(92 days)
ESG-300: The electrosurgical generator ESG-300, in conjunction with electrosurgical accessories and ancillary equipment, is intended for cutting and coagulation of tissue in open surgery, laparoscopic surgery and endoscopic surgery. For monopolar argon plasma coagulation (MAPC) of tissue, the electrosurgical generator is intended to be used with a compatible Olympus argon plasma coagulation unit to deliver ionized argon gas.
Accessories:
APU-300: The argon plasma coagulation unit and its accessories, in conjunction with a compatible Olympus electrosurgical generator and monopolar argon plasma coagulation (MAPC) probes, are intended argon gas for monopolar argon plasma coagulation of tissue.
Pressure Reducer (accessory of APU-300): The pressure reducers are accessories and must only be used in conjunction with the compatible argon plasma coagulation unit APU-300. Observe the instructions for use of the compatible argon plasma coagulation unit APU-300 regarding: intended use/ contraindications/ environment of use/ compatible equipment
MAPC probes: The single use and flexible monopolar argon plasma coagulation with a compatible Olympus argon plasma coagulation unit and a compatible Olympus electrosurgical generator, are intended to deliver ionized argon gas for monopolar argon plasma coagulation of tissue.
The subject device ESG-300 is a reusable, non-sterile electrosurgical generator that features different monopolar and bipolar cutting and coagulation modes. In combination with the compatible argon plasma coagulation unit APU-300, it features monopolar argon plasma coagulation modes. The maximum output power is 120 W.
The front panel of the proposed ESG-300 features a touch screen GUI (graphical user interface) that displays the current settings of the chosen output mode, the connection status of accessories and peripherals connected to the electrosurgical generator. Soft keys are integrated into the GUI to switch between the output sockets, to enter the Menu in order to edit settings/ procedures (e.g. create/ edit userdefined settings/ procedures), to edit preferences (e.g. select language, touch tone control, output volume, or brightness) and to show service options (e.g. software version identifier, for service and maintenance purposes) or to assess user-defined settings and procedures.
The electrosurgical generator can be used in conjunction with the compatible Olympus argon plasma coagulation unit and its accessories as well as the monopolar argon plasma coagulation (MAPC) probes. The single use MAPC probes only will be provided in sterile condition.
The front panel of the argon plasma coagulation unit APU-300 features the Argon socket (to connect a compatible MAPC probe), a purge button (to purge the system with argon gas) and the power switch.
The single use MAPC probes are offered in three different beam types, length and outer diameter each. The plug is proprietary to the APU-300.
The provided text describes the submission for a 510(k) premarket notification for electrosurgical devices (ESG-300 with accessories: APU-300, Pressure Reducer, MAPC Probes).
The document is a Summary of a 510(k) submission, not a detailed study report. Therefore, it primarily focuses on demonstrating substantial equivalence to predicate devices through various tests and compliance with recognized standards, rather than proving the device meets specific acceptance criteria for a novel AI/ML medical device.
Based on the provided text, the device is an electrosurgical generator, not an AI/ML device. The "acceptance criteria" discussed in the document are primarily related to safety, performance (including tissue effects and electrical waveforms), and compliance with FDA recognized standards, rather than AI-specific metrics like AUC, sensitivity, or specificity.
Therefore, many of the requested points regarding AI/ML device validation (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are not applicable or not explicitly stated in the context of an electrical medical device submission like this one.
However, I can extract information relevant to the device's validation and "acceptance criteria" as described in this submission:
Acceptance Criteria and Device Performance (as inferred from the document):
The submission's core "acceptance criteria" revolve around demonstrating substantial equivalence to predicate devices in terms of:
- Safety: Compliance with electrical safety, EMC, thermal safety, and biocompatibility standards.
- Performance: Comparable tissue effects and electrical waveforms to the predicate devices across various modes and tissue types.
- Functionality: The device performs its intended cutting and coagulation functions.
- Usability: Acceptable residual risk and user interface design.
