The ENDOPATH Electrosurgery Probe Plus II system has application in minimally invasive procedures to facilitate tissue dissection, coagulation, irrigation, and fluid evacuation through a common trocar sleeve.

Device Description

The Endopath® Electrosurgery Probe Plus II device with the pencil handle configuration (product code EPH04) works with a standard monopolar unit and has applications for minimally invasive procedures to facilitate tissue dissection, coagulation, irrigation, and fluid evacuation through a common trocar sleeve. Previously cleared shafts (K160128) EPS01 through EPS07 all attach to the EPH04 pencil handle in the same manner as the previously cleared pistol handle, and are for use through a 5mm diameter surgical trocar or a larger trocar with a 5mm reducer.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Endopath Electrosurgery Probe Plus II, Pencil Grip Handle" (EPH04), which is seeking substantial equivalence to a predicate device, the "Endopath® Electrosurgery Probe Plus II cleared under K160128" (EPH02, pistol handle configuration).

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Bench Testing	- Flow rate of suction and irrigation requirements met. - Impedance requirements met. - Minimum distal retraction force requirements met. - Sheath extension force requirements met. - (Implicit: Performance demonstrates substantial equivalence to predicate device)	"Data generated from these tests met the predetermined acceptance criteria." "The results of the bench testing demonstrate that the Endopath® Electrosurgery Proble Plus II Pencil device (product code EPH04) is as safe and effective and performs as well as the identified legally marketed predicate device."
Electrical Safety	Compliance with IEC 60601-2-2:2009 & IEC 60601-1:2005+A1:2012	"the system complies with IEC 60601-2-2:2009 & IEC 60601-1:2005+A1:2012 for electrical safety."
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2:2007	"the system complies with IEC 60601-1-2:2007 for electromagnetic compatibility"
Sterilization	Sterilized to an accepted sterility assurance level.	"both devices are sterilized to the same sterility assurance level." (in comparison to the predicate device)

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

The document does not specify the exact sample sizes used for the bench tests. It only states that bench testing was conducted.
The data provenance is from bench testing and is therefore laboratory-generated, not from human or animal subjects in the clinical sense. No country of origin for the data is specified, but the applicant company is located in Guaynabo, PR, and Cincinnati, OH. The data is prospective in the sense that it was generated specifically for this submission.

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

Not applicable. The ground truth for this type of device (electrosurgical probe) is established through engineering and performance specifications and international standards, not expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation or subjective assessment that would require an adjudication method. Performance is measured against objective engineering criteria.

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

Not applicable. This device is an electrosurgical probe, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is a physical electrosurgical medical device, not a software algorithm. Its performance is measured directly through bench tests.

7. The Type of Ground Truth Used

The ground truth used for this device is based on engineering specifications, international medical device standards (IEC 60601 series), and performance characteristics of the legally marketed predicate device. For example, flow rates, impedance, and mechanical forces are objectively measured and compared against predefined acceptable ranges or the predicate device's performance.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or artificial intelligence that would require a "training set."

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

Not applicable, as there is no training set for this type of device.

Summary

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May 7, 2018

Ethicon Endo-Surgery, LLC David Locke Regulatory Affairs Manager 4545 Creek Road Cincinnati, Ohio 45242

Re: K180031

Trade/Device Name: Endopath Electrosurgery Probe Plus II, Pencil Grip Handle Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: April 5, 2018 Received: April 6, 2018

Dear David Locke:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 medical devices and radiation-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. Jennifer R. Stevenson 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 SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K180031

Device Name

ENDOPATH Electrosurgery Probe Plus II (Pencil)

Indications for Use (Describe)

Indications

Contraindications

· These instruments are not intended for contraceptive coagulation of fallopian tissue but may be used to achieve hemostasis following transection of the fallopian tube.

· These instruments are not intended for use when minimally invasive techniques are contraindicated.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

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510(k) Summary

Company

Ethicon Endo-Surgery 475 Calle C Guaynabo, PR 00969

Contact

David Locke, DRSc, MS, RAC Manager, Regulatory Affairs Ethicon Endo-Surgery, LLC. 4545 Creek Road Cincinnati, OH 45242 Telephone: (513) 337-1281 Fax: (513) 337- 4366 Email: dlocke1 @its.jnj.com

Date Prepared January 2, 2018

Device Name

Trade Name: Evacuation/Irrigation/Electrosurgical Device Classification Name: Laparoscope, General & Plastic Surgery Common Name: Endopath® Electrosurgery Probe Plus II, Pencil Grip Handle Catalog Number: EPH04

Device Class Class II

Device Panel General & Plastic Surgery

Product Code GEI

Predicate Device Endopath® Electrosurgery Probe Plus II cleared under K160128

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Device Description

Indications for Use

The ENDOPATH Electrosurgery Probe Plus II system has application in minimally invasive procedures to facilitate tissue dissection, coagulation, irrigation and fluid evacuation through a common trocar sleeve.

Contraindications

These instruments are not intended for contraceptive coagulation of fallopian tissue but ● may be used to achieve hemostasis following transection of the fallopian tube.
These instruments are not intended for use when minimally invasive techniques are . contraindicated.

Technological Characteristics

The subject ENDOPATH Electrosurgery Probe Plus II Pencil device (EPH04) and predicate ENDOPATH Electrosurgery Probe Plus II Pistol device (EPH02) use the same monopolar technology to perform their intended use. The subject and predicate devices also use the same standard suction and irrigation modalities to perform their intended use. The subject ENDOPATH Electrosurgery Probe Plus II Pencil device is similar to the predicate ENDOPATH Electrosurgery Probe Plus II Pistol device with respect to the primary modes of action which include suction, irrigation and hemostasis. As compared with the predicate devices, the subject device takes on a straight pencil configuration as to where the cleared predicate device takes on a pistol configuration.

Performance Data

Bench testing was conducted to demonstrate that the ENDOPATH Electrosurgery Probe Plus II Pencil device (product code EPH04) performed as intended.

Sterilization

The subject device and the predicate device are sterilized via gamma radiation; both devices are sterilized to the same sterility assurance level.

Biocompatibility

Biocompatibility was not required for this submission as no new materials were introduced on this device.

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EMC

Electrical safety and EMC testing were conducted on the ENDOPATH Electrosurgery Probe Plus II Pencil device; the system complies with IEC 60601-1-2:2007 for electromagnetic compatibility and IEC IEC 60601-2-2:2009 & IEC 60601-1:2005+A1:2012 for electrical safety.

Bench

Flow rate of suction and irrigation, impedance, minimum distal retraction force and sheath extension force were evaluated for the ENDOPATH Electrosurgery Probe Plus II Pencil device to support substantial equivalent to the predicate device. Data generated from these tests met the predetermined acceptance criteria.

Animal

This premarket notification does not rely on preclinical animal testing to demonstrate substantial equivalence.

Clinical

This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence.

Conclusion

The results of the bench testing demonstrate that the Endopath® Electrosurgery Proble Plus II Pencil device (product code EPH04) is as safe and effective and performs as well as the identified legally marketed predicate device.

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.