DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES

K072789 · Encision, Inc. · GEI · Oct 19, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K072789
• Device Name: DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES
• Applicant: Encision, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

AEM Disposable Electrodes and AEM Disposable Handpieces are electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. The devices are intended for use by qualified medical personnel trained in the use of electrosurgical equipment. AEM instruments incorporate the use of AEM technology and are intended for use with the Encision AEM Monitoring System and electrosurgical generators having compatibility with the AEM Monitor.

Device Story

AEM Disposable Electrodes and Handpieces are electrosurgical accessories used in open, endoscopic, and laparoscopic surgery. The device connects to an electrosurgical generator via the Encision AEM Monitor. The system utilizes AEM (Active Electrode Monitoring) technology to minimize stray energy injuries; it monitors current returned via a shield circuit near the electrode tip and shuts down the generator if excessive current is detected (insulation failure or capacitive coupling). Electrodes feature an insulated tip, shaft, and shield assembly; handpieces provide cut/coagulation switching (hand or foot-controlled). Surgeons use the device to perform tissue ablation, resection, and coagulation. The system benefits patients by reducing the risk of unintended thermal injury during monopolar electrosurgery.

Clinical Evidence

Bench testing only. Verification included continuity and capacitance measurements, and compatibility testing with a worst-case representative electrosurgical generator and the AEM Monitor.

Technological Characteristics

Monopolar electrosurgical accessories; disposable electrodes and handpieces. Features insulated conductors, shafts, and AEM shield assembly. Connectivity: connects to Encision AEM Monitor and compatible electrosurgical generators. Sterilization: provided sterile, single-use only. Control: hand-switching or foot-switching modes.

Indications for Use

Indicated for ablation, removal, resection, and coagulation of soft tissue requiring hemostasis in open, endoscopic, and laparoscopic surgical procedures. Intended for use by qualified medical personnel trained in electrosurgical equipment.

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

• Model ES1000 series Monopolar Laparoscopic Electrodes with Electroshield (ENCISION INC.)
• Model 30-6000 series Reusable Monopolar Electrodes (Kirwin Surgical Products)
• Model 8380 series Unipolar Electrodes (Richard Wolf Medical Instruments Corp.)
• Models SW11100, SW11200, SW11202, SW11300 (Reusable) and SW1220, SW12202, SW12300 (Disposable) Electrosurgical Pencils (Shining World Healthcare Co., Ltd.)
• Model ES4000 AEM Cord (ENCISION INC.)
• Model E2508 Disposable Pencil (Valleylab, Inc.)

Submission Summary (Full Text)

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### ENCISIGN

K 072-789

#### 510(k) Summary

DATE: 5/19/07

510(k) Submitter: ENCISION INC. 6797 Winchester Circle Boulder, CO 80301 USA Establishment Registration: 1722040 JU7 1 § 2007

Contact Person.

Judith V. King, VP Regulatory Affairs and Quality Assurance Phone: [phone] Fax: [phone] e-mail: jking(a encision.com

Device Name: AEM Disposable Electrodes and AEM Disposable Handpieces

Common name: Device, Electrosurgical, Cutting and Coagulation and Accessories

Classification: CFR Section: 878.4400

Class: II

Product Code: GEI

Predicate Devices:

#### Electrodes

| Trade, Proprietary or Model Name | Manufacturer |
|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Model ES1000 series Monopolar Laparoscopic Electrodes with<br>Electroshield | ENCISION INC. |
| Model 30-6000 series Reusable Monopolar Electrodes | Kirwin Surgical Products |
| Model 8380 series Unipolar Electrodes | Richard Wolf Medical<br>Instruments Corp. |
| Models SW11100, SW11200, SW11202, SW11300 (Reusable)<br>and SW1220, SW12202, SW12300 (Disposable) Electrosurgical<br>Pencils | Shining World Healthcare<br>Co., Ltd. |

#### Handpieces

| Trade, Proprietary or Model Name | Manufacturer |
|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Model ES1000 series Monopolar Laparoscopic Electrodes with<br>Electroshield | ENCISION INC. |
| Model ES4000 AEM Cord (AEM Monitor accessory) | ENCISION INC. |
| Model E2508 Disposable Pencil | Valleylab, Inc. |
| Models SW11100, SW11200, SW11202, SW11300 (Reusable)<br>and SW1220, SW12202, SW12300 (Disposable) Electrosurgical<br>Pencils | Shining World Healthcare<br>Co., Ltd. |

