Habib EUS RFA

K150029 · Emcision , Ltd. · GEI · Jun 24, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K150029
• Device Name: Habib EUS RFA
• Applicant: Emcision , Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 24, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Habib EUS RFA 6700 is indicated for coagulation of soft tissue when used in conjunction with compatible radio frequency generator.

Device Story

Habib EUS RFA 6700 is a monopolar catheter delivered via 19 or 22G endoscopic needles during EUS procedures. Device connects to compatible RF generator via accessory cable; requires patient grounding pad. RF current emitted from exposed electrode tip induces ion agitation in surrounding tissue; friction converts energy to heat, causing coagulation necrosis. Used in clinical settings by physicians. Output is thermal energy for tissue coagulation. Benefits include targeted soft tissue ablation.

Clinical Evidence

Bench testing only. Testing included compatibility with endoscope needles, trackability, pushability, heating zone consistency, abrasive testing, fatigue bending resistance, pull testing, and package integrity (burst/seal dye penetration). Biocompatibility testing included elution cytotoxicity, hemolysis, implantation, intracutaneous toxicity, and acute systemic injection. Electrical safety and EMC testing performed per IEC 60601-1, IEC 60601-2-2, and IEC 60601-2-18.

Technological Characteristics

Monopolar electrosurgical catheter; stainless steel electrode tip; 0.33mm shaft diameter. Energy source: compatible RF generator (up to 460 kHz). Sterilization: Ethylene Oxide. Standards: IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, ISO 10993-1/4/5/7/10. Connectivity: wired connection to RF generator.

Indications for Use

Indicated for coagulation of soft tissue in patients requiring electrosurgical intervention, used in conjunction with a compatible RF generator.

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

• LeVeen™ Standard Needle Electrode System (K140495)
• ACE Monopolar Attachment (K123061)

Submission Summary (Full Text)

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

June 24, 2015

EMcision LTD. % Mr. Louis-Paul Marin MMA Certification Incorporated 2025 Michelin Laval, Quebec H7L 5B7 Canada

Re: K150029

Trade/Device Name: Habib EUS RFA 6700 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, JOS Dated: May 21, 2015 Received: May 27, 2015

Dear Mr. Marin:

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 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 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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Jennifer R. Stevenson -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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## Indications for Use

510(k) Number (if known) K150029

Device Name Habib EUS RFA 6700

### Indications for Use (Describe)

The Habib EUS RFA 6700 is indicated for coagulation of soft tissue when used in conjunction with compatible radio frequency generator.

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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Image /page/3/Picture/0 description: The image shows the logo for EMcision Ltd. The logo consists of the word "EMcision" in a bold, sans-serif font. The "M" in "EMcision" is stylized with an orange swoosh above it. Below the main logo is the text "EMcision Ltd." in a smaller font.

### Habib EUS RFA 6700

### 510(k) Summary

| 1. | Type of submission: | Traditional |
|----|------------------------------|---------------------------------------------------------------------------|
| 2. | Preparation Date | June 22, 2015 |
| 3. | Submitter | EMcision Ltd. |
| | Address | Department of Surgery |
| | | Hammersmith Hospital |
| | | DuCane Road |
| | | London W12 0HS |
| | | United Kingdom |
| | | Phone [phone] |
| | Contact | François Poulin |
| 4. | Contact Person: | Louis-Paul Marin, ing., LL.B., LL.M.<br>President, MMA Certification Inc. |
| | Phone: | 1-450-781-1578 ext 225 |
| | Fax: | 1-450-681-9663 |
| | Email: | [e-mail] |
| 5. | Identification of the Device | |
| | Proprietary Name/Trade Name | Habib EUS RFA 6700 |
| | Common Name: | Monopolar electrosurgical device |
| | Classification Name: | Electrosurgical cutting and coagulation device<br>and<br>accessories |
| | Device Classification: | II |
| | Regulation Number: | 878.4400 |
| | Panel: | 79 - General and Plastic Surgery |
| | Product Code: | GEL IOS |

#### 6. Identification of the Predicate

Predicate Device Name: 510(k) Number:

Predicate Device Name: 510(k) Number:

LeVeen™Standard Needle Electrode System

ACE Monopolar Attachment

K140495

K123061

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#### 7. Intended use of the subject device

The Habib EUS RFA 6700 is indicated for coagulation of soft tissue when used in conjunction with compatible radio frequency generator.

#### 8. Device Description

The Habib EUS RFA 6700 is a catheter that is delivered during an EUS procedure, through 19 or 22 Gauge (G) endoscopic needles. The Habib EUS RFA 6700 is monopolar configuration and thus, must be used in conjunction with patient grounding pad. RF energy is produced by connecting the catheter to a compatible RF generator via an accessory cable. When attached to a generator, RF current is emitted from the exposed portion of the electrode and this current translates into ion agitation within the surrounding tissue, which is converted by friction into heat and induces cellular death by mans of coagulation necrosis.

### 9. Performance Data

Performance bench testing, biocompatibility testing, and electrical testing were performed on the proposed Habib EUS RFA 6700, which demonstrates that it met the required specifications for the completed design verification, biocompatibility tests, and electrical tests.