Since this is a submission to demonstrate substantial equivalence of a non-AI electrosurgical device, the acceptance criteria are largely qualitative and based on comparative bench testing and compliance with recognized standards, rather than quantitative metrics typically seen for AI/ML performance.
Table of Acceptance Criteria and Reported Device Performance (Inferred from the document):
| Acceptance Criteria Category (Inferred) | Specific Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Electrical Safety & EMC | Compliance with recognized standards (IEC 60601-1, IEC 60601-1-2, AAMI ANSI IEC 60601-2-2) and FDA guidance for EMC. | "The design of the ESG-300 with accessories complies with recognized standards as listed in section 2.10." and "The FDA guidance 'Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices', CDRH July 11, 2016 has been followed." |
| Thermal Safety | Compliance with recognized standards. | "The design of the ESG-300 with accessories complies with recognized standards as listed in section 2.10." |
| Biocompatibility | Compliance with ISO 10993-1 for patient-contacting components (MAPC probes). | "Biocompatibility testing of the MAPC probes accessories has been successfully conducted according to ISO 10993-1... Testing included the following tests: Cytotoxicity, Irritation, Sensitization." (ESG-300, APU-300, and Pressure Reducer do not require biocompatibility testing as they don't have direct/indirect patient contact). |
| Functional Performance (Tissue Effects) | Comparable tissue effects (size of thermal coagulation zone - length, width, depth) to predicate devices across different modes and tissue types. Quantitative & qualitative assessment. | "Testing confirmed that comparable tissue effects could be achieved for applicable modes of operation with the three tissue types." "For all modes the tests demonstrated comparable tissue effects and electrically comparable waveforms." "The thermal damage of the tissue due to the HF current was measured in terms of size (length, width and depth) of the thermal coagulation zone." |
| Functional Performance (Electrical Waveforms) | Electrically comparable waveforms to predicate devices. | "For all modes the tests demonstrated comparable tissue effects and electrically comparable waveforms." "the waveforms of the generators were compared. For all modes the tests demonstrated comparable tissue effects and electrically comparable waveforms." "The range of output waveforms is identical but the power levels are decreased in comparison to the FDA cleared ESG-400..." (for primary predicate) / "The range of output waveforms is identical in comparison to the FDA cleared ERBE ESU Model VIO 300 D..." (for secondary predicate). |
| Software Validation | Compliance with FDA Guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". | "The software validation activities were performed in accordance with the FDA Guidance..." "The device software is considered a 'Major Level of Concern'." |
| Usability | Acceptable residual risk based on risk management plan and ISO 14971. | "Usability and user interface was also assessed according to the risk management plan... The assessment was based on Olympus predecessor product. Use-related hazardous situations were assessed and risk mitigation measures in terms of usability design for safety were defined. The residual risk was evaluated as acceptable." |
| Sterilization & Shelf Life (MAPC probes) | Sterile assurance level (SAL) of 10-6, EtO residuals within limits, and stability for stated shelf-life. | "A sterility assurance level (SAL) of 10-6 was reached during validation and will be used for routine sterilization..." "The EtO residuals are within the limits after tunnel degassing time." "Shelf Life testing was conducted... to support a shelf life of 1 year for the MAPC probes." |
Study Information (Based on the document):
-
Sample Size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients" as would be seen for clinical or AI studies. The "test set" consisted of:
- Tissue types: "three clinically relevant tissue types: porcine muscle for endoscopic procedures, porcine liver for open procedures and porcine kidney for laparoscopic procedures." The number of individual tissue samples or repetitions per setting is not specified.
- Modes/Settings: Minimum, default, and maximum intensity settings for all applicable modes were tested.
- Instruments: A "representative selection of HF instruments" was used.
- Data Provenance: The preclinical (simulated use) evaluation was performed using porcine tissue. The location where these studies were conducted (e.g., country) is not specified. It is a preclinical bench study, not a clinical one, so it is neither retrospective nor prospective in the human patient sense.
- Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients" as would be seen for clinical or AI studies. The "test set" consisted of:
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not stated. For this type of electrosurgical device, "ground truth" typically refers to objective measurements of tissue effects (e.g., coagulation zone size) and electrical waveforms, not expert consensus on image interpretation or diagnosis. The measurements were quantitative and qualitative assessments of physical effects. Thus, human "experts" establishing a diagnostic ground truth are not relevant for this type of submission.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As above, this is not a diagnostic study involving human interpretation that would require an adjudication process. Measurements of tissue effects and electrical waveforms are objective bench tests.
-
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. This is not an AI-assisted diagnostic device, and no MRMC study was performed. Clinical studies were explicitly stated as "not conducted for this submission."
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm. The device itself performs the function. The bench testing performed could be considered "standalone" in the sense that the device's physical output and effect were measured objectively, independent of a human operator's diagnostic interpretation.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For functional performance (tissue effects and electrical waveforms): The "ground truth" was established by objective measurements of characteristics such as:
- Size (length, width, depth) of the thermal coagulation zone in porcine tissue.
- Electrical waveforms (compared directly to predicate devices).
- For safety: Compliance with a multitude of recognized international standards and specific FDA guidances.
- For functional performance (tissue effects and electrical waveforms): The "ground truth" was established by objective measurements of characteristics such as:
-
The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
-
How the ground truth for the training set was established:
- Not applicable. No training set was used.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 26, 2018
Olympus Winter & Ibe GmbH % Mr. Dolan Mills Senior Specialist, Regulatory Affairs Gyrus ACMI, Inc. 136 Turnpike Road Southborough, Massachusetts 01772
Re: K180200
Trade/Device Name: ESG-300, APU-300, Pressure Reducer, MAPC Probes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: March 21, 2018 Received: March 22, 2018
Dear Mr. Mills:
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, 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 (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Jennifer R. Stevenson -S3 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K180200
Device Name
Electrosurgical Generator ESG-300 with Accessories
Indications for Use (Describe)
ESG-300: The electrosurgical generator ESG-300, in conjunction with electrosurgical accessories and ancillary equipment, is intended for cutting and coagulation of tissue in open surgery, laparoscopic surgery and endoscopic surgery. For monopolar argon plasma coagulation (MAPC) of tissue, the electrosurgical generator is intended to be used with a compatible Olympus argon plasma coagulation unit to deliver ionized argon gas.
Accessories:
APU-300: The argon plasma coagulation unit and its accessories, in conjunction with a compatible Olympus electrosurgical generator and monopolar argon plasma coagulation (MAPC) probes, are intended argon gas for monopolar argon plasma coagulation of tissue.
Pressure Reducer (accessory of APU-300): The pressure reducers are accessories and must only be used in conjunction with the compatible argon plasma coagulation unit APU-300. Observe the instructions for use of the compatible argon plasma coagulation unit APU-300 regarding: intended use/ contraindications/ environment of use/ compatible equipment
MAPC probes: The single use and flexible monopolar argon plasma coagulation with a compatible Olympus argon plasma coagulation unit and a compatible Olympus electrosurgical generator, are intended to deliver ionized argon gas for monopolar argon plasma coagulation of tissue.
