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.

Device Description

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.

AI/ML Overview

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: Statistical significance for safety and efficacy in incision/ablation/vaporization of highly delicate tissue (human lens capsule, <50 microns thick), demonstrating untraumatized incision wall and strong biomechanical characteristics. - K041019: Statistical significance for safety and efficacy in incision/ablation/vaporization of extremely dense, strong tissue (scleral tissue), showing resistance-free incisions with minimal adjacent tissue trauma. - K050933: Statistical significance for safety and efficacy in incision/ablation/vaporization with hemostasis in highly vascular tissue (vascular uveal layer of the eye).
Intended Use Equivalence: Capable of performing the listed oral soft tissue procedures with safety and efficacy.	The device is intended for incision, excision, ablation, vaporization, and hemostasis of oral soft tissue for various dental procedures. The aforementioned clinical data from delicate, dense, and vascular tissues (though ocular) are used to support the general capability and safety of the Fugo Blade technology for oral soft tissue, implying it can perform the listed dental procedures effectively and safely.

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

Sample Size: The document does not explicitly state a sample size for a new test set specifically for the Fugo Blade for Dentistry. Instead, it references studies performed for previous 510(k) submissions for ophthalmic applications (K001498, K041019, K050933). The sample sizes for those specific studies are not provided in this summary.
Data Provenance: The data provenance for the supporting clinical studies is:
- K001498: University of South Carolina (presumably prospective clinical studies, though not explicitly stated).
- K041019: Louisiana State University (presumably prospective clinical studies, though not explicitly stated).
- K050933: No specific institution mentioned for clinical studies, but states "statistical significance for safety and efficacy."
- The preclinical studies on plasma formation were conducted under the supervision of Dr. Michael Brown, director of the Swarthmore College Plasma Lab, Swarthmore, PA.

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 510(k) summary. The document refers to "studies at the University of South Carolina" and "studies at Louisiana State University," but does not detail the specific methodology for establishing ground truth, the number of experts, or their qualifications for those studies.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Given the nature of electrosurgical device studies (often involving direct observation of tissue effects, histological analysis, or functional outcomes), adjudication methods like 2+1 or 3+1 for image interpretation would typically not be applicable.

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

No, an MRMC comparative effectiveness study involving human readers with or without AI assistance was not done. The Fugo Blade is an electrosurgical device, not an AI-driven diagnostic or imaging aid.

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

The Fugo Blade is a medical device for direct surgical use, not an algorithm. Therefore, a standalone algorithm-only performance study is not applicable. The "standalone performance" of the device itself is demonstrated through its physical and functional characteristics (e.g., generating a plasma field, cutting tissue, achieving hemostasis), which are supported by the referenced studies.

7. The Type of Ground Truth Used

Based on the descriptions:

K001498 (Lens Capsule): Implied ground truth would be based on histological analysis of incision walls for structural integrity and biomechanical testing for strength characteristics.
K041019 (Scleral Tissue): Implied ground truth would be based on histological analysis for tissue trauma adjacent to the incision and possibly direct observation of incision characteristics (resistance-free).
K050933 (Vascular Uveal Layer): Implied ground truth would involve assessment of hemostasis, likely through direct observation and potentially histological confirmation of coagulation without excessive damage.
Preclinical Plasma Field Studies: Ground truth was established by plasma physicists at Swarthmore College, involving direct observation and analysis of the generated plasma field, possibly using microscopy and other analytical techniques.

8. The Sample Size for the Training Set

The concept of a "training set" as typically understood in machine learning or AI is not applicable here. This device involves direct physical interaction with tissue, and its "training" or development would involve engineering design, bench testing, and in vitro and in vivo studies to refine its physical parameters and performance characteristics. The document does not provide sample sizes for any studies used in the development of the device.

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

As above, the concept of a "training set" in the AI sense does not apply. The ground truth for the underlying scientific principles and performance characteristics of the electrosurgical technology was established through scientific investigation, experimental observation, and analysis (e.g., plasma physics studies at Swarthmore College). For the previous clinical studies referenced, ground truth would have been established through expert assessment, histological analysis, and objective measurements of tissue effects and outcomes, as described in point 7.

