(151 days)
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 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 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 features a touch screen GUI that displays current settings, connection status, and allows access to menus for editing settings, procedures, and preferences. Compatible accessories include previously cleared footswitches.
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 POWERSEAL devices are 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. The jaws 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 opens and closes the jaws. A second control initiates bipolar energy delivery for sealing. A separate control activates a blade for tissue division.
The provided text details the 510(k) submission for the Olympus Electrosurgical Generator ESG-400 and Accessories, and the POWERSEAL Curved Jaw Sealer and Divider, Double Action. The study described focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and proving direct performance against them in a traditional sense. The performance data provided is primarily in the context of comparative testing to established predicate devices.
Here's an attempt to extract the information requested, with indications where the information is not explicitly available in the provided document:
1. Table of acceptance criteria and the reported device performance
The document doesn't explicitly state specific numerical acceptance criteria for performance metrics (e.g., burst pressure in mmHG, or a specific range for coagulation time). Instead, it states that the device "met all acceptance criteria" for biocompatibility and that "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."
The performance is described qualitatively as being "comparable" or having "equivalent technology and performance" to predicate/reference devices. For example, for vessel sealing, the key performance indicator mentioned is "vessel burst pressure testing."
Therefore, a table of acceptance criteria and reported numerical performance values cannot be fully constructed from the provided text in the typical quantitative manner.
Table 1: Acceptance Criteria and Reported Device Performance (as inferred and stated qualitatively)
| Performance Aspect | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (Qualitative Statement) |
|---|---|---|
| Biocompatibility | Met all criteria of ISO 10993 | Met all acceptance criteria for Cytotoxicity, Material Mediate Pyrogen, ISO Acute Systemic Injection Test, ISO Intracutaneous Irritation Test, ISO Guinea Pig Maximization Sensitization |
| Electrical Safety & EMC | Compliance with IEC standards | Design of subject devices comply with recognized standards (AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-2) |
| Thermal Safety | Compliance with recognized standards | Design of subject devices comply with recognized standards (referencing Table 11, which includes IEC 60601-1, IEC 60601-2-2) |
| Software Validation | Compliance with FDA Guidance for "Major Level of Concern" | Software validation activities performed; existing functionalities not influenced by new mode; electrical waveforms of "predicate modes" verified. |
| Vessel Sealing Performance | Comparable to predicate devices in animal and bench tests | Demonstrated substantial equivalence to predicate device in chronic and acute animal studies. Performance requirements met, comparable to predicate and reference devices in ex-vivo vessel burst pressure testing. |
| Shelf Life and Sterilization | Compliance with ISO 11607-1, ASTM F1980-16, ISO 11135 | Stability evaluation supports three-year shelf life; accelerated aging test conducted as required. |
| Risk Management | Acceptable residual risk per ISO 14971 | Risk analysis carried out, residual risk evaluated as acceptable. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document does not specify exact sample sizes for the "test set" in terms of number of cases or samples for the animal studies or bench testing (e.g., how many vessels were sealed for burst pressure testing). It only states that "ex-vivo Vessel Burst Pressure testing was conducted."
- Data Provenance (Country of Origin, Retrospective/Prospective): Not explicitly stated. The studies were likely conducted in a controlled lab or animal facility. The document refers to FDA guidance documents, which are for U.S. regulatory submissions, but doesn't specify where the actual testing took place. It also doesn't specify if the animal studies or bench tests were retrospective or prospective, though performance testing is generally prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information (number of experts, their qualifications, and their role in establishing ground truth) is typically related to clinical studies involving human interpretation or pathology. The reported studies are primarily bench (ex-vivo) and animal studies. Therefore, this information is not applicable in the context of the provided document. The "ground truth" for these studies would be objective measurements (e.g., burst pressure from instrumentation) rather than expert consensus on clinical findings.
4. Adjudication method for the test set
This is also typically relevant for clinical studies with human interpretation. For bench and animal studies (e.g., measuring vessel burst pressure), the "adjudication" is typically through objective measurements and statistical analysis, not a consensus process among experts as described by methods like 2+1 or 3+1. Therefore, this information is not applicable in the context of the provided document.
5. 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
- MRMC Study Done: No. This study is for an electrosurgical device, not an AI-assisted diagnostic tool involving human readers.
- Effect Size of Human Readers: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable to this type of device. The device itself is an electrosurgical tool, not an algorithm, and it is used by a human surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance testing, the ground truth was established through objective physical measurements in bench and animal studies:
- Biocompatibility: In vitro and in vivo (animal tissue/systems) tests following ISO 10993 standards.
