(90 days)
No
The document describes a laser system for soft tissue procedures and does not mention any AI or ML components or capabilities.
Yes.
The device performs therapeutic functions such as incision, excision, vaporization, coagulation, and hemostasis of soft tissue.
No
The device description and intended use indicate that the Solea system is used for surgical procedures (incision, excision, vaporization, coagulation, hemostasis of soft tissue) using pulsed laser energy, not for diagnosing conditions.
No
The device description clearly states it is a "mobile, cart-based dental treatment system that uses pulsed laser energy to cut soft tissue," indicating it is a hardware device that utilizes laser technology.
Based on the provided information, the Solea system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the Solea system is for surgical procedures (incision, excision, vaporization, coagulation, hemostasis) on soft tissue within the oral cavity. This is a therapeutic/surgical function, not a diagnostic one.
- Device Description: The device description confirms it's a laser system used for cutting and treating tissue, not for analyzing biological samples to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze blood, urine, tissue samples, or any other biological material for the purpose of diagnosing a disease or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Solea system's function is to directly treat tissue.
N/A
Intended Use / Indications for Use
The Solea system is indicated for the following:
- Incision
- Excision
- Vaporization
- Coagulation
- Hemostasis
of soft tissue in the oral cavity.
Product codes
GEX
Device Description
The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy 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 incision, excision, vaporization, coagulation, and hemostasis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
Indicated Patient Age Range
Not Found
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)
Bench Testing:
- Study Type: Solea Soft Tissue Testing - Performance data collection and quantitative analysis.
- Sample Size: Not specified.
- Key Results: The study evaluated the depth, width, and length of cuts, conducted a histological assessment of changes in sample tissue, and assessed the effect on tissue surrounding the incision areas. The results showed substantially equivalent results for both the Solea system and the predicate device.
Other Non-Clinical Testing:
- Electrical Safety Testing: The system passed electrical safety testing in accordance with requirements for medical electrical equipment.
- Electromagnetic Compatibility (EMC): The system passed EMC testing.
- Laser Safety: The system passed particular requirements for the safety of diagnostic and therapeutic laser equipment.
- Cleaning and Sterilization: The handpieces passed cleaning and sterilization validations for reusable medical devices.
- Software: Verification testing was conducted; all tests were completed successfully.
- Usability: Usability testing was conducted; all acceptance criteria for user design validation were met.
Clinical Testing:
- No clinical testing was required to support the medical device as the indications for use are equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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K123 494 1/4
510(k) Summary
1. Submission Sponsor
FEB 1 1 2013
Convergent Dental, Inc. 2 Vision Drive Natick, MA 01760 USA Phone: (508) 500-5656 Contact: Jon Quillard, VP of Regulatory Affairs
2. Submission Correspondent
Emergo Group 611 West 5th Street, Third Floor Austin, TX 78701 Cell Phone: (720) 838.4113 Office Phone: (512) 327 9997 Fax: (512) 327.9998 Contact: Carrie Hetrick, Senior Consultant Email: project.management@emergogroup.com
3. Date Prepared
23 October 2012
4. Device Identification
| Trade/Proprietary Name: | Solea |
|---|---|
| Common/Usual Name: | CO2 laser |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and dermatology |
| Classification Regulation: | 878.4810 |
| Product Code: | GEX |
| Device Class: | Class II |
| Classification Panel: | General and Plastic Surgery |
5. Predicate Devices
Lutronic Corporation Spectra DENTA II Laser System, 510(k) Number: K091320
6. Device Description
The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy 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 incision, excision, vaporization, coagulation, and hemostasis.
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K123499 2/4
7. Intended Use
The Solea system is indicated for the following:
- . Incision
- . Excision
- . Vaporization
- . Coagulation
- Hemostasis
of soft tissue in the oral cavity.
