(208 days)
JOULE 1927nm Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).
The JOULE 1927nm Laser System consists of a console and laser deliver accessories. It uses focusing optics to deliver optical energy to the treatment site. The control console houses the power supply, cooling system, articulated arm delivery system and/or fiber optic arm delivery system with a handpiece. The user activates laser emission by means of a footswitch.
The Sciton, Inc. JOULE 1927nm Laser System is a laser surgical instrument intended for dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions. The device received 510(k) clearance (K182173) on March 6, 2019, based on demonstrating substantial equivalence to predicate devices, namely the Solta FraxelDUAL (K130193) and the Lutronic LASEMD Laser System (K171009).
This device did not undergo a study to prove it met specific acceptance criteria in terms of clinical performance metrics like sensitivity, specificity, or reader improvement. Instead, its acceptance was based on non-clinical performance data and a comparison of its technological characteristics and indications for use to legally marketed predicate devices.
Here's the breakdown of the information provided in the context of your request:
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Table of Acceptance Criteria and Reported Device Performance: This information is not presented as a table of acceptance criteria for clinical performance in the provided document. The device's acceptance was based on demonstrating substantial equivalence to predicate devices in terms of its technological characteristics, intended use, and safety. The provided table (on page 4) lists the specifications of the JOULE 1927nm Laser System and its predicate devices, indicating where they are substantially equivalent.
Specification Predicate Device (FraxelDUAL) Predicate Device (LASEMD Laser System) This Application (JOULE 1927nm) Substantially Equivalent Indications for Use Same as JOULE Same as JOULE Dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions. Yes CDRH Laser Class Class 4 Class 4 Class 4 Yes Laser Type Thulium Laser Thulium Laser Thulium Laser Yes Energy Source 1927 nm 1927 nm 1927 nm Yes Spot Size 256 – 620 µm 100 - 200 µm 100 – 620 µm Yes Maximum Tip Width 7 and 15 mm 10 mm 15 mm Yes Wavelength 1927 nm 1927 nm 1927 nm Yes Pulse Repetition Rate 0 – 3 kHz 43.5 - 307.7 Hz 0 – 3 kHz Yes Pulse Duration Up to 10 ms Up to 20 ms Up to 20 ms Yes Energy Up to 20 mJ Up to 20 mJ Up to 20 mJ Yes Utilities 120-240 VAC, 50/60 Hz 100-240 VAC, 50/60 Hz 200-240 VAC/25A, 50/60 Hz Yes Power 12 W (1927 nm) 5 W (1927 nm) 12 W (1927 nm) Yes Aiming Beam Red Red Red Yes Delivery System Fiber optic Fiber and Handpiece Articulated Arm or Fiber optic Yes Emission Control Footswitch Footswitch Footswitch Yes Display Screen Yes Yes Yes Yes Cooling System Air to Air Air to Air Water to Air Yes (Functionally Equivalent) Control System Microprocessor Microprocessor Microprocessor Yes Energy Monitor Display Indicates Energy Delivered to Tissue Display Indicates Energy Delivered to Tissue Display Indicates Energy Delivered to Tissue Yes Safety Safety Eyewear and Remote Interlock Connector Safety Eyewear and Remote Interlock Connector Safety Eyewear and Remote Interlock Connector Yes -
Sample size used for the test set and the data provenance: Not applicable. The FDA clearance was based on non-clinical performance data and substantial equivalence arguments, not on a clinical test set with patient data for assessing diagnostic or treatment efficacy in the same way an AI device might be. The non-clinical tests relate to device safety and functionality.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there was no clinical test set for which ground truth needed to be established by experts for performance evaluation.
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Adjudication method for the test set: Not applicable.
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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 treatment, not an AI-assisted diagnostic device for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device, a laser system, not an algorithm.
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The type of ground truth used: For the non-clinical performance data, the "ground truth" would be established by validated test methods and engineering specifications. For example, for electrical safety, the ground truth is adherence to standards like IEC 60601-1. For biocompatibility, the ground truth is determined by testing against ISO 10993-1. These are objective measures against established standards.
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The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set.
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How the ground truth for the training set was established: Not applicable.
