(28 days)
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.
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.
The provided text describes the regulatory clearance (K172691) for the Olympus Medical Systems Corp. Ultrasonic Generator USG-400 (Ver 2). However, it does not contain acceptance criteria for device performance or a study that proves the device meets specific performance criteria related to diagnostic accuracy or clinical outcomes.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (USG-400 Ver 1) based on similar technological characteristics and non-clinical testing.
Here's an analysis of the requested information based on the provided text, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Explicitly stated in text) | Reported Device Performance (as per non-clinical testing) |
|---|---|
| Electrical safety and EMC performance compliance with relevant requirements. | Confirmed compliance with IEC60601-1: 2005+A1, IEC60601-1-2 Edition 3: 2007-03, AAMI / ANSI / IEC 60601-2-2:2009. |
| Software compliance with FDA guidance "ODE Guidance for the Contents of Premarket Submission for Software Contained in Medical Devices". | Software testing and documentation supports a "Major" Level of Concern classification. |
| Implicit Acceptance for Substantial Equivalence: | |
| Ex-vivo Vessel Burst Pressure performance comparable to predicate. | Performed a study to demonstrate vessel sealing performance, comparing subject and predicate devices. (Specific performance metrics or equivalence thresholds for burst pressure are not provided). |
| Ex-vivo Cutting Performance (Cutting time) comparable to predicate. | Performed a study to demonstrate cutting performance, comparing subject and predicate devices. (Specific performance metrics or equivalence thresholds for cutting time are not provided). |
| Acute Animal Study (seal performance, safety, thermal spread, degeneration) comparable to predicate. | Performed an acute animal study to demonstrate seal performance and safety (e.g., seal maintenance rates, thermal spread, degree of degeneration), comparing subject and predicate devices. (Specific performance metrics or equivalence thresholds for these aspects are not provided). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified for ex-vivo or animal testing. The text only mentions "porcine blood vessels" and "porcine mesentery" for ex-vivo tests, and "porcine animal models" for the acute animal study, without quantitative sample sizes.
- Data provenance: For ex-vivo and animal testing, the data origin is implied to be laboratory/animal study data, not human clinical data. The country of origin for the studies is not explicitly stated, but the manufacturer (Olympus Medical Systems Corp.) and the testing sites might be in Japan (where the manufacturer is located) or elsewhere. The studies are prospective in nature as they involve controlled experiments.
3. 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 applicable. The "ground truth" here refers to objective measurements in in-vitro and animal models (e.g., burst pressure, cutting time, thermal spread). These are assessed directly through experimental methods, not by expert interpretation like in diagnostic accuracy studies. Therefore, no experts were used to establish ground truth in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As noted above, the testing involves objective measurements in laboratory and animal settings, not subjective human assessment requiring adjudication.
5. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an ultrasonic generator, not an AI-powered diagnostic or assistive tool for human readers.
- The document explicitly states: "Clinical testing using the proposed device was not conducted."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of an AI algorithm. The device itself is an "Ultrasonic Generator" for surgical procedures. The performance evaluated was the direct performance of the device's functional outputs (sealing, cutting, safety) using its hardware and embedded software. This is inherently a "standalone" or "algorithm only" performance for the device's operational capabilities, but not in the sense of a standalone AI algorithm interpreting data.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the non-clinical tests was established through direct objective measurement in controlled laboratory (ex-vivo) and animal (in-vivo acute) settings. Examples include:
- Ex-vivo Vessel Burst Pressure: Direct measurement of the pressure required to burst a sealed vessel.
- Ex-vivo Cutting Performance: Direct measurement of cutting time.
- Acute Animal Study: Direct observation and measurement of seal maintenance rates, thermal spread, and degree of degeneration in animal tissues.
8. The sample size for the training set
- Not applicable. The document describes a medical device (ultrasonic generator), not a machine learning model that requires a "training set" of data for algorithm development. Any internal development and testing would have used engineering and performance data, but it's not referred to as a "training set" in a machine learning sense.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" in the machine learning context.
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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 (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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm.
Sincerely,
Image /page/1/Picture/5 description: The image shows the name "Jennifer R. Stevenson -S3" in a large, sans-serif font. The text is black and appears to be against a white background. The letters are clear and easy to read.
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: (+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 |
| 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 | ProposedUSG-400 Ver. 2 | PredicateUSG-400 (#K111202) Ver. 1 |
|---|---|---|
| Manufacturer | Identical to PD | OLYMPUS MEDICAL SYSTEMSCORP. |
| Size: Width xHeight x Depth | Identical to PD | $375 \times 156 \times 480$ mm |
| Weight | Identical to PD | 9kg |
| Indications forUse | Identical to PD | The Ultrasonic Generator (USG-400)is intended to be used with theElectrosurgical Generator (ESG-400),the THUNDERBEAT Transducer(TD-TB400), the SONICBEATTransducer (TD-SB400), theTHUNDERBEAT, and / or theSONICBEAT for open, laparoscopic(including single-site surgery), andendoscopic surgery to cut (dissect) orcoagulate soft tissue or to ligate (sealand cut) vessels. |
| Power supply:Rated voltageRated frequencyInput current | Identical to PD | 120V AC / 220-240V AC50 - 60 Hz360 VA |
| Type of protectionagainst electricshock | Identical to PD | Class 1 |
| Degree ofprotectionagainst electricshock | Identical to PD | CF |
| Display | Identical to PD | LCD (5.7inch, color) |
| Sockets forinstruments | Identical to PD | Socket for THUNDERBEAT: 1Socket for SONICBEAT: 1 |
| Socket forFootswitch | Identical to PD | Footswitch for THUNDERBEAT: 1Footswitch for SONICBEAT: 1 |
| Output mode | Identical to PD | Ultrasonic output,Combined output (ultrasonic from |
| Feature | ProposedUSG-400 Ver. 2 | PredicateUSG-400 (#K111202) Ver. 1 |
| Output level | Identical to PD | Ultrasonic output: Level 1 - Level 3(by 1step)Combined output: Level 1 - Level 3(by 1step)Output timing is controlled betweenUltrasonic and RF Bipolar by levelsetting. |
| Ultrasonic OutputFrequency | Identical to PD | 47 kHz |
| Ultrasonic OutputVoltage | Identical to PD | 1000Vpp max |
| Ultrasonic OutputCurrent | Identical to PD | 0.57App |
| ITM (IntelligentTissueMonitoring) | 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.
| TestCode | Item | Contents |
|---|---|---|
| #A | Ex-vivo Vessel BurstPressure | Ex-vivo burst pressure testing of porcineblood vessels was conducted on both thesubject and predicate devices to demonstratevessel sealing performance. |
| #B | Ex-vivo CuttingPerformance | Ex-vivo Cutting performance (Cutting time)testing of porcine mesentery was conductedon both the subject and predicate devices todemonstrate cutting performance. |
Bench Testing:
| Animal Testing: Porcine animal models were used for performance testing D. | ||||||||
|---|---|---|---|---|---|---|---|---|
| ---------------------------------------------------------------------------- | -- | -- | -- | -- | -- | -- | -- | -- |
| TestCode | Item | Contents |
|---|---|---|
| #D | Acute Animal Study | Acute animal study of porcine was conductedon both the subject and predicate devices todemonstrate seal performance and safety (ex.seal maintenance rates include vessels up to7.0mm in diameter and lymphatics and tissuebundles, thermal spread, degree ofdegeneration). |
Software testing:
| Test | Item | Contents |
|---|---|---|
| Code | ||
| NA | Software | Software was classified as a “Major” Level ofConcern according to guidance. Softwaretesting and documentation supports this Levelof 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.
N/A