(151 days)
No
The summary describes a standard electrosurgical generator and bipolar sealing/cutting device. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on traditional metrics like seal performance and electrical safety.
Yes.
The device is intended for tissue cutting and coagulation (ESG-400), and ligation and division of vessels, tissue bundles, and lymphatics (POWERSEAL Sealer and Divider), all of which are direct actions on biological tissue to achieve a therapeutic effect.
No
The devices (ESG-400 electrosurgical generator and POWERSEAL Sealer and Divider) are intended for tissue cutting, coagulation, ligation, and division during surgery. They are therapeutic devices, not diagnostic.
No
The device description clearly outlines both a hardware component (electrosurgical generator and bipolar device with integral cutting blade) and software (touch screen GUI). The performance studies also include hardware-related testing like electrical safety, EMC, and thermal safety.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the devices are for "tissue cutting and coagulation in open, laparoscopic and endoscopic surgery" and "ligation and division of vessels, tissue bundles, and lymphatics." This describes a surgical procedure performed on a living patient, not a test performed on a sample taken from a patient outside the body.
- Device Description: The description details an electrosurgical generator and a bipolar electrosurgical instrument used for sealing and cutting tissue during surgery. This aligns with surgical tools, not diagnostic tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information about a patient's condition based on such analysis.
In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The devices described here are used directly on the patient's tissue during surgery.
N/A
Product codes (comma separated list FDA assigned to the subject device)
GEI
Intended Use / Indications for Use
The ESG-400 is an electrosurgical generator intended for tissue cutting and coagulation in open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.
The POWERSEAL Sealer and Divider is a bipolar electrosurgical device intended for use in laparoscopic/minimally invasive or open surgical procedures where ligation of vessels, tissue bundles, and lymphatics is desired. POWERSEAL devices can be used on vessels (arteries and veins, pulmonary arteries, pulmonary veins) up to and including 7 mm, lymphatics, and tissue bundles. POWERSEAL devices are indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, cholecystectomy, adhesiolysis, sleeve gastrectomy, hysterectomy, oophorectomy.
The POWERSEAL Sealer and Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the POWERSEAL devices for these procedures.
Device Description
The subject device ESG-400 is a reusable, non-sterile electrosurgical generator that features different mono- and bipolar cutting and coagulation modes. The maximum output power is 320 W.
The front panel of the proposed ESG-400 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.
Push buttons are placed next to GUI to switch between the output sockets, to enter the Menu in order to edit settings/ procedures (e.g. save or delete a procedure), 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).
Compatible accessories, two footswitches a double-pedal footswitch, which is delivered with the generator and may also be ordered separately, and an optional singlepedal footswitch have been previously cleared (K141225) and are not impacted by the SW update described in this submission. Changes to the footswitches that have been made since original clearance are outlined below and discussed in Device Description and Specifications:
- Labeling Changes -
- Improvement of bend relief -
- Packaging change -
The POWERSEAL 5mm laparoscopic curved jaw sealer divider is an electrosurgical bipolar device with an integral extending cutting blade. It features a pistol grip handle and will be provided in shaft lengths of 23, 37, and 44 cm.
The subject POWERSEAL devices will be provided as sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with Olympus electrosurgical generators to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics. Similar to the predicate LigaSure Maryland Jaw, the jaws of the POWERSEAL are designed to seal vessels, and grasp and dissect tissue during open and minimally invasive general surgical procedures using high frequency (HF) energy. A hand actuated mechanism allows the user to open and close the instrument jaws. When the instrument jaws are correctly placed over tissue or vessel to be sealed, the user operates a second control to initiate delivery of bipolar energy, which seals the tissue. When the sealing is complete, the user operates a separate control to activate a blade, which divides the tissue along the seal line.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels (arteries and veins, pulmonary arteries, pulmonary veins), lymphatics, tissue bundles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
open, laparoscopic and endoscopic surgery
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing
The following performance data were provided in support of the substantial equivalence determination. All standards applied are FDA recognized conformance standards.
For the ESG-400 Generator, 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.
For the POWERSEAL Sealer and Divider, all data was prepared in accordance with the following FDA guidance documents: "Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery" Guidance for Industry and Food and Drug Administration Staff, issued on August 15, 2016; and "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgerv" Guidance for Industry and Food and Drug Administration Staff, issued on March 9, 2020. The guidance documents were followed for all relevant sections.
