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510(k) Data Aggregation
(212 days)
AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G
Coagulation (thermoablation) of soft tissue. Not for use in cardiac procedures.
The devices subject of this submission, generator AGN-H-1.3, generator AGN-3.3 and AMICA-PROBE 17G & 18G applicators, belong to the HS AMICA devices family and they represent an evolution and implementation of previous models, already authorized by FDA under K182605. The working configuration of the HS AMICA commercial system consists of:
- . A programmable generator for the generation and control of the energy required for the thermoablative treatment;
- . Disposable applied parts (or applicators) for the direct release of energy into the patients or for temperature measurements inside the patient's body.
The result is an integrated system for thermoablation of tissues through controlled emission of nonionizing electromagnetic radiations in the microwave and radiofrequency ranges. The generators and its accessories are able to emit only microwaves (MW, 2450 MHz), or only radiofrequency waves (RF, 450 kHz) or either microwaves or radiofrequency waves (not simultaneously). The new electrosurgical devices introduced by H.S. Hospital Service S.p.A. are the AMICA-GEN models named AGN-H-1.3 and AGN-3.3, along with 17G and 18G AMICA-PROBE disposable applicators.
This document describes the premarket notification (510(k)) for the HS AMICA devices family, specifically the AMICA-GEN AGN-H-1.3 and AGN-3.3 generators, and AMICA-PROBE 17G & 18G applicators. The submission aims to establish substantial equivalence to a previously cleared device (K182605).
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly based on demonstrating substantial equivalence to the predicate devices through adherence to safety and performance standards for electrosurgical cutting and coagulation devices. The reported device performance primarily focuses on the device's functionality, adherence to electrical safety and EMC standards, and a single ex-vivo bench test for the new applicators.
Table of Acceptance Criteria (Implied) and Reported Device Performance:
| Feature/Test | Acceptance Criteria (Implied by Predicate Equivalence and Standards) | Reported Device Performance |
|---|---|---|
| Indications for Use | Coagulation (thermoablation) of soft tissue. Not for use in cardiac procedures. | Coagulation (thermoablation) of soft tissue. Not for use in cardiac procedures. (Unchanged, met) |
| Generators (AGN-H-1.3, AGN-3.3) | Evolution of predicate models (AGN-H-1.2, AGN-3.2) with increased MW rated power (190W to 250W) in pulsed mode, while maintaining principles of operation, design, architecture, and critical components. | Increased MW rated power from 190W to 250W (CW max) and 140W to 180W (pulsed mode). This change "solely affects the PULSED energy delivery mode and does not alter the total amount of microwave energy that the HS AMICA system may administer to a patient in a single treatment session." Tested for electrical safety and EMC. |
| Applicators (AMICA-PROBE 17G & 18G) | New, smaller diameter needles (17G, 18G) compared to predicate (11G, 14G, 16G); same performance specifications and manufacturing materials as authorized applicators. Sterile and disposable. | New applicators are 17G and 18G. They share the same performance specifications and manufacturing materials with already approved applicators. Sterilization method (Ethylene Oxide) revalidated. Ex-vivo test conducted to validate functional ablation performances, supporting "moving shot" technique. |
| Electrical Safety | Compliance with IEC 60601-2-6 and IEC 60601-2-2. | Complies with IEC 60601-2-6 and IEC 60601-2-2. (Met) |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2. | Complies with IEC 60601-1-2. (Met) |
| Software Verification & Validation | Validation according to FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005) and IEC 62304. Moderate Level of Concern (Class B). | Software validated to specified guidance and standards. Considered "Moderate Level of Concern." "Changes introduced to adapt the functioning of the new applicators can be considered marginal and therefore only a few validation tests have been performed." |
| Biocompatibility | Not necessary if using same materials as predicate devices. | Not necessary, as manufactured using same materials as predicate devices. (Met) |
| Performance (Functional Ablation) | Demonstrated ability of new applicators to perform functional ablation, particularly for the thinnest probe (18G). | Ex-vivo test conducted for 18G-gauge AMICA-PROBE to validate functional ablation performances, supporting the "moving shot" technique. Specific quantitative metrics of performance (e.g., ablation zone size, consistency) are not detailed in this summary. |
2. Sample Size Used for the Test Set and Data Provenance:
- The document mentions "ex-vivo test" for the 18G-gauge AMICA-PROBE.
- Sample Size: Not specified for the ex-vivo test.
- Data Provenance: The ex-vivo test was conducted by HS Hospital Service Spa. The country of origin for the test is not explicitly stated, but the company is based in Italy. The study is a bench test, and inherently retrospective in the sense that the results were analyzed after the experiments. It is not a clinical study involving human subjects or patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not provided. The study appears to be a bench test rather than a clinical study requiring expert consensus on image interpretation or clinical outcomes. The "ground truth" for a bench test would be objective measurements of physical parameters (e.g., ablation volume, temperature distribution), which are typically established by the testing methodology itself, not by expert readers.
4. Adjudication Method for the Test Set:
- Not applicable as this is a bench test, not a study requiring reader adjudication on a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not performed. This submission focuses on demonstrating substantial equivalence for an electrosurgical device family, particularly new models and smaller-gauge applicators, primarily through engineering principles, electrical safety, EMC, software validation, and bench testing. It does not involve AI software or human-in-the-loop performance evaluation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No, a standalone algorithm performance study was not performed. This device is a hardware electrosurgical system with integrated software, not a standalone diagnostic AI algorithm.
7. Type of Ground Truth Used:
- For the ex-vivo bench test, the ground truth would be objective physical measurements related to ablation performance (e.g., thermal lesion size, shape, or temperature profiles) achieved in the ex-vivo tissue model. The document states "validate the functional ablation performances," implying that quantitative or qualitative measurements of the ablation were the "ground truth" for this specific test.
8. Sample Size for the Training Set:
- Not applicable. This device is an electrosurgical system, not an AI/ML model that undergoes a "training" phase with a dataset. The software validation is based on standard software engineering principles and testing, not machine learning.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no "training set" for this type of medical device submission.
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