(85 days)
Dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures.
The CLEAR+BRILLIANT™ Laser System is a non-ablative laser system designed for use in non-invasive dermatological procedures. The CLEAR+BRILLIANT™ Laser System has a laser source in the hand piece which is controlled by an embedded processor. The console is electrically connected to the facility power source. Laser energy produced by the unit is delivered to the tissue through the removable (disposable) contact treatment tips which attach to the hand piece.
The provided 510(k) summary for the CLEAR+BRILLIANT™ Laser System (K110349) describes a non-ablative laser system for dermatological procedures. It primarily relies on demonstrating substantial equivalence to a predicate device (Fraxel IV SR Laser System, K063808) rather than presenting a traditional clinical study with defined acceptance criteria for device performance in terms of diagnostic accuracy or effect size in comparison to a gold standard.
Here's an analysis of the provided information concerning acceptance criteria and the study:
1. A table of acceptance criteria and the reported device performance
Since this is a submission for substantial equivalence based on technological performance and histological outcome mirroring the predicate device, the "acceptance criteria" are implied by compliance with standards and a comparative histological assessment, rather than specific performance metrics (e.g., sensitivity, specificity, accuracy) typical of diagnostic or decision-support AI devices.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Electrical Safety: Compliance with ISO 60601-1 | Compliant with ISO 60601-1 for electrical safety. |
| EMI/EMC: Compliance with IEC 60601-1-2 | Compliant with IEC 60601-1-2 for EMI/EMC. |
| Laser Safety: Compliance with ISO 60825 | Compliant with ISO 60825 (Laser Safety). |
| Biocompatibility: Compliance with ISO 10993-1 for treatment tips | Compliant with ISO 10993-1 for biocompatibility of the treatment tips. |
| Histological Outcome: Treatment skin response equivalent to predicate device at same energy density settings. | Histology confirms the treatment skin response is the same as for the predicate Fraxel IV SR laser system when used at the same energy density settings. This implies that the device achieved the expected tissue reaction and depth of treatment for its intended dermatological procedures, consistent with the predicate. |
2. Sample size used for the test set and the data provenance
The submission text does not specify a separate "test set" in the context of diagnostic or AI performance evaluation. Instead, it refers to:
- Histology: "Histology confirms the treatment skin response is the same as for the predicate Fraxel IV SR laser system when used at the same energy density settings."
- Sample Size: Not explicitly stated. The number of subjects or tissue samples used for histological comparison is not provided.
- Data Provenance: The provenance (e.g., country of origin, retrospective/prospective) for the histological data is not mentioned. It is implied to be from a scientific study or series of studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not explicitly provided in the 510(k) summary. For histological assessments, it is standard practice to have pathologists interpret the tissue samples, but neither the number nor their qualifications are detailed.
4. Adjudication method for the test set
Not applicable/not specified. The document does not describe an adjudication method for the histological assessment, which is typical for such comparisons where a pathologist's interpretation is generally considered definitive for a given sample.
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
Not applicable. This device is a laser system for dermatological procedures, not an AI-assisted diagnostic or decision-support tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used
For the key performance claim related to clinical effect, the ground truth was histology (histological outcome/treatment skin response). This means that tissue samples were examined under a microscope to confirm the expected changes induced by the laser treatment, establishing the biological effect.
8. The sample size for the training set
Not applicable, as this is a medical device (laser system), not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI device.
Summary of the Study:
The "study" presented in this 510(k) is primarily a comparative technological and biological assessment designed to demonstrate substantial equivalence to a legally marketed predicate device (Fraxel IV SR Laser System, K063808).
- Objective: To show that the CLEAR+BRILLIANT™ Laser System, despite having pre-determined energy settings (unlike the user-selectable settings of the predicate), performs equivalently to the predicate device in terms of safety standards, biocompatibility, and, crucially, histological outcome.
- Methodology:
- Compliance Testing: The device underwent testing to confirm compliance with international standards for electrical safety (ISO 60601-1), EMI/EMC (IEC 60601-1-2), laser safety (ISO 60825), and biocompatibility of its treatment tips (ISO 10993-1).
