The THUNDERBEAT Open Fine Jaw hand instrument is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer, (TD-TB400).

Seal & Cut mode:

The THUNDERBEAT Open Fine Jaw 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, and tonsillectomy) for only ligation (sealing and cutting) of vessels, lymphatics and tissue bundles 2-3mm*1 away from unintended thermally sensitive structures such as nerves and parathyroid glands.

Seal mode:

The THUNDERBEAT Open Fine Jaw 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, and tonsillectomy) for sealing of vessels, lymphatics and tissue bundles 2-3mm*1 away from unintended thermally sensitive structures such as nerves and parathyroid glands.

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

1 It should be extended appropriately depending on the operation situation.

Device Description

The THUNDERBEAT Open Fine Jaw TB-0009OF is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer, (TD-TB400).

The THUNDERBEAT Open Fine Jaw TB-0009OF is provided as a sterile, single use device. It is a 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 for open, open ENT procedures in surgery.

AI/ML Overview

This document is a 510(k) premarket notification for the "THUNDERBEAT Open Fine Jaw TB-0009OF" device, an electrosurgical cutting and coagulation device. The document describes various non-clinical (bench and animal) tests conducted to demonstrate substantial equivalence to predicate devices, but no clinical studies or studies involving human readers and AI assistance are mentioned.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document, as it pertains to AI-driven diagnostic or interpretative devices, which this is not.

Here's what can be extracted based on the provided text, primarily focusing on the device's technical and non-clinical evaluations:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists several non-clinical tests (bench and animal) with their objectives. However, specific numerical acceptance criteria (e.g., minimum burst pressure for vessel seals) and the exact quantitative reported performance metrics from these tests are not provided in this summary. The summary only states the objective of each test.

Test Code	Objective	Implied Acceptance Criterion	Summary of Reported Performance (Qualitative)
#A1	To confirm the sealing & cutting and sealing performances of THUNDERBEAT Open Fine Jaw.	Performance is comparable/sufficient for intended use.	Not explicitly stated; implied as meeting the objective for substantial equivalence.
#A2	To compare the sealing & cutting performance of the THUNDERBEAT Open Fine Jaw with the conventional bipolar device.	Performance is comparable to conventional bipolar devices.	Not explicitly stated; implied as meeting the objective for substantial equivalence.
#B1	To compare the cutting performance of THUNDERBEAT Open Fine Jaw with those of THUNDERBEAT, conventional bipolar and ultrasonic devices.	Performance is comparable to predicate and conventional devices.	Not explicitly stated; implied as meeting the objective for substantial equivalence.
#Fb1	To verify the sealing performance and characteristics of THUNDERBEAT Open Fine Jaw during SEAL&CUT mode output compared with a conventional ultrasonic device.	Sealing performance and characteristics are comparable.	Not explicitly stated; implied as meeting the objective for substantial equivalence.
#Fb2	To verify the characteristics of THUNDERBEAT Open Fine Jaw during SEAL&CUT mode output compared with a conventional ultrasonic device.	Characteristics are comparable.	Not explicitly stated; implied as meeting the objective for substantial equivalence.
#H	To confirm grasping and dissection performance of the THUNDERBEAT Open Fine Jaw by comparison with the control devices.	Grasping and dissection performance is comparable to control devices.	Not explicitly stated; implied as meeting the objective for substantial equivalence.
#I/J	To compare maximum temperature and cooling time of the grasping section of the THUNDERBEAT Open Fine Jaw and the control devices.	Temperature/cooling time are within acceptable ranges and comparable.	Not explicitly stated; implied as meeting the objective for substantial equivalence.
#L	To compare subject device to predicate device regarding evenness of grasping force across grasping section.	Grasping force evenness is comparable to predicate device.	Not explicitly stated; implied as meeting the objective for substantial equivalence.
#D	To confirm the performance of THUNDERBEAT Open Fine Jaw on blood vessels up to 7.0 mm in diameter, lymphatics and tissue bundles, and its safety on blood vessels up to 7.0 mm in diameter and tissue bundles with blood vessels and lymphatics by comparing the seal achievement rate, thermal spread, degree of degeneration and seal achievement with those yielded.	Acceptable seal achievement rate, thermal spread, and degree of degeneration, comparable to predicate or established norms.	Not explicitly stated; implied as demonstrating performance and safety.
#Ca	To confirm the performance of THUNDERBEAT Open Fine Jaw on blood vessels up to 7.0 mm in diameter, lymphatics and tissue bundles by comparing the seal achievement and maintenance rates with those yielded.	Acceptable seal achievement and maintenance rates.	Not explicitly stated; implied as demonstrating performance.
#G	To confirm the safety and performance of THUNDERBEAT Open Fine Jaw when utilized during ENT procedures including thyroidectomy, parathyroidectomy, parotidectomy, and tonsillectomy.	Acceptable safety and performance for ENT procedures.	Not explicitly stated; implied as demonstrating safety and performance.
#M	To confirm the safety and performance of THUNDERBEAT Open Fine Jaw when utilized during ENT procedures... The thermal spread and the acute tissue response... were evaluated in comparison with the control devices.	Acceptable thermal spread and acute tissue response, comparable to control devices.	Not explicitly stated; implied as demonstrating safety and performance.

