Habib EndoHPB

K180165 · Emcision , Ltd. · KNS · Mar 20, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K180165
• Device Name: Habib EndoHPB
• Applicant: Emcision , Ltd.
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Mar 20, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

8F RF bipolar catheter; introduced via endoscope biopsy channel; connects to external RF generator. Device delivers bipolar RF energy to two ring electrodes at catheter tip; generates heat to ablate surrounding tissue. Used in clinical settings by physicians for endoscopic procedures. Output is thermal ablation of tissue; facilitates biliary drainage, decompression, and stent clearance. Benefits include minimally invasive treatment of pancreatic/biliary obstructions and malignant/benign tissue management.

Clinical Evidence

Clinical studies provided to support expanded indications for use. Bench testing validated 3-year shelf-life and compatibility with new generators. Electrical safety and electromagnetic compatibility testing performed per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, and IEC 60601-2-18.

Technological Characteristics

8F bipolar RF catheter; stainless steel electrodes; endoscopic delivery. Energy source: external RF generator. Sterilization: ETO. Shelf-life: 3 years. Compatible with multiple RF generators (e.g., RITA, Olympus, ERBE).

Indications for Use

Indicated for patients requiring partial or complete tissue ablation in the pancreatic and biliary tracts, including ablation of malignant or benign tissue for biliary drainage, decompression, or clearing of occluded stents.

Regulatory Classification

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.

Predicate Devices

• Habib EndoHPB (K083292)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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.

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.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------|----------------------------------------------------------------|
| <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) Summary

| 1. | Type of submission | Traditional |
|----|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Preparation Date | January 17, 2018 |
| 3. | Submitter Address | EMcision Ltd.<br>Department of Surgery<br>Hammersmith Hospital<br>DuCane Road<br>London W12 0HS<br>United Kingdom<br>Phone: [phone]<br>Contact: François Poulin |
| 4. | Contact Person | Louis-Paul Marin<br>President of LOK North America Inc.<br>Phone: [phone] ext. 225<br>Fax: [phone]<br>Email: [e-mail] |
| 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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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 9.

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.

#### 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<br>(K083292) | Habib EndoHPB |
| | Substantial Equivalence | |
| Classification | II | II |
| Code of Federal<br>Regulation | 876.4300 | 876.4300 |
| Prescription Medical<br>Devices | Yes | Yes |
| Indications for Use | The Habib EndoHPB is<br>intended to be used in the<br>coagulation of tissue during<br>Endoscopic surgical procedures<br>in the Gastro-intestinal Tract. | The Habib EndoHPB is a<br>radiofrequency (RF) catheter<br>which provides bipolar energy to<br>perform partial or complete<br>ablation of tissue in the<br>pancreatic and biliary tracts.<br><br>The Habib EndoHPB is also<br>intended for use to ablate<br>malignant or benign tissue,<br>notably to perform endoscopic<br>biliary drainage or<br>decompression, prior to stent<br>placement or afterwards, to clear<br>occluded stent. |
| Anatomical sites | Gastro-intestinal Tract | Pancreatic and Biliary Tracts |
| Operating Mode | Bipolar RF energy | Bipolar RF energy |
| Active Electrode<br>Material | Stainless Steel | Stainless Steel |
| Catheter Size | 7.5F | 8F |
| Number of Active<br>Electrodes | 2 | 2 |
| Electrode Shape | Central electrode assembly and<br>outer ring electrode | Central electrode assembly and<br>outer ring electrode |
| Delivery Mode | Endoscopic | Endoscopic |
| Single Use | Yes | Yes |
| Sterilization | ETO | ETO |
| Packaging | Coil inside a Tyvek pouch<br>mounted in a carton | Coil inside a Tyvek pouch<br>mounted in a carton |
| Shelf-Life | 6 months | 3 years |
| Compatible<br>Generators | RITA Medical Systems 1500<br>RITA Medical Systems 1500X<br>Radionics Cosman Coagulator<br>CC-1 | RITA Medical Systems 1500<br>RITA Medical Systems 1500X<br>Olympus ESG-100<br>Genii GI 4000<br>ERBE 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.