(30 days)
The Sonata® Transcervical Fibroid Ablation System 2.2 is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.
The Sonata System 2.2 provides radiofrequency (RF) ablation of uterine fibroids using a transcervical approach that is uterine sparing without incisions or material uterine distension. The system enables a clinician to deliver radiofrequency energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue. The system combines two technologies - ultrasound for visualization, and radiofrequency energy for ablative therapy - in a single integrated handpiece. The Sonata System is comprised of medical equipment, software, and various single-use and reusable instruments. A single-use Radiofrequency Ablation (RFA) Handpiece attaches to a reusable Intrauterine Ultrasound (IUUS) Probe to provide sonography-guided RF ablation. Once connected, the combination is referred to as the "Treatment Device". The RFA Handpiece connects to the Sonata RF Generator and contains the Needle Electrodes that deliver radiofrequency energy to the target tissue. The IUUS Probe connects to the SMART Tablet and provides diagnostic ultrasound imaging and guidance. Ultrasound guidance is used to localize the fibroids from within the uterine cavity, guide placement of the RFA Handpiece Needle Electrodes into a target fibroid and ensure safety with respect to the serosa. The Sonata System allows for treatment planning through the use of a graphical interface and automated control of RF energy delivery. Sonata Graphical Guidance Software (GGS) includes the SMART Guide and integrates treatment planning, targeting, and ablation of fibroids. The SMART Guide displays a real-time graphic overlay on the live ultrasound image for targeting and deployment of radiofrequency ablation.
The provided document is a 510(k) summary for the Sonata® Transcervical Fibroid Ablation System 2.2. It describes changes made to the device compared to its predicate (Sonata System 2.1) and summarizes the testing conducted to demonstrate substantial equivalence.
However, the document does not contain the detailed information requested regarding acceptance criteria for a study proving the device meets acceptance criteria. Instead, it outlines the company's internal design control procedures, risk analysis, and verification/validation activities for the modifications to the device. It also references prior clinical data from the predicate device and states that no additional clinical data was needed for the 2.2 version.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance from a study proving device meets acceptance criteria. It lists "Performance testing - System level (bench)" and "Performance testing - Ablation" but describes the types of tests, not the specific acceptance criteria or quantitative results.
- Sample sizes used for a test set in the context of proving performance against acceptance criteria.
- Number of experts, their qualifications, or adjudication methods for establishing ground truth for a test set. This type of information is usually relevant for AI/ML device evaluations, which this device is not.
- Details on an MRMC comparative effectiveness study or standalone performance. This device is not an AI/ML device subject to these types of studies.
- Type of ground truth (e.g., pathology, outcomes data) for a test set.
- Sample size for a training set.
- How ground truth for a training set was established.
What the document does provide, relative to your questions:
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Acceptance Criteria & Performance (General):
- The document states that "The test methods and acceptance criteria used established methods consisting of FDA recognized standards and/or the same methods and criteria as were used in the predicate device submission; thus, meeting the FDA's requirement for a Special 510(k). In all cases, the verification and validation testing met the acceptance criteria."
- It lists general safety and performance standards met (e.g., Electrical Safety & EMC: ANSI/AAMI ES60601-1, IEC 60601-1-2, etc.).
- Acoustic Output: Specific values are given for B Mode: ISPTA ≤ 720 mW/cm² (Value: 162 mW/cm²) and MI ≤ 1.9 (Value: 1.7). These are presented as performance measurements.
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Study Proving Device Meets Acceptance Criteria:
- The document focuses on demonstrating that the changes to the Sonata System 2.2 do not raise new questions of safety and effectiveness, relying heavily on the predicate device's existing data.
- It mentions "verification and validation testing met the acceptance criteria" for the changes, but doesn't provide a specific study report for this, instead summarizing design control activities in Table 5. These are generally internal engineering tests.
- For clinical data: "No additional clinical study data was needed to validate the Sonata System 2.2." It explicitly states that "Sonata System 2.2 continues to rely on the clinical trial study as Sonata System 2.1."
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Clinical Trial for Predicate Device (G140114, NCT02228174):
- Sample Size: n = 147 subjects.
- Data Provenance: 22 centers with treated patients. (Country of origin not specified, but typically US-based for FDA filings). The trial design was a "Single-arm cohort study with each subject serving as her own control."