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

Bench Tests (Ex-vivo): Specific sample sizes for ex-vivo vessel and tissue tests (#A1, #A2, #B1, #Fb1, #Fb2, #H, #I/J, #L) are not provided in this summary. The provenance is implied to be laboratory-controlled settings.
Animal Tests (In-vivo):
- For performance testing M and G: Canine animal model was used. Specific number of animals not stated.
- For performance testing Ca and D: Porcine animal models were used. Specific number of animals not stated.
- Data Provenance: Laboratory animal models.

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

This document describes non-clinical performance testing of a surgical device. It does not involve human interpretation of medical images or data that would typically require "experts to establish ground truth" related to diagnostic accuracy, as is common in AI/ML device submissions. The "ground truth" for the device's performance would be the direct physical measurement and observation of its interaction with tissue and vessels in the described bench and animal models.

4. Adjudication Method for the Test Set

Not applicable in the context of this device and the tests described. Adjudication methods are typically used for disagreements among human readers or for establishing consensus in clinical interpretations. The reported tests are objective measurements of device performance.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. This document explicitly states: "Clinical testing using the subject device itself was not conducted." The submission focuses on non-clinical data and comparison to predicate devices, not human reader performance with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No. This is a hardware surgical device, not an algorithm or AI.

7. The Type of Ground Truth Used

For the non-clinical tests (bench and animal studies), the "ground truth" refers to direct physical measurements and observations of the device's performance on tissues and vessels, such as:
- Measurement of seal achievement rate.
- Measurement of thermal spread.
- Assessment of tissue degeneration.
- Comparison of cutting performance and characteristics.
- Measurement of grasping force distribution.
- Measurement of maximum temperature and cooling time.
- Pathological examination of animal tissue responses.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The device's design and manufacturing process are validated through engineering and non-clinical performance testing.

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

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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

February 26, 2016

Olympus Medical Systems Corp. % Mr. Graham Baillie Manager, Regulatory Affairs Gyrus ACMI. Inc. 136 Turnpike Road Southborough, Massachusetts 01772

Re: K151743

Trade/Device Name: Thunderbeat Open Fine Jaw Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, LFL Dated: January 26, 2016 Received: January 27, 2016

Dear Mr. Baillie:

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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 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 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 yours,

Jennifer R. Stevenson -A

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) K151743

Device Name THUNDERBEAT Open Fine Jaw TB-0009OF

Indications for Use (Describe)

The THUNDERBEAT Open Fine Jaw hand instrument is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer, (TD-TB400).

Seal & Cut mode:

This mode is also indicated for open ENT procedure in adults (thyroidectomy, parotidectorny, and tonsillectomy) for only ligation (sealing and cutting) of vessels, lymphatics and tissue bundles 2-3mm*1 away from unintended thermally sensitive structures such as nerves and parathyroid glands.

Seal mode:

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

1 It should be extended appropriately depending on the operation situation.

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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THUNDERBEAT Open Fine Jaw Hand Instrument Gyrus ACMI, Inc.

Traditional 510(k) Notification Feb 25, 2016

510(k) Summary Gyrus ACMI, Inc. THUNDERBEAT Open Fine Jaw TB-0009OF

General Information

Applicant: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Phone: (+81) 42-642-2694 Fax: (+81) 42-642-2307 Establishment Registration Number: 8010047 Manufacturer: Aomori Olympus 248-1 Okkonoki 2-chome Kuroishi-shi, Aomori, Japan 036-0367 Phone: (+81) 172-52-8543 Fax: (+81) 172-52-8515 Establishment Registration Number: 9614641 510(k) Submitter: Gyrus ACMI, Inc. 136 Turnpike Rd. Southborough, MA 01772-2104 3003790304 Establishment Registration Number: Contact Person: Graham Baillie Manager, Regulatory Affairs

Date Prepared:

Classification Name:

Regulation Number: Regulatory Class: Product Codes: Review Panel: Trade Name:

Generic/Common Name:

Electrosurgical cutting and coagulation device and accessories 21 CFR 878.4400 Class II, GEI, LFL General & Plastic Surgery THUNDERBEAT Open Fine Jaw Hand Instrument Ultrasonic and electrosurgical devices

February 25, 2016

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K151743

THUNDERBEAT Open Fine Jaw Hand Instrument Gyrus ACMI, Inc.

