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510(k) Data Aggregation
(89 days)
The BiZact device is a bipolar instrument intended for use in open surgical procedures where ligation of vessels, tissue bundles and lymphatics is desired. The tissue fusion of the device can be used on vessels (arteries and veins) and lymphatics up to an including 3 mm diameter. The BiZact device is indicated for use in open general surgical procedures.
It's also indicated for adult, children and adolescent ENT procedures (3 years of age and above), including tonsillectorny, for the ligation and division of vessels, tissue bundles 2-3 mm away from unintended thermally sensitive structures.
The BiZact device has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use for these procedures.
The BiZact™ Tonsillectomy Device Advanced Bipolar Tissue/Divider is a sterile, single use, hand-held electrosurgical device that incorporates radio frequency (RF) tissue fusion technology for a desired tissue effect when used with the ForceTriad™ Energy Platform (Force Triad), the Valleylab™ LS10 Generator (VLLS10GEN), or the Valleylab™ FT10 Energy Platform (VLFT10GEN) for ligation and division of vessels, tissue bundles, and lymphatics during open general surgical procedures.
The BiZact™ Tonsillectomy Device Advanced Bipolar Tissue/Divider attaches to a compatible electrosurgical generator with a 10-foot cord containing a proprietary connector. The generator can identify the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue/Divider via the radiofrequency identification (RFID) tag embedded in the connector (VLLS10GEN and VLFT10GEN) or with a barcode on the connector (ForceTriad). The generator delivers energy to the device using a defined algorithm that adjusts the generator output as a function of the electrical resistance of the tissue.
This document describes the FDA's decision to clear the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (K193356) for an expanded indication to include children aged 3 to less than 12 years. The key basis for this clearance is the demonstration of substantial equivalence to a previously cleared device (K182451).
The provided text details a clinical study to support the expanded indication but does not provide specific acceptance criteria in a quantitative table format that directly correlates to a device's performance in terms of metrics like sensitivity, specificity, or accuracy, which are typical for AI/diagnostic devices. This is because the BiZact device is a surgical instrument, not an AI or diagnostic device. Its performance is assessed through safety and effectiveness in a surgical context, primarily focusing on clinical outcomes.
Therefore, I will interpret "acceptance criteria" here as the clinical safety and effectiveness benchmarks that the device needed to meet for the expanded indication, and "device performance" as the clinical outcomes observed in the study.
Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (K193356)
Given that this is a surgical device, not an AI or diagnostic tool, the "acceptance criteria" are based on clinical safety and effectiveness endpoints for the surgical procedure it facilitates. The study primarily aimed to demonstrate that expanding the indication to include children (3 to <12 years) does not introduce new safety or effectiveness concerns compared to its existing use in adults and adolescents.
1. Table of Acceptance Criteria (Clinical Endpoints for Expanded Indication) and Reported Device Performance
| Acceptance Criterion (Clinical Endpoint) | Reported Device Performance in Clinical Study |
|---|---|
| Primary Objective: Intra-operative blood loss (quantitatively assess effectiveness). | Significantly less than the benchmark derived from a large meta-analysis. (This met the primary objective). |
| Safety: Occurrence of device-related adverse events (AEs). | 0 out of 60 subjects had adverse events related to the use of the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider. |
| Safety: Occurrence of serious adverse events (SAEs). | 0 out of 60 subjects qualified as serious AEs. |
| Safety: Device-related readmissions/hospitalizations to manage adverse events. | None of the subjects were admitted or readmitted to the hospital during this study for adverse events. (Note: Four subjects had 5 dehydration events requiring outpatient IV fluids, but no hospital admission.) |
| Overall Effectiveness and Safety for Expanded Population. | The clinical study demonstrated that the addition of children patients (3 to <12 years) does not raise new questions of safety or effectiveness, supporting the conclusion that the device is substantially equivalent to the predicate for this expanded indication. The device performed as expected, with favorable clinical outcomes and a low incidence of device-related or serious adverse events. Tonsillectomy-related AEs (e.g., fever, vomiting, throat pain) were observed, but these were related to the procedure itself, not the device, and were largely manageable. |
2. Sample Size and Data Provenance for the Test Set (Clinical Study)
- Sample Size: Sixty (60) pediatric subjects.
- Data Provenance: The document does not explicitly state the country of origin. It indicates it was a "multi-center" study, suggesting multiple sites potentially within one or more countries. It was a prospective clinical study.
3. Number of Experts and Qualifications for Ground Truth Establishment (Clinical Study)
- Number of Experts: Investigators (referring to the operating surgeons/clinicians at each site) and an Independent External Medical Monitor. The exact number of investigators is not specified (since it was multi-center). Only one Independent External Medical Monitor is mentioned.
- Qualifications: "Investigators" are physicians performing the tonsillectomy and assessing patients. The "Independent External Medical Monitor" typically holds medical qualifications (e.g., MD) and experience in clinical trial oversight, often specializing in the relevant medical field (ENT/pediatrics in this case), to ensure patient safety and data integrity. Specific years of experience are not provided.
4. Adjudication Method for the Test Set (Clinical Study)
- Adjudication of adverse events was performed by the "Investigators and an Independent External Medical Monitor." This suggests a process where initial assessment is made by the site investigator, and then reviewed/confirmed by an independent monitor. The specific "2+1" or "3+1" type of formal consensus is not explicitly detailed, but there was an independent review process for AE assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This device is a surgical instrument, not an AI or diagnostic imaging system. Therefore, an MRMC study designed to assess human reader performance with or without AI assistance is not relevant to its evaluation. The study focused on clinical outcomes of using the device during surgery.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- Not applicable. This is a surgical device, always used with human-in-the-loop (i.e., by a surgeon). There is no "algorithm only" performance to evaluate. Its function is directly tied to the surgeon's use during a procedure.
7. Type of Ground Truth Used (Clinical Study)
- Clinical Outcomes and Expert Assessment: The ground truth for safety and effectiveness was established through direct clinical observation of intra-operative blood loss, patient follow-up for adverse events, and assessment by clinical investigators and an independent medical monitor. This combines objective clinical measurements (blood loss) with subjective clinical evaluations of patient well-being and adverse event causality.
8. Sample Size for the Training Set
- Not applicable. This is a hardware surgical device, not a machine learning model. There is no concept of a "training set" for the device itself.
- However, if we consider "training" in a broader sense as prior experience or data that informed the device's design and previous clearances, then the predicate device (K182451) and its associated studies (likely including animal studies, bench testing, and potentially clinical data on adults/adolescents) could be seen as foundational.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, there is no "training set" for the device. The device's design and performance claims are based on engineering principles, bench testing (e.g., burst pressure), biocompatibility testing, a previously cleared predicate device, and prior animal/clinical studies described in previous 510(k) submissions. These prior studies would have established their ground truth through standard preclinical and clinical methods relevant to surgical devices.
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