The Generator GI I 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 tissue. 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 Ethicon Endo-Surgery Generator G11 supplies energy to 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 Harmonic and one for EnSeal® instruments) are used to enable the generator to power currently cleared surgical instruments.

AI/ML Overview

This document describes the 510(k) submission for the Ethicon Endo-Surgery Generator G11. The submission focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and performance data, rather than specific acceptance criteria for AI performance. Therefore, many of the requested categories are not applicable to this type of device submission.

Here's an analysis based on the provided text, addressing the requested points where possible:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This 510(k) submission is for a surgical generator, a hardware device, not an AI/software device. Therefore, many of the requested categories related to AI performance, such as sample size for test sets, ground truth establishment, MRMC studies, and training set details, are not applicable to this submission. The performance data provided is focused on demonstrating the generator's ability to power surgical instruments safely and effectively, consistent with its intended use and comparable to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a hardware device (electrosurgical and ultrasonic generator) and not an AI or software product, the concept of "acceptance criteria" for AI performance metrics (like sensitivity, specificity, AUC) is not relevant. The "performance data" provided refers to engineering and animal model testing to ensure the generator functions as intended and is safe.

Acceptance Criteria Category (Hypothetical for AI)	Reported Device Performance (as per 510(k) for Generator G11)
Generator Functionality	"Bench testing and laboratory evaluations in an animal model were conducted to demonstrate that the Generator G11 performs as intended." (This implies the generator successfully delivered appropriate power, voltage, current, and frequency to EnSeal® electrosurgical and Harmonic® ultrasonic instruments, consistent with their intended use for cutting, sealing, grasping, dissecting tissue, and achieving hemostasis.)
Safety	The FDA clearance (K101990) implies that the device met safety requirements, likely demonstrated through electrical safety testing (e.g., against IEC 60601-1), EMC testing, and performance as observed in animal models, showing no unexpected adverse effects related to the generator's operation.
Substantial Equivalence	The FDA determined the device is "substantially equivalent" to predicate devices (EnSeal® RF60, EnSeal® Universal, UltraCision Harmonic® Scalpel Generator 300) for its stated indications for use. This means it has similar technological characteristics (despite a broader range of power parameters and a combined functionality) and raises no new questions of safety or effectiveness.
User Interface Usability	Implied through the incorporation of a "touchscreen user interface" to "provide the user with information, control, and feedback during use." While not explicitly detailed in terms of usability metrics, it would have been tested to ensure safe and effective operation by users.

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

Not Applicable (N/A) for AI/software test sets. The performance data involved "Bench testing and laboratory evaluations in an animal model."
Sample Size: Not specified in the summary. For bench testing, this would refer to the number of tests performed on the device or its components. For animal models, it would be the number of animals used. This information is typically found in the detailed test reports submitted to the FDA, not in the public summary.
Data Provenance: The studies were conducted by Ethicon Endo-Surgery, LLC. The specific country of origin for the studies is not stated but is presumably the USA, where Ethicon Endo-Surgery, Inc. is located (Cincinnati, OH). The studies would be prospective in nature, designed specifically to test the G11 generator.

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

Not Applicable (N/A). This device is a surgical generator, not an AI diagnostic tool requiring expert-established ground truth for image interpretation or similar tasks. The "ground truth" for this device would be its ability to generate specified power outputs and enable its associated instruments to perform their intended surgical functions (e.g., cutting, sealing tissue) effectively and safely. This is typically assessed by engineers and veterinary surgeons/pathologists in animal studies.

4. Adjudication Method for the Test Set

Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers/experts when establishing ground truth for AI algorithms. This is not relevant for a surgical generator. Performance would be assessed against engineering specifications and observable surgical outcomes in animal models.

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 (N/A). This is a hardware device; no AI assistance for human readers is involved.

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

Not Applicable (N/A). This is a hardware device; there is no algorithm or AI component to be tested in a standalone fashion. The generator itself is "standalone" in the sense that its functionality (power generation) can be tested independently of a human operator's skill, but its intended use is always with human-operated surgical instruments.

