ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508

K091290 · Ethicon Endo-Surgery, Inc. · GEI · Oct 29, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K091290
• Device Name: ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 29, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Monopolar electrosurgical instrument; used for cutting, dissecting, and cauterizing soft tissue during endoscopic procedures. Device comprises flexible wire cable, hook knife electrode, and handle with control knobs. Operated by physician during endoscopy; device passes through endoscope working channels (≥2.8 mm). Connected to external electrosurgical generator; delivers RF monopolar energy to surgical site via metal electrode tip. Rotation of electrode controlled via handle knobs. Single-patient use; supplied sterile. Facilitates precise tissue manipulation and hemostasis during endoscopic surgery.

Clinical Evidence

Bench testing only. Biocompatibility evaluated per ISO 10993-1. Electrical safety and electromagnetic compatibility testing performed per IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, and IEC 60601-1-2.

Technological Characteristics

Monopolar electrosurgical instrument; flexible wire shaft; metal "L" hook electrode. Energy source: external electrosurgical generator (RF monopolar). Dimensions: compatible with ≥2.8 mm endoscope working channels. Sterilization: sterile, single-patient use. Standards: ISO 10993-1 (biocompatibility), IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, IEC 60601-1-2.

Indications for Use

Indicated for cutting, dissecting, and cauterizing soft tissue during endoscopic electrosurgical procedures. No specific patient population or contraindications 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)

Submission Summary (Full Text)

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# 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: [phone] Fax: [phone] Email: [e-mail]

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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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 [phone] or [phone] 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)

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