(173 days)
ESG-410:
The electrosurgical generator, in conjunction with electrosurgical accessories and ancillary equipment, is intended for cutting and coagulation of tissue in the following medical fields:
- Open surgery
- Laparoscopic surgery
- Endoscopic surgery
Only for use by a qualified physician in an adequate medical environment.
PK Cutting Forceps (CF-PK0533):
The PK Cutting Forceps are indicated for electrosurgical coagulation, mechanical cutting, and grasping of tissue during the performance of laparoscopic and open general surgical procedures.
ESG-410 Generator:
The subject device ESG-410 is a reusable, non-sterile electrosurgical generator that features different mono- and bipolar cutting and coagulation modes. The maximum output power is 320 W. The front panel of the proposed ESG-410 features a touch screen GUI (graphical user interface) that displays 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 user-defined 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.
PK Cutting Forceps:
The PK Cutting Forceps are a bipolar electrosurgical device that may be utilized in laparoscopic and open general surgery to grasp, coagulate, transect, dissect and retract tissue. The PK Cutting Forceps were cleared via K142759. They are currently intended to be used only with the existing ESG-400 generator per the Indications for Use statement. This submission will demonstrate compatibility with the new ESG-410 generator, and the Indications for Use statement will remove a specific generator model and the compatible generators will be reflected in the labeling. Minor modifications, which did not affect safety and effectiveness, were assessed via internal documentation since the original clearance and will be identified within the submission.
The provided text describes a 510(k) premarket notification for an electrosurgical generator (ESG-410) and accessories, including PK Cutting Forceps. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or safety through large-scale clinical trials.
Therefore, the information you're asking for, particularly regarding acceptance criteria tied to device performance in terms of patient outcomes or diagnostic accuracy, and detailed MRMC studies with expert adjudication and effect sizes, is not typically found in a 510(k) submission for a device like an electrosurgical generator.
The "acceptance criteria" for this type of device are primarily related to meeting recognized electrical safety, electromagnetic compatibility (EMC), thermal safety, software validation, and functional performance standards. The "study that proves the device meets the acceptance criteria" refers to a series of bench and non-clinical/preclinical tests designed to show that the new device performs comparably to the predicate device and meets relevant performance standards.
Let's break down what is available in the document related to your questions, and where specific requested information is not applicable or provided.
Acceptance Criteria and Reported Device Performance
The core "acceptance criterion" for a 510(k) submission is substantial equivalence to a predicate device. This is demonstrated by showing similar technological characteristics, intended use, and comparable safety and effectiveness. "Performance" here largely refers to meeting technical specifications and demonstrating similar tissue effects to the predicate, not clinical outcomes in patients.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Acceptance Criteria Category | Specific Criteria (Inferred from document) | Reported Device Performance / Method of Proof |
|---|---|---|
| Substantial Equivalence (Overall) | Demonstrate equivalent technology, performance, dimensions, intended use, and materials to predicate devices, and no new concerns of safety or effectiveness. | Extensive comparison to predicate ESG-400 (K141225) and reference devices (Covidien Valleylab FT10 K151649, Erbe VIO 300D K060484). Detailed comparison of output modes (monopolar cut/coag, bipolar cut/coag). Bench testing confirms comparable tissue effects and electrical waveforms. |
| Electrical Safety | Compliance with AAMI/ANSI ES 60601-1:2005/(R)2012 and IEC 60601-2-2:2017 Ed.6. | Design complies with recognized standards. Specifically, "ACTIVE ACCESSORY HF Dielectric Strength" testing per IEC 60601-2-2:2017 Ed.6, Clause 201.8.8.3.103 was repeated for PK Cutting Forceps with ESG-410. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 Ed. 4.0:2014. | Design complies with recognized standards. FDA guidance "Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices" was followed. |
| Thermal Safety | Compliance with recognized standards (implied, likely IEC 60601-1). | Design complies with recognized standards. "Maximum Temperature During Normal Use" testing per IEC 60601-2-2:2017 Ed.6, Clause 201.11.1.1 was repeated for PK Cutting Forceps with ESG-410. |
| Software Validation | Compliance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) for a "Major Level of Concern". | Software validation activities performed in accordance with the FDA Guidance. |
| Functional Performance (Electrosurgical Generator) | Same range of waveform outputs and power levels as predicate. Comparable tissue effects and electrical waveforms to predicate/reference devices across various modes. Usability, user interface, and risk assessment are acceptable. | Verification and validation tests; bench studies including electrical, dimensional, functional, stability tests. Preclinical (simulated use) evaluation and testing of tissue effects and thermal safety on three clinically relevant tissue types. Comprehensive validation bench tests confirmed comparable tissue effects for applicable modes. |
