(117 days)
The EUSRA RF Electrode is indicated for coagulation of soft tissue when used in conjunction with compatible radio frequency generator.
The EUSRA RF Electrode is a monopolar electrode. The EUSRA RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF generator (K163450). They are not intended to function with other RF generators. The EUSRA RF Electrode consists of the tubing set and grounding pad. The grounding pad is FDA cleared (K163450).
The EUSRA RF Electrode consists of an electrode tip, insulation part, handle. Patient contacting materials of EUSRA RF Electrode are stainless steel 304, polyimide, polyether block polyamide copolymer and PTFE. Cooling of the EUSRA RF Electrode is provided by chilled water which is pumped through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and the water is not to be in contact with the patient.
This document describes the EUSRA RF Electrode, a device indicated for the coagulation of soft tissue when used with a compatible radio frequency generator. The provided text outlines the performance criteria and studies for this device, but it is important to note that this is a medical device (hardware) and not an AI/software device. Therefore, many of the typical acceptance criteria and study descriptions for AI/software (like sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, etc.) do not apply in this context.
The document focuses on demonstrating substantial equivalence to a predicate device (Habib EUS RFA 6700) through non-clinical testing and adherence to international safety and performance standards.
Here's an adaptation of your requested information based on the provided hardware device context:
1. A table of acceptance criteria and the reported device performance
Since this is a hardware device submission, the "acceptance criteria" are primarily based on meeting established safety and performance standards and demonstrating equivalence to a predicate device, rather than specific performance metrics like sensitivity/specificity for an AI algorithm. The "reported device performance" refers to the successful completion of various non-clinical tests.
| Acceptance Criteria Category | Specific Criteria/Standard Adhered To | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1 | Complies |
| IEC 60601-2-2 | Complies | |
| IEC 60601-2-18 | Complies | |
| Electromagnetic Compatibility | IEC 60601-1-2 (implied for both electrical safety and EMC) | Complies |
| Biocompatibility | ISO 10993-1 | Complies |
| ISO 10993-5 (In vitro cytotoxicity) | Complies | |
| ISO 10993-10 (Irritation & skin sensitization) | Complies | |
| ISO 10993-11 (Systemic toxicity) | Complies | |
| Mechanical Integrity | Drop test | Met acceptance criteria |
| Bending force test | Met acceptance criteria | |
| Length control test | Met acceptance criteria | |
| Thermal Effects (Efficacy) | FDA Guidance 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery' | Demonstrated effectiveness comparable to predicate; results showed efficacy not affected by tip diameter/length differences. |
| Substantial Equivalence | Comparison to predicate device K150029 | Demonstrated substantial equivalence in intended use, technological characteristics, energy used, operation principle, sterile nature, and single-use design. Differences (physical specifications, patient contacting materials, neutral electrodes, extensible tip length) do not raise new safety or effectiveness concerns. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable to this 510(k) submission for a hardware medical device. There are no "test sets" of patient data in the context of an AI algorithm evaluation. The testing involved various non-clinical (bench, ex vivo) studies as described below.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as this is a hardware medical device, not an AI/software device requiring ground truth establishment by experts for specific diagnostic or prognostic tasks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a hardware medical device.
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. MRMC studies are relevant for evaluating AI-assisted diagnostic tools, not a hardware electrosurgical electrode.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable as this is a hardware device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the thermal effects test, the "ground truth" would be the direct measurement of thermal damage in tissue samples, determined experimentally.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of hardware medical device.
9. How the ground truth for the training set was established
Not applicable.
§ 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.