(317 days)
The NeuWave Medical Certus 140™ 2.45 GHz Ablation System and Accessories are indicated for the ablation (coagulation) of soft tissue in percutaneous, open surgical and in conjunction with laparoscopic surgical settings, including the partial or complete ablation of non-resectable liver tumors.
The Certus 140™ 2.45 GHz Ablation System is not indicated for use in cardiac procedures.
The system is designed for facility use and should only be used under the orders of a clinician.
The system has a single 2.45 GHz signal source generator and three (3) independent power amplifiers, each capable of producing up to 140W each. One, easy to use, touch-screen user interface controls the system. The User Interface can be set for either Ablation Mode. An optional footswitch can be connected to the system to control power delivery in Surgical Mode. Up to three (3) energy delivery accessories can be connected to and powered by the system at one time. An intermediate junction box or Power Distribution Module (PDM) reduces system set up complexity.
A variety of sterile, single-patient use energy delivery accessories (ablation probes and surgical tools) are available for use with the Certus 140. All are comprised of a sharp trocar on the end of a cannula, a cable and a connector assembly.
Models Certus", and Certus " ablation probes are available in either 17- gauge cannulas and are available in 15 cm and 20 cm lengths. These probes have a cable length of 1.4m.
Models Certus™ ablation probes are available only in 17-gauge cannulas and are available in 15 cm and 20 cm lengths. These probes have a cable length of 1.4m.
The model Certus® ablation probe has a 13-gauge cannula and is available in a 25 cm length only. Certus® probes have a cable length of 1.4m.
Each energy delivery accessory contains temperature measurement sensors that help monitor performance and ensure patient and operator safety.
The antenna of the Certus °° probe is designed to limit the length of the ablation for instances when a shorter ablation zone is desired. Certus Probes were developed to provide physicians with an additional ablation probe designed specifically for creating smaller ablation zones than the Certus" and Certus" probes. The Certus® probes are designed to produce ablations that encompass the tip of the probe while limiting the overall length of the ablation. Certus °° probes will enable physicians to ablate smaller lesions while limiting necrosis of adjacent tissue when compared to other Certus probes.
The Certus® probes length and gauge size result in a probe for use in laparoscopic applications.
A CO2 based cooling system ensures the non-active portion of the probe does not exceed temperature requirements. Additionally, the CO2 enables the Tissu-Loc function, which can be used to adhere or stick the probe in place prior to starting ablation therapy.
The system uses two (2) E-sized CO2 cylinders. When a tank in use empties, the system will automatically switch to using the other tank and notify the user to replace the empty tank.
An accessory, a small plastic probe clip that can hold two 17-gauge probes and allow the user to easily hold both while performing planar coagulation, is available.
Ablation Confirmation software (K171022) is available as an option on the Certus 140. When this option is supplied, a second monitor is provided with the system which hosts the Ablation Confirmation user interface.
Here's a breakdown of the acceptance criteria and study information for the Certus 140 2.45 GHz Ablation System, based on the provided FDA 510(k) summary:
Acceptance Criteria and Device Performance Table:
It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive clinical trial with specific performance metrics against pre-defined acceptance criteria. The "acceptance criteria" here are inferred from the demonstrated equivalence and the nature of the modifications. The performance is largely shown through the comparison and the conclusion of equivalence.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Device Safety: Compliance with relevant international standards and biocompatibility. | Compliant: The device complies with IEC60601-1:2005, IEC60601-2-2:2006, IEC60601-2-6:2012, IEC60601-1-2:2014, ENISO 11607-1:2009, and ISO 10993-1:2009. Biocompatibility testing (Cytotoxicity, Sensitization, Irritation) demonstrated the ablation probes are biocompatible. Ethylene Oxide sterilization validated to SAL of 10^-6, with residual EO and ECH levels below FDA recognized limits. 48-month shelf life validated by accelerated aging tests. Potential risks analyzed and satisfactorily mitigated. |
| Device Effectiveness for Soft Tissue Ablation: Equivalent performance to predicate for general soft tissue ablation. | Equivalent through Substantial Equivalence: Features (probe applications, UI modes, power delivery, accessories, probe dimensions, generator output power, antenna design, power, target ablation time, planar coagulation time) are reported as unchanged or having no impact on safety and effectiveness compared to the predicate (K160936). Nonclinical acute in-vivo (porcine) studies concluded similar technological performance (ablation zone sizes and histological results) compared to the reference predicate (K053290 Cool-Tip™). |
