Habib EUS RFA

K161305 · Emcision , Ltd. · GEI · Jul 7, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K161305
• Device Name: Habib EUS RFA
• Applicant: Emcision , Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 7, 2016
• 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 and ablation of soft tissue when used in conjunction with compatible radio frequency generator.

Device Story

Habib EUS RFA 6700 is a monopolar electrosurgical catheter delivered via 19G endoscopic needles during EUS procedures. Device connects to a compatible RF generator via accessory cable. RF current emitted from electrode tip induces ion agitation in surrounding tissue, converting to heat via friction, resulting in coagulation necrosis. Used in clinical settings by physicians. Output is thermal energy for tissue ablation. Benefits include targeted soft tissue coagulation/ablation. Includes mechanical positioning guide for procedure support.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included trackability, pushability, heating consistency, abrasion, mechanical assembly tests (pull, bending, compression, fatigue, peel), transport/package integrity, accelerated aging, seal/bubble tests, usability validation, and functional validation for soft tissue indication. Biocompatibility testing per ISO 10993-1, -5, -7, -10. Electrical/EMC testing per IEC 60601-1, 60601-2-2, and 60601-2-18.

Technological Characteristics

Monopolar electrosurgical catheter; stainless steel electrode tip; 0.33mm shaft diameter. Insulation: polyimide coating over stainless steel core. Electrical junction: crimped with Santoprene overmould. Energy source: external RF generator (up to 480 kHz). Sterilization: Ethylene Oxide. Standards: IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, ISO 10993 series, ISO 11135, ISO 11607-1, ASTM D4332, D642, D999, D5276, F1886, F88, F1980.

Indications for Use

Indicated for coagulation and ablation of soft tissue in patients requiring such procedures, when used with a compatible radio frequency 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

• Habib EUS RFA 6700 (K150029)

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

July 7, 2016

EMcision Ltd. % Mr. Me Louis-Paul Marin LOK North America, Inc. 2025 Michelin Laval, Quebec H7L 5B7 Canada

Re: K161305

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 3, 2016 Received: May 10, 2016

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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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/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 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 -A

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<br>Food and Drug Administration<br><b>Indications for Use</b> | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | K161305 |
| Device Name | Habib EUS RFA |
| Indications for Use (Describe) | The Habib EUS RFA 6700 is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radio frequency generator. |

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

| <span style="text-decoration: underline;"><b></b></span> 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/1 description: The image shows the word "EMcision" in a stylized font. The letters "EM" are larger than the rest of the word. There is a small, orange, check-mark-like shape above the "M". The rest of the word is in black.

EMcision International Inc.

| 510(k) Summary |
|----------------|
|----------------|

- 1. Type of submission Traditional 2. Preparation Date June 27, 2016 3. Submitter Address EMcision Ltd. Department of Surgery Hammersmith Hospital DuCane Road London W12 OHS United Kingdom Phone: [phone] Contact: François Poulin 4. Contact Person Mr. Louis-Paul Marin eng., LL.B., LL.M. President of LOK North America Inc. Phone: [phone] ext. 225 Fax: [phone] Email: marin.lp(@lok-corporation.com 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 and accessories Device Classification II 878.4400 Regulation Number Panel 79 - General and Plastic Surgery Product Code JOS. GEI 6. Identification of the Predicate Predicate Device Name HABIB EUS RFA 6700 510(k) Number K150029
## 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

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## K161305

The Habib EUS RFA 6700 is a catheter that is delivered during an EUS procedure, through 19 Gauge (G) endoscopic needles. The subject device 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 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 means of coagulation necrosis.

### 9. Performance Data

Performance bench testing, biocompatibility testing and electrical testing were performed on the subject device, 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:

- -Trackability and Pushability Test;
- Consistency of Heating Zone and Temperature Test; -
- . Abrasion Test:
- Mechanical Tests on the Electrical Assembly including Pull Test; Three Points Bending; = Test; Compression Test; Fatigue Resistance Test; and Peel Resistance Test;
- -Transport Simulation and Package Integrity;
- -Accelerated Aging;
- -Seal Integrity (visual inspection);
- = Bubble Test (package integrity);
- Peel Test (seal strength): .
- Ambient Preconditioning; ﯿﺮ
- . Controlled Conditioning;
- 201 Distribution Simulation:
- -Design and Usability Validation;
- Functional Validation for Soft Tissue Indication; -
- ﺷ Label Inspection;
- -Usability of Pouch;
- = Functional testing of catheter insertion in the endoscope needle;
- = Deflection Test;
- Mechanical Tests on the Positioning Guide; and 奥
- IPX2 Test. ్లి

The following biocompatibility tests were performed:

- = ISO 10993-1:2009 Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests for in vitro cytotoxicity
- ISO 10993-7:2008 Biological Evaluation of Medical Devices Part 7: Ethylene oxide ਦ sterilization residuals
- ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests for . irritation and skin sensitization

