The Habib EndoHPB is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts.

The Habib EndoHPB is also intended for use to ablate malignant or benign tissue, notably to perform endoscopic biliary drainage or decompression, prior to stent placement or afterwards, to clear occluded stent.

Device Description

The Habib EndoHPB is an 8F RF bipolar catheter that consists of a catheter with 2 ring electrodes, introduced via an endoscope's biopsy channel. It has an attached cable which connects the device to an RF Generator. RF is applied to the two electrodes at the top of the catheter so that heat is applied to tissue surrounding the catheter.

AI/ML Overview

This document, a 510(k) Pre-market Notification for the Habib EndoHPB, details the device's substantial equivalence to a predicate device, focusing on its expanded indications for use. It outlines the performance and clinical data submitted to support these expanded uses.

Acceptance Criteria and Reported Device Performance

The provided document does not contain a typical "acceptance criteria" table with specific quantitative thresholds for device performance (e.g., sensitivity, specificity, accuracy) akin to what might be seen for diagnostic AI devices. Instead, the "acceptance criteria" for this device, which is a therapeutic radiofrequency (RF) catheter, are implicitly demonstrated through:

Substantial Equivalence: The primary acceptance criterion for a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This involves showing that the device is as safe and effective as the predicate.
Performance Data: Non-clinical (bench) testing to confirm fundamental device properties, such as shelf-life and compatibility with new generators.
Clinical Data: Studies to demonstrate the safety and effectiveness of the device for its expanded indications for use, particularly for the ablation of tissue in pancreatic and and biliary tracts, and for clearing occluded stents.

Therefore, the table below summarizes the differences and the justification for substantial equivalence, which serves as the "acceptance criteria" framework for this type of device submission.

Acceptance Criterion (implicitly demonstrated through substantial equivalence)	Reported Device Performance/Justification
Expanded Indications for Use (Safety and effectiveness for new target anatomical sites and therapeutic actions)	Reported Performance: The Habib EndoHPB is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts. It is also intended for use to ablate malignant or benign tissue, notably to perform endoscopic biliary drainage or decompression, prior to stent placement or afterwards, to clear occluded stent. Justification: "Multiple clinical studies are being submitted to demonstrate that the Habib EndoHPB is as safe and effective as the predicate. All the clinical studies provided within this submission have been performed using the subject device and clearly support the new intended use." The subject device has the same fundamental technology, design attributes, materials, and functions as the predicate.
Extended Shelf-Life (Device functionality and safety maintained over 3 years)	Reported Performance: New claimed shelf-life of 3 years. Justification: "The results obtained support the claimed 3-year shelf-life." This implies non-clinical testing was performed (e.g., accelerated aging, real-time aging studies) to confirm material degradation, sterility, and functional performance over the extended period.
Compatibility with New Generators (Safe and effective operation when connected to additional RF generators)	Reported Performance: Compatibility with additional generators: Olympus ESG-100, Genii GI 4000, ERBE VIO 200, ERBATOM ICC 200, 300, 350. (The predicate was compatible with RITA Medical Systems 1500, RITA Medical Systems 1500X, Radionics Cosman Coagulator CC-1). Justification: "The results obtained support... the compatibility with new generators." This implies testing was performed to ensure that the device performs as intended and safely (e.g., no overheating, appropriate power delivery, no electrical hazards) when used with these new generators, meeting relevant electrical safety and EMC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18).
Fundamental Technological Equivalence (No significant changes in design, material, energy source, or manufacturing process that raise new questions of safety or effectiveness)	Reported Performance: "Compared to the predicate device, there has been no change or modification in design, material, energy source or manufacturing process in the subject device." The device remains an 8F RF bipolar catheter with 2 ring electrodes, stainless steel active electrode material, delivered endoscopically, single-use, and ETO sterilized. The core mechanism of action (bipolar RF energy ablation) is unchanged. Justification: The 510(k) submission states that "the evidence collected in the table above clearly demonstrate that, except for insignificant differences, the subject device, the Habib EndoHPB, is identical to the previously cleared Habib EndoHPB (K083292) in terms of fundamental technology, design attributes, materials, features, functions, and performance."
Electrical Safety and Electromagnetic Compatibility (EMC) (Compliance with recognized international standards for medical electrical equipment)	Reported Performance: "Electromagnetic compatibility and electrical safety testing have been performed on the Habib EndoHPB to validate that it meets the requirements of the latest Recognized Consensus Standards." Justification: Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18.

Study Proving Device Meets Acceptance Criteria

The document states that "multiple clinical studies are being submitted to demonstrate that the Habib EndoHPB is as safe and effective as the predicate" for its new intended use. However, the details of these specific studies (e.g., design, endpoints, results) are not provided within this 510(k) summary. This summary only states that such studies were submitted and supported the new intended use.

Based on the provided text, the following information regarding the study cannot be definitively extracted:

Sample sizes used for the test set and the data provenance: Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/specified. This is a therapeutic device, not a diagnostic AI device requiring expert consensus for ground truth on images. The "ground truth" would relate to clinical outcomes (e.g., successful ablation, stent clearance, complication rates).
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/specified.
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: Not applicable. This is a therapeutic device, not an AI-assisted diagnostic imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a therapeutic device that works with a human operator.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): While not explicitly stated, for a therapeutic device performance, the ground truth for clinical studies would typically involve outcomes data such as:
- Successful ablation (e.g., histological confirmation if biopsies are taken, imaging follow-up)
- Successful biliary drainage/decompression
- Successful stent clearance
- Complication rates (e.g., perforation, bleeding, pancreatitis)
- Adverse event rates
- Patient survival/quality of life (if long-term follow-up was part of the study).
The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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March 20, 2018

EMcision Ltd. % Louis-Paul Marin President LOK North America Inc. 2025 Michelin LAVAL, H71 5b7 CANADA

Re: K180165

Trade/Device Name: Habib EndoHPB Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: KNS Dated: January 17, 2018 Received: January 22, 2018

Dear Louis-Paul 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

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801); medical device reporting of medical 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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180165

Device Name Habib EndoHPB

Indications for Use (Describe)

The Habib EndoHPB is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts.