Summary

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K063468

APR 1 & 2007

10001

Medisurg Ltd. 100 West Fornance St. Norristown, PA 19401 Phone (610) 277-3937 Fax (610) 277-7256

Pre-market Notification [510(k)] Summary

Submitters name: Richard J Fugo M.D., Ph.D. Contact person: Richard J Fugo M.D., Ph.D.

Date: October 30, 2006

Names: (807.92(a)(2))

B) Classification name: Unit, electrosurgical, and accessories, dental
C) Common/ usual name: The Fugo Blade for Dentistry
D) Proprietary name: The Fugo Blade

Equivalence predicate device: (807.92(a)(3))

A) Equivalence from an intended use standpoint: FDA cleared
Wallach Quantum 500 electrosurgical generator for surgery -K000768
B) Equivalence from a technologic standpoint:
- a. Fugo Blade for Capsulotomy FDA # K001498
- b. Fugo Blade for Glaucoma FDA # K041019
- c. Fugo Blade for Peripheral Iridotomy FDA # K050933

Description of the device (807.92(a)(4))

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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. This process was evaluated extensively in the FDA 510K submission K050933: The Fugo Blade for Peripheral Iridotomy.

Intended use of device (807.92(a)(5))

Summary of technological characteristics (807.92(a)(6))

The Fugo Blade for Dentistry: Electromagnetic (EM) energy from flashlight size ("C" cell ) batteries is fed into a proprietary network system. This electronic system takes EM energy from the batteries then conditions, tunes (9.8 +/- 2.0 x 106 Hz) and focuses this EM energy around an incising probe at the end of the Fugo Blade electrosurgical hand piece. This column of EM energy is capable of reacting with tissue in an intended path of incision. This reaction causes the molecular bonds in the tissues which come in contact with the Fugo Blade to absorb the Fugo Blade EM energy and thereby have the molecular bonds shatter. Upon shattering, the molecules ionize and create a substance that physicists refer to as a "plasma field". In this way, the molecular lattice of the tissue is broken down, thereby creating an incision, excision, ablation, vaporization as well as hemostasis of oral soft tissue. The plasma field generation can easily be visualized under a microscope. Such images have been published by Medisurg Ltd. in scientific journals and advertisements. This Fugo Blade plasma cloud has been studied and analyzed by the Plasma Lab at Swarthmore College, Swarthmore, PA. The issue of Fugo Blade field generation was addressed and evaluated in the

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FDA 510K submission # K050933 "The Fugo Blade for Peripheral Iridotomy".

Non-clinical performance data (807.92(b)(1))

The Fugo Blade uses 7.2 V batteries to focus an electromagnetic field into tissue in a path of incision, thereby ionizing molecules in the tissue lattice thus creating a plasma field as discussed in FDA 510 submission K050933. This was substantiated by proprietary studies under the supervision of Dr Michael Brown, director of the Swarthmore college plasma lab, Swarthmore, PA. It is well know in the electrosurgical literature that all electrosurgical incision units including a Wallach Quantum 500 generate "arcs" which are plasma clouds at the incising tip.

The same electronic system as the Fugo Blade for Dentistry has previously been FDA cleared in FDA 510 K submissions K001498. K041019 and K050933. The Fugo Blade system has also received UL approval and is CSA compliant. The Fugo Blade system complies with ANSI/AAMI HF18:2001, clause 4.2.3.1 for thermal safety. The Fugo Blade system complies with high frequency leakage current requirements specified by ANSI/AAMI HF18:2001, clause 4.2.5.2. These findings support substantial equivalency with the Wallach Quantum 500 system.