| Functional Performance (PK Cutting Forceps Compatibility) | Confirm compatibility with the new ESG-410 generator. | Basic compatibility testing conducted. Specific tests (HF Dielectric Strength, Maximum Temperature) repeated with ESG-410. |
| Biocompatibility | Not directly in patient contact for ESG-410; PK Cutting Forceps established in prior 510(k). | ESG-410 and accessories do not have direct/indirect patient contact; biocompatibility not required. For PK Cutting Forceps, established in K142759 per ISO 10993-1, no changes affecting biocompatibility. |
| Risk Management | Compliance with ISO 14971:2007. Residual risk evaluated as acceptable. | Risk analysis carried out according to internal acceptance criteria based on ISO 14971:2007. Use-related hazardous situations assessed. |
Detailed Responses to Specific Questions:
-
A table of acceptance criteria and the reported device performance:
- See table above. The "performance" for this type of device is predominantly technical and functional performance against standards and predicate devices, not clinical effectiveness in terms of patient outcomes.
-
Sample sizes used for the test set and the data provenance:
- Sample Size: The document does not specify "sample sizes" in the typical clinical study sense for test sets of patients or cases. Instead, it refers to "bench studies" and "preclinical (simulated use) evaluation and testing of tissue effects." For tissue effects, it mentions "three clinically relevant tissue types were evaluated in all applicable modes." This implies material samples or ex-vivo tissue, not a patient cohort.
- Data Provenance: The tests are described as bench and preclinical (simulated use), conducted by the manufacturer (Olympus Winter & Ibe GmbH) and contract manufacturer (STEUTE TECHNOLOGIES GMBH & CO. KG), both located in Germany. There is no mention of country of origin of patient data as no clinical studies were deemed necessary. The studies were non-clinical/preclinical.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this submission. Ground truth, in the context of diagnostic AI or similar devices, is established by expert review (e.g., radiologists) for specific patient cases. This device is an electrosurgical generator. Its "ground truth" is its ability to adhere to technical specifications, produce specific electrical waveforms, and achieve desired tissue effects in a controlled, non-clinical environment, which is assessed through engineering and physical measurements. No human expert "ground truth" for a test set of medical images/cases is mentioned or relevant here.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used in clinical studies where multiple readers interpret cases and their consensus/disagreement needs to be resolved to establish ground truth or compare diagnostic performance. This is a technical performance and safety submission for an electrosurgical device, not a diagnostic one.
-
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, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic devices to assess how AI assistance impacts human reader performance. The ESG-410 is an electrosurgical generator, a surgical tool, and does not involve human "readers" interpreting images with or without AI assistance. Clinical and animal studies were explicitly stated as "not necessary."
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The ESG-410 contains "software," and "software validation activities were performed." This implies standalone testing of the software's functionality, but not in the context of an "algorithm only" performance for things like diagnostic accuracy (e.g., a standalone AI imaging algorithm). For this device, standalone performance refers to its ability to generate the correct electrical outputs and control the surgical modes as programmed. This was part of the "non-clinical (electrical, dimensional, functional, stability)" testing.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on engineering specifications, physical measurements of electrical output waveforms, and qualitative/quantitative assessment of tissue effects in simulated environments (preclinical/bench testing). This is not a "ground truth" derived from human experts, pathology, or patient outcomes data, as no clinical studies were performed.
-
The sample size for the training set:
- Not applicable/Not mentioned. This is not an AI/machine learning device that requires a training set of data for an algorithm to learn from in the typical sense (e.g., imaging data for a diagnostic algorithm). The software validation refers to standard software development life cycle processes, not machine learning model training.
-
How the ground truth for the training set was established:
- Not applicable. As explained above, there's no "training set" in the context of machine learning for this device. Its software and functional parameters are designed and validated based on established engineering principles and performance standards for electrosurgical devices, rather than learned from a data set with pre-established ground truth labels.
