(90 days)
Dental Soft Tissue Indications
Incision, excision, vaporization, ablation of oral soft-tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:
- · Excisional and incisional biopsies
- · Exposure of unerupted teeth
- Fibroma removal
- · Frenectomy
- · Frenotomy
- · Gingival troughing for crown impressions
- · Gingivectomy
- · Gingivoplasty
- · Gingival incision and excision
- Hemostasis and coagulation
- · 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
- · Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
- · Vestibuloplasty
- · Tissue retraction for impression
- · Laser soft-tissue curettage
- · Laser removal of diseased, inflamed and necrosed soft-tissue within the periodontal pocket
· Sulcular debridement (removal of diseased, inflamed and necrosed soft-tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility)
-
· Reduction of bacterial level (decontamination) and inflammation
• Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium -
· Lesion (tumor) removal
-
· Removal of hyperplastic tissues
-
· Laser assisted flap surgery
-
· Removal of granulation tissue
Whitening
- · Light activation for bleaching materials for teeth whitening
- · Laser-assisted whitening/bleaching of teeth
Pain Therapy
· Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
The Epic 980 diode laser is a surgical and therapeutic device designated for a wide variety of oral soft-tissue procedures and dental whitening as well as for use in providing a temporary relief of minor pain.
The device uses a solid-state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a handpiece that emits the energy to the treatment site.
The laser is comprised of a base console, a wireless footswitch which activates the laser and a detachable delivery system consisting of a fiber optic cable, surgical handpiece and single-use disposable tips designed and optimized for different applications.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Biolase Epic 980 device.
This document describes a 510(k) premarket notification for the Biolase Epic 980, which is primarily a regulatory submission demonstrating substantial equivalence to already cleared predicate devices. As such, it relies heavily on the equivalence of the device's technical characteristics and previously cleared indications for use rather than new, extensive performance studies for the expanded indications.
Therefore, the information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial with specific performance metrics is limited. Instead, the "acceptance criteria" here are implicitly met by demonstrating substantial equivalence to the predicate devices, and the "study" is largely a comparison of specifications and previously cleared uses.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a substantial equivalence submission, explicit "acceptance criteria" for the expanded indications are not defined in terms of performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the criterion for acceptance is that the device's technological characteristics and proposed expanded indications for use are substantially equivalent to those of legally marketed predicate devices, and these expanded indications have already been cleared.
The "reported device performance" is essentially that the Epic 980 shares the same core technological characteristics as the predicates and that, where parameters differ (like maximum power output), these differences do not lead to significantly different clinical performance for the specified indications.
| Acceptance Criteria (Implicit for Substantial Equivalence to Predicates) | Reported Device Performance (Comparison with Predicates) |
|---|---|
| Same laser source type | Solid state diode laser |
| Same wavelength | 980 ± 10 nm |
| Same intended use area (oral soft tissue) | Incision, excision, vaporization, ablation, and coagulation of oral soft-tissues. |
| Same core indications for use (dental soft tissue, whitening, pain therapy) | Listed expanded indications are already cleared for predicate devices. |
| Similar design, delivery system, and control mechanism | Software-operated portable laser unit, footswitch activated, fiber optic cable, handpiece, single-use disposable tips. |
| Compliance with relevant electrical safety and EMC standards | Complies with IEC 60601-1-2:2014, IEC 60601-1:2012, IEC 60601-2-22:2007+A1:2012, IEC 60825-1:2014, IEC 80601-2-60:2012. |
| Software developed, tested, and documented per standards | Developed, tested, and documented in accordance with IEC 62304:2015 and FDA guidance. |
| Biocompatibility and sterilization unchanged from predicate | Patient-contacting accessories remain the same as previously cleared (K192430). |
| Maximum power settings for expanded indications do not exceed predicate device capabilities | Although Epic 980 capable of 10W, settings for expanded indications do not exceed 1W, which falls under maximum power of K103753 and K152032. |
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states: "Since the expanded indications for use have been already cleared for equivalent devices, therefore any additional clinical and/or performance testing was not required."
This indicates that there was no new "test set" or study involving human subjects or specific performance data generated for this submission to prove the expanded indications. The "data provenance" for the original clearances of the predicate devices' expanded indications would be where this information implicitly lies, but it is not provided in this document. This submission relies on the existing clearances of the predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Given the statement in point 2, there was no new test set and therefore no new "ground truth" established for this specific submission. The reliance is on the regulatory history and clearances of the predicate devices, which would have had their own evidence for their respective indications.
