The ENSEAL X1 Tissue Sealers are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic surgical procedures to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.

Indications for use include open and laparoscopic general, gynecological, urologic, thoracic, plastic and reconstructive, and ENT surgical procedures or any procedure where vessel ligation (cutting and sealing), tissue grasping, dissection, and division of vessels, lymphatics, and tissue bundles is performed (e.g. bowel resections, hysterectomies, gall bladder procedures, Nissen Fundoplication, adhesiolysis, and oophorectomies). 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 X 1 Tissue Sealers have 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 ENSEAL X1 Tissue Sealer, Curved Jaw Articulating instrument is a sterile, single patient use surgical instrument 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 iaw, and a knife. The instrument shaft can be rotated 360° to facilitate visualization and enable easy access to targeted tissue. The instrument shaft, normally in the straight position, can be articulated using the articulation wheel to gain additional access to tissue and facilitate additional angles across tissue and/or vascular bundles. The 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. The ENSEAL X1 Tissue Sealer, Curved Jaw Articulating has separate seal and cut capabilities. The lower jaw of the ENSEAL X1 Tissue Sealer, Curved Jaw Articulating can be used in the open or closed position to deliver energy based on the electrode configuration and jaw design. Bipolar energy is delivered when the SEAL button or the MIN foot pedal is pressed. Pressing the CUT button advances the knife the length of the jaws to cut the targeted tissue. The power cord is permanently attached to the device and connects the instrument to the generator. The ENSEAL X1 Tissue Sealer, Curved Jaw Articulating instrument is designed for use exclusively with the Ethicon Generator G11 (GEN11) software version 2016-1 or later, packaged separately.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ENSEAL X1 Tissue Sealer, Curved Jaw Articulating, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from study description)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993-1 and FDA guidance for biological evaluation.	Device shares materials with a previously cleared device (K172580) which met these criteria; no new testing was required.
Electrical Safety & EMC	Compliance with IEC 60601-1-2 (EMC) and IEC 60601-1 & IEC 60601-2-2 (Electrical Safety).	The system complies with specified IEC standards.
Sterilization/Shelf-Life	Sterility Assurance Level (SAL) of 10^-6 via Ethylene Oxide per ISO 11135.	Validated to achieve SAL of 10^-6.
Shelf-Life	Designated shelf-life of 1 year.	Achieves designated 1-year shelf-life.
Mechanical Testing	Ability to perform under worst-case scenarios for: Axial Jaw Retention, Jaw Strength, Hinge Pin Weld Strength, Tip Compression, Jaw Gap, and Impedance (for both 37 cm and 45 cm shaft lengths).	Demonstrated ability to perform as well as the predicate device for all specified mechanical tests. Both 37 cm and 45 cm shafts were found equivalent.
Bench Testing (Vessel Burst Pressure)	Ability to seal and divide vessels up to 7 mm effectively. Data generated must meet "predetermined acceptance criteria" (specific values not provided).	Data generated met the predetermined acceptance criteria.
Acute Animal Study (Tissue Effects)	No difference in tissue effects compared to the predicate device when sealing and dividing vessels up to and including 7 mm.	Demonstrated no difference in tissue effects and ability to seal and divide vessels up to 7mm as well as the predicate device.
Survival Animal Study (Tissue Effects)	No difference in tissue effects compared to the predicate device after 30 days when sealing and dividing vessels up to and including 7 mm (arteries, veins, vessel pedicles).	Demonstrated no difference in tissue effects and ability to seal and divide vessels up to 7mm as well as the predicate device after 30 days.

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

Bench Testing: The document states "Porcine arteries were used in this testing" but does not specify the sample size (number of arteries/vessels tested). The data is likely prospective, as it's part of a device validation study. The country of origin is not specified, but typically such studies are conducted in the country of the manufacturer or a contract research organization.
Acute Animal Study: "an acute porcine study" was conducted. Specific sample size (number of animals or applications) is not provided. The data is prospective.
Survival Animal Study: "a chronic survival study" was conducted. Specific sample size (number of animals or applications) is not provided. The data is prospective.

