(230 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard laser technology components and operation.
Yes
The device is intended for coagulation, ablation, or cutting of soft tissue, which are direct therapeutic interventions.
No
Explanation: The device is intended for therapeutic procedures such as coagulation, ablation, or cutting of soft tissue, not for diagnosing conditions.
No
The device description explicitly states it consists of a console and laser delivery accessories, including hardware components like a power supply, cooling system, and handpiece. While software is mentioned for verification and validation, the core device is a hardware-based laser system.
Based on the provided information, the JOULE diVa Laser Device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "coagulation, ablation, or cutting of soft tissue (skin)" and "Dermatological procedures and Skin resurfacing procedures." These are all procedures performed directly on the patient's body.
- Device Description: The description details a laser system that delivers optical energy to the treatment site on the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body. The JOULE diVa Laser Device is a therapeutic device used for surgical and dermatological procedures directly on the patient.
N/A
Intended Use / Indications for Use
The JOULE diVa Laser Device with its accessories is intended for coagulation, vaporization, 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (skin) in Dermatology, Plastic Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
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, 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K101916 Joule Multi-Platform System, K060033 Profile Multi-Platform System, K210634 MCL 31 Dermablate System
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.
Not Found
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).
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line.
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
1
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
2
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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3
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 Marketed | |
| Predicate Device: | K101916 Joule Multi-Platform System |
| K060033 Profile Multi-Platform System | |
| K210634 MCL 31 Dermablate System | |
| Description of JOULE | |
| diVa 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 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. | |
| Intended Use: | The JOULE diVa Laser Device with its accessories is intended for coagulation, |
| vaporization, 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. |
| Technological
Characteristics: | The JOULE diVa Laser Device shares the same indications for use,
and as noted below, shares similar design features (including wavelength, laser
medium and delivery systems, power supply, cooling and control system), functional
features (including power output, repetition rate, energy, spot size and fluence), and
is therefore substantially equivalent to the above legally marketed predicate devices. |
4
| JOULE diVa Laser Device | |||||
|---|---|---|---|---|---|
| Specification | Predicate Device | Predicate Device | Predicate Device | This Application | Similar |
| Ref. 510(k) | K101916 | K060033 | K210634 | K213761 | -- |
| Product | Joule Multi-Platform | ||||
| System | |||||
| 1470 nm Laser System | Joule Multi-Platform | ||||
| System | |||||
| 2940 nm Laser System | MCL 31 Dermablate | ||||
| System | Joule diVa Laser Device | -- | |||
| Indications for | |||||
| Use | The JOULE 1470 nm | ||||
| Multi-Platform Systems | |||||
| and delivery accessories | |||||
| are intended for delivery | |||||
| of laser light to soft tissue | |||||
| for use in incision, | |||||
| excision, vaporization, | |||||
| ablation, hemostasis or | |||||
| coagulation of soft tissue. | |||||
| The device is indicated | |||||
| for the treatment of reflux | |||||
| of the saphenous veins | |||||
| associated with varicose | |||||
| veins and varicosities. | |||||
| The JOULE 14 70 nm | |||||
| Multi-Platform Systems | |||||
| with Profractional | |||||
| handpiece and delivery | |||||
| system is intended for | |||||
| use in dermatological | |||||
| procedures requiring skin | |||||
| resurfacing and | |||||
| coagulation of soft tissue. | General Surgery | ||||
| The Er: YAG is intended | |||||
| for the surgical | |||||
| incision/excision, | |||||
| vaporization and | |||||
| coagulation of soft tissue | |||||
| during any general surgery | |||||
| application where skin | |||||
| incision, tissue dissection, | |||||
| excision of external tumors | |||||
| and lesions, complete or | |||||
| partial resection of internal | |||||
| organs, tumors, tissue | |||||
| ablation and/or vessel | |||||
| coagulation. | |||||
| Gynecology: | |||||
| Indications include cervical | |||||
| intraepithelial neoplasia | |||||
| (CIN), herpes simplex, | |||||
| endometrial adhesions, | |||||
| cysts and condyloma. | The MCL 31 Dermablate | ||||
| system with its accessories | |||||
| is indicated for coagulation, | |||||
| vaporization, ablation, or | |||||
| cutting of soft tissue (skin) in | |||||
| Dermatology, Plastic | |||||
| Surgery, Oral Surgery, ENT, | |||||
| Gynecology, General | |||||
| Surgery, Podiatry, and | |||||
| Ophthalmology (skin around | |||||
| the eyes). | |||||
| The MCL 31 Dermablate | |||||
| System, when used with its | |||||
| micro beam handpieces, is | |||||
| intended for use in | |||||
| Dermatological procedures | |||||
| and Skin resurfacing | |||||
| procedures. | The JOULE diVa Laser | ||||
| Device with its accessories is | |||||
| intended for coagulation, | |||||
| vaporization, 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. | Yes | ||||
| CDRH Laser | |||||
| Class | Class 4 | Class 4 | Class 4 | Class 4 | Yes |
| Energy | |||||
| Source | Diode Laser, CW, pulsed | Erbium YAG Laser | Erbium YAG Laser | Diode Laser, CW, pulsed | |
| Erbium YAG Laser | Yes | ||||
| Laser | |||||
| Wavelength | 1470 nm | 2940 nm | 2940 nm | 1470 nm and 2940 nm | Yes |
| Pulse | |||||
| Duration | 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 |
| Pulse | |||||
| Repetition | |||||
| Rate | -- | 5-60 Hz | 20 Hz | 5-60 Hz | Yes |
| Energy per | |||||
| Pulse | -- | 0.2-7.0 Joules | 2.5 Joules | 0.2-7.0 Joule | Yes |
| Display | |||||
| Screen | 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 |
| Delivery | |||||
| System | Articulated Arm or Fiber | ||||
| Optic | Articulated Arm or Fiber | ||||
| optic | Articulated Arm | Articulated Arm or Fiber optic | Yes | ||
| Cooling | |||||
| System | Water to Air | Water to Air | Water to Air | Water to Air | Yes |
| Control | |||||
| System | Microprocessor | Microprocessor | Microprocessor | Microprocessor | Yes |
| Energy | |||||
| Monitor | Display Indicates Energy | ||||
| Delivered to Tissue | 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 | Safety Eyewear and Remote | ||||
| Interlock Connector | Yes | ||||
| Console | |||||
| Dimensions | 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 per | |||||
| Pulse |