(28 days)
K11202
K11202
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies do not mention any AI/ML capabilities.
Yes.
The device is used to cut, coagulate, and ligate tissues and vessels during surgery, which directly addresses medical conditions by altering biological structures for therapeutic purposes.
No
The device is described as an ultrasonic generator used for surgical procedures like cutting, coagulating, ligating, grasping, and dissecting soft tissue and vessels, indicating a therapeutic rather than diagnostic function.
No
The device description explicitly states it is an "ultrasonic generator" and mentions electrical safety and EMC performance testing, indicating it is a hardware device with embedded software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description reinforces its use in surgical procedures for "vessel sealing & cutting, tissue coagulating & cutting, grasping, and dissecting."
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information about a patient's health. IVDs are designed for this type of testing.
In summary, the device is an ultrasonic surgical tool used during surgery on a patient, not for diagnostic testing of samples in a laboratory setting.
N/A
Intended Use / Indications for Use
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.
Product codes
LFL, GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Bench Testing:
- Ex-vivo Vessel Burst Pressure: Ex-vivo burst pressure testing of porcine blood vessels was conducted on both the subject and predicate devices to demonstrate vessel sealing performance.
- Ex-vivo Cutting Performance: Ex-vivo Cutting performance (Cutting time) testing of porcine mesentery was conducted on both the subject and predicate devices to demonstrate cutting performance.
Animal Testing: Porcine animal models were used for performance testing.
- Acute Animal Study: Acute animal study of porcine was conducted on both the subject and predicate devices to demonstrate seal performance and safety (ex. seal maintenance rates include vessels up to 7.0mm in diameter and lymphatics and tissue bundles, thermal spread, degree of degeneration).
Software testing:
Software was classified as a “Major” Level of Concern according to guidance. Software testing and documentation supports this Level of Concern.
Clinical testing using the proposed device was not conducted.
Key Metrics
Not Found
Predicate Device(s)
K11202
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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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.
1
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,
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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
2
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: |
4
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.
5
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
USG-400 Ver. 2 | Predicate
USG-400 (#K111202) Ver. 1 |
|--------------------------------------------------------------------|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Identical to PD | OLYMPUS MEDICAL SYSTEMS
CORP. |
| Size: Width x
Height x Depth | Identical to PD | $375 \times 156 \times 480$ mm |
| Weight | Identical to PD | 9kg |
| Indications for
Use | Identical to PD | 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. |
| Power supply:
Rated voltage
Rated frequency
Input current | Identical to PD | 120V AC / 220-240V AC
50 - 60 Hz
360 VA |
| Type of protection
against electric
shock | Identical to PD | Class 1 |
| Degree of
protection
against electric
shock | Identical to PD | CF |
| Display | Identical to PD | LCD (5.7inch, color) |
| Sockets for
instruments | Identical to PD | Socket for THUNDERBEAT: 1
Socket for SONICBEAT: 1 |
| Socket for
Footswitch | Identical to PD | Footswitch for THUNDERBEAT: 1
Footswitch for SONICBEAT: 1 |
| Output mode | Identical to PD | Ultrasonic output,
Combined output (ultrasonic from |
| Feature | Proposed
USG-400 Ver. 2 | Predicate
USG-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 between
Ultrasonic and RF Bipolar by level
setting. |
| Ultrasonic Output
Frequency | Identical to PD | 47 kHz |
| Ultrasonic Output
Voltage | Identical to PD | 1000Vpp max |
| Ultrasonic Output
Current | Identical to PD | 0.57App |
| ITM (Intelligent
Tissue
Monitoring) | Equipped | Not equipped |
Table 5.1 Comparison Table of Proposed and Predicate Devices
6
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.
7
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
| Code | Item | Contents |
|---|---|---|
| #A | Ex-vivo Vessel Burst | |
| Pressure | Ex-vivo burst pressure testing of porcine | |
| blood vessels was conducted on both the | ||
| subject and predicate devices to demonstrate | ||
| vessel sealing performance. | ||
| #B | Ex-vivo Cutting | |
| Performance | Ex-vivo Cutting performance (Cutting time) | |
| testing of porcine mesentery was conducted | ||
| on both the subject and predicate devices to | ||
| demonstrate cutting performance. |
Bench Testing:
| Animal Testing: Porcine animal models were used for performance testing D. | ||||||||
|---|---|---|---|---|---|---|---|---|
| ---------------------------------------------------------------------------- | -- | -- | -- | -- | -- | -- | -- | -- |
| Test
| Code | Item | Contents |
|---|---|---|
| #D | Acute Animal Study | Acute animal study of porcine was conducted |
| on both the subject and predicate devices to | ||
| demonstrate seal performance and safety (ex. | ||
| seal maintenance rates include vessels up to | ||
| 7.0mm in diameter and lymphatics and tissue | ||
| bundles, thermal spread, degree of | ||
| degeneration). |
Software testing:
| Test | Item | Contents |
|---|---|---|
| Code | ||
| NA | Software | Software was classified as a “Major” Level of |
| Concern according to guidance. Software | ||
| testing and documentation supports this Level | ||
| of Concern |
8
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.