogenicity. Considered externally communicating, limited exposure < 24 hours).
Sterilization	ISO 11737-1, ISO 11135:2014	Met requirements (Testing conducted).
Shelf Life	N/A (Standard not explicitly listed)	Met requirements (Testing conducted).
Electrical Safety	IEC 60601-1, IEC 60601-2-2	In compliance (Electrical safety and EMC testing were conducted and found to be in compliance with associated standards).
Electromagnetic Compatibility (EMC)	IEC 60601-1, IEC 60601-2-2	In compliance (Electrical safety and EMC testing were conducted and found to be in compliance with associated standards).
Mechanical Testing	N/A (Standard not explicitly listed)	Met requirements (Testing conducted).
Performance Testing - Anatomical Access	Customer needs for neurosurgical and spine procedures	Met requirements (Access study conducted to ensure ability to access key anatomy).
Performance Testing - Thermal Effect	"Premarket Notification (510(k) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff"	Substantially equivalent to the predicate device (Comparative performance testing assessed thermal effect in in-vivo porcine model and ex-vivo tissue).

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

The document does not specify exact sample sizes for most tests.

Cadaver Study (Anatomical Access): "The access study was conducted to ensure that the MIS FELX will be able to access key anatomy..." No sample size (number of cadavers) is given. Data provenance is not specified beyond being an "access study."
In-vivo Porcine Model (Comparative Performance): "The second study was a comparative performance test, which was conducted in an in-vivo porcine model." No specific number of animals is given. Data provenance is "in-vivo porcine model."
Ex-vivo Tissue Testing (Comparative Performance): "Ex-vivo tissue testing was also completed." No sample size (number of tissue samples) is given. Data provenance is "ex-vivo tissue."
Biocompatibility, Sterilization, Shelf Life, Electrical Safety, EMC, Mechanical Testing: These are generally performed on device units. The specific number of units tested is not provided, which is typical for a 510(k) summary. Data provenance would be laboratory testing.

All testing described appears to be prospective, laboratory-based, or animal-based, as part of the device development and validation process. The country of origin of the data is not specified but is implicitly from the manufacturer's testing facilities or contract labs.

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

Cadaver Study (Anatomical Access): The document mentions ensuring access to "key anatomy and meet customer needs for neurosurgical and spine procedures." This implies involvement of medical experts (e.g., neurosurgeons, spine surgeons). However, the number of experts, their qualifications, or how they established "ground truth" for access (e.g., by subjective evaluation, objective measurement of reach) is not specified.
For other tests (biocompatibility, electrical safety, thermal effect), "ground truth" is typically defined by adherence to recognized standards and objective measurements, rather than expert consensus on a test set.

4. Adjudication Method for the Test Set

Not applicable in the conventional sense for a device of this type, especially for performance studies described. The "acceptance" was based on meeting pre-defined requirements or demonstrating substantial equivalence to a predicate, not on a human-expert adjudication of results. For the access study, evaluation criteria for "meeting needs" would have been set by the manufacturer, possibly in consultation with clinicians, but an adjudication method is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document describes a "comparative performance test" for thermal effect, but this was a technical comparison of the device against a predicate in animal and ex-vivo models, not a study evaluating human readers' performance with and without AI assistance. This device is an electrosurgical tool, not an AI-assisted diagnostic or interpretative system that would typically warrant an MRMC study.

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

This question is not applicable as the device is not an algorithm or AI system. It is a physical electrosurgical device. The "standalone" performance refers to its direct functional capabilities (e.g., thermal effect, access).

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Biocompatibility: Adherence to ISO standards, measured biological responses (e.g., cytotoxicity, irritation, sensitization).
Electrical Safety & EMC: Adherence to IEC standards, objective electrical measurements.
Performance (Thermal Effect): Objective measurements of thermal effect (e.g., temperature, tissue charring, coagulation depth) in animal and ex-vivo models, compared against the predicate and potentially against defined specifications derived from predicate performance. The "ground truth" is primarily the measured physical effect relative to established benchmarks and predicate performance.
Performance (Anatomical Access): Likely subjective or objective assessment of the device's ability to reach target anatomical locations in cadavers, possibly based on expert opinion/feedback from surgeons.

