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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information based on the provided document:

This document is a 510(k) Pre-Market Notification for a medical device called "Habib EUS RFA 6700." The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective. As such, the "acceptance criteria" here are generally to demonstrate substantial equivalence through meeting performance, biocompatibility, and electrical safety standards comparable to the predicate devices. The "study" refers to the pre-clinical (bench) testing performed to show this.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a quantitative, pass/fail table for all performance tests. Instead, it states that the device "met the required specifications" and "performance clearly demonstrate that the Habib EUS RFA 6700 is safe and effective." The performance tests listed are qualitative descriptions of the tests performed.

However, we can infer some "acceptance criteria" for the device based on the tests conducted and the need to demonstrate substantial equivalence:

Acceptance Criteria (Inferred)	Reported Device Performance
Functional Performance	Met the required specifications.
Compatibility with endoscope needle	Tested and results reported; implies successful compatibility with 19 or 22 Gauge (G) endoscopic needles as described in Section 8.
Trackability and pushability	Tested and results reported. (Demonstrates ease of navigation through endoscope)
Consistency of heating zone	Tested and results reported; implies consistent and predictable tissue coagulation.
Abrasion resistance	Tested and results reported. (Ensures structural integrity during use)
Fatigue bending resistance	Tested and results reported. (Ensures durability against repeated bending during procedure)
Pull test	Tested and results reported. (Measures strength and integrity of connections/components)
Shipping and transportation stability	Tested and results reported. (Ensures device integrity during transit)
Package evaluation (burst test, visual inspection, seal dye)	Tested and results reported. (Ensures sterility and protection until use)
Functional validation for soft tissue indication	Tested and results reported. (Directly validates the primary indication for use: coagulation of soft tissue)
Biocompatibility	Met the required specifications.
Non-cytotoxic	Elution Cytotoxicity testing was performed.
Non-hemolytic	Hemolysis testing was performed.
Non-toxic (systemic, intracutaneous, implantation)	Implantation Test, Intracutaneous toxicity, Acute systemic injection tests were performed.
Electrical Safety & EMC	Met the required specifications.
Compliance with various IEC/EN/ANSI/CSA 60601-1 standards	Tested per IEC 60601-1:2006 + A1:2012, EN 60601-1:2006, ANSI/AAMI ES60601-1:2005 + C1:2009 + A2:2012 + A1:2010, CAN/CSA-C22.2 No. 60601-1:2014.
Compliance with IEC 60601-2-2 (HF Surgical Equipment)	Tested per IEC 60601-2-2:2009 + C1:2014.
Compliance with EN IEC 60601-2-18 (Endoscopic equipment)	Tested per EN IEC 60601-2-18:2009.
Compliance with various EMC standards (EN 55011, EN 61000-3-2, -3-3, -4-3, -4-8)	Tested per EN 55011:2007, EN 61000-3-2:2006, EN 61000-3-3:2006, EN 61000-4-3:2006, EN 61000-4-8:1993.

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

The document details a series of "Performance bench testing," "biocompatibility testing," and "electrical testing." However, it does not provide specific sample sizes (number of devices or tests performed) for these tests. It only lists the types of tests conducted.

For data provenance (country of origin, retrospective/prospective), the tests appear to be pre-clinical bench tests. This kind of testing generally occurs in a lab setting, likely where the device is manufactured or tested, which is EMcision Ltd. in the United Kingdom based on the submitter's address. It is not clinical data (retrospective or prospective from human subjects).

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

This information is not provided in the document. For pre-clinical bench testing, "ground truth" isn't typically established by clinical experts in the same way it would be for diagnostic AI. Instead, the "ground truth" for these tests would be the established scientific and engineering principles of the test methods (e.g., a pulling test measures force until failure, a biocompatibility test assesses cellular response). The personnel performing these tests would be engineers, lab technicians, and scientists qualified in their respective fields (materials science, electrical engineering, biology, etc.), but their specific number and qualifications are not mentioned.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided since the studies described are pre-clinical bench tests, not studies requiring expert adjudication of clinical outcomes or images. Adjudication methods like "2+1" or "3+1" are typical for clinical studies or studies involving human readers and ground truth establishment from multiple experts.

