(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 Periodontal Procedures
- · 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) -
- 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 temperary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
- Pain Therapy
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 Epic 980 uses an Indium Gallium Arsenide (InGaAs) 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.
A visible light is emitted at the same time to visually identify the treatment location. 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.
The provided text describes the 510(k) premarket notification for the Biolase Epic 980 device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for meeting specific acceptance criteria and detailed performance of the subject device itself. Therefore, many of the requested data points (like sample size for test sets, ground truth establishment, MRMC study results, etc.) are not available in this document.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define acceptance criteria as numerical targets for performance metrics in the way one might expect for an AI/ML device. Instead, the "acceptance criteria" are implied by the various tests and standards to which the device was found compliant, demonstrating safety and efficacy primarily through establishing equivalence to predicate devices. The "reported device performance" is mainly a statement of equivalency rather than specific numerical outcomes.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Compliance with ISO 10993-1. Results demonstrate biocompatibility. |
| Electrical Safety | Compliance with IEC 60601-1-2. |
| EMC | Compliance with IEC 60601-1. |
| Laser Safety | Compliance with IEC 60601-2-22 and IEC 60825-1. |
| Dental Equipment Safety | Compliance with IEC 80601-2-60. |
| Usability | Compliance with IEC 60601-1-6. |
| Software Verification & Validation | Compliance with IEC 62304 and FDA guidance document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices." |
| Clinical Performance (Equivalency) | Ex-vivo testing on soft tissue demonstrated performance equivalency to the predicate device leading to the conclusion that clinical testing was not necessary due to no change in intended use/indications. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified for any of the tests.
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as the document does not describe a study involving expert-established ground truth for a test set. The equivalency was based on objective technical standards and ex-vivo testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as the document does not describe a study involving adjudication for a test set.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a laser surgical instrument, not an AI diagnostic or assistance tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this device is a physical laser instrument. The concept of "standalone algorithm only" is not applicable here. Performance was assessed through technical compliance and comparative ex-vivo testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For biocompatibility, the ground truth is established through adherence to ISO 10993-1 biological evaluation methods.
- For electrical safety, EMC, laser safety, dental equipment safety, and usability, the ground truth is established by compliance with the specified IEC standards.
- For the ex-vivo bench testing, the "ground truth" was the performance of the predicate device, against which the subject device was compared for equivalency. The exact metrics for this comparison are not detailed beyond "the results demonstrate equivalency."
8. The sample size for the training set
- Not applicable. This device is a laser hardware system and not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, there is no "training set" for this type of device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.
December 4, 2019
Biolase, Inc. Alicia Mszyca Director, Regulatory Affairs 4 Cromwell Irvine, California 92618
Re: K192430
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, ILY Dated: November 8, 2019 Received: November 8, 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.
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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); 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 medical devices and radiation-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.
Purva Pandya Acting Assistant Director DHT4A: Division of General Surgery Devices OHT5: 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)
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 Periodontal Procedures
- · 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)
-
- 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 temperary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
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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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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: August 30, 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 and in dermatology (21 CFR 878.4810) |
| Device Class: | II |
| Product Code: | GEX, ILY |
III. PREDICATE DEVICE
Epic 10, K121286 Epic Pro, K163128 (reference device) SIROLaser Advance +, K170500 (reference device)
DESCRIPTION OF THE DEVICE SUBJECT TO PREMERKET NOTIFICATION IV.
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 Epic 980 uses an Indium Gallium Arsenide (InGaAs) 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.
A visible light is emitted at the same time to visually identify the treatment location. 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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INDICATIONS FOR USE V.