4. Adjudication Method for the Test Set
As there was no new test set for this submission, there was no adjudication method applied.
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
This is a laser surgical instrument, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study was not applicable and not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The Epic 980 is a physical laser device operated by a human. It is not a standalone algorithm. Therefore, no standalone (algorithm only) performance study was conducted.
7. The Type of Ground Truth Used
For this specific 510(k) submission, the "ground truth" for the expanded indications relies on the prior regulatory clearances of the predicate devices for those indications. The FDA deemed those predicate devices safe and effective for those uses based on their own submissions, which may have included clinical data, pre-clinical studies, and expert consensus at the time of their clearance.
8. The Sample Size for the Training Set
This document does not describe the development or training of a software algorithm that would typically require a "training set." While the device has software, it's for control and functionality, not for "learning" or "decision-making" in the sense of AI. Therefore, a "training set" in the context of an AI/machine learning algorithm is not applicable to this submission. Software verification and validation were performed as per IEC 62304:2015.
9. How the Ground Truth for the Training Set Was Established
Given that a "training set" in the AI/ML context is not applicable, the method for establishing its "ground truth" is also not applicable. The software's performance was validated against its specifications and intended functions.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Biolase, Inc Alicia Mszyca Director, Regulatory Affairs 4 Cromwell Irvine, California 92618
Re: K193486
Trade/Device Name: Epic 980 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: December 13, 2019 Received: December 17, 2019
Dear Alicia Mszyca:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Mavadia-Shukla, Ph.D. Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193486
Device Name Epic 980
Indications for Use (Describe)
Dental Soft Tissue Indications
Incision, excision, vaporization, ablation of oral soft-tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:
- · Excisional and incisional biopsies
- · Exposure of unerupted teeth
- Fibroma removal
- · Frenectomy
- · Frenotomy
- · Gingival troughing for crown impressions
- · Gingivectomy
- · Gingivoplasty
- · Gingival incision and excision
- Hemostasis and coagulation
- · 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
- · Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
- · Vestibuloplasty
- · Tissue retraction for impression
- · Laser soft-tissue curettage
- · Laser removal of diseased, inflamed and necrosed soft-tissue within the periodontal pocket
· Sulcular debridement (removal of diseased, inflamed and necrosed soft-tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility)
-
· Reduction of bacterial level (decontamination) and inflammation
• Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium -
· Lesion (tumor) removal
-
· Removal of hyperplastic tissues
-
· Laser assisted flap surgery
-
· Removal of granulation tissue
Whitening
- · Light activation for bleaching materials for teeth whitening
- · Laser-assisted whitening/bleaching of teeth
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Pain Therapy
· Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
Type of Use (Select one or both, as applicable)
| ✖ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
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Image /page/4/Picture/1 description: The image shows the word "BIOLASE" in a bold, sans-serif font. The word is all capitalized and is a dark blue color. The background is white, which makes the word stand out.
510(k) SUMMARY
I. SUBMITTER
Biolase, Inc. 4 Cromwell Irvine, CA 92618 USA Tel: (949) 226-8471 Fax: (949) 273-6688 Contact Person: Alicia Mszyca Date Prepared: December 13, 2019
II. DEVICE
| Name of Device: | Epic 980 |
|---|---|
| Common Name: | Dental Diode Laser |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery andin dermatology (21 CFR 878.4810) |
| Device Class: | II |
| Product Code: | GEX |
III. PREDICATE DEVICES
Epic 980 (K192430) QuickLase 980, 810 & Dual (K100474) SIROLase Advance (K103753) Elumi 810+980 (K152032) Curative980 Diode Laser (K082445)
IV. DEVICE DESCRIPTION
The Epic 980 diode laser is a surgical and therapeutic device designated for a wide variety of oral soft-tissue procedures and dental whitening as well as for use in providing a temporary relief of minor pain.
The device uses a solid-state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a handpiece that emits the energy to the treatment site.
The laser is comprised of a base console, a wireless footswitch which activates the laser and a detachable delivery system consisting of a fiber optic cable, surgical handpiece and single-use disposable tips designed and optimized for different applications.
