The THUNDERBEAT hand instruments are 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 hand instruments when used in combination with the Seal & Cut mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. These devices have 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 procedures in adults for ligation (sealing and cutting) of vessels, lymphatics and tissue bundles away from unintended thermally sensitive structures.

Seal mode:
The THUNDERBEAT hand instruments when used in combination with the Seal mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc), and endoscopic surgery or in any procedure in which vessel sealing, coagulation, grasping is performed. These devices have 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 procedures in adults for sealing of vessels, lymphatics and tissue bundles away from unintended thermally sensitive structures.

The THUNDERBEAT hand instruments have 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

The THUNDERBEAT hand instruments are intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer, (TD-TB400).

The THUNDERBEAT hand instruments are provided as sterile, single use devices. These are functional devices capable of vessel sealing & cutting, tissue coagulating & cutting, grasping, dissecting. These instruments have been designed to seal and cut vessels up to and.including 7 mm in diameter, tissue bundles, and lymphatics for open, laparoscopic, open ENT and endoscopic procedures in surgery.

AI/ML Overview

The provided text describes a 510(k) submission for the THUNDERBEAT hand instruments. This submission aims to demonstrate substantial equivalence to predicate devices and expand the Indications for Use. The information primarily focuses on performance testing rather than the detailed acceptance criteria and a standalone study with specific performance metrics against those criteria in a format directly requested by the prompt.

Therefore, many sections of your requested output cannot be directly extracted from the provided text. The document refers to "performance testing" being conducted but does not provide a table of acceptance criteria with corresponding device performance for a specific study. It also lacks details about sample sizes for test sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, specific ground truth types for training/test sets, or training set sample size and ground truth establishment.

However, I can extract the types of performance tests conducted, which are often used to demonstrate that the device meets its intended use, even if the precise quantitative acceptance criteria and results are not explicitly listed in a comparative table.

Here's an attempt to populate the table and answer the questions based on the available information:

Acceptance Criteria and Device Performance

The document describes various performance tests conducted to support the expanded indications for use and marketing claims. While specific quantitative acceptance criteria or a direct comparison table are not provided, the tests aim to confirm the device's functional equivalence and safety.

Acceptance Criteria (Implied from tests)	Reported Device Performance (Implied from "Confirmation Test," "Comparison")
Vessel Sealing & Cutting Performance (Ex-vivo)	Confirmed ("Performance Confirmation Test")
Cutting Performance on Blood Vessels and Mesentery (Ex-vivo)	Confirmed ("Cutting Performance Confirmation Test")
Sealing performance of SEAL & CUT mode	Confirmed ("Sealing performance of the THUNDERBEAT SEAL & CUT mode")
Sealing performance and characteristic of SEAL & CUT mode during activation	Confirmed ("Sealing performance and characteristic of the THUNDERBEAT SEAL & CUT mode during activation")
Comparison of dissecting performance vs. control devices	Demonstrated satisfactory comparative performance ("Comparison of dissecting performance between the THUNDERBEAT vs. Control devices")
Comparison of heating at grasping section vs. control devices	Demonstrated satisfactory comparative performance regarding heat ("A comparison of heating at the grasping section of THUNDERBEAT Hand Instruments vs. Control devices")
Histopathological confirmation of Sealing & Cutting/Sealing (Ex-vivo)	Confirmed ("Histopathological Confirmation Test on Blood Vessels")
In-vivo Sealing & Cutting and Sealing Performance (Porcine)	Confirmed ("THUNDERBEAT In-vivo Sealing & Cutting and Sealing Performance Confirmation Testing on Porcine Blood Vessels, Lymphatics and Tissue Bundles.")

1. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: Not specified in the provided text for any of the performance tests.
Data Provenance:
- Country of Origin: Not explicitly stated for each test. The applicant is from Japan, and the manufacturer is Aomori Olympus, Japan. The in-vivo animal test used "Porcine Blood Vessels, Lymphatics and Tissue Bundles," which could be from various locations.
- Retrospective or Prospective: Unclear. The tests are described as "Performance Confirmation Tests," which suggests prospective testing designed for this submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not specified in the provided text. The "Histopathological Confirmation Test" implies expert pathological analysis would have been used, but no details are given.

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

Not specified in the provided text.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was mentioned. This device is an electrosurgical hand instrument, not an AI-assisted diagnostic tool.

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

This question is not applicable as the device is a surgical instrument, not an algorithm, and is used with a human (surgeon) always in the loop. The performance tests evaluate the instrument's capabilities directly.

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

The ground truth for sealing and cutting performance would likely be based on:
- Functional Observation: Successful cutting and sealing during bench and animal tests.
- Physical Measurement: Assessment of seal strength, thermal spread, cutting efficiency.
- Histopathology: For cellular and tissue-level confirmation of vessel sealing and tissue effects (explicitly mentioned: "Histopathological Confirmation Test on Blood Vessels").
- Biocompatibility Testing: Confirmed compliance to ISO-10993.