ENCISION 510(k) Notification Summary AEM® Disposable Electrodes and AEM Disposable Handpieces

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#### Description of Devices:

The AEM Disposable Electrode and the AEM Disposable Handpiece connect to a compatible electrosurgical generator via an adapter on the ENCISION AEM Monitor. The handpiece has foot switching and hand switching versions. The electrodes and handpieces are single use products, which are provided sterile. They are designed not to be re-sterilized.

The AEM Monitoring System, including the electrodes and handpieces, are designed to minimize the likelihood of stray energy injuries caused by active insulation failure or capacitive coupling. The monitor does this by shutting down the ESU when excessive current is returned via the shield circuit which extends to near the tip of the electrode.

The electrodes, which consist of an insulated tip, shaft with locking knob, and AEM shield assembly, are available in various tip styles. The electrode has an inner insulation between the active conductor and shield tube, as well as a secondary outer insulation on the outside of the clectrode shaft. The electrodes snap into the handpiece.

One version of the handpiece provides switching for the Cut and Coag functions of the ESU. This version has an integral cord. The other version uses foot-switching provided with the electrosurgical generator. The foot-switching handpiece connects to either the existing reusable or disposable AEM Cord from Encision. The electrodes may be removed from the handpiece and replaced with another electrode within the sterile field.

The electrode can rotate freely or be locked in one of multiple orientations relative to the handpiece, as preferred by the surgeon.

#### Intended 【Jse:

AEM Disposable Electrodes and AEM Disposable Handpieces are electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.

The devices are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

AEM instruments incorporate the use of AEM technology and are intended for use with the Encision AEM Monitoring System and electrosurgical generators having compatibility with the AEM Monitor.

#### Technological Characteristics:

The Encision AEM Disposable Electrodes and AEM Disposable Handpieces incorporate the same technological characteristics as the predicate devices for delivery of the ESU high frequency current, consisting of insulated conductors and shafts with appropriately shaped tips for electrosurgery. The control for ESU Cut and Coag modes on the handswitching handpiece is a switch similar in design and function to the predicate handpiece.

Like the Encision predicate devices, the AFM Disposable Electrodes and AEM Disposable Handpieces include an additional AEM shielding function which diverts stray energy from the shaft of the instrument and is monitored by the Encision AEM Monitor.

#### Non-clinical Performance Testing:

Performance of the devices' AFM technology and delivery of electrosurgical energy has heen verified by bench testing consisting of continuity and capacitance measurements, and

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compatibility testing with a worst case representative electrosurgical generator and the AEM Monitor.

Conclusions:

The AEM Disposable Electrodes and AEM Disposable Handpieces are safe and effective and are substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 three overlapping human profiles facing to the right, creating a sense of depth and unity.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 2007

Encision, Inc. % Intertek Testing Services Mr. Daniel W. Lehtonen 2307 East Aurora Road Unit B7 Twinsburg, Ohio 44087

Re: K072789

Trade/Device Name: AEM Disposable Electrodes and AEM Disposable Handpieces Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 28, 2007 Received: October 1, 2007

Dear Mr. Lehtonen:

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. Daniel W. Lehtonen

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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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Image /page/5/Picture/0 description: The image shows the word "ENCISION" in all caps. The letters are in a bold, sans-serif font and are black. The "O" in "ENCISION" is replaced by a circular logo with a white curved line running through it. There is a registered trademark symbol to the upper right of the last letter N.

### Indications for Use

510(k) Number (if known):

K 072789

Device Name:

AEM Disposable Electrodes and AEM Disposable Handpieces

Indications For Use:

The AEM Disposable Electrodes and AEM Disposable Handpieces are electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.

The devices are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

X Prescription Use (Part 21 CFR 801 Subpart D)

OR

Over-The-Counter Use (Part 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)

Division Sign Off

Division of General, Restorative, and Neurological Devices

510(k) Number 462289