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510(k) Data Aggregation
(123 days)
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.
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.
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.
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