(58 days)
Not Found
No
The description focuses on standard electrosurgical generator functions, user interface, and electrical performance, with no mention of AI or ML capabilities. The "automatic instrument recognition" is likely a simple electrical or digital handshake, not an AI/ML feature.
Yes
The device is described as an "Electrosurgical generator intended for tissue cutting and coagulation," indicating its direct involvement in modifying or treating the body by cutting and coagulating tissue.
No
The device description and intended use clearly state that the Electrosurgical generator is "intended for tissue cutting and coagulation." There is no mention of it being used for diagnosis or detection of any disease or condition.
No
The device is described as a reusable, non-sterile electrosurgical generator with physical components like a touch screen GUI, push buttons, and sockets for accessories. It generates electrical waveforms for tissue cutting and coagulation, which is a hardware function. While it includes software for the GUI and control functions, it is fundamentally a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "tissue cutting and coagulation with electrosurgical accessories and ancillary equipment." This describes a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details an electrosurgical generator used for cutting and coagulating tissue during surgery. It focuses on electrical output, modes of operation, and user interface for controlling these functions. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples, etc.)
- Detecting or measuring specific analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly intended for therapeutic use during surgical procedures, not for diagnostic testing.
N/A
Intended Use / Indications for Use
Electrosurgical generator intended for tissue cutting and coagulation with electrosurgical accessories and ancillary equipment.
Product codes
GEI
Device Description
The Olympus ESG-200 Electrosurgical Generators: (CELON Elite WA90001A, WA90002A and CELON Precision WA90008A, WA90009A), including its two variants the Celon Elite and Celon Precision are reusable, non-sterile electrosurgical generators that feature different mono- and bipolar cutting and coagulation modes. The maximum output power is 120 W. Both variants of the ESG-200 are intended for cutting and coagulation of tissue in open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.
The front panels of the proposed ESG-200 features a touch screen GUI (graphical user interface) that displays the connection status of accessories and peripherals connected to the electrosurgical generator. Two contact quality indicators (one for split and one for non-split electrodes) are green illuminated if neutral electrodes are correctly connected and red if not. Three additional push buttons allow recalling a previously saved setting (Select Procedure), to assign a footswitch to a specific output socket (Footswitch), and to control several other functions (Menu), e.g. select language, touch tone control, output volume, or brightness. The touch screen is also used to show and modify the output settings (e.g. mode, output power, effect) as well as to control other functions (e.g. save settings). In addition, the proposed ESG-200 has a bipolar socket (with automatic instrument recognition of selected Olympus instruments), a monopolar socket (E- or B-Type depending on the model), and a neutral electrode socket.
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
Performance Testing - Bench: The evaluations compared the function of the ESG-200 against the performance characteristics defined by the Design Specification and in comparison to the performance characteristics of the predicate devices. To demonstrate substantial equivalence the following aspects were considered within the validation versus the predicate devices: 1. Performance and validation tests incorporated the same range of waveform outputs and power levels. 2. During the validation testing the waveforms and test results were compared directly between the subject and predicate devices. An oscilloscope and high voltage probe were used as measuring and test equipment. The electrical waveforms of the ESG-200 were in all cases comparable to the electrical waveforms of the predicate. This was confirmed for all output modes (waveforms) at rated load. Porcine muscle, kidney and liver tissue were used to demonstrated tissue effect equivalence between subject and predicate devices. Testing confirmed that comparable tissue effects and electrical waveforms could be achieved for all modes of operation. Clinical and animal studies were not deemed necessary to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 4, 2016
Olympus Winter & Ibe GmbH % Mr. Graham Baillie Manager, Regulatory Affairs Gyrus ACMI. Inc. 136 Turnpike Rd. Southborough, Massachusetts 01772
Re: K160639
Trade/Device Name: Olympus ESG-200 Electrosurgical Generator: (CELON Elite WA90001A, WA90002A and CELON Precision WA90008A, WA90009A) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 2, 2016 Received: March 7, 2016
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
1
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/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 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.
Jennifer R. Stevenson -A
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) K160639
Device Name
Olympus ESG-200 Electrosurgical Generator: (CELON Elite WA90002A and CELON Precision WA90008A, WA 90009A)
Indications for Use (Describe)
Electrosurgical generator intended for tissue cutting and coagulation with electrosurgical accessories and ancillary equipment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary May 4, 2016 K160639
General Information
| Manufacturer: | Olympus Winter & Ibe GmbH
Kuehnstr. 61
22045 Hamburg, Germany
Establishment Registration Number: 9610773 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Graham A.L. Baillie, MS
Manager, Regulatory Affairs
Gyrus ACMI, Inc.
136 Turnpike Rd.
Southborough, MA 01772-2104
Phone: 508.804.2738
Fax: 508. 804.2624
Email: Graham.baillie@olympus-osta.com
Establishment Registration Number: 300379030- |
Device Identification
| Proprietary name: | Olympus ESG-200 Electrosurgical Generators:
(CELON Elite WA90001A, WA90002A and
CELON Precision WA90008A, WA90009A) | |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------|--|
| 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
Both variants (CELON PRECISION / CELON ELITE) of the proposed ESG-200 are considered substantially equivalent to the following legally marketed device:
Olympus ESG-400 (Primary Predicate, K141225) .
