ETHICON ENDO SURGERY ARTICULATING SNARE

K073288 · Ethicon Endo-Surgery, Inc. · FDI · Jun 12, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K073288
• Device Name: ETHICON ENDO SURGERY ARTICULATING SNARE
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: FDI · Gastroenterology, Urology
• Decision Date: Jun 12, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Articulating Snare is intended for the electrosurgical removal and cauterization of gastrointestinal tract polyps through an endoscope.

Device Story

Flexible wire cable and loop device; used with endoscopes having ≥3.2 mm working channels. Operated by clinician via three-finger actuator to extend, rotate, articulate, and retract snare. Delivers monopolar electrical current to cut and cauterize gastrointestinal polyps. Articulation feature provides improved tissue targeting compared to standard snares. Single-patient use; sterile. Output is physical tissue removal and cauterization; clinician visualizes procedure via endoscope to guide targeting and activation.

Clinical Evidence

Bench testing only. Biocompatibility evaluated per ISO 10993-1. Compliance testing performed for AAMI HF 18 (2001), IEC/EN 60601-2-2 (2000), and IEC/EN 60601-2-18 (1996).

Technological Characteristics

Flexible wire cable and loop; monopolar RF energy source; three-finger actuator; rotation knob; articulation mechanism for end-effector. Biocompatible materials per ISO 10993-1. Complies with AAMI HF 18, IEC/EN 60601-2-2, and IEC/EN 60601-2-18.

Indications for Use

Indicated for the electrosurgical removal and cauterization of gastrointestinal tract polyps in patients undergoing endoscopic procedures.

Regulatory Classification

Identification

An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

Predicate Devices

• Rotatable Snare (K992477)
• Single-Use Polypectomy Snare (K941750)

Submission Summary (Full Text)

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K073288
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## 510(k) Summary

JUN 1 2 2008

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

Contact Glenda C Marsh QS/RA Sr. Project Manager Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 Telephone: [phone] [phone] Fax: Email: gmarsh(@eesus.jnj.com

Date Prepared November 19, 2007

- New Device Name Trade Name: Ethicon Endo Surgery Articulating Snare Common or Usual Name: Snare, Flexible Classification Name: Endoscopic electrosurgical unit and accessories (21 CFR 876.4300, Product Code FDI)
Predicate Devices Rotatable Snare (K992477) Single-Use Polypectomy Snare (K941750)

Device Description The Ethicon Endo Surgery Articulating Snare consists of a flexible wire cable and loop, which can be extended, rotated, articulated, and retracted from the flexible outer shaft using a three-finger actuator. It is passed through endoscopes having a 3.2 mm or larger working channels. When activated, the snare delivers a monopolar electrical current to cut and cauterize tissue within the loop. The device is supplied sterile for single-patient use.

Indications for Use The Articulating Snare is intended for the electrosurgical removal and cauterization of gastrointestinal tract polyps through an endoscope.

Technological Characteristics The EES device has similar technologic characteristics to the predicate devices in that it consists of a flexible wire cable and loop that is used to remove polyps utilizing monopolar RF energy under endoscopic visualization. In all devices, the operator can deploy and retract the snare by using three fingers. As in the predicate devices, the EES device features rotation of the end-effector by manipulation of a rotation knob. In addition, the EES device features articulation of the end-effector to provide the clinician with improved tissue targeting capability.

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K073288
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Performance Data. Bench testing was performed to demonstrate that the EES device performs as intended. The device materials 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:

- AAMI HF 18, 2001 : Electrosurgical Devices

- IEC/EN 60601-2-2, 2000 : Particular Requirements for the Safety of Endoscopic Equipment

- IEC/EN 60601-2-18, 1996 : Particular Requirements for the Safety of High Frequency of Surgical Equipment

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

## JUN 12 2008

Ms. Glenda Marsh Senior Project Manager, Quality Systems & Regulatory Affairs Ethicon Endo-Surgery, Incorporated 4545 Creek Road CINCINNATI OH 45242

Re: K073288

Trade/Device Name: Ethicon Endo Surgery® Articulating Snare Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FDI Dated: May 29, 2008 Received: May 29, 2008

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 (Premarket Approval), 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.

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Protecting and Promoting Public Health

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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.

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 one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You max 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 vours.

Nancy C. Burgdon

Nancy C. Brogdon . Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): 13288

Device Name:

## Ethicon Endo Surgery® Articulating Snare

Indications for Use:

The Articulating Snare is intended for the electrosurgical removal and cauterization of gastrointestinal tract polyps through an endoscope.

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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(Posted November 13, 2003)

| (Division Sign-Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K073288 |