The ENSEAL® 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 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® 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 Ethicon Endo-Surgery ENSEAL® Tissue Sealers are sterile, biopolar electrosurgical instruments for single patient use. They are designed to seal and cut vessels, and to cut, grasp and dissect soft tissue during open and laparoscopic surgery. The instrument shaft can be rotated using the rotation knob to facilitate visualization and enable easy access to targeted tissue. The power cord is permanently attached to the device and connects the instrument to the generator. The devices are offered in different shaft lengths with curved or straight blade geometries to accommodate the needs of the surgeon.

AI/ML Overview

Here's an analysis of the provided text regarding the Ethicon Endo-Surgery ENSEAL® Tissue Sealing Devices and their acceptance criteria, based on the information provided in the 510(k) summary:

Note: The provided document is a 510(k) summary for a medical device seeking an additional indication (ENT procedures) based on substantial equivalence to existing predicate devices. As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of establishing substantial equivalence for this new indication, rather than a de novo approval requiring extensive novel clinical trials with specific numerical performance targets.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Equivalence in Vessel Sealing Capability (bench testing)	"bench testing... demonstrated equivalent performance" to the predicate (LigaSure Small Jaw device with ENT indication).
Equivalence or Superiority in Hemostasis (preclinical animal model)	"demonstrated that the ENSEAL® Tissue Sealing devices perform equivalently or better than the predicate device."
Equivalence or Superiority in Thermal Spread (preclinical animal model)	"demonstrated that the ENSEAL® Tissue Sealing devices perform equivalently or better than the predicate device." and "The subject and predicate devices demonstrate similar thermal spread profiles."
Successful Long-term Outcome (preclinical animal model)	"Data from a successful 30-day chronic survival study was submitted in support of the use of ENSEAL® tissue sealing devices for use in ENT procedures."
Clinical Efficacy (ENT Procedures)	No specific numerical targets for clinical efficacy are stated beyond the implication that equivalent performance in preclinical models is sufficient for the addition of the ENT indication, given prior clearances for other procedures. The claim is based on substantial equivalence to a predicate already cleared for ENT.
Safety	"The results of the bench testing and preclinical testing demonstrate that the ENSEAL® Tissue Sealing devices are as safe and as effective as the predicate devices in cutting and sealing vessels in ENT surgical procedures, and cutting, grasping and dissecting tissue during surgery."

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

Sample Size for Test Set: Not explicitly stated as a number of animals or specific tests. The text refers to "preclinical laboratory evaluations of ENT surgical procedures in an animal model" and "a successful 30-day chronic survival study."
Data Provenance: The studies were "preclinical laboratory evaluations in an animal model." The country of origin is not specified, but typically these studies are conducted in facilities compliant with GLP (Good Laboratory Practice) standards. The studies were prospective in nature, as they were conducted to specifically support this submission.

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

This information is not provided in the text. Given that the studies were "preclinical laboratory evaluations in an animal model" and "bench testing," the "ground truth" would likely be established by quantitative measurements (e.g., burst pressure for vessel sealing, thermal imaging for thermal spread, and histopathology/gross examination for animal survival studies) performed by laboratory personnel or veterinary pathologists rather than clinical experts adjudicating outcomes from human cases.

4. Adjudication Method for the Test Set

The text does not specify an adjudication method. For preclinical and bench testing, adjudication typically involves adherence to a pre-defined protocol and objective measurement criteria, often with blind assessment where applicable, rather than multi-expert consensus on subjective observations.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device in question is a surgical instrument, not an AI or imaging diagnostic tool that would typically involve human readers interpreting output. The evaluation focused on substantial equivalence through bench and preclinical testing.

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

This question is not applicable as the device is a surgical instrument, not an algorithm. Performance was evaluated in standalone physical testing (bench) and biological models (preclinical animal studies).

7. The Type of Ground Truth Used

The ground truth for the performance evaluations likely involved a combination of:

Quantitative measurements: For bench testing (e.g., burst pressure of sealed vessels, measurement of thermal spread zones).
Pathology/Histology and Gross Examination: For the animal model, evaluating hemostasis, tissue healing, thermal injury, and overall animal health/survival.
Survival Data: For the 30-day chronic survival study.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical surgical instrument, not an AI/machine learning algorithm that requires a training set.

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

This question is not applicable as there is no training set for this type of device.