In summary, the provided FDA 510(k) document details a substantial equivalence claim for an electrosurgical generator and its accessories. The "acceptance criteria" and "proof" provided are consistent with a regulatory pathway for electrical surgical devices, focusing on meeting established technical performance standards and demonstrating comparability to predicate devices through bench and preclinical testing, rather than extensive clinical studies or AI algorithm performance validation metrics typical for imaging diagnostics.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 28, 2021
Olympus Winter & Ibe GmbH % Christina Flores Regulatory Affairs Manager Olympus Surgical Technologies America 118 Turnpike Road Southborough, Massachusetts 01772
Re: K203277
Trade/Device Name: Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: March 29, 2021 Received: March 30, 2021
Dear Christina Flores:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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.
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name Electrosurgical Generator ESG-410 and Accessories
Indications for Use (Describe)
ESG-410:
The electrosurgical generator, in conjunction with electrosurgical accessories and ancillary equipment, is intended for cutting and coagulation of tissue in the following medical fields:
- · Open surgery
· Laparoscopic surgery
· Endoscopic surgery
Only for use by a qualified physician in an adequate medical environment.
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)
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."
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name PK Cutting Forceps (CF-PK0533)
Indications for Use (Describe)
The PK Cutting Forceps are indicated for electrosurgical coagulation, mechanical cutting, and grasping of tissue during the performance of laparoscopic and open general surgical procedures.
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)
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."
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2 510(k) Summary of Safety and Effectiveness
2.1 General Information
| Applicant is: | Olympus Winter & Ibe GmbHKuehnstrasse 6122045 HamburgGermanyEstablishment Registration Number: 9610773 |
|---|---|
| Manufacturer: | Olympus Winter & Ibe GmbHBerlin FacilityRheinstrasse 814513 TeltowGermanyEstablishment Registration Number: 3003724334 |
| Contract Manufacturer: | STEUTE TECHNOLOGIES GMBH & CO. KGBrueckenstrasse 9132584 Loehne Nordrhein-WestfalenGermanyEstablishment Registration Number: 3015515531 |
| 510(k) Correspondent: | Christina Flores, RACManager, Regulatory AffairsOlympus Surgical Technologies America118 Turnpike RoadSouthborough, MA 01772Phone:508-808-3341Email: christina.flores@olympus.comEstablishment Registration Number: 3003790304 |
| Date prepared: | November 5, 2020 |
2.2 Device Identification
| Device name and models: | Electrosurgical Generator ESG-410 and Accessories, andPK Cutting Forceps (PK-CF0553) |
|---|---|
| Common name: | Electrosurgical Generator and Accessories,Electrosurgical devices |
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| Classification Number: | 21 CFR 878.4400 |
|---|---|
| Classification name: | Electrosurgical cutting and coagulation device andaccessories |
| Product code: | GEI |
| Product code name: | Electrosurgical, Cutting & Coagulation Accessories |
| Regulatory class: | Class II |
| Review Panel: | General & Plastic Surgery |
2.3 Predicate Device
The ESG-410 and accessories are considered substantially equivalent to the following legally marketed devices:
| Predicate Device | Manufacturer | 510(k) No |
|---|---|---|
| ESG-400 | Olympus Winter & Ibe GmbH | K141225 |
| PK Cutting Forceps | Olympus Surgical TechnologiesAmerica | K142759 |
Table 2.1: Identification of predicate device
The following reference devices for the ESG-410 for particular monopolar and/or bipolar cutting and/or coagulation modes only have been chosen for substantial equivalence discussion in terms of safety and effectiveness.
| Reference devices | Manufacturer | 510(k) No |
|---|---|---|
| Valleylab™ FT10 Energy Platform | Covidien | K151649 |
| VIO ESU (Model VIO 300D) | Erbe USA, Inc. | K060484 |
Table 2.2: Reference devices for a few specific features
2.4 Product Description
ESG-410 Generator
The subject device ESG-410 is a reusable, non-sterile electrosurgical generator that features different mono- and bipolar cutting and coagulation modes. The maximum output power is 320 W.
The front panel of the proposed ESG-410 features a touch screen GUI (graphical user interface) that displays the connection status of accessories and peripherals connected to the electrosurgical generator.
The front panel of the proposed ESG-410 features a touch screen GUI (graphical user interface) that displays the current settings of the chosen output mode, the connection
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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 user-defined 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.