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V. INDICATIONS FOR USE STATEMENT
Dental Soft Tissue Indications
Incision, excision, vaporization, ablation and coagulation of oral soft-tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:
- Excisional and incisional biopsies
- Exposure of unerupted teeth ●
- Fibroma removal ●
- Frenectomy
- Frenotomv
- Gingival troughing for crown impressions ●
- Gingivectomy
- Gingivoplasty
- Gingival incision and excision
- Hemostasis and coagulation
- 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
- . Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
- Vestibuloplasty
- Tissue retraction for impression
- Laser soft-tissue curettage
- Laser removal of diseased, inflamed and necrosed soft-tissue within the periodontal pocket
- Sulcular debridement (removal of diseased, inflamed and necrosed soft-tissue ● in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
- Reduction of bacterial level (decontamination) and inflammation ●
- Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium
- Lesion (tumor) removal
- Removal of hyperplastic tissues ●
- Laser assisted flap surgery
- Removal of granulation tissue
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Image /page/6/Picture/0 description: The image shows the word "BIOLASE" in all capital letters. The word is written in a bold, sans-serif font. The color of the text is a dark blue.
Whitening
- · Light activation for bleaching materials for teeth whitening
- · Laser-assisted whitening/bleaching of teeth
Pain Therapy
- · Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS VI.
The Epic 980 subject device is the same as Epic 980 (K192430) except for the expanded indications for use already cleared for devices: Ouicklase 810, 980, Dual + (K100474) by QuickLase Limited, SIROLaser Advance (K103753) by Sirona, Elumi 810 + 980 (K152032) by Azena Medical, LLC and Curative980 (K082445) by OroScience, Inc.
The Epic 980 shares the same technological characteristic as the predicate devices including:
- the same laser source: solid state diode producing invisible infrared energy
- the same wavelength: 980nm
- the same intended use: incision, excision, vaporization, ablation and coagulation of ● oral soft tissue
- the same indications for use
- . the same patient-contacting components: glass fiber used in contact and non-contact mode the same use environment
- the same tissue type and application regimen
- the same principle of operation and emission mode: continuous wave, pulsed or . both the same control mechanism
- similar design consisting of software-operated portable laser unit, initiated by a ● footswitch similar delivery system comprising of an optical fiber, handpiece and single use disposable tips
- . the same human factors of user interface
Although some parameters such as maximum power output, power density, pulse rate differ among the devices, these differences do not result is a significantly different clinical performance since the settings and used for the expanded indications as well as the treatment regimen are essentially the same. Therefore, the consolidation of clinical applications creates no new risks or safety concerns.
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Companson of the technological characteristics, intended use, indications for use of the Epic 980 subject and predicate devices:
| Subject Device | Predicate Devices | Reference Device | Pulse duration | 0.01 - 20 ms | 0.01 - 20 ms | 50, 30, 10ms | 0.01 – 0.99 s | variable | unknown | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specification | Biolase Inc.Epic 980 | Biolase, Inc.Epic 980(K192430) | QuickLase LimitedQuickLase 980, 810and Dual+(K100474) | SironaSIROLaser Advance(K103753) | Azena Medical,LLCElumi 810 + 980(K152032) | OroScience, Inc.Curative980 DiodeLaser (K082445) | Spot size tips | 200 – 400 μm | 200 – 400 μm | 400 μm | 200 - 320 μm | 400 μm | unknown |
| Laser medium | Solid state diodelaser | Solid state diodelaser | Solid state diodelaser | Solid state diodelaser | Solid state diodelaser | Solid state diodelaser | Power density | Up to28294W/cm² | Up to28294W/cm² | Up to15915W/cm² | Up to44563W/cm² | Up to3138W/cm² | unknown |
| Wavelength | 980 ±10 nm | 980 ±10 nm | 980 ± 10 nm, or810 ± 10nm, ordual (810+980) | 970 ± 15nm | 980 ±10 nm, or810 ± 10nm, ordual (810+980) | 980 ± 10 nm | Aiming beam | diodemax 1mW625 - 670 nm | diodemax 1mW625 - 670 nm | diodemax 5mW640 - 650nm | diode,max 1mW635 - 650nm | diodemax 5mW640 - 660nm | diode650nm |
| The devices cleared under K100474 and K152032 operate in 3 different wavelengths: 980nm alone, 810nmalone and dual (810+980nm). Biolase is claiming equivalence to the 980 nm version only.Therefore, substantially equivalent. | Control panel | Touch screen | Touch screen | Touch screen | Touch screen | Touch screen | Touch screen | ||||||
