(89 days)
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No
The document does not mention AI, ML, or related concepts like neural networks, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on laser technology and its application.
Yes
The device is used for medical purposes such as ablation of hard tissue for caries removal, incision of soft tissue, and aiding in the reduction of mineral loss in dental enamel, which are therapeutic interventions.
No
The device description and intended use indicate that the Solea system is used for treatment procedures such as ablation, incision, excision, and aiding in the reduction of mineral loss, rather than for diagnosis.
No
The device description clearly states it is a "mobile, cart-based dental treatment system that uses pulsed laser energy" and includes a "DR Handpiece," indicating it is a hardware-based system that delivers energy, not a software-only device.
Based on the provided information, the Solea system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Solea System Function: The Solea system is a laser-based dental treatment system that directly interacts with the patient's oral tissues (hard tissue, soft tissue, bone, enamel) for therapeutic purposes (ablation, incision, excision, etc.). It does not analyze samples taken from the body.
The description clearly indicates a device used for direct treatment and modification of tissues within the oral cavity, which falls under the category of a therapeutic or surgical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for 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
Product codes (comma separated list FDA assigned to the subject device)
NVK, GEX
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
oral cavity, dental enamel, tooth enamel
Indicated Patient Age Range
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Intended User / Care Setting
Healthcare Professional / dental and oral surgery
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed to demonstrate substantial equivalence to the predicate devices in terms of safety and performance.
- 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 mineral loss, without significant damage to the enamel. Additionally, inhibition of surface softening and surface loss during pH cycling was observed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 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.
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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.
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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 oral | ||
| laser surgery | For use in dental and oral laser | ||
| surgery | Same | ||
| Indications for | |||
| Use | 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 | 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) | Same with the exception | ||
| of adding the reduction | |||
| in mineral loss in dental | |||
| enamel. Performance | |||
| data is provided which | |||
| supports substantial | |||
| equivalence. | |||
| Clearance Type | Prescription | Prescription | Same |
| User | Healthcare Professional | Healthcare Professional | Same |
| Device | |||
| Description | The Solea system is a mobile, | ||
| cart-based dental treatment | |||
| system that uses pulsed laser | |||
| energy to cut and ablate hard | |||
| and soft tissue in the oral | |||
| cavity. The Solea system | The Solea system is a mobile, | ||
| cart-based dental treatment | |||
| system that uses pulsed laser | |||
| energy to cut and ablate hard | |||
| and soft tissue in the oral | |||
| cavity. The Solea system | Same |
Solea Substantial Equivalence
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| | utilizes advanced CO2 laser
technology with a wavelength
of 9.25µm to safely and
effectively perform ablation,
incision, excision,
vaporization, coagulation and
hemostasis. | utilizes advanced CO2 laser
technology with a wavelength
of 9.25 µm to safely and
effectively perform ablation,
incision, excision,
vaporization, coagulation and
hemostasis. | |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Laser Source | CO2 | CO2 | Same |
| Mode | Single | Single | Same |
| Laser
Wavelength | 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 Power
Output | 1 KW | 1 KW | Same |
| Average Power | 0 to 30 W | 0 to 30 W | Same |
| Power Accuracy | +/- 20% | +/- 20% | Same |
| Max Pulse
Energy | 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 diode
5mW (Safety classification
3R) | 520-535 nm diode
5mW (Safety classification
3R) | Substantially equivalent |
| Fluence Energy
per mm² | 0.008 J/mm² (mineral loss
reduction)
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 mode
added for reduction in
mineral loss. All other
modes are the same as
the predicate device. |
| Operating Modes | Ablation laser : Pulsed
Aiming laser : Continuous | Ablation laser : Pulsed
Aiming laser : Continuous | Same |
| Beam Delivery | Articulating Arm (Free space) | Articulating Arm (Free space) | Same |
| Sterilization
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.
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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
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.