Traditional 510(k) Notification Feb 25, 2016

Model Name	Device Name
TB-0009OF	THUNDERBEAT Open Fine Jaw

Predicate Devices

Olympus Medical Systems Corp. THUNDERBEAT TB-0510IC/0520IC	K132703
Covidien LigaSure Small Jaw	K113572
Ethicon Harmonic Focus	K100597

Device Description

The THUNDERBEAT Open Fine Jaw TB-0009OF is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer, (TD-TB400).

Technological Characteristics

The THUNDERBEAT Open Fine Jaw TB-0009OF has two different output modes:

Seal and Cut mode: Activating the Ultrasonic output (generated by the USG-● 400, Ultrasonic Generator) and the HF Bipolar output (generated by the ESG-400) simultaneously enables sealing and cutting of vessels, tissue bundles, and lymphatics and cutting and coagulation soft tissue.
Seal mode: Uses only the HF Bipolar (ESG-400) energy output which enables vessel, tissue bundle and lymphatic sealing and hemostasis.

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Intended Use

The THUNDERBEAT Open Fine Jaw hand instrument is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer, (TD-TB400).

Seal & Cut mode:

This mode is also indicated for open ENT procedure in adults (thyroidectomy, parathyroidectomy, parotidectomy, and tonsillectomy) for only ligation (sealing and cutting) of vessels, lymphatics and tissue bundles 2-3mm*1 away from unintended thermally sensitive structures such as nerves and parathyroid glands.

Seal mode:

This mode is also indicated for open ENT procedure in adults (thyroidectomy, parathyroidectomy, parotidectomy, and tonsillectomy) for sealing of vessels, lymphatics and tissue bundles 2-3mm*1 away from unintended thermally sensitive structures such as nerves and parathyroid glands.

The THUNDERBEAT Open Fine Jaw 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.

1 It should be extended appropriately depending on the operation situation.

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Traditional 510(k) Notification Feb 25, 2016

Comparison of Technological Characteristics

The subject and predicate devices have similar technology, priciples of operation, performance, dimensions and materials. A side-by-side comparison of the marketed and proposed devices is provided below.

Feature	ProposedTHUNDERBEAT OpenFine JawTB-0009OF	PredicateTHUNDERBEATTB-0510IC/0520IC(K132073)	PredicateLigaSureSmall JawK113572	PredicateHarmonicFocusK100597
Instrumentworking length	9cm	10, 20cm	Unknown	9cm
Shaft rotation	No rotation	360 degrees	No rotation	No rotation
Output mode	Seal andCut modeCombinedoutput(Ultrasonicand HFBipolar)	Seal andCut modeCombinedoutput(Ultrasonicand HFBipolar)	Seal mode(HFBipolar)	HFBipolar	Ultrasonic
Ultrasonicoutput	UltrasonicOutputFrequency	47kHz	Notactivated	47kHz	Notactivated	Notactivated	55kHz
	ProbeAmplitude	64μm	Notactivated	80μm	Notactivated	Notactivated	Unknown
HF Bipolaroutput	Activated	Activated	Activated	Activated	Notactivated
Tissue or vesselcuttingmechanism	ultrasonicvibration	Nocutting	ultrasonicvibration	Nocutting	Amechanical bladedeploys	Ultrasonicvibration
Shaft Diameter	No shaft	No shaft	5.5mm	5.5mm	No shaft	No shaft
Handle	hemostat-style body	Inline Grip with shaftbody	hemostat-style body	hemostat-style body

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Compliance to Voluntary Standards

The design of the THUNDERBEAT Open Fine Jaw TB-0009OF complies with the following standards:

IEC60601-1: 2005+A1 Medical electrical equipment - Part1: General ● Requirements for basic safety and essential performance
. IEC60601-1-2 Edition 3: 2007-03 Medical electrical equipment - Part 1-2; General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirement and tests
AAMI ANSI IEC60601-2-2:2009 Medical electrical equipment. Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
ISO10993-1: Forth Edition 2009-10-15 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
AAMI ANSI ISO10993-5: 2009/(R) 2014 Biological evaluation of medical . devices - Part5: Tests for in vitro cytotoxicity
ISO10993-7 Second Edition: 2008-10-15 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
AAMI ANSI ISO10993-10: 2010 Biological evaluation of medical devices. ● Tests for irritation and sensitization
. ISO10993-11 Second Edition: 2006-08-15 Biological evaluation of medical devices. Tests for systemic toxicity
ISO11135-1:2007 Sterilization of health-care products - ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices
. ISO14971 Second Edition: 2007-03-01 - Medical devices - Application of risk management to medical devices
ASTM F1980-07(Reapproved 2011) Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical devices

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Traditional 510(k) Notification

Feb 25, 2016

THUNDERBEAT Open Fine Jaw Hand Instrument Gyrus ACMI, Inc.

