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510(k) Data Aggregation
(153 days)
THE FUGO BLADE FOR DENTISTRY
The Fugo Blade system is intended for incision, excision, ablation, vaporization and hemostasis of oral soft tissue e.g. excisional and incisional biopsies; exposure of unerupted teeth; fibroma removal; frenectomy and frenotomy; gingival troughing for crown impressions; gingiyoplasty: gingivectomy; gingival incision and excision; hemostasis; implant recovery; incision and drainage of abscess; leukoplakia; operculectomy; oral papillectomies; pulpotomy; pulpotomy as an adjunct to root canal therapy; reduction of gingival hypertrophy; soft tissue crown lengthening; secular debridement; treatment of aphthous ulcers; vestibuloplasty; biopsy incision and excision; and lesion (tumor) removal.
The Fugo Blade for dentistry is an electrosurgical device that is powered by the electromagnetic (EM) energy from flashlight size batteries. This energy is conditioned, tuned (9.8+/- 2.0 x 106 Hz) and focused on a thin blunt cutting filament. Moreover, the EM energy from flashlight size (C cell) batteries is fed into a proprietary electronic network system which is activated by the surgeon with an on/off switch. This electronic system is fed EM energy from the battery energy supply source, then conditions it in a proprietary fashion and transfers it to the surgeon cutting filament. This column of EM energy is capable of reacting with tissue. This column of EM energy causes the molecular bonds in the tissue which come in contact with the EM field to ionize and thereby break apart, a condition that plasma physicists refer to as "plasma formation". In this way, the molecular lattice of the tissue is broken into micro-fragments, thereby creating an incision, excision, ablation, vaporization, and hemostasis of oral soft tissue.
The provided 510(k) summary for the "Fugo Blade for Dentistry" is a pre-market notification to establish substantial equivalence to a predicate device, not a report on a study proving the device meets specific acceptance criteria in the manner typically seen for novel efficacy claims. This document primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device (Wallach Quantum 500 electrosurgical generator for surgery, K000768) and other previously cleared Fugo Blade products (K001498, K041019, K050933) for ophthalmic use.
Therefore, the acceptance criteria and study details are interpreted in the context of demonstrating substantial equivalence rather than novel performance claims against predefined metrics.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, specific acceptance criteria in terms of numerical performance thresholds (e.g., sensitivity, specificity, accuracy) for the dental application are not explicitly stated in this document. Instead, the "acceptance criteria" are implied to be the established safety and efficacy of the predicate devices. The "reported device performance" refers to the demonstration that the Fugo Blade for Dentistry shares the same technological characteristics and clinical effects as these predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological Equivalence: Same electronic system as previously FDA cleared Fugo Blade devices (K001498, K041019, K050933). | The Fugo Blade for Dentistry uses the "same electronic system" as the technologic predicates. It conditions, tunes (9.8+/- 2.0 x 106 Hz), and focuses EM energy from C-cell batteries to create a plasma field for tissue interaction. UL approval, CSA compliant, and compliance with ANSI/AAMI HF18:2001 (thermal safety, high frequency leakage current). |
| Safety and Efficacy Equivalence (General Electrosurgery): As safe and effective as the Wallach Quantum 500 system (K000768) for dentistry. | Preclinical Data: The Fugo Blade uses EM energy to create a plasma field, substantiated by proprietary studies at Swarthmore College Plasma Lab. This mechanism is compared to "arcs" (plasma clouds) generated by other electrosurgical units like the Wallach Quantum 500. |
| Clinical Data (Referenced from Prior Submissions): |
- [K001498](https://510k.innolitics.com/search/K001498): Statistical significance for safety and efficacy in incision/ablation/vaporization of highly delicate tissue (human lens capsule,
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(171 days)
THE FUGO BLADE FOR GLAUCOMA
Sclerostomy for the treatment of primary open- angle glaucoma where maximum tolerated medical therapy and trabeculoplasty have failed.
The entire electronic system of Fugo Blade for thermocauterization in glaucoma is equivalent to the predicate system. The only difference in the two systems is the geometry of the disposable incision tips as delineated in detail above.
The provided text is a 510(k) Premarket Notification Summary for "The Fugo Blade for Thermocauterization in Glaucoma." It details the device's name, intended use, and its equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, device performance data, sample sizes, ground truth establishment, or clinical study details.
The document's primary purpose is to demonstrate substantial equivalence to a legally marketed predicate device, which is a regulatory pathway for approval rather than a detailed performance study. Therefore, I cannot extract the requested information from the provided text.
Specifically, the following information is not available in the provided document:
- Table of acceptance criteria and reported device performance: No performance metrics or criteria are mentioned.
- Sample sizes used for the test set and data provenance: No test sets, sample sizes, or data origins are described.
- Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth establishment or expert involvement is discussed for performance evaluation.
- Adjudication method for the test set: Not applicable as no test set evaluation is described.
- Multi-reader multi-case (MRMC) comparative effectiveness study information: No MRMC study or human-in-the-loop performance is mentioned.
- Standalone (algorithm only) performance study details: Not applicable as the device is a surgical instrument, not an algorithm.
- Type of ground truth used: Not applicable as no performance evaluation study is detailed.
- Sample size for the training set: Not applicable as it's not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
The document focuses on:
- Device Name: The Fugo Blade for Thermocauterization in Glaucoma.
- Intended Use: Sclerostomy for the treatment of primary open-angle glaucoma where maximum tolerated medical therapy and trabeculoplasty have failed.
- Predicate Device: The Fugo Blade for anterior capsulotomy.
- Equivalence Basis: The electronic system of the device is identical to the predicate device, producing the same electronic output signal characteristics, thus reacting identically with tissue. The only difference is the geometry of the disposable incision tips.
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(87 days)
THE FUGO BLADE
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