(92 days)
No
The summary describes a standard electrosurgical generator with different modes and power levels. There is no mention of AI, ML, image processing, or any data-driven decision-making processes. The performance studies focus on comparing waveform output and power levels to predicate devices, not on evaluating algorithmic performance.
Yes
The device is used for cutting and coagulation of tissue in surgery, which constitutes a therapeutic intervention.
No
The device is an electrosurgical unit intended for cutting and coagulation of tissue, not for diagnosis.
No
The device description explicitly states it is a "reusable, non-sterile electrosurgical generator" with a maximum output power of 320 W, indicating it is a hardware device that generates electrical energy for surgical procedures.
Based on the provided information, the Olympus ESG-400 electrosurgical unit is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "cutting and coagulation of tissue in open, laparoscopic and endoscopic surgery." This describes a surgical procedure performed directly on a patient's tissue, not a test performed on a sample taken from the body.
- Device Description: The device is described as a "reusable, non-sterile electrosurgical generator" used for "cutting and coagulation of tissue." This aligns with surgical equipment, not diagnostic equipment that analyzes samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue samples, etc.), which is a defining characteristic of IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The ESG-400 is a therapeutic device used during surgery.
N/A
Intended Use / Indications for Use
The Olympus ESG-400 electrosurgical unit is intended for cutting and coagulation of tissue in open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The ESG-400 is a reusable, non-sterile electrosurgical generator that features different mono- and bipolar cutting and coagulation modes. The maximum output power is 320 W. It is intended for cutting and coagulation of tissue in open, laparoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.
The updated ESG-400 allows Olympus Plasma Kinetic (PK) instruments to be connected at the device.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
- Bench Test Validation versus Gyrus G400 Demonstrating the capability to use PlasmaKinetic (PK) instruments in the same manner as they are currently supported by the legally distributed/FDA cleared predicate Gyrus G400 generator, K081954.
The same range of waveform output and power levels were used for performance and validation testing. During the validation, the waveform and test results were compared directly to the predicate device. - Validation with representative HF instruments.
- Validation Comparison to Predicate Generators:
- ESG-400, Olympus Electrosurgical Generator, SW 3.06-A (K103032, K111202)
- G400 Gyrus ACMI General Surgery Workstation, SW 2.06 (K081954)
- Force FX, Valleylab Electrosurgical Generator (K944602)
Risk analysis was carried out in accordance with established internal acceptance criteria based on ISO-14971:2007.
Reprocessing validation was carried out in accordance with "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance – April 1996."
The software validation activities were performed in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Minor Level of Concern."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal, there is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 12, 2014
Olympus Winter & Ibe GmbH % Mr. Graham Baillie Gyrus ACMI Incorporated Olympus Surgical Technologies America (OSTA) 136 Turnpike Road Southborough, Massachusetts 01722
Re: K141225 Trade/Device Name: ESG-400 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 18, 2014 Received: July 21, 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
1
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 forth in 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
for
Sincerely yours,
David Krause -S
- 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name ESG-400
Indications for Use (Describe)
The Olympus ESG-400 electrosurgical unit is intended for cutting and coagulation of tissue in open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.
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 FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
David Krause -SA 2014.08.12 12:42:38 -04'00'
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Electrosurgical Generator ESG-400 Olympus Winter & Ibe
510(k) Summary of Safety and Effectiveness
General information
| Applicant: | Olympus Winter & Ibe GmbH
Kuehnstrasse 61
22045 Hamburg
Germany |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration No.: | 9610773 |
| Manufacturer: | Olympus Winter & Ibe GmbH
Kuehnstrasse 61
22045 Hamburg
Germany |
| 510(k) Submitter: | Gyrus ACMI, Inc.
Olympus surgical Technologies America (OSTA)
136 Turnpike Road
Southborough, MA 01772
Phone (508) 804-2738
Fax (508) 804-2624
Establishment Registration No. 3003790304 |
| Official Correspondent: | Graham Baillie
Regulatory Affairs Manager
Phone: 508.804.2738
Fax: 508.804.2624
Email: Graham.baillie@olympus-osta.com |
| Contact person: | Mr. Holger Nadler
Phone: +49-66966-2860
Fax: +49-66966-2134
Email: holger.nadler@olympus-oste.eu |
| Date Prepared: | May 8th, 2014 |
| Trade Name: | ESG-400 |
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Device identification
| Proprietary name: | ESG-400 |
|---|---|
| Device Classification name: | Electrosurgical cutting and coagulation device |
| and accessories. | |
| Regulation Medical Specialty: | General & Plastic Surgery |
| Regulations Number: | 21 CFR 878.4400 |
| Regulatory class: | Class II |
| Product code: | GEI |
Predicate device
K103032: ESG-400
Description of device
The ESG-400 is a reusable, non-sterile electrosurgical generator that features different mono- and bipolar cutting and coagulation modes. The maximum output power is 320 W. It is intended for cutting and coagulation of tissue in open, laparoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.
