(150 days)
IntelliBlate Microwave Ablation System:
The IntelliBlate Microwave Ablation System is intended for coagulation (ablation) of soft tissue. The IntelliBlate Microwave Ablation System is not intended for use in cardiac procedures.
IntelliBlate Ximitry Probe Assembly:
The IntelliBlate Ximitry Probe Assembly, used with the IntelliBlate Microwave Ablation System is intended for coagulation (ablation) of soft tissue.
The IntelliBlate Ximitry Probe Assembly is not intended for use in cardiac procedures.
The IntelliBlate Microwave Ablation System is a software-controlled microwave therapy delivery system with graphical user interface and hardware to control and monitor the therapy delivered to the target tissues.
The system consists of a 2.45 GHz microwave generator (console) with an integrated peristaltic pump assembly for coolant fluid delivery, a coolant Fluid Mount and an optional mobile cart for the console. Accessories for the system include IntelliBlate Ximitry Probe Assembly - a sterile, single-use disposable microwave ablation assembly with ablation probes and a cassette for coolant fluid tubing (closed cooling circuit).
The provided text does not contain detailed acceptance criteria for the IntelliBlate Microwave Ablation System that would typically be found in a clinical study report or a more extensive submission. The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical testing summaries.
However, based on the information provided, we can infer some general acceptance criteria related to safety and performance, and describe the studies conducted as reported in the "Performance Data" section.
Here's an attempt to structure the information based on the provided text, acknowledging the limitations in detail for many of the requested points:
Implicit Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Performance Data) | Reported Device Performance (as stated in the document) |
|---|---|
| Functional Design and Performance: Device meets established design criteria. | The subject devices successfully completed functional testing. |
| Ablation Performance in Ex-vivo Tissues: Ablation performance is substantially equivalent to predicate devices in various tissues. | Ex-vivo testing of the devices at single, double, and track ablation settings in porcine liver, kidney, and muscle demonstrated that the differences in design and system characteristics do not affect the ablation performance of the subject device in comparison to the predicate device. |
| Usability and Performance (Acute Animal Model): Devices are usable and perform as expected in living tissue models. | Acute GLP studies validated usability and performance of the devices on porcine soft tissue models. |
| Reliability: Device maintains consistent operation over time. | The subject devices successfully completed reliability testing. |
| Electrical Safety: Device complies with relevant electrical safety standards. | The IntelliBlate Microwave Ablation System and its accessories comply with applicable IEC 60601 series of standards: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-6, and IEC 60601-1-2. |
| Electromagnetic Compatibility: Device complies with relevant electromagnetic compatibility standards. | The IntelliBlate Microwave Ablation System and its accessories comply with applicable IEC 60601 series of standards: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-6, and IEC 60601-1-2. |
| Sterility: Ximitry Probe Assembly achieves a minimum sterility assurance level of 10^-6. | Ximitry Probe Assembly is sterilized utilizing 100% ethylene oxide gas to ensure a minimum sterility assurance level of 10^-6 in accordance with ISO 11135, ISO 10993-7, ISO 11138-1, ISO 11737-1, and ISO 11737-2. |
| Software Verification: Software functions are verified according to medical device software standards and FDA guidance. | Software verification was conducted in accordance with IEC 62304 and FDA guidance "Content of Premarket Submissions for Device Software Functions." |
| Cybersecurity: Cybersecurity requirements are assessed and addressed per FDA guidance. | Cybersecurity requirements were assessed per FDA guidance's "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, Postmarket Management of Cybersecurity in Medical Devices." |
| Thermal Effects and Temperature Monitoring: Thermal performance is substantially equivalent to predicate devices and monitoring is effective. | Comparison of thermal effects between IntelliBlate Microwave Ablation System and its predicate demonstrated that the performance of the subject device is substantially equivalent to the predicate device. Thermal effects and temperature monitoring testing were completed in accordance with FDA Guidance. |
| Biocompatibility: Patient-contacting components are biocompatible. | Biocompatibility testing of the Ximitry Probe Assembly in accordance with ISO 10993-1 demonstrated that the patient-contacting components are biocompatible. |
| Packaging Integrity and Shelf Life: Packaging maintains integrity and device remains viable for its intended shelf life. | Packaging integrity and shelf-life testing was performed in accordance with ISO 11607-1 and ISO 11607-2. |
Here's a breakdown of the other requested information based on the provided text. Please note that many of these details are not explicitly stated in the summary document.
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated for specific non-clinical tests. For the ex-vivo ablation performance study, it mentions testing in "porcine liver, kidney and muscle," but no specific numbers of samples or experimental runs are provided.
- Data provenance:
- Ex-vivo ablation performance: Porcine tissues. Origin of the pigs not specified.
- Acute animal testing: Porcine soft tissue models. Conducted in accordance with GLP Regulations (21 CFR Part 58) in the United States.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The studies mentioned (ex-vivo, animal GLP) would likely involve trained personnel or researchers, but their specific qualifications or role in establishing "ground truth" (e.g., assessing ablation zones) are not described. The document primarily focuses on engineering and animal model performance rather than human expert interpretation of results.
4. Adjudication method for the test set:
- This information is not provided in the document. Given the nature of the non-clinical and animal studies described, a formal adjudication method (like 2+1 or 3+1 often used for diagnostic AI) is very unlikely to have been applied. The evaluation would be based on direct measurements and observations by the researchers.
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:
- No, an MRMC comparative effectiveness study was not done. The IntelliBlate Microwave Ablation System is a hardware-based therapeutic device, not an AI diagnostic or assistance tool for human readers. Therefore, this type of study is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is a physical system for microwave ablation. The "software" mentioned in the document is for controlling the device's functions and user interface, not for standalone diagnostic or interpretive performance. Therefore, the concept of "standalone (algorithm only)" as it applies to AI diagnostics is not applicable here. The device's performance is inherently "standalone" in its therapeutic action, but this is not an algorithm acting independently of human control.
7. The type of ground truth used:
- For Ex-vivo Ablation Performance: The "ground truth" would be the actual measured ablation zone characteristics (e.g., volume, size, shape) in the porcine tissues, determined by direct observation or histological analysis post-ablation.
- For Acute Animal Testing: The "ground truth" would be the observed acute effects of ablation in porcine soft tissues, assessed through direct observation, physiological measurements, and potentially necropsy/histopathology.
- For Sterilization, Biocompatibility, Electrical Safety, etc.: The "ground truth" is adherence to specified standards and objective measurements (e.g., sterility assurance level, physical/chemical properties, electrical performance).
8. The sample size for the training set:
- This information is not applicable in the context of the studies described. The device is a microwave ablation system, and the testing described (functional, ex-vivo, animal, electrical, etc.) are verification and validation studies against pre-defined engineering and safety criteria, not training of a machine learning model.
9. How the ground truth for the training set was established:
- This information is not applicable for the reasons stated in point 8. There is no mention of a "training set" for a machine learning model. The "training" that occurs is in the development and refinement of the device's design and operational parameters based on engineering principles and iterative testing.
§ 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.