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.

AI/ML Overview

The provided text describes a 510(k) submission for the Habib EUS RFA 6700 device, asserting its substantial equivalence to a predicate device (K150029). The submission outlines various performance, biocompatibility, and electrical tests conducted to demonstrate that the device meets required specifications.

Here's the information extracted and organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Tests Performed	Reported Device Performance
Performance Bench Tests	Trackability and Pushability Test	Met required specifications for design verification
	Consistency of Heating Zone and Temperature Test	Met required specifications for design verification
	Abrasion Test	Met required specifications for design verification
	Mechanical Tests on the Electrical Assembly (Pull Test, Three Points Bending, Compression Test, Fatigue Resistance Test, Peel Resistance Test)	Met required specifications for design verification
	Transport Simulation and Package Integrity	Met required specifications for design verification
	Accelerated Aging	Met required specifications for design verification
	Seal Integrity (visual inspection)	Met required specifications for design verification
	Bubble Test (package integrity)	Met required specifications for design verification
	Peel Test (seal strength)	Met required specifications for design verification
	Ambient Preconditioning	Met required specifications for design verification
	Controlled Conditioning	Met required specifications for design verification
	Distribution Simulation	Met required specifications for design verification
	Design and Usability Validation	Met required specifications for design verification
	Functional Validation for Soft Tissue Indication	Met required specifications for design verification
	Label Inspection	Met required specifications for design verification
	Usability of Pouch	Met required specifications for design verification
	Functional testing of catheter insertion in the endoscope needle	Met required specifications for design verification
	Deflection Test	Met required specifications for design verification
	Mechanical Tests on the Positioning Guide	Met required specifications for design verification
	IPX2 Test	Met required specifications for design verification
Biocompatibility Tests	ISO 10993-1:2009 Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process	Met required specifications for biocompatibility tests
	ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests for in vitro cytotoxicity	Met required specifications for biocompatibility tests
	ISO 10993-7:2008 Biological Evaluation of Medical Devices Part 7: Ethylene oxide sterilization residuals	Met required specifications for biocompatibility tests
	ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests for irritation and skin sensitization	Met required specifications for biocompatibility tests
Electrical Testing	IEC 60601-1:2006: Medical electrical equipment - part 1: General requirements for basic safety and essential performance	Met required specifications for electrical tests
	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	Met required specifications for electrical tests
	IEC 60601-2-18:2009 Endoscopic equipment	Met required specifications for electrical tests

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for any of the performance tests. The tests appear to be laboratory-based bench tests and biocompatibility tests, rather than clinical studies with patient data. Therefore, details regarding country of origin or retrospective/prospective nature of patient data are not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. The evaluations described are primarily engineering and biocompatibility tests, not interpretations of clinical data requiring expert consensus or ground truth establishment in that context.

4. Adjudication Method for the Test Set

This information is not applicable as the tests are objective engineering and biological assessments, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not done. This device is an electrosurgical tool, not an AI-powered diagnostic or assistive technology for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable. The device is a physical electrosurgical catheter and not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed can be considered the established scientific and engineering standards outlined by the various ISO and IEC standards cited (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety). The performance bench tests would have had internal engineering specifications as their "ground truth."

8. The Sample Size for the Training Set

This information is not applicable as the device is not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as the device is not an AI algorithm that requires a training set.

Summary

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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 (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

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See 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)
-------------------------------------------------------------------------------------------------------	-----------------------------------------------

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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.

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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: 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

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K161305

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 DeviceHabib EUS RFA 6700(K150029)	Subject DeviceHabib 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 isindicated for coagulation andablation of soft tissue when usedin conjunction with compatibleradio frequency generator.	The Habib EUS RFA 6700 isindicated for coagulation andablation of soft tissue when usedin conjunction with compatibleradio frequency generator.
Active AccessoryConfiguration	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 11138-1ISO 11138-2
Performance Tests	- Compatibility withendoscope needle- Trackability and PushabilityTest- Consistency of Heating ZoneTest- Abrasion Test- Fatigue Bending ResistanceTest- Pull Test- Shipping and TransportationTest- Burst Test (Packageevaluation)- Package Seal DyePenetration Test- Functional Validation forSoft Tissue Indication	- Trackability and PushabilityTest- Consistency of Heating Zoneand Temperature Test- Abrasion Test- Mechanical Tests on theElectrical Assembly includingPull Test; Three PointsBending Test; CompressionTest; Fatigue Resistance Test;and Peel Resistance Test- Transport Simulation andPackage Integrity- Accelerated Aging- Seal Integrity (visualinspection)- Bubble Test (packageintegrity)- Peel Test (seal strength)- Ambient Preconditioning- Controlled Conditioning- Distribution Simulation- Design and UsabilityValidation- Functional Validation for SoftTissue Indication- Label Inspection- Usability of Pouch- Functional testing of catheterinsertion in the endoscopeneedle- Deflection Test- Mechanical Tests on thePositioning Guide- IPX2 Test
Sterilization	Ethylene Oxide	Ethylene Oxide
Dimension	Shaft Ø 0.33mm	Shaft Ø 0.33mm
Delivery Mode	Endoscopic needle, laparoscopes,ports, trocars	Endoscopic needle, laparoscopes,ports, trocars
Rated Frequency	Up to 460 kHz	480 kHz
Length of the adaptor cable(cm)	200	200
Type of generator plug	8mm Monopolar Jack (PN 5470)and LEMO 9 PINPAG.MO.9NL.AC65NZ (PN5250)	8mm Monopolar Jack (PN 5470)and LEMO 9 PINPAG.MO.9NL.AC65NZ (PN5250)
	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
Adaptor	None	Positioning guide

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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.

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.