(144 days)
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.
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.
The ENSEAL G2 Cordless Curved Jaw Tissue Sealer is a medical device designed for cutting, grasping, dissecting, and sealing tissue and vessels during surgical procedures. The provided 510(k) summary outlines the performance data used to demonstrate its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define "acceptance criteria" in a quantitative manner as typically seen for AI/ML device performance. Instead, it demonstrates performance through comparative testing against predicate devices. The implicit acceptance criterion is that the subject device performs comparably to the predicate devices in key areas.
| Performance Metric/Characteristic | Acceptance Criteria (Implicit: Comparable to Predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| Biocompatibility | Met for predicate devices | Met |
| Electrical Safety | Met for predicate devices | Met |
| Software Validation | Met for predicate devices | Met |
| Vessel Burst Pressure | Comparable to predicate devices | Comparable to predicate devices |
| Acute Animal Studies | Comparable to predicate devices | Comparable to predicate devices |
| Survival Animal Studies | Comparable to predicate devices | Comparable to predicate devices |
Note: The document states, "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." This implies that the observed performance of the subject device met the unstated acceptance criteria of being "comparable to" or "not worse than" the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes for each test (e.g., number of vessels tested for burst pressure, number of animals in acute/survival studies). It refers to "bench testing and laboratory evaluations in an animal model."
- Data Provenance: The studies were conducted in an "animal model," indicating prospective animal studies and bench testing (in vitro/ex vivo). The country of origin of the data is not specified, but the applicant is Ethicon Endo-Surgery, LLC, with a contact in the US (Cincinnati, Ohio), suggesting the studies were likely conducted in the US or under their oversight.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of device (electrosurgical instrument) does not typically involve human experts establishing "ground truth" in the same way an AI diagnostic device would. Instead, performance is measured objectively through physical characteristics or physiological outcomes.
- Ground Truth Establishment: For vessel burst pressure, acute, and survival animal studies, the "ground truth" is likely established by objective measurements (e.g., pressure readings, histological analysis, observation of physiological outcomes). These measurements would be performed by trained lab personnel, veterinarians, and potentially pathologists, but not "experts" in the context of diagnostic image interpretation.
- Qualifications: Not specified, but implied to be qualified laboratory and veterinary professionals involved in preclinical testing.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "ground truth" for this device's performance studies is based on objective measurements and physiological outcomes, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices where human readers interpret data, often with and without AI assistance, to assess the impact of AI on reader performance. The ENSEAL G2 is an electrosurgical instrument, not a diagnostic device, so an MRMC study is not applicable.
6. Standalone Performance Study (Algorithm Only)
Not applicable. The ENSEAL G2 is a physical medical device (an electrosurgical instrument), not an AI algorithm. Its performance is inherent to the device itself and its interaction with tissue, not a standalone algorithm.
7. Type of Ground Truth Used
The "ground truth" used for performance evaluation includes:
- Objective Measurements: For bench testing (e.g., vessel burst pressure, electrical parameters).
- Physiological/Pathological Outcomes: In acute and survival animal studies (e.g., tissue healing, integrity, adverse events, histological assessment).
8. Sample Size for the Training Set
Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm that learns from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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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
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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.
| TechnologicalCharacteristic | Predicate Devices(K072177 and K072493) | Subject Device ENSEALG2 Cordless CurvedTissue 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
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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.
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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
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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
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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
§ 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.