K Number
K123212
Device Name
ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS
Date Cleared
2013-03-08

(144 days)

Product Code
Regulation Number
878.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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 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.
More Information

Not Found

No
The document describes a standard electrosurgical tissue sealer and does not mention any AI or ML components or functionalities.

Yes
The device is described as an electrosurgical instrument used for cutting, sealing, grasping, and dissecting tissue and vessels during surgical procedures, which are therapeutic actions.

No
The device is described as an electrosurgical instrument intended for cutting, grasping, dissecting tissue, and sealing vessels during surgical procedures. Its function is interventional, not diagnostic.

No

The device description clearly states it is a "sterile, single patient use, self-contained, disposable RF electrosurgical instrument" with an integrated RF generator and battery, indicating it is a hardware device. While software validation is mentioned, it is part of the overall device validation, not the sole component.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
  • Device Function: The Ethicon Endo Surgery ENSEAL G2 Cordless Curved Jaw Tissue Sealers are described as surgical instruments used during surgery to cut, seal, grasp, and dissect tissue and vessels within the body.
  • Lack of Specimen Examination: The device does not examine specimens outside of the body. Its function is performed directly on tissues and vessels during a surgical procedure.

Therefore, the intended use and function of this device clearly fall outside the scope of an In Vitro Diagnostic.

N/A

Intended Use / 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.

Product codes

PDG, HGI

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.

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 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K072177, K072493

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

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