| Operatingmodes | Continuous,pulsed | Continuous,pulsed | Continuous,pulsed | Continuous,chopped(pulsed),peak pulse | Pulsed | Continuous,pulsed | Activation | Footswitch | Footswitch | Footswitch | Footswitch | Footswitch | Footswitch |
| Max Power(CW) | 10 W | 10 W | 10W | 7W | 2W | 10 W | Deliverysystem | Fiber optic cable,handpiece anddisposable tips | Fiber optic cable,handpiece anddisposable tips | Quarts glass fiber | Fiber optic cable,handpiece anddisposable tips | Quartz glass fiberand tips, handpieceand disposable tips | Optical fibers,handpieces anddisposable tips |
| Although Epic 980 is capable of reaching 10W max power, the power settings used for all expanded indications donot exceed 1W, which is sufficient for effective performance and also falls under the maximum power of devicescleared under K103753 and K152032. Therefore, substantially equivalent. | Fiber Tips | Quartz single-usetips varying inlength and corediameter(200 - 400μm) | Quartz single-usetips varying inlength and corediameter(200 - 400μm) | Fiber(400μm) | Single use tipsvarying in corediameter(200 - 320 μm) | Quarts tips (400μm) | Single use tips | ||||||
| Max PeakPower | 10 W | 10 W | 10W @980, or10W @810, or20W @ dual | 14W | 10W @980, or10W @810, or20W @ dual | unknown | Materials | Medical gradeplastics, stainlesssteel, aluminum,brass, andelectronic partsand components | Medical gradeplastics, stainlesssteel, aluminum,brass, andelectronic partsand components | Medical gradeplastics, stainlesssteel, and electronicparts andcomponents | Medical gradeplastics, stainlesssteel, and electronicparts andcomponents | Medical gradeplastics, stainlesssteel, and electronicparts andcomponents | Medical gradeplastics, stainlesssteel, and electronicparts andcomponents |
| Repetition rate(Frequency) | Up to 20 kHz | Up to 20 kHz | Up to 20 kHz | Up to 20 kHz | 50 Hz | unknown |
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Intended use and Indications for Use
| Epic 980(subject device) | Epic 980K192430 | QuickLase 810,980 &Dual+K100474 | SiroLaser AdvanceK103753 | Elumi 810 + 980K152032 | Curative 980K082445 |
|---|---|---|---|---|---|
| Dental soft tissueindications:incision, excision,vaporization, ablationand coagulation of oralsoft-tissues includingmarginal and inter-dental gingival andepithelial lining of freegingiva and thefollowing specificindications: | Dental soft tissueindications:Incision, excision,vaporization, ablationand coagulation of oralsoft-tissues includingmarginal and inter-dental gingival andepithelial lining of freegingiva and thefollowing specificindications: | Intended forincision, excision,vaporization,hemostasis andtreatment of oral soft-tissue.Examples: | Indicated for intra andextraoral surgeryincluding incision.excision, hemostasis,coagulation andvaporization of soft-tissues includingmarginal and inter-dental gingival andepithelial lining of freegingiva and is indicatedfor: | Soft tissue laserintended for theincision, excision,vaporization,hemostasis andtreatment of oral soft-tissues. the followingare the oropharyngealindications for use: | Indicated forincision, excision,vaporization, ablationand coagulation of oralsoft-tissues (intraoraland extraoral) includingmarginal and inter-dental gingival andepithelial lining of freegingiva and thefollowing specificindications: |
| excisional andincisional biopsies | excisional andincisional biopsies | excisional andincisional biopsies | biopsies | excisional andincisional biopsies | excisional andincisional biopsies |
| exposure of uneruptedteeth | exposure of uneruptedteeth | exposure of uneruptedteeth | exposure of unerupted/partially erupted teeth | exposure of uneruptedteeth | exposure of unerupted/partially erupted teeth |
| fibroma removal | fibroma removal | fibroma removal | fibroma removal | fibroma removal | fibroma removal |
| frenectomy | frenectomy | frenectomy | frenectomy | frenectomy | frenectomy |
| frenotomy | frenotomy | frenotomy | frenotomy | frenotomy | frenotomy |
| gingival troughing forcrown impressions | gingival troughing forcrown impressions | gingival troughing forcrown impressions | gingival troughing | gingival troughing forcrown impressions | gingival troughing forcrown impressions |
| gingivectomy | gingivectomy | gingivectomy | gingivectomy | gingivectomy | gingivectomy |
| gingivoplasty | gingivoplasty | gingivoplasty | gingivoplasty | gingivoplasty | gingivoplasty |
| gingival incision and | gingival incision and | gingival incision and | gingival incision and | gingival incision and | gingival incision and |
