Ablation of hard tissue for caries removal and cavity preparation
Incision, Excision, Vaporization, Coagulation and Hemostasis of soft tissue in the oral cavity
Cutting, shaving, contouring and resection of oral osseous tissue (bone)

Device Description

The Solea system is a dental laser device previously cleared by the FDA for soft tissue dental indications (K123494) and hard tissue indications (K130420). The only changes from the previously cleared device are the addition of the osseous tissue indications. There have been no software changes or graphic changes to the Solea system. The osseous tissue settings are the same as the previously cleared device (K130420). The osseous settings have substantially equivalent fluence and irradiation as the hard tissue predicate devices. There are no other hardware or software changes to the Solea system device pending herein when compared to the device cleared under K123494 and K130420.

The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy to cut and ablate hard tissue and to cut soft tissue in the oral cavity. The Solea system utilizes advanced CO2 laser technology with a wavelength of 9.25μm to safely and effectively perform ablation, incision, excision, vaporization, coagulation and hemostasis procedures.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study that directly proves the device meets specific acceptance criteria in a quantitative manner as typically expected for assessing diagnostic accuracy (e.g., sensitivity, specificity).

However, it outlines a series of non-clinical tests that demonstrate the device's substantial equivalence to predicate devices in terms of safety and performance, indirectly serving as "acceptance criteria" for regulatory clearance. Since no clinical testing was performed or required due to substantial equivalence, metrics like sensitivity, specificity, or reader improvement with AI assistance are not applicable in this context.

Here's an interpretation of the non-clinical testing and how it relates to acceptance criteria fulfillment:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Electrical Safety (compliance with IEC 60601-1)	The system passed electrical safety testing in accordance with requirements for IEC 60601-1.
Electromagnetic Compatibility (EMC) (compliance with IEC 60601-1-2)	The system passed electromagnetic compatibility (EMC) testing to meet requirements for IEC 60601-1-2.
Laser Safety (compliance with IEC 60601-2-22 and IEC 60825-1)	The system passed particular requirements for IEC 60601-2-22 and IEC 60825-1 for the safety of diagnostic and therapeutic laser equipment.
Cleaning and Sterilization (Sterility Assurance Level (SAL) of at least 10^-6, conventional autoclave cycles qualified to ANSI/AAMI ST79)	The handpieces of the Solea system passed cleaning and sterilization validations for reusable medical devices based on the overkill approach to demonstrate sterilization cycle lethality as described in AAMI TIR12 to achieve a Sterility Assurance Level (SAL) of at least 10^-6<. The Solea system handpieces are designed for sterilization by exposure to moist heat under conventional autoclave cycles qualified to ANSI/AAMI ST79.
Software Verification and Validation	Verification and validation testing was conducted on the Solea software. All tests were completed successfully with respect to stated pass/fail criteria thereby deeming the device and software appropriate for its intended use.
Usability (as described in IEC 62366, acceptance criteria for user design validation met)	Usability testing was conducted on the Solea system as described in IEC 62366. Based on the participant feedback and ratings of usability of the Solea system, all of the acceptance criteria for the user design validation have been met for the intended use.
Hard Tissue Performance (Thermal Effects) (substantially equivalent results to predicate systems)	Performance data was collected from Bench Testing for hard tissue. Results show that hard tissue thermal effects are equivalent. The results show substantially equivalent results for the Solea system and predicate systems. This implies that the thermal effects caused by the Solea system on hard tissue are within acceptable limits and comparable to those of already approved predicate devices.
Overall Design, Biocompatibility	The document states, "The Solea system meets all the requirements for overall design, sterilization, biocompatibility, and electrical safety." While detailed results are not provided for overall design and biocompatibility in the same way as other tests, the statement indicates these requirements were met.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: The document does not provide specific sample sizes (e.g., number of handpieces for sterilization, number of samples for hard tissue testing, number of participants for usability). It generally describes "testing."
Data Provenance: The testing was "non-clinical testing" and "bench testing." This implies laboratory or simulated environments, rather than human clinical data. The country of origin for the data is not specified, but the submission is to the U.S. FDA, suggesting the testing was conducted under standards acceptable for U.S. regulatory review. The data is retrospective in the sense that it's reported after the tests were performed to support the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable to the non-clinical testing described. The "ground truth" for these tests are objective measurements against established engineering, safety, and performance standards (e.g., IEC standards for electrical safety, AAMI standards for sterilization validation). Expert consensus or qualifications for ground truth establishment are not relevant for these types of tests.

