ENSEAL X1 Large Jaw Tissue Sealer:
The Enseal® X1 Large Jaw Tissue Sealer instrument is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. It is a bipolar instrument for use with the Ethicon Generator G11 (GEN11). It is intended for use during open surgery to cut and seal vessels, cut, grasp, and dissect tissue during surgery. Indications for use include open general, gynecologic, thoracic, and vascular procedures. These procedures include hysterectomies, colectomies, Nissen fundoplication, adhesiolysis, oo. The devices can be used on vessels (arteries, veins, pulmonary vasculature, lymphatics) up to and including 7 mm and tissue bundles.

The Enseal® X1 Curved Large Jaw instrument 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 efficacy of the Enseal® X1 Curved Large Jaw instrument for the indication of contraceptive tubal coagulation (permanent female sterilization) has not been evaluated and is unknown. The EnSeal® Tissue Sealing Device is significantly different from bipolar designs that are marketed for the indication of contraceptive tubal coagulation. The design differences may affect the efficacy of the procedure and failure rates may not be comparable.

Ethicon Generator 11:
The Generator G11 provides radiofrequency power to drive Enseal electrosurgical instruments that are used during open or laparoscopic general and gynecological surgery to cut and seal vessels and to cut, grasp, and dissect tissues. In addition, the generator provides power to drive Harmonic ultrasonic surgical instruments that are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Enseal and Harmonic instruments when used with the Generator G11 have not been shown to be effective for sterilization procedures or tubal coagulation. Do not use these instruments for these procedures.

Device Description

The Enseal® X1 Large Jaw Tissue Sealer instrument is a sterile, single patient use surgical instrument used to coagulate and transect vessels up to and including 7 mm in diameter, tissue and/or vascular bundles. This device is for soft tissue only. The instrument consists of a grip housing assembly, a rotating shaft, a moveable jaw, and a knife. The instrument shaft can be rotated 360° to facilitate visualization and enable easy access to targeted tissue. The curved jaws are in a normally-opened position and can be partially or fully closed by squeezing the closing handle. The jaws are designed for grasping and holding targeted tissue when clamped. Bipolar energy is delivered when the seal button or MIN foot pedal is pressing the cut button advances the knife the length of the jaws to cut the targeted tissue. It should be noted that this device has independent seal and cut capabilities. The power cord is permanently attached to the device and connects the instrument to the generator.

The device system has three essential components: the generator, the footswitch and the subject device. The Generator 11 supplies energy to the Enseal® electrosurgical instruments and Harmonic® ultrasonic surgical instruments. The generator utilizes a touchscreen display interface and has a receptacle port that accepts either Enseal® or Harmonic® devices. Connectors (one for Enseal® and one for Harmonic® devices) are used to enable the generator to power currently cleared surgical instruments. The Generator 11 hardware has not changed since the predicate device was cleared under K101990. The Enseal® X1 Large Jaw Tissue Sealer instrument is designed for use exclusively with the Ethicon Generator G11 (GEN11) software version 2016-1 or later, which has been updated to increase the maximum Power output to 200W.

AI/ML Overview

The provided FDA 510(k) summary for the Enseal® X1 Large Jaw Tissue Sealer does not describe a study involving an AI/CADe device. Instead, it details the testing and evaluation of a medical device (an electrosurgical instrument and its generator) against a predicate device to demonstrate substantial equivalence for regulatory approval.

Therefore, many of the typical questions for an AI study, such as expert consensus, MRMC studies, standalone performance, and training set details, are not applicable here.

