(116 days)
Not Found
No
The summary describes a bipolar electrosurgical instrument for cutting and sealing tissue, with no mention of AI or ML capabilities.
No
The device is described as an electrosurgical instrument for cutting and sealing tissue during surgery, which is a surgical tool rather than a therapeutic device.
No
This device is designed for therapeutic purposes, specifically for bipolar coagulation and mechanical transection of tissue during surgical procedures, not for identifying or investigating the nature or cause of a disease.
No
The device description clearly states it is a hand-actuated instrument with a shaft and tissue effector, indicating it is a physical hardware device used for surgical procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures." This describes a surgical instrument used on the patient's body during a procedure.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. The ENSEAL G2 Tissue Sealers do not perform such tests.
- Device Description: The description details a surgical instrument for grasping, coagulating, and transecting tissue, not a device for analyzing biological samples.
The device is a surgical instrument used in vivo (within the living body), not in vitro (in glass or outside the body).
N/A
Intended Use / Indications for Use
The ENSEAL® G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures.
The devices are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic, general and gynecological surgery to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.
Indications for use include open and laparoscopic, general and 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 is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments.
The ENSEAL® G2 Tissue Sealers have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use these devices for these procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI, HGI
Device Description
The Ethicon Endo-Surgery ENSEAL G2 Tissue Sealers are for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The devices allow the surgeon to grasp, coagulate, and transect soft tissue with a single instrument. The devices are hand-actuated with a shaft and tissue effector that can be rotated. The energy delivery can be activated with hand activation or with a foot switch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Bench testing and laboratory evaluations in an animal model including an acute and a 30-day chronic survival study were conducted to demonstrate that the Ethicon Endo-Surgery ENSEAL G2 Tissue Sealers perform as intended.
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.
Not Found
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
Image /page/0/Figure/0 description: The image shows the text 'K11 2033' with a line underneath it. There is also a circled text 'Pg 1 of 2'. The date 'NOV - 8 2011' is visible in the upper right corner of the image. The text appears to be handwritten.
510(k) Summary
Company Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969
Contact Donovan May Regulatory Affairs Associate II Ethicon Endo-Surgery, Inc. Telephone: (513) 337-7981 Fax: (513) 337-2793 Email: dmay3@its.jnj.com
Date Prepared July 14, 2011
Device Name Trade Name: ENSEAL® G2 Tissue Sealers Common Name: Electrosurgical Cutting and Coagulating Instrument
Classification Names
- · Electrosurgical, Cutting & Coagulation & Accessories (21 CFR 878.4400, Product Code GEI)
- · Electrocautery, Gynecologic and Accessories (21 CFR 884.4120, Product Code HGI)
Predicate Devices
ENSEAL Tissue Sealing Devices cleared under K072177 on August 29, 2007 and K072493 on September 5, 2007 as part of the ENSEAL Vessel Sealing and Hemostasis System
Device Description:
The Ethicon Endo-Surgery ENSEAL G2 Tissue Sealers are for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The devices allow the surgeon to grasp, coagulate, and transect soft tissue with a single instrument. The devices are hand-actuated with a shaft and tissue effector that can be rotated. The energy delivery can be activated with hand activation or with a foot switch.
1
K112033
pg 2 of 2
Indications for Use:
The ENSEAL G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures.
The devices are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic, general and gynecological surgery to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.
Indications for use include open and laparoscopic, general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectornies, cholecystectomies, gall bladder procedures. Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments.
The ENSEAL G2 Tissue Sealers have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use these devices for these procedures.
The predicate devices were submitted as part of a surgical system; thus, the Indications for Use statements cleared in the predicate submissions did not contain indication language specific to the function of the electrosurgical instruments except for those included in the labeling. Additionally, the electrosurgical energy type (bipolar) and means of transection (mechanical) were added to the Indications for Use statement for the subject devices. This additional information was added for clarity. These differences in the indications for use do not alter the intended surgical effects or intended use of the subject devices from that of the predicate devices.
Technological Characteristics: The Ethicon Endo-Surgery ENSEAL G2 Tissue Sealers incorporate the same technological characteristics as that of the predicate devices with an ergonomic handle and an integrated energy activation/knife release button. Additionally, a change was made to a patient contacting material of the 3 mm jaw version of the subject devices.
Performance Data: Bench testing and laboratory evaluations in an animal model including an acute and a 30-day chronic survival study were conducted to demonstrate that the Ethicon Endo-Surgery ENSEAL G2 Tissue Sealers perform as intended.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle's perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV - 8 2011
Ethicon Endo-Surgery, Inc. % Mr. Donovan May 4545 Creek Road Cincinnati, Ohio 45242
Re: K112033
Trade/Device Name: ENSEAL® G2 Tissue Sealers Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, HGI Dated: October 07, 2011 Received: October 11, 2011
Dear Mr. May:
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. Iisting 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
3
Page 2 - Mr. Donovan May
CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
cery yours,
N. Melkerson
Mark N. Melk Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K112033
Device Name: ENSEAL® G2 Tissue Sealers
Indications for Use:
The ENSEAL® G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures.
The devices are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic, general and gynecological surgery to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.
Indications for use include open and laparoscopic, general and 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 is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments.
The ENSEAL® G2 Tissue Sealers have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use these devices 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)
Division Sign Off
(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112033
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