Seal & Cut mode:
The THUNDERBEAT Open Fine Jaw Type X hand instrument when used in combination with the Seal & Cut mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. The device has been designed to seal and cut vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.

This mode is also indicated for open ENT procedure in adults (thyroidectomy, parathyroidectomy, parotidectomy, radical neck dissection, and tonsillectomy) for only ligation (sealing and cutting) of vessels, lymphatics and tissue bundles greater than 3mm away from unintended thermally sensitive structures such as nerves and parathyroid glands.

Seal mode:
The THUNDERBEAT Open Fine Jaw Type X hand instrument when used in combination with the Seal mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which vessel sealing, coagulation, grasping is performed. The device has been designed to seal vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
This mode is also indicated for open ENT procedure in adults (thyroidectomy, parathyroidectomy, parotidectomy, radical neck dissection, and tonsillectomy) for sealing of vessels, lymphatics and tissue bundles greater than 3mm away from unintended thermally sensitive structures such as nerves and parathyroid glands.

The THUNDERBEAT Open Fine Jaw Type X hand instrument has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

Device Description

THUNDERBEAT Open Fine Jaw Type X hand instrument is intended to be used for open surgery to cut, seal, coagulate, grasp, and dissect.

The THUNDERBEAT Open Fine Jaw Type X hand instrument is provided as a sterile, single use device. The subject device is functional device capable of vessel sealing & cutting, tissue coagulating & cutting, grasping, and dissecting. This device has been designed to seal and cut vessels up to and including 7 mm in diameter, tissue bundles, and lymphatics. This device also has been designed for open ENT procedures in adults.

AI/ML Overview

Based on the provided text, the device in question is the THUNDERBEAT Open Fine Jaw Type X hand instrument, an electrosurgical cutting and coagulation device. The document is an FDA 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical trial to establish novel effectiveness.

Therefore, the study described here is primarily a bench and animal testing study to support the substantial equivalence claim, especially concerning design modifications and an expanded indication. It is not an AI/Medical Imaging device, so many of the requested elements (like MRMC study, expert judgment for image ground truth, training set information) are not applicable.

Here's the breakdown based on the provided text:

Acceptance Criteria and Device Performance:

The document doesn't explicitly list "acceptance criteria" in a typical table format with quantitative thresholds for each performance metric, as might be seen for a novel device. Instead, the performance testing was conducted to demonstrate equivalence to the predicate device and ensure safety and effectiveness despite modifications and expanded indications. The "acceptance criteria" can be inferred as meeting the performance standards of the predicate device and showing no new safety concerns.

Table of Acceptance Criteria and Reported Device Performance (Inferred from Study Purpose):

Acceptance Criteria Category (Inferred)	Specific Test / Performance Metric	Reported Device Performance (Comparison to Predicate)
Vessel Sealing Performance	Ex-vivo Vessel Burst Pressure	Subject and predicate devices were tested. Presumed to demonstrate comparable or equivalent vessel sealing performance. (Details on specific burst pressure values are not provided, only that testing was conducted.)
Thermal Characteristics / Safety	Ex Vivo Testing for Temperature-time History	Subject and predicate devices were tested to compare spatio-temporal temperature distribution and thermal damage. Presumed to demonstrate comparable or safe thermal profiles. (Details on specific temperature data are not provided.)
In-vivo Seal Performance & Safety	Chronic Animal Study (seal maintenance rates, thermal spread, healing progression)	Conducted on both subject and predicate devices to demonstrate seal performance (including vessels up to 7.0mm in diameter, lymphatics, and tissue bundles), thermal spread, and degree of healing progression. Presumed to demonstrate equivalent performance and safety. (Specific rates/measurements are not detailed in this summary.)
Acute Seal Performance & Safety	Acute Animal Study (seal maintenance rates, thermal spread, degeneration)	Conducted on both subject and predicate devices to demonstrate seal performance and safety (including vessels up to 7.0mm in diameter, lymphatics, and tissue bundles), thermal spread, and degree of degeneration. Presumed to demonstrate equivalent performance and safety. (Specific rates/measurements are not detailed in this summary.)
Biocompatibility	Full biocompatibility testing (ISO-10993 series)	Biocompatibility performed on all patient contacting surfaces in compliance with ISO-10993 series. This indicates the device materials are safe for patient contact.
Sterility & Shelf Life	Sterilization and Stability Testing	Conducted in accordance with FDA guidance for sterile devices and ASTM F1980-16 for accelerated aging. Supports a three-year shelf life.

