The Rotating Hook Knife is a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures.

Device Description

The Ethicon Endo Surgery® (EES) Rotating Hook Knife is a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. The device consists of a flexible wire cable and hook knife electrode, which can be extended and rotated from the flexible outer shaft using two handle control knobs. When connected to an electrosurgical generator and activated, the hook knife delivers a monopolar electrical current to the surgical site. This device passes through endoscopes having a 2.8 mm or larger working channel. This device is supplied sterile for single-patient use.

AI/ML Overview

The provided document is a 510(k) summary for the Ethicon Endo Surgery® Rotating Hook Knife. It describes the device, its intended use, and its technological characteristics compared to a predicate device. The document also lists the performance data submitted to demonstrate compliance with various safety standards.

However, the document does not contain information about acceptance criteria for a study proving device performance, nor details of a specific study meeting said criteria in the format usually associated with clinical validation of AI/ML or diagnostic devices. Instead, it details bench testing performed to demonstrate that the device performs as intended and complies with several international standards related to medical electrical equipment, biocompatibility, and electromagnetic compatibility.

Therefore, I cannot extract the information required in your request about acceptance criteria, reported device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Based on the information provided, here's what can be stated about the performance data:

A table of acceptance criteria and the reported device performance:
Not provided in the document. The document lists the standards the device was tested against, but not specific acceptance criteria within those standards or a table of measured performance against those criteria.
Sample size used for the test set and the data provenance:
Not specified. The document mentions "bench testing," but does not detail sample sizes, or data provenance (e.g., country of origin, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The performance data described is "bench testing" against engineering and safety standards, not a study requiring expert-established ground truth.
Adjudication method for the test set:
Not applicable. The performance data described is "bench testing," not a study requiring adjudication.
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/ML device or a diagnostic device where MRMC studies would typically be performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical electrosurgical instrument, not an algorithm.
The type of ground truth used:
Not applicable in the context of clinical/diagnostic AI studies. For bench testing, the "ground truth" would be the specifications and requirements outlined in the listed international standards (e.g., IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, IEC 60601-1-2, ISO 10993-1).
The sample size for the training set:
Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.

Summary of Performance Data from Document:

The document states:

"Bench testing was performed to demonstrate that the EES device performs as intended."
"The patient contact portions of the device have been evaluated for biocompatibility and comply with the requirements of ISO 10993-1."
"The device was tested to demonstrate compliance with the following standards:"
- Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
- Medical Electrical Equipment - Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment, IEC 60601-2-2, 2006/07/01
- Medical Electrical Equipment - Part 2-18: Particular Requirements for the Safety of Endoscopic Equipment, IEC 60601-2-18, 1996/08/01
- Medical Electrical Equipment Part 1-2: General Requirements for Safety: Electromagnetic Compatibility, IEC 60601-1-2 (2004)

This indicates that the "study" for performance consisted of engineering bench tests against recognized international safety and performance standards for electrosurgical and endoscopic devices, and biocompatibility. Specific numerical acceptance criteria or performance metrics beyond "compliance" are not detailed in this summary.

Summary

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Image /page/0/Picture/1 description: The image shows a handwritten string of numbers. The numbers are '1091290'. The numbers are written in black ink on a white background. The handwriting is somewhat messy and difficult to read.

510(k) Summary

Company Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242

Contact Tom Bosticco QSRA Principal Project Manager Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 Telephone: (513) 337-8935 Fax: (513) 337-2935 Email: tbosticc@its.jnj.com

OCT 2 9 2009

Date Prepared October 27, 2009

New Device Name

Trade Name: Ethicon Endo Surgery® Rotating Hook Knife Common or Usual Name: Electrosurgical Hook Electrodes Classification Name: Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400, Product Code GEI)

Predicate Device

Ethicon Endo Surgery® Articulating Hook Knife (K082955)

Device Description The Ethicon Endo Surgery® (EES) Rotating Hook Knife is a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. The device consists of a flexible wire cable and hook knife electrode, which can be extended and rotated from the flexible outer shaft using two handle control knobs. When connected to an electrosurgical generator and activated, the hook knife delivers a monopolar electrical current to the surgical site. This device passes through endoscopes having a 2.8 mm or larger working channel. This device is supplied sterile for single-patient use.

Indications for Use The Rotating Hook Knife is a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures.

Technological Characteristics The EES Rotating Hook Knife device is very similar to the EES Articulating Hook Knife (K082955). Both devices consist of an electrode, an elongated flexible wire shaft and a handle. The handle allows for the manipulation of the electrode via the control knobs. In both devices, the metal electrode tip is used to deliver monopolar energy to the surgical site. Both devices are designed to be connected to electrosurgical generators, and utilize RF monopolar energy for operation. The "L" hook shape of the electrode in the Rotating Hook Knife is the same as in the EES Articulating

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Hook Knife. Both devices feature rotation of the electrode. The Rotating Hook Knife does not contain the articulating feature present in the Articulating Hook Knife.

Performance Data. Bench testing was performed to demonstrate that the EES device performs as intended. The patient contact portions of the device have been evaluated for biocompatibility and comply with the requirements of ISO 10993-1. The device was tested to demonstrate compliance with the following standards:

Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
Medical Electrical Equipment - Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment, IEC 60601-2-2, 2006/07/01
Medical Electrical Equipment - Part 2-18: Particular Requirements for the Safety of Endoscopic Equipment, IEC 60601-2-18, 1996/08/01
Medical Electrical Equipment Part 1-2: General Requirements for Safety: Electromagnetic Compatibility, IEC 60601-1-2 (2004)

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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 image of an eagle or other bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ethicon Endo-Surgery, Inc. % Ms. Glenda Marsh QS/RA Project Manager 4545 Creek Road Cincinnati, Ohio 45242

OCT 2 9 2009

Re: K091290

Trade Name: Ethicon Endo-Surgery® Rotating Hook Knife Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulation Class: II Product Code: GEI Dated: October 15, 2009 Received: October 19, 2009

Dear Ms. Marsh:

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.

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 mav 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 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.

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Page 2 – Ms. Glenda Marsh

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/ReportalProblem/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 A. Mathews

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):

Device Name:

Ethicon Endo Surgery® Rotating Hook Knife

Indications for Use:

The Rotating Hook Knife is a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures.

FOR M. MELKERSON

(Division Sign (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091290

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)

Page 1 of 1 (Posted November 13, 2003)

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.