| excision | excision | excision | excision | excision | excision |
| hemostasis and | hemostasis and | hemostasis and | hemostasis of donor | hemostasis and | hemostasis and |
| coagulation | coagulation | coagulation | site | coagulation | coagulation |
| implant recovery | implant recovery | implant recovery | implant recovery | implant recovery | implant recovery |
| incision and drainage of | incision and drainage of | incision and drainage of | incision and drainage of | incision and drainage of | incision and drainage of |
| abscess | abscess | abscess | abscess | abscess | abscess |
| leukoplakia | leukoplakia | leukoplakia | leukoplakia | leukoplakia | leukoplakia |
| operculectomy | operculectomy | operculectomy | operculectomy | operculectomy | operculectomy |
| oral papillectomies | oral papillectomies | oral papillectomies | papillectomy | oral papillectomies | oral papillectomies |
| pulpotomy | pulpotomy | pulpotomy | pulpotomy | pulpotomy | pulpotomy |
| pulpotomy as an | pulpotomy as an | pulpotomy as an | pulpotomy as an | pulpotomy as an | pulpotomy as an |
| adjunct to root canal | adjunct to root canal | adjunct to root canal | adjunct to root canal | adjunct to root canal | adjunct to root canal |
| therapy | therapy | therapy | therapy | therapy | therapy |
| reduction of gingival | reduction of gingival | reduction of gingival | reduction of gingival | reduction of gingival | reduction of gingival |
| hypertrophy | hypertrophy | hypertrophy | hypertrophy | hypertrophy | hypertrophy |
| soft-tissue crown | soft-tissue crown | soft-tissue crown | crown lengthening | soft-tissue crown | soft-tissue crown |
| lengthening | lengthening | lengthening | lengthening | lengthening | |
| treatment of canker | treatment of canker | treatment of canker | treatment of canker | treatment of canker | treatment of canker |
| sores, herpetic and | sores, herpetic and | sores, herpetic and | sores, herpetic and | sores, herpetic and | sores, herpetic and |
| aphthous ulcers of the | aphthous ulcers of the | aphthous ulcers of the | aphthous ulcers of the | aphthous ulcers of the | aphthous ulcers of the |
| oral mucosa | oral mucosa | oral mucosa | oral mucosa | oral mucosa | oral mucosa |
| vestibuloplasty | vestibuloplasty | vestibuloplasty | vestibuloplasty | vestibuloplasty | vestibuloplasty |
| tissue retraction forimpression | tissue retraction forimpression | tissue retraction forimpression | tissue retraction forimpression | tissue retraction forimpression | tissue retraction forimpression |
| laser soft-tissue | laser soft-tissue | laser soft-tissue | laser soft-tissue | laser soft-tissue | laser soft-tissue |
| curettage | curettage | curettage | curettage | curettage | curettage |
| laser removal of | laser removal of | laser removal of | NA | laser removal of | NA |
| diseased, infected, | diseased, infected, | diseased, infected, | diseased, infected, | diseased, infected, | |
| inflamed and necrosed | inflamed and necrosed | inflamed and necrosed | inflamed and necrosed | inflamed and necrosed | |
| soft-tissue within the | soft-tissue within the | soft-tissue within the | soft-tissue within the | soft-tissue within the | |
| periodontal pocket | periodontal pocket | periodontal pocket | periodontal pocket | ||
| sulcular debridement | sulcular debridement | sulcular debridement | sulcular debridement | sulcular debridement | sulcular debridement |
| (removal of diseased, | (removal of diseased, | (removal of diseased, | (removal of diseased, | (removal of diseased, | (removal of diseased, |
| infected, inflamed and | infected, inflamed and | infected, inflamed and | infected, inflamed and | infected, inflamed and | infected, inflamed and |
| necrosed soft-tissue in | necrosed soft-tissue in | necrosed soft-tissue in | necrosed soft-tissue in | necrosed soft-tissue in | necrosed soft-tissue in |
| the periodontal pocket | the periodontal pocket | the periodontal pocket | the periodontal pocket | the periodontal pocket | |
| to improve clinical | to improve clinical | to improve clinical | to improve clinical | to improve clinical | |
| indices including | indices including | indices including | indices including | indices including | |
| gingival index, gingival | gingival index, gingival | gingival index, gingival | gingival index, gingival | gingival index, gingival | |
| bleeding index, probe | bleeding index, probe | bleeding index, probe | bleeding index, probe | bleeding index, probe | |
| depth, attachment loss | depth, attachment loss | depth, attachment loss | depth, attachment loss | depth, attachment loss | |