The document concludes that the "THUNDERBEAT Open Fine Jaw Type X hand instrument is substantially equivalent to the predicate device and presents no new questions of safety or effectiveness." This statement implies that the device met the (implicit) acceptance criteria for demonstrating equivalence.

Study Details:

Sample Size Used for the Test Set and Data Provenance:
- Bench Testing:
  - Ex-vivo Vessel Burst Pressure: Tested on "porcine blood vessels" for both subject and predicate devices. No specific quantitative sample size is provided (e.g., number of vessels).
  - Ex Vivo Testing for Temperature-time History: Tested on "both the subject and predicate devices." No specific sample size provided.
- Animal Test (In-vivo):
  - Chronic Animal Study: Conducted using "porcine/Beagle Dogs" for both subject and predicate devices. No specific number of animals or instances is provided.
  - Acute Animal Study: Conducted using "porcine/Beagle Dogs" for both subject and predicate devices. No specific number of animals or instances is provided.
- Data Provenance: The animal studies use "porcine/Beagle Dogs," implying controlled animal laboratory environments. The ex-vivo testing uses "porcine blood vessels."
- Retrospective or Prospective: These are prospective, controlled laboratory and animal studies designed specifically for this submission.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable: This is not a study involving human expert interpretation (e.g., radiologists reading images). Ground truth is established through direct physiological measurements (burst pressure, temperature, direct observation of tissue effects in animals).
Adjudication Method for the Test Set:
- Not Applicable: Not applicable as it's not an expert-based subjective assessment. The "ground truth" is derived from quantitative measurements and histological/gross pathology observation in animal models.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No: This type of study (MRMC, human readers with/without AI assistance) is typically performed for AI-powered diagnostic devices (e.g., for medical imaging). This is a surgical instrument, and its performance is evaluated via direct physical and biological effects.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No: This concept applies to AI algorithms. The device itself is a surgical instrument. Its "performance" is its direct mechanical and energy-delivery function. The testing described (bench and animal) is effectively "standalone" performance relative to its predicate, but the term does not apply in the context of AI.
The Type of Ground Truth Used:
- Physiological/Biological Outcomes and Direct Measurement:
  - Ex-vivo: Vessel burst pressure, temperature distribution, thermal damage.
  - In-vivo (Animal): Seal maintenance rates, thermal spread, degree of healing progression, degree of degeneration.
  - Biocompatibility: Compliance with ISO-10993 standards.
  - Sterilization & Shelf Life: Compliance with relevant standards and FDA guidance.
- The "ground truth" is established through direct observation, measurement, and pathological analysis in controlled experimental settings.
The Sample Size for the Training Set:
- Not Applicable: This device does not involve machine learning or AI that would require a "training set."
How the Ground Truth for the Training Set Was Established:
- Not Applicable: This device does not involve machine learning or AI that would require a "training set" or "ground truth for training."

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 11, 2020

Olympus Medical Systems Corp. Christina Flores Manager, Regulatory Affairs Gyrus ACMI inc. 136 Turnpike Road Southborough, Massachusetts 01772

Re: K192103

Trade/Device Name: Thunderbeat Open Fine Jaw Type X Hand Instrument Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, LFL Dated: May 6, 2020 Received: May 7, 2020

Dear Christina Flores:

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. 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 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

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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 medical devices and radiation-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,

for Michael J. Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192103

Device Name

THUNDERBEAT Open Fine Jaw Type X hand instrument

Indications for Use (Describe)

The THUNDERBEAT Open Fine Jaw Type X hand instrument is intended to be used for open surgery to cut, seal, coagulate, grasp, and dissect.

Seal & Cut mode:

The THUNDERBEAT Open Fine Jaw Type X hand instrument when used in combination with the Seal & Cut mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. The device has been designed to seal and cut vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.

This mode is also indicated for open ENT procedure in adults (thyroidectomy, parotidectomy, partical neck dissection, and tonsillectory) for only ligation (sealing and cutting) of vessels, lymphatics and tissue bundles greater than 3 mm away from unintended thermally sensitive structures such as nerves and parathyroid glands.

