(230 days)
The JOULE diVa Laser Device with its accessories is intended for coagulation, ablation, or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes).
The JOULE diVa Laser System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.
The JOULE diVa Laser Device 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 provided document is a 510(k) summary for the Sciton JOULE diVa Laser Device, which is a medical device and not an AI/ML-driven device. Therefore, the information requested about acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and MRMC studies, which are typically relevant for AI/ML device evaluations, is not applicable to this submission.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, intended use, and non-clinical performance (safety).
Here's a breakdown of the information provided in the document from the perspective of non-AI device validation, aligning with the sections of your request where applicable:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table with specific acceptance criteria directly alongside performance metrics in the way one would for an AI model's accuracy, sensitivity, or specificity. Instead, it demonstrates performance by showing compliance with recognized consensus standards for safety and electrical characteristics.
| Criteria Category | Acceptance Standard | Reported Device Performance |
|---|---|---|
| Safety and Performance | IEC 60601-2-22 (3rd Ed. + A1:2012) | Conforms (basic safety and essential performance of laser equipment) |
| IEC 60601-1:2005 | Conforms (general requirements for basic safety and essential performance) | |
| IEC 60601-1-2 (Ed 4.0): 2014 | Conforms (basic safety and essential performance in presence of electromagnetic disturbance and emission) | |
| IEC 60601-1-6: 2010 AMD1:2013 | Conforms (usability of the system and accessories) | |
| Biocompatibility | ISO 10993-5 (Cytotoxicity) | Passing |
| USP guidelines (Cytotoxicity) | Passing | |
| ISO 10993-10 (Irritation) | Met requirements | |
| ISO 10993-23 (Irritation) | Met requirements | |
| ISO 10993-10 (Sensitization) | Met requirements | |
| Software | "Guidance for the content of premarket submissions for software contained in medical devices" | All items (risk analysis, development procedure, cybersecurity, requirements, design, test plan, traceability) met requirements. |
| Sterility | Not applicable | No component or accessory is sold sterile. |
| Shelf-life | Not applicable | Low likelihood of time-dependent product degradation. |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable in the context of an AI/ML device validation. The performance evaluation here relies on standardized testing protocols (e.g., electrical safety tests, EMC tests, biocompatibility tests), not a "test set" of data in the AI sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. Ground truth as typically defined for AI model validation (e.g., expert-labeled data) is not relevant for this type of device submission. Compliance with standards and successful completion of physical and software tests are the "ground truth" here, established by accredited testing bodies and internal quality controls.
4. Adjudication Method for the Test Set:
Not applicable. There is no "test set" or human-driven adjudication process described for the device's technical performance in the AI/ML context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
Not applicable. The JOULE diVa Laser Device is a hardware-based medical device for surgical procedures, not a diagnostic or AI-powered imaging interpretation tool that would typically undergo MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an algorithm-only device. Its performance is evaluated through its physical and electrical characteristics and compliance with safety standards.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is established by:
- Compliance with recognized consensus standards: This includes electrical safety (IEC 60601-1, IEC 60601-2-22), electromagnetic compatibility (IEC 60601-1-2), and usability (IEC 60601-1-6).
- Biocompatibility testing: Performed according to international standards (ISO 10993-5, ISO 10993-10, ISO 10993-23) to assess cytotoxicity, irritation, and sensitization.
- Software verification and validation: Demonstrated against FDA guidance for medical device software.
8. The Sample Size for the Training Set:
Not applicable. This device does not use an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As noted, there is no AI/ML training set for this device.
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July 19, 2022
Sciton, Inc Jay Patel VP of Regulatory Affairs 925 Commercial Street Palo Alto, California 94303
Re: K213761
Trade/Device Name: Joule diVa 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: June 8, 2022 Received: June 9, 2022
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
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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 medical devices and radiation-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,
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control 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) K213761
Device Name JOULE diVa Laser Device
Indications for Use (Describe)
The JOULE diVa Laser Device with its accessories is intended for coagulation, ablation, or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes).
The JOULE diVa Laser System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.
