(373 days)
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.
| Acceptance Criterion (Implicit) | Reported Device Performance (Table 1 - Ablation Dimensions) |
|---|---|
| Ablation pattern dimensions comparable to predicate devices. | 360° ACOUSTx Applicator: |
- 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.
§ 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.