4. Adjudication method for the test set

Not applicable. Testing against objective engineering and safety standards typically involves direct measurement and comparison to pass/fail criteria, not consensus-based adjudication as would be used for image interpretation.

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

Not applicable. The Solea system is a dental laser device for ablation, incision, excision, etc., not an AI-assisted diagnostic imaging device. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. The Solea system is a physical device used by a human operator, not a standalone algorithm.

7. The type of ground truth used

The "ground truth" for the non-clinical tests were:

Established engineering standards and regulatory requirements: For electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and laser safety (IEC 60601-2-22, IEC 60825-1).
Established sterilization validation protocols: For cleaning and sterilization (AAMI TIR12, ANSI/AAMI ST79).
Software verification and validation criteria: For software performance.
Usability evaluation criteria: For usability (IEC 62366), presumably objective metrics and participant feedback aligned with the standard.
Comparative performance data against predicate devices: For hard tissue performance (thermal effects were shown to be "substantially equivalent" to predicate systems).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set mentioned or implied for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized human figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Convergent Dental Incorporated % Ms. Carrie Hetrick Emergo 816 Congress Avenue, Suite 1400 Austin, Texas 78701

September 23, 2015

Re: K151306 Trade/Device Name: Solea 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: May 14, 2015 Received: May 18, 2015

Dear Ms. Hetrick:

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. 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 801); medical device reporting of medical device

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related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Joshua C. Nipper -S

For I

Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151306

Device Name Solea

Indications for Use (Describe)

The Solea system is indicated for the following:

Ablation of hard tissue for caries removal and cavity preparation
Incision, Excision, Vaporization, Coagulation and Hemostasis of soft tissue in the oral cavity
Cutting, shaving, contouring and resection of oral osseous tissue (bone)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

for

Solea

1. Submission Sponsor

Convergent Dental, Inc. 2 Vision Drive Natick, MA 01760 USA Phone: (508) 500.5656 Contact: Mike Manor, Director QA/RA

2. Submission Correspondent

Emergo 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (720) 838.4113 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Carrie Hetrick, Senior Consultant, RA Email: project.management@emergogroup.com

3. Date Prepared

August 14, 2015

4. Device Identification

Trade/Proprietary Name:	Solea
Common/Usual Name:	Powered laser surgical instrument
Classification Name:	Laser surgical instrument for use in general and plastic surgeryand dermatology
Classification Regulation:	21 CFR §878.4810
Product Code:	GEX
Device Class:	Class II
Classification Panel:	General and Plastic Surgery

5. Legally Marketed Predicate Device(s)

Convergent Dental, Inc., Solea, 510(k) Numbers: K123494, K130420 Biolase Technology, Inc., Waterlase MD, 510(k) Number: K091746 Fotona d.d., LightWalker Laser System, 510(k) Number: K101817

6. Device Description

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7. Indication for Use Statement

The Solea system is indicated for the following:

। Ablation of hard tissue for caries removal and cavity preparation
Incision, Excision, Vaporization, Coagulation and Hemostasis of soft tissue in the oral ၊ cavity
-Cutting, shaving, contouring and resection of oral osseous tissue (bone)

8. Substantial Equivalence Discussion

The following table compares the Solea to the predicate devices with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

The Convergent Dental, Inc. Solea system is a dental laser previously cleared by the FDA for hard tissue indications (K130420) and soft tissue indications (123494).

The Solea system included herein is the same device that was previously cleared by the FDA in K130420 (Solea, expanded hard tissue indications) and K123494 (Solea®, indications for soft tissue indications). There are no unique applications, materials or specifications presented herein. All the presented indications for use retain the same meaning as their equivalent indications cleared by the FDA.

The subject Solea system is substantially equivalent to the Biolase Technology, Inc. Waterlase MD (K091746) and the Fotona d.d., LightWalker Laser System (K101817) for the osseous tissue indications in terms of fluence, measured comparative performance data, and all features that affect safety or effectiveness.

The following table compares the subject Convergent Dental, Inc. Solea system to the Biolase Technology Inc. Waterlase MD, Fotona d.d. LightWalker Laser System Family, and the previously cleared Solea systems, with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence for intended uses.