Seal mode:

The THUNDERBEAT Open Fine Jaw Type X hand instrument when used in combination with the Seal mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which vessel sealing, coagulation, grasping is performed. The device has been designed to seal vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.

This mode is also indicated for open ENT procedure in adults (thyroidectomy, parotidectomy, radical neck dissection, and tonsillectomy) for sealing of vessels, lymphatics and tissue bundles greater than 3 mm away from unintended thermally sensitive structures such as nerves and parathyroid glands.

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)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly rounded and have a glossy appearance. There is a thin, horizontal, yellow line underneath the word. The registered trademark symbol is located to the right of the letter "S".

510(k) Summary Gyrus ACMI, Inc. THUNDERBEAT Open Fine Jaw Type X hand instrument

General Information

Applicant:	OLYMPUS MEDICAL SYSTEMSCORP.2951 Ishikawa-cho, Hachioji-shi, Tokyo,Japan 192-8507Phone: (+81) 42-642-2694Fax: (+81) 42-642-2307
Establishment Registration Number:	8010047
Manufacturer:	Aomori Olympus2-248-1 okkonokikuroishi-shi aomori, Japan 036-0357Phone: (+81) 172-52-8543Fax: (+81) 172-52-8515
Establishment Registration Number:	9614641
510(k) Submitter:	Gyrus ACMI, Inc.136 Turnpike Rd.Southborough, MA 01772-2104
Establishment Registration Number:	3003790304
Contact Person:	Christina Flores, RACManager, Regulatory Affairs
Date Prepared:	May 10, 2020

Device Description

Classification Name: Electrosurgical cutting and coagulation device and accessories Regulation Number: 21 CFR 878.4400 Regulatory Class: Class II, Product Codes: GEI, LFL Review Panel: General & Plastic Surgery

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Trade Name:

THUNDERBEAT Open Fine Jaw Type

		X hand instrument
	Model Name	Device Name
	TB-0009OFX	THUNDERBEAT Open Fine Jaw Type X hand instrument
	Generic/Common Name:	Ultrasonic and electrosurgical devices

Ultrasonic and electrosurgical devices

Primary Predicate Device

Device name	510(k) Submitter	510(k) No.
THUNDERBEAT Open Fine Jaw(TB-0009OF)	OLYMPUS MEDICALSYSTEMS CORP.	K151743

Secondary Predicate Device

Device name	510(k) Submitter	510(k) No.
LigaSure Curved, Small Jaw, OpenSealer/Divider	COVIDIEN	K113572

Product Description

THUNDERBEAT Open Fine Jaw Type X hand instrument is intended to be used for open surgery to cut, seal, coagulate, grasp, and dissect.

Comparison of Technological Characteristics

The basic principle and operational characteristics of the subject device are identical to the predicate device. The proposed THUNDERBEAT Open Fine Jaw Type X Hand Instrument is equivalent to the predicate device in that each device is connected to Surgical Tissue Management System, specifically the ESG-400 Electrosurgical Generator, USG-400 Ultrasonic Generator and THUNDERBEAT Transducer (TD-TB400). Like the predicate device, the subject device activates combined HF Bipolar (FineCoag) output and Ultrasonic output [Seal & Cut mode] simultaneously or only the HF Bipolar output (Seal mode) while grasping vessels, tissue bundles and lymphatics between the Probe and the H electrode in the Grasping section.

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In terms of the design concept of the subject device, the differences from the predicate device are as follows:

Addition of the Radical Neck Dissection indication
Removal of generator specific information from indications for use
Adding resin cover (PEEK) on the H electrode
Changing a material of H electrode in the grasping section and Sheath cover

A side by side comparison of the subject device and the predicate device is provided below.