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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510(k) Summary

1.	Type of submission	Traditional
2.	Preparation Date	January 17, 2018
3.	Submitter Address	EMcision Ltd.Department of SurgeryHammersmith HospitalDuCane RoadLondon W12 0HSUnited KingdomPhone: 1 (514) 994-9649Contact: François Poulin
4.	Contact Person	Louis-Paul MarinPresident of LOK North America Inc.Phone: 1 (450) 781-1578 ext. 225Fax: 1 (450) 681-9663Email: marin.lp@lok-corporation.com
5.	Identification of the Device
	Proprietary Name/Trade Name	Habib EndoHPB
	Regulation Description	Endoscopic electrosurgical unit and accessories
	Device Classification	II
	Regulation Number	876.4300
	Panel	Gastroenterology/Urology
	Product Code	KNS
6.	Identification of the Predicate
	Predicate Device Name	Habib EndoHPB

7. Purpose of this Submission

510(k) Number

The main purpose of this submission is to gain clearance to expand the indication for use of the previously cleared Habib EndoHPB (K083292) by including a treatment indication and update the original 510(k) submission to current configurations in terms of shelf life duration and insignificant changes to the labeling.

K083292

8. Intended use of the Subject Device

The Habib EndoHPB is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts.

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Device Description 9.

10. Performance Data

Compared to the predicate device, there has been no change or modification in design, material, energy source or manufacturing process in the subject device. The only modifications that have required performance testing are the following:

New claimed shelf-life; and -
-Compatibility with new generators.

The results obtained support the claimed 3-year shelf-life and the compatibility with new generators.

11. Clinical Data

The subject device indications for use is significantly different when compared to the predicate device. Therefore, multiple clinical studies are being submitted to demonstrate that the Habib EndoHPB is as safe and effective as the predicate. All the clinical studies provided within this submission have been performed using the subject device and clearly support the new intended use.

12. Electromagnetic and Electrical Testing

Electromagnetic compatibility and electrical safety testing have been performed on the Habib EndoHPB to validate that it meets the requirements of the latest Recognized Consensus Standards:

-IEC 60601-1 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
-IEC 60601-1-2 Medical Electrical Equipment -- Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements and Tests
-IEC 60601-2-2 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
-IEC 60601-2-18 Medical Electrical Equipment – Part 2-18: Particular Requirements for the Basic Safety and Essential Performance of Endoscopic Equipment

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13. Substantial Equivalence Determination

The overall technological comparisons between the subject device and the predicate are summarized in the following table:

Item	Predicate Device	Subject Device
	Habib EndoHPB(K083292)	Habib EndoHPB
	Substantial Equivalence
Classification	II	II
Code of FederalRegulation	876.4300	876.4300
Prescription MedicalDevices	Yes	Yes
Indications for Use	The Habib EndoHPB isintended to be used in thecoagulation of tissue duringEndoscopic surgical proceduresin the Gastro-intestinal Tract.	The Habib EndoHPB is aradiofrequency (RF) catheterwhich provides bipolar energy toperform partial or completeablation of tissue in thepancreatic and biliary tracts.The Habib EndoHPB is alsointended for use to ablatemalignant or benign tissue,notably to perform endoscopicbiliary drainage ordecompression, prior to stentplacement or afterwards, to clearoccluded stent.
Anatomical sites	Gastro-intestinal Tract	Pancreatic and Biliary Tracts
Operating Mode	Bipolar RF energy	Bipolar RF energy
Active ElectrodeMaterial	Stainless Steel	Stainless Steel
Catheter Size	7.5F	8F
Number of ActiveElectrodes	2	2
Electrode Shape	Central electrode assembly andouter ring electrode	Central electrode assembly andouter ring electrode
Delivery Mode	Endoscopic	Endoscopic
Single Use	Yes	Yes
Sterilization	ETO	ETO
Packaging	Coil inside a Tyvek pouchmounted in a carton	Coil inside a Tyvek pouchmounted in a carton
Shelf-Life	6 months	3 years
CompatibleGenerators	RITA Medical Systems 1500RITA Medical Systems 1500XRadionics Cosman CoagulatorCC-1	RITA Medical Systems 1500RITA Medical Systems 1500XOlympus ESG-100Genii GI 4000ERBE VIO 200

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ERBATOM ICC 200, 300, 350
---------------------------

The evidence collected in the table above clearly demonstrate that, except for insignificant differences, the subject device, the Habib EndoHPB, is identical to the previously cleared Habib EndoHPB (K083292) in terms of fundamental technology, design attributes, materials, features, functions, and performance.

The differences between the subject and the predicate device are as follows:

-Expanded indications for use;
Extended shelf-life; and -
Compatibility with more generators. -

Performance data provided within this submission support the substantial equivalence of the subject device to the predicate. Additionally, clinical and performance data provided demonstrated the Habib EndoHPB to be safe and effective for the expanded indication for use, extended shelf-life, and compatibility with additional generators.

14. Conclusion

The information provided by EMcision in this submission demonstrates that the subject device Habib EndoHPB is substantially equivalent to the currently cleared predicate device (K083292) and raises no new questions of safety and effectiveness.

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).