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	ConvergentDental, Inc.	ConvergentDental, Inc.	ConvergentDental, Inc.	BiolaseTechnology, Inc.	Fotona d.d.
Trade Name	Solea	Solea	Solea	Waterlase® MD	LightWalkerLaser SystemFamily
510(k)Number	K152306	K130420	K123494	K091746	K101817
Commonname	PoweredLaser surgicalinstrument	PoweredLaser surgicalinstrument	PoweredLaser surgicalinstrument	Powered Lasersurgicalinstrument	Powered Lasersurgicalinstrument
FDAClassificationNames	PoweredLaser surgicalinstrument	PoweredLaser surgicalinstrument	PoweredLaser surgicalinstrument	Powered LasersurgicalinstrumentDrill, bone,poweredSystem, Dental,Hydrokinetic,Carries Removal& CavityPreparation	Powered Lasersurgicalinstrument
FDAClassificationcodes	GEX, a ClassII device	GEX, a ClassII device	GEX, a Class IIdevice	GEX, MXF, DZI, aClass II device	GEX, a Class IIdevice
Predicatescited	K130420 andK123494 forhard and softtissueindicationsK091746,K101817 forosseoustissueindications	K091746,K101817 forhard tissueindicationsK123494 forsoft tissueindications	K091320 forsoft tissueindications	K031140,K071363,K090181 forhard tissueindications	K093162 forhard tissueindications
Target User	Generalpractitionerdentists andspecialists	Generalpractitionerdentists andspecialists	Generalpractitionerdentists andspecialists	Generalpractitionerdentists andspecialists	Generalpractitionerdentists andspecialists
Indicationsfor Use	The Soleasystem isindicated forthefollowing:- Ablationof hardtissueforcariesremovalandcavitypreparation- Incision,	The Soleasystem isindicated forthefollowing:- Ablationof hardtissueforcariesremovalandcavitypreparation.- Incision,	The Soleasystem isindicated forthe following:- Incision,- Excision,- Vaporization,- Coagulationand- Hemostasis of softtissue inthe oralcavity.	GeneralIndicationsClass I, II, III, IVand V cavitypreparationCaries removalHard tissuesurfaceroughening oretchingEnameloplasty,excavation ofpits and fissuresfor placement ofsealants* For use on	The LightWalkerEr:YAG laser,and itsaccessories, areintended foruse in dentistry,dermatologyand othersurgical areas inthe followingprocedures:In dentistry, for:- Intra-oralsoft tissuesurgery(incision,
Convergent	Convergent	Convergent	Biolase	Fotona d.d.
Dental, Inc.	Dental, Inc.	Dental, Inc.	Technology, Inc.
Vaporiza	Vaporiza		pediatric	ablation
tion,	tion,		patients	coagulation
Coagulat	Coagulat		Root Canal Hard	)
ion and	ion and		Tissue	Leukoplaki
Hemosta	Hemosta		Indications	a
sis of	sis of		Tooth	- Pulpotomy
soft	soft		preparation to	as adjunct
tissue in	tissue in		obtain access to	to root
the oral	the oral		root canal	canal
cavity	cavity.		Root canal	retreatmen
- Cutting,			preparation	t
shaving,			including	- Pulp
contouri			enlargement	extirpation
ng and			Root canal	- Removal of
resectio			debridement	fibroma
n of oral			and cleaning	- Removal of
osseous			Root Canal	granulated
tissue			Disinfection	tissue
(bone)			Laser root canal	- Caries
			disinfection after	removal,
			endodontic	cavity
			instrumentation	preparatio
			Bone Surgical	n, enamel
			Indications	roughening
			Cutting, shaving,	- Sulcular
			contouring and	debrideme
			resection of oral	nt
			osseous tissues	- Tooth
			(bone)	preparatio
			Osteotomy	n to obtain
			Endodontic	access to
			Surgery (Root	root canal,
			Amputation)	root canal
			Indications	debrideme
			Flap preparation	nt and
			– incision of soft	cleaning,
			tissue to prepare	root
			a flap and	- canal
			expose the	preparatio
			bone.	n including
			Cutting bone to	enlargeme
			prepare a	nt
			window access	- Cutting,
			to the apex	shaving,
			(apices) of the	contouring
			root(s).	and
			Apicoectomy -	resection
			amputation of	of oral
			the root end.	osseous
			Root end	tissue
			preparation for	(bone)
			retrofill	Osteotomy
ConvergentDental, Inc.	ConvergentDental, Inc.	ConvergentDental, Inc.	BiolaseTechnology, Inc.	Fotona d.d.
			amalgam orcomposite.Removal ofpathologicaltissues (i.e.,cysts, neoplasmor abscess) andhyperplastictissues (i.e.,granulationtissue) fromaround the apexNOTE: Any tissuegrowth (i.e.,cyst, neoplasmor other lesions)must besubmitted to aqualifiedlaboratory forhistopathological evaluation.Soft TissueIndicationsincluding PulpalTissues*Incision,excision,vaporization,ablation andcoagulation oforal soft tissues,including:Excisional andincisionalbiopsiesExposure ofunerupted teethFibroma removalFlap preparation– incision of softtissue to preparea flap andexpose thebone.Flap preparation– incision of softtissue to preparea flap andexposeunerupted teeth	osseouscrownlengthening,osteoplastyApicectomysurgery.Removal ofsubgingivalcalculi inperiodontalpockets withperiodontitis byclosed or opencurettage
Convergent	Convergent	Convergent	Biolase	Fotona d.d.
Dental, Inc.	Dental, Inc.	Dental, Inc.	Technology, Inc.
			tissue
			impactions)
			Frenectomy and
			frenotomy
			Gingival
			troughing for
			crown
			impressions
			Gingivectomy
			Gingival incision
			and excision
			Hemostasis
			Implant recovery
			Incision and
			drainage of
			abscesses
			Laser soft tissue
			curettage of the
			post-extraction
			tooth sockets
			and the
			periapical area
			during apical