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)
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510(k) Summary
General Information 2.1
| Manufacturer: | Olympus Winter & Ibe GmbH |
|---|---|
| Kuehnstr. 61 | |
| 22045 Hamburg | |
| Germany | |
| Establishment Registration Number: 9610773 | |
| Official Correspondent: | Dolan Mills |
| Regulatory Affairs | |
| Olympus Surgical Tech. America | |
| Gyrus ACMI, Inc. | |
| 136 Turnpike Road | |
| Southborough, MA 01772 | |
| Email: dolan.mills@olympus-osta.com | |
| Phone: (901) 373-0236 | |
| Establishment Registration No. 3003790304 |
Date Prepared: April 17, 2018
2.2 Device Identification
| Proprietary name: | |
|---|---|
| HF Generator: | Electrosurgical Generator ESG-300 |
| Argon Plasma Unit: | APU-300 |
| Argon Plasma Probes: | MAPC probes |
| Device Classification name: | Electrosurgical cutting and coagulation and accessories |
| Regulation Medical Specialty: | General & Plastic Surgery |
| Regulations Number: | 21 CFR 878.4400 |
| Regulatory class: | Class II |
| Product code: | GEI |
2.3 Predicate Device
The proposed electrosurgical generator ESG-300 and accessories is considered substantially equivalent to the following legally marketed devices:
| Primary Predicate Device Manufacturer | 510(k) No | |
|---|---|---|
| ESG-400 | Olympus Winter & Ibe GmbH | K141225 |
| THE TICAL TIC COLLECT COLLECT COLLECT CONSULT CONSULT CONSULT CONSULT CONSULT CONSULT CONSULT CONSULT CONSULT CONSULT CONSULT CONSULT CONSULT CONSULT CONSULT CONSULT CONSULT |
Table 2.1: Identification of primary predicate device
The following secondary predicates for monopolar argon plasma coagulation (MAPC) modes only have been chosen for substantial equivalence discussion in terms of safety and effectiveness.
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| Assigned components ofthe subject device | Reference Predicate Device | Manufacturer | 510(k) No |
|---|---|---|---|
| ESG-300(monopolar argon plasmacoagulation modes only) | ERBE ESU Model VIO 300D with Accessories | Erbe USA, Inc. | K083452 |
| APU-300 with accessories | ERBE VIO APC (Model 2)with Accessories | Erbe USA, Inc. | K024047 |
| MAPC probes | ERBE APC Integrated FilterProbes and Adapter | Erbe USA, Inc. | K060183 |
Table 2.2: Identification of secondary predicate device
2.4 Product Description
2.4.1 Electrosurgical generator
The subject device ESG-300 is a reusable, non-sterile electrosurgical generator that features different monopolar and bipolar cutting and coagulation modes. In combination with the compatible argon plasma coagulation unit APU-300, it features monopolar argon plasma coagulation modes. The maximum output power is 120 W.
The front panel of the proposed ESG-300 features a touch screen GUI (graphical user interface) that displays the current settings of the chosen output mode, the connection status of accessories and peripherals connected to the electrosurgical generator. Soft keys are integrated into the GUI to switch between the output sockets, to enter the Menu in order to edit settings/ procedures (e.g. create/ edit userdefined settings/ procedures), to edit preferences (e.g. select language, touch tone control, output volume, or brightness) and to show service options (e.g. software version identifier, for service and maintenance purposes) or to assess user-defined settings and procedures.
The subject device ESG-300 with accessories is a class II medical device under the regulation number 878.4400 and the product code GEI - "Electrosurgical cutting and coagulation device and accessories". Regulation Medical Specialty: General & Plastic Surgery.
It is compliant with FDA recognized consensus safety standards as listed in section III, Appendix III - Standard Conformity and Test Reports.
2.4.2 Accessories
The electrosurgical generator can be used in conjunction with the compatible Olympus argon plasma coagulation unit and its accessories as well as the monopolar argon plasma coagulation (MAPC) probes. The single use MAPC probes only will be provided in sterile condition.
The front panel of the argon plasma coagulation unit APU-300 features the Argon socket (to connect a compatible MAPC probe), a purge button (to purge the system with argon gas) and the power switch.
The single use MAPC probes are offered in three different beam types, length and outer diameter each. The plug is proprietary to the APU-300.
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2.5 Indications for Use
Electrosurgical generator 2.5.1
The ESG-300, in conjunction with electrosurgical accessories and ancillary equipment, is intended for cutting and coagulation of tissue in open surgery, laparoscopic surgery and endoscopic surgery. For monopolar argon plasma coagulation (MAPC) of tissue, the electrosurgical generator is intended to be used with a compatible Olympus argon plasma coagulation unit to deliver ionized argon gas.