Biocompatibility testing
ESG-400 Generator
The ESG-400 and its accessories do not contain components that come directly or indirectly in patient contact. Biocompatibility testing according to ISO 10993 is not required.
POWERSEAL Sealer and Divider
In accordance with ISO 10993-1 and the 2016 FDA guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", the subject devices met all acceptance criteria for the following biocompatibility evaluations:
Cytotoxicity - ISO 10993-5:2009 Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity
Material Mediate Pyrogen - ISO 10993-11:2017. Biological Evaluation of Medical Devices, Part 11: Tests for Systemic Toxicity.
ISO Acute Systemic Injection Test - ISO 10993-11: 2017 Biological Evaluation of Medical Devices Part 11: Tests for Systemic Toxicity.
ISO Intracutaneous Irritation Test - ISO 10993-10: 2010 Standard, Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Skin Sensitization.
ISO Guinea Pig Maximization Sensitization - ISO 10993-10:2010. Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Skin Sensitization.
Sterilization and Shelf Life Discussion
ESG-400 and accessories
The ESG-400 generator and its accessories are not provide sterile. They are reusable devices.
POWERSEAL Sealer and Divider
Sterilization testing for the POWERSEAL Sealer and Divider was conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". Stability evaluation for the sterile packaging and for product performance supports the three year shelf life. Accelerated aging test was conducted as required per ISO 11607-1 and in accordance with ASTM F1980-16, the standard guide for accelerated aging of sterile barrier systems for medical devices.
Electrical safety and electromagnetic compatibility (EMC)
Basic safety and performance testing was performed in accordance with IEC standards. The design of the subject ESG-400 and footswitches and the subject POWERSEAL Sealer and Divider comply with recognized standards as listed in Table 11, respectively.
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
The design of the subject ESG-400 Generator and the subject POWERSEAL Sealer and Divider, comply with recognized standards as listed in Table 11.
Clinical and Animal Studies
Clinical studies were not necessary for the subject devices.
Animal Studies, including Acute and Chronic testing conducted demonstrate substantial equivalence of the subject POWERSEAL Sealer and Divider to the predicate device.
All data was prepared in accordance with the FDA guidance. "Premarket Notification (510/k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgerv" Guidance for Industry and Food and Drug Administration Staff, issued on August 15, 2016; and "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 documents were followed for all relevant sections.
Chronic Animal Study: Chronic animal study was conducted on both the subject and predicate devices to demonstrate seal performance.
Acute Animal Study: Acute animal study was conducted on both the subject and predicate devices to demonstrate seal performance and safety.
Software
The software validation activities were performed for the subject ESG-400 Generator in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", issued May 11, 2005. The device software is considered a "Major Level of Concern".
The output modes of the subject device to the predicate device (K141225) have not been changed. Software regression tests confirmed that existing functionalities are not influenced and remain unaffected/ unchanged by the addition of the new coagulation mode. The electrical waveforms of these "predicate modes" have been verified.
The POWERSEAL Sealer and Divider does not contain software.
Performance Testing Bench
Verification and comparison bench studies were conducted to evaluate the functional performance of the newly implemented "POWERSEAL" mode. Ex-vivo Vessel Burst Pressure testing was conducted on both the subject and predicate devices to demonstrate vessel sealing performance.
Testing demonstrated that the performance requirements defined in the User Requirements Specification and Design Specification were met for both subject devices, and that they exhibit comparable performance characteristics to the predicate device and reference devices.
Bench testing results support the claim of substantial equivalence of the subject ESG400 and the subject POWERSEAL Sealer and Divider, to the predicate and reference devices.
The following non-clinical and preclinical tests were conducted:
-
- non-clinical (electrical, mechanical, functional)
-
- preclinical (simulated use) evaluation and testing of tissue effects and thermal safety and vessel burst pressure testing and vessel thermal margin
Usability and user interface were also assessed according to the risk management plan. 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.
Reprocessing
Required cleaning, disinfecting and drying procedures are described in the instructions for use for the ESG-400 Generator and accessories.