| Device Effectiveness for Non-Resectable Liver Tumors: Ability to access and effectively ablate non-resectable liver tumors. | Demonstrated by Real-World Evidence (RWE) Meta-analysis and Nonclinical Testing: RWE meta-analysis, encompassing 18 studies and 1,924 patients, consistently showed technique efficacy (complete tumor ablation/complete response) of microwave ablation for liver tumors (HCC or metastasis). Nonclinical acute in-vivo (porcine) studies confirmed the ability of the system and probes to reach target tumors. The meta-analysis supported that the device could reliably access liver tumors in percutaneous and laparoscopic settings. |
| Software Functionality: Software changes do not impact essential performance or safety. | No Significant Impact: Software version updated from V2.0.X to V3.0.X. Changes were made to address minor anomalies, improve user experience, and support CO2 tank configurations outside the US. These changes are stated to have no impact on energy delivery, temperature measurement, CO2 cooling control, other risk mitigations, or essential performance of US configured units. |
Study Details:
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Sample Size used for the test set and the data provenance:
- Nonclinical Acute In-Vivo (porcine) Studies: Sample size not explicitly stated in the summary, but it involved animal testing. Data provenance is implied to be internal (conducted by or for NeuWave Medical).
- Real-World Evidence (RWE) Meta-analysis:
- Sample Size: 1,924 patients across 18 studies.
- Data Provenance: Retrospective, derived from published peer-reviewed literature. The studies included both randomized controlled trials (RCTs) and observational studies. Specific countries of origin are not detailed beyond "peer-reviewed articles," but such literature typically comes from various international sources.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the nonclinical in-vivo studies, the summary mentions "histological results were analyzed and evaluated." However, the number and qualifications of experts interpreting these results are not specified.
- For the Real-World Evidence Meta-analysis, the "ground truth" was the reported clinical outcome of "technique efficacy (effectiveness) (defined as complete tumor ablation or complete response), measured at one week to three months post ablation" as reported in the individual studies included in the meta-analysis. The meta-analysis itself was conducted by "two independent reviewers" with "adjudication from a third reviewer" for discrepancies in study selection and data extraction. Their qualifications are not explicitly stated, but for a systematic review and meta-analysis, they would typically be researchers or statisticians with expertise in clinical evidence synthesis.
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Adjudication method for the test set:
- For the nonclinical in-vivo studies, no specific adjudication method is mentioned.
- For the Real-World Evidence Meta-analysis, "Records were evaluated for eligibility by two independent reviewers and discrepancies were resolved either through consensus, or by adjudication from a third reviewer." This is a standard adjudication method for systematic reviews, often referred to as a "2+1" method for disagreement.
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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:
- No MRMC comparative effectiveness study was done in the context of AI assistance. This device is an ablation system, not an AI-powered diagnostic or assistive tool for human readers. The meta-analysis compared microwave ablation (MWA) to radiofrequency ablation (RFA), not human readers with or without AI.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The Certus 140 is a medical device for tissue ablation, not a standalone algorithm. Its performance is directly tied to the physical ablation process.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the nonclinical in-vivo studies, the ground truth appears to be histological results and ablation zone sizes, which would be assessed by trained histopathologists and researchers.
- For the Real-World Evidence Meta-analysis, the primary ground truth was clinical outcomes data reported in the included studies, specifically "complete tumor ablation or complete response" as assessed by clinical follow-up imaging. This would typically be based on radiologic assessment (e.g., CT, MRI) often interpreted by radiologists, potentially with expert consensus within those original studies.
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The sample size for the training set:
- This information is not explicitly provided in the 510(k) summary. Given that the device is a physical ablation system (not an AI algorithm requiring a training set), this concept of a "training set" in the machine learning sense is not directly relevant for device performance. Training would refer to the development and refinement of the device's design and operating parameters, which would involve various benchtop and animal studies over time, but not a distinct "training set" like in AI.
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How the ground truth for the training set was established:
- As with the training set size, this question is not directly applicable to a physical ablation device in the way it is for an AI algorithm. The "ground truth" during device development (analogous to training) would typically involve engineering specifications, safety standards, and performance benchmarks derived from technical knowledge, predicate devices, and early-stage experimental data (benchtop, ex-vivo, in-vivo animal studies).
§ 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.