2.5.2 Accessories:
Argon Plasma Coagulation Unit (APU-300):
The argon plasma coagulation unit and its accessories, in conjunction with a compatible Olympus electrosurgical generator and monopolar argon plasma coagulation (MAPC) probes, are intended to deliver ionized argon gas for monopolar argon plasma coagulation of tissue.
Pressure Reducer (accessory of APU-300):
The pressure reducers are accessories and must only be used in conjunction with the compatible argon plasma coagulation unit APU-300.
Observe the instructions for use of the compatible argon plasma coagulation unit APU-300 regarding: intended use/ contraindications/ user qualifications/ environment of use/ compatible equipment
MAPC probes:
The single use and flexible monopolar argon plasma coagulation probes, in conjunction with a compatible Olympus argon plasma coagulation unit and a compatible Olympus electrosurgical generator, are intended to deliver ionized argon gas for monopolar argon plasma coagulation of tissue.
2.6 Technological Characteristics
The ESG-300 has the same intended use and technological characteristics as the primary predicate device ESG-400.
Various instruments can be connected to the monopolar and bipolar sockets. Because the PK modes of the primary predicate device (K141225) are not integrated in the ESG-300, the flare out detection is not applicable. 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.
2.6.1 Output modes in comparison to the primary predicate device ESG-400
In comparison to the primary predicate device the following output modes are available:
| Subject Device:ESG-300 | Primary Predicate Device:ESG-400 (K141225) |
|---|---|
| PureCut | PureCut |
| Blend Cut | Blend Cut |
| PulseCut slow | PulseCut slow |
| PulseCut fast | PulseCut fast |
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| N/A | FineCut |
|---|---|
| N/A | PureCut |
| Tohlo 22. Mananolon Cut Madea |
Table 2.3: Monopolar Cut Modes
| Subject Device: | Primary Predicate Device: |
|---|---|
| ESG-300 | ESG-400 (K141225) |
| SoftCoag | SoftCoag |
| PowerCoag | PowerCoag |
| ForcedCoag | ForcedCoag |
| SprayCoag | SprayCoag |
Table 2.4: Monopolar Coagulation Modes
| Subject Device: | Primary Predicate Device: |
|---|---|
| ESG-300 | ESG-400 (K141225) |
| BipolarCut | BipolarCut |
| N/A | SalineCut |
| N/A | PK PureCut |
| N/A | PK SoftCut |
| N/A | PK LoopCut |
| N/A | PK MorceCut |
Table 2.5: Bipolar Cut Modes
| Subject Device: | Primary Predicate Device: |
|---|---|
| ESG-300 | ESG-400 (K141225) |
| RFCoag | RFCoag |
| AutoCoag | AutoCoag |
| BiSoftCoag | BiSoftCoag |
| N/A | SalineCoag |
| N/A | HardCoag |
| N/A | FineCoag |
| N/A | PK Coag |
| N/A | PK SoftCoag |
| N/A | PK AutoCoag |
Table 2.6: 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.
2.6.2 Monopolar argon plasma coagulation output modes in comparison to the secondary predicate devices
Additional Monopolar argon plasma coagulation modes were implemented exclusively for the argon plasma coagulation in conjunction with dedicated Olympus accessories.
| Subject Device:ESG-300 | Secondary predicate device:ERBE ESU Model VIO 300D (K083452) |
|---|---|
| ForcedArgon | Forced APC |
| PulsedArgon Slow | Pulsed APC (Effect 1) |
| PulsedArgon Fast | Pulsed APC (Effect 2) |
| SmartArgon | Precise APC |
Table 2.7: Monopolar Argon Plasma Coagulation Modes
The range of output waveforms is identical in comparison to the FDA cleared ERBE ESU Model VIO 300 D, K083452.