Clinical performance data 807.92(b)(2)

FDA submission K001498 provides statistical significance for safety and efficacy for the Fugo Blade system in the incision/ ablation/ vaporization of highly delicate tissue, namely anterior human lens capsule. Lens capsule is less than 50 microns thick and is extremely fragile tissue. Yet, studies at the University of South Carolina show that the Fugo Blade incision wall of lens capsule had a structural integrity which was untraumatized and a biomechanical strength characteristic equal to or better than other electrosurgical units. (Appendix #8)

FDA submission 510K K041019 provides statistical significance for safety and efficacy in the incision/ablation/vaporization of extremely dense, strong tissue, namely scleral tissue of the eye. Also, studies at Louisiana State University demonstrated that the Fugo Blade can provide resistance free incisions with minimal trauma to the tissue adjacent to the incision. (Appendix #7)

FDA submission K 050933 provides statistical significance for safety and efficacy for incision/ablation/vaporization with hemostasis in highly vascular tissue, namely the vascular uveal layer of the eye.

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K063468
4074

These studies support substantial equivalency in clinical performance of the Fugo Blade system to the Wallach Quantum 500 system for Dentistry (FDA 510K K000768) from an intended use perspective (intended use predicate). From a technologic perspective (technologic predicate), the Fugo Blade for Dentistry has been shown to be equivalent to the Fugo Blade for Capsulotomy (FDA 510K K001498), the Fugo Blade for Glaucoma (FDA 510K K041019), and the Fugo Blade for Peripheral Iridotomy (FDA 510K K050933).

Summary 807.92(b)(3)

The Fugo Blade for Dentistry is as safe and as effective as the predicate devices. From a technologic perspective (technologic predicate) the Fugo Blade for Dentistry is the same electronic system as FDA cleared systems K001498, K041019, K050933. Therefore, the Fugo Blade for Dentistry has been shown to be equivalent to the technologic predicates.

From an intended use perspective, the Fugo Blade for Dentistry has been shown to be equivalent in terms of safety and effectiveness to the Wallach Quantum 500 system for dentistry (FDA # K000768). These findings are based on preclinical data and clinical data discussed in this application. This data has also previously been described in FDA 510K application K001498, K041019, K050933.

Therefore, the Fugo Blade for Dentistry has been demonstrated to have equivalent safety and efficacy as its technologic predicate and its intended use predicate based on non-clinical and clinical tests.

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Image /page/4/Picture/1 description: The image shows the seal for the Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richard J. Fugo M.D., Ph.D. MediSurg Limited 100 West Fornance Street Norristown, Pennsylvania 19401

APR 1 & 2007

Re: K063468

Trade/Device Name: The Fugo Blade for Dentistry Regulation Number: 21 CFR 872.4920 Regulation Name: Dental Electrosurgical Unit and Accessories Regulatory Class: II Product Code: EKZ Dated: March 19, 2007 Received: April 9, 2007

Dear Dr. Fugo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Fugo

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Surfie Y. Michael Davis

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K063468

Indications for Use

510(k) Number (if known): K063468

The Fugo Blade for Dentistry Device Name:

Indications For Use:

Excisional and incisional biopsy .
Exposure of unerupted teeth .
Fibroma removal
Frenectomy and frenotomy .
Gingival troughing for crown impressions .
Leukoplakia .
Operculectomy t
Gingivoplasty (contouring of gingival tissue) .
Gingivectomy (excision of unsupported gingival tissue) .
Gingival incision and excision .
Hemostatis ●
Implant recovery .
Incision and drainage of abscess .
Oral papillectomies .
Pulpotomy .
Pulpotomy as an adjunct to root canal therapy .
Reduction of gingival hypertrophy ●
Soft tissue crown lengthening .
Treatment of aphthous ulcers .
Vestibuloplasty .
Biopsy incision and excision .
Lesion removal .
Tumor removal �

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number:	K063468
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Page 1 of 1

Regulation Number and Section

§ 872.4920 Dental electrosurgical unit and accessories.

(a)
Identification. A dental electrosurgical unit and accessories is an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. This device is intended to cut or remove soft tissue or to control bleeding during surgical procedures in the oral cavity. An electrical current passes through the tip of the electrode into the tissue and, depending upon the operating mode selected, cuts through soft tissue or coagulates the tissue.(b)
Classification. Class II.