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

This information is not provided and not applicable. The document describes the pre-clinical validation of a physical medical device (an electrosurgical electrode), not an AI algorithm. Therefore, no MRMC study, human reader improvement with AI, or effect size is discussed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not provided and not applicable. The "Habib EUS RFA 6700" is a physical medical device. It is not an algorithm, and therefore, standalone algorithm performance is not relevant to this submission.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the performance and electrical bench tests, the "ground truth" is defined by the validated test methods and specifications themselves. For example:

Functional tests: Adherence to physical properties (e.g., dimensions, strength, flexibility), consistent activation, and effective tissue coagulation as determined by engineering and material science principles.
Biocompatibility tests: Adherence to biological safety standards as defined by ISO 10993 series and evaluated in laboratory settings (e.g., cell cultures for cytotoxicity, animal models for implantation).
Electrical/EMC tests: Conformance to published international and national safety standards for medical electrical equipment (e.g., IEC 60601-1, IEC 60601-2-2, various EN standards for EMC).

There is no "expert consensus" or "pathology/outcomes data" ground truth in the context of these pre-clinical tests.

8. The Sample Size for the Training Set

This information is not provided and not applicable. The "Habib EUS RFA 6700" is a physical medical device, not an AI model or algorithm that requires a training set.

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

This information is not provided and not applicable, as there is no training set for a physical medical device.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three faces in profile, connected by flowing lines. The figure is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a sans-serif font.

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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

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."

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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 1-514-994-9649
	Contact	François Poulin
4.	Contact Person:	Louis-Paul Marin, ing., LL.B., LL.M.President, MMA Certification Inc.
	Phone:	1-450-781-1578 ext 225
	Fax:	1-450-681-9663
	Email:	lpmarin@groupemma.ca
5.	Identification of the Device
	Proprietary Name/Trade Name	Habib EUS RFA 6700
	Common Name:	Monopolar electrosurgical device
	Classification Name:	Electrosurgical cutting and coagulation deviceandaccessories
	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:

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

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 DeviceAce MonopolarAttachment(K123061)	Predicate DeviceLeVeen™ Standard NeedleElectrode System(K140495)	Subject DeviceHabib EUS RFA 6700(K150029)
Similarities
Classification	II	II	II
Code of FederalRegulation	878.440	878.4400	878.4400
PrescriptionMedical Devices	Yes	Yes	Yes
Intended Use	The Ace MonopolarAttachement is intendedto be used with thecompatible ERBEMonopolar DisposableElectrosurgical Pencil forcoagulation and cutting ofsoft tissue when used inconjunction withcompatible ERBEElectrosurgical Generator(ESU) System.	The LeVeen™ NeedleElectrode Family (whichincludes the LeVeen™Standard NeedleElectrode System and theLeVeen™ CoAccess™Need Electrode System)is intended to be used inconjunction with theRF3000 Generator for thethermal coagulationnecrosis of soft tissues,including partial orcomplete ablation ofnonresectable liver	The Habib EUS RFA6700 is indicated forcoagulation and ablationof soft tissue when usedin conjunction withcompatible radiofrequency generator.
		lesions.
Active AccessoryConfiguration	Monopolar	Monopolar	Monopolar
Material ofelectrode tip	Stainless Steel	n/a	Stainless Steel
Safety Standards	IEC 60601-1IEC 60601-1-2IEC 60601-2-2ISO 10993-1ISO10993-5ISO 10993-10	IEC 60601-1IEC 60601-2-2	IEC 60601-1IEC 60601-2-2IEC 60601-2-18ISO 10993-1ISO 10993-4ISO 10993-5ISO 10993-7ISO 10993-10
PerformanceTests	- Arcing Test- Charring Test- Thermal Spread Test- Dropping Test- Pulling Test	- Insulated CannulaOuter Diameter- Cannula Insulation- Adhesion- Cannula Tensile- Cannula/Array- Housing Handle- CompressionStrength	- Compatibility withendoscope needle- Trackability andpushability test- Consistency ofheating zone test- Abrasion test- Fatigue bendingresistance test- Pull Test- Shipping andTransportation Test- Burst Test (Packageevaluation)- Package Seal DyePenetration Test- Functional Validationfor Soft TissueIndication
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,laparoscopes, ports,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.

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.