(62 days)
The Ion Medical Bipolar Coagulation Pen is a single use instrument intended to coagulate tissue using radiofrequency electric current during general and ophthalmic surgical procedures where wet field conditions exist.
The lon Medical Bipolar Coagulation Pen is a handheld electrosurgical device which conducts low power radiofrequency current to target tissue for the purpose of coagulation. The device is comprised of an ABS plastic handle with a stainless steel coaxial probe tip and a 2-pin style connector at the proximal end for connection with compatible bipolar radiofrequency coagulation generators and cables.
The provided text describes a 510(k) summary for the Ion Medical Bipolar Coagulation Pen. This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria in the way a new, innovative device might. Therefore, many of the typical elements of a study proving a device meets acceptance criteria are not present.
Here's an analysis based on the information provided, highlighting what can be inferred and what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The 510(k) summary does not detail specific quantitative performance metrics or acceptance criteria for the device's function (e.g., coagulation time, temperature efficacy, tissue damage limits). Instead, it relies on demonstrating compliance with safety standards and substantial equivalence to existing devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. The submission focuses on substantial equivalence and compliance with general safety and biocompatibility standards rather than specific performance metrics for coagulation efficacy against defined criteria. | Not specified in this document. The document states compliance with general electrical safety and biocompatibility, but no quantitative performance data for coagulation is provided. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. As this is a 510(k) for substantial equivalence, the document describes what was tested (electrical safety, biocompatibility) but not the sample sizes for those tests, nor does it refer to a "test set" of clinical data in the typical sense for performance evaluation. The data provenance (country of origin, retrospective/prospective) for any clinical performance is therefore also not applicable/provided.
The testing mentioned relates to:
- Device electrical safety: Compliance with ANSI/AAMI HF18 and IEC 60601-2-2.
- Biocompatibility: Evaluation and testing in accordance with ISO 10993-1.
These are standard engineering and materials tests, not a clinical study on a patient population.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. Given that no clinical "test set" for performance evaluation is described, there's no mention of experts establishing a ground truth for such a set.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable as no clinical test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not done and is not applicable to this 510(k) submission. This type of study is typically used for diagnostic or imaging devices where human interpretation is involved and AI assistance is being evaluated. The Ion Medical Bipolar Coagulation Pen is a surgical instrument.
6. Standalone (Algorithm Only) Performance Study
A standalone algorithm performance study was not done and is not applicable. This device is a physical electrosurgical handpiece, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the claims made in this submission is implicit in the compliance with recognized standards for electrical safety (ANSI/AAMI HF18, IEC 60601-2-2) and biocompatibility (ISO 10993-1). For the core function of coagulation, the ground truth is established by its substantial equivalence to already legally marketed predicate devices (Kirwan Bipolar Pencil Coagulator (K962678) and Mentor Wet-Field Hemostatic Eraser Bipolar Instrument (K911160)). This means the FDA assumes similar safety and effectiveness to the predicates based on similar technology and intended use.
There is no mention of pathology, outcomes data, or expert consensus being used to establish a "ground truth" for the device's performance in the typical sense of a clinical trial.
8. Sample Size for the Training Set
This information is not provided and is not applicable. This device does not involve machine learning or an "algorithm" that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable. As there is no training set mentioned, there is no discussion of how its ground truth would be established.
In summary, the provided 510(k) document is a regulatory submission focused on demonstrating substantial equivalence to legally marketed predicate devices and compliance with relevant safety and biocompatibility standards. It is not a clinical study designed to test specific performance criteria against a predefined acceptance threshold using a clinical dataset.
§ 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.