Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states "There have been no software changes" and "There are no other hardware or software changes". There is no mention of AI or ML in the document.

Therapeutic

Yes.
The device is used for medical procedures such as ablation, incision, excision, vaporization, coagulation, and hemostasis of tissues in the oral cavity for treating caries and preparing cavities, which are therapeutic interventions.

Diagnostic

No

Explanation: The device is described as a dental laser system used for ablation, incision, excision, vaporization, coagulation, and hemostasis of tissues, which are all therapeutic or surgical procedures, not diagnostic ones.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "dental laser device" and a "mobile, cart-based dental treatment system that uses pulsed laser energy to cut and ablate hard tissue and to cut soft tissue". This indicates it is a hardware device that utilizes laser technology, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissues, and urine, from the human body to provide information for diagnosis, monitoring, or screening.
Solea System Function: The Solea system is a dental laser device that directly interacts with the patient's tissues (hard tissue, soft tissue, and bone) within the oral cavity. It performs procedures like ablation, incision, excision, vaporization, coagulation, hemostasis, cutting, shaving, contouring, and resection.
Lack of Specimen Analysis: The description does not mention the device analyzing any specimens taken from the body. Its function is to directly treat the patient's tissues.

Therefore, the Solea system falls under the category of a therapeutic or surgical device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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)

Product codes (comma separated list FDA assigned to the subject device)

GEX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Oral cavity, oral osseous tissue (bone)

Indicated Patient Age Range

pediatric patients (mentioned in predicate device indication)

Intended User / Care Setting

General practitioner dentists and specialists

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Testing:

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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K123494, K130420, K091746, K101817

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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

1

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 surgery
and 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

4

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.

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.

5

| | Convergent
Dental, Inc. | Convergent
Dental, Inc. | Convergent
Dental, Inc. | Biolase
Technology, Inc. | Fotona d.d. |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Solea | Solea | Solea | Waterlase® MD | LightWalker
Laser System
Family |
| 510(k)
Number | K152306 | K130420 | K123494 | K091746 | K101817 |
| Common
name | Powered
Laser surgical
instrument | Powered
Laser surgical
instrument | Powered
Laser surgical
instrument | Powered Laser
surgical
instrument | Powered Laser
surgical
instrument |
| FDA
Classification
Names | Powered
Laser surgical
instrument | Powered
Laser surgical
instrument | Powered
Laser surgical
instrument | Powered Laser
surgical
instrument
Drill, bone,
powered
System, Dental,
Hydrokinetic,
Carries Removal
& Cavity
Preparation | Powered Laser
surgical
instrument |
| FDA
Classification
codes | GEX, a Class
II device | GEX, a Class
II device | GEX, a Class II
device | GEX, MXF, DZI, a
Class II device | GEX, a Class II
device |
| Predicates
cited | K130420 and
K123494 for
hard and soft
tissue
indications
K091746,
K101817 for
osseous
tissue
indications | K091746,
K101817 for
hard tissue
indications
K123494 for
soft tissue
indications | K091320 for
soft tissue
indications | K031140,
K071363,
K090181 for
hard tissue
indications | K093162 for
hard tissue
indications |
| Target User | General
practitioner
dentists and
specialists | General
practitioner
dentists and
specialists | General
practitioner
dentists and
specialists | General
practitioner
dentists and
specialists | General
practitioner
dentists and
specialists |
| Indications
for Use | The Solea
system is
indicated for
the
following:

Ablation
of hard
tissue
for
caries
removal
and
cavity
preparation
Incision, | The Solea
system is
indicated for
the
following:
Ablation
of hard
tissue
for
caries
removal
and
cavity
preparation.
Incision, | The Solea
system is
indicated for
the following:
Incision,
Excision,
Vaporization,
Coagulation
and
Hemostas
is of soft
tissue in
the oral
cavity. | General
Indications*
Class I, II, III, IV
and V cavity
preparation
Caries removal
Hard tissue
surface
roughening or
etching
Enameloplasty,
excavation of
pits and fissures
for placement of
sealants*

For use on | The LightWalker
Er:YAG laser,
and its
accessories, are
intended for
use in dentistry,
dermatology
and other
surgical areas in
the following
procedures:
In dentistry, for:

Intra-oral
soft tissue
surgery
(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 | |
| Convergent
Dental, Inc. | Convergent
Dental, Inc. | Convergent
Dental, Inc. | Biolase
Technology, Inc. | Fotona d.d. | |
| | | | amalgam or
composite.
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
or other lesions)
must be
submitted to a
qualified
laboratory for
histopathologica
l evaluation.
Soft Tissue
Indications
including Pulpal
Tissues*
Incision,
excision,
vaporization,
ablation and
coagulation of
oral soft tissues,
including:
Excisional and
incisional
biopsies
Exposure of
unerupted teeth
Fibroma removal
Flap preparation
– incision of soft
tissue to prepare
a flap and
expose the
bone.
Flap preparation
– incision of soft
tissue to prepare
a flap and
expose
unerupted teeth | osseous
crown
lengthenin
g,
osteoplasty
Apicectomy
surgery.

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7

8

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10

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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

12

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,

13

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.