| 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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K213761 Summary
| Submitter: | Sciton, Inc. |
|---|---|
| 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: | July 16, 2022 |
| Device Trade Name: | JOULE diVa Laser Device |
| Common Name: | Laser Powered Surgical Device (and Accessories) |
| Classification Name: | Laser Surgical Instrument, 21 CFR 878.4810. |
| Product Code: | GEX |
| Legally MarketedPredicate Device: | K101916 Joule Multi-Platform SystemK060033 Profile Multi-Platform SystemK210634 MCL 31 Dermablate System |
| Description of JOULEdiVa Laser Device: | The JOULE diVa Laser Device consists of a console and laser deliver accessories.It uses focusing optics to deliver optical energy to the treatment site. The controlconsole houses the power supply, cooling system, articulated arm delivery systemand/or fiber optic arm delivery system with a handpiece. The user activates laseremission by means of a footswitch. |
| Intended Use: | The JOULE diVa Laser Device with its accessories is intended for coagulation,vaporization, ablation, or cutting of soft tissue (skin) in Dermatology, PlasticSurgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skinaround the eyes).The JOULE diVa Laser System, when used with its micro beam handpieces, isintended for use in Dermatological procedures and Skin resurfacing procedures. |
| TechnologicalCharacteristics: | The JOULE diVa Laser Device 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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| JOULE diVa Laser Device | |||||
|---|---|---|---|---|---|
| Specification | Predicate Device | Predicate Device | Predicate Device | This Application | Similar |
| Ref. 510(k) | K101916 | K060033 | K210634 | K213761 | -- |
| Product | Joule Multi-PlatformSystem1470 nm Laser System | Joule Multi-PlatformSystem2940 nm Laser System | MCL 31 DermablateSystem | Joule diVa Laser Device | -- |
| Indications forUse | The JOULE 1470 nmMulti-Platform Systemsand delivery accessoriesare intended for deliveryof laser light to soft tissuefor use in incision,excision, vaporization,ablation, hemostasis orcoagulation of soft tissue.The device is indicatedfor the treatment of refluxof the saphenous veinsassociated with varicoseveins and varicosities.The JOULE 14 70 nmMulti-Platform Systemswith Profractionalhandpiece and deliverysystem is intended foruse in dermatologicalprocedures requiring skinresurfacing andcoagulation of soft tissue. | General SurgeryThe Er: YAG is intendedfor the surgicalincision/excision,vaporization andcoagulation of soft tissueduring any general surgeryapplication where skinincision, tissue dissection,excision of external tumorsand lesions, complete orpartial resection of internalorgans, tumors, tissueablation and/or vesselcoagulation.Gynecology:Indications include cervicalintraepithelial neoplasia(CIN), herpes simplex,endometrial adhesions,cysts and condyloma. | The MCL 31 Dermablatesystem with its accessoriesis indicated for coagulation,vaporization, ablation, orcutting of soft tissue (skin) inDermatology, PlasticSurgery, Oral Surgery, ENT,Gynecology, GeneralSurgery, Podiatry, andOphthalmology (skin aroundthe eyes).The MCL 31 DermablateSystem, when used with itsmicro beam handpieces, isintended for use inDermatological proceduresand Skin resurfacingprocedures. | The JOULE diVa LaserDevice with its accessories isintended for coagulation,vaporization, ablation, orcutting of soft tissue (skin) inDermatology, Plastic Surgery,ENT, Gynecology, GeneralSurgery, Podiatry, andOphthalmology (skin aroundthe eyes).The JOULE diVa LaserSystem, when used with itsmicro beam handpieces, isintended for use inDermatological proceduresand Skin resurfacingprocedures. | Yes |
| CDRH LaserClass | Class 4 | Class 4 | Class 4 | Class 4 | Yes |
| EnergySource | Diode Laser, CW, pulsed | Erbium YAG Laser | Erbium YAG Laser | Diode Laser, CW, pulsedErbium YAG Laser | Yes |
| LaserWavelength | 1470 nm | 2940 nm | 2940 nm | 1470 nm and 2940 nm | Yes |
| PulseDuration | Up to 100 sec | 100 $\mu$ s-1000 ms | 100 - 1000 $\mu$ s | Up to 1000 ms | Yes |
| Power | Up to 100 W | 100W | -- | Up to 100 W | Yes |
| PulseRepetitionRate | -- | 5-60 Hz | 20 Hz | 5-60 Hz | Yes |
| Energy perPulse | -- | 0.2-7.0 Joules | 2.5 Joules | 0.2-7.0 Joule | Yes |
| DisplayScreen | Yes | Yes | Yes | Yes | Yes |
| Utilities | 230 VAC/30A, 50/60 Hz | 220 VAC/ 50/60 Hz/ 1φ | -- | 230 VAC/30A, 50/60 Hz | Yes |
| Aiming Beam | Red/Green | Red | Red | Red/Green | Yes |
| DeliverySystem | Articulated Arm or FiberOptic | Articulated Arm or Fiberoptic | Articulated Arm | Articulated Arm or Fiber optic | Yes |
| CoolingSystem | Water to Air | Water to Air | Water to Air | Water to Air | Yes |
| ControlSystem | Microprocessor | Microprocessor | Microprocessor | Microprocessor | Yes |
| EnergyMonitor | Display Indicates EnergyDelivered to Tissue | Display Indicates EnergyDelivered to Tissue | Display Indicates EnergyDelivered to Tissue | Display Indicates EnergyDelivered to Tissue | Yes |
| Safety | Safety Eyewear andRemote InterlockConnector | Safety Eyewear andRemote InterlockConnector | Safety Eyewear andRemote Interlock Connector | Safety Eyewear and RemoteInterlock Connector | Yes |
| ConsoleDimensions | 14" x 21" x 41" high | 14" x 21" x 41" high | 11" x 23" x 37" high | 14" x 21" x 41" high | Yes |