However, I can extract the acceptance criteria and performance data for the electrosurgical device as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria	Reported Device Performance
Bench Testing	Device performs as intended, able to seal and divide vessels up to 7mm. Data generated met predetermined acceptance criteria for maximum, minimum values, standard deviation, and mean for sealed vessel burst tests.	"Data generated from the bench testing met the predetermined acceptance criteria." The device successfully sealed and divided vessels up to 7mm. The maximum and minimum values, standard deviation, and mean were recorded for sealed vessel burst tests.
Acute Animal (Porcine) Testing	No significant difference in tissue effects compared to the predicate device. Ability to seal and divide vessels up to and including 7mm.	"The results of the study demonstrated the ability of the subject device (NSLX120L) to perform as well as the legally identified predicate device." No difference in tissue effects observed. Successfully sealed and divided vessels up to and including 7mm.
Survival Animal (Porcine) Testing	No significant difference in tissue effects compared to the predicate device. Ability to seal and divide vessels up to and including 7mm.	"The results of the study demonstrated the ability of the subject device (NSLX120L) to perform as well as the legally identified predicate device." Tissue effects were not different than the predicate device. Successfully sealed and divided vessels up to and including 7mm.
Sterilization	Sterilization via ethylene oxide to specified sterility assurance level.	Both subject and predicate devices are sterilized via ethylene oxide to the same sterility assurance level.
Biocompatibility	Compliance with ISO 10993:2009 and FDA Blue Book Memorandum #G95-1. Passed specific tests.	The device passed ISO Cytotoxicity, ISO Sensitization, ISO Intracutaneous Reactivity, and ISO Acute Systemic Toxicity tests.
EMC (Electrical Safety and Electromagnetic Compatibility)	Compliance with IEC 60601-1-2:2007 (EMC) and IEC 60601-1:2005 & IEC 60601-2-2:2009 (Electrical Safety).	The system complies with IEC 60601-1-2:2007 for electromagnetic compatibility and IEC 60601-1:2005 and IEC 60601-2-2:2009 for electrical safety.
Software Verification & Validation	Compliance with FDA Guidance for industry and staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "General Principles of Software Validation: Final Guidance for Industry and FDA Staff."	Applicable software verification and validation testing was completed per FDA guidance.

2. Sample Size Used for the Test Set and Data Provenance

Bench Testing: The document states "sealed vessel burst test were evaluated" and involved "evaluation of the devices performance and ability to seal and divide vessels up to 7 mm." Specific sample sizes (e.g., number of vessels tested) are not provided.
Acute Animal (Porcine) Testing: "Testing was performed in an acute animal study." The number of animals or specific test cases is not provided. The data provenance is described as "acute animal study" using "porcine" models. This is prospective animal data.
Survival Animal (Porcine) Testing: "Testing was performed in survival animal studies." The number of animals or specific test cases is not provided. The data provenance is described as "survival animal studies" using "porcine" models. This is prospective animal data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This is not applicable as this is not an AI/CADe study requiring expert interpretation of medical images or data for ground truth. The "ground truth" (or rather, performance validation) was established through direct physical and biological testing (burst pressure, tissue effects, etc.) against pre-defined criteria and comparison to a legally marketed predicate device.

4. Adjudication Method for the Test Set

Not applicable, as this is not an AI/CADe study involving human readers or adjudicators for setting ground truth. Performance was measured directly through physical and biological tests.

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

Not applicable. This is not an AI/CADe device or an MRMC study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as this is not an AI/CADe device. The performance data refers to the standalone performance of the electrosurgical device itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance relies on several methods:

Pre-defined Performance Specifications: For bench testing, criteria related to burst pressure, ability to seal specific vessel sizes, and maintenance of tissue integrity.
Comparative Performance to a Predicate Device: For animal studies, the "ground truth" for "safety and effectiveness" effectively means demonstrating performance "as well as" the legally marketed predicate device, with no significant differences in tissue effects.
Compliance with Standards: For sterilization, biocompatibility, EMC, and software, adherence to established international and FDA standards (ISO, IEC, FDA guidance documents).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/CADe device; there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set for an AI model.

Summary of the Study:

The study was a series of non-clinical tests (bench, acute animal, and survival animal studies) conducted to demonstrate the safety and effectiveness of the Enseal® X1 Large Jaw Tissue Sealer and its Generator 11. The primary objective was to demonstrate substantial equivalence to existing legally marketed predicate devices. The studies focused on physical performance characteristics (e.g., vessel sealing capabilities up to 7mm), tissue effects, and compliance with various regulatory standards (sterilization, biocompatibility, electrical safety, software validation). The device met all predetermined acceptance criteria in these tests, indicating it performed as safely and effectively as the predicate devices. No human clinical trial data was used for this premarket notification.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 9, 2016

Ethicon Endo-Surgery, LLC Mr. David Locke Senior Regulatory Affairs Specialist 4545 Creek Rd Cincinnati, Ohio 45242

Re: K160554

Trade/Device Name: EnSeal X1 Large Jaw Tissue Sealer, Ethicon Generator 11 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, HGI, LFL Dated: August 2, 2016 Received: August 3, 2016

Dear Mr. Locke:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR Part 803); good manufacturing practice requirements as set forth

