ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2507

K091824 · Ethicon Endo-Surgery, Inc. · GEI · Nov 27, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K091824
• Device Name: ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2507
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 27, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Rotating Endoscopic Scissors are a sterile, single-patient-use, disposable monopolar electrosurgical instrument. Device consists of a flexible wire cable and a scissors end-effector capable of independent rotation. Designed for use with gastroscopes having working channels of 2.8 mm or larger. Operated by a physician during endoscopic procedures; device connects to an external electrosurgical generator via a 4.5 mm monopolar cable (not supplied). When activated, the device delivers RF monopolar electrical current to the surgical site through the scissors electrode to cut, dissect, or cauterize soft tissue. The handle allows for electrode manipulation via control knobs. The device provides a mechanical cutting function combined with electrosurgical coagulation, aiding in tissue management during endoscopic surgery.

Clinical Evidence

Bench testing only. Biocompatibility evaluated per ISO 10993-1. Compliance testing performed for IEC 60601-1 (General Safety), IEC 60601-2-2 (High Frequency Surgical Equipment), IEC 60601-2-18 (Endoscopic Equipment), and IEC 60601-1-2 (Electromagnetic Compatibility).

Technological Characteristics

Monopolar electrosurgical instrument; flexible shaft with rotating scissors end-effector. Compatible with 2.8 mm+ gastroscope working channels. Energy source: external electrosurgical generator (RF monopolar). Biocompatibility: ISO 10993-1. Safety standards: IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, IEC 60601-1-2. Sterile, single-patient use.

Indications for Use

Indicated for cutting, dissecting, and cauterizing soft tissue during endoscopic electrosurgical procedures. No specific patient population, age, or gender restrictions provided.

Regulatory Classification

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.

Predicate Devices

• Ethicon Endo Surgery® Articulating Hook Knife (K082955)
• TeleMed Systems Flexible Endoscopic Scissors (K010412)

Submission Summary (Full Text)

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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: [phone] [phone] 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 [phone] or [phone] 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)

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