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

The document does not mention the use of human experts to establish ground truth for the test sets in the traditional sense of diagnostic AI. The ground truth for this medical device (electrosurgical sealer) is established through technical measurements (e.g., burst pressure, mechanical force) and biological outcomes (e.g., tissue effects, vessel patency/occlusion, healing) observed in the animal studies. These evaluations are typically performed by veterinarians, histopathologists, and engineers, whose qualifications are implied by their roles in such studies, but not explicitly stated.

4. Adjudication Method for the Test Set

Not applicable in the context of this device study. Adjudication methods like "2+1" or "3+1" are relevant for expert consensus in image interpretation or clinical diagnosis, not for physical device performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for assessing the diagnostic performance of AI algorithms in medical imaging, usually comparing human readers with and without AI assistance. This document describes the validation of a surgical electrosurgical device, not a diagnostic AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Again, this question is not applicable. The device is a physical electrosurgical instrument, not an algorithm. Its performance is inherent to its design and how it interacts with tissue.

7. The Type of Ground Truth Used

Biocompatibility: Compliance with established biological safety standards (ISO 10993-1).
Electrical Safety & EMC: Compliance with international electrical safety and electromagnetic compatibility standards (IEC 60601 series).
Sterilization/Shelf-Life: Achieved sterility assurance level (SAL).
Mechanical Testing: Measured physical properties (e.g., force, dimension) against engineering specifications and comparison to the predicate device.
Bench Testing: Measured burst pressure of sealed vessels (a quantitative biological outcome) and qualitative assessment of vessel division, compared against predetermined acceptance criteria.
Acute Animal Study: Histopathological and gross evaluation of tissue effects (e.g., seal integrity, thermal damage) in live porcine models, compared to the predicate device.
Survival Animal Study: Long-term histopathological and gross evaluation of tissue effects and healing after 30 days in live porcine models, compared to the predicate device. The "ground truth" here is the biological response and healing process observed by experts.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that undergoes "training." Its design and performance are based on engineering principles, materials science, and preclinical testing.

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

Not applicable, as there is no "training set" for this type of medical device.

Summary

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May 23, 2018

Ethicon Endo-Surgery, LLC % Kweku Biney Senior Regulatory Affairs Program Lead Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242

Re: K180403

Trade/Device Name: ENSEAL X1 Tissue Sealer, Curved Jaw Articulating, 37 cm and 45 cm Shaft Length Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, HGI Dated: April 20, 2018 Received: April 23, 2018

Dear Kweku Biney:

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, 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 of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth 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 1000-1050.

Also, please note the regulation entiled, "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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Jennifer R. Stevenson -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)

K180403

Device Name ENSEAL X1 Tissue Sealer, Curved Jaw Articulating

Indications for Use (Describe)

The ENSEAL X 1 Tissue Sealers have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system 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, LLC 475 Calle C Guaynabo, PR 00969 Contact Kweku Binev Sr. Regulatory Affairs Program Lead Ethicon Endo-Surgery, Inc.
Telephone: (513) 337-3135 Email: kbiney@its.jnj.com

Date Prepared

February 9, 2018

Device Name

Trade Name: ENSEAL® X1 Tissue Sealer, Curved Jaw Articulating Common Name: Electrosurgical Cutting and Coagulating Instruments

Classification Name

· Electrosurgical, Cutting & Coagulation & Accessories (21 CFR 878.4400, Product Code GEI)

· Electrocautery, Gynecologic and Accessories (21 CFR 884.4120, Product Code HGI)

Regulatory Class

Class II

Predicate Device

ENSEAL® G2 Tissue Sealers initially cleared under K112033 and K131435 on November 8. 2011 and October 3, 2013 respectively as part of the ENSEAL Tissue Sealing Devices platform.

Recall Information

Ethicon Endo-Surgery, LLC initiated a voluntary recall for the predicate device ENSEAL G2 Tissue Sealers on February 9, 2012 and November 26, 2012. Both recalls have been addressed and are officially closed.

Reference Device

ENSEAL® X1 Tissue Sealers cleared under K172580 on November 20, 2017.

