Ultrasonic Generator

K172691 · Olympus Medical Systems Corp. · LFL · Oct 4, 2017 · SU

Device Facts

• Record ID: K172691
• Device Name: Ultrasonic Generator
• Applicant: Olympus Medical Systems Corp.
• Product Code: LFL · SU
• Decision Date: Oct 4, 2017
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Ultrasonic Generator (USG-400 Ver 2) is intended to be used with the Electrosurgical Generator (ESG-400), the THUNDERBEAT Transducer (TD-TB400), the SONICBEAT Transducer (TD-SB400), the THUNDERBEAT, and / or the SONICBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.

Device Story

The USG-400 Ver 2 is an ultrasonic generator used in surgical settings (open, laparoscopic, endoscopic) by surgeons. It functions as a power source for compatible transducers (THUNDERBEAT, SONICBEAT) and electrosurgical generators (ESG-400). The device converts electrical energy into ultrasonic output (47 kHz) or combined ultrasonic/HF bipolar energy to perform tissue cutting, coagulation, and vessel sealing. It features Intelligent Tissue Monitoring (ITM) to manage output. The surgeon operates the device via footswitches and monitors status via an integrated LCD. The output affects tissue by providing mechanical vibration for cutting and thermal energy for coagulation/sealing, facilitating surgical procedures and potentially reducing operative time or blood loss.

Clinical Evidence

No clinical testing was conducted. Evidence consists of bench testing (ex-vivo porcine vessel burst pressure and cutting performance) and an acute porcine animal study evaluating seal performance, safety, thermal spread, and tissue degeneration on vessels up to 7.0mm.

Technological Characteristics

Ultrasonic generator; 47 kHz output frequency; 1000Vpp max voltage; 0.57App max current. Features 5.7-inch color LCD. Class 1, Type CF protection against electric shock. Complies with IEC 60601-1, IEC 60601-1-2, and AAMI/ANSI/IEC 60601-2-2. Includes Intelligent Tissue Monitoring (ITM).

Indications for Use

Indicated for open, laparoscopic (including single-site), and endoscopic surgery to cut/dissect or coagulate soft tissue, or to ligate/seal and cut vessels. Used in conjunction with compatible transducers and electrosurgical generators.

Predicate Devices

• Olympus Medical Systems Corp. Ultrasonic Generator USG-400 Ver 1 (K111202)

Submission Summary (Full Text)

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October 4, 2017

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

Re: K172691

Trade/Device Name: Ultrasonic Generator Regulatory Class: Unclassified Product Code: LFL, GEI Dated: August 31, 2017 Received: September 6, 2017

Dear Graham Baillie:

We have reviewed vour 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. Isting of devices, good manufacturing practice, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm.

Sincerely,

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

Enclosure

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## Indications for Use

510(k) Number (if known) K172691

Device Name Ultrasonic Generator USG-400

#### Indications for Use (Describe)

The Ultrasonic Generator (USG-400) is intended to be used with the Electrosurgical Generator (ESG-400), the THUNDERBEAT Transducer (TD-TB400), the SONICBEAT Transducer (TD-SB400), the THUNDERBEAT, and / or the SONICBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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## K172691 Page 1 of 6

### 510(k) Summary: Gyrus ACMI, Inc. Ultrasonic Generator USG-400

### 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 |
| Establishment Registration Number: | 3003790304 |
| Contact Person: | Graham A.L. Baillie MS Manager, Regulatory Affairs |
| Date Prepared: | August 31, 2017 |
| Classification Name: | Endoscopic Electrosurgical unit and accessories |
| Regulation Number: | Unclassified |
| Regulatory Class: | LFL, GEI |
| Product Codes: | General & Plastic Surgery |
| Review Panel: | Ultrasonic Generator USG-400 |
| Trade Name: | |

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# K172691

#### Page 2 of 6

Generic/Common Name:

Ultrasonic Generator

| Model Name | Device Name |
|------------|----------------------|
| USG-400 | Ultrasonic Generator |

### Predicate Devices

Olympus Medical Systems Corp. Ultrasonic Generator USG-400 Ver 1 K11202

### Device Description

The Ultrasonic Generator USG-400 Ver 2 is intended to be used with the Electrosurgical Generator ESG-400, the THUNDERBEAT Transducer TD-TB400, the SONICBEAT Transducer TD-SB400, the THUNDERBEAT hand instruments, and / or the SONICBEAT hand instruments.

It is an ultrasonic generator capable of vessel sealing & cutting, tissue coagulating & cutting, grasping, and dissecting.

#### Technological Characteristics

Output mode and Control [Seal & Cut mode (THUNDERBEAT)] The USG-400 Ver 2 communicates with the ESG-400 to control the HF Bipolar (FineCoag) output for the Seal & Cut mode. It also generates drive current for the Seal & Cut mode. The drive current is converted into the Ultrasonic output by the Transducer.

[Seal mode (THUNDERBEAT)] The USG-400 Ver 2 communicates with the ESG-400 to control the HF Bipolar (HardCoag) output for the Seal mode.

[Ultrasonic (SONICBEAT)] The USG-400 Ver 2 generates drive current for the ultrasonic output.

