(89 days)
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
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.
The information provided describes the Solea laser system, which is intended for dental procedures, including a new indication for "aiding in the reduction of mineral loss in dental enamel."
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria for the new indication ("aiding in the reduction of mineral loss in dental enamel") with corresponding reported performance values. Instead, it describes generic safety and performance testing for various aspects of the device and a specific finding from "bench testing" relating to the new indication.
Implicit Acceptance Criteria (for the new indication related to mineral loss in dental enamel):
| Acceptance Criteria | Reported Device Performance (for the new indication) |
|---|---|
| Pulpal temperature increase below 5.5º C | Increase in pulpal temperature following the procedure was less than the maximum threshold of 5.5º C |
| No visually observed structural changes (melting, charring, carbonization) in the tooth | No visually observed structural changes such as melting, charring or carbonization |
| Significant benefit in aiding in the reduction of mineral loss in dental enamel (measured by relative mineral loss in depth and surface mineral loss) | 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 mineral loss |
| No significant damage to the enamel | No significant damage to the enamel |
| Inhibition of surface softening and surface loss during pH cycling | Inhibition of surface softening and surface loss during pH cycling was observed |
General Safety and Performance Criteria (for the device as a whole):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety (IEC 60601-1) | Passed electrical safety testing |
| Electromagnetic Compatibility (IEC 60601-1-2) | Passed electromagnetic compatibility (EMC) testing |
| Laser Safety (IEC 60601-2-22 and IEC 60825-1) | Passed laser safety particular requirements |
| Cleaning and Sterilization (AAMI TIR12, ANSI/AAMI ST79) | Passed cleaning and sterilizations for reusable medical devices; achieved SAL of at least 10^-6 |
| Software Verification and Validation | Verification and validation testing completed successfully with respect to stated pass/fail criteria |
2. Sample size used for the test set and the data provenance
The document states, "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." It also mentions, "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 mineral loss, without significant damage to the enamel. Additionally, inhibition of surface softening and surface loss during pH cycling was observed."
- Sample Size for test set: Not specified.
- Data Provenance: The studies are described as "in vitro studies" and "bench testing," indicating laboratory-based studies. The country of origin of the data is not specified. The studies appear to be prospective to evaluate the device's performance under specific conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The studies mentioned are in vitro/bench testing, which often relies on objective measurements rather than expert consensus on subjective interpretations (like image-based diagnoses). Thus, the concept of "ground truth established by experts" as typically seen in diagnostic AI is not directly applicable or reported here.
4. Adjudication method for the test set
This information is not provided in the document. Since the testing involves in vitro objective measurements and assessments of physical changes (pulpal temperature, structural changes, mineral loss), an adjudication method as typically used for subjective expert evaluations is unlikely to have been relevant or performed.
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 explicitly mentioned or implied. This device is a laser system for treatment, not a diagnostic AI tool, so an MRMC study comparing human reader performance with and without AI assistance is not applicable to its stated purpose.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a laser system operated by a healthcare professional. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in the typical sense of a diagnostic AI algorithm. The performance mentioned ("significant benefit in aiding in the reduction of mineral loss," etc.) refers to the device's direct physical effect on dental enamel as tested in vitro, not an algorithmic output.
7. The type of ground truth used
For the specific new indication:
- The "ground truth" implicitly used for the effectiveness testing (reduction of mineral loss, inhibition of softening/loss) would be quantitative measurements of mineral content, depth, and surface characteristics of dental enamel, along with objective measurement of pulpal temperature and visual observation for structural damage. This falls under scientific measurement/bench testing data.
For other safety aspects (electrical, EMC, laser, sterilization):
- Compliance with established industry standards and regulatory requirements (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, AAMI TIR12, ANSI/AAMI ST79) serves as the "ground truth" for these safety parameters.
8. The sample size for the training set
The document describes this as a medical device (laser system), not an AI/machine learning algorithm that typically requires a training set. Therefore, information about a "training set sample size" is not applicable and not provided.
9. How the ground truth for the training set was established
As described above, the device is a laser system, not an AI/machine learning algorithm requiring a training set, so this information is not applicable and not provided.
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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.
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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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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
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Indications for Use
510(k) Number (if known)
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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: jvojir@convergentdental.com
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.
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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 orallaser surgery | For use in dental and oral lasersurgery | Same |
| Indications forUse | Ablation of hard tissue for• caries removal and cavitypreparation• Incision, excision,vaporization, coagulationand hemostasis of softtissue in the oral cavity• Cutting, shaving,contouring and resectionof oral osseous (bone)• Aiding in the reduction ofmineral loss in dentalenamel | Ablation of hard tissue for• caries removal and cavitypreparation• Incision, excision,vaporization, coagulationand hemostasis of softtissue in the oral cavity• Cutting, shaving,contouring and resection oforal osseous (bone) | Same with the exceptionof adding the reductionin mineral loss in dentalenamel. Performancedata is provided whichsupports substantialequivalence. |
| Clearance Type | Prescription | Prescription | Same |
| User | Healthcare Professional | Healthcare Professional | Same |
| DeviceDescription | The Solea system is a mobile,cart-based dental treatmentsystem that uses pulsed laserenergy to cut and ablate hardand soft tissue in the oralcavity. The Solea system | The Solea system is a mobile,cart-based dental treatmentsystem that uses pulsed laserenergy to cut and ablate hardand soft tissue in the oralcavity. The Solea system | Same |
Solea Substantial Equivalence
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| utilizes advanced CO2 lasertechnology with a wavelengthof 9.25µm to safely andeffectively perform ablation,incision, excision,vaporization, coagulation andhemostasis. | utilizes advanced CO2 lasertechnology with a wavelengthof 9.25 µm to safely andeffectively perform ablation,incision, excision,vaporization, coagulation andhemostasis. | ||
|---|---|---|---|
| Laser Source | CO2 | CO2 | Same |
| Mode | Single | Single | Same |
| LaserWavelength | 9.25 µm | 9.25 µm | Same |
| Frequency | Up to 10KHz (hard tissue)20 to 100 Hz (soft tissue) | Up to 10KHz (hard tissue)20 to 100 Hz (soft tissue) | Same |
| Max Peak PowerOutput | 1 KW | 1 KW | Same |
| Average Power | 0 to 30 W | 0 to 30 W | Same |
| Power Accuracy | +/- 20% | +/- 20% | Same |
| Max PulseEnergy | 15 mJ (hard tissue)100 mJ (soft tissue) | 15 mJ (hard tissue)100 mJ (soft tissue) | Same |
| Pulse Duration | 5-90 us (hard tissue)10-250 us (soft tissue) | 5-90 us (hard tissue)10-250 us (soft tissue) | Same |
| Aiming Beam | 520nm diode5mW (Safety classification3R) | 520-535 nm diode5mW (Safety classification3R) | Substantially equivalent |
| Fluence Energyper mm² | 0.008 J/mm² (mineral lossreduction)0.39 J/mm² (hard tissue)1.13 J/mm² (soft tissue)2.0 J/mm² | 0.39 J/mm² (hard tissue)1.13 J/mm² (soft tissue)2.0 J/mm² | New low fluence modeadded for reduction inmineral loss. All othermodes are the same asthe predicate device. |
| Operating Modes | Ablation laser : PulsedAiming laser : Continuous | Ablation laser : PulsedAiming laser : Continuous | Same |
| Beam Delivery | Articulating Arm (Free space) | Articulating Arm (Free space) | Same |
| SterilizationMethods | 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.
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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
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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.
§ 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.