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## 10. Electromagnetic and Electrical Testing

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

- -IEC 60601-1:2006: Medical electrical equipment - part 1: General requirements for basic safety and essential performance;
- ﻴﺮ IEC 60601-2-2:2009 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; and
- . IEC 60601-2-18:2009 Endoscopic equipment

## 11. Substantial Equivalence Determination

The subject device, the Habib EUS RFA 6700, is substantially equivalent to legally marketed predicate device (K150029) with respect ton indications for use and technology characteristics. The Table below present side by side comparisons for each major component for each device:

| Item | Predicate Device<br>Habib EUS RFA 6700<br>(K150029) | Subject Device<br>Habib EUS RFA 6700 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Classification | II | II |
| Code of Federal Regulation | 878.4400 | 878.4400 |
| Prescription Medical Devices | Yes | Yes |
| Indications for Use | The Habib EUS RFA 6700 is<br>indicated for coagulation and<br>ablation of soft tissue when used<br>in conjunction with compatible<br>radio frequency generator. | The Habib EUS RFA 6700 is<br>indicated for coagulation and<br>ablation of soft tissue when used<br>in conjunction with compatible<br>radio frequency generator. |
| Active Accessory<br>Configuration | Monopolar | Monopolar |
| Material of electrode tip | Stainless Steel | Stainless Steel |
| Safety Standards | IEC 60601-1 | IEC 60601-1 |
| | IEC 60601-2-2 | IEC 60601-2-2 |
| | IEC 60601-2-18 | IEC 60601-2-18 |
| | ISO 10993-1 | ISO 10993-1 |
| | ISO 10993-4 | ISO 10993-5 |
| | ISO 10993-5 | ISO 10993-7 |
| | ISO 10993-7 | ISO 10993-10 |
| | ISO 10993-10 | ISO 14971 |
| | | ASTM D4332 |
| | | ASTM D642 |
| | | ASTM D999 |
| | | ASTM D5276 |
| | | ASTM F1886 |
| | | ASTM 2096 |
| | | ASTM F88 |
| | | ASTM 1980 |
| | | ISO 11607-1 |
| | | ISO 11135 |
| | | ISO 11138-1<br>ISO 11138-2 |
| Performance Tests | - Compatibility with<br>endoscope needle<br>- Trackability and Pushability<br>Test<br>- Consistency of Heating Zone<br>Test<br>- Abrasion Test<br>- Fatigue Bending Resistance<br>Test<br>- Pull Test<br>- Shipping and Transportation<br>Test<br>- Burst Test (Package<br>evaluation)<br>- Package Seal Dye<br>Penetration Test<br>- Functional Validation for<br>Soft Tissue Indication | - Trackability and Pushability<br>Test<br>- Consistency of Heating Zone<br>and Temperature Test<br>- Abrasion Test<br>- Mechanical Tests on the<br>Electrical Assembly including<br>Pull Test; Three Points<br>Bending Test; Compression<br>Test; Fatigue Resistance Test;<br>and Peel Resistance Test<br>- Transport Simulation and<br>Package Integrity<br>- Accelerated Aging<br>- Seal Integrity (visual<br>inspection)<br>- Bubble Test (package<br>integrity)<br>- Peel Test (seal strength)<br>- Ambient Preconditioning<br>- Controlled Conditioning<br>- Distribution Simulation<br>- Design and Usability<br>Validation<br>- Functional Validation for Soft<br>Tissue Indication<br>- Label Inspection<br>- Usability of Pouch<br>- Functional testing of catheter<br>insertion in the endoscope<br>needle<br>- Deflection Test<br>- Mechanical Tests on the<br>Positioning Guide<br>- IPX2 Test |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Dimension | Shaft Ø 0.33mm | Shaft Ø 0.33mm |
| Delivery Mode | Endoscopic needle, laparoscopes,<br>ports, trocars | Endoscopic needle, laparoscopes,<br>ports, trocars |
| Rated Frequency | Up to 460 kHz | 480 kHz |
| Length of the adaptor cable<br>(cm) | 200 | 200 |
| Type of generator plug | 8mm Monopolar Jack (PN 5470)<br>and LEMO 9 PIN<br>PAG.MO.9NL.AC65NZ (PN<br>5250) | 8mm Monopolar Jack (PN 5470)<br>and LEMO 9 PIN<br>PAG.MO.9NL.AC65NZ (PN<br>5250) |
| | Differences | |
| Shaft insulation | Polyimide tube on PTFE coating | Polyimide coating over 0.013" |
| | over 0.013" OD stainless steel | OD stainless steel core |
| | core | |
| Shaft-cable electrical junction | SN-AG Solder | Crimping |
| Coating of wire connections | Plastic | Santoprene overmould…