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The Thera Vision Ultrasound Ablation System, ACOUSTx Applicators, and accessories are intended for the laparoscopic, intraoperative, and percutaneous coagulation and ablation of soft tissue. It is not indicated for ablation of prostate tissue.

The TheraVision System consists of the following subsystems:

• 4.1 Computer System: The computer system consists of a PC Compatible type computer running Microsoft Windows® Operating system.
• 4.2 Visualization Options: Visualization options include utilization with compatible, legally marketed imaging systems. Patient images may be imported in DICOM format from MRI, CT, US, Fluoroscopic X-Ray, and PET-CT scanners.
• 4.3 Software: A set of user interface and display modules allow user interaction and high-level control over the system, including power generation and safety monitoring. Top-level modules provide top level menu options and implement next-generation Microsoft Windows® display functionality.
• 4.4 Thermometry System: Temperature monitoring is accomplished using an optional multichannel type T patient isolated thermocouple data acquisition system.
• 4.5 RF Generation System: A Multichannel RF power generator system provides the RF enerqy needed drive the piezoelectric transducers for generation of sufficient ultrasound acoustic energy from the applicators to raise the temperature to therapeutic levels in the targeted tissue
• 4.6 Cooling System: Degassed sterile water is pumped through the ultrasound transducers in the applicators and provides ultrasound energy coupling to tissue and also provides a means for cooling the applicator.

ACOUSTx Applicators:
The ultrasound energy generated from ACOUSTx Applicators is absorbed during treatment producing thermal therapy within the targeted tissue region. The ACOUSTx Applicators are sterile and single-use and can be utilized with the TheraVision System and may contain up to four transducers each with angular insonation patterns of 360° or 180° for application of thermal therapy.

The provided FDA 510(k) summary (K150019) describes the TheraVision™ Ultrasound Ablation System and ACOUSTx™ Applicators. The submission aims to demonstrate substantial equivalence to predicate devices, focusing on the device's ability to create comparable ablation patterns.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pre-defined manner typical for clinical trials or formal performance goals. Instead, the performance is demonstrated by showing "comparable ablation patterns and times" to predicate devices. The implicit acceptance criterion is that the device should produce ablation dimensions within a range that is considered safe and effective, and comparable to legally marketed predicate devices.

• Liver: Penetration Depth: 1.4 - 3.4 cm, Pattern Length: 1.1 - 4.7 cm
• Muscle: Penetration Depth: 1.63 - 3.4 cm, Pattern Length: 1.2 - 4.7 cm
• Kidney: Penetration Depth: 1.5 - 2.7 cm, Pattern Length: 1.1 - 2.5 cm*

180° ACOUSTx Applicator:

• Liver: Penetration Depth: 1.9 - 2.8 cm, Pattern Length: 1.1 - 4.6 cm
• Muscle: Penetration Depth: 1.8 - 3.0 cm, Pattern Length: 1.1 - 4.6 cm
• Kidney: Penetration Depth: 1.6 - 2.7 cm, Pattern Length: 1.1 - 2.4 cm*

Comparison to Predicates:

• Sonatherm: penetration depth up to 3 cm (wedge-shaped pattern)
• Cool-tip™: ablation diameter 2.3 – 2.6 cm at lengths of 2.6 – 3.7 cm (ellipsoidal pattern)
• Valleylab: ablation diameter 1.8 - 3 cm at lengths of 3.9 - 5 cm (ellipsoidal pattern) |
  | Ablation times comparable to predicate devices. | The study involved different treatment times (3, 6, and 9 minutes) and concluded "comparable ablation patterns and times with respect to the three listed predicate devices." (Specific comparable times for predicates are not detailed here, but the range of times used demonstrates performance over an operational spectrum). |
  | Safety and efficacy for intended use and technology. | "Results from bench, animal, performance, and safety testing demonstrate the safety and efficacy of this device's intended use and technology." Compliance with IEC 60601-1, IEC 60601-1-2, IEC 61000-3-2, and IEC 61000-3-3. |

*1 or 2 active transducers longitudinally

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a precise numerical sample size for the in vivo testing (e.g., number of animals). It states that in vivo testing was performed "using a porcine model" and "three tissue types were treated: liver, muscle, and kidney." For ex vivo testing, the text mentions using "360° and 180° ACOUSTx Applicator models to apply thermal therapy to both chicken breast tissue and porcine tissue: liver, muscle, and kidney."
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: Prospective, as the testing was conducted specifically to support the 510(k) submission. These are controlled laboratory and animal studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This section is not applicable. The measurements of ablation dimensions (penetration depth, pattern length) are objective physical measurements taken from the ablated tissue, not subjective expert interpretations requiring consensus. Therefore, no experts were used to establish a "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

Not applicable, as the data collection involved objective physical measurements, not subjective evaluations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This study focuses on the physical ablation properties of a device, not on diagnostic performance or human reader interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This device is an ablation system, not a diagnostic algorithm. The "standalone" performance in this context refers to the device's ability to produce specific thermal lesions. The in vivo and ex vivo testing conducted are effectively "standalone" performance tests of the device itself (without human interpretation of diagnostic output).

7. The Type of Ground Truth Used

The ground truth used was physical measurement of tissue ablation dimensions (penetration depth, pattern length) resulting from the device's operation. This is directly observable and measurable data from the treated tissue (ex vivo and in vivo).

8. The Sample Size for the Training Set

Not applicable. This device is a physical ablation system, not an AI or machine learning algorithm that requires a "training set" in the conventional sense. The device's operational parameters and design are based on engineering principles and preclinical testing, rather than data-driven learning from a large "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device.

