Solea

K221761 · Convergent Dental, Inc. · NVK · Sep 14, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K221761
• Device Name: Solea
• Applicant: Convergent Dental, Inc.
• Product Code: NVK · General, Plastic Surgery
• Decision Date: Sep 14, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Solea system is indicated for the following: - Ablation of hard tissue for caries removal and cavity prevention - Incision, excision, vaporization, coagulation and hemostasis of soft tissue in the oral cavity - Cutting, shaving, contouring and resection of oral osseous tissue (both) - Aiding in the reduction of mineral loss in dental enamel

Device Story

Solea is a mobile, cart-based dental laser system using 9.3 µm CO2 laser energy. It features a new DR Handpiece delivering controlled sub-ablative energy to heat tooth surface mineral without ablation, intended to reduce mineral loss in enamel. Operated by healthcare professionals in clinical settings, the device allows users to select operating modes via a UI. The laser energy is delivered via an articulating arm. The system performs hard/soft tissue ablation, incision, and osseous resection. The new sub-ablative mode provides a therapeutic benefit by inhibiting surface softening and mineral loss during pH cycling. Clinical decision-making is supported by the device's ability to perform precise dental procedures with minimal thermal impact on pulp (below 5.5°C threshold) and no structural damage like charring or carbonization.

Clinical Evidence

Bench testing only. In vitro studies evaluated pulpal temperature changes and structural enamel integrity. Results showed pulpal temperature increase remained below 5.5°C threshold. No visual evidence of melting, charring, or carbonization. Testing demonstrated significant reduction in mineral loss depth and surface loss during pH cycling.

Technological Characteristics

Mobile cart-based CO2 laser system; 9.3 µm wavelength; articulating arm beam delivery. Electrical safety: IEC 60601-1. EMC: IEC 60601-1-2. Laser safety: IEC 60601-2-22, IEC 60825-1. Sterilization: Steam autoclave (ANSI/AAMI ST79, AAMI TIR12, SAL 10^-6).

Indications for Use

Indicated for dental and oral surgery patients requiring hard tissue ablation (caries removal/cavity prep), soft tissue procedures (incision, excision, vaporization, coagulation, hemostasis), oral osseous tissue resection, and reduction of mineral loss in dental enamel.

Regulatory Classification

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.

Predicate Devices

• Solea (K151306)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 14, 2022

Convergent Dental, Inc. Jhung Vojir Chief Operating Officer 140 Kendrick Street Needham, Massachusetts 02494

Re: K221761

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: NVK. GEX Dated: June 16, 2022 Received: June 17, 2022

Dear Jhung Vojir:

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.

{1}------------------------------------------------

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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Michael E. Adjodha, M.ChE., Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

K221761

Device Name Solea

Indications for Use (Describe)

The Solea system is indicated for the following:

- · Ablation of hard tissue for caries removal and cavity prevention
- · Incision, excision, vaporization, coagulation and hemostasis of soft tissue in the oral cavity
- · Cutting, shaving, contouring and resection of oral osseous tissue (both)
- · Aiding in the reduction of mineral loss in dental enamel

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| <div> <span> </span> <span> </span> <span> X Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> </span> <span> </span> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# K221761

## 510(k) SUMMARY

# Convergent Dental, Inc. Solea

### 510(k) Owner

Convergent Dental, Inc. 140 Kendrick Street, Bldg C3 Needham, MA 02494, USA

Contact person: Jhung Won Vojir, PhD Chief Operating Officer Email: [e-mail]

Date Prepared: June 16, 2022

Trade Name of Device Solea

Common or Usual Name Powered laser surgical instrument

### Classification Name

Laser surgical instrument for use in general and plastic surgery and dermatology; 21 C.F.R. §878.4810 Class II Product Code: GEX

### Predicate Device

Convergent Dental, Inc. Solea cleared in K151306 (Primary Predicate)

### Device Description

The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy for 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). The Solea system utilizes CO2 laser technology with a wavelength of 9.3 um.

The modification to the cleared Solea system is the introduction of the DR Handpiece which allows the system to deliver controlled sub-ablative energy necessary to heat the tooth surface mineral without ablation for the new treatment of aiding in the reduction of mineral loss in the tooth enamel.

{4}------------------------------------------------

The Solea system will be used in the same way it is used for the currently cleared indications for use. The user will select the desired operating mode from the user interface and apply the energy via a handpiece in the same method as used for the previously cleared indications.

# Indications for Use

The Solea system is indicated for:

- 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 (bone)
- Aiding in the reduction of mineral loss in dental enamel .

### Substantial Equivalence

Convergent Dental believes that the Solea described in this notification and for use under the conditions of the proposed labeling is substantially equivalent to a legally marketed predicate device that is a Class II medical device which is the Solea cleared in K151306. The table below compares the properties of the two devices.