Epic 980 is indicated for
1. Dental soft tissue indications
Incision, excision, vaporization, ablation, and coagulation of oral soft tissue including marginal and inter-dental gingiva and epithelial lining of free gingiva and the following specific indications:
- Excisional and incisional biopsies o
- Exposure of unerupted teeth O
- Fibroma removal O
- Frenectomy O
- Frenotomy O
- Gingival troughing for crown impressions O
- O Gingivectomy
- Gingivoplasty O
- Gingival incision and excision O
- Hemostasis and coagulation O
- Implant recovery O
- Incisions and draining of abscesses O
- Leukoplakia O
- Operculectomy. O
- Oral papillectomies O
- O Pulpotomy
- Pulpotomy as an adjunct to root canal therapy O
- Reduction of gingival hypertrophy O
- Soft tissue crown lengthening O
- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa O
- Vestibuloplasty O
- O Tissue retraction for impressions
2. Laser Periodontal Procedures
- Laser soft tissue curettage O
- Laser removal of diseased, inflamed and necrosed soft tissue within the O periodontal packet
- sulcular debridement (removal of diseased or inflamed soft tissue in the о periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
3. Whitening
- Laser activation for bleaching materials for teeth whitening o
- о Laser assisted whitening /bleaching of teeth
4. Pain Relief
- Topical heating for the purpose of elevating tissue temperature for a temporary O relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscle back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
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SUMMARY OF SIMILARITIES AND DIFFERENCES VI.
The Epic 980 diode laser is identical to the Epic 10 predicate device except for the diode laser module. The 940nm module used in the Epic 10 is replaced with a 980nm module in the Epic 980. The diode is a component from the same diode family with equivalent operating characteristic that does not impact product safety and efficacy.
In addition, two other reference devices were identified to further support the submission. The devices are SIROLaser Advance + (K170500) manufactured by Dentsply Sirona and Epic Pro (K163128) manufactured by Biolase, Inc.
Both generate infrared laser energy via a solid-state diode laser, operate in a similar manner and have been legally marketed for the same intended use and indications for use as the Epic 980.
Detailed comparison of the intended use. indications for use and design of the Epic 980. and the predicate devices is presented in tables below.
| Subject Device | Primary Predicate | Reference Devices | ||
|---|---|---|---|---|
| Specification | Biolase Inc.Epic 980 | Biolase Inc.Epic 10(K121286) | Biolase Inc.Epic Pro(K163128) | Dentsply SironaSIROLaser Advance +(K170500) |
| Laser source | Diode (InGaAs) | Diode (InGaAs) | Diode | Diode |
| Wavelength | $980 \pm 10 nm$ | $940 \pm 10 nm$ | $980 nm \pm 20 nm$ | $970 nm$$(-10 /+ 15nm)$ |
| Max outputpower | 10 W | 10 W | 25W | 7W |
| Operatingmodes | Continuous,pulse modulation | Continuous,pulse modulation | Pulsed or continuous | Continuous, chopped/peak pulse |
| Repetition Rate(Frequency) | Up to 20 kHz | Up to 20 kHz | Up to 20 kHz | Up to 20 kHz |
| Pulse duration | 0.01 - 20 ms | 0.01 - 20 ms | 50ms - 99.9s | 0.01 - 0.99 s |
| Pulse interval(off timebetween pulses) | 0.04 - 20 ms | 0.04 - 20 ms | N/A | N/A |
| Aiming beam | diode,max 1mW,625 - 670 nm | diode,max 1mW,625 - 670 nm | diode,max 5mW,650nm | diode,max 1mW,$660 \pm 5nm$ |
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| Spot size | ||||
|---|---|---|---|---|
| TipsDeep Tissue HPWhitening HP | 200 – 400 μm30mm diameter35mm x 8mm | 200 – 400 μm30mm diameter35mm x 8mm | 300-400 μm | 200,320 μm |
| Power density | Up to28294W/cm2 | Up to28294W/cm2 | Up to 70736W/cm2 | Up to 44563W/cm2 |
| Control panel | Touch screen | Touch screen | Touch screen | Touch screen |
| Footswitch | Wireless | Wireless | Wireless | Wireless |
| Delivery system | Fiber optic cable,handpiece anddisposable tips | Fiber optic cable,handpiece anddisposable tips | Fiber optic cable,handpiece anddisposable tips | Fiber optic cable,handpiece anddisposable tips |
| Fiber Tips | Quartz single-use tips varyingin length andcore diameter(200 – 400μm) | Quartz single-usetips varying inlength and corediameter(200 – 400μm) | Quartz single-usetips varying inlength and corediameter (300 –400μm) | Single use tips |
