(123 days)
Not Found
No
The summary describes a standard electrosurgical device with mechanical and electrical functions, with no mention of AI or ML capabilities.
No
The device is used for tissue dissection, coagulation, irrigation, and fluid evacuation, which are surgical tools or functions, not therapeutic treatments.
No
The device's intended use is for facilitating tissue dissection, coagulation, irrigation, and fluid evacuation, which are therapeutic and procedural functions, not diagnostic ones.
No
The device description clearly describes a physical electrosurgery probe with a handle and shafts, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used during surgical procedures for tissue manipulation (dissection, coagulation, irrigation, fluid evacuation). This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description reinforces its use in minimally invasive surgical procedures, working with a standard monopolar unit and trocar sleeves. This is consistent with a surgical instrument, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on facilitating surgical procedures.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was conducted to demonstrate that the ENDOPATH Electrosurgery Probe Plus II Pencil device (product code EPH04) performed as intended.
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.
This premarket notification does not rely on preclinical animal testing to demonstrate substantial equivalence.
This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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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
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.
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
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.
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.