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in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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

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 Industry and Consumer Education 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,

Christopher J. Ronk -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160554

Device Name EnSeal X1 Large Jaw Tissue Sealer Ethicon Generator 11

Indications for Use (Describe)

ENSEAL X1 Large Jaw Tissue Sealer:

The Enseal® X1 Large Jaw Tissue Sealer instrument is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. It is a bipolar instrument for use with the Ethicon Generator G11 (GEN11). It is intended for use during open surgery to cut and seal vessels, cut, grasp, and dissect tissue during surgery. Indications for use include open general, gynecologic, thoracic, and vascular procedures. These procedures include hysterectomies, colectomies, Nissen fundoplication, adhesiolysis, oo. The devices can be used on vessels (arteries, veins, pulmonary vasculature, lymphatics) up to and including 7 mm and tissue bundles.

(permanent female sterilization) has not been evaluated and is unknown. The EnSeal® Tissue Sealing Device is significantly different from bipolar designs that are marketed for the indication of contraceptive tubal coagulation. The design differences may affect the efficacy of the procedure and failure rates may not be comparable.

Ethicon Generator 11:

The Generator G11 provides radiofrequency power to drive Enseal electrosurgical instruments that are used during open or laparoscopic general and gynecological surgery to cut and seal vessels and to cut, grasp, and dissect tissues. In addition, the generator provides power to drive Harmonic ultrasonic surgical instruments that are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Enseal and Harmonic instruments when used with the Generator G11 have not been shown to be effective for sterilization procedures or tubal coagulation. Do not use these instruments for these procedures.

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 C)

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510(k) Summary

Company

Ethicon Endo-Surgery 475 Calle C Guaynabo, PR 00969

Contact

David Locke, DRSc, MS, RACSenior Regulatory Affairs Program Lead4545 Creek Rd.Cincinnati, OH 45242Email: dlocke1 @its.jnj.comTelephone: (513) 337-1281/ Fax: (513) 337- 4366
Date Prepared:	September 9, 2016
Device Common Name:	Electrosurgical Cutting and Coagulation Device and AccessoriesElectrosurgical & Ultrasonic Surgical Generator
Trade Name:	Enseal® X1 Large Jaw Tissue Sealer
	Generator 11
Classification Name:	Electrosurgical Cutting and Coagulation Devices and Accessories,
	Gynecologic Electrocautery and Accessories
	(Enseal® X1 Large Jaw Tissue Sealer)
	Electrosurgical Cutting and Coagulation Devices and Accessories,
	Gynecologic Electrocautery and Accessories; Instrument,
	Ultrasonic Surgical
	(Generator 11)
Device Class:	Class II (Enseal® X1 Large Jaw Tissue Sealer)
	Class II (Generator 11)
Product Code:	GEI, HGI (Enseal® X1 Large Jaw Tissue Sealer)
	GEI, HGI, LFL (Generator 11)
Classification Regulation:	21 CFR section 878.4400, 21 CFR 884.4120
	(Enseal® X1 Large Jaw Tissue Sealer)
	21 CFR 878.4400, 21 CFR 884.4120 & Unclassified (LFL)
	(Generator 11)
Panel:	General and Plastic Surgery, Gynecologic Electrocautery and
	Accessories
Primary Predicate:	Predicate - Ligasure Impact Curved, Large Jaw, Open
	Sealer/Divider, K123444
Additional Predicates:	Predicate - Ethicon Endo-Surgery Generator 11, K141122
	Predicate - Generator 11 Footswitch, K141122
	Predicate - Generator 11 Cart, K141122
	Predicate - Harmonic and Enseal Connectors, K141122

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Device Description

Indications for Use

Enseal® X1 Large Jaw Tissue Sealer

The Enseal® X1 Large Jaw Tissue Sealer instrument is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. It is a bipolar instrument for use with the Ethicon Generator G11 (GEN11). It is intended for use during open surgery to cut and seal vessels, cut, grasp, and dissect tissue during surgery. Indications for use include open general, gynecologic, thoracic, and vascular procedures. These procedures include hysterectomies, colectomies, Nissen fundoplication, adhesiolysis, oophorectomies, etc. The devices can be used on vessels (arteries, veins, pulmonary vasculature, lymphatics) up to and including 7 mm and tissue bundles.