It is compliant with FDA recognized consensus safety standards as listed in section 2.8.8 below.
PK Cutting Forceps
The PK Cutting Forceps are a bipolar electrosurgical device that may be utilized in laparoscopic and open general surgery to grasp, coagulate, transect, dissect and retract tissue. The PK Cutting Forceps were cleared via K142759. They are currently intended to be used only with the existing ESG-400 generator per the Indications for Use statement. This submission will demonstrate compatibility with the new ESG-410 generator, and the Indications for Use statement will remove a specific generator model and the compatible generators will be reflected in the labeling. Minor modifications, which did not affect safety and effectiveness, were assessed via internal documentation since the original clearance and will be identified within the submission.
2.5 Indications for Use
ESG-410 Electrosurgical Generator
The electrosurgical generator. in conjunction with electrosurgical accessories and ancillary equipment, is intended for cutting and coagulation of tissue in the following medical fields:
- . Open surgery
- Laparoscopic surgery .
- . Endoscopic surgery
Only for use by a qualified physician in an adequate medical environment.
PK Cutting Forceps
The PK Cutting Forceps are indicated for electrosurgical coagulation, mechanical cutting, and grasping of tissue during the performance of laparoscopic and open surgical procedures.
2.6 Technological Characteristics
The subject ESG-410 has the same intended use and technological characteristics as the predicate device ESG-400.
Various instruments can be connected to the two monopolar sockets or one bipolar socket as well as to the two universal sockets. In addition, dedicated Olympus
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instruments or Olympus cables can be connected to the two universal sockets with instrument recognition.
The basic design philosophy of the User Interface (UI) and GUI flow chart concept is equivalent. Compared to the ESG-400, the ESG-410 offers additional output modes.
There have been no changes to the intended use or technological characteristics of the PK Cutting Forceps, since its clearance in K142759.
Output modes in comparison to the predicate device ESG-400 2.6.1
In comparison to the predicate device the following output modes are available:
| Subject Device: | Predicate Device: |
|---|---|
| ESG-410 | ESG-400 (K141225) |
| PureCut | PureCut |
| BlendCut | BlendCut |
| PulseCut Fast | PulseCut Fast |
| PulseCut Slow | PulseCut Slow |
| FineCut | FineCut |
| PowerCut | PowerCoag |
Table 2.3: Monopolar Cut Modes
| Subject Device: | Predicate Device: |
|---|---|
| ESG-410 | ESG-400 (K141225) |
| Spray | SprayCoag (Effect 3) |
| SprayCoag | SprayCoag |
| PowerCoag | PowerCoag |
| ForcedCoag | ForcedCoag |
Table 2.4: Monopolar Coagulation Modes
| Subject Device: | Predicate Device: |
|---|---|
| ESG-410 | ESG-400 (K141225) |
| BipolarCut | BipolarCut |
| PlasmaCut | SalineCut |
| PK LoopCut | PK LoopCut |
| PK MorceCut | PK MorceCut |
| PK PureCut | PK PureCut |
| PK SoftCut | PK SoftCut |
Table 2.5: Bipolar Cut Modes
| Subject Device: | Predicate Device: |
|---|---|
| ESG-410 | ESG-400 (K141225) |
| BiSoftCoag | BiSoftCoag |
| AutoCoag | AutoCoag |
| HardCoag | HardCoag |
| SalineCoag | SalineCoag |
| PK SoftCoag | PK SoftCoag |
| PK Coag | PK Coag |
| N/A | RFCoag (w/o RCAP) |
| N/A | RFCoag (w/ RCAP) |
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| Subject Device: | Predicate Device: |
|---|---|
| ESG-410 | ESG-400 (K141225) |
| N/A | FineCoag |
| N/A | PK AutoCoag |
Table 2.6: Bipolar Coagulation Modes
The range of output waveforms and the power levels are identical in comparison to the FDA cleared ESG-400 electrosurgical generator, K141225.
Output modes in comparison to the reference devices 2.6.2
As stated above, the reference devices are solely used for specific additional monopolar tissue cutting and coagulation modes that are comparable in the subject device and reference device.