8. The Sample Size for the Training Set

Not applicable. This device is a physical electrosurgical instrument, not an AI or machine learning algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

Summary

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

September 7, 2017

Medtronic Advanced Energy Heather Valley Principal Regulatory Affairs Specialist 180 International Drive Portsmouth, New Hampshire 03801

Re: K170381

Trade/Device Name: Aquamantys MIS FLEX and Aquamantys MIS FLEX Mini Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: August 18, 2017 Received: August 21, 2017

Dear Heather Valley:

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

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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 contact the Division of Industry and Consumer Education (DICE) 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. 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

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 Industry and Consumer Education (DICE) 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,

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For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K170381

Device Name

Aquamantys(TM) Minimally Invasive Sealer (MIS) FLEX Aquamantys(TM) Minimally Invasive Sealer (MIS) FLEX Mini

Indications for Use (Describe)

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

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MIS FLEX

Traditional 510(k) Premarket Notification

510(k) Summary

Submitter:	Medtronic Advanced Energy180 International DrivePortsmouth, NH 03801
Contact Person:	Heather Valley, RACPrincipal Regulatory Affairs SpecialistPhone: (603) 294-5447Fax: (603) 742-1488E-mail: Heather.a.valley@medtronic.com
Date Summary Prepared:	September 5, 2017
Device Trade Name:	Aquamantys™ Minimally Invasive Sealer (MIS) FLEX andAquamantys™ Minimally Invasive Sealer (MIS) FLEX Mini
Common Name:	Electrosurgical Instrument
Classification Name:	Electrosurgical cutting and coagulation device and accessories(21 CFR 878.4400)
Regulatory Class:	Class II
Product Code:	GEI
Predicate Device:	Aquamantys SBS 5.0 (K132974)
Device Description:	MIS FLEX and MIS FLEX Mini are single-use, disposable, bipolardevices. The MIS FLEX and MIS FLEX Mini employ radio-frequency(RF) energy and saline irrigation (termed Transcollation Technology™)for hemostatic sealing and coagulation. The devices are equipped withdual electrode tips while saline and electrical lines exit the opposite endof the handpiece from the electrodes. The handpiece is equipped with anon-off button that simultaneously activates both RF and saline flow. Asaline fluid delivery line is provided with the device and includes asection of pump tubing and drip chamber or spike. The three-pinelectrical connector is designed to be plugged into either of the FDAcleared AEX (K143175) or Aquamantys (K052859) Pump Generators.The MIS FLEX devices feature a fully malleable shaft, altered salinedelivery and dual ports for saline delivery (two for each electrode). Thedistal end of the device features small, rounded electrode geometry.The MIS FLEX and MIS FLEX Mini differ by the length of the shaft. TheMIS FLEX is designed for transsphenoidal and MIS Spine procedureswhile the MIS FLEX Mini is designed for craniotomies with application inposterial cervical and other spinal procedures.
Indications for Use:	The Aquamantys™ Minimally Invasive Sealer (MIS) FLEX andAquamantys™ Minimally Invasive Sealer (MIS) Flex Mini are sterile,single-use bipolar electrosurgical devices intended to be used in

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K170381 p 2/4

Traditional 510(k) Premarket Notification

conjunction with a qualified Pump Generator for delivery of Radiofrequency (RF) energy and saline for hemostatic sealing and coaqulation of soft tissue and bone at the operative site. They are intended for, but not limited to orthopaedic, neurosurgical, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein sealing during surgery. These devices are not intended for contraceptive tubal coagulation (permanent female sterilization).

Technological Characteristics:

The MIS FLEX devices are similar to the predicate devices as they are sterile, single use, bipolar electrosurgical devices used to provide hemostatic sealing and coagulation of soft tissue and bone at the operative site.

The three major differences between the subject and predicate device are the malleable shaft, altered saline delivery and electrode size. These new features do not impact the safety or effectiveness of the device.