Summary

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Ethicon Endo-Surgery, LLC

Premarket Notification (Traditional) K131435 EnSeal Tissue Sealing Devices - addition of ENT Indication

510(k) Summary of Safety and Effectiveness

Ethicon Endo-Surgery, LLC Company 475 Calle C Guaynabo, PR 00969

Contact c/o Marcia Arentz, MBA, MS, RAC, CQA Regulatory Affairs Portfolio Leader Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 Telephone: (513) 337-1066 Fax: (513) 337-2016 Email: marentz5@its.inj.com

OCT 0 3 2013

Date: Sep 26, 2013

Device Name: Trade Name: ENSEAL® Tissue Sealing Devices Common Name: Electrosurgical Cutting and Coagulation Instruments

Classification Names:

Electrosurgical, Cutting & Coagulation & Accessories (21CFR878.4400, Product Code GEI) Electrocautery, Gynecologic and Accessories (21 CFR 884.4120, Product Code HGI)

Classification: Class II

Predicate Devices:

K113572: LigaSure™ Curved Small Jaw, Open Sealer/Divider LF1212
K072177: ENSEAL® Round Tip Tissue Sealing Devices
K072493: ENSEAL® Round Tip Tissue Sealing Device (45 cm shaft length)
K123141: ENSEAL® Trio Tissue Sealing Device
K112033: ENSEAL® G2 Tissue Sealers

Device Description:

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Intended Use Statement:

The ENSEAL® 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® 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.

The subject ENSEAL® devices are the same ENSEAL® tissue sealing devices that were cleared in prior 510(k) submissions. The intended use remains the same: to cut and seal vessels and to cut, grasp and dissect tissue during surgery. This submission is to support the addition of a specific indication, the use of the devices in ENT surgical procedures, to the indications for use statement for the ENSEAL® devices. The use of ENSEAL® devices in ENT procedures is supported by demonstration of substantial equivalence to the legally marketed predicate device that was cleared previously for use in ENT procedures.

The differences in the wording of the indications for use statements between the subject and predicate devices are grammatical and do not alter the intended use of these surgical devices to cut and seal vessels and to cut, grasp and dissect tissue during surgery.

Technological Characteristics:

The predicate and subject devices all use bipolar electrosurgical technology to seal vessels and are provided sterile, for single patient use. The subject ENSEAL devices for which the specific ENT indication was evaluated are identical in their patient contacting materials and use the same energy source (generator) as the previously cleared predicate ENSEAL® devices. There was one minor change to the activation button in the ENSEAL® G2 Tissue Curved and Straight Sealing devices but this change does not affect hemostasis or thermal spread.

Performance Data:

Bench testing comparing the vessel sealing capability of the predicate (LigaSure Small Jaw device with ENT indication) and subject device (ENSEAL® tissue sealing device) demonstrated equivalent performance. Preclinical laboratory evaluations of ENT surgical

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procedures in an animal model, including comparative acute studies to evaluate hemostasis and thermal spread, demonstrated that the ENSEAL® Tissue Sealing devices perform equivalently or better than the predicate device. Data from a successful 30-day chronic survival study was submitted in support of the use of ENSEAL® tissue sealing devices for use in ENT procedures. No clinical studies were required to support a finding of substantial equivalence.

Conclusion:

The results of the bench testing and preclinical testing demonstrate that the ENSEAL® Tissue Sealing devices are as safe and as effective as the predicate devices in cutting and sealing vessels in ENT surgical procedures, and cutting, grasping and dissecting tissue during surgery. The subject and predicate devices demonstrate similar thermal spread profiles. The results from testing support the substantial equivalence of the ENSEAL® Tissue Sealing devices to the legally marketed predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES: USA" arranged in a circular fashion around the eagle. The text is in all caps and is oriented to follow the curve of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

October 3, 2013

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

Ethicon Endo-Surgery, Incorporated c/o Ms. Marcia Arentz, MBA, MS. RAC, COA Regulatory Affairs Portfolio Leader 4545 Creek Road Cincinnati, Ohio 45242

Re: K131435

Trade/Device Name: EnSeal Tissue Scaling Devices Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 25, 2013 Received: September 30, 2013

Dear Ms. Arentz:

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 10 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. Isting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Marcia Arentz, MBA, MS, RAC, CQA

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,

Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

のほど、・・

Enclosure

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Indications for Use

510(k) Number (if known): K131435

Device Name: EnSeal Tissue Sealing Devices

Indications for Use (revised):

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® 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.

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)

Lona H. Chen .-

For MXM

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K131435

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.