8. Comparison of Technological Characteristics
The following table compares the Solea to the predicate device with respect to the intended use, technological characteristics, and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
| Convergent Dental, Inc. | Lutronic Corporation | |
|---|---|---|
| Trade Name | Solea | Spectra DENTA II |
| 510(k) | ||
| Number | Pending | K091320 |
| Common | ||
| Name | CO2 Laser | CO2 Laser |
| Classification | ||
| Names (FDA) | Powered Laser Surgical Instrument | Powered Laser Surgical Instrument |
| FDA | ||
| Classification | ||
| Codes | GEX | GEX |
| Predicates | ||
| cited | K091320 | K050254, K030147, K935563, K963229, |
| K991297, K021508, K081181 | ||
| Target User | General practitioner dentists and | |
| specialists | General practitioner dentists and specialists | |
| Indications | ||
| for use | The Solea system is indicated for the | |
| following: | ||
| • Incision | ||
| • Excision | ||
| • Vaporization | ||
| • Coagulation | ||
| • Hemostasis | ||
| of soft tissue in the oral cavity. | The Spectra DENTA II Laser System is | |
| indicated for use in soft tissue dental | ||
| indications including periodontic procedures | ||
| such as, but not limited to, removal of | ||
| diseased or inflamed soft tissue in the | ||
| periodontal pocket (sulcular debridement), | ||
| vaporization, gingivectomy-removal of | ||
| hyperplasias, gingivoplasty, papillectomy, | ||
| vestibuloplasty, fibroma (nonmalignant | ||
| tumor, mucosa, tongue), epulis, incision and | ||
| excision, removal of soft tissue, cysts, and | ||
| tumors, and laser assisted new attachment | ||
| procedure (cementum mediated periodontal | ||
| ligament new attachment to the root surface | ||
| in the absence of long junctional epithelium); | ||
| Oral surgery such as frenectomy, frenum | ||
| release, drainage (abscess), flap surgery, | ||
| incisional and excisional biopsy, incision and |
Table 5A – Comparison of Characteristics
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K123494 3/4
| Convergent Dental, Inc. | Lutronic Corporation | |
|---|---|---|
| Trade Name | Solea | Spectra DENTA II |
| excision of aphthous ulcers, incision of infection when used with antibiotic therapy, excision and ablation of benign and malignant lesions, oral cavity tumors and hemangiomas, salivary gland pathologies, preprosthetic gum preparation, leukoplakia; partial glossectomy, periodontal gum resection, homeostasis, operculectomy, and crown lengthening. | ||
| Laser | ||
| classification | Class 4 (IV) Laser Product | Class 4 (IV) Laser Product |
| Type of Laser | CO₂ (Carbon Dioxide) | CO₂ (Carbon Dioxide) |
| Wavelength | 9.25µm (9250 nm) | 10.6µm (10600 nm) |
| Fluence: | ||
| Energy per | ||
| mm² | 1.13J/mm² | 1.08J/mm² |
| Irradiance: | ||
| Power per | ||
| mm² | 112.80W/mm² | 194.80W/mm² |
| Operating | ||
| Modes | Ablation laser: Pulsed | |
| Aiming laser: Continuous | Ablation laser: Pulsed | |
| Aiming laser: Continuous | ||
| Beam | ||
| Delivery | Articulating Arm (Free Space) | Articulating Arm (Free Space) |
| Sterilization | ||
| Methods | Steam Autoclave | Steam Autoclave |
| RF emissions | CISPR 11 Group 1 | CISPR 11 Group 1 |
| EMC | ||
| compliance | CISPR 11 Class A | CISPR 11 Class A |
| Harmonic | ||
| emissions | IEC 61000-3-2 Class A | IEC 61000-3-2 Class A |
| Voltage | ||
| fluctuations/ | ||
| flicker | ||
| emissions | IEC 61000-3-3 | IEC 61000-3-3 Class A |
9. Non-Clinical 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 device 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 medical electrical equipment.
Electromagnetic Compatibility: .
The system passed electromagnetic compatibility (EMC) testing to meet requirements for medical electrical equipment.
3
Laser Safety: .
The system passed particular requirements 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.
. Software:
Verification 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. 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 Soft Tissue Testing:
Performance data was collected using the Solea system and the predicate device. A quantitative analysis was conducted evaluating the depth, width and length of cuts, a histological assessment of changes in sample tissue, and effect on tissue surrounding the incision areas. The results show substantially equivalent results for both 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 device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the use of the device. The nonclinical 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 device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.
It has been shown in this 510(k) submission that the difference between the Solea system and the predicate devices do not raise any questions regarding its safety and effectiveness. Performance testing and compliance with voluntary standards, demonstrate that the Solea system is substantially equivalent to the relevant aspects of the predicate devices in terms of design, components, materials, principals of operation, sterilization, biocompatibility, performance characteristics, and intended use. Solea, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Convergent Dental, Incorporated % Emergo Group. Incorporated Ms. Carrie Hetrick Senior Regulatory Consultant 611 West 5th Street Third Floor Austin, Texas 78701
February 11, 2013
Re: K123494
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: November 05, 2012 Received: November 13, 2012
Dear Mr. 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
5
Page 2 - Ms. Carrie Hetrick
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 (reporting of medical device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
FOR ·
Peter Di Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
510(k) Number (if known): K123494
Device Name: Solea
Indications for Use:
The Solea system is indicated for the following:
- Incision .
- . Excision
- . Vaporization
- . Coagulation
- Hemostasis .
of soft tissue in the oral cavity.
Prescription Use ×
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R Ogden 2013.02.11 ,1 3:12:15 -05'00'
. .
(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ K123494