7. The sample size for the training set

This concept of a "training set" is not applicable as the submission is for a physical medical device (surgical hand instrument), not an AI/ML algorithm.

8. How the ground truth for the training set was established

Not applicable for a physical medical device.

Summary

{0}------------------------------------------------

Traditional 510(k) Notification May 5, 2014

510(k) Summary Gyrus ACMI, Inc. THUNDERBEAT TB-0535PC/0545PC/0510IC/0520IC/0535IC/0545IC

MAY 1 9 2014

General Information

Applicant:

Establishment Registration Number:

Manufacturer:

Establishment Registration Number:

510(k) Submitter:

Establishment Registration Number:

Contact Person:

Date Prepared:

Device Identification

Classification Name:

Regulation Number: Product Code(s): Regulatory Class: Review Panel: Generic/Common Name: Trade Name:

OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Phone: (+81) 42-642-2694 Fax: (+81) 42-642-2307

8010047

Aomori Olympus 248-1 Okkonoki 2-chome Kuroishi-shi. Aomori, Japan 036-0367 Phone: (+81) 172-52-8543 Fax: (+81) 172-52-8515

9614641

Gyrus ACMI, Inc. 136 Turnpike Rd. Southborough, MA 01772-2104

3003790304

Graham Baillie Manager, Regulatory Affairs

May 5, 2014

Electrosurgical cutting and coagulation device and accessories 21 CFR 878.4400 GEI, LFL II. Unclassified General & Plastic Surgery Ultrasonic and electrosurgical devices THUNDERBEAT Hand Instruments

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Traditional 510(k) Notification May 5, 2014

Model Name	Device Name
TB-0545PC	THUNDERBEAT 5mm, 45cm, Pistol Grip
TB-0535PC	THUNDERBEAT 5mm, 35cm, Pistol Grip
TB-0545IC	THUNDERBEAT 5mm, 45cm, Inline Grip
TB-0535IC	THUNDERBEAT 5mm, 35cm, Inline Grip
TB-0520IC	THUNDERBEAT 5mm, 20cm, Inline Grip
TB-0510IC	THUNDERBEAT 5mm, 10cm, Inline Grip

Predicate Devices

Olympus Medical Systems Corp. THUNDERBEAT TB-0535PC,
0545PC, 0510IC, 0520IC, 0535IC and 0545IC	K111202
Covidien LigaSure Small Jaw	K113572

Product Description

The THUNDERBEAT hand instruments are 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 activates combined HF Bipolar (FineCoag) output and Ultrasonic output [Sea] and Cut model simultaneously while grasping a tissue or a vessel between the Probe and the Grasping section.

The THUNDERBEAT also performs the HF Bipolar (HardCoag) output [Seal mode]. Those outputs lead to sealing and cutting/sealing of vessels or coagulating and cutting soft tissue.

The hand switches provided on the grip handle enable those output operations. However, the technological features of the subject devices are identical to the predicate (K111202) such as the shaft length, shaft rotation, and shaft diameter.

Material

The patient contacting materials are well established and identical to the predicate devices cleared under K111202. Full biocompatibility testing on all patient contacting surfaces has been performed in compliance to the relevant requirements of ISO-10993.

{2}------------------------------------------------

Traditional 510(k) Notification May 5, 2014

Intended Uses

The purpose of this submission is to demonstrate equivalence to predicate devices and to expand the Indication for Use for the existing (subject) TB-0535PC/0545PC/0535IC/05451C/0510IC/05201C. The additional indications appear as bolded text under the Intended Use section below.

THUNDERBEAT TB-0535PC/0545PC/0535IC/0545IC

The THUNDERBEAT hand instruments are 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 hand instruments when used in combination with the Seal & Cut mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. These devices have been designed to seal and cut vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.

Seal mode:

The THUNDERBEAT hand instruments when used in combination with the Seal mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc), and endoscopic surgery or in any procedure in which vessel sealing, coagulation. grasping is performed. These devices have been designed to seal vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.

The THUNDERBEAT hand instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

{3}------------------------------------------------

K132703

Page 4 of 6

THUNDERBEAT TB-0510IC/0520IC

The THUNDERBEAT hand instruments are 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 procedures in adults for ligation (sealing and cutting) of vessels, lymphatics and tissue bundles away from unintended thermally sensitive structures.

Seal mode:

The THUNDERBEAT hand instruments when used in combination with the Seal mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc), and endoscopic surgery or in any procedure in which vessel sealing, coagulation, grasping is performed. These devices have 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 procedures in adults for sealing of vessels, lymphatics and tissue bundles away from unintended thermally sensitive structures.

