ENDOSHIELD BURN PROTECTION SYSTEM

K140006 · Encision, Inc. · GEI · Jun 16, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K140006
• Device Name: ENDOSHIELD BURN PROTECTION SYSTEM
• Applicant: Encision, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

The EndoShield Burn Protection System is an accessory for use with electrosurgical generators and electrodes that is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive coupling. EndoShield performs active electrode monitoring intended to control stray monopolar energy, caused by insulation failure and capacitive coupling in surgical instruments, along the shaft of the instrument.

Device Story

EndoShield is a single-use, battery-powered electronic module used during monopolar laparoscopic surgery. It connects between an electrosurgical unit (ESU) and an AEM laparoscopic instrument. The device monitors the instrument's shield for stray high-frequency (HF) energy caused by insulation breakdown or capacitive coupling. If stray energy exceeds a predetermined threshold, the device interrupts the HF energy delivery path via a relay and triggers a visual red 'X' alert. A green '✓' indicates system readiness. The device is operated by surgical staff in an OR setting. By shunting stray energy to the ESU return-electrode ground, it prevents unanticipated burns outside the surgeon's field of view, enhancing patient safety during electrosurgery.

Clinical Evidence

Bench testing only. Performance was evaluated in 10 units, demonstrating equivalent performance to the predicate EM3 AEM Monitor. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-1-6, and IEC 62366 was confirmed via third-party testing and design-file review.

Technological Characteristics

Battery-powered (3V Lithium) electronic module; discrete digital/analog circuitry; HF power relays; gold-plated spring-loaded instrument connector; standard CQM-type return electrode plug; visual LED indicators (green/red). Sterilized via ethylene oxide (ANSI-AAMI-ISO 11135-1).

Indications for Use

Indicated for use as an accessory with electrosurgical generators during monopolar laparoscopic surgery to prevent patient injury from insulation failure and capacitive coupling.

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

• EM3 AEM Monitor (K122383)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the word "ENCISION" in bold, sans-serif font. Below the word is a thin line, and below that are some blurred words. The "O" in "ENCISION" has a graphic inside of it.

JUN 1 6 2014

# 510(k) Summary

| Device | EndoShield Burn Protection System | |
|------------------|-------------------------------------------------------------|------------------------------------------------------|
| Owner | Encision, Inc. | |
| Contact | Mike Biggs, Director Engineering and Interim Director RA/QA | |
| Date | 11 June 2014 | |
| Subject Device | Trade name | EndoShield Burn Protection System |
| | Model number | EM100 |
| | Common name | Disposable AEM Monitor |
| | Device name | Electrosurgical, Cutting & Coagulation & Accessories |
| | Regulation number | 21 CFR 878.4400 |
| | Product code | GEI |
| | Device class | 2 |
| | Panel | General and Plastic Surgery |
| Predicate Device | Trade name | EM3 AEM Monitor |
| | Device name | Electrosurgical, Cutting & Coagulation & Accessories |
| | Manufacturer | Encision Inc. |
| | Market clearance | 510(k): K122383 (2013) |

# Device Description

人

| Device<br>purpose | • Enables AEM Monitoring and protection during monopolar laparoscopy<br>• Transfers high-frequency (HF) energy from monopolar electrosurgical unit<br>(ESU) to AEM laparoscopic instruments while providing AEM Monitoring of<br>HF current returning from the instrument's shield<br>• Disables HF energy delivery and presents a visual alert whenever a set up<br>or operational fault is detected |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AEM<br>technology | • Safety system for minimally-invasive monopolar electrosurgery<br>• Prevents unanticipated or undetected burns from stray HF energy outside<br>the surgeon's field of view<br>• Works by shielding instrument's shaft from stray HF energy due to insulation<br>breakdown or capacitive coupling<br>• Monitors level of energy picked up by shield; interrupting energy delivery<br>when energy in shield approaches excessive levels |
| | Continued on next page |

ENCISION INC. + 6797 WINCHESTER CIRCLE • BCULDER, CO BO3D1 • 303,444.2693 • WWENDSHON.COM

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## Device Description (continued)

| Device | EndoShield is a self-contained battery-powered electronic module (about the |
|------------|-----------------------------------------------------------------------------|
| components | size of a cell phone) with integral instrument and HF power cords: |
| | • Module plugs directly into return-electrode receptacle of ESU |

- · Integral cords connect module to
- AEM laparoscopic instrument
- Foot-control power output receptacle of ESU

## Technological Characteristics

EndoShield miniaturizes and integrates the primary monopolar functions of the predicate device, , EM3 AEM monitor, into a single-use, self-contained system.

### Technology

| Logic | • Battery-powered digital and analog electronic circuitry<br>• 3V Lithium battery<br>• Normally-open relay controlling primary HF energy path<br>• DSP HF current measurement of shield-to-ground HF energy<br>• Shield HF threshold detection results in opening of relay of primary HF path<br>and lighting of red visual indicator |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Instrument<br>connector | Dual, gold plated, spring loaded, connector allowing free rotation of connector<br>on instrument post at end of instrument cord |
| ESU return<br>connector | Standard CQM-type return electrode three-pin plug on back of monitor<br>module |
| ESU HF<br>output<br>connector | Standard ESU foot-control instrument plug on short cord from module |
| Visual<br>indicator | • Green light-emitting diode lighting a ready light: a "✓" molded into the<br>electronic module housing<br>• Red light-emitting diode lighting an alarm/not-ready light: an "X" molded into<br>the electronic module housing |