### Intended Use

The Ultrasonic Generator (USG-400 Ver 2) is intended to be used with the Electrosurgical Generator (ESG-400), the THUNDERBEAT Transducer (TD-TB400), the SONICBEAT Transducer (TD-SB400), the THUNDERBEAT, and / or the SONICBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.

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### K172691 Page 3 of 6

### Comparison of Technological Characteristics

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

| Feature | Proposed<br>USG-400 Ver. 2 | Predicate<br>USG-400 (#K111202) Ver. 1 |
|--------------------------------------------------------------------|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Identical to PD | OLYMPUS MEDICAL SYSTEMS<br>CORP. |
| Size: Width x<br>Height x Depth | Identical to PD | $375 \times 156 \times 480$ mm |
| Weight | Identical to PD | 9kg |
| Indications for<br>Use | Identical to PD | The Ultrasonic Generator (USG-400)<br>is intended to be used with the<br>Electrosurgical Generator (ESG-400),<br>the THUNDERBEAT Transducer<br>(TD-TB400), the SONICBEAT<br>Transducer (TD-SB400), the<br>THUNDERBEAT, and / or the<br>SONICBEAT for open, laparoscopic<br>(including single-site surgery), and<br>endoscopic surgery to cut (dissect) or<br>coagulate soft tissue or to ligate (seal<br>and cut) vessels. |
| Power supply:<br>Rated voltage<br>Rated frequency<br>Input current | Identical to PD | 120V AC / 220-240V AC<br>50 - 60 Hz<br>360 VA |
| Type of protection<br>against electric<br>shock | Identical to PD | Class 1 |
| Degree of<br>protection<br>against electric<br>shock | Identical to PD | CF |
| Display | Identical to PD | LCD (5.7inch, color) |
| Sockets for<br>instruments | Identical to PD | Socket for THUNDERBEAT: 1<br>Socket for SONICBEAT: 1 |
| Socket for<br>Footswitch | Identical to PD | Footswitch for THUNDERBEAT: 1<br>Footswitch for SONICBEAT: 1 |
| Output mode | Identical to PD | Ultrasonic output,<br>Combined output (ultrasonic from |
| Feature | Proposed<br>USG-400 Ver. 2 | Predicate<br>USG-400 (#K111202) Ver. 1 |
| Output level | Identical to PD | Ultrasonic output: Level 1 - Level 3<br>(by 1step)<br>Combined output: Level 1 - Level 3<br>(by 1step)<br>Output timing is controlled between<br>Ultrasonic and RF Bipolar by level<br>setting. |
| Ultrasonic Output<br>Frequency | Identical to PD | 47 kHz |
| Ultrasonic Output<br>Voltage | Identical to PD | 1000Vpp max |
| Ultrasonic Output<br>Current | Identical to PD | 0.57App |
| ITM (Intelligent<br>Tissue<br>Monitoring) | Equipped | Not equipped |

## Table 5.1 Comparison Table of Proposed and Predicate Devices

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### K172691 Page 4 of 6

### Compliance to Voluntary Standards

The design of the proposed USG-400 Ver 2 complies with the following standards:

- Medical electrical equipment Part1: General ● IEC60601-1: 2005+A1 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 / IEC 60601-2-2:2009, medical electrical equipment - part 2-2: particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories.
- . ISO14971 Second Edition: 2007-03-01 - Medical devices - Application of risk management to medical devices

### 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.

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### K172691 Page 5 of 6

#### Summary of Non-clinical Testing

Electrical safety and EMC performance testing have confirmed the subject USG-400 to be in compliance with relevant requirements.

Software testing has been performed and documented to be in compliance with the FDA guidance "ODE Guidance for the Contents of Premarket Submission for Software Contained in Medical Devices" issued on May 11, 2005.

| Test<br>Code | Item | Contents |
|--------------|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| #A | Ex-vivo Vessel Burst<br>Pressure | Ex-vivo burst pressure testing of porcine<br>blood vessels was conducted on both the<br>subject and predicate devices to demonstrate<br>vessel sealing performance. |
| #B | Ex-vivo Cutting<br>Performance | Ex-vivo Cutting performance (Cutting time)<br>testing of porcine mesentery was conducted<br>on both the subject and predicate devices to<br>demonstrate cutting performance. |

#### Bench Testing:

| Animal Testing: Porcine animal models were used for performance testing D. | | | | | | | | |
|----------------------------------------------------------------------------|--|--|--|--|--|--|--|--|
|----------------------------------------------------------------------------|--|--|--|--|--|--|--|--|

| Test<br>Code | Item | Contents |
|--------------|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| #D | Acute Animal Study | Acute animal study of porcine was conducted<br>on both the subject and predicate devices to<br>demonstrate seal performance and safety (ex.<br>seal maintenance rates include vessels up to<br>7.0mm in diameter and lymphatics and tissue<br>bundles, thermal spread, degree of<br>degeneration). |

#### Software testing:

| Test | Item | Contents |
|------|----------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Code | | |
| NA | Software | Software was classified as a “Major” Level of<br>Concern according to guidance. Software<br>testing and documentation supports this Level<br>of Concern |

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## K172691 Page 6 of 6

### Summary of Clinical Testing

Clinical testing using the proposed device was not conducted.

#### Conclusion:

Performance tests summarized above demonstrate that the proposed USG-400 Ver 2 is substantially equivalent to the predicate USG-400 Ver 1 and presents no new questions of safety or efficacy.