Device Description

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shaft, normally in the straight position, can be articulated using the articulation wheel to gain additional access to tissue and facilitate additional angles across tissue and/or vascular bundles. The 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. The ENSEAL X1 Tissue Sealer, Curved Jaw Articulating has separate seal and cut capabilities. The lower jaw of the ENSEAL X1 Tissue Sealer, Curved Jaw Articulating can be used in the open or closed position to deliver energy based on the electrode configuration and jaw design. Bipolar energy is delivered when the SEAL button or the MIN foot pedal is pressed. Pressing the CUT button advances the knife the length of the jaws to cut the targeted tissue. The power cord is permanently attached to the device and connects the instrument to the generator. The ENSEAL X1 Tissue Sealer, Curved Jaw Articulating instrument is designed for use exclusively with the Ethicon Generator G11 (GEN11) software version 2016-1 or later, packaged separately.

Indications for Use

The ENSEAL X1 Tissue Sealers 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 ENSEAL X1 Tissue Sealer. Curved Jaw Articulating are the predicate device in that they are electrosurgical bipolar vessel sealing instruments used to cut and seal vessels, 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 the articulation feature, separate energy and cut button, ergonomic differences, jaws configuration, steps for use and separate seal and cut functionality.

Performance Data

The following performance data, were provided in support of the substantial equivalence determination.

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Biocompatibility testing

Biocompatibility testing was not repeated for the subject device, testing data from the referenced device, K172580 was leveraged for the subject device since both devices share the same materials. Testing on reference device was based on ISO 10993-1: "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing" and on FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued on June 16, 2016.

Electrical Safety and Electromagnetic Compatibility

Electrical safety and EMC testing were conducted on ENSEAL X1 Tissue Sealer, Curved Jaw Articulating; the system complies with IEC 60601-1-2 for electromagnetic compatibility and IEC 60601-1 and IEC 60601-2-2 for electrical safety.

Sterilization/Shelf-Life

The ENSEAL X1 Tissue Sealer, Curved Jaw Articulating were validated to achieve a sterility assurance level of 10 ° using Ethylene Oxide per ISO 11135. The designated shelf-life for ENSEAL X1 Tissue Sealer, Curved Jaw Articulating is 1-year.

Mechanical Testing

The following mechanical testing were conducted to verify that the ENSEAL X1 Tissue Sealer, Curved Jaw Articulating can perform under worst case scenarios:

· Axial Jaw Retention
· Jaw Strength
Hinge Pin Weld Strength

Shaft Equivalence: To demonstrate equivalence between 37 cm and 45 cm shaft lengths, both lengths were tested for tip compression, jaw gap and impedance. Testing concludes that both shafts are equivalent.

The results of the mechanical testing demonstrated the ability of the ENSEAL X1 Tissue Sealer, Curved Jaw Articulating to perform as well as the predicate device.

Bench Testing

Sealed vessel burst pressure test were evaluated for the ENSEAL X 1 Tissue Sealer, Curved Jaw Articulating to support substantial equivalence to the predicate device. The bench testing involved evaluation of the device performance and ability to seal and divide vessels up to 7 mm. Porcine arteries were used in this testing. The maximum and minimum values, standard deviation and the mean were recorded. Data generated from the bench testing met the predetermined acceptance criteria.

Acute Animal Study

Testing was performed in an acute porcine study with the ENSEAL X1 Tissue Sealer, Curved Jaw Articulating vs. the predicate device to demonstrate that there was no difference in the tissue effects when using the subject device versus 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 acute study demonstrated the ability of ENSEAL X1 Tissue Sealer, Curved Jaw Articulating to perform as well as the predicate device.

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Survival Animal Study

Testing was performed in a chronic survival study with the ENSEAL X1 Tissue Sealers, Curved Jaw Articulating versus the predicate device to demonstrate that there was no difference in the tissue effects when using the subject device and the predicate device. The survival testing involved evaluation of the performance and ability of the device to seal and divide vessels up to and including 7 mm. The 30-day survival testing was performed targeting arteries, veins and vessel pedicles less than or equal to 7mm in diameter. The results of the survival study demonstrated the ability of the ENSEAL X1 Tissue Sealer, Curved Jaw Articulating to perform as well as the legally identified predicate device.

Conclusion

The results of the bench and animal testing performed demonstrate that the ENSEAL X1 Tissue Sealer, Curved Jaw Articulating are substantially equivalent to the identified predicate device.

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.