THUNDERBEAT Open Fine Jaw

K151743 · Olympus Medical Systems Corp. · GEI · Feb 26, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K151743
• Device Name: THUNDERBEAT Open Fine Jaw
• Applicant: Olympus Medical Systems Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 26, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

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: 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, 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: 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, 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 coagulation for sterilization procedures, and should not be used for these procedures.

Device Story

THUNDERBEAT Open Fine Jaw is a sterile, single-use surgical hand instrument; used with USG-400 Ultrasonic Generator, ESG-400 Electrosurgical Generator, and TD-TB400 Transducer. Device features hemostat-style handle; provides ultrasonic vibration for cutting and HF bipolar energy for sealing. Operates in two modes: 'Seal and Cut' (simultaneous ultrasonic and HF bipolar) and 'Seal' (HF bipolar only). Used in open general and ENT surgeries by surgeons to manipulate, seal, and transect tissue bundles and vessels up to 7mm. Output allows for precise tissue management; benefits include reduced thermal spread and efficient hemostasis. Device is manually operated; provides tactile feedback to the surgeon during grasping and dissection.

Clinical Evidence

No clinical testing conducted. Evidence based on non-clinical bench testing (ex-vivo sealing/cutting performance, grasping force, temperature/cooling time) and acute/chronic animal studies (canine/porcine models) evaluating seal achievement, thermal spread, and tissue response in general and ENT surgical applications. Meta-analysis of predicate device clinical data supported safety and effectiveness.

Technological Characteristics

Materials compliant with ISO 10993. Energy: Ultrasonic (47kHz) and HF Bipolar. Dimensions: 9cm working length. Connectivity: Wired to USG-400/ESG-400 generators. Sterilization: Ethylene oxide (ISO 11135-1). Standards: IEC 60601-1, IEC 60601-1-2, AAMI ANSI IEC 60601-2-2, ISO 10993 series, ISO 14971, ASTM F1980.

Indications for Use

Indicated for open general surgery (including plastic/reconstructive) and open ENT procedures (thyroidectomy, parathyroidectomy, parotidectomy, tonsillectomy) in adults. Used for vessel ligation, sealing, cutting, coagulation, grasping, and dissection of vessels up to 7mm, tissue bundles, and lymphatics. Contraindicated for tubal sterilization/coagulation.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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 [phone] or [phone] 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 [phone] or [phone] 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:

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, 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 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.

| 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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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: [phone] Fax: [phone] Establishment Registration Number: 8010047 Manufacturer: Aomori Olympus 248-1 Okkonoki 2-chome Kuroishi-shi, Aomori, Japan 036-0367 Phone: [phone] Fax: [phone] 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).

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.

## 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:

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, 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:

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, 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 | Proposed<br>THUNDERBEAT Open<br>Fine Jaw<br>TB-0009OF | Predicate<br>THUNDERBEAT<br>TB-0510IC/0520IC<br>(K132073) | Predicate<br>LigaSure<br>Small Jaw<br>K113572 | Predicate<br>Harmonic<br>Focus<br>K100597 | | | |
|------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------------|-------------------------------------------|----------------------------------|-------------------------|---------|
| Instrument<br>working length | 9cm | 10, 20cm | Unknown | 9cm | | | |
| Shaft rotation | No rotation | 360 degrees | No rotation | No rotation | | | |
| Output mode | Seal and<br>Cut mode<br>Combined<br>output<br>(Ultrasonic<br>and HF<br>Bipolar) | Seal and<br>Cut mode<br>Combined<br>output<br>(Ultrasonic<br>and HF<br>Bipolar) | Seal mode<br>(HF<br>Bipolar) | HF<br>Bipolar | Ultrasonic | | |
| Ultrasonic<br>output | Ultrasonic<br>Output<br>Frequency | 47kHz | Not<br>activated | 47kHz | Not<br>activated | Not<br>activated | 55kHz |
| | Probe<br>Amplitude | 64μm | Not<br>activated | 80μm | Not<br>activated | Not<br>activated | Unknown |
| HF Bipolar<br>output | Activated | Activated | Activated | Activated | Not<br>activated | | |
| Tissue or vessel<br>cutting<br>mechanism | ultrasonic<br>vibration | No<br>cutting | ultrasonic<br>vibration | No<br>cutting | A<br>mechanical blade<br>deploys | Ultrasonic<br>vibration | |
| Shaft Diameter | No shaft | No shaft | 5.5mm | 5.5mm | No shaft | No shaft | |
| Handle | hemostat-style body | Inline Grip with shaft<br>body | 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.