			surgery
			Leukoplakia
			Operculectomy
			Oral
			papillectomies
			Pulpotomy
			Pulp extirpation
			Pulpotomy as an
			adjunct to root
			canal therapy
			Root canal
			debridement
			and cleaning
			Reduction of
			gingival
			hypertrophy
			Removal of
			pathological
			tissues (i.e.,
			cysts, neoplasm
			or abscess) and
			hyperplastic
			tissues (i.e.,
			granulation
			tissue) from
			around the apex
			NOTE: Any tissue
			growth (i.e.,
			cyst, neoplasm
Convergent	Convergent	Convergent	Biolase	Fotona d.d.
Dental, Inc.	Dental, Inc.	Dental, Inc.	Technology, Inc.
			or other lesions)must besubmitted to aqualifiedlaboratory forhistopathological evaluation.Soft tissuecrownlengtheningTreatment ofcanker sores,herpetic andaphthous ulcersof the oralmucosaVestibuloplastyLaserPeriodontalProceduresFull thicknessflapPartial thicknessflapSplit thicknessflapLaser soft tissuecurettageLaser removal ofdiseased,infected,inflamed andnecrosed softtissue within theperiodontalpocketRemoval ofhighly inflamededematoustissue affectedby bacteriapenetration ofthe pocket liningjunctionalepitheliumRemoval ofgranulationtissue from bonydefectsSulculardebridement(removal of
Convergent	Convergent	Convergent	Biolase	Fotona d.d.
Dental, Inc.	Dental, Inc.	Dental, Inc.	Technology, Inc.
			diseased,
			infected,
			inflamed or
			necrosed soft
			tissue in the
			periodontal
			pocket to
			improve clinical
			indices including
			gingival index,
			gingival bleeding
			index, probe
			depth,
			attachment loss
			and tooth
			mobility)
			Osteoplasty and
			osseous
			recontouring
			(removal of
			bone to correct
			osseous defects
			and create
			physiologic
			osseous
			contours)
			Ostectomy
			(resection of
			bone to restore
			bony
			architecture,
			resection of
			bone for
			grafting, etc.)
			Osseous crown
			lengthening
			Laser assisted
			new attachment
			procedure
			(cementum-
			mediated
			periodontal
			ligament new-
			attachment to
			the root surface
			in the absence of
			long junctional
			epithelium).
			Removal of
			subgingival
			calculi in
			periodontal
	ConvergentDental, Inc.	ConvergentDental, Inc.	ConvergentDental, Inc.	BiolaseTechnology, Inc.pockets withperiodontitis byclosed or opencurettage.	Fotona d.d.
Laserclassification	Class 4 (IV)LaserProduct	Class 4 (IV)LaserProduct	Class 4 (IV)Laser Product	Class 4 (IV) LaserProduct	Class 4 (IV)Laser Product
Type ofLaser	CO2 (CarbonDioxide)	CO2 (CarbonDioxide)	CO2 (CarbonDioxide)	Er,Cr:YSGG(Erbium,Chromium:Yttrium,Scandium,Gallium, Garnet)	Er:YAG (Erbium:Yttrium,Aluminum,Garnet)Nd:YAG(Neodymium-doped: Yttrium,Aluminum,Garnet)
Wavelength	9.25μm(9250nm)	9.25μm(9250nm)	9.25μm(9250nm)	2.78μm(2780nm)	Er:YAG =2.94μm(2940nm)Nd:YAG =1.064μm(1064nm)
Fluence:Energy permm2	0.39J/mm²(hard tissue)1.13J/mm²(soft tissue)	0.39J/mm²(hard tissue)1.13J/mm²(soft tissue)	1.13J/mm²	0.33J/mm²	0.25J/mm²
Irradiance:Power permm2	6W/mm²(hard tissue)112.8W/mm2(soft tissue)	6W/mm²(hard tissue)112.8W/mm2(soft tissue)	112.80W/mm2	10W/mm²	13W/mm²
OperatingModes	Ablationlaser: PulsedAiming laser:Continuous	Ablationlaser: PulsedAiming laser:Continuous	Ablation laser:PulsedAiming laser:Continuous	Ablation laser:PulsedAiming laser:Continuous	Ablation laser:PulsedAiming laser:Continuous
BeamDelivery	ArticulatingArm (FreeSpace)	ArticulatingArm (FreeSpace)	ArticulatingArm (FreeSpace)	Fiber	ArticulatingArm (FreeSpace)
Sterilization	Steam	Steam	Steam	Steam Autoclave	Steam
Method	Autoclave	Autoclave	Autoclave		Autoclave
RF emissions	CISPR 11Group 1	CISPR 11Group 1	CISPR 11Group 1	CISPR 11 Group1	CISPR 11 Group1
EMCcompliance	CISPR 11Class A	CISPR 11Class A	CISPR 11 ClassA	CISPR 11 Class A	CISPR 11 Class A