The THUNDERBEAT hand instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

{4}------------------------------------------------

ditional 510(k) Notification lav 5. 2014

Compliance to Voluntary Standards

The design of the THUNDERBEAT TB-0535PC. 0545PC. 0510IC. 0520IC. 0535IC and 0545IC complies with the following standards:

AAMI/ ANSI60601-1: 2005/(R)2012 and CI:2009/(R)2012 IEC60601-1-1:2000 IEC60601-2-2:2009 IEC60601-1-2:2007 IEC60601-2-18: 2009 ISO10993-1:2009 ISO11135-1:2007 ISO14971:2007

Summary of Sterilization and Shelf Life Discussion

The sterilization had been tested to comply with ISO11135-1: 2007.

Real Time Aging testing confirmed that the subject devices have a three year shelf life.

Summary of Performance Testing

The following performance testing was conducted.

Bench Testing

Test #A: THUNDERBEAT Ex-vivo Sealing & Cutting Performance Confirmation Test on Blood Vessels

Test #B: THUNDERBEAT Ex-vivo Cutting Performance Confirmation Test on Blood Vessels and Mesentery.

Test #Fa: Sealing performance of the THUNDERBEAT SEAL & CUT mode

Test #Fb: Sealing performance and characteristic of the THUNDERBEAT SEAL & CUT mode during activation

Test #Fc: Sealing performance of the THUNDERBEAT SEAL & CUT mode

Test #H: Comparison of dissecting performance between the THUNDERBEAT vs. Control devices

Test #I/J: A comparison of heating at the grasping section of THUNDERBEAT Hand Instruments vs. Control devices.

{5}------------------------------------------------

Traditional 510(k) Notification May 5, 2014

Test #P: THUNDERBEAT Ex-vivo Sealing & Cutting and Sealing Performance -Histopathological Confirmation Test on Blood Vessels.

Animal Test

Test Ea: THUNDERBEAT In-vivo Sealing & Cutting and Sealing Performance Confirmation Testing on Porcine Blood Vessels, Lymphatics and Tissue Bundles.

Substantial Equivalence

The subject devices have identical technology, performance, dimensions and materials. The differences between the predicate and the subject devices are expanded indications for use and additional marketing claims. To support the proposed indications for use and marketing claims, the performance tests summarized above were conducted.

Conclusion:

In summary, the Gyrus ACMI THUNDERBEAT TB-0535PC, 0545PC, 0510IC, 05201C, 0535IC and 0545IC handpieces are substantially equivalent to the predicate devices and present no new questions of safety or efficacy.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circumference of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 19, 2014

OLYMPUS MEDICAL SYSTEMS CORPORATION % Mr. Graham Baillie Gyrus ACMI Incorporated 136 Turnpike Road Southborough, Massachusetts 01772

Rc: K132703

Trade/Device Name: Thunderbeat Regulation Number: 21 CFR 878.4400 Regulation Name; Electrosurgical, Cutting & Coagulation and Accessories Regulatory Class: Class II Product Code: GEI, LFL Dated: April 16, 2014 Received: April 18, 2014

· 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{7}------------------------------------------------

Page 2 - Mr. Graham Baillie

forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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,

David Krause -S

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

{8}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510{k} Number (if known) K132703

Device Name

THUNDERBEAT TB-0535PC/0545PC/0510IC/0520IC/05351C/05451C

Indications for Use (Describe) THUNDERBEAT TB-0535PC/0545PC/0535IC/05451C

The THUNDERBEAT hand instruments are intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer, (TD-TB400).

Seal & Cut mode:

Seal mode:

adhesiolysis, oophorectorny, hysterectomies (both vaginal assisted and abdominal) etc), and endoscopic surgery or in any procedure in which vessel sealing, coagulation, grasping is performed. These devices have been designed to seal vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.

The THUNDERBEAT hand instruments have not been shown to be effective for tubal coagulation for sterilization procedures, and should not be used for these procedures.

THUNDERBEAT TB-0510IC/0520IC

The THUNDERBEAT hand instruments are 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 hand instruments when used in combination with the Seal & Cut mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including wologic, thoracic, laboropio (including mage on resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cuting), coagulation, grasping, and dissection is performed. These devices have 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 procedures in adults for ligation (sealing and cutting) of vessels, lymphatics and tissue bundles away from unintended thermally sensitive structures.

Seal mode:

The THUNDERBEAT hand instruments when used in combination with the Seal mode are indicated for open,

FORM FDA 3881 (1/14)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{9}------------------------------------------------

laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication,

adhesiolysis, oophorectorny, hysterectomies (both vaginal assisted and abdominal) etc), and endoscopic surgery or in any procedure in which vessel sealing, coasing is performed. These devices have 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 procedures in adults for sealing of vessels, lymphatics and tissue bundles away from unintended thermally sensitive structures.

The THUNDERBEAT hand instruments have not been shown to be effective for tubal coagulation for sterilization procedures, and should not be used for these procedures.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOR FOR FOR FOR FOR FOR FOR FOR

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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.