The Enseal® X1 Curved Large Jaw instrument 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 efficacy of the Enseal® X1 Curved Large Jaw instrument for the indication of contraceptive tubal coagulation (permanent female sterilization) has not been evaluated and is unknown. The design of the EnSeal® Tissue Sealing Device is significantly different from bipolar designs that are marketed for the indication of contraceptive tubal coagulation. The design differences may affect the efficacy of the procedure and failure rates may not be comparable.

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Generator 11

The Generator 11 provides radiofrequency power to drive Enseal electrosurgical instruments that are used during open or laparoscopic general and gynecological surgery to cut and seal vessels and to cut, grasp and dissect tissues. In addition, the generator provides power to drive Harmonic ultrasonic surgical instruments that are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Enseal and Harmonic instruments when used with the Generator 11 have not been shown to be effective for sterilization procedures or tubal coagulation. Do not use these instruments for these procedures

Technological Characteristics and Differences

The Enseal® X1 Large Jaw Tissue Sealer is the same as the predicate devices in that they are electrosurgical bipolar vessel sealing instruments used to cut and seal vessels, cut, grasp and dissect tissues during surgery, and utilize the same technology. Differences with the device as compared to the predicate device within this submission include energy and cut button location, ability to fully rotate the shaft, force to fire, ergonomic differences, shaft configuration and overall shaft length, and both devices use different generators to power the devices. The subject Enseal® X1 Large Jaw Tissue Sealer Device only uses the Generator 11 (GEN11) as its power source, and the device utilizes software version 2016-1 or later to enable a maximum power output of 200W.

Performance Data

Bench testing and laboratory evaluations were conducted to demonstrate that the Enseal® X1 Large Jaw Tissue Sealer performed as intended.

Sterilization

Both the subject and predicate devices are sterilized via ethylene oxide as a sterilization method and both devices are sterilized to the same sterility assurance level.

Biocompatibility

The biocompatibility evaluation for the Ensea19 X1 Large Jaw Tissue Sealer device was conducted in accordance with the following standards: ISO 10993:2009. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and FDA Blue Book Memorandum #G95-1: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The device passed the following tests:

□ISO Cytotoxicity

□ISO Sensitization

□ISO Intracutaneous Reactivity

□ISO Acute System Toxicity

EMC

Electrical safety and EMC testing were conducted on the Enseal® X1 Large Jaw Tissue Sealer device; the system complies with IEC 60601-1-2:2007 for electromagnetic compatibility and IEC 60601-1:2005 and IEC 60601-2-2:2009 for electrical safety.

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Bench

Sealed vessel burst test were evaluated for Enseal® X1 Large Jaw Tissue Sealer device to support substantial equivalence to the predicate device. The bench testing involved evaluation of the devices performance and ability to seal and divide vessels up to 7 mm. The maximum and minimum values, standard deviation and the mean were recorded for the aforementioned tests. Data generated from the bench testing met the predetermined acceptance criteria.

Acute Animal (Porcine) Testing

Testing was performed in an acute animal study with the Enseal® X1 Large Jaw Tissue Sealer vs. the predicate device to demonstrate that there was no difference in the tissue effects when using the subject device and the predicate device. Moreover, the acute testing involved evaluation of the devices performance and ability to seal and divide vessels up to and including 7 mm. The results of the study demonstrated the ability of the subject device (NSLX120L) to perform as well as the legally identified predicate device.

Survival Animal (Porcine) Testing

Testing was performed in survival animal studies with the Enseal® X1 Large Jaw Tissue Sealer vs. the predicate device to demonstrate that the tissue effects were not different than the predicate device. Moreover, the survival testing involved evaluation of the devices performance and ability to seal and divide vessels up to and including 7 mm. The results of the study demonstrated the ability of the subject device (NSLX120L) to perform as well as the legally identified predicate device.

Clinical

This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence.

Conclusion

The indications for use for the subject device and the predicate device are similar. The results of the bench testing and laboratory evaluations in an animal model demonstrate that the Enseal® X1 Large Jaw Tissue Sealer device is as safe and effective and performs as well as the identified legally marketed predicate device for cutting and coagulating soft tissue and sealing vessels up to 7 mm in diameter, as measured in situ. Moreover, applicable software verification and validation testing was completed per FDA Guidance for industry and staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "General Principles of Software Validation: Final Guidance for Industry and FDA Staff."

Regulation Number and Section

§ 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.