| Test<br>Code | Title | Objective |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| #A1 | THUNDERBEAT Open Fine<br>Jaw Ex-vivo Sealing & Cutting<br>and Sealing Performances<br>Confirmation Test on Blood<br>Vessels | This test was designed to confirm the<br>sealing & cutting and sealing performances<br>of THUNDERBEAT Open Fine Jaw |
| #A2 | THUNDERBEAT Open Fine<br>Jaw Ex-vivo Sealing & Cutting<br>Performance - Comparative Test<br>on Blood Vessels | This test was designed to compare the<br>sealing & cutting performance of the<br>THUNDERBEAT Open Fine Jaw with the<br>conventional bipolar device |
| #B1 | THUNDERBEAT Open Fine<br>Jaw Ex-vivo Cutting<br>Performance Comparative Test<br>on Mesentery. | This test was designed to compare the<br>cutting performance of THUNDERBEAT<br>Open Fine Jaw with those of<br>THUNDERBEAT, conventional bipolar and<br>ultrasonic devices |
| #Fb1 | Sealing performance and<br>characteristics of the<br>THUNDERBEAT Open Fine<br>Jaw SEAL & CUT mode during<br>activation. | This test was designed to verify the sealing<br>performance and characteristics of<br>THUNDERBEAT Open Fine Jaw during<br>SEAL&CUT mode output compared with a<br>conventional ultrasonic device |
| #Fb2 | Cutting performance and<br>characteristics of the<br>THUNDERBEAT Open Fine<br>Jaw SEAL & CUT mode during<br>activation. | This test was designed to verify the<br>characteristics of THUNDERBEAT Open<br>Fine Jaw during SEAL&CUT mode output<br>compared with a conventional ultrasonic<br>device |
| #H | Comparison of grasping and<br>dissection performance between<br>the THUNDERBEAT Open<br>Fine Jaw and the control<br>devices. | This test was designed to confirm grasping<br>and dissection performance of the<br>THUNDERBEAT Open Fine Jaw by<br>comparison with the control devices |
| #I/J | THUNDERBEAT Open Fine<br>Jaw Maximum Temperature and<br>Cooling Time of the Grasping<br>Section. | This test was designed to compare<br>maximum temperature and cooling time of<br>the grasping section of the<br>THUNDERBEAT Open Fine Jaw and the<br>control devices |
| #L | THUNDERBEAT Open Fine<br>Jaw Grasping force distribution<br>verification report on wiper jaw | The purpose of this test is to compare<br>subject device to predicate device regarding<br>evenness of grasping force across grasping<br>section. |
| Test | Title | Objective |
| Code | | |
| #D | THUNDERBEAT Open Fine<br>Jaw Performance and Safety<br>Confirmation Test on Blood<br>Vessels, Lymphatics and Tissue<br>Bundle (Acute Animal Testing) | This test was designed to confirm the<br>performance of THUNDERBEAT Open<br>Fine Jaw on blood vessels up to 7.0 mm in<br>diameter, lymphatics and tissue bundles,<br>and its safety on blood vessels up to 7.0 mm<br>in diameter and tissue bundles with blood<br>vessels and lymphatics by comparing the<br>seal achievement rate, thermal spread,<br>degree of degeneration and seal<br>achievement with those yielded |
| #Ca | THUNDERBEAT Open Fine<br>Jaw Performance Confirmation<br>Test on Blood Vessels,<br>Lymphatics and Tissue Bundles<br>(Chronic Animal Testing) | This test was designed to confirm the<br>performance of THUNDERBEAT Open<br>Fine Jaw on blood vessels up to 7.0 mm in<br>diameter, lymphatics and tissue bundles by<br>comparing the seal achievement and<br>maintenance rates with those yielded |
| #G | THUNDERBEAT Open Fine<br>Jaw Safety and Performance<br>Confirmation Test on ENT<br>Procedures (Chronic Animal<br>Testing) | This test was designed to confirm the safety<br>and performance of THUNDERBEAT<br>Open Fine Jaw when utilized during ENT<br>procedures including thyroidectomy,<br>parathyroidectomy, parotidectomy, and<br>tonsillectomy |
| #M | THUNDERBEAT Open Fine<br>Jaw Safety and Performance<br>Confirmation Test on ENT<br>Procedures (Acute Animal<br>Testing) | This test was designed to confirm the safety<br>and performance of THUNDERBEAT<br>Open Fine Jaw when utilized during ENT<br>procedures including thyroidectomy,<br>parathyroidectomy, parotidectomy, and<br>tonsillectomy. The thermal spread and the<br>acute tissue response of the<br>THUNDERBEAT Open Fine Jaw on the<br>usage in the ENT procedures were<br>evaluated in comparison with the control<br>devices |

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.