ETHICON ENDO-SURGERY ARTICULATING HOOK KNIFE, MODEL IN4505

K082955 · Ethicon Endo-Surgery, Inc. · GEI · Jan 15, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K082955
• Device Name: ETHICON ENDO-SURGERY ARTICULATING HOOK KNIFE, MODEL IN4505
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 15, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Monopolar electrosurgical instrument for endoscopic procedures; used for cutting, dissecting, and cauterizing soft tissue. Device features flexible wire cable, hook knife electrode, and handle with two control knobs for extension, rotation, and articulation of the end effector; hook electrode rotates independently. Device passes through endoscopes with 3.7 mm or larger working channels. Operated by clinicians in endoscopic settings. Connects to external electrosurgical generator to deliver RF monopolar energy to surgical site. Provides improved tissue-targeting capability via articulation and rotation. Single-patient use; supplied sterile.

Clinical Evidence

Bench testing only. Device evaluated for biocompatibility per ISO 10993-1. Compliance testing performed for AAMI HF18 (2001), IEC 60601-2-2 (2006), IEC 60601-2-18 (1996), and IEC 60601-1 (1995).

Technological Characteristics

Monopolar electrosurgical instrument; metal 'L' hook electrode tip. Flexible wire shaft with handle-actuated articulation and rotation. Compatible with standard electrosurgical generators. Designed for 3.7 mm or larger endoscope working channels. Biocompatible materials per ISO 10993-1. Standards: AAMI HF18, IEC 60601-2-2, IEC 60601-2-18, IEC 60601-1. Sterile, single-patient use.

Indications for Use

Indicated for cutting, dissecting, and cauterizing soft tissue during endoscopic electrosurgical procedures. For prescription use only.

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 Needle Knife (K073046)
• Valleylab Laparoscopic Electrodes (K964175)
• Ethicon Endo Surgery Evacuation/Irrigation/Electrosurgical Device (K912492)

Submission Summary (Full Text)

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Ko82955

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## 510(k) Summary

Company

Contact

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

Tom Bosticco Principal OS/RA Project Manager Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 Telephone: [phone] Fax: [phone] Email: [e-mail]

JAN 1 5 2009

Date Prepared September 30, 2008

### New Device Name

Trade Name: Ethicon Endo Surgery® Articulating 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 Devices

Ethicon Endo Surgery® Articulating Needle Knife (K073046) Valley lab Laparoscopic Electrodes (K964175) Ethicon Endo Surgery Evacuation/Irrigation/Electrosurgical Device (K912492)

Device Description The Ethicon Endo Surgery (EES) Articulating Hook Knife is a monopolar instrument intended for use in endoscopic electrosurgical procedures where cutting, dissecting, and cauterizing soft tissue are desired. The device consists of a flexible wire cable and hook knife electrode, which can be extended, rotated, and articulated from the flexible outer shaft using two handle control knobs. In addition, the hook electrode can be rotated independently of the end effector. 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 3.7 mm or larger working channels. This device is supplied sterile for single-patient use.

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

Technological Characteristics The EES device has similar technologic characteristics to the predicate devices (K964175 and K912492) in that it contains a metal electrode tip that is used to deliver monopolar energy to the surgical site. In all devices the electrode tip is in the shape of a 'L' Hook. All devices can be introduced through 5mm ports. All devices are designed to be connected to electrosurgical generators, and utilize RF monopolar energy for operation.

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Ko82955

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In addition, the Articulating Hook Knife device is very similar to the Articulating Needle Knife (K073046) in that it consists of an elongated flexible wire shaft and a handle. These devices allow for the manipulation of the electrode via the handle of the device. Both devices feature rotation and articulation of the end-effector to provide the clinician with improved tissue-targeting capability.

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:

- Electrosurgical Devices, AAMI HF18, 2001/01/01

t

- 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: General Requirements for Safety: Safety Requirements for Medical Electrical Systems, IEC 60601-1:1995

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ethicon Endo-Surgery, Inc. % Mr. Tom Bosticco Principal QS/RA Project Manager 4545 Creek Road Cincinnati, Ohio 45242

JAN 1 5 2009

### Re: K082955

Trade/Device Name: Ethicon Endo Surgery Articulating Hook Knife Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 9, 2009 Received: January 12, 2009

Dear Mr. Bosticco:

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 such 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); 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 - Mr. Tom Bosticco

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark M Milkerson

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

Enclosure

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KOS'2955

# Indications for Use

510(k) Number (if known); K082955

Ethicon Endo Surgery® Articulating Hook Knife Device Name:

Indications for Use:

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

David Stone for LUXM 1/10

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K082955

Prescription Use X (Part 21 CFR 801 Subpart D)

ﺍﻟﻤﺘﺤﺪﺓ

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)