Summary of the "Study" and Acceptance Criteria:
The "study" in this context refers to the non-clinical performance testing and the comparative analysis against predicate devices to demonstrate substantial equivalence.
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Acceptance Criteria: The primary acceptance criterion was demonstrating substantial equivalence to the legally marketed predicate devices (Solta FraxelDUAL K130193 and Lutronic LASEMD Laser System K171009) in terms of:
- Intended Use: The JOULE 1927nm Laser System shares the same Indications for Use as the predicates (dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions).
- Technological Characteristics: The device shares similar design features (wavelength, laser medium and delivery systems, power supply, cooling and control system) and functional features (power output, repetition rate, energy, spot size, and fluence). Minor differences in cooling system (Water to Air vs. Air to Air) and physical dimensions were deemed not to raise new questions of safety or effectiveness.
- Safety Standards: Adherence to recognized electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-22, and IEC 60825-1).
- Software Verification and Validation: Successful performance of software V&V.
- Biocompatibility: Patient-contacting components were tested for biocompatibility per ISO 10993-1.
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Device Performance:
- Non-Clinical Performance Data: Electrical safety, electromagnetic compatibility, software verification and validation, and biocompatibility testing were all "successfully performed" according to the relevant standards.
- Comparative Performance: The JOULE 1927nm Laser System's specifications (e.g., energy, pulse repetition rate, spot size, wavelength) fall within the range or are comparable to those of the predicate devices, supporting the claim of substantial equivalence for its intended use.
In conclusion, the FDA clearance for the JOULE 1927nm Laser System was based on non-clinical engineering and safety tests, and a direct comparison of its technical specifications and indications for use against already-cleared predicate devices, rather than a clinical study evaluating its direct performance against a ground truth from a patient-based test set or an AI algorithm's performance.
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Sciton, Inc Jay M. Patel VP of Regulatory Affairs 925 Commercial Street Palo Alto, California 94303
March 6, 2019
Re: K182173
Trade/Device Name: Joule System 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: February 6, 2019 Received: February 8, 2019
Dear Jay Patel:
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.
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
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Digitally signed by Neil R Neil R Ogden -S Ogden -S Date: 2019.03.06 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182173
Device Name Joule 1927nm Laser System
Indications for Use (Describe)
JOULE 1927nm Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
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| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Attachment IV
510(k) Summary
| Submitter: | Sciton, Inc. |
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| Address: | 925 Commercial Street, Palo Alto, CA 94303 |
| Phone: | (650) 493-9155 |
| Fax : | (650) 493-9146 |
| Contact Person: | Jay M. Patel, VP of Regulatory Affairs |
| Date Prepared: | March 6, 2019 |
| Device Trade Name: | JOULE 1927nm Laser System |
| Common Name: | Laser Powered Surgical Device (and Accessories) |
| Classification Name: | Laser Surgical Instrument, 21 CFR 878.4810. |
| Product Code: | GEX |
| Legally MarketedPredicate Device: | K130193: Solta FraxelDUALK171009: Lutronic LASEMD Laser System |
| Description ofJOULE 1927nmLaser System: | The JOULE 1927nm Laser System consists of a console and laser deliveraccessories. It uses focusing optics to deliver optical energy to the treatment site.The control console houses the power supply, cooling system, articulated armdelivery system and/or fiber optic arm delivery system with a handpiece. The useractivates laser emission by means of a footswitch. |
| Intended Use: | The JOULE 1927nm Laser System with its accessories is intended for use indermatological procedures requiring the coagulation of soft tissue, treatment ofactinic keratosis, and treatment of benign pigmented lesions such as, but notlimited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles). |