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2.7 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 device ESG-400 are:
- only one monopolar socket, no universal socket, vertical alignment of the ● output sockets
- to be used only in conjunction with a double pedal footswitch
- . no PK instruments incorporation
- Monopolar argon plasma coagulation in conjunction with dedicated Olympus accessories
- does not enable the user to select the effect of the output modes
- . GUI modifications (additional strings, languages, sounds, screens, windows)
Regarding the additionally implemented monopolar argon plasma coagulation modes, a secondary predicate device and its required accessories have been chosen, because of their specific output modes. For both the substantial equivalence is demonstrated by acknowledged verification/validation methodologies. The subject device has equivalent technology and performance in respect to the compared modes.
2.8 Performance Data
The following performance data were provided in support of the substantial equivalence determination. All standards applied are FDA recognized international standards.
The data was prepared in accordance with the FDA guidance, Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff, issued on August 15, 2016. The guidance was followed for all relevant sections.
Biocompatibility testing 2.8.1
The ESG-300 and its accessories APU-300 and pressure reducer do not contain components that come directly or indirectly in patient contact. Biocompatibility testing according to ISO 10993 for these components is not required.
Biocompatibility testing of the MAPC probes accessories has been successfully conducted according to ISO 10993-1 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing. Additionally, the FDA guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" was followed.
Testing included the following tests:
- Cytotoxicity -
- -Irritation
- Sensitization -
contacting device is considered external The patient communicating, tissue/bone/dentin, for a duration of less than 24 hours.
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2.8.2 Electrical safety and electromagnetic compatibility (EMC)
The design of the ESG-300 with accessories complies with recognized standards as listed in section 2.10.
The FDA guidance "Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices", CDRH July 11, 2016 has been followed.
Thermal Safety 2.8.3
The design of the ESG-300 with accessories complies with recognized standards as listed in section 2.10.
2.8.4 Animal Studies
Not applicable.
Clinical Studies 2.8.5
Clinical studies were not conducted for this submission.
Software 2.8.6
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 "Major Level of Concern".
Performance Testing Bench 2.8.7
To demonstrate substantial equivalence Olympus considered the following subject device aspects in regards to the predicate devices within the design validation:
-
- Performance and validation tests incorporated the same range of waveform outputs and power levels.
- During the validation testing the waveforms and tissue effects were 2. compared directly between the subject and predicate device.
Bench testing supports the claim of substantial equivalence to the predicate devices. The validation plan specifies modes, instruments and test protocols/plans for tissue effects and electrical waveforms. Beside tissue effects, the waveforms of the generators were compared. For all modes the tests demonstrated comparable tissue effects and electrically comparable waveforms.
The following non-clinical and preclinical tests were conducted:
- non-clinical (electrical, dimensional, functional, biocompatibility, stability) 2) preclinical (simulated use) evaluation and testing of tissue effects and thermal safety
Non-clinical: Basic safety and performance testing was performed in accordance with IEC standards. In addition, verification and comparison bench studies were conducted to evaluate the functional performance.
Stability: Sterile samples were subjected to accelerated aging to confirm that the disposable devices maintain functionality and continue to meet specifications over time. The results of the accelerated age testing demonstrate that the device will be
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stable for the stated shelf-life. In addition, real time age testing will confirm the results of the accelerated age testing. Samples were also subjected to environmental conditioning and ship testing.
Preclinical: Evidence obtained from preclinical simulated use studies demonstrate that the device performs substantially equivalent to the predicate device in relevant aspects associated with usability, tissue effects, and thermal effects. For simulated use testing, three clinically relevant tissue types were evaluated in all applicable modes: porcine muscle for endoscopic procedures, porcine liver for open procedures and porcine kidney for laparoscopic procedures. In accordance with FDA Guidance, Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery, the thermal damage of the tissue due to the HF current was measured in terms of size (length, width and depth) of the thermal coagulation zone. The tissue effects testing included quantitative and qualitative assessment. Furthermore, each test included the minimum, default and maximum intensity settings. All modes were compared to the predicate. Where the minimum or maximum intensity settings of the test and predicate device differed in terms of output wattage by specification the closest applicable settings were chosen.