- Histological Comparison: Histological examination was conducted to compare the "treatment skin response" of the CLEAR+BRILLIANT™ system to that of the predicate device when both were operated at the same energy density settings.
- Key Finding: "Histology confirms the treatment skin response is the same as for the predicate Fraxel IV SR laser system when used at the same energy density settings." This was the primary evidence for the clinical equivalence of the device's effects on tissue, supporting its intended use.
- Conclusion for Equivalence: Based on the satisfactory results of safety and biocompatibility testing, and the confirmed histological equivalence to the predicate, the submission concluded that the CLEAR+BRILLIANT™ laser system is substantially equivalent to the Fraxel IV SR laser system and raises no new questions of safety and effectiveness.
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510(k) SUMMARY STATEMENT
MAY - 3 2011
This 510(k) summary is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990, 21 CFR 807.92
1. General Information
Date of Submission: February 4, 2011
Submitted By:
Solta Medical, Inc. 25881 Industrial Blvd Hayward, CA 94545
Contact Person:
Kristine Foss V.P., Regulatory, Clinical & Quality 510-780-4657 (Direct Phone) 510-780-4857 Fax kfoss@solta.com
2. Trade/Proprietary Name of Device:
| Trade Name: | CLEAR+BRILLIANTT™ Laser System |
|---|---|
| Common Name: | Laser Surgical Instrument |
| Regulation Number | 878.4810 |
| Product Code: | GEX |
| Device Panel: | General Surgery/Restorative Devices |
| Device Classification: | Class II |
3. Legally Marketed Predicate Device for Claimed Equivalence:
Name: Fraxel IV SR Laser System 510(k) #: K063808
4. Device Description
The CLEAR+BRILLIANT™ Laser System is a non-ablative laser system designed for use in non-invasive dermatological procedures.
The CLEAR+BRILLIANT™ Laser System has a laser source in the hand piece which is controlled by an embedded processor. The console is electrically connected to the facility power source. Laser energy produced by the unit is delivered to the tissue through the removable (disposable) contact treatment tips which attach to the hand piece.
4. Indications for Use:
Dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures.
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ડ. Technological Performance Data:
The CLEAR+BRILLIANT™ Laser System is compliant with ISO 60601-1 for electrical safety, IEC 60601-1-2 for EMI/EMC, ISO 60825 and 10993-1 for biocompatibility of the treatment tips.
Histology confirms the treatment skin response is the same as for the predicate Fraxel IV SR laser system when used at the same energy density settings.
The difference between the CLEAR+BRILLIANT™ device and its predicate is that the CLEAR+BRILLIANT™ device is operated at pre-determined energy settings (the lower end of the range in the predicate); not user selectable settings, as in the predicate.
ર્. Summary Statement:
With the same intended use, same patient population, same setting (wavelength, spot-size, fractional treatment and pattern of micro treatment zone punctures, same optical tracking system, and histological ooutcome), the CLEAR+BRILLIANT™ laser system is equivalent to the Fraxel IV SR laser system. Based upon the passing test results for laser safety and electrical safety, as well as biocompatibility and histology, when compared to the predicate, the CLEAR+BRILLIANT™ laser raises no new safety and effectiveness questions.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY - 3 2011
Solta Medical, Inc. % Ms. Kristine Foss V.P., Regulatory, Clinical & Quality 25881 Industrial Boulevard Hayward, California 94545
Re: K110349
Trade/Device Name: CLEAR+BRILLIANT™ Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: ONG Dated: April 5, 2011 Received: April 7, 2011
Dear Ms. Foss:
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. Iisting 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
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Page 2 - Ms. Kristine Foss
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 (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.lda.gov/Mcdicall.cvices/Safetv/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Molkerson
Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
. -Enclosure
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Indications for Use
510(k) Number (if known): _ KII 0349
CLEAR+BRILLIANT™ Laser System Device Name:
Indications For Use:
Dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of C te of Device Evaluation (ODE)
J.R. M. Sale for mkn
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110349
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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.