- Electrical/Thermal Safety & EMC: Measurements against IEC standards.
- Vessel Sealing Performance: Chronic and acute animal studies demonstrating seal performance, and ex-vivo vessel burst pressure testing. The "ground truth" here would be the measured burst pressure values and observed tissue effects.
8. The sample size for the training set
The document describes an electrosurgical device, not a machine learning or AI algorithm in the context of diagnostic imaging. Therefore, the concept of a "training set" in this context is not applicable. The "training" for such a device involves engineering design, prototyping, and testing against specifications and regulatory standards.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm being developed.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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 GmbHKuehnstr. 6122045 Hamburg GermanyEstablishment Registration Number: 9610773 |
|---|---|
| Manufacturer (POWERSEALSealer and Divider) | Olympus Surgical Technologies America9600 Louisiana Ave. NorthBrooklyn Park, MN 55455USAEstablishment Registration Number: 3011050570 |
| Official Correspondent: | Christina Flores, RACManager, Regulatory AffairsOlympus Surgical Technologies America118 Turnpike RoadSouthborough, MA 01772Phone: 508.808-3341Email: christina.flores@olympus.comEstablishment Registration Number: 3003790304 |
| Device Identification | |
| Proprietary names: | Electrosurgical Generator ESG-400POWERSEAL Curved Jaw Sealer and Divider,Double Action (PS-0523CJDA, PS-0537CJDA, PS-0544CJDA) |
| Device Classification name: | Electrosurgical cutting and coagulation device andaccessories |
| Regulation Medical Specialty: | General & Plastic Surgery |
| Regulations Number:Regulatory class: | 21 CFR 878.4400Class 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 ElectrosurgicalPlatform | 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-StepSealer/Divider, Curved | Covidien | K141153 |
| Reference device | Manufacturer | 510(k) No |
| Ligasure Maryland Jaw ThoracicSealer/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 DeviceCOVIDIEN Valleylab™ FT10Electrosurgical 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 DevicePOWERSEAL Sealer and Divider | Predicate DeviceLigaSure Maryland Jaw Sealer/Divider(#K141153) | Reference DeviceLigasure Maryland Jaw ThoracicSealer/Divider One-Step Sealing, Nano-Coated (#K181085) |
|---|---|---|---|
| Indications forUse | The POWERSEAL Sealer and Divider is a bipolarelectrosurgical device intended for use inlaparoscopic/minimally invasive or open surgicalprocedures where ligation and division of vessels,tissue bundles, and lymphatics is desired.POWERSEAL devices can be used on vessels(arteries and veins, pulmonary arteries, pulmonaryveins) up to and including 7 mm, lymphatics, andtissue bundles. POWERSEAL devices areindicated for use in general surgery and suchsurgical 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 POWERSEALSealer and Divider has not been shown to beeffective for tubal sterilization or tubal coagulationfor sterilization procedures. Do not use thePOWERSEAL devices for these procedures. | The LigaSure Sealer/Divider is a bipolarelectrosurgical instrument intended for usein minimally invasive or open surgicalprocedures where ligation and division ofvessels, tissue bundles, and lymphatics isdesired. The LigaSure Sealer/Divider can beused on vessels (arteries and veins) up to andincluding 7 mm. It is indicated for use ingeneral surgery and such surgicalspecialities as urologic, vascular, thoracic,and gynecologic. Procedures may include,but are not limited to, Nissen fundoplication,colectomy, cholecystectomy, adhesiolysis,hysterectomy, oophorectomy, etc. TheLigaSure system has not been shown to beeffective for tubal sterilization or tubalcoagulation for sterilization procedures. Donot use the LigaSure system for theseprocedures. | The LigaSure Sealer/Divider is a bipolarelectrosurgical instrument intended for use inminimally invasive or open surgicalprocedures where ligation and division ofvessels, tissue bundles, and lymphatics isdesired. The LigaSure Sealer/Divider can beused on vessels (arteries and veins, pulmonaryarteries, pulmonary veins) up to and including7 mm. It is indicated for use in generalsurgery and such surgical specialities asurologic, vascular, thoracic, and gynecologic.Procedures may include, but are not limitedto. Nissen fundoplication, colectomy,cholecystectomy, adhesiolysis, hysterectomy,oophorectomy, etc.The LigaSure system has not been shown tobe effective for tubal sterilization or tubalcoagulation for sterilization procedures. Donot use the LigaSure system for theseprocedures. |