Summary of Non-Clinical Testing:

The design and performance of the MIS FLEX devices were verified and validated through bench testing. The following performance data were provided in support of the substantial equivalence determination:

Biocompatibility ●
Sterilization ●
Shelf Life
Electrical Safety ●
Electromagnetic Compatibility ●
Mechanical Testing
Performance Testing .

Biocompatibility Testing

The Biocompatibility evaluation for MIS FLEX was conducted in accordance with the following International Standard ISO-10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process", as recognized by FDA. The testing includes the following:

InVitro Cytotoxicity ●
. Acute System Toxicity
Irritation or Intracutaneous Reactivity ●
Sensitization ●
. Pyrogenicity

The MIS FLEX devices are considered externally communicating devices (Tissue/Bone/Dentin) with limited exposure of less than 24 hours.

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MIS FLEX

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MIS FLEX

Traditional 510(k) Premarket Notification

Electrical Safety Testing

Electrical safety and EMC testing were conducted on MIS FLEX devices and were found to be in compliance with associated IEC 60601-1 and IEC 60601-2-2 standards.

Performance Testing

Two studies were completed in support of the MIS FLEX 510(k). One study was limited to validating anatomical access (Cadaver Study). The second study was a comparative performance test, which was conducted in an in-vivo porcine model. Ex-vivo tissue testing was also completed.

The access study was conducted to ensure that the MIS FELX will be able to access key anatomy and meet customer needs for neurosurgical and spine procedures. The devices met the requirements for access.

The comparative performance testing assessed the thermal effect of the MIS FLEX devices in both the in-vivo and ex-vivo models against the predicate in accordance with the "Premarket Notification (510(k) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff". The subject devices were substantially equivalent.

Testing of the MIS FLEX and MIS FLEX Mini were conducted in accordance with the following FDA recognized standards:

RecognitionNumber	Standard	Title of Standard
19-4	ES60601-1:20 X05/(R)2012 AndA1:2012	C1:2009/(R)2012 And A2:2010/(R)2012 (ConsolidatedText) Medical Electrical Equipment - Part 1: GeneralRequirements For Basic Safety And EssentialPerformance (IEC 60601-1:2005, MOD)
9-64	IEC 60601-2-2Ed 5.0	Medical Electrical Equipment - Part 2-2: ParticularRequirements For The Basic Safety And EssentialPerformance Of High Frequency Surgery EquipmentAnd High Frequency Surgical Accessories
14-407	11737-1 Second Edition 2006-04-01	Sterilization Of Medical Devices - MicrobiologicalMethods - Part 1: Determination Of A Population OfMicroorganisms On Products [Including: TechnicalCorrigendum 1 (2007)]
14-479	11135:2014	Sterilization Of Health Care Products - Ethylene Oxide- Requirements For Development, Validation AndRoutine Control Of A Sterilization Process For MedicalDevices.
2-220	10993-1 Fourth Edition 2009-10-15	Biological Evaluation Of Medical Devices - Part 1:Evaluation And Testing Within A Risk ManagementProcess [Including: Technical Corrigendum 1 (2010)]

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K170381 p 4/4

MIS FLEX

Traditional 510(k) Premarket Notification

2-235	10993-4 Second Edition 2002-10-15 AMENDMENT 1	Biological Evaluation Of Medical Devices - Part 4:Selection Of Tests For Interaction With Blood[Including: Amendment 1 (2006)].
2-153	10993-5:2009/(R)2014	Biological Evaluation Of Medical Devices - Part 5:Tests For In Vitro Cytotoxicity
2-174	10993-10 Third Edition 2010-08-01	Biological Evaluation Of Medical Devices - Part 10:Tests For Irritation And Skin Sensitization
2-176	10993-11 Second Edition 2006-08-15	Biological Evaluation Of Medical Devices - Part 11:Tests For Systemic Toxicity

Summary of Clinical Tests: Clinical testing was not required for this product.

Conclusion: The indications for use, technology and performance characteristics of the MIS FLEX and MIS FLEX Mini are equivalent to that of the predicate device and therefore Medtronic Advanced Energy claims substantial equivalence to the predicate device.

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.