| Characteristic | Solea | Solea | Comments |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Convergent Dental | Convergent Dental | Same |
| 510(k) Number | K221761 | K151306 | Same |
| Product Code | GEX | GEX | Same |
| Regulation | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Intended Use | For use in dental and oral<br>laser surgery | For use in dental and oral laser<br>surgery | Same |
| Indications for<br>Use | Ablation of hard tissue for<br>• caries removal and cavity<br>preparation<br>• Incision, excision,<br>vaporization, coagulation<br>and hemostasis of soft<br>tissue in the oral cavity<br>• Cutting, shaving,<br>contouring and resection<br>of oral osseous (bone)<br>• Aiding in the reduction of<br>mineral loss in dental<br>enamel | Ablation of hard tissue for<br>• caries removal and cavity<br>preparation<br>• Incision, excision,<br>vaporization, coagulation<br>and hemostasis of soft<br>tissue in the oral cavity<br>• Cutting, shaving,<br>contouring and resection of<br>oral osseous (bone) | Same with the exception<br>of adding the reduction<br>in mineral loss in dental<br>enamel. Performance<br>data is provided which<br>supports substantial<br>equivalence. |
| Clearance Type | Prescription | Prescription | Same |
| User | Healthcare Professional | Healthcare Professional | Same |
| Device<br>Description | The Solea system is a mobile,<br>cart-based dental treatment<br>system that uses pulsed laser<br>energy to cut and ablate hard<br>and soft tissue in the oral<br>cavity. The Solea system | The Solea system is a mobile,<br>cart-based dental treatment<br>system that uses pulsed laser<br>energy to cut and ablate hard<br>and soft tissue in the oral<br>cavity. The Solea system | Same |

# Solea Substantial Equivalence

{5}------------------------------------------------

| | utilizes advanced CO2 laser<br>technology with a wavelength<br>of 9.25µm to safely and<br>effectively perform ablation,<br>incision, excision,<br>vaporization, coagulation and<br>hemostasis. | utilizes advanced CO2 laser<br>technology with a wavelength<br>of 9.25 µm to safely and<br>effectively perform ablation,<br>incision, excision,<br>vaporization, coagulation and<br>hemostasis. | |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Laser Source | CO2 | CO2 | Same |
| Mode | Single | Single | Same |
| Laser<br>Wavelength | 9.25 µm | 9.25 µm | Same |
| Frequency | Up to 10KHz (hard tissue)<br>20 to 100 Hz (soft tissue) | Up to 10KHz (hard tissue)<br>20 to 100 Hz (soft tissue) | Same |
| Max Peak Power<br>Output | 1 KW | 1 KW | Same |
| Average Power | 0 to 30 W | 0 to 30 W | Same |
| Power Accuracy | +/- 20% | +/- 20% | Same |
| Max Pulse<br>Energy | 15 mJ (hard tissue)<br>100 mJ (soft tissue) | 15 mJ (hard tissue)<br>100 mJ (soft tissue) | Same |
| Pulse Duration | 5-90 us (hard tissue)<br>10-250 us (soft tissue) | 5-90 us (hard tissue)<br>10-250 us (soft tissue) | Same |
| Aiming Beam | 520nm diode<br>5mW (Safety classification<br>3R) | 520-535 nm diode<br>5mW (Safety classification<br>3R) | Substantially equivalent |
| Fluence Energy<br>per mm² | 0.008 J/mm² (mineral loss<br>reduction)<br>0.39 J/mm² (hard tissue)<br>1.13 J/mm² (soft tissue)<br>2.0 J/mm² | 0.39 J/mm² (hard tissue)<br>1.13 J/mm² (soft tissue)<br>2.0 J/mm² | New low fluence mode<br>added for reduction in<br>mineral loss. All other<br>modes are the same as<br>the predicate device. |
| Operating Modes | Ablation laser : Pulsed<br>Aiming laser : Continuous | Ablation laser : Pulsed<br>Aiming laser : Continuous | Same |
| Beam Delivery | Articulating Arm (Free space) | Articulating Arm (Free space) | Same |
| Sterilization<br>Methods | Steam Autoclave | Steam Autoclave | Same |
| RF Emissions | CISPR 11 Group 1 | CISPR 11 Group 1 | Same |
| RF Emissions | CISPR 11 Class A | CISPR 11 Class A | Same |

The intended use of the Solea as well as the predicate device Solea is for use in dental and oral surgery. The indications for use have been revised to add "aiding in the reduction of mineral loss in dental enamel". Both devices are mobile, cart-based dental treatment systems that use pulsed laser energy to cut and ablate hard and soft tissue in the oral cavity. Both systems use CO2 laser technology with 9.25 um wavelength. Key treatment parameters such as max pulse energy, frequency and pulse duration are unchanged between the Solea cleared in K151306 and the version that is the subject of this 510(k).

The device modifications proposed in this supplement are for a device with similar mechanism of action and method of use as the cleared version of the device but with significantly lower energy delivered which reduces the overall risk profile compared to the currently cleared device. An assessment of risks found that risks are minimal compared to the currently cleared version of the Solea system.

{6}------------------------------------------------

Data demonstrate substantial equivalence regarding increase in pulpal temperature and other structural changes to the tooth such as melting, charring or carbonization. The in vitro studies found that the increase in pulpal temperature following the procedure was less than the maximum threshold of 5.5º C and there were no visually observed structural changes such as melting, charring or carbonization.

In conclusion, given the available information, for the proposed addition to the indications for use statement of "for aiding in the reduction of mineral loss in dental enamel", can be found substantially equivalent to the predicate device.

# Performance Data

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 demonstrate substantial equivalence to the predicate devices in terms of safety and performance. The following nonclinical 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 sterilizations 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.

#### • Bench Testing:

In vitro testing demonstrated a significant benefit of the Solea system in aiding in the reduction of mineral loss in dental enamel as measured by the relative mineral loss in depth and surface

{7}------------------------------------------------

mineral loss, without significant damage to the enamel. Additionally, inhibition of surface softening and surface loss during pH cycling was observed.

### Conclusion

Based on the substantial equivalence discussion and the performance testing, the Solea system is substantially equivalent to the Solea system cleared in K151306.