Item	Subject Device	Primary PredicateDevice (PD) K151743	SecondaryPredicate Device(PD2)K113572	Discussion
	TB-0009OFX	TB-0009OF	LigaSure Curved,Small Jaw, OpenSealer/Divider
Indications forUse	The THUNDERBEATOpen Fine Jaw Type Xhand instrument isintended to be used foropen surgery to cut,seal, coagulate, grasp,and dissect.Seal & Cut mode:The THUNDERBEATOpen Fine Jaw Type Xhand instrument whenused in combinationwith the Seal & Cutmode is indicated foropen, general surgery(including plastic andreconstructive, etc.) orin any procedure inwhich cutting, vesselligation (sealing andcutting), coagulation,grasping, anddissection isperformed. The devicehas been designed toseal and cut vessels (upto and including 7 mmin diameter), tissuebundles, andlymphatics.This mode is alsoindicated for openENT procedure inadults (thyroidectomy	The THUNDERBEATOpen Fine Jaw handinstrument is intendedto be used with theUltrasonic Generator(USG-400), theElectrosurgicalGenerator (ESG-400),and theTHUNDERBEATTransducer, (TD-TB400).Seal & Cut mode:The THUNDERBEATOpen Fine Jaw handinstrument when usedin combination withthe Seal & Cut mode isindicated for open,general surgery(including plastic andreconstructive, etc) orin any procedure inwhich cutting, vesselligation (sealing andcutting), coagulation,grasping, anddissection isperformed. The devicehas been designed toseal and cut vessels (upto and including 7 mmin diameter), tissuebundles, andlymphatics.	The LigaSure™Curved, Small Jaw,Open Sealer /Divider is a bipolarelectrosurgicalinstrumentintended to be usedwith theForceTriad™energy platform.The instrument isindicated for use inopen generalsurgical procedureswhere ligation anddivision of vessels(up to 7 mm indiameter), tissuebundles, andlymphatics isperformed, such asurologic, thoracic,plastic, andreconstructive, andincluding suchprocedures asbowel resections,gall bladderprocedures, Nissenfundoplication,adhesiolysis, etc.The device is alsoindicated for openENT procedures inadults	Thedifferencesbetween SDand PD are theremoval of thespecificgeneratorinformationand theaddition of theRadical NeckDissectionindication.The RadicalNeckDissectionindication iscarried by thePD2.
Item	Subject Device	Primary PredicateDevice (PD) K151743	SecondaryPredicate Device(PD2)K113572	Discussion
	TB-0009OFXparathyroidectomy,parotidectomy, radicalneck dissection, andtonsillectomy) for onlyligation (sealing andcutting) of vessels,lymphatics and tissuebundles greater than3mm away fromunintended thermallysensitive structuressuch as nerves andparathyroid glands.Seal mode:The THUNDERBEATOpen Fine Jaw Type Xhand instrument whenused in combinationwith the Seal mode isindicated for open,general surgery(including plastic andreconstructive, etc.) orin any procedure inwhich vessel sealing,coagulation, graspingis performed. Thedevice has beendesigned to sealvessels (up to andincluding 7 mm indiameter), tissuebundles, andlymphatics.This mode is alsoindicated for openENT procedure inadults (thyroidectomy,parathyroidectomy,parotidectomy, radicalneck dissection, andtonsillectomy) forsealing of vessels,lymphatics and tissuebundles greater than3mm away from	TB-0009OFThis mode is alsoindicated for openENT procedure inadults (thyroidectomy,parathyroidectomy,parotidectomy, andtonsillectomy) for onlyligation (sealing andcutting) of vessels,lymphatics and tissuebundles 2-3 mm*1away from unintendedthermally sensitivestructures such asnerves and parathyroidglands.Seal mode:The THUNDERBEATOpen Fine Jaw handinstrument when usedin combination withthe Seal mode isindicated for open,general surgery(including plastic andreconstructive, etc.) orin any procedure inwhich vessel sealing,coagulation, graspingis performed. Thedevice has beendesigned to sealvessels (up to andincluding 7 mm indiameter), tissuebundles, andlymphatics.This mode is alsoindicated for openENT procedure inadults (thyroidectomy,parathyroidectomy,parotidectomy, andtonsillectomy) forsealing of vessels,	LigaSure Curved,Small Jaw, OpenSealer/Divider(thyroidectomy,radical neckdissection,parotidectomy, andtonsillectomy) forligation anddivision of vessels,lymphatics andtissue bundles 2-3mm away fromunintendedthermally sensitivestructures such asnerves andparathyroid glands.The LigaSuresystem has notbeen shown to beeffective for tubalsterilization ortubalcoagulation forsterilizationprocedures. Do notuse the LigaSuresystem for theseprocedures.