Both ESG-200 variants also have two secondary predicates for specific features as identified below:
| Subject device variant | Secondary predicate | 510(k) No |
|---|---|---|
| CELON PRECISION | ||
| ESG-200 | VNUS Radiofrequency | |
| Generator, Model RFG2 | K040638 | |
| CELON ELITE ESG-200 | Celon Lab ENT | K032838 |
Table 2.1: secondary predicate devices for a few specific features
4
Device Description
The Olympus ESG-200 Electrosurgical Generators: (CELON Elite WA90001A, WA90002A and CELON Precision WA90008A, WA90009A), including its two variants the Celon Elite and Celon Precision are reusable, non-sterile electrosurgical generators that feature different mono- and bipolar cutting and coagulation modes. The maximum output power is 120 W. Both variants of the ESG-200 are intended for cutting and coagulation of tissue in open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.
The front panels of the proposed ESG-200 features a touch screen GUI (graphical user interface) that displays the connection status of accessories and peripherals connected to the electrosurgical generator. Two contact quality indicators (one for split and one for non-split electrodes) are green illuminated if neutral electrodes are correctly connected and red if not. Three additional push buttons allow recalling a previously saved setting (Select Procedure), to assign a footswitch to a specific output socket (Footswitch), and to control several other functions (Menu), e.g. select language, touch tone control, output volume, or brightness. The touch screen is also used to show and modify the output settings (e.g. mode, output power, effect) as well as to control other functions (e.g. save settings). In addition, the proposed ESG-200 has a bipolar socket (with automatic instrument recognition of selected Olympus instruments), a monopolar socket (E- or B-Type depending on the model), and a neutral electrode socket.Indications for Use
Intended Use
Olympus ESG-200 Electrosurgical Generators intended for tissue cutting and coagulation in conjunction with electrosurgical accessories and ancillary equipment.
Technological Characteristics
The ESG-200 generator has the same intended use and technological characteristics as the primary predicate ESG-400 device. Various instruments can be connected to the monopolar and bipolar sockets. In addition, dedicated Olympus instruments can be connected to the bipolar socket with integrated self-recognition.
The PK modes of the primary predicate device (K141225) are not integrated in the ESG-200. The basic design philosophy of the User Interface (UI) and GUI flow chart concept is identical, except for the special ESG-400 amendment in regards to the PK instruments.
In comparison to the primary predicate device the following output modes are available:
| Subject ESG-200 Model
"CELON PRECISION" | Subject ESG-200 Model
"CELON ELITE" | Predicate ESG-400 |
|--------------------------------------------|----------------------------------------|--------------------------|
| FineCut | FineCut | FineCut (Effect 1) |
| PureCut | PureCut | PureCut (Effect 2) |
| StrongCut | StrongCut | PureCut (Effect 3) |
| N/A | PulseCut | PulseCut slow (Effect 2) |
Output modes in comparison to the primary predicate device ESG-400
5
| N/A | N/A | Blend Cut |
|---|---|---|
| N/A | N/A | PulseCut fast |
Monopolar Cut Modes
| Subject ESG-200Model
"CELON PRECISION" | Subject ESG-200Model
"CELON ELITE" | Predicate ESG-400 |
|-------------------------------------------|---------------------------------------|-----------------------|
| SoftCoag | SoftCoag | SoftCoag (Effect 3) |
| ForcedCoag | ForcedCoag | ForcedCoag (Effect 3) |
| N/A | N/A | PowerCoag |
| N/A | N/A | SprayCoag |
Monopolar Coagulation Modes
| Subject ESG-200 Model
"CELON PRECISION" | Subject ESG-200 Model
"CELON ELITE" | Predicate ESG-400 |
|--------------------------------------------|----------------------------------------|-----------------------|
| FineCut | FineCut | BipolarCut (Effect 1) |
| PureCut | PureCut | BipolarCut (Effect 2) |
| StrongCut | StrongCut | BipolarCut (Effect 3) |
| N/A | N/A | SalineCut |
| N/A | N/A | PK PureCut |
| N/A | N/A | PK SoftCut |
| N/A | N/A | PK LoopCut |
| N/A | N/A | PK MorceCut |
Bipolar Cut Modes
| Subject ESG-200 Model
"CELON PRECISION" | Subject ESG-200
Model "CELON ELITE" | Predicate ESG-400 |
|--------------------------------------------|----------------------------------------|-----------------------|
| SoftCoag | SoftCoag | BiSoftCoag (Effect 3) |
| N/A | Strong RFITT | RFCoag (w/o RCAP) |
| N/A | Strong RFITT + RCAP | RFCoag (w/ RCAP) |
| N/A | N/A | AutoCoag |
| N/A | N/A | SalineCoag |
| N/A | N/A | HardCoag |
| N/A | N/A | FineCoag |
| N/A | N/A | PK Coag |
| N/A | N/A | PK Softcoag |
| N/A | N/A | PK AutoCoag |
Bipolar Coagulation Modes
The range of output waveforms is identical but the power levels are decreased in comparison to the FDA cleared ESG-400 electrosurgical generator, K141225.