The POWERSEAL Sealer and Divider is provided sterile, for single-use. It is not intended to be reprocessed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
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May 17, 2021
Olympus Winter & Ibe GmbH % Christina Flores Regulatory Affairs Manager Olympus Surgical Technologies America 118 Turnpike Road Southborough, Massachusetts 01772
Re: K203682
Trade/Device Name: Electrosurgical Generator ESG-400 and Accessories, POWERSEAL Curved Jaw Sealer and Divider, Double Action (PS-0523CJDA, PS-0537CJDA, PS-0544CJDA). Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: December 16, 2020 Received: December 17, 2020
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/odth/cfdocs/cfpmn/pmn.cfm identifies coombination 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
1
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-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-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE assistance/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
2
Indications for Use
510(k) Number (if known)
K203682
Device Name
Electrosurgical Generator ESG-400 and Accessories
Indications for Use (Describe)
The ESG-400 is an electrosurgical generator intended for tissue cutting and coagulation in open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.
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 D) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------- |
|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.
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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
Indications for Use
510(k) Number (if known)
K203682
Device Name
POWERSEAL Curved Jaw Sealer and Divider, Double Action (PS-0523CJDA, PS-0537CJDA, PS-0544CJDA)
Indications for Use (Describe)
The POWERSEAL Sealer and Divider is a bipolar electrosurgical device intended for use in laparoscopic/minimally invasive or open surgical procedures where ligation of vessels, tissue bundles, and lymphatics is desired. POWERSEAL devices can be used on vessels (arteries and veins, pulmonary arteries, pulmonary veins) up to and including 7 mm, lymphatics, and tissue bundles. POWERSEAL devices are indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, cholecystectomy, adhesiolysis, sleeve gastrectomy, hysterectomy, oophorectomy.
The POWERSEAL Sealer and Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the POWERSEAL devices for these procedures.
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."
4
510(k) Summary of Safety and Effectiveness
Date Prepared: December 16, 2020
General Information
| Manufacturer
(ESG-400 Generator): | Olympus Winter & Ibe GmbH
Kuehnstr. 61
22045 Hamburg Germany
Establishment Registration Number: 9610773 |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer (POWERSEAL
Sealer and Divider) | Olympus Surgical Technologies America
9600 Louisiana Ave. North
Brooklyn Park, MN 55455
USA
Establishment Registration Number: 3011050570 |
| Official Correspondent: | Christina Flores, RAC
Manager, Regulatory Affairs
Olympus Surgical Technologies America
118 Turnpike Road
Southborough, MA 01772
Phone: 508.808-3341
Email: christina.flores@olympus.com
Establishment Registration Number: 3003790304 |
| Device Identification | |
| Proprietary names: | Electrosurgical Generator ESG-400
POWERSEAL Curved Jaw Sealer and Divider,
Double Action (PS-0523CJDA, PS-0537CJDA, PS-
0544CJDA) |
| Device Classification name: | Electrosurgical cutting and coagulation device and
accessories |
| Regulation Medical Specialty: | General & Plastic Surgery |
| Regulations Number:
Regulatory class: | 21 CFR 878.4400
Class II |
| Product code: | GEI |
| Generic/Common Name: | Electrosurgical, Cutting & Coagulation & Accessories |
5
Predicate Device
ESG-400 Generator
The initial version of the proposed medical device ESG-400 was cleared by the FDA in 2011 (K103032). This submission is based on a modification of the initial device version ESG-400 cleared by the FDA in 2014 (K141225). The 2014 clearance is the latest clearance for the device to date. The subject device ESG-400 therefore is a modification of the already legally marketed predicate electrosurgical generator ESG400 (K141225).
| Predicate Device | Manufacturer | 510(k) No |
|---|---|---|
| ESG-400 | Olympus Winter & Ibe GmbH | K141225 |
Table 1: Identification of predicate device
This submission has been triggered by the development of new compatible POWERSEAL instruments, and the subsequent required software update of the generator.
The ESG-400 software update extends the instrument portfolio which can be driven by the ESG-400. It adds a new coagulation mode to support the POWERSEAL technology to be used with sealing instruments for open and laparoscopic surgery.