| 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 modeand name | Bipolar Sealing = POWERSEAL (Coag) | Bipolar Sealing = LigaSure (Coag) | Bipolar Sealing = LigaSure (Coag) |
| Sterility, singlepatient 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, Part5: Tests for In Vitro Cytotoxicity |
|---|---|
| Material Mediate Pyrogen | ISO 10993-11:2017. Biological Evaluation of Medical Devices, Part11: Tests for Systemic Toxicity. |
| ISO Acute SystemicInjection Test | ISO 10993-11: 2017 Biological Evaluation of Medical Devices Part11: Tests for Systemic Toxicity. |
| ISO Intracutaneous IrritationTest | ISO 10993-10: 2010 Standard, Biological Evaluation of MedicalDevices, Part 10: Tests forIrritation and Skin Sensitization. |
| ISO Guinea PigMaximization 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 onboth the subject and predicate devices todemonstrate seal performance |
| Acute Animal Study | Acute animal study was conducted onboth the subject and predicate devices todemonstrate seal performance andsafety |
{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-Recognitionno + date | Applicability |
|---|---|---|---|
| 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 essentialperformance (IEC 60601-1:2005, MOD) | 19-407/09/2014 | -ESG-400 Generator-POWERSEALInstrument |
| IEC 60601-1-2 Ed. 4.0:2014 | Medical electrical equipment - Part 1-2:General requirements for basic safety andessential performance - Collateral Standard:Electromagnetic disturbances - Requirementsand tests | 19-809/17/2018 | -ESG-400 Generator-POWERSEALInstrument |
| IEC 60601-1-8 Ed. 2.1:2012 | Medical electrical equipment - Part 1-8:General requirements for basic safety andessential performance - Collateral Standard:General requirements, tests and guidance foralarm systems in medical electrical equipmentand medical electrical systems | 5-7608/06/2013 | -ESG-400-POWERSEALInstrument |
| IEC 60601-2-2 Ed. 6.0:2017 | Medical electrical equipment - Part 2-2:Particular requirements for the basic safety andessential performance of high frequencysurgical equipment and high frequencysurgical accessories | 6-38908/21/2017 | -ESG-400 Generator-POWERSEALInstrument |
| IEC62304Ed. 1.12015consolidated version | Medical device software - Software life cycleprocesses | 13-7901/14/2019 | -ESG-400 |
| IEC 60601-1-6 Ed. 3.1:2013 | Medical electrical equipment Part 1-6: Generalrequirements for basic safety and essentialperformance - Collateral standard:Usability | 5-8906/27/2016 | -ESG-400 |
| IEC 62366-1Edition 1.02015 | Medical devices - Part 1: Application ofusability engineering to medical devices[Including CORRIGENDUM 1 (2016)] | 5-11412/23/2016 | -ESG-400 Generator-POWERSEALInstrument |
| ISO 14971 secondedition 2007/2019 | Medical devices – Application of riskmanagement to medical devices | 5-4006/27/2016 | -ESG-400 Generator-POWERSEAL |
| Instrument | |||
| ISO 11135: 2014 | Sterilization of health care products - Ethyleneoxide - Requirements for development,validation and routine control of a sterilizationprocess for medical devices. | 14-52907/15/2019 | -POWERSEALInstrument |
| ISO 11607-1Second edition 2019-02 | Packaging for terminally sterilized medicaldevices - Part 1: Requirements for materials,sterile barrier systems and packaging systems | 14-53007/15/2019 | -POWERSEALInstrument |
| ASTM F1980-16 | Standard Guide for Accelerated Aging ofSterile Barrier Systems for Medical Devices | 14-49712/23/2016 | -POWERSEALInstrument |
| ISO 10993-5: 2009 | Biological Evaluation of Medical Devices,Part 5: Tests for In Vitro Cytotoxicity | 2-24512/23/2016 | -POWERSEALInstrument |
| Standard No. | Standard Title | FDA-Recognitionno +date | Applicability |
| ISO 10993-10: 2010 | Biological Evaluation of Medical Devices,Part 10: Tests forIrritation and Skin Sensitization | 2-17407/26/2016 | -POWERSEALInstrument |
| ISO 10993-11: Thirdedition 2017-09 | Biological Evaluation of Medical Devices,Part 11: Tests for Systemic Toxicity | 2-25509/17/2018 | -POWERSEALInstrument |
| ISO 10993-7: Secondedition 2008-10-15 | Biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals | 14-40801/30/2014 | -POWERSEALInstrument |
| ISO 10993-18:2020 | Biological evaluation of medical devices —Part 18: Chemical characterization of medicaldevice materials within a risk managementprocess | 2-27607/06/2020 | -POWERSEALInstrument |
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.
§ 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.