RFITT output modes in comparison to the secondary predicate devices
Additional bipolar coagulation modes were implemented exclusively for the RFITT (radiofrequency induced thermotherapy) functionality in conjunction with dedicated Olympus bipolar applicators.
| Subject ESG-200 Model
"CELON PRECISION" | Secondary predicate VNUS Radiofrequency Generator,
Model RFG2 (K040638) |
|--------------------------------------------|----------------------------------------------------------------------------|
| RFITT | only RF power available |
| Pulse RFITT | (no further modes) |
| Power RFITT | |
CELON PRECISION RFITT - Bipolar Coagulation Modes
6
| Subject ESG-200 Model
| "CELON ELITE" | Secondary predicate Celon Lab ENT (K032838) |
|---|---|
| Fine RFITT | RFITT mode |
| Pure RFITT | (no further modes) |
| CELON ELITE RFITT - Bipolar Coagulation Modes |
CELON ELITE RFITT - Bipolar Coagulation Modes
Substantial Equivalence
Substantial equivalence is demonstrated by acknowledged verification/validation methodologies. The subject devices have equivalent technology, performance, dimensions and materials. The differences to the primary predicate ESG-400 are:
- only one monopolar socket, no universal socket, no docking station interface . on the bottom
- to be used only in conjunction with a double pedal footswitch ●
- new enclosure
- no PK instruments incorporation ●
- RFITT Radiofrequency induced thermotherapy in conjunction with . dedicated Olympus instruments
Regarding the additionally implemented bipolar coagulation modes, exclusively for RFITT (radiofrequency induced thermotherapy) functionality, two secondary predicate devices were chosen because of their specific output modes. Substantial equivalence has been demonstrated by acknowledged verification/validation methodologies. The subject devices have equivalent technology and performance in respect to the compared modes.
Performance Data
The following performance data were provided in support of the substantial equivalence determination. All standards applied were FDA recognized international standards. The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005). The device software is considered a "Moderate Level of Concern".
Performance Testing - Bench
In general, the evaluations compared the function of the ESG-200 against the performance characteristics defined by the Design Specification and in comparison to the performance characteristics of the predicate devices. To demonstrate substantial equivalence the following aspects were considered within the validation versus the predicate devices. The results demonstrate that comparable tissue effects and electrical waveforms are achieved with subject and predicate devices for all modes of operation.
-
- Performance and validation tests incorporated the same range of waveform outputs and power levels.
-
- During the validation testing the waveforms and test results were compared directly between the subject and predicate devices.
7
The purpose of the bench validation testing was to show equivalence of the electrical waveform between the subject and predicate devices. Appendices in section 12 detail the validation testing. An oscilloscope and high voltage probe were used as measuring and test equipment. The electrical waveforms of the ESG-200 were in all cases comparable to the electrical waveforms of the predicate. This was confirmed for all output modes (waveforms) at rated load.
Porcine muscle, kidney and liver tissue were used to demonstrated tissue effect equivalence between subject and predicate devices (Appendix 12b). Waveform Validation reports for ESG-200 at all outputs and at rated load are provided in Appendix 12c
Comprehensive validation bench tests demonstrated and confirmed substantial equivalence to the predicate devices. Testing confirmed that comparable tissue effects and electrical waveforms could be achieved for all modes of operation. Clinical and animal studies were not deemed necessary to support substantial equivalence.
| Standard No. | Standard Title | FDA-Recognition
no + date |
|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| AAMI/ANSI ES
60601-1:2005/(R)2012
and C1:2009/(R)2012
and, A2:2010/(R)2012 | Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
(IEC 60601-1:2005, MOD) | 19-5
07/09/2014 |
| IEC 60601-1-2
Ed. 3.0 b:2007 | Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance -
Collateral Standard: Electromagnetic disturbances -
Requirements and tests | 19-1
10/17/2014 |
| IEC 60601-1-8 Ed. 2.1:
2012 | 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 | 5-76
08/05/2013 |
| IEC 60601-2-2 Ed. 5.0:
2009 | Medical electrical equipment - Part 2-2: Particular
requirements for the basic safety and essential
performance of high frequency surgical equipment and
high frequency surgical accessories [Including:
Technical Corrigendum 1 (2014)] | 6-336
01/27/2015 |
| IEC 62304 Ed. 1.0 b:
2006 | Medical device software - Software life cycle processes | 13-8
08/20/2012 |
| IEC 60601-1-6 Ed. 3.0:
2010 | Medical electrical equipment Part 1-6: General
requirements for basic safety and essential performance -
Collateral standard: Usability | 5-85
07/09/2014 |
| ISO 14971Second
edition 2007 | Medical devices - Application of risk management to
medical devices | 5-40
08/20/2012 |
Applied standards
8
Conclusion
The performance data support the safety of the device and demonstrate that the subject devices comply with the recognized standards as specified.
In summary, we believe the ESG-200 is substantially equivalent with the predicate devices with respect to the general design approach, function, and the intended use. The ESG-200 raises no new concerns of safety or effectiveness when compared to the predicate devices.