2.6.2.1 COVIDIEN ValleylabTM FT10 Energy Platform
The reference device COVIDIEN Valleylab TM FT10 Energy Platform is provided for implementation of monopolar cutting and for monopolar coagulation modes that are not presented in the predicate device, the ESG-400.
| Subject Device:ESG-410 | Reference DeviceCOVIDIEN ValleylabTM FT10 EnergyPlatform (K151649) |
|---|---|
| Pure | Pure |
| Blend | Blend |
Table 2.7: Monopolar Cut Modes - Reference Device - COVIDIEN Valleylab™ FT10 Energy Platform
| Subject Device: | Reference Device |
|---|---|
| ESG-410 | COVIDIEN ValleylabTM FT10 EnergyPlatform (K151649) |
| Fulgurate | Fulgurate |
Table 2.8: Monopolar Coagulation Modes - Reference Device - COVIDIEN Valleylab™ FT10 Energy Platform
The range of output waveforms and the power levels are equivalent in comparison to the FDA cleared COVIDIEN ValleylabTM FT10 Energy Platform, K151649.
2.6.2.2 ERBE VIO ESU (Model VIO 300D)
The reference device ERBE VIO ESU (Model VIO 300D) is provided for implementation of the monopolar coagulation mode SoftCoag, that is not presented in the predicate device, the ESG-400.
| Subject Device:ESG-410 | Reference DeviceERBE VIO ESU (Model VIO 300D)(K060484) |
|---|---|
| SoftCoag | Soft Coag |
Table 2.9: Monopolar Coagulation Mode - Reference Device - ERBE VIO ESU (Model VIO 300D)
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The range of output waveforms and the power levels are equivalent in comparison to the FDA cleared ERBE VIO ESU (Model VIO 300D), K060484.
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 predicate device ESG-400 are:
- o Two identical monopolar output sockets in the ESG-410, compared to two various monopolar (E-type and B-type) output sockets in the predicate device
- o Two universal output sockets in the ESG-410. compared to one universal output socket in the predicate device
- no docking station interface on the bottom in the ESG-410 .
- . Three foot switch sockets, all suitable for double pedal wired and wireless and for single pedal wired in the ESG-410, compared to two foot switch socket, both suitable for double pedal and single pedal
- The COM indicator is integrated into the touch screen of the ESG-410, in the . predicate device the CQM indicator is placed below the lower monopolar output socket
- . The touch screen of the ESG-410 is approximately one third larger compared to the size of the predicate device.
- Three soft buttons for 'Settings', 'Procedure', 'Foot switch' and one Info . button for the 'COM' are integrated in the home screen of the ESG-410 compared to three buttons that were integrated into the touch screen of the predicate device
- The ESG-410 has one additional ventilation slot on the rear panel. .
- . The ESG-410 provides 28 ventilation slots on the side panels, compared to 32 ventilation slots provided by the predicate device
- The ESG-410 provides an USB-socket for storage, import and export of user-. defined procedures on a portable USB flash drive. The USB-socket is not provided in the ESG-400
Regarding the additionally implemented monopolar cutting and coagulation modes two reference devices have been chosen, because of their specific output modes. For those two reference devices, the substantial equivalence is demonstrated by acknowledged verification/ validation methodologies. The subject devices have equivalent technology and performance in respect to the compared modes.
The previously cleared PK Cutting Forceps (K142759) are included in this submission to demonstrate compatibility with the subject ESG-410 generator and to update the labeling. There have been no changes to the technological characteristics or intended use of the device since its original clearance. The basic compatibility testing and limited electrical testing demonstrate substantial equivalence to the originally cleared PK Cutting Forceps.
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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.
All 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 March 9, 2020. The guidance was followed for all relevant sections.
2.8.1 Biocompatibility testing
The ESG-410 and its accessories do not contain components that come directly or indirectly in patient contact. Biocompatibility testing according to ISO 10993 is not required.
Biocompatibility evaluation of the previously cleared PK Cutting Forceps (PK-CF0533) was successfully established in K142759 according to ISO 10993-1 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing. There have been no changes to the device that affect the biocompatibility established in K142759.
Electrical safety and electromagnetic compatibility (EMC) 2.8.2
The design of the ESG-410 complies with recognized standards as listed in section 2.8.8.
The FDA guidance "Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices", CDRH July 11, 2016 has been followed.