| TechnologicalCharacteristics: | The JOULE 1927nm Laser System shares the same indications for use,and as noted below, shares similar design features (including wavelength, lasermedium and delivery systems, power supply, cooling and control system), functionalfeatures (including power output, repetition rate, energy, spot size and fluence), andis therefore substantially equivalent to the above legally marketed predicate devices. |
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| Specification | Predicate Device | Predicate Device | This Application | SubstantiallyEquivalent |
|---|---|---|---|---|
| FraxelDUAL | LASEMD Laser System | JOULE 1927 nm | -- | |
| Indications forUse | The Fraxel 1927 nm laser isindicated for use indermatological proceduresrequiring the coagulation ofsoft tissue, treatment of actinickeratosis, and treatment ofpigmented lesions such as,but not limited to lentigos (agespots), solar lentigos (sunspots) and ephelides(freckles). | The LASEMD Laser Systemis indicated for use indermatological proceduresrequiring the coagulation ofsoft tissue, treatment ofactinic keratosis, andtreatment of benignpigmented lesions such as,but not limited to lentigos(age spots), solar lentigos(sun spots) and ephelides(freckles). | JOULE 1927nm LaserSystem is indicated for use indermatological proceduresrequiring the coagulation ofsoft tissue, treatment ofactinic keratosis, andtreatment of benignpigmented lesions such as,but not limited to lentigos(age spots), solar lentigos(sun spots) and ephelides(freckles). | Yes |
| Ref. 510(k) | K130193 | K171009 | N/A | -- |
| CDRH LaserClass | Class 4 | Class 4 | Class 4 | Yes |
| Laser Type | Thulium Laser | Thulium Laser | Thulium Laser | Yes |
| Energy Source | 1927 nm | 1927 nm | 1927 nm | Yes |
| Spot Size | 256 – 620 μm | 100 - 200 μm | 100 – 620 μm | Yes |
| Maximum TipWidth | 7 and 15 mm | 10 mm | 15 mm | Yes |
| Wavelength | 1927 nm | 1927 nm | 1927 nm | Yes |
| Pulse RepetitionRate | 0 – 3 kHz | 43.5 - 307.7 Hz | 0 – 3 kHz | Yes |
| Pulse Duration | Up to 10 ms | Up to 20 ms | Up to 20 ms | Yes |
| Energy | Up to 20 mJ | Up to 20 mJ | Up to 20 mJ | Yes |
| Utilities | 120-240 VAC,50/60 Hz | 100-240 VAC, 50/60 Hz | 200-240 VAC/25A, 50/60 Hz | Yes |
| Power | 12 W (1927 nm) | 5 W (1927 nm) | 12 W (1927 nm) | Yes |
| Aiming Beam | Red | Red | Red | Yes |
| Delivery System | Fiber optic | Fiber and Handpiece | Articulated Arm or Fiber optic | Yes |
| Emission Control | Footswitch | Footswitch | Footswitch | Yes |
| Display Screen | Yes | Yes | Yes | Yes |
| Cooling System | Air to Air | Air to Air | Water to Air | Yes |
| Control System | Microprocessor | Microprocessor | Microprocessor | Yes |
| Energy Monitor | Display Indicates EnergyDelivered to Tissue | Display Indicates EnergyDelivered to Tissue | Display Indicates EnergyDelivered to Tissue | Yes |
| Safety | Safety Eyewear and RemoteInterlock Connector | Safety Eyewear and RemoteInterlock Connector | Safety Eyewear and RemoteInterlock Connector | Yes |
| ConsoleDimensions | 19" x 18" x 18" high | 16" x 10" x 13" high | 14" x 21" x 41" high | Yes |
| Weight | 55 lbs | 73 lbs | 200 lbs | -- |
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| Non-ClinicalPerformance Data | Electrical safety and electromagnetic compatibility testing was performed perstandards IEC 60601-1: 2012 reprint, IEC 60601-1-2:2007, IEC 60601-1-6:2010,IEC 60601-2-22:2007 and IEC 60825-1:2014. Software verification and validation wassuccessfully performed. Patient contacting component was tested for biocompatibilityper ISO 10993-1 and was determined to be biocompatible. |
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| Safety andEffectiveness: | The indications for use are based upon the indications for use for predicate systems.Technologically, the JOULE 1927nm Laser System is substantially equivalent to thelisted predicate devices. Therefore, the risks and benefits for the JOULE 1927nmLaser System is comparable to the predicate devices. |
| Conclusion: | JOULE 1927nm Laser System shares similar indications for use, design features, andsimilar functional features as, and therefore is substantially equivalent to the currentlymarketed predicate devices. |
§ 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.