In order to exclude variations due to the instrument, the tissue effect was probed with the subject and predicate generators and the same instruments. A representative selection of HF instruments was made that cover the broad spectrum of applications.
These comprehensive validation bench tests support equivalence to the predicate device. Testing confirmed that comparable tissue effects could be achieved for applicable modes of operation with the three tissue types. Therefore, comparison testing does support that the subject device is substantially equivalent to and is as safe and effective as the legally marketed predicate device.
Usability and user interface was also assessed according to the risk management plan. The assessment was based on Olympus predecessor product. Use-related hazardous situations were assessed and risk mitigation measures in terms of usability design for safety were defined. The residual risk was evaluated as acceptable.
Risk analysis was carried out in accordance with established internal acceptance criteria based on ISO 14971:2007.
2.9 Reprocessing, Sterilization and Shelf Life
Required cleaning, disinfecting and drying procedures are described in the instructions for use. Reprocessing of the single use MAPC probes is not applicable. Sterilization of the MAPC probes is performed according to ISO 11135 and packaging conforms to ISO 11607-1. The EtO sterilization cycle has been validated.
A sterility assurance level (SAL) of 10-6 was reached during validation and will be used for routine sterilization in compliance with regulations in force for sterile medical devices.
{10}------------------------------------------------
The EtO residuals are within the limits after tunnel degassing time. Shelf Life testing was conducted, including performance testing and package integrity testing, to support a shelf life of 1 year for the MAPC probes.
| Standard No. | Standard Title | FDA-Recognition no + date |
|---|---|---|
| AAMI/ANSI ES60601-1:2005/(R)2012and A1:2012 | Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance (IEC 60601-1:2005, MOD) | 19-407/09/2014 |
| IEC60601-1-2Ed. 4.0 b:2014 | Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral Standard:Electromagnetic disturbances - Requirements andtests | 19-806/27/2016 |
| IEC60601-1-8Ed. 2.1:2012 | Medical electrical equipment - Part 1-8: Generalrequirements for basic safety and essentialperformance - Collateral Standard: Generalrequirements, tests and guidance for alarmsystems in medical electrical equipment andmedical electrical systems | 5-7608/05/2013 |
| AAMI ANSI IEC60601-2-2Ed. 5.0:2009 | Medical electrical equipment - Part 2-2: Particularrequirements for the basic safety and essentialperformance of high frequency surgery equipmentand high frequency surgical accessories | 6-22908/05/2013 |
| IEC62304Ed. 1.1:2015 | Medical device software - Software life cycleprocesses | 13-7904/04/2016 |
| IEC60601-1-6Ed. 3.1:2013 | Medical electrical equipment Part 1-6: Generalrequirements for basic safety and essentialperformance - Collateral standard: Usability | 5-8906/27/2016 |
| ISO14971Second edition2007 | Medical devices - Application of riskmanagement to medical devices | 5-4008/20/2012 |
| AAMI ANSI ISO10993-12009/(R) 2013 | Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk managementprocess | 2-15607/26/2016 |
| ISO11135Second Edition2014 | Sterilization of health-care products - ethyleneoxide - requirements for the development,validation and routine control of a sterilizationprocess for medical devices. | 14-45204/04/2016 |
| ISO11607-12006 | Packaging for terminally sterilized medicaldevices - Part 1: Requirements for materials,sterile barrier systems and packaging systems[Including: Amendment 1 (2014)] | 14-45401/27/2015 |
| 2.10 Applied standards | ||
|---|---|---|
| -- | -- | ------------------------ |
Table 2.8: Applied standards
2.11 Conclusion
The performance data support the safety of the device and demonstrate that the subject devices comply with the recognized standards as specified.
{11}------------------------------------------------
In summary, we believe the ESG-300 with accessories is substantially equivalent with the predicate devices with respect to the general design approach, function, and the intended use. The ESG-300 with accessories raises no new concerns of safety or effectiveness when compared to the predicate devices.
§ 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.