(153 days)
No
The device description and performance studies focus on the electrosurgical mechanism and its equivalence to predicate devices, with no mention of AI or ML.
Yes
The device is described as an electrosurgical device intended for various surgical procedures on oral soft tissue, such as incision, excision, ablation, vaporization, and hemostasis, which are therapeutic actions.
No
The Fugo Blade system is intended for surgical procedures such as incision, excision, ablation, vaporization, and hemostasis of oral soft tissue. It is an electrosurgical device that performs therapeutic actions, not diagnostic ones.
No
The device description clearly states it is an electrosurgical device powered by batteries and includes a proprietary electronic network system and a cutting filament, indicating it is a hardware device.
Based on the provided information, the Fugo Blade system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "incision, excision, ablation, vaporization and hemostasis of oral soft tissue". This describes a surgical procedure performed directly on a living patient's tissue.
- Device Description: The description details how the device uses electromagnetic energy to interact with and modify tissue in situ.
- Anatomical Site: The specified anatomical site is "oral soft tissue", which is part of a living organism.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. The Fugo Blade does not perform this function.
The Fugo Blade is an electrosurgical device used for surgical procedures on living tissue, not for testing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
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.
Product codes
EKZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral soft tissue, gingival tissue, gum tissue, unerupted teeth.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical performance data: 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. 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:
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. 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.
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. 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.
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.
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.
Key results: The Fugo Blade for Dentistry is as safe and as effective as the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K000768, K001498, K041019, K050933
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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:
Description of the device (807.92(a)(4))
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
1
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))
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.
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
2
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.
3
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)
C
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.
4
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.
5
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
6
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)
| of Anesthesiology, General Hospital, |
|---|
| Infection Control, Dental Devices |
| 510(k) Number: | K063468 |
|---|---|
| ---------------- | --------- |
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