The following performance bench tests were performed:

- Compatibility with endoscope needle -
- -Trackability and pushability test
- Consistency of heating zone -
- Abrasive test -
- Fatigue bending resistance -
- -Pull test
- -Shipping and transportation test
- -Package evaluation using the burst test
- -Visual inspection of medical packaging to determine integrity
- -Package seal dye penetration test
- Functional validation for soft tissue indication -

The following biocompatibility tests were performed:

- Elution Cytotoxicity and Hemolysis -
- Implantation Test -
- -Intracutaneous toxicity
- -Acute systemic injection

### 10. Electromagnetic and Electrical Testing

Testing was performed per the requirements of the following electromagnetic compatibility and electrical standards:

- -IEC 60601-1:2006 + A1:2012, EN 60601-1:2006, ANSI/AAMI ES60601-1:2005 + C1:2009 + A2:2012 + A1:2010, and CAN/CSA-C22.2 No. 60601-1:2014: Medical electrical equipment -Part 1: General requirements for basic safety and essential performance

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- -IEC 60601-2-2:2009 + C1:2014 Medical electrical equipment = Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- -EN IEC 60601-2-18:2009 Endoscopic equipment; In conjunction with BS EN 60601-1:2006 +A11 and IEC 60601-1:2005 Medical electrical equipment - Part 1 - General requirements for basic safety and essential performance
- -EN 55011:2007 Limits and methods of measurements of electromagnetic disturbance characteristics of industrial, scientific and medical (ISM) radio-frequency equipment
- EN 61000-3-2: 2006 Electromagnetic compatibility (EMC) -- Part 3-2: Limits for harmonic current emissions (equipment input current <= 16 A per phase)
- -EN 61000-3-3:2006 Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current <= 16 A per phase and not subject to conditional connection
- -EN 61000-4-3:2006 Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques – Radiated, radio-frequency, electromagnetic field immunity test
- -EN 61000-4-8:1993 Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test

### 11. Substantial Equivalence Determination

The subject device, the Habib EUS RFA 6700 is substantially equivalent to legally marketed predicate devices, the Ace Monopolar Attachment and the LeVeen™ Standard Needle Electrode System with respect to indications for use and technology characteristics. The Table below presents side by side comparisons for each major component of for each device:

| Item | Predicate Device<br>Ace Monopolar<br>Attachment<br>(K123061) | Predicate Device<br>LeVeen™ Standard Needle<br>Electrode System<br>(K140495) | Subject Device<br>Habib EUS RFA 6700<br>(K150029) |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | | |
| Classification | II | II | II |
| Code of Federal<br>Regulation | 878.440 | 878.4400 | 878.4400 |
| Prescription<br>Medical Devices | Yes | Yes | Yes |
| Intended Use | The Ace Monopolar<br>Attachement is intended<br>to be used with the<br>compatible ERBE<br>Monopolar Disposable<br>Electrosurgical Pencil for<br>coagulation and cutting of<br>soft tissue when used in<br>conjunction with<br>compatible ERBE<br>Electrosurgical Generator<br>(ESU) System. | The LeVeen™ Needle<br>Electrode Family (which<br>includes the LeVeen™<br>Standard Needle<br>Electrode System and the<br>LeVeen™ CoAccess™<br>Need Electrode System)<br>is intended to be used in<br>conjunction with the<br>RF3000 Generator for the<br>thermal coagulation<br>necrosis of soft tissues,<br>including partial or<br>complete ablation of<br>nonresectable liver | The Habib EUS RFA<br>6700 is indicated for<br>coagulation and ablation<br>of soft tissue when used<br>in conjunction with<br>compatible radio<br>frequency generator. |
| | | lesions. | |
| Active Accessory<br>Configuration | Monopolar | Monopolar | Monopolar |
| Material of<br>electrode tip | Stainless Steel | n/a | Stainless Steel |
| Safety Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-2<br>ISO 10993-1<br>ISO10993-5<br>ISO 10993-10 | IEC 60601-1<br>IEC 60601-2-2 | IEC 60601-1<br>IEC 60601-2-2<br>IEC 60601-2-18<br>ISO 10993-1<br>ISO 10993-4<br>ISO 10993-5<br>ISO 10993-7<br>ISO 10993-10 |
| Performance<br>Tests | - Arcing Test<br>- Charring Test<br>- Thermal Spread Test<br>- Dropping Test<br>- Pulling Test | - Insulated Cannula<br>Outer Diameter<br>- Cannula Insulation<br>- Adhesion<br>- Cannula Tensile<br>- Cannula/Array<br>- Housing Handle<br>- Compression<br>Strength | - Compatibility with<br>endoscope needle<br>- Trackability and<br>pushability test<br>- Consistency of<br>heating zone test<br>- Abrasion test<br>- Fatigue bending<br>resistance test<br>- Pull Test<br>- Shipping and<br>Transportation Test<br>- Burst Test (Package<br>evaluation)<br>- Package Seal Dye<br>Penetration Test<br>- Functional Validation<br>for Soft Tissue<br>Indication |
| Differences | | | |
| Sterilization | Gamma irradiation | Ethylene Oxide | Ethylene Oxide |
| Dimension | Shaft $ ⌀ $ 2.35mm | Shaft $ ⌀ $ 1.5-2.4mm | Shaft $ ⌀ $ 0.33mm |
| Delivery Mode | Electrosurgical pencil | Cannula (percutaneous) | Endoscopic needle,<br>laparoscopes, ports,<br>trocars |
| Rated Frequency | n/a | 480 kHz | Up to 460 kHz |

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### 13. Conclusion

The Habib EUS RFA 6700 is substantially equivalent to the predicates Ace Monopolar Attachment (K123061) and LeVeen™Standard Needle Electrode System (K140495). The minor differences between the Habib EUS RFA 6700 and the predicates do not raise any new questions of safety or effectiveness. All product performance testing and electrical testing performance clearly demonstrate that the Habib EUS RFA 6700 is safe and effective.