← Product Code [PDG](/submissions/SU/subpart-e%E2%80%94surgical-devices/PDG) · K123212 # ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS (K123212) _Ethicon Endo-Surgery, LLC · PDG · Mar 8, 2013 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDG/K123212 ## Device Facts - **Applicant:** Ethicon Endo-Surgery, LLC - **Product Code:** [PDG](/submissions/SU/subpart-e%E2%80%94surgical-devices/PDG.md) - **Decision Date:** Mar 8, 2013 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4400 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use The Ethicon Endo Surgery ENSEAL® G2 Cordless Curved Jaw Tissuc Sealers are intended for use during open or laparoscopic, general and gynccological surgery to cut and scal vessels, cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic general, gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and scaling), tissue grasping and dissection are performed. The devices can be used on vessels up to (and including) 7mm and bundles as large as will fit in the jaws of the instruments. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures. ## Device Story Sterile, single-use, cordless RF electrosurgical instrument; powered by integrated Lithium Ion Polymer (LiPo) battery; eliminates need for external generator. Device features 3mm curved jaw with I-blade knife; operated by surgeon during open or laparoscopic procedures. User squeezes closing handle to grasp/clamp tissue; pressing energy activation button delivers bipolar RF energy to seal vessels; full handle closure advances I-blade to transect tissue. PTC technology regulates energy delivery. Benefits include cordless mobility, integrated power, and efficient vessel ligation/dissection. Device is self-contained; no user-rechargeable components. ## Clinical Evidence No human clinical studies. Evidence based on bench testing, electrical safety, biocompatibility, vessel burst pressure testing, and animal acute/survival studies. Testing demonstrated performance equivalent to predicate devices. ## Technological Characteristics Bipolar electrosurgical instrument; 3mm curved jaw; 14cm, 35cm, 45cm shaft lengths; 5mm shaft diameter. Integrated LiPo battery power source; PTC (Positive Temperature Coefficient) technology for energy regulation. Mechanical I-blade knife for transection. Single-patient use, sterile. ## Regulatory 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. ## Predicate Devices - ENSEAL Vessel Sealing and Hemostasis System ([K072177](/device/K072177.md)) - ENSEAL Vessel Sealing and Hemostasis System ([K072493](/device/K072493.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K123212 Page 1 of 3 Ethicon Endo-Surgery, LLC 510(k) Premarket Notification (Traditional) ENSEAL® G2 Cordless Tissue Sealer # 510(k) Summary Ethicon Endo-Surgery, LLC Company 475 Calle C Guaynabo, PR 00969 Contact Liping Wu, MD, PhD, RAC Regulatory Affairs Associate II Ethicon Endo-Surgery, Inc. Telephone: (513) 337-3135 Fax: (513) 337-2930 Email: LWu@its.jnj.com Date Prepared March 5, 2013 #### Device Name Trade Name: Ethicon Endo- Surgery ENSEAL G2 Cordless Curved Jaw Tissue Sealer Common Name: Electrosurgical Cutting and Coagulating Instrument # Classification Names - · Electrosurgical, Cutting & Coagulation & Accessories (21 CFR 878.4400, Product Code PDG) - · Electrocautery, Gynecologic and Accessories (21 CFR 884.4120, Product Code HGI) # Predicate Devices ENSEAL Vessel Sealing and Hemostasis System cleared under K072177 on August 29, 2007 and K072493 cleared on September 5, 2007. The ENSEAL Vessel Sealing and Hemostasis System include ENSEAL Bipolar Electrosurgical Sealing Devices and an Electrosurgical Generator. #### Device Description: The Ethicon Endo-Surgery ENSEAL G2 Cordless Curved Jaw Tissue Sealer is a sterile, single patient use, self-contained, disposable RF electrosurgical instrument. The cordless hand-held device is powered by a Lithium Ion Polymer (LiPo) battery with an RF (radiofrequency) generator integrated into the device handle and does not require connection to an external generator or power source. The integrated generator provides the required RF energy to seal vessels during a surgical procedure. The battery is a DC power source that is charged during manufacturing; the battery cannot be removed from the device, or be recharged by the user. The device is configured with 3mm curved jaw and is intended to cut, grasp and dissect soft tissue, and coagulate and transect vessels up to and including 7mm in diameter. MAR 8 2013 {1}------------------------------------------------ ENSEAL® G2 Cordless Tissue Sealer ### Indications for Use: The EES ENSEAL G2 Cordless Curved Jaw Tissue Sealers are intended for use during open or laparoscopic, general and gynecological surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic general, gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection are performed. The devices can be used on vessels up to (and including) 7mm and bundles as large as will fit in the jaws of the instruments. The devices have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures. ## Technological Characteristics: The Ethicon Endo-Surgery ENSEAL G2 Cordless Curved Jaw Tissue Sealers are configured with curved jaws and are intended to coagulate and transect vessels. The instrument consists of a grip housing assembly, a rotating shaft, and a moveable jaw with an I-blade™ knife in the tip. The devices will be available in 14cm, 35cm and 45cm shaft length options, and the instruments can be rotated 360° to facilitate visualization and enable easy access to targeted tissue. The jaw is curved in a normally opened position and can be partially or fully closed by squeezing the Closing Handle. The jaw has teeth for grasping and holding targeted tissue when clamped. Bipolar energy is delivered to the clamped tissue when the Energy Activation Button is pressed. Full activation of the Closing Handle advances the I-blade™ the length of the jaws, and the targeted tissue is compressed, coagulated, and transected. The I-blade™ knife cannot be advanced to transect tissue without fully pressing the Energy Activation Button. | Technological
Characteristic | Predicate Devices
(K072177 and K072493) | Subject Device ENSEAL
G2 Cordless Curved
Tissue Sealer | |---------------------------------|--------------------------------------------------------|--------------------------------------------------------------| | | Energy type | Bipolar | | Jaw shape | Curved 3 mm | Curved 3mm | | Shaft lengths | 14 cm, 35 cm, 45 cm | 14 cm, 35 cm, 45 cm | | Shaft diameter | 5 mm | 5 mm | | I-blade | Yes | Yes | | PTC technology | Yes | Yes | | Energy Source | Generator | Battery | | Function | Cut and seal vessels, cut,
grasp and dissect tissue | Cut and seal vessels, cut,
grasp and dissect tissue | Comparison of Technological Characteristics {2}------------------------------------------------ ENSEAL® G2 Cordless Tissue Sealer ## Performance Data: Bench testing and laboratory evaluations in an animal model were conducted to demonstrate that the Ethicon Endo-Surgery ENSEAL G2 Cordless Curved Jaw Tissue Sealers perform as intended. Biocompatibility studies, electrical safety studies, software validation, vessel burst pressure testing and animal acute and survival studies were performed comparing the predicate device to the subject device to support the determination of substantial equivalence. Clearance was not based on human clinical studies. ## Conclusions Based on performance testing and functional similarities to the predicate devices, the Ethicon Endo-Surgery ENSEAL G2 Cordless Curved Jaw Tissue Sealer devices are substantially equivalent to the predicate devices. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle. #### DEPARTMENT OF HEALTH & HUMAN SERVICES #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 8, 2013 Ethicon Endo-Surgery, LLC % Ethicon Endo-Surgery, Incorporated Liping Wu, MD, PhD, RAC Regulatory Affairs Associate II 4545 Creek Road Cincinnati, Ohio 45242 Re: K123212 Trade/Device Name: Ethicon Endo Surgery ENSEAL G2 Cordless Curved Jaw Tissue Sealers Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: PDG, HGI Dated: February 11, 2013 Received: February 13, 2013 Dear Liping Wu: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 {4}------------------------------------------------ Page 2 - Liping Wu, MD, PhD, RAC CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, For # Peter D库Ruimm -S Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Page 1 of 1. Ethicon Endo-Surgery, LLC 510(k) Premarket Notification (Traditional) ENSEAL® G2 Cordless Tissuc Scaler Indications for Use 510(k) Number (if known): J. 123212 Device Name: Ethicon Endo Surgery ENSEAL G2 Cordless Curved Jaw Tissue Sealers Indications for Use: The Ethicon Endo Surgery ENSEAL® G2 Cordless Curved Jaw Tissuc Sealers are intended for use during open or laparoscopic, general and gynccological surgery to cut and scal vessels, cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic general, gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and scaling), tissue grasping and dissection are performed. The devices can be used on vessels up to (and including) 7mm and bundles as large as will fit in the jaws of the instruments. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Long H. Chen -A # for MXM (Division Sign-Off) Division of Surgical Devices 510(k) Number K123212 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDG/K123212](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDG/K123212) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com