| and tooth mobility) | and tooth mobility) | and tooth mobility) | and tooth mobility) | and tooth mobility) | |
| light activation for | light activation for | light activation for | NA | light activation for | light activation for |
| bleaching materials for | bleaching materials for | bleaching materials for | bleaching materials for | bleaching materials for | |
| teeth whitening | teeth whitening | teeth whitening | teeth whitening | teeth whitening | |
| laser-assisted | laser-assisted | laser-assisted | NA | laser-assisted | laser-assisted |
| whitening/bleaching of | whitening/bleaching of | whitening/bleaching of | whitening/bleaching of | whitening/bleaching of | |
| teeth | teeth | teeth | teeth | teeth | |
| topical heating for thepurpose of elevatingtissue temperature for atemporary relief ofminor muscle and jointpain and stiffness,minor arthritis pain, ormuscle spasm, minorsprains and strains, andminor muscular backpain; the temporaryincrease in local blood | topical heating for thepurpose of elevatingtissue temperature for atemporary relief ofminor muscle and jointpain and stiffness,minor arthritis pain, ormuscle spasm, minorsprains and strains, andminor muscular backpain; the temporaryincrease in local blood | NA | NA | NA | topical heating for thepurpose of elevatingtissue temperature for atemporary relief ofminor muscle and jointpain and stiffness,minor arthritis pain, ormuscle spasm, minorsprains and strains, andminor muscular backpain; the temporaryincrease in local blood |
| circulation; thetemporary relaxation ofmuscle. | circulation; thetemporary relaxation ofmuscle. | circulation; thetemporary relaxation ofmuscle. | circulation; thetemporary relaxation ofmuscle. | ||
| Reduction of bacteriallevel(decontamination)and inflammation | NA | Reduction of bacteriallevel (decontamination)and inflammation | NA | Reduction of bacteriallevel (decontamination)and inflammation | Reduction of bacteriallevel (decontamination)and inflammation |
| Removal of highlyinflamed edematoustissue affected bybacteria penetration ofthe pocket lining andjunctional epithelium | NA | Removal of highlyinflamed edematoustissue affected bybacteria penetration ofthe pocket lining andjunctional epithelium | NA | Removal of highlyinflamed edematoustissue affected bybacteria penetration ofthe pocket lining andjunctional epithelium | NA |
| Lesion (tumor) removal | NA | Lesion (tumor) removal | NA | Lesion (tumor) removal | NA |
| Laser assisted flapsurgery | NA | NA | Laser assisted flapsurgery | NA | Laser assisted flapsurgery |
| Removal of granulationtissue | NA | NA | Removal of granulationtissue | NA | Removal of granulationtissue |
| Removal ofhyperplastic tissues | NA | NA | Removal ofhyperplastic tissues | NA | NA |
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VII. PERFORMANCE DATA
Clinical and Bench Testing
Since the expanded indications for use have been already cleared for equivalent devices, therefore any additional clinical and/or performance testing was not required.
Biocompatibility and Sterilization Testing
No new biocompatibility and sterilization testing were performed. All patient-contacting accessories remain the same as previously cleared under K192430.
Electrical Safety and Electromagnetic Compatibility (EMC)
All relevant electrical safety and EMC testing have been conducted in accordance with current recognized standards. The Epic 980 diode laser complies with the requirements.
IEC 60601-1-2:2014 Medical electrical equipment- Part 1-2- electromagnetic compatibility (EMC)
IEC 60601-1:2012
Medical electrical equipment - Part 1: general requirements for basic safety and essential performance
IEC 60601-2-22:2007+ A1:2012
Medical electrical equipment- Part 2-22: particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60825-1:2014
Safety of laser products- Part 1: equipment classification and requirements
IEC 80601-2-60:2012
Medical electrical equipment - Part 2-60: particular requirements for the basic safety and essential performance of dental equipment
Software Verification and Validation
Software contained in Epic 980 was developed, tested and documented in accordance with IEC 62304:2015 – Medical Device Software - Software Lifecycle and the FDA guidance document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices". Verification and validation testing demonstrate performance according to specifications and functions intended.
VIII. CONCLUSION
Comparison of the Epic 980 subject device with the predicate devices demonstrate substantial equivalence in technological and performance characteristics and supports the safety and effectiveness of the Epic 980 for the stated indications for use.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.