FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The FiAPC® plus probes are sterile, single-use flexible probes intended for argon plasma coagulation (APC) and ablation of tissue. The probes have a plug on the proximal end that enables the connection to the compatible electrosurgical unit (ESU) and APC unit. The plug is ergonomically designed and contains a filter that isolates the device side from the patient side. The plug also contains an instrument recognition which ensures that the instrument can only be operated with the compatible parent devices. The connector is followed by a long tube so that the probe can be inserted into the working channel of an endoscope. At the distal end there is an opening through which the argon plasma is released. The flexible FiAPC® plus probes are available in different variants. All variants have the same outer diameter but differ in their length and distal opening.

AI/ML Overview

This FDA 510(k) summary describes a device (FiAPC plus probes) that is an electrosurgical accessory, not an AI/ML powered device. As such, it does not involve acceptance criteria related to algorithmic performance, ground truth, expert opinions, sample sizes for training/test sets, or MRMC studies that are typically associated with AI/ML devices.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing. The evaluation is centered on the physical and functional characteristics of the probes, particularly a new variant with a modified tip design.

Here's an analysis of the provided information within the context of hardware/electrosurgical accessory evaluation:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily related to its physical and functional performance, safety, and equivalence to predicate devices. These criteria are established through adherence to various international and FDA-specific guidance documents and standards.

Acceptance Criteria Category	Reported Device Performance and Compliance
Functional Equivalence (Tissue Effects & Ignition Distance)	- Equivalent tissue effects (coagulation depth and area): Demonstrated through side-by-side tissue testing. The subject device showed comparable coagulation depth and area to the predicate device.

Equivalent ignition distances: Confirmed through side-by-side tissue testing.
Compliance with FDA Guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", issued on March 9, 2020. |
| Design Controls | - Verification of design change: Performed in compliance with 21 CFR 820.30 to ensure safety and effectiveness of the device. |
| Sterilization | - Sterilization validation: Complied with ISO 11135.
Sterility Assurance Level (SAL): Documented at 10^-6, aligning with FDA Guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile".
EO residual testing: Complied with ISO 10993-7. |
| Packaging and Shelf-life | - Packaging and shelf-life validation: Complied with ISO 11607-1.
Accelerated aging: Performed using ASTM F 1980, demonstrating safety and effectiveness for the defined shelf-life. |
| Biocompatibility | - Biocompatibility testing: Complied with ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
No toxicologically relevant released substances: Chemical characterization showed no such substances.
No cytotoxic, sensitizing, irritating, or acute systemic toxic properties: Demonstrated by testing.
Absence of pyrogens: Fulfilled criteria.
Biocompatible over entire life cycle: Conclusion based on tests. |
| Electromagnetic Compatibility (EMC) & Electrical Safety | - Successful testing: Complied with IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, and IEC 60601-1-2, as applicable. |
| Software Impact (of parent device) | - Software documentation: Complied with IEC 62304 and FDA Guidance "Content of Premarket Submissions for Device Software Functions".
Probe recognition and mode limitation: Software updates in the parent device allow for this.
No impact on safety/performance: User interface updates do not affect safety or performance.
No changes to mode parameters, gas flow, or performance-relevant specifications: Confirmed. |

Given that this is a hardware device (electrosurgical probes) and not an AI/ML software device, the following points are not applicable or interpreted differently:

Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML test set. For physical testing (e.g., tissue testing, sterilization), sample sizes would be determined by relevant engineering standards for statistical significance and regulatory compliance, but are not specified in this summary. The data provenance would be from internal lab studies and external testing facilities.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Tissue effects are assessed by objective measurements (e.g., coagulation depth, area) rather than expert consensus on a 'truth' dataset.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for subjective interpretations of data (e.g., image review), which is not the case here.
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, as this is not an AI-assisted diagnostic or therapeutic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this device does not involve an algorithm. The probes are medical instruments used by human operators.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physical performance aspects like tissue effects, the "ground truth" would be the objective measurements obtained from laboratory testing (e.g., histological analysis of tissue for coagulation depth) and instrumental measurements for ignition distance.
The sample size for the training set: Not applicable, as there is no training set for an AI/ML model.
How the ground truth for the training set was established: Not applicable.

Summary

Regulation Number and Section

§ 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.