Summary of Non-clinical Testing

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

Sterilization has been tested to comply with ISO11135-1: 2007. Accelerated Aging testing confirmed that the subject device has a three year shelf life.

TestCode	Title	Objective
#A1	THUNDERBEAT Open FineJaw Ex-vivo Sealing & Cuttingand Sealing PerformancesConfirmation Test on BloodVessels	This test was designed to confirm thesealing & cutting and sealing performancesof THUNDERBEAT Open Fine Jaw
#A2	THUNDERBEAT Open FineJaw Ex-vivo Sealing & CuttingPerformance - Comparative Teston Blood Vessels	This test was designed to compare thesealing & cutting performance of theTHUNDERBEAT Open Fine Jaw with theconventional bipolar device
#B1	THUNDERBEAT Open FineJaw Ex-vivo CuttingPerformance Comparative Teston Mesentery.	This test was designed to compare thecutting performance of THUNDERBEATOpen Fine Jaw with those ofTHUNDERBEAT, conventional bipolar andultrasonic devices
#Fb1	Sealing performance andcharacteristics of theTHUNDERBEAT Open FineJaw SEAL & CUT mode duringactivation.	This test was designed to verify the sealingperformance and characteristics ofTHUNDERBEAT Open Fine Jaw duringSEAL&CUT mode output compared with aconventional ultrasonic device
#Fb2	Cutting performance andcharacteristics of theTHUNDERBEAT Open FineJaw SEAL & CUT mode duringactivation.	This test was designed to verify thecharacteristics of THUNDERBEAT OpenFine Jaw during SEAL&CUT mode outputcompared with a conventional ultrasonicdevice
#H	Comparison of grasping anddissection performance betweenthe THUNDERBEAT OpenFine Jaw and the controldevices.	This test was designed to confirm graspingand dissection performance of theTHUNDERBEAT Open Fine Jaw bycomparison with the control devices
#I/J	THUNDERBEAT Open FineJaw Maximum Temperature andCooling Time of the GraspingSection.	This test was designed to comparemaximum temperature and cooling time ofthe grasping section of theTHUNDERBEAT Open Fine Jaw and thecontrol devices
#L	THUNDERBEAT Open FineJaw Grasping force distributionverification report on wiper jaw	The purpose of this test is to comparesubject device to predicate device regardingevenness of grasping force across graspingsection.
Test	Title	Objective
Code
#D	THUNDERBEAT Open FineJaw Performance and SafetyConfirmation Test on BloodVessels, Lymphatics and TissueBundle (Acute Animal Testing)	This test was designed to confirm theperformance of THUNDERBEAT OpenFine Jaw on blood vessels up to 7.0 mm indiameter, lymphatics and tissue bundles,and its safety on blood vessels up to 7.0 mmin diameter and tissue bundles with bloodvessels and lymphatics by comparing theseal achievement rate, thermal spread,degree of degeneration and sealachievement with those yielded
#Ca	THUNDERBEAT Open FineJaw Performance ConfirmationTest on Blood Vessels,Lymphatics and Tissue Bundles(Chronic Animal Testing)	This test was designed to confirm theperformance of THUNDERBEAT OpenFine Jaw on blood vessels up to 7.0 mm indiameter, lymphatics and tissue bundles bycomparing the seal achievement andmaintenance rates with those yielded
#G	THUNDERBEAT Open FineJaw Safety and PerformanceConfirmation Test on ENTProcedures (Chronic AnimalTesting)	This test was designed to confirm the safetyand performance of THUNDERBEATOpen Fine Jaw when utilized during ENTprocedures including thyroidectomy,parathyroidectomy, parotidectomy, andtonsillectomy
#M	THUNDERBEAT Open FineJaw Safety and PerformanceConfirmation Test on ENTProcedures (Acute AnimalTesting)	This test was designed to confirm the safetyand performance of THUNDERBEATOpen Fine Jaw when utilized during ENTprocedures including thyroidectomy,parathyroidectomy, parotidectomy, andtonsillectomy. The thermal spread and theacute tissue response of theTHUNDERBEAT Open Fine Jaw on theusage in the ENT procedures wereevaluated in comparison with the controldevices

Bench Testing

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Animal Testing:

Canine animal model was used for performance testing M and G, and porcine animal models were used for performance testing Ca and D.

Summary of Clinical Testing

Clinical testing using the subject device itself was not conducted. Therefore, a clinical meta-analysis that considered the safety and effectiveness of predicate devices being used in the same procedures proposed for the subject device was conducted.

Conclusion:

Performance tests summarized above demonstrated that the Gyrus ACMI THUNDERBEAT Open Fine Jaw TB-0009OF is substantially equivalent to the predicate devices and presents no new questions of safety or efficacy.

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.