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9. Non-Clinical Testing

The Solea system meets all the requirements for overall design, sterilization, biocompatibility, and electrical safety. The results of the non-clinical testing confirm the output meets the design inputs and specifications. Bench testing was performed to

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demonstrate substantial equivalence to the predicate devices in terms of safety and performance. The following non-clinical testing was performed:

. Electrical Safety Testing:

The system passed electrical safety testing in accordance with requirements for IEC 60601-1 medical electrical equipment.

● Electromagnetic Compatibility:

The system passed electromagnetic compatibility (EMC) testing to meet requirements for IEC 60601-1-2 medical electrical equipment.

● Laser Safety:

The system passed particular requirements for IEC 60601-2-22 and IEC 60825-1 for the safety of diagnostic and therapeutic laser equipment.

. Cleaning and Sterilization:

The handpieces of the Solea system passed cleaning and sterilization validations for reusable medical devices based on the overkill approach to demonstrate sterilization cycle lethality as described in AAMI TIR12 to achieve a Sterility Assurance Level (SAL) of at least 10-6. The Solea system handpieces are designed for sterilization by exposure to moist heat under conventional autoclave cycles qualified to ANSI/AAMI ST79.

● Software:

Verification and validation testing was conducted on the Solea software. All tests were completed successfully with respect to stated pass/fail criteria thereby deeming the device and software appropriate for its intended use.

● Usability:

Usability testing was conducted on the Solea system as described in IEC 62366. During the usability evaluation, dentists used the system to perform procedures on simulated tissues in a laboratory environment that replicates the intended deployment environment of the dental office. Based on the participant feedback and ratings of usability of the Solea system, all of the acceptance criteria for the user design validation have been met for the intended use.

. Bench Testing: Solea Hard Tissue Testing:

Performance data was collected from Bench Testing for hard tissue. Results show that hard tissue thermal effects are equivalent. The results show substantially equivalent results for the Solea system and predicate systems.

10. Clinical Testing

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate devices. These types of devices, including the predicate devices, have been on the market for many years have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device.

The Solea system has the same or similar intended use, indications, principles of operation,

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and technological characteristics as the predicate devices. Solea, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices in terms of intended use, design, materials, and function.

Regulation Number and Section

§ 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.