| Weight | 200 lbs | 200 lbs | 165 lbs | 200 lbs | Yes |
| Handpiece | |||||
| Photos | Image: handpiece 1 | Image: handpiece 2 | Image: handpiece 3 | Image: handpiece 4 | |
| Spot Size | 430 μm | 425 μm & 600 μm | 450 μm | Yes | |
| Energy perPulse | < 70 mJ/microbeam | -- | < 70 mJ/microbeam | Yes | |
| Fluence | Up to 48 J/cm² | Up to 35 J/cm² | Up to 48 J/cm² | Yes | |
| PulseDuration | Up to 1000 ms | -- | Up to 1000 ms | Yes | |
| DistanceIndicator | Stainless steel spacer | Dilator | Strengthened quartz dilator | Yes | |
| Aiming Beam | 630 – 680 nm <2.5 mW | 630 – 680 nm <2.5 mW | 630 – 680 nm <2.5 mW | Yes | |
| Output Mode | Fractional pulsed mode | Fractional pulsed mode | Fractional pulsed mode | Yes | |
| Laser Media | Flashlamp pumped solid state laser and laser diode | Flashlamp pumped solid state laser and laser diode | Flashlamp pumped solid state laser and laser diode | Yes |
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The indications for use are based upon the indications for use for predicate systems. Effectiveness: Technologically, the JOULE diVa Laser Device is substantially equivalent to the listed predicate devices. Therefore, the risks and benefits for the JOULE diVa Laser Device are comparable to the predicate devices.
Summary of Non-clinical Tests:
Safety and
Performance: FDA recognized consensus standards were utilized to evaluate the JOULE system for nonclinical performance. These included electrical, mechanical, EMC testing, usability and essential performance of the JOULE system.
The following information summarizes the non-clinical bench performance testing performed for the predicate devices and the subject device (Joule diVa Laser Device).
| Joule Multi-Platform System1470 nm Laser System | Joule Multi-Platform System2940 nm Laser System | MCL 31 DermablateSystem | Joule diVa LaserDevice |
|---|---|---|---|
| IEC 60601-1-4 | IEC 60601-1-4 | - | - |
| IEC 60601-2-22 | IEC 60601-2-22 | IEC 60601-2-22 | IEC 60601-2-22:2007 (3d edition) +A1:2012 |
| IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | IEC 60601-1: 2005 |
| IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 (Ed4.0): 2014 |
| IEC 60601-1-6 | - | - | IEC 60601-1-6: 2010AMD1:2013 |
- . IEC 60601-2-22: 2007 (3d edition) +A1:2012 indicates the conformity of JOULE system with the particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnose laser equipment. Examples of test performed are Interruption of power supply, indication of laser output, indications of parameters relevant to safety and emergency stop.
- IEC 60601-1:2005 is applicable for the general requirements concerning basic safety and essential ● performance that are applicable to medical electrical equipment. Examples of tests performed on the JOULE system based upon this standard are power input,
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humidity, durability of markings, leakage current, dielectric strength, excessive temperature, push & impact tests, etc.
- . IEC 60601-1-2 (Ed 4.0): 2014 indicates the conformity of the JOULE system to the basic safety and essential performance of medical equipment (ME) in the presence of electromagnetic disturbance and for electromagnetic emission of ME systems. Examples of the tests performed are electrostatic discharge immunity test, electromagnetic field immunity, transient immunity, power frequency magnetic field immunity, voltage dips/interruptions immunity tests, etc.
- . IEC 60601-1-6: 2010 AMD1:2013 indicates the usability of JOULE system and its associated accessories. Examples of evaluations performed are usability of engineering principles, hazards related to usability, user interface, medical benefits versus risks, etc.
Biocompatibility: The biocompatibility of the patient-contacting component of the JOULE diVa delivery system (HEREAUS QUARTZ GLASS TUBE HLQ 200 V8) were confirmed in testing by Nelsons Lab with passing cytotoxicity, irritation and sensitivity test results.
The cytotoxicity test was conducted in accordance with ISO 10993-5 and USP guidelines. The Irritation test result met the requirements of the ISO 10993-10 and ISO 10993-23 guidelines. The sensitization test results met the requirements of the ISO 10993-10 guidelines.
Software: Software verification and validation testing documents were provided as recommended by "Guidance for the content of premarket submissions for software contained in medical devices." All the items in the software risk analysis, software development procedure, cybersecurity risk analysis, software requirement specification, software design documentation, software test plan and traceability analysis met the requirements.
Sterility: The JOULE system has no component or accessory that is sold sterile.
Shelf-life: Shelf-life is not applicable for JOULE system because of low likelihood of time-dependent product degradation.
Conclusion: The conclusions drawn from the non-clinical tests demonstrate that the JOULE diVa Laser device is as safe as the legally marketed device (predicate).
Conclusion:
JOULE diVa Laser Device shares similar indications for use, design features, and similar functional features, and is therefore substantially equivalent to the currently marketed 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.