(22 days)
The intended use for the Cobra Surgical Probes is as follows:
The Probe (Probe) is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The Probe can be used during general surgery to coagulate soft tissues. The Probe may also be used to coagulate blood and soft tissue to produce hemostasis.
The Cobra Surgical Probes are Electrosurgical Probes, with either a malleable or flexible shaft, used in conjunction with the Cobra Electrosurgical Unit (ESU). The system is intended for use by surgeons for the coagulation of cardiac and soft tissues during open surgical procedure.
This submission describes a Special 510(k) for the Cobra Surgical Probes, which are electrosurgical probes used for the coagulation of cardiac and soft tissues. The submission asserts substantial equivalence to the previously cleared Cobra Surgical Probe (K013873).
Here's an analysis based on the provided documents:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria or detailed device performance metrics. Instead, it relies on a comparison to a predicate device and a general statement about non-clinical testing.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Design-Input Criteria Met | "non-clinical tests conducted for the Device showed the device met its design-input criteria" |
| Safety Profile | "non-clinical tests conducted for the Device showed the device...was safe for its intended use" |
| Effectiveness for Intended Use | "non-clinical tests conducted for the Device showed the device...was effective for its intended use" |
| Compliance with GLP | "Where appropriate, testing conformed to the requirements of 21 CFR Part 58 (Good Laboratory Practices (GLP))" |
| Intended Use Match | The intended use for the modified device is identical to the predicate device. |
| Device Characteristics Match | All key device characteristics (Manufacturer, Device Description, Regulatory Class, Device Classification, Intended Use, Mode, Single Use?, EO Sterilized?, Shaft Size, Tip Material, Length, Electrode Size, Electrode Number) are "Same" as the predicate device. |
2. Sample Sizes and Data Provenance
The document does not specify sample sizes used for any test sets, nor does it provide details on data provenance (e.g., country of origin, retrospective/prospective). The testing mentioned is "non-clinical tests," which typically refers to bench or animal testing rather than human clinical data.
3. Number of Experts and Qualifications for Ground Truth
The document makes no mention of expert involvement in establishing ground truth for any test set. The evaluation is based on non-clinical testing and comparison to a predicate device.
4. Adjudication Method
There is no mention of an adjudication method as the evaluation is based on non-clinical testing and comparison to a predicate device, not expert review of cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed or mentioned in the document. The submission focuses on non-clinical testing and substantial equivalence to a predicate device, not on evaluating the improvement of human readers with AI assistance.
6. Standalone Performance Study
A "standalone" performance study in the context of an algorithm (i.e., algorithm only without human-in-the-loop performance) is not applicable here as the device is a physical electrosurgical probe, not an AI algorithm. The document states "non-clinical tests conducted for the Device showed the device met its design-input criteria, and was safe and effective for its intended use," which pertains to the device's functional performance in isolation.
7. Type of Ground Truth Used
The "ground truth" for this medical device submission appears to be based on:
- Design-input criteria: The device's performance was measured against its established design specifications.
- Safety and effectiveness benchmarks: Established through non-clinical testing, likely involving simulations, bench testing, and potentially animal studies (though not explicitly detailed beyond "non-clinical tests").
- Predicate device characteristics and performance data: The modified device's characteristics and intended use are directly compared to a legally marketed predicate device (K013873).
There is no mention of pathology, outcomes data, or expert consensus in relation to human clinical cases for defining ground truth in this document.
8. Sample Size for the Training Set
No training set is mentioned or applicable here, as the device is a physical electrosurgical probe and not an AI or machine learning algorithm.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.