The following reference device has been chosen to support the substantial equivalence claim in terms of safety and effectiveness for the bipolar vessel sealing mode "POWERSEAL" only.
| Reference device | Manufacturer | 510(k) No |
|---|---|---|
| Valleylab™ FT10 Electrosurgical | ||
| Platform | Covidien | K151649 |
Table 2: Reference devices for one specific feature
POWERSEAL Sealer and Divider, Curved Jaw
The primary predicate device of the subject POWERSEAL Sealer/Divider is the Ligasure Maryland Jaw One-Step Sealer/Divider, Curved; and the reference predicate is the Ligasure Maryland Jaw Thoracic Sealer/Divider One-Step Sealing, Nano-Coated. The subject POWERSEAL shares the same fundamental technologies, including design, intended use, and principle of operation with both the predicate and reference device.
6
| Predicate Device | Manufacturer | 510(k) No |
|---|---|---|
| Ligasure Maryland Jaw One-Step | ||
| Sealer/Divider, Curved | Covidien | K141153 |
| Reference device | Manufacturer | 510(k) No |
| Ligasure Maryland Jaw Thoracic | ||
| Sealer/Divider One-Step Sealing, | Covidien | K181085 |
Product Description
ESG-400 Generator
The subject device ESG-400 is a reusable, non-sterile electrosurgical generator that features different mono- and bipolar cutting and coagulation modes. The maximum output power is 320 W.
The front panel of the proposed ESG-400 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.
Push buttons are placed next to GUI to switch between the output sockets, to enter the Menu in order to edit settings/ procedures (e.g. save or delete a procedure), 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).
Compatible accessories, two footswitches a double-pedal footswitch, which is delivered with the generator and may also be ordered separately, and an optional singlepedal footswitch have been previously cleared (K141225) and are not impacted by the SW update described in this submission. Changes to the footswitches that have been made since original clearance are outlined below and discussed in Device Description and Specifications:
- Labeling Changes -
- Improvement of bend relief -
- Packaging change -
POWERSEAL Sealer and Divider
The POWERSEAL 5mm laparoscopic curved jaw sealer divider is an electrosurgical bipolar device with an integral extending cutting blade. It features a pistol grip handle and will be provided in shaft lengths of 23, 37, and 44 cm.
7
The subject POWERSEAL devices will be provided as sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with Olympus electrosurgical generators to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics. Similar to the predicate LigaSure Maryland Jaw, the jaws of the POWERSEAL are designed to seal vessels, and grasp and dissect tissue during open and minimally invasive general surgical procedures using high frequency (HF) energy. A hand actuated mechanism allows the user to open and close the instrument jaws. When the instrument jaws are correctly placed over tissue or vessel to be sealed, the user operates a second control to initiate delivery of bipolar energy, which seals the tissue. When the sealing is complete, the user operates a separate control to activate a blade, which divides the tissue along the seal line.
The subject devices, ESG-400 and accessories and the POWERSEAL Sealer and Divider are class II medical devices under the regulation number 878.4400 and the product code GEI - "Electrosurgical cutting and coagulation device and accessories". Regulation Medical Specialty: General & Plastic Surgery.
They are compliant with FDA recognized consensus safety standards as listed in Table 11.
Indications for Use
ESG-400 Generator
The ESG-400 is an electrosurgical generator intended for tissue cutting and coagulation in open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.
POWERSEAL Sealer and Divider
The POWERSEAL Sealer and Divider is a bipolar electrosurgical device intended for use in laparoscopic/minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. POWERSEAL devices can be used on vessels (arteries and veins, pulmonary arteries, pulmonary veins) up to and including 7 mm, lymphatics, and tissue bundles. POWERSEAL devices are indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, sleeve gastrectomy, hysterectomy, oophorectomy.
The POWERSEAL Sealer and Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the POWERSEAL devices for these procedures.
Technological Characteristics
8
ESG-400 Generator
The ESG-400 has the same intended use and technological characteristics as the predicate device ESG-400 (K141225).
Various instruments can be connected to various output sockets: two monopolar socket, one bipolar socket and one universal socket. In addition, dedicated Olympus instruments or Olympus cables can be connected to the universal socket with instrument recognition.
With respect to the predicate device ESG-400 (K141225) the basic design philosophy of the User Interface (UI) and GUI flow chart concept was not changed. User interface modifications were the result of implementing the new output mode to support the POWERSEAL technology as well as improvement of GUI usability derived from market surveillance. POWERSEAL technology related GUI changes have been implemented. They follow the general GUI flow chart concept of the ESG-400 referring to All/ Set/ Mode Screens.