7. The Type of Ground Truth Used

Engineering Specifications and Animal Model Outcomes: The "ground truth" for this device's performance would be:
- Engineering Specifications: Successful delivery of specific power, voltage, current, and frequency outputs as designed for the EnSeal® and Harmonic® instruments.
- Animal Model Outcomes: Observable biological effects (e.g., effective vessel sealing, tissue cutting, dissection, hemostasis) consistent with the intended use of the respective instruments when powered by the G11 generator, and comparison to established performance of predicate devices or clinical standards. Pathology might be used to confirm tissue effects.

8. The Sample Size for the Training Set

Not Applicable (N/A). This device does not have an AI component that requires a training set.

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

Not Applicable (N/A). This device does not have an AI component requiring a training set with established ground truth.

Summary of Device and Performance Data:

The Ethicon Endo-Surgery Generator G11 is a hardware device designed to power both electrosurgical (EnSeal®) and ultrasonic (Harmonic®) surgical instruments. Its 510(k) clearance was based on demonstrating "substantial equivalence" to existing predicate devices. Performance data included "Bench testing and laboratory evaluations in an animal model" to show that the generator "performs as intended" by successfully delivering the necessary power to the surgical instruments for their specified indications (cutting, sealing vessels, dissecting tissue, achieving hemostasis). The technological characteristics, such as the ability to power both types of instruments and a touchscreen interface, were detailed, but the core performance validation focused on the output characteristics and biological effects consistent with safe and effective surgical use.

Summary

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510(k) Summary

K101990

Company Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969
Donovan May Contact Regulatory Affairs Associate II Ethicon Endo-Surgery, Inc. Telephone: (513) 337-7981 Fax: (513) 337-2793 Email: dmay3@its.jnj.com

July 14, 2010 Date Prepared

Device Name Trade Name: Ethicon Endo-Surgery Generator G11 Common Name: Electrosurgical & Ultrasonic Surgical Generator

Classification Names

· Electrosurgical, Cutting & Coagulation & Accessories (21 CFR 878.4400, Product Code GEI)
· Electrocautery, Gynecologic and Accessories (21 CFR 884.4120, Product Code HGI)
· Instrument, Ultrasonic Surgical (Unassigned, Product Code LFL)

Predicate Devices

· EnSeal® RF60 Electrosurgical Generator (cleared under K072177 on September 5, 2007 as part of the EnSeal® Vessel Sealing and Hemostasis System)
· EnSeal® Universal Generator (cleared under K081129 on July 28, 2008 as a system with the EnSeal PowerTip instrument)
· UltraCision Harmonic® Scalpel Generator 300 (cleared under K002906 on December 15,
2000 as part of the UltraCision Harmonic® Scalpel Generator 300 System)

Device Description:

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Indications for Use:

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 tissue. 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.

The differences between the intended use of the subject device and those of the predicate devices do not affect the safety and effectiveness of the subject device when used as labeled for the following reasons:

· The Generator G11 provides power for the use of both EnSeal electrosurgical and Harmonic ultrasonic surgical open and laparoscopic surgical instruments. The predicate devices referenced are only able to provide power for one of these surgical instrument : types.
· The predicate devices were each submitted as part of a surgical system thus the Indications for Use statements included in the submissions associated with them did not contain indications specific to the function of the generators except for those in the labeling. These differences do not alter the intended surgical effects of the subject device from that of the predicate devices.

Technological Characteristics: The Ethicon Endo-Surgery Generator G11 incorporates the technological characteristics of the predicate devices in a single surgical generator but allows for a greater range of power, voltage, current, and frequency for both the EnSeal electrosurgical and Harmonic ultrasonic surgical modes. A touchscreen user interface has been incorporated to provide the user with information, control, and feedback during use.

Performance Data: Bench testing and laboratory evaluations in an animal model were conducted to demonstrate that the Generator G11 performs as intended.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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

Ethicon Endo-Surgery, LLC % Mr. Donovan May Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242

JUN 1 3 2011

Re: K101990

Trade Name: Generator G11 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, LFL, HGI Dated: June 1, 2011 Received: June 2, 2011

Dear Mr. May:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nevers forrewed your bother is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent 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 r ou may are see of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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 or uny 1 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 - Mr. Donovan May

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.

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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Euis D. Keith

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

Enclosure

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Indications for Use

510(k) Number (if known): K101990

Device Name: Generator G11

Indications for Use:

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)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

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KIO 990 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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.