(99 days)
Not Found
No
The 510(k) summary describes a standard electrosurgical device for tissue manipulation and does not mention any AI or ML capabilities.
Yes
The device is described as facilitating tissue dissection, coagulation, irrigation, and fluid evacuation in minimally invasive procedures, which are therapeutic actions.
No
The device description indicates its use for tissue dissection, coagulation, irrigation, and fluid evacuation, which are therapeutic and manipulative actions, not diagnostic.
No
The device description clearly outlines physical components (handle, shafts) and its function in surgical procedures involving tissue dissection and coagulation, indicating it is a hardware device with electrosurgical capabilities.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes facilitating tissue dissection, coagulation, irrigation, and fluid evacuation during minimally invasive surgical procedures. This is a direct surgical intervention on the body, not a test performed on a sample taken from the body.
- Device Description: The description details a surgical probe used with a standard monopolar unit, designed for use through a trocar sleeve. This is a surgical instrument.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The ENDOPATH Electrosurgery Probe Plus II system is a surgical tool used for direct intervention on tissue within the body.
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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Endopath® Electrosurgery Probe Plus II device (product codes beginning with EPH and EPS) work 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. The subject device system offers one handle (EPH02) and seven shafts (EPS01-EPS07) which allow for a variety of configurations to best meet the surgeon's needs. Shafts EPS01 through EPS07 are for use through a 5 mm diameter surgical trocar or a larger trocar with a 5 mm 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 and laboratory evaluations were conducted to demonstrate that the ENDOPATH Electrosurgery Probe Plus II 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: The biocompatibility evaluation for the ENDOPATH Electrosurgery Probe Plus II device was conducted in accordance with ISO 10993:2009 and FDA Blue Book Memorandum #G95-1. The device passed all biocompatibility ISO testing which included cytotoxicity, sensitization, intracutaneous reactivity and acute system toxicity testing.
EMC: Electrical safety and EMC testing were conducted on the ENDOPATH Electrosurgery Probe Plus II; the system complies with IEC 60601-1-2:2007 for electromagnetic compatibility and IEC 60601-1:2005 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 to support substantial equivalent to the predicate device. Data generated from these tests met the predetermined acceptance criteria.
Acute: Testing was performed in an acute study with the ENDOPATH Electrosurgery Probe Plus II vs. the currently marketed predicate device to demonstrate that the tissue effects were not different than the predicate device. The results of the study demonstrated the ability of the subject device to create tissue planes, dissect tissue, and provide hemostasis in different tissue types.
Clinical: 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Ethicon Endo-Surgery, LLC David Locke Senior Regulatory Affairs Specialist 4545 Creek Road Cincinnati, Ohio 45242
Re: K160128
Trade/Device Name: Endopath Electrosurgery Probe Plus II Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: January 19, 2016 Received: January 20, 2016
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. Isting 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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/ResourcesforYou/Industry/default.htm. 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.
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 -A
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)
Device Name ENDOPATH Electrosurgery Probe Plus II
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Company
Ethicon Endo-Surgery 475 Calle C Guaynabo, PR 00969
Contact
David Locke, DRSc, MS, RAC Senior Regulatory Affairs Program Lead Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 Telephone: (513) 337-1281 Fax: (513) 337- 4366 Email: dlocke1 @its.jnj.com
Date Prepared 19 January 2016
Device Name
Trade Name: Evacuation/Irrigation/Electrosurgical Device Classification Name: Laparoscope, General & Plastic Surgery Common Name: Endopath® Electrosurgery Probe Plus II Catalog Number: EPH02, EPS01, EPS02, EPS03, EPS04, EPS05, EPS06, EPS07
Device Class Class II
Device Panel General & Plastic Surgery
Product Code GEI
Predicate Device
Ethicon Evacuation/Irrigation/Electrosurgical Device cleared under K912492
Device Description
The Endopath® Electrosurgery Probe Plus II device (product codes beginning with EPH and EPS) work 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. The subject device system offers one handle (EPH02) and seven shafts (EPS01-EPS07) which allow for a variety of configurations to best meet the surgeon's needs. Shafts EPS01 through EPS07 are for use through a 5 mm diameter surgical trocar or a larger trocar with a 5 mm reducer.
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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 device and predicate Ethicon Evacuation/Irrigation/Electrosurgical device 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 device is similar to the predicate Ethicon Evacuation/Electrosurgical device with respect to the primary modes of action which include suction, irrigation and hemostasis. A few technological differences were identified between the subject device and the currently marketed predicate devices, attributable to the respective design of each. As compared with the predicate devices, the subject device does however incorporates several design enhancements which includes suction and irrigation button force improvement, monopolar activation force improvement, elimination of the button pin, improved ergonomics, and combined hand and foot activation capability (hand activation through the ENDOPATH Electrosurgery Probe Plus II device itself and foot activation through a monopolar electrosurgery unit (ESU) generator foot pedal).
Performance Data
Bench testing and laboratory evaluations were conducted to demonstrate that the ENDOPATH Electrosurgery Probe Plus II 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
The biocompatibility evaluation for the ENDOPATH Electrosurgery Probe Plus II device was conducted in accordance with the following standards: ISO 10993:2009. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and FDA Blue Book Memorandum #G95-1: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The device passed all biocompatibility ISO testing which included cytotoxicity, sensitization, intracutaneous reactivity and acute system toxicity testing.
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EMC
Electrical safety and EMC testing were conducted on the ENDOPATH Electrosurgery Probe Plus II; the system complies with IEC 60601-1-2:2007 for electromagnetic compatibility and IEC 60601-1:2005 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 to support substantial equivalent to the predicate device. Data generated from these tests met the predetermined acceptance criteria.
Acute
Testing was performed in an acute study with the ENDOPATH Electrosurgery Probe Plus II vs. the currently marketed predicate device to demonstrate that the tissue effects were not different than the predicate device. The results of the study demonstrated the ability of the subject device to create tissue planes, dissect tissue, and provide hemostasis in different tissue types.
Clinical
This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence.
Conclusion
The results of the bench testing and laboratory evaluations in an animal model demonstrate that the Endopath® Electrosurgery Proble Plus II device is as safe and effective and performs as well as the identified legally marketed predicate device.