Output modes in comparison to the predicate device ESG-400
In this chapter the different unchanged monopolar and bipolar cutting and coagulation modes of the subject and predicate device are listed:
| Subject Device:
ESG-400 | Predicate Device:
ESG-400 (K141225) |
|--------------------------------------|----------------------------------------|
| PureCut | PureCut |
| BlendCut | BlendCut |
| PulseCut Slow | PulseCut Slow |
| PulseCut Fast | PulseCut Fast |
| FineCut | FineCut |
| Table 3: Monopolar Cut Modes | |
| Subject Device:
ESG-400 | Predicate Device:
ESG-400 (K141225) |
| SoftCoag | SoftCoag |
| ForcedCoag | ForcedCoag |
| SprayCoag | SprayCoag |
| PowerCoag | PowerCoag |
| Table 4: Monopolar Coagulation Modes | |
| Subject Device:
ESG-400 | Predicate Device:
ESG-400 (K141225) |
| BipolarCut | BipolarCut |
| SalineCut | SalineCut |
| Table 5: Bipolar Cut Modes | |
| Subject Device:
ESG-400 | Predicate Device:
ESG-400 (K141225) |
| BiSoftCoag | BiSoftCoag |
9
| AutoCoag | AutoCoag |
|---|---|
| Subject Device: | |
| ESG-400 | Predicate Device: |
| ESG-400 (K141225) | |
| SalineCoag | SalineCoag |
| HardCoag | HardCoag |
| FineCoag | FineCoag |
| RFCoag (RCAP) | RFCoag (RCAP) |
Table 6: Bipolar Coagulation Modes
| Subject Device:
ESG-400 | Predicate Device:
ESG-400 (K141225) |
|----------------------------|----------------------------------------|
| PK PureCut | PK PureCut |
| PK SoftCut | PK SoftCut |
| PK LoopCut | PK LoopCut |
| PK MorceCut | PK MorceCut |
Table 7: Bipolar Plasmakinetic Cut Modes
| Subject Device:
ESG-400 | Predicate Device:
ESG-400 (K141225) |
|----------------------------|----------------------------------------|
| PK Coag | PK Coag |
| PK SoftCoag | PK SoftCoag |
| PK AutoCoag | PK AutoCoag |
Table 8: Bipolar Plasmakinetic 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 device
As stated above, the reference device, Covidien Valleylab FT10 Electrosurgical Platform (K151649), is solely used for the newly implemented bipolar vessel sealing mode "POWERSEAL", that is comparable in the subject device and in the reference device.
| Subject Device:
ESG-400 | Reference Device
COVIDIEN Valleylab™ FT10
Electrosurgical Platform (K151649) |
|----------------------------|------------------------------------------------------------------------------------|
| SEAL | LigaSure |
Table 9: Bipolar Coagulation Mode - Reference Device - COVIDIEN Valleylab™ FT10 Electrosurgical Platform
10
The range of output waveforms and the power levels of the POWERSEAL mode are comparable to the LigaSure mode of the FDA cleared COVIDIEN Valleylab™ FT10 Electrosurgical Platform, K151649.
POWERSEAL Sealer and Divider
The basic fundamental technology, including design, intended use, and principles of operation are the same between the subject and predicate Ligasure devices. Both the subject and predicate devices connect to a radiofrequency (RF) energy source The Indications for Use statement is also similar but identifies additional surgical specialties that otherwise fall under the broader indications of the predicate devices. The following table outlines the similarities and differences between the subject and predicate devices.
11
K203682 Electrosurgical Generator ESG-400 and Accessories Olympus Winter & Ibe GmbH
Traditional 510(k) Notification
| Feature | Subject Device
POWERSEAL Sealer and Divider | Predicate Device
LigaSure Maryland Jaw Sealer/Divider
(#K141153) | Reference Device
Ligasure Maryland Jaw Thoracic
Sealer/Divider One-Step Sealing, Nano-
Coated (#K181085) |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The POWERSEAL Sealer and Divider is a bipolar
electrosurgical device intended for use in
laparoscopic/minimally invasive or open surgical
procedures where ligation and division of vessels,
tissue bundles, and lymphatics is desired.
POWERSEAL devices can be used on vessels
(arteries and veins, pulmonary arteries, pulmonary
veins) up to and including 7 mm, lymphatics, and
tissue bundles. POWERSEAL devices are
indicated for use in general surgery and such
surgical specialties as urologic, colorectal,
bariatric, vascular, thoracic, and gynecologic.
