(237 days)
The EPi-Sense Guided Coagulation System with VisiTrax is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniques.
The EPi-Sense Guided Coagulation System with VisiTrax may be used for temporary cardiac signal sensing and recording during surgery when connected to an external recording device.
The EPi-Sense Guided Coagulation System with VisiTrax - generation 4 product) consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, & 3cm sizes provided) intended to be used to coagulate cardiac tissue. The flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical Generator (non-sterile, re-useable) connected through an Instrument Cable (sterile). An optional temporary sensing electrode feature may be used with . an off-the-shelf electrogram recording system with the use of an additional instrument cable (non-sterile).
The provided text describes a 510(k) premarket notification for the nContact Surgical, Inc. EPi-Sense Guided Coagulation System with VisiTrax. This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing de novo acceptance criteria and performance against them.
Therefore, the study described is primarily focused on demonstrating equivalence to existing predicate devices, not on proving that the device meets novel, independently established acceptance criteria through a clinical trial with a defined ground truth and expert consensus. The acceptance criteria in this context are implicitly met by demonstrating this equivalence through non-clinical testing.
Here's an analysis based on the information provided, highlighting why it doesn't fit the typical "acceptance criteria and study proving performance" structure you're looking for, but rather focuses on substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state numerical acceptance criteria (e.g., sensitivity, specificity thresholds) for device performance in a clinical context, nor does it report specific performance metrics for such criteria. Instead, the "acceptance criteria" are implied by demonstrating equivalence to a predicate device, and the "performance" is judged by successful completion of non-clinical tests.
| Acceptance Criteria (Implied by Equivalence) | Reported Device Performance (as demonstrated by non-clinical tests) |
|---|---|
| Biocompatibility as per ISO 10993 | Successfully completed |
| Sterilization validation as per ISO 11137-2 | Successfully completed |
| Reliability (shipping, accelerated aging) | Successfully completed |
| Tensile strength of critical bonds and joints | Successfully completed |
| Flexion fatigue | Successfully completed |
| Electrical integrity per IEC 60601-1-2 | Successfully completed |
| Equivalent performance for coagulating cardiac tissue (in-vivo) | Successfully demonstrated |
| Equivalent performance for temporary cardiac signal sensing (in-vivo) | Successfully demonstrated |
| Tissue coagulation feature equivalence (in-vitro) | Successfully demonstrated |
| Device design features and specifications are equivalent to predicate devices | Verified through design controls and testing |
| No substantial changes or modifications affecting safety or efficacy compared to predicate devices | Verified through design controls and testing |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes non-clinical testing (bench and in-vivo pre-clinical testing). There is no mention of human clinical trial data, and therefore no "test set" in the sense of patient data.
- Sample Size for Test Set: Not applicable, as no human clinical test set data is described.
- Data Provenance: Not applicable, as no human clinical test set data is described.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable, as no human clinical test set data or ground truth established by experts for such data is described. The "ground truth" for the non-clinical tests would be the established performance of the predicate device and the design specifications.
4. Adjudication Method for the Test Set:
Not applicable, as no human clinical test set data is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was performed or described. The submission is for a medical device (surgical system) used for coagulation and sensing, not for an imaging or diagnostic AI device that would typically involve an MRMC study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is a surgical instrument where human interaction is integral to its function. Its "performance" is inherently tied to its use by a human surgeon or clinician. There is no isolated algorithm being evaluated for standalone performance.
7. Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" is established by:
- Predicate Device Performance: The primary ground truth is the established safety and effectiveness profile of the legally marketed predicate devices.
- Design Specifications: The device's design specifications serve as a benchmark for bench testing.
- ISO and IEC Standards: Compliance with relevant international standards (e.g., ISO 10993, ISO 11137-2, IEC 60601-1-2) defines successful performance in those areas.
8. Sample Size for the Training Set:
Not applicable. This device is a hardware system, not an AI/ML model that requires a "training set" of data in the typical sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reason as above.
§ 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.