Item	Subject Device	Primary Predicate Device (PD) K151743	Secondary Predicate Device (PD2) K113572	Discussion
	TB-00090FXunintended thermallysensitive structuressuch as nerves andparathyroid glands.The THUNDERBEATOpen Fine Jaw Type Xhand instrument hasnot been shown to beeffective for tubalsterilization or tubalcoagulation forsterilizationprocedures, and shouldnot be used for theseprocedures.	TB-0009OFlymphatics and tissuebundles 2-3mm1away from unintendedthermally sensitivestructures such asnerves and parathyroidglands.The THUNDERBEATOpen Fine Jaw handinstrument has notbeen shown to beeffective for tubalsterilization or tubalcoagulation forsterilizationprocedures, and shouldnot be used for theseprocedures.1 It should beextended appropriatelydepending on theoperation situation.	LigaSure Curved,Small Jaw, OpenSealer/Divider
RegulationNumber	878.4400	878.4400	878.4400	Same as PD
Regulation Name	Electrosurgical, cutting& coagulation &accessories	Electrosurgical, cutting& coagulation &accessories	Electrosurgical,cutting &coagulation &accessories
Regulatory Class	II	II	II
ProductCode	GEI, LFL	GEI, LFL	GEI
ClassificationPanel	General & PlasticSurgery	General & PlasticSurgery	General & PlasticSurgery
Basicprinciple	Seal and Cut mode:Activating theUltrasonic output(generated by theUSG-400, UltrasonicGenerator) and the HFBipolar output(generated by theESG-400)	Seal and Cut mode:Activating theUltrasonic output(generated by theUSG-400, UltrasonicGenerator) and the HFBipolar output(generated by theESG-400)	High-frequencycurrent generatedby Covidien'sElectrosurgicalGenerators (suchas Force Triad) isdelivered to thejaw (electrodes),and coagulate(seal) vessels,	Same as PD
Item	Subject DeviceTB-0009OFX	Primary PredicateDevice (PD) K151743TB-0009OF	SecondaryPredicate Device(PD2)K113572LigaSure Curved, Small Jaw, OpenSealer/Divider	Discussion
	sealing and cutting ofvessels, tissue bundles,and lymphatics andcutting and coagulationsoft tissue.Seal mode: Uses onlythe HF Bipolar (ESG-400) energy outputwhich enables vessel,tissue bundle andlymphatic sealing and	sealing and cutting ofvessels, tissue bundles,and lymphatics andcutting and coagulationsoft tissue.Seal mode: Uses onlythe HF Bipolar (ESG-400) energy outputwhich enables vessel,tissue bundle andlymphatic sealing and	tissue bundles,lymphaticsclamped by thejaw. The internalmechanical bladein the jaw makesthe soft tissuesdivided
Handleshape	hemostasis.hemostat-style body	hemostasis.hemostat-style body	hemostat-stylebody	Same as PD
Tipshape	Probe and H electrode	Probe and H electrode	Jaw	Same as PD
Resincover onthe tip ofgraspingsection	Equipped	N/A	Unknown	The resincover is addedon the Helectrode.
Graspingsection	PTFE/SUS630	PTFE/Aluminum alloy	SUS	The materialof the Helectrode waschanged fromaluminumalloy toSUS63.
Deviceperformance	Performance testing including Bench and Animal testing was conducted in support of thesubstantial equivalence determination.
Reprocessing	Sterile, for single use	Sterile, for single use	Sterile, for singleuse	Same as PD
ShelfLife	3years	3years	Unknown	Same as PD
Item	Subject Device	Primary Predicate Device (PD) K151743	Secondary Predicate Device (PD2) K113572	Discussion
	TB-0009OFX	TB-0009OF	LigaSure Curved, Small Jaw, Open Sealer/Divider
Patient ContactingMaterials	Poly-carbonate,ADC12, PEEK, PTFE,SUS630, PTFEcomposite nickelplating, SUS304,SUS303, Ti-6Al-4V	Poly-carbonate,ADC12, Zircon oxide,PFA, PTFE,Aluminum alloy(A7075-T6), PTFE,composite nickelplating, Parylene HT(tetrafluoro-di- para-xylylene), Aluminumalloy (ADC12), Zirconoxide (inside),SUS303, Ti-6Al-4V	SUSOther materials areunknown.	Biologicalsafety of thematerial wastested inaccordancewithISO10993.