Procedures may include, but are not limited to,
Nissen fundoplication, colectomy,
cholecystectomy, adhesiolysis, sleeve gastrectomy,
hysterectomy, oophorectomy. The POWERSEAL
Sealer and Divider has not been shown to be
effective for tubal sterilization or tubal coagulation
for sterilization procedures. Do not use the
POWERSEAL devices for these procedures. | The LigaSure Sealer/Divider is a bipolar
electrosurgical instrument intended for use
in minimally invasive or open surgical
procedures where ligation and division of
vessels, tissue bundles, and lymphatics is
desired. The LigaSure Sealer/Divider can be
used on vessels (arteries and veins) up to and
including 7 mm. It is indicated for use in
general surgery and such surgical
specialities as urologic, vascular, thoracic,
and gynecologic. Procedures may include,
but are not limited to, Nissen fundoplication,
colectomy, cholecystectomy, adhesiolysis,
hysterectomy, oophorectomy, etc. The
LigaSure system has not been shown to be
effective for tubal sterilization or tubal
coagulation for sterilization procedures. Do
not use the LigaSure system for these
procedures. | The LigaSure Sealer/Divider is a bipolar
electrosurgical instrument intended for use in
minimally invasive or open surgical
procedures where ligation and division of
vessels, tissue bundles, and lymphatics is
desired. The LigaSure Sealer/Divider can be
used on vessels (arteries and veins, pulmonary
arteries, pulmonary veins) up to and including
7 mm. It is indicated for use in general
surgery and such surgical specialities as
urologic, vascular, thoracic, and gynecologic.
Procedures may include, but are not limited
to. Nissen fundoplication, colectomy,
cholecystectomy, adhesiolysis, hysterectomy,
oophorectomy, etc.
The LigaSure system has not been shown to
be effective for tubal sterilization or tubal
coagulation for sterilization procedures. Do
not use the LigaSure system for these
procedures. |
| Design | Pistol Grip with Shaft and curved jaw | Pistol Grip with Shaft and curved jaw | Pistol Grip with Shaft and curved jaw |
| Size Range | 5mm diameter in lengths of 23, 37, 44cm | 5mm diameter in lengths of 23, 37, 44cm | 5mm diameter in length of 30cm |
| Output mode
and name | Bipolar Sealing = POWERSEAL (Coag) | Bipolar Sealing = LigaSure (Coag) | Bipolar Sealing = LigaSure (Coag) |
| Sterility, single
patient use,
disposable | Yes | Yes | Yes |
12
K203682 Electrosurgical Generator ESG-400 and Accessories Olympus Winter & Ibe GmbH
Table 10: Subject and Predicate comparison table
13
Substantial Equivalence
ESG-400 Generator
Substantial equivalence is demonstrated by acknowledged verification/validation methodologies. The subject device is a modified version of the predicate device ESG400 (K141225) and has equivalent technology, performance, dimensions and materials. The difference to the predicate device ESG-400 is:
- The newly implemented bipolar coagulation mode to support the POWERSEAL technology to be used with sealing instruments for open and laparoscopic surgery.
Regarding the additionally implemented bipolar coagulation mode "POWERSEAL". one reference devices has been chosen, because of its specific output mode. For this reference devices the substantial equivalence is demonstrated by acknowledged verification/ validation methodologies. The reference device has equivalent technology and performance in respect to the compared mode.
POWERSEAL Sealer and Divider
In establishing substantial equivalence of the subject POWERSEAL Sealer and Divider to the predicate Ligasure Maryland devices, an evaluation of the indications for use, intended use and technological characteristics was conducted. The subject and predicate devices have similar technology, performance, dimensions and materials. Performance testing confirmed that the subject device is as safe and effective as the predicate device for the proposed indications for use.
Performance Testing
The following performance data were provided in support of the substantial equivalence determination. All standards applied are FDA recognized conformance standards.
For the ESG-400 Generator, 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.
For the POWERSEAL Sealer and Divider, all data was prepared in accordance with the following FDA guidance documents: "Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery" Guidance for Industry and Food and Drug Administration Staff, issued on August 15, 2016; and "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgerv" Guidance for Industry and Food and Drug Administration Staff, issued on March 9, 2020. The guidance documents were followed for all relevant sections.
