(149 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.
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 or Surgical 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 handle, a cable and a connector assembly.
Models Certus™, Certus ", and Certus " ablation probes have 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 6 probes have a cable length of 1.4m.
CertuSurg" surgical tool is hand-held and has a 6cm, 17 gauge cannula designed specifically for surgical coagulation (including Planar Coagulation) in open surgical settings. This device has a finger-activated power delivery mechanism and a cable length of 2.9m.
Each energy delivery accessory contains temperature measurement sensors that help monitor performance and ensure patient and operator safety.
Additionally, the different percutaneous ablation probes have been designed to optimize the energy transfer efficiency from the probe into different types of tissue based on known electrical properties of each tissue.
Certus " probes are designed to perform optimally, in terms of efficiently transferring energy into tissue, in liver and kidney tissue. Certus " probes are designed to perform optimally, in terms of efficiently transferring energy into tissue, in lung tissue.
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 ablating smaller lesions. The Certus® probes are designed to produce ablations that quickly 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 sturdy probe ideal for use in laparoscopic applications.
The CertuSurg " surgical tool is designed to produce focal, rapid coagulation of soft tissue in open surgical applications, including planar coagulation performed prior to tissue resection.
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. This function is similar in use to the stick function available on cryogenic ablation systems. CertuSurg" surgical tool does not have the Tissu-Loc function.
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.
The provided document describes the NeuWave Medical Certus 140 2.45 GHz Ablation System and Accessories, which is indicated for the ablation (coagulation) of soft tissue. The submission is a 510(k) to update the system with a new surgical tool (CertuSurgST) and associated software updates.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of specific performance metrics or thresholds (e.g., minimum ablation size, maximum temperature, etc.) for the device. Instead, it refers to compliance with international standards and substantial equivalence to a predicate device.
The reported device performance is general, focusing on the functionality and design of the various probes and the overall system.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with International Standards (UL 60601-1, IEC 60601-1, IEC 60601-2-2, IEC 60601-2-6, IEC 60601-1-2, EN ISO 11607-1, ISO 10993-1) | System has been "verified through rigorous testing that, in part, supports the compliance" to these standards. |
| Substantial Equivalence to Predicate Device (Certus 140 2.45 GHz Ablation System and Accessories - K100744, K113237, K122217) | "The Certus 140 2.45 GHz Ablation System and Accessories and the predicate devices are substantially equivalent in design concepts, technologies and materials." Ex-vivo studies were conducted to compare performance. |
| Optimal energy transfer/ablation characteristics for various tissues and lesion sizes | "Certus" probes for liver and kidney; "Certus" probes for lung tissue; "Certus" probes for shorter ablations/smaller lesions; "Certus" probes for quickly encompassing tip while limiting overall length; "Certus" probes for laparoscopic applications. |
| Temperature monitoring and patient/operator safety | Energy delivery accessories contain temperature measurement sensors; CO2 based cooling system ensures non-active portion doesn't exceed temperature requirements. |
| Functionality of new features (CertuSurgST surgical tool, Tissu-Loc) | CertuSurgST for focal, rapid coagulation in open surgical applications including planar coagulation. Tissu-Loc (except for CertuSurgST) for adhering/sticking probe in place. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Ex-vivo studies were conducted to compare the performance of the Certus 140 2.45 GHz Ablation System and Accessories to a predicate device."
- Sample Size for Test Set: Not specified. The document does not provide any numerical details about the sample size (e.g., number of ablation procedures, number of tissue samples, number of devices tested).
- Data Provenance: Ex-vivo. This indicates the studies were performed on excised tissue rather than living organisms. The country of origin is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable/Not specified. The evaluations appear to be objective, physical measurements or comparisons in an ex-vivo setting. There is no mention of human experts establishing "ground truth" for the performance characteristics.
4. Adjudication Method for the Test Set
Not applicable/Not specified. As the "ground truth" was not established by human experts, there would be no need for an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document does not describe an MRMC study or any study involving human readers or comparative effectiveness with or without AI assistance. The device is a microwave ablation system, not a diagnostic imaging AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Not applicable. This device is a physical medical device (ablation system), not an algorithm or AI system. The performance testing described (ex-vivo studies) would be considered "standalone" in the sense that the device's physical capabilities are being
evaluated.
7. The Type of Ground Truth Used
For the ex-vivo studies, the "ground truth" would likely involve objective physical measurements of ablation outcomes, such as:
- Ablation Zone Dimensions: Size, shape, and volume of the coagulated tissue.
- Temperature Measurements: Within and around the ablation zone.
- Tissue Specificity: How effectively the device ablates target tissue while sparing adjacent tissue.
- Power Delivery Characteristics: Stability and accuracy of energy output.
The document does not explicitly detail the specific measurements used, but these are typical for such devices.
8. The Sample Size for the Training Set
Not applicable/Not specified. This device is hardware for medical procedures, not a machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no machine learning model or "training set," this question is not relevant.
§ 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.