There have been no changes to the PK Cutting Forceps since the original clearance that affect electrical safety or electromagnetic compatibility. However, "ACTIVE ACCESSORY HF Dielectric Strength" testing per IEC 60601-2-2:2017 Ed.6, Clause 201.8.8.3.103 and "Maximum Temperature During Normal Use" testing per IEC 60601-2-2:2017 Ed.6, Clause 201.11.1.1 were repeated for the PK Cutting Forceps with the ESG-410 generator. This testing was part of the basic compatibility testing to demonstrate compatibility of the PK Cutting Forceps with the subject ESG-410 generator.
2.8.3 Thermal Safety
The design of the ESG-410 complies with recognized standards as listed in section 2.8.8.
2.8.4 Clinical and animal Studies
Clinical and animal studies were not necessary.
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2.8.5 Software
The subject ESG-410 generator contains software. 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".
The previously cleared PK Cutting Forceps (K147259) do not contain software.
2.8.6 Performance Testing Bench
ESG-410 Electrosurgical Generator
To demonstrate substantial equivalence following aspects were considered within the validation versus the predicate devices.
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- Performance and validation tests incorporated the same range of waveform outputs and power levels.
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- During the validation testing the waveforms and tissue effects were compared directly between the subjected and predicate device and between the subject and reference devices.
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:
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- non-clinical (electrical, dimensional, functional, stability)
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- 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.
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. The tissue effects testing included quantitative and qualitative assessment.
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 three tissue types.
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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.
PK Cutting Forceps ( PK-CF0533)
Basic compatibility testing was conducted to confirm compatibility of the legacy PK Cutting Forceps with the subject ESG-410 generator. "ACTIVE ACCESSORY HF Dielectric Strength" testing per IEC 60601-2-2:2017 Ed.6, Clause 201.8.8.3.103 and "Maximum Temperature During Normal Use" testing per IEC 60601-2-2:2017 Ed.6, Clause 201.11.1.1 were repeated for the PK Cutting Forceps with the ESG-410 generator as part of the basic compatibility testing to demonstrate compatibility with the new generator.
2.8.7 Reprocessing
Required cleaning, disinfecting and drying procedures are described in the instructions for use.
The PK Cutting Forceps are provided sterile, for single-use. They are not intended to be reprocessed.
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2.8.8 Applied standards
| Standard No. | Standard Title | FDA-Recognitionno + date |
|---|---|---|
| AAMI/ANSI ES60601-1:2005/(R)2012and C1:2009/(R)2012and, A2:2010/(R)2012 | Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance(IEC 60601-1:2005, MOD) | 19-407/09/2014 |
| IEC60601-1-2Ed. 4.0:2014 | Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances -Requirements and tests | 19-809/17/2018 |
| IEC60601-1-8Ed. 2.1:2012 | Medical electrical equipment - Part 1-8: Generalrequirements for basic safety and essential performance -Collateral Standard: General requirements, tests andguidance for alarm systems in medical electricalequipment and medical electrical systems | 5-7608/06/2013 |
| IEC60601-2-2Ed. 6.0:2017 | Medical electrical equipment - Part 2-2: Particularrequirements for the basic safety and essentialperformance of high frequency surgical equipment andhigh frequency surgical accessories | 6-38908/21/2017 |
| IEC62304Ed. 1.12015consolidated version | Medical device software - Software life cycle processes | 13-7901/14/2019 |
| IEC60601-1-6Ed. 3.1:2013 | Medical electrical equipment Part 1-6: Generalrequirements for basic safety and essential performance -Collateral standard: Usability | 5-8906/27/2016 |
| IEC 62366-1Edition 1.02015 | Medical devices - Part 1: Application of usabilityengineering to medical devices [IncludingCORRIGENDUM 1 (2016)] | 5-11412/23/2016 |
| ISO 14971 secondedition 2007 | Medical devices - Application of risk management tomedical devices | 5-4006/27/2016 |
Table 2.10: Applied standards
2.9 Conclusion
The performance data support the safety of the devices and demonstrate that the subject devices comply with the recognized standards as specified.
In summary, we believe the ESG-410 and accessories are substantially equivalent with the predicate devices with respect to the general design approach, function, and the intended use. The subject ESG-410 and the compatibility of the PK Cutting Forceps with the subject ESG-410, raise no new concerns of safety or effectiveness when compared to the predicate and the reference 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.