Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical mechanism of radiofrequency ablation and does not mention any AI/ML components or functions.

Therapeutic

Yes
The device is indicated for "coagulation and ablation of soft tissue," which is a therapeutic intervention. It aims to treat or modify a physiological function by inducing cellular death to address medical conditions.

Diagnostic

No

The device is used for coagulation and ablation of soft tissue, which are therapeutic actions, not diagnostic ones. Its function is to destroy tissue, not gather information about it.

SaMD (Software as a Medical Device)

No

The device is a physical catheter designed for use in conjunction with a radio frequency generator and grounding pad, clearly indicating it is a hardware medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Habib EUS RFA 6700 is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
Habib EUS RFA 6700 Function: The description clearly states that the Habib EUS RFA 6700 is a catheter used for "coagulation and ablation of soft tissue" within the body during an EUS procedure. It directly interacts with and treats tissue inside the patient.

Therefore, the Habib EUS RFA 6700 is a therapeutic device used for a medical procedure performed in vivo (within the living body), not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

GEI, JOS

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

soft tissue

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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;
Controlled Conditioning;
201 Distribution Simulation;
Design and Usability Validation;
Functional Validation for Soft Tissue Indication;
Label Inspection;
Usability of Pouch;
Functional testing of catheter insertion in the endoscope needle;
Deflection Test;
Mechanical Tests on the Positioning Guide; and
IPX2 Test.

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 sterilization residuals
ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests for . irritation and skin sensitization

Electromagnetic and Electrical 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;
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

Key Metrics

Not Found

Predicate Device(s)

K150029

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.

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

1

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

2

| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
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)

Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
-------------------------------------------------------------------------------------------------------	-----------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14) TO BE ABLE TO SUCCESSFULLY COMPLETE THE FORM AND SUBMIT IT TO THE FDA. I AM A TEXT CORRECTION EXPERT AND I AM HERE TO HELP YOU WITH ANY QUESTIONS OR CONCERNS YOU MAY HAVE. PLEASE DO NOT HESITATE TO ASK ME ANYTHING YOU NEED TO KNOW. I AM HERE TO HELP YOU IN ANY WAY THAT I CAN.

3

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: 1 (514) 994-9649 Contact: François Poulin 4. Contact Person Mr. Louis-Paul Marin eng., LL.B., LL.M. President of LOK North America Inc. Phone: 1 (450) 781-1578 ext. 225 Fax: 1 (450) 681-9663 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

4

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

5

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
Habib EUS RFA 6700
(K150029) | Subject Device
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
indicated for coagulation and
ablation of soft tissue when used
in conjunction with compatible
radio frequency generator. | The Habib EUS RFA 6700 is
indicated for coagulation and
ablation of soft tissue when used
in conjunction with compatible
radio frequency generator. |
| Active Accessory
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
ISO 11138-2 |
| Performance Tests | - Compatibility with
endoscope needle

```
        Trackability and Pushability
```

Test

```
        Consistency of Heating Zone
```

Test

```
        Abrasion Test
```
```
        Fatigue Bending Resistance
```

Test

```
        Pull Test
```
```
        Shipping and Transportation
```

Test

```
        Burst Test (Package
```

evaluation)

```
        Package Seal Dye
```

Penetration Test

```
        Functional Validation for
```

Soft Tissue Indication | - 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
```
```
        Controlled Conditioning
```
```
        Distribution Simulation
```
```
        Design and Usability
```

Validation

```
        Functional Validation for Soft
```

Tissue Indication

```
        Label Inspection
```
```
        Usability of Pouch
```
```
        Functional testing of catheter
```

insertion in the endoscope
needle

```
        Deflection Test
```
```
        Mechanical Tests on the
```

Positioning Guide

```
        IPX2 Test |
```

6

7

K161305

As per the table set forth above, it is clear that the subject device is substantially equivalent to the predicate device and hence, this device is at least as safe and effective as the predicate device.

The predicate device, the Habib EUS RFA 6700, was initially cleared in K150029. The subject device has the same intended use, function and fundamental technology as the predicate device. The differences between the subject device are the following and all pertinent test results supported that they do not raise new issues of safety and effectiveness:

1. Shaft insulation; change from a PTFE coated with polyimide sleeve to a wire with only polyimide coating. The size and type of wire remains the same;
1. Shaft-cable electrical junction; replace soldering of the wire to connecting wire by a crimping operation:
1. Electrical junction insulation; replace plastic cover of wire connections by a Santoprene overmould; and
1. Positioning guide; addition of a mechanical positioning guide to replace between the introducer and the probe.

11. Conclusion

The Habib EUS RFA 6700 is substantially equivalent to the predicate Habib EUS RFA 6700 (K150029). The minor differences between the Habib EUS RFA 6700 and the predicate do not raise any new questions of safety or effectiveness. All product performance testing and the electrical testing performance clearly demonstrate that the Habib EUS RFA 6700 is safe and effective.