(150 days)
The PenEvac SI is a multifunction handpiece that is meant to provide the following optional functions: monopolar electrode handpiece in an electrosurgery generator system, suction, and to facilitate the removal of smoke generated during the procedure. The intended use is the same as the predicate devices.
The PenEvac SI is a multifunction device that optionally features suction, irrigation, electrosurgery "cut" or "coag, " and smoke evacuator functions. The device is intended to be used with an I.C. Medical Suction/Irrigator/Smoke Evacuator and common electrosurgery generators.
The PenEvac SI has a handpiece body that accepts various tips and endpieces to furnish different operating functions. The handpiece body will be available as either a sterile single use device or as a reusable device. The handpiece features two pushbutton switches and an electrosurgery cord and connector. The handpiece bodies are identical to the predicate Telescoping PenEvac bodies.
Changing the tip will change the function of the handpiece. There are three different configurations available: SIE (Suction, Irrigation, monopolar Electrode) Configuration, SI (Suction, Irrigation) 2 Channel, and SI (Suction, Irrigation) 1 Channel.
This 510(k) summary describes a medical device called the "PenEvac SI," which is an electrosurgery, suction, and irrigation handpiece with smoke evacuation. The document focuses on demonstrating that the PenEvac SI is substantially equivalent to existing predicate devices already on the market (the "Telescoping PenEvac" by I.C. Medical and the "Disposable Laparoscopic Handswitch" by Valleylab).
Based on the provided text, there is no acceptance criteria or study that proves device performance in the way typically associated with AI/ML-driven medical devices. The document is a 510(k) summary for a physical surgical handpiece, not a software algorithm. Therefore, many of the requested categories (like sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set size, etc.) are not applicable to this type of device submission.
The "studies" mentioned are non-clinical engineering tests to ensure safety and fundamental operational equivalence to predicate devices, rather than performance metrics for an AI algorithm.
Here's a breakdown based on the categories, with explanations for why some are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a physical device and not an AI/ML algorithm with performance metrics like sensitivity/specificity, acceptance criteria are generally focused on safety, functionality, and equivalence to predicate devices. The document implies that the "acceptance criteria" were met if the PenEvac SI performed similarly in fundamental engineering tests to the predicate devices and complied with relevant standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Flammability: Must not exhibit flammability issues when used with various electrosurgery generators. | Samples of all proposed tip materials passed the same flammability tests applied to the Lexan polycarbonate used with the predicate ESU shroud. |
| Smoke Evacuation & Electrocautery Pencil Functions: Must perform comparably to predicate devices. | The PenEvac SI was bench tested with different electrosurgery generators, and its smoke evacuation and electrocautery pencil functions were found to be the same as the predicate ESU shroud and pencils. |
| Electrical Safety (ANSI/AAMI HF-18): Must comply with applicable portions of the ANSI/AAMI HF-18:1993 Electrosurgical Device standard. | Prototype devices tested by the Chief Engineer and/or cable/connector/switches manufacturer complied with applicable portions of ANSI/AAMI HF-18: 1993. Validation on production devices planned. |
| Capacitive Resistance (for laparoscopic devices): Must have comparable capacitive resistance to predicate Valleylab laparoscopic devices. | Relative capacitive resistance between the PenEvac SI and the predicate Valleylab laparoscopic devices was evaluated by measuring current flow to the ground pad in a simulated normal use condition. It was concluded that both laparoscopic devices have "virtually identical capacitive resistance." |
| Sterilization Efficacy & Residuals: Must achieve required sterility assurance level and acceptable ETO residual levels (for single-use sterile devices). | Sterile disposable products will use the same contract sterilizer and sterilization validation method as the predicate I.C. Medical Telescoping PenEvac and ESU shrouds (which was reviewed and accepted by FDA in June 1995). The Sterility Assurance Level and ETO Residual Level will be the same as predicate ESU shrouds. |
| Sterilization Compatibility (for reusable devices): Must withstand specified sterilization methods without degradation (ETO, steam, steris, flash autoclave up to 134°C). | The reusable PenEvac SI body may be sterilized by ETO, steam, steris, or flash autoclave up to 134 degrees Centigrade. (Implicitly, it's expected to withstand these without failing continuity checks or showing signs of wear/damage). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a numerical sample size in the document for the non-clinical tests. The tests were performed on "samples of all proposed tip materials" and "prototype devices," as well as the PenEvac SI itself. This likely refers to a small number of physical units or components used for engineering verification.
- Data Provenance: The tests were non-clinical bench tests performed by I.C. Medical (the submitter) or its manufacturing partners (Chief Engineer, manufacturer of cable/connector/switches). There's no mention of country of origin of patient data, as no patient data was used. These were laboratory/engineering tests.
- Retrospective or Prospective: These were prospective engineering tests on prototypes and samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in the context of AI/ML algorithms refers to expert labels or definitive diagnoses. For this physical device, the "ground truth" for the tests was established by engineering standards (e.g., ANSI/AAMI HF-18), objective measurements (e.g., current flow, flammability observations), and comparison to the known performance of predicate devices. The "experts" involved were likely engineers, technicians, and potentially the Chief Engineer and relevant manufacturers, who defined and executed the tests based on objective criteria.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. Adjudication methods are used to reach consensus on labels for ground truth in clinical data. These were direct engineering measurements and observations.
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 is a surgical handpiece, not an AI system designed to assist human readers (e.g., radiologists). No such study was performed or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. There is no algorithm to test in a standalone fashion. The device's function is a direct physical action (suction, irrigation, electrosurgery, smoke evacuation) controlled by the surgeon.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for these non-clinical tests was based on:
- Engineering standards: e.g., compliance with ANSI/AAMI HF-18.
- Predicate device performance: establishing that the PenEvac SI performed "the same as" or "virtually identical" to the legally marketed predicate devices, implying the predicate's performance is the accepted benchmark.
- Objective physical measurements/observations: e.g., current flow for capacitive resistance, visual assessment of flammability, functional testing of smoke evacuation and electrocautery.
8. The Sample Size for the Training Set
Not applicable. There is no AI/ML algorithm, and therefore no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set exists.
In summary: The provided document is a 510(k) summary for a conventional medical device (a surgical handpiece). The "acceptance criteria" and "studies" are focused on demonstrating fundamental safety, functionality, and substantial equivalence to already-cleared predicate devices through non-clinical engineering and bench tests, in line with typical 510(k) requirements for such devices. The questions related to AI/ML performance metrics, clinical studies with human readers, and ground truth establishment for datasets are not relevant to this submission.
§ 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.