14
Biocompatibility testing
ESG-400 Generator
The ESG-400 and its accessories do not contain components that come directly or indirectly in patient contact. Biocompatibility testing according to ISO 10993 is not required.
POWERSEAL Sealer and Divider
In accordance with ISO 10993-1 and the 2016 FDA guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", the subject devices met all acceptance criteria for the following biocompatibility evaluations:
| Cytotoxicity | ISO 10993-5:2009 Biological Evaluation of Medical Devices, Part
5: Tests for In Vitro Cytotoxicity |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Material Mediate Pyrogen | ISO 10993-11:2017. Biological Evaluation of Medical Devices, Part
11: Tests for Systemic Toxicity. |
| ISO Acute Systemic
Injection Test | ISO 10993-11: 2017 Biological Evaluation of Medical Devices Part
11: Tests for Systemic Toxicity. |
| ISO Intracutaneous Irritation
Test | ISO 10993-10: 2010 Standard, Biological Evaluation of Medical
Devices, Part 10: Tests for
Irritation and Skin Sensitization. |
| ISO Guinea Pig
Maximization Sensitization | ISO 10993-10:2010. Biological Evaluation of Medical Devices,
Part 10: Tests for Irritation and Skin Sensitization. |
Sterilization and Shelf Life Discussion
ESG-400 and accessories
The ESG-400 generator and its accessories are not provide sterile. They are reusable devices.
POWERSEAL Sealer and Divider
Sterilization testing for the POWERSEAL Sealer and Divider was conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". Stability evaluation for the sterile packaging and for product performance supports the three year shelf life. Accelerated aging test was conducted as required per ISO 11607-1 and in accordance with ASTM F1980-16, the standard guide for accelerated aging of sterile barrier systems for medical devices.
15
Electrical safety and electromagnetic compatibility (EMC)
Basic safety and performance testing was performed in accordance with IEC standards. The design of the subject ESG-400 and footswitches and the subject POWERSEAL Sealer and Divider comply with recognized standards as listed in Table 11, respectively.
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
The design of the subject ESG-400 Generator and the subject POWERSEAL Sealer and Divider, comply with recognized standards as listed in Table 11.
Clinical and Animal Studies
Clinical studies were not necessary for the subject devices.
Animal Studies, including Acute and Chronic testing conducted demonstrate substantial equivalence of the subject POWERSEAL Sealer and Divider to the predicate device.
All data was prepared in accordance with the FDA guidance. "Premarket Notification (510/k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgerv" Guidance for Industry and Food and Drug Administration Staff, issued on August 15, 2016; and "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 documents were followed for all relevant sections.
| Test | Contents |
|---|---|
| Chronic Animal Study | Chronic animal study was conducted on |
| both the subject and predicate devices to | |
| demonstrate seal performance | |
| Acute Animal Study | Acute animal study was conducted on |
| both the subject and predicate devices to | |
| demonstrate seal performance and | |
| safety |
16
Software
The software validation activities were performed for the subject ESG-400 Generator in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", issued May 11, 2005. The device software is considered a "Major Level of Concern".
The output modes of the subject device to the predicate device (K141225) have not been changed. Software regression tests confirmed that existing functionalities are not influenced and remain unaffected/ unchanged by the addition of the new coagulation mode. The electrical waveforms of these "predicate modes" have been verified.
The POWERSEAL Sealer and Divider does not contain software.
Performance Testing Bench
Verification and comparison bench studies were conducted to evaluate the functional performance of the newly implemented "POWERSEAL" mode. Ex-vivo Vessel Burst Pressure testing was conducted on both the subject and predicate devices to demonstrate vessel sealing performance.
Testing demonstrated that the performance requirements defined in the User Requirements Specification and Design Specification were met for both subject devices, and that they exhibit comparable performance characteristics to the predicate device and reference devices.
Bench testing results support the claim of substantial equivalence of the subject ESG400 and the subject POWERSEAL Sealer and Divider, to the predicate and reference devices.
The following non-clinical and preclinical tests were conducted:
-
- non-clinical (electrical, mechanical, functional)
-
- preclinical (simulated use) evaluation and testing of tissue effects and thermal safety and vessel burst pressure testing and vessel thermal margin
Usability and user interface were also assessed according to the risk management plan. 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.