The updated ESG-400 allows Olympus Plasma Kinetic (PK) instruments to be connected at the device.
Intended use
The Olympus electrosurgical unit is intended for cutting and coagulation of tissue in open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.
Comparison of Technological characteristics
The ESG-400 upgrade has the identical intended use. The existing functionalities stay unaffected/unchanged and are not influenced by the modifications.
The proposed ESG-400 extends the portfolio of instruments which can be driven by the generator. Olympus plasma kinetic (PK) instruments can be connected at the existing universal socket with integrated self-recognition. To support the additional PK hand instruments, the generator's database of connectable bipolar and monopolar instruments was expanded and new output modes were implemented. Additional modes were implemented specifically for the PK instruments.
- Bipolar Coag* H
- Bipolar Coag N
- Bipolar Coag O
- Bipolar Cut** D
- I Bipolar Cut F
- Bipolar Cut J
- Bipolar Cut K ■
- *: Coagulation mode, **: Cutting mode
The range of output waveforms and power levels are identical to the FDA cleared Gyrus G400 electrosurgical generator, K081954.
5
Flare out detection was integrated as an additional safety feature which is available only in PK cut modes. Flare out could result from electrical current peaks during activation. The HF is immediately disabled and automatically re-activated. A warning tone is given and an error is displayed to inform the user.
User Interface (UI) modifications specifically for the additional PK instruments were amended but did not change the basic design philosophy. The GUI flow chart concept was not changed.
A monopolar cut mode (Monopolar Cut E) was added/implemented to complete the range for High Frequency (HF) instruments.
Compliance to Voluntary Standards
| Standard No. | Standard Title |
|---|---|
| ES60601-1:2005/A1:2012 | Medical electrical equipment - Part 1: General requirements for |
| basic safety and essential performance | |
| IEC 60601-1-2 Edition | |
| 3:2007-03 | Medical electrical equipment - Part 1-2: General requirements for |
| basic safety and essential performance - Collateral standard: | |
| Electromagnetic compatibility - Requirements and tests | |
| IEC 60601-1-8:2012-11 | |
| Edition 2.1 | Medical electrical equipment - Part 1-8: General |
| requirements for basic safety and essential performance - | |
| Collateral Standard: General requirements, tests and | |
| guidance for alarm systems in medical electrical equipment | |
| and medical electrical systems | |
| IEC 60601-2-2 Edition 5.0 | |
| 2009-2 | 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. | |
| IEC 62304 First edition | |
| 2006-05 | Medical device software - Software life cycle processes |
| IEC 62366: 2007 First | |
| edition | Medical devices - Application of usability engineering to |
| medical devices | |
| ISO 14971 Second edition | |
| 2007-03-01 | Medical devices - Application of risk management to medical devices |
The design of the ESG-400 complies with the following standards:
Table A10-1: List of FDA recognized consensus standards
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Summary of Performance Testing
The following performance testing was conducted.
-
- Bench Testing
- . Bench Test Validation versus Gyrus G400 Demonstrating the capability to use PlasmaKinetic (PK) instruments in the same manner as they are currently supported by the legally distributed/FDA cleared predicate Gyrus G400 generator, K081954.
The same range of waveform output and power levels were used for performance and validation testing. During the validation, the waveform and test results were compared directly to the predicate device.
- . Validation with representative HF instruments.
- . Validation Comparison to Predicate Generators:
| Device code | Predicate device | 510(k) |
|---|---|---|
| I | ESG-400, Olympus Electrosurgical Generator, | |
| SW 3.06-A | K103032, K111202 | |
| II | G400 Gyrus ACMI General Surgery | |
| Workstation, SW 2.06 | K081954 | |
| III | Force FX, Valleylab Electrosurgical Generator | K944602 |
Table A10-2: Comparison to Predicate Devices
Risk analysis was carried out in accordance with established internal acceptance criteria based on ISO-14971:2007.
Reprocessing validation was carried out in accordance with "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance – April 1996."
The software validation activities were performed in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Minor Level of Concern."
Substantial Equivalence
Substantial equivalence is demonstrated by acknowledged verification methodologies. The subject devices have identical technology, performance, dimensions and materials. The difference between the predicate and new ESG-400 is to extend the portfolio of instruments which can be driven by the generator. Olympus plasma kinetic (PK) instruments can be connected at the existing universal socket with integrated self-recognition. The proposed modifications are supported by the performance tests summarized above.
Conclusion
In summary, the upgraded ESG-400 is substantially equivalent to its predicate device.