| Materials | Medical gradeplastics, steel,stainless steel,aluminum, brass,and electronicparts andcomponents | Medical gradeplastics, steel,stainless steel,aluminum, brass,and electronicparts andcomponents | Medical gradeplastics, steel,stainless steel,aluminum, brass,and electronic partsand components | Medical gradeplastics, steel,stainless steel,aluminum, brass,and electronic partsand components |
Indications for use
| Epic 980 | Epic 10 | Epic Pro | SIROLaser Advance + |
|---|---|---|---|
| (subject device) | (primary predicate) | (reference device) | (reference device) |
| Dental Soft TissueIndicationsIncision, excision,vaporization, ablationand coagulation of oralsoft-tissues includingmarginal and inter-dental gingival andepithelial lining of freegingiva and thefollowing specificindications: | Dental Soft TissueIndicationsIncision, excision,vaporization, ablationand coagulation of oralsoft-tissues includingmarginal and inter-dental gingival andepithelial lining of freegingiva and thefollowing specificindications: | The Epic Pro with dentallaser operation isintended for incision,excision, vaporization,ablation, hemostasis, orcoagulation of intraoraland extra-oral soft tissue(including marginal andinterdental gingiva andepithelial lining of freegingiva); examplesinclude | Intended for intra andextra-oral surgeryincluding incision,excision, hemostasis,coagulation andvaporization of softtissue includingmarginal and inter -dental gingival andepithelial lining of freegingiva and is indicatedfor: |
| excisional and incisionalbiopsies | excisional and incisionalbiopsies | biopsy | biopsy |
| exposure of uneruptedteeth | exposure of uneruptedteeth | exposure of uneruptedteeth /partially eruptedteeth; | exposure ofunerupted/partiallyerupted teeth; |
| fibroma removal | fibroma removal | N/A | fibroma removal |
| frenectomy | frenectomy | frenectomy | frenectomy |
| frenotomy | frenotomy | frenotomy | frenotomy |
| gingival troughing forcrown impressions | gingival troughing forcrown impressions | gingival troughing | gingival troughing |
| gingivectomy | gingivectomy | gingivectomy | gingivectomy |
| gingivoplasty | gingivoplasty | gingivoplasty | gingivoplasty |
| gingival incision andexcision | gingival incision andexcision | N/A | gingival incision andexcision |
| hemostasis andcoagulation | hemostasis andcoagulation | hemostasis of donor site | hemostasis of donor site |
| implant recovery | implant recovery | implant recovery | implant recovery |
| incision and drainage ofabscess | incision and drainage ofabscess | incisions and draining ofabscesses; | incisions and drainingof abscesses; |
| leukoplakia | leukoplakia | leukoplakia | leukoplakia |
| operculectomy | operculectomy | operculectomy | operculectomy |
| oral papillectomies | oral papillectomies | papillectomy | papillectomy |
| pulpotomy | pulpotomy | pulpotomy | pulpotomy |
| pulpotomy as an adjunctto root canal therapy | pulpotomy as an adjunctto root canal therapy | pulpotomy as an adjunctto root canal therapy, | pulpotomy as anadjunct to root canaltherapy |
| reduction of gingivalhypertrophy | reduction of gingivalhypertrophy | N/A | reduction of gingivalhypertrophy |
| soft-tissue crownlengthening | soft-tissue crownlengthening | crown lengthening | crown lengthening |
| treatment of cankersores, herpetic andaphthous ulcers of theoral mucosa | treatment of cankersores, herpetic andaphthous ulcers of theoral mucosa | treatment of aphthousulcers | treatment of cankersores, herpetic andaphthous ulcers of theoral mucosa |
| vestibuloplasty | vestibuloplasty | vestibuloplasty | vestibuloplasty |
| tissue retraction for | tissue retraction for | tissue retraction for | tissue retraction for |
| impression | impression | impressions | impression |
| Laser Periodontal Procedures | |||
| laser soft-tissuecurettage | laser soft-tissuecurettage | N/A | laser soft-tissuecurettage |
| laser removal ofdiseased, infected,inflamed and necrosedsoft-tissue within theperiodontal pocket | laser removal ofdiseased, infected,inflamed and necrosedsoft-tissue within theperiodontal pocket | N/A | laser removal ofdiseased, infected,inflamed and necrosedsoft-tissue within theperiodontal pocket |