- Ground Truth: For the clinical trial, the "ground truth" would be related to clinical outcomes (safety and effectiveness, e.g., reduction in heavy menstrual bleeding, fibroid volume reduction, adverse events) as assessed by clinicians or objective measurements, not image-based expert consensus. The document does not detail how these clinical outcomes were specifically established, but this is typical for clinical trials where physician assessment and quantitative measurements are used.
- Retrospective/Prospective: Clinical trials are typically prospective.
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AI/ML Specific Questions (not applicable to this device, as it's not an AI/ML diagnostic tool):
- Number of experts, qualifications, and adjudication methods for ground truth (Q3, Q4) are not relevant as this is not an AI/ML device.
- MRMC comparative effectiveness study (Q5) is not relevant.
- Standalone performance (Q6) is not relevant in the context of AI/ML algorithms. The device's performance is as an integrated system, not a standalone algorithm.
- Training set information (Q8, Q9) is not relevant as there's no mention of a machine learning algorithm being trained.
Summary Table based on provided text (limited details):
| Acceptance Criteria Category | Acceptance Criteria (from text, often general statements or standards) | Reported Device Performance (from text, values if available) | Notes |
|---|---|---|---|
| General Compliance | Met FDA recognized standards and/or methods from predicate submission | "In all cases, the verification and validation testing met the acceptance criteria." | Refers to internal testing of modifications. |
| Electrical Safety & EMC | ANSI/AAMI ES60601-1:2005/(R)2012, IEC 60601-1-2 Ed 4: 2014-02, etc. | Implied compliance by citing standards. | |
| Biocompatibility | ISO 10993-1, -5, -10, -11 | "Is biocompatible with intended use in compliance with..." | |
| Usability & Human Factors | IEC 60601-1-6 Ed 3.1 2013-10, ANSI AAMI IEC 62366-1:2015 | "Sonata System 2.2 continues to rely on HFE validation of Sonata System 2.1." | Prior HFE validation was "successfully completed." |
| Ablation Performance | "System performs as intended and per specifications." | "Ablation capability was confirmed and the radiofrequency ablation provides a reproducible, discretely demarcated zone of tissue necrosis." | Concluded from early clinical and bench ablation testing (predicate). |
| Acoustic Output (B Mode) | ISPTA ≤ 720 mW/cm² ; MI ≤ 1.9 | ISPTA: 162 mW/cm² ; MI: 1.7 | Meets limits. |
| Safety Features (Software) | Enhanced safety by enabling automatic RF termination for hazardous situations | RF delivery "terminated without physician intervention." | Modification is an "enhancement" to risk mitigation. |
| Reusable Cable Durability | (Implied) Validation of thorough cleaning/sterilization; cable life testing. | Cable Life testing including shipping stress & multiple cycles of simulated use, cleaning, disinfection & sterilization; System Integration Testing completed. | These are verification activities for the changes. |
| Sterilization Options | (Implied) Addition of validated instructions for STERIS V-PRO sterilizers. | Sterilization Validation; Residuals Testing; Impact on IUUS Probe Use Life completed. | These are verification activities for the changes. |
Study Proving Device Meets Acceptance Criteria (Clinical Trial of Predicate):
- Sample size: n = 147 subjects.
- Data Provenance: 22 centers. (Retrospective/Prospective: Typically Prospective for clinical trials). Country not explicitly stated, but for FDA submissions, often includes US sites.
- Number of experts used to establish ground truth & qualifications: Not applicable for a device that is not an AI/ML diagnostic. The clinical trial would establish efficacy and safety through patient outcomes and physician assessments.
- Adjudication method for the test set: Not applicable for device performance against a test set in the AI/ML sense. Data in the clinical trial would be collected and analyzed using standard clinical trial methodologies.
- MRMC comparative effectiveness study: No.
- Standalone performance: Not applicable in the AI/ML context. This is an integrated surgical system.
- Type of ground truth used: Clinical outcomes data (e.g., reduction in heavy menstrual bleeding, fibroid volume, adverse events) from a single-arm cohort study where each subject served as her own control.
- Sample size for training set: Not applicable (not an AI/ML device).
- How ground truth for training set was established: Not applicable.
§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).