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Material

Full biocompatibility testing on all patient contacting surfaces has been performed in compliance to the relevant requirements of ISO-10993 series.

Indications for use

The THUNDERBEAT Open Fine Jaw Type X hand instrument is intended to be used for open surgery to cut, seal, coagulate, grasp, and dissect.

Seal & Cut mode:

Seal mode:

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coagulation, grasping is performed. The device has been designed to seal vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics. This mode is also indicated for open ENT procedure in adults (thyroidectomy, parathyroidectomy, parotidectomy, radical neck dissection, and tonsillectomy) for sealing of vessels, lymphatics and tissue bundles greater than 3mm away from unintended thermally sensitive structures such as nerves and parathyroid glands.

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Image /page/11/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are closely spaced together, creating a solid block of text. A thin, gold line is located underneath the word, adding a subtle accent to the logo. The registered trademark symbol is located on the top right of the word.

Compliance to Voluntary Standards

The design of the THUNDERBEAT Open Fine Jaw Hand Instrument complies with the following standards:

ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 IEC60601-1-2: 2014 IEC60601-2-2:2017 ISO10993-1:2009 ISO10993-5: 2009 ISO10993-10: 2010 ISO10993-11: 2006 ISO11135:2014 ISO10993-7: 2008 ISO11607-1: 2006/Amd 1:2014 ISO11607-2: 2006/Amd 1:2014 ASTM F1980-16 ISO14971:2007

Device-specific guidance

Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery - Guidance for Industry and Food and Drug Administration Staff, 08/15/2016
Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery - Guidance for Industry and Food and Drug Administration Staff, 08/15/2016

Summary of Sterilization and Shelf Life Discussion

Sterilization testing for the THUNDERBEAT Open Fine Jaw Type X hand instrument was conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". Stability evaluation for the sterile packaging and for product performance supports the three year shelf life. Accelerated aging test was conducted in accordance with ASTM F1980-16, the standard guide for accelerated aging of sterile barrier systems for medical devices.

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Summary of Performance Testing

The following performance testing was conducted in support of the substantial equivalence determination.

1. Bench Testing
Test Code	Item	Contents
OFJX-001	Ex-vivo VesselBurst Pressure	Ex-vivo burst pressure testing of porcine bloodvessels was conducted on both the subject andpredicate devices to demonstrate vessel sealingperformance.
OFJX-020	Ex Vivo Testingfor Temperature-time History	Ex Vivo Testing for Temperature-time Historywas conducted on both the subject and predicatedevices compare the spatio-temporaltemperature distribution and thermal damage.

2. Animal Test

Test Code	Item	Contents
OFJX-012OFJX-014OFJX-015	Chronic AnimalStudy	Chronic animal study of porcine/ Beagle Dogswas conducted on both the subject and predicatedevices to demonstrate seal performance (ex.seal maintenance rates include vessels up to7.0mm in diameter and lymphatics and tissuebundles, thermal spread, degree of healingprogression ).
OFJX-011-aOFJX-013OFJX-018bOFJX-016	Acute AnimalStudy	Acute animal study of porcine/ Beagle Dogswas conducted on both the subject and predicatedevices to demonstrate seal performance andsafety (ex. seal maintenance rates includevessels up to 7.0mm in diameter and lymphaticsand tissue bundles, thermal spread, degree ofdegeneration).

Clinical Testing

Clinical testing was not performed.

Substantial Equivalence

The subject and predicate device have the same fundamental technology. Compared with the primary predicate device (K151743), the subject device proposes the expanded indication of Radical Neck Dissection; the removal of generator specific information from indications for use; a design modification that includes a resin cover (PEEK) addition on the electrode; and the material change of H electrode and Sheath cover. The secondary predicate device (K113572) is being used for the expanded indication of Radical Neck Dissection. To support the proposed modifications, the performance tests summarized above were conducted.

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Conclusion

In summary, the THUNDERBEAT Open Fine Jaw Type X hand instrument is substantially equivalent to the predicate device and presents no new questions of safety or effectiveness.

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.