| sulcular debridement(removal of diseased,infected, inflamed andnecrosed soft-tissue inthe periodontal pocket toimprove clinical indicesincluding gingival index,gingival bleeding index,probe depth, attachmentloss and tooth mobility) | sulcular debridement(removal of diseased,infected, inflamed andnecrosed soft-tissue inthe periodontal pocket toimprove clinical indicesincluding gingival index,gingival bleeding index,probe depth, attachmentloss and tooth mobility) | sulcular debridement(removal of diseased orinflamed soft tissue inthe periodontal pocket) | sulcular debridement(removal of diseased,infected, inflamed andnecrosed soft-tissue inthe periodontal pocketto improve clinicalindices includinggingival index, gingivalbleeding index, probedepth, attachment loss |
| Whitening | |||
| light activation forbleaching materials forteeth whitening | light activation forbleaching materials forteeth whitening | light activation ofbleaching materials forteeth whitening. | light activation forbleaching materials forteeth whitening |
| laser-assistedwhitening/bleaching ofteeth | laser-assistedwhitening/bleaching ofteeth | N/A | laser-assistedwhitening/bleaching ofteeth |
| Pain Therapy (Low Level laser Therapy) | |||
| Topical heating for thepurpose of elevatingtissue temperature for atemporary relief ofminor muscle and jointpain and stiffness, minorarthritis pain, or musclespasm, minor sprainsand strains, and minormuscular back pain; thetemporary increase in | Topical heating for thepurpose of elevatingtissue temperature for atemporary relief ofminor muscle and jointpain and stiffness, minorarthritis pain, or musclespasm, minor sprainsand strains, and minormuscular back pain; thetemporary increase in | N/A | Intended to emit energyin the red and infraredspectrum to providetopical heating for thepurpose of elevatingtissue temperature forthe temporary relief ofminor muscle and jointpain and stiffness,minor arthritis pain, ormuscle spasm and for |
| local blood circulation;the temporary relaxationof muscle. | local blood circulation;the temporary relaxationof muscle. | the temporary increasein local bloodcirculation and/ortemporary relaxation ofmuscle. |
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VII. PERFORMANCE DATA
The following information was provided to support the submission:
Biocompatibility Testing
The biocompatibility evaluation of the modified device was conducted in accordance with ISO 10993-1 Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing within a Risk Management Process
The results demonstrate biocompatibility of the device and its accessories.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and electromagnetic compatibility testing conducted according to the current revisions of recognized standards demonstrate compliance with the standards:
- IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for ● safety -electromagnetic compatibility (EMC)- requirements and tests.
- IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
- IEC 60601-2-22: 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: Safety of Laser Products Part 1: Equipment classification and ● requirements.
- IEC 80601-2-60: Medical electrical equipment Part 2-60: Particular requirements ● for the basic safety and essential performance of dental equipment.
- . IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance -collateral standard: usability
Software Verification and Validation
Software contained in the Epic 980 was developed in accordance with IEC 62304. Software verification and validation testing were performed, and documentation provided in accordance with the FDA guidance document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices".
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Bench Testing
Ex-vivo testing was conducted on soft tissue to compare performance of the subject device to its predicate. The results demonstrate equivalency.
Clinical Testing
Clinical testing was not performed since there was no change to the intended use and indications for use and the performance characteristics between the subject device and its predicate is equivalent.
VIII. CONCLUSION
Comparison of the Epic 980 subject device with Epic 10 primary predicate (K121286), and two additional reference devices Epic Pro (K163128) and SIROLaser Advance+ (K170500), demonstrates the safety and effectiveness of the Epic 980 and supports substantial equivalence to the identified legally-marketed devices.
§ 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.