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The Valleylab Microwave Ablation Generator is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors.

The Valleylab Microwave Ablation Generator is designed to provide microwave power for the ablation of soft tissue in medical procedures. It was cleared for commercial distribution (K011676) by demonstrating substantial equivalence to existing Radiofrequency and Microwave Ablation systems.

The Microwave Ablation Generator is designed to be used with proprietary microwave antennas (cleared in K011676 and K032702) which are placed directly into the tissue to be ablated. The Valleylab Microwave Ablation Generator is a nonsterile electrical device that is not intended to contact the patient.

The Microwave Ablation Generator is used with a pump to circulate cooling fluid (sterile saline) to the antennas, and an optional integrated cart. The device's power output and duration (time) are controlled by the user via manual controls on the front panel of the generator. The display on the front of the device shows power (watts), duration of power delivery (minutes and seconds), and elapsed time.

The antenna is connected to the generator and radiates power to the tissue under treatment. The antennas are provided sterile, for single use only. The shaft of each antenna is made of insulated stainless steel. Three antennas of different lengths are available for use in percutaneous procedures, and a single length antenna fing surgical procedures. The active portion of the antenna is 3.7cm in length for all models. The percutaneous antennas are cooled by circulating sterile saline through the antenna. The surgical antennas are not internally cooled. The system pump circulates fluid from a reservoir to the antenna through sterile tubing. Sterile fluid is confined within the antenna and tubing, and does not contact the patient.

This appears to be a 510(k) summary for the Valleylab Microwave Ablation Generator, seeking to expand its intended use to include the ablation of non-resectable liver tumors.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for the expanded indication in a quantitative, tabular format. Instead, it describes comparative non-clinical testing and refers to existing clinical studies.

2. Sample Size Used for the Test Set and Data Provenance

• Non-clinical Testing (Bench and In-vivo):

  • Sample Size: Not explicitly stated (e.g., number of livers, number of ablations). It mentions "single and multiple antenna comparisons."
  • Data Provenance:
    • Bench Testing: Bovine livers (ex-vivo, not human or patient data).
    • In-vivo Testing: Porcine livers (animal model, not human or patient data).
    • Retrospective/Prospective: These were likely prospective studies designed for this submission.

• Clinical Testing:

  • Sample Size: Not explicitly stated. The document refers to "A review of the existing studies," implying a synthesis of previously conducted research rather than a new clinical trial undertaken for this submission.
  • Data Provenance: Not specified, but generally, human clinical studies would be prospective or retrospective patient data from various clinical sites. The text indicates "existing studies," so it would be entirely retrospective in relation to this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document for either the non-clinical or clinical testing.

4. Adjudication Method for the Test Set

This information is not provided in the document. For the non-clinical testing, it mentions lesions were "evaluated histologically and physically," which implies some form of assessment, but not an adjudication method. For the clinical testing, as it's a "review of existing studies," the adjudication method would depend on the individual studies reviewed, which are not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This document describes a device for microwave ablation, not an AI/CAD (Computer-Aided Detection/Diagnosis) device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not conducted as described in this summary.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is not an algorithm. It's a medical device (generator and antennas) for tissue ablation. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

• Non-clinical Testing (Bovine/Porcine Livers):

  • Histology: Lesions were "evaluated histologically." This implies detailed microscopic examination of tissue.
  • Physical Evaluation: Lesions were also evaluated "physically," likely referring to gross measurements and visual inspection.
  • This combines expert assessment (histology interpretation) with direct measurement.

• Clinical Testing (Review of Existing Studies):

  • The document states the review "shown that the use of the system to be clinically safe and effective." This often implies ground truth established through a combination of:
    • Pathology: Confirmation of tumor type and complete ablation in excised specimens or biopsies.
    • Imaging Follow-up: Assessment of tumor recurrence or residual disease using modalities like CT, MRI, or ultrasound.
    • Clinical Outcomes Data: Patient survival, complications, quality of life, etc.
  • The specific methods for establishing ground truth within the "existing studies" are not detailed in this summary.

8. The Sample Size for the Training Set

This document does not describe the development of an algorithm that would require a "training set." It's a hardware device (microwave ablation generator). Therefore, the concept of a training set sample size is not applicable.

9. How the Ground Truth for the Training Set Was Established

As explained above, this concept is not applicable to the device described.

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The Tri-Loop™ Microwave Ablation Probe is intended for coagulation of soft tissue. Not for use in cardiac procedures.

The device consists of 3 pre-shaped curved microwave antennas which is contained within 3 delivery cannulas. The cannulas are attached to a handle mechanism that deploys the antennas into the targeted tissue. RF energy can be used to facilitate deployment of the antennas into tissue. The Vivant VivaWave™ Microwave Generator (K011676) is used to deliver the microwave energy to the curved antennas which heats the tissue within and around the antennas.

The provided text is a 510(k) summary for the Tri-Loop™ Microwave Ablation Probe. It states the device's intended use and claims substantial equivalence to a predicate device. However, it does not contain any studies, acceptance criteria, or performance data to directly answer your specific questions about device performance and study methodology.

The supplied document is a regulatory submission for premarket clearance, which focuses on demonstrating equivalence to an already legally marketed device (predicate device). Such submissions typically do not include detailed performance studies with acceptance criteria in the way you've described for AI/diagnostic devices.

Therefore, I cannot populate the table or answer the subsequent questions based on the provided input. The document explicitly states:

• "Summary of Substantial Equivalence: The Tri-Loop™ Microwave Ablation Probe is equivalent to the predicate products. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent."

This indicates that the clearance was based on equivalence, not on independent performance studies against defined acceptance criteria for a novel functionality.

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