The Rotating Endoscopic Scissors are a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures.

Device Description

The Ethicon Endo Surgery (EES) Rotating Endoscopic Scissors are a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. The Rotating Endoscopic Scissors are a sterile, single patient use, disposable instrument consisting of a flexible wire cable and scissors end effector. The end effector can be rotated independently of the shaft. When connected to an electrosurgical generator using a 4.5 mm monopolar cable (not supplied) and activated, the Rotating Scissors delivers a monopolar electrical current to the surgical site. This device passes through gastroscopes having a 2.8 mm or larger working channels. This device is supplied sterile for single-patient use.

AI/ML Overview

The provided text describes a 510(k) summary for the Ethicon Endo Surgery® Rotating Endoscopic Scissors. This document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant safety standards, rather than reporting on a study meeting specific performance acceptance criteria like those found in AI/ML device submissions.

Therefore, many of the requested categories for AI/ML device studies are not applicable to this submission type. I will fill in the relevant information available and explicitly state when a category is not applicable.

Key points to understand:

This is a submission for a physical surgical instrument, not an AI/ML diagnostic tool.
The "performance data" discussed is related to bench testing for safety and functionality, not diagnostic accuracy or efficacy requiring ground truth, expert consensus, or MRMC studies.
The "acceptance criteria" are related to compliance with established medical device safety standards.

Acceptance Criteria and Device Performance Study for Ethicon Endo Surgery® Rotating Endoscopic Scissors

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance	Comments
Biocompatibility	ISO 10993-1	Complies with requirements	Patient contact portions evaluated.
Electrical Safety	IEC 60601-1 (1988, Amd 1 1991, Amd 2 1995)	Tested to demonstrate compliance	General requirements for safety.
High Frequency Surgical Equipment Safety	IEC 60601-2-2 (2006/07/01)	Tested to demonstrate compliance	Particular requirements for safety of high frequency surgical equipment.
Endoscopic Equipment Safety	IEC 60601-2-18 (1996/08/01)	Tested to demonstrate compliance	Particular requirements for safety of endoscopic equipment.
Electromagnetic Compatibility (EMC)	IEC 60601-1-2 (2004)	Tested to demonstrate compliance	General requirements for safety: Electromagnetic Compatibility.
Intended Functionality	Not explicitly stated as a quantifiable metric, but implied.	"Bench testing was performed to demonstrate that the EES device performs as intended."	Device intended for cutting, dissecting, and cauterizing soft tissue.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size: Not specified. The document states "Bench testing was performed," which typically involves testing a defined number of devices or components according to a protocol. However, specific quantities are not provided.
Data provenance: Not explicitly stated, but assumed to be internal laboratory testing conducted by Ethicon Endo-Surgery, Inc., located in Cincinnati, Ohio, USA. This would be considered prospective testing, as devices were manufactured and then tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A. This device does not have "ground truth" in the diagnostic sense (e.g., presence or absence of a disease). Its performance is evaluated against engineering standards and functional requirements through bench testing. Expert clinicians might be involved in defining performance requirements or evaluating usability, but not in establishing ground truth for a diagnostic test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. Adjudication methods are relevant for subjective medical assessments (e.g., image interpretation). Bench testing for medical device standards typically involves objective measurements and pass/fail criteria, not expert adjudication of results against a medical ground truth.

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

N/A. This is a physical surgical instrument, not an AI/ML diagnostic or assistive device for human readers. Therefore, MRMC studies are not applicable.

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

N/A. This is a physical surgical instrument. The concept of "standalone algorithm performance" is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

N/A. As explained in point 3, the device is evaluated against established engineering and safety standards, and functional performance on tissue surrogates, not against a medical "ground truth" for diagnosis. The "truth" in this context is whether the device meets specific engineering specifications and safety requirements.

8. The sample size for the training set

N/A. This is a physical surgical instrument. There is no "training set" in the context of machine learning. The device design is based on engineering principles and predicate device comparison, not on data-driven model training.

9. How the ground truth for the training set was established

N/A. As there is no training set for an AI/ML model, this question is not applicable.

Summary

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K691824

510(k) Summary

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

Contact Glenda Marsh QSRA Senior Project Manager Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 Telephone: (513) 337-7659 (513) 337-2860 Fax: Email: gmarsh(@its.jnj.com

Date Prepared October 30, 2009

New Device Name

Trade Name: Ethicon Endo Surgery® Rotating Endoscopic Scissors Common or Usual Name: Electrosurgical 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) TeleMed Systems Flexible Endoscopic Scissors (K010412)

Device Description The Ethicon Endo Surgery (EES) Rotating Endoscopic Scissors are a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. The Rotating Endoscopic Scissors are a sterile, single patient use, disposable instrument consisting of a flexible wire cable and scissors end effector. The end effector can be rotated independently of the shaft. When connected to an electrosurgical generator using a 4.5 mm monopolar cable (not supplied) and activated, the Rotating Scissors delivers a monopolar electrical current to the surgical site. This device passes through gastroscopes having a 2.8 mm or larger working channels. This device is supplied sterile for single-patient use.

Indications for Use The Rotating Endoscopic Scissors are a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures.

Technological Characteristics The EES Rotating Endoscopic Scissors device is very similar to the TeleMed Systems Flexible Endoscopic Scissors (K010412) in that it consists of an elongated flexible shaft with scissors end-effectors. Both devices are designed for cutting tissue. The main technological difference between these two devices is that the TeleMed scissors cannot be energized while the new EES Rotating Endoscopic Scissors can deliver RF energy when connected to a Monopolar RF energy supply.

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The EES Rotating Endoscopic Scissors device is also similar to Ethicon Endo Surgery Articulating Hook Knife (K082955). 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 main difference between these two devices is the shape of the electrode. In the Articulating Hook Knife, the electrode is in the shape of an "L" hook, while in the new Endoscopic Scissors, the scissors also comprise the electrode. Both devices feature rotation of the electrode. The Rotating Endoscopic Scissors does not contain the articulating feature present in the Articulating Hook Knife.

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In all three devices, the handle allows for the manipulation of the electrode via the control knobs.

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 - IEC 60601 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings forming a flowing, abstract design.

Public Health Service

NOV 2 7 2009

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 45242-2839

Re: K091824

Trade Name: Ethicon Endo-Surgery Rotating Endoscopic Scissors, Model IN2507 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulation Class: Class II Product Code: GEI Dated: October 30, 2009 Received: November 2, 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 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

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Page 2 - Ms. Glenda Marsh

device-related adverse events) (21 CFR 803); good 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. 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/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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mark N. Wilkerson

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):

Ethicon Endo Surgery® Rotating Endoscopic Scissors Device Name:

Indications for Use:

The Rotating Endoscopic Scissors are a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures.

KIMBERLY A. AMOS FOR M.MELKERSON

(Division Sign-(Division Sign-on), Orthopedic, Division for the Devices

510(k) Number K091824

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.