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510(k) Summary: EndoShield Burn Protection System

| Function | |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Enables<br>energy<br>delivery | Assures all connections are proper before enabling energy delivery and<br>presenting a visual "ready" indication by lighting a green "✓" on face of<br>electronic module |
| Shields from<br>stray energy | Monitor connections shunt stray energy, attempting to pass through the<br>insulated shaft of an AEM instrument by insulation breakdown or capacitive<br>coupling, back to the ESU |
| Disables<br>energy<br>delivery | Monitor shuts down the electrosurgical procedure if the level of stray energy<br>reaches dangerous levels |
| Indicates fault | Visual alert—extinguishes green "✓" and lights red "X" on face of electronic<br>module—indicates a fault is detected, either at set up (system not ready) or<br>during operation (excess stray energy) |

## Intended Use

The EndoShield Burn Protection System is an accessory for use with electrosurgical generators and electrodes that is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive coupling.

EndoShield performs active electrode monitoring intended to control stray monopolar energy, caused by insulation failure and capacitive coupling in surgical instruments, along the shaft of the instrument.

## Equivalence

Based on operating principle, intended use, technology, safety, and performance; the EndoShield Burn Protection System is substantially equivalent to its predicate device, the monopolar function of the EM3 AEM Monitor.

| | EndoShield equivalence to EM3 (Monopolar function) |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Identical intended use as an accessory for use with electrosurgical generators<br>and electrodes to safely deliver electrosurgical energy and to prevent injury<br>caused by insulation failure and capacitive coupling through active electrode<br>monitoring. |
| Operating<br>principle | Identical operating principle: shunting stray energy from the shield of an AEM<br>Instrument to ESU return-electrode ground and disabling energy delivery<br>should stray-energy current exceed a predetermined threshold. |

Continued on next page

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## Equivalence (continued)

| | EndoShield equivalence to EM3 (Monopolar function) |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | Substantially equivalent materials: typical electrical wires, connectors, analog<br>and logic components, and printed circuit boards; primary differences are<br>battery instead of mains power and plastic instead of metal enclosure. |
| Technology | Substantially equivalent circuitry: discrete digital logic, analog electronics,<br>and HF power relays instead of FPGA logic device (with software), analog<br>electronics, and HF power relays |
| Performance | Substantially equivalent: specifications are equivalent, except for the alarm<br>display being visual only and not specific to the type of fault detected |
| EMC and<br>Electrical<br>Safety | Identical standards and internal design control assurances, including<br>recognized international standards:<br>• IEC 60601-1 (3rd Ed.) compliant<br>• IEC 60601-1-2 compliance<br>• IEC 60601-2-2 compliance |
| Human<br>factors/<br>usability | Identical standards and internal design control assurances, including<br>recognized international standards:<br>• IEC 60601-1-6 compliance<br>• IEC 62366 compliance |

# Bench Testing

| Essential<br>performance<br>testing | In accordance with Design Control requirements per 21 CFR 820.30,<br>essential performance tested in 10 units showed equivalent performance to<br>monopolar function of EM3 AEM Monitor predicate system. |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| EMC,<br>electrical<br>safety,<br>usability | Third-party testing and design-file review demonstrated equivalent<br>performance to monopolar function of EM3 AEM Monitor predicate system. |

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510(k) Summary: EndoShield Burn Protection System

# Biocompatibility

| Patient Contact | No direct or indirect contact with patient |
|-----------------------------|--------------------------------------------|
| Biocompatibility Evaluation | None required |

## Sterility / Packaging

| Sterility | • Method of sterilization: ethylene oxide gas<br>• Methodology: ANSI-AAMI-ISO 11135-1:2007<br>• Sterility assurance level: 10⁻⁶ or better<br>• Sterilization performance: By a qualified contract sterilizer |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterility<br>Maintenance/<br>Shelf Life | • Initially, product validated for sterility and function to one year shelf life<br>• Assurance method: accelerated aging<br>• Validated shelf life indication: "use by" date on all labels-boxes and<br>pouches<br>• Post-market extension of shelf life: life extended as data from accelerated<br>and real-time aging tests demonstrate greater longevity |

## Conclusion

EndoShield Burn Protection System is substantially equivalent to the monopolar function of its predicate devices in performance and intended use. There are no significant differences between EndoShield Burn Protection System and the EM3 predicate in design which would raise new issues of safety and effectiveness, performance, function or intended use of the device. Technological similarities between the predicate device and the proposed device also demonstrate equivalence.

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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings and three wavy lines below, possibly representing water. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 16, 2014

Encision Incorporated Mr. Mike Biggs Vice President, Regulatory and Quality 6797 Winchester Circle Boulder, Colorado 80301

Re: K140006

Trade/Device Name: EndoShield Burn Protection System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical, Cutting & Coagulation & Accessories Regulatory Class: Class II Product Code: GEI Dated: May 14, 2014 Received: May 15, 2014

Dear Mr. Biggs:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subicct 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Mike Biggs

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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,

# David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K140006

Device Name

EndoShield Burn Protection System

#### Indications for Use (Describe)

The EndoShield Burn Protection System is an accessory for use with electrosurgical generators and is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive coupling. EndoShield performs acive electrode monitoring intended to control stray monopolar energy, caused by insulation failure and capacitive coupling in surgical instruments, along the instrument.

#### Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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