17
Reprocessing
Required cleaning, disinfecting and drying procedures are described in the instructions for use for the ESG-400 Generator and accessories.
The POWERSEAL Sealer and Divider is provided sterile, for single-use. It is not intended to be reprocessed.
| Standard No. | Standard Title | FDA-Recognition
no + date | Applicability |
|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|------------------------------------------------|
| 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) | 19-4
07/09/2014 | -ESG-400 Generator
-POWERSEAL
Instrument |
| IEC 60601-1-
2 Ed. 4.0:
2014 | Medical electrical equipment - Part 1-2:
General requirements for basic safety and
essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements
and tests | 19-8
09/17/2018 | -ESG-400 Generator
-POWERSEAL
Instrument |
| 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
08/06/2013 | -ESG-400
-POWERSEAL
Instrument |
| IEC 60601-2-
2 Ed. 6.0:
2017 | 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 | 6-389
08/21/2017 | -ESG-400 Generator
-POWERSEAL
Instrument |
| IEC
62304
Ed. 1.1
2015
consolidated version | Medical device software - Software life cycle
processes | 13-79
01/14/2019 | -ESG-400 |
| IEC 60601-1-
6 Ed. 3.1:
2013 | Medical electrical equipment Part 1-6: General
requirements for basic safety and essential
performance - Collateral standard:
Usability | 5-89
06/27/2016 | -ESG-400 |
| IEC 62366-1
Edition 1.0
2015 | Medical devices - Part 1: Application of
usability engineering to medical devices
[Including CORRIGENDUM 1 (2016)] | 5-114
12/23/2016 | -ESG-400 Generator
-POWERSEAL
Instrument |
| ISO 14971 second
edition 2007/2019 | Medical devices – Application of risk
management to medical devices | 5-40
06/27/2016 | -ESG-400 Generator
-POWERSEAL |
| | | | Instrument |
| ISO 11135: 2014 | Sterilization of health care products - Ethylene
oxide - Requirements for development,
validation and routine control of a sterilization
process for medical devices. | 14-529
07/15/2019 | -POWERSEAL
Instrument |
| ISO 11607-1
Second edition 2019-
02 | Packaging for terminally sterilized medical
devices - Part 1: Requirements for materials,
sterile barrier systems and packaging systems | 14-530
07/15/2019 | -POWERSEAL
Instrument |
| ASTM F1980-16 | Standard Guide for Accelerated Aging of
Sterile Barrier Systems for Medical Devices | 14-497
12/23/2016 | -POWERSEAL
Instrument |
| ISO 10993-5: 2009 | Biological Evaluation of Medical Devices,
Part 5: Tests for In Vitro Cytotoxicity | 2-245
12/23/2016 | -POWERSEAL
Instrument |
| Standard No. | Standard Title | FDA-Recognition
no +
date | Applicability |
| ISO 10993-10: 2010 | Biological Evaluation of Medical Devices,
Part 10: Tests for
Irritation and Skin Sensitization | 2-174
07/26/2016 | -POWERSEAL
Instrument |
| ISO 10993-11: Third
edition 2017-09 | Biological Evaluation of Medical Devices,
Part 11: Tests for Systemic Toxicity | 2-255
09/17/2018 | -POWERSEAL
Instrument |
| ISO 10993-7: Second
edition 2008-10-15 | Biological evaluation of medical devices -
Part 7: Ethylene oxide sterilization residuals | 14-408
01/30/2014 | -POWERSEAL
Instrument |
| ISO 10993-18:2020 | Biological evaluation of medical devices —
Part 18: Chemical characterization of medical
device materials within a risk management
process | 2-276
07/06/2020 | -POWERSEAL
Instrument |
Applied standards
18
K203682 Electrosurgical Generator ESG-400 and Accessories Olympus Winter & Ibe GmbH
Traditional 510(k) Notification
Table 11: Applied standards
Conclusion
The performance data supports the safety of the device and demonstrate that the subject devices comply with the recognized standards as specified.
In summary, Olympus believes the ESG-400 Generator and accessories and the POWERSEAL Sealer and Divider are substantially equivalent to the predicate devices with respect to the general design approach, function, and the intended use. The subject ESG-400 Generator and the POWERSEAL Sealer and Divider raise no new concerns of safety or effectiveness when compared to the predicates and the reference devices.