(574 days)
The mJoule RF System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
The mJOULE RF System consists of console and radio frequency delivery accessories. The control console houses the power supply, cooling system and RF delivery system. The treatment parameters are entered via a touchscreen on the console. The user activates RF emission by means of a footswitch.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of diagnostic accuracy or clinical outcomes. Instead, it details the FDA 510(k) clearance for the mJOULE RF System, focusing on its substantial equivalence to a predicate device (Potenza K192545) based on technical specifications and safety testing.
However, I can extract the information about the performance testing that was conducted to demonstrate safety and effectiveness for the purpose of regulatory clearance.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative "acceptance criteria" in the format of a clinical performance study with sensitivity, specificity, or similar metrics. Instead, it describes a series of engineering and safety performance tests designed to show the device operates within specifications and is safe. The "reported device performance" is that the device successfully passed these tests.
| Acceptance Criteria (Implicit from testing) | Reported Device Performance |
|---|---|
| Performance Parameters: | |
| Frequency accuracy (Bipolar at 1MHz) | Tested and confirmed |
| Power measurement accuracy | Tested and confirmed |
| Energy per pin and total energy accuracy | Tested and confirmed |
| Impedance measurement accuracy and range | Tested and confirmed |
| Safety test of various warnings/failsafe mechanisms | Tested and confirmed |
| Needle depth accuracy | Tested and confirmed |
| Motor speed level | Tested and confirmed |
| Biocompatibility: | |
| Acute systemic toxicity | Passed (ISO 10993 compliant) |
| Cytotoxicity | Passed (ISO 10993 compliant) |
| Irritation | Passed (ISO 10993 compliant) |
| Sensitization | Passed (ISO 10993 compliant) |
| Pyrogenicity | Passed (ISO 10993 compliant) |
| Sterilization: | |
| Sterility Assurance Level (SAL) | Achieved at least 10^-6 |
| Electrical Safety & EMC: | |
| IEC 60601-1 compliance | Compliant |
| IEC 60601-1-2 compliance (EMC) | Compliant |
| IEC 60601-2-2 compliance (High-frequency surgical equipment) | Compliant |
| IEC 60601-1-6 compliance | Compliant |
| Software Verification & Validation: | |
| Compliance with FDA Software Guidance | Confirmed |
| Thermal Testing (Efficacy): | |
| Creation of coagulative zones below tissue surface | Successfully created; proportional to energy delivered |
| Safe and effective for specified indications | Concluded to be safe and effective |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated as a number of patients or cases. For bench testing, it refers to the number of tests performed on the device. For thermal testing, "ex vivo porcine tissue" was used, but the quantity of samples is not given.
- Data Provenance: The bench and thermal testing were conducted by Sciton, Inc. and are therefore considered internal company data. The thermal testing used "ex vivo porcine tissue." This is likely retrospective, as it's part of the development and verification process before submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The "ground truth" for the performance tests is derived from engineering specifications and established scientific standards (e.g., ISO, IEC). For thermal testing, the evaluation of coagulative zones would typically be done by qualified personnel, but their number and specific qualifications are not mentioned.
4. Adjudication Method for the Test Set:
Not applicable or not described for the types of tests mentioned. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies with human evaluators to resolve discrepancies in diagnostic interpretations. These tests are primarily technical performance and safety assessments against predefined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC comparative effectiveness study was not done. The device (mJOULE RF System) is an electrosurgical cutting and coagulation device, not an AI-assisted diagnostic tool for human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable in the context of this device. This device is a physical instrument for medical procedures, not a standalone algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for the tests described is based on:
- Engineering Specifications: For parameters like frequency, power, energy, impedance, needle depth, motor speed, and safety mechanisms.
- International Standards: For biocompatibility (ISO 10993), sterilization (SAL of 10^-6), and electrical safety/EMC (IEC 60601 series).
- FDA Guidance: For software verification and validation, and for thermal testing procedures (Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery, March 9, 2020).
- Ex Vivo Observation: For thermal testing, confirming the creation of coagulative zones.
8. The Sample Size for the Training Set:
Not applicable. This device is a hardware system, not a machine learning algorithm that requires a training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a machine learning algorithm.
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April 23, 2024
Sciton, Inc. Jay Patel VP of Regulatory Affairs 925 Commercial Street Palo Alto, California 94303
Re: K222958
Trade/Device Name: mJOULE RF System and Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: March 22, 2024 Received: March 25, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.04.23 08:18:06 -04'00'
Mark Trumbore, Ph.D. Acting Division 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
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Indications for Use
510(k) Number (if known) K222958
Device Name mJoule RF System
Indications for Use (Describe)
The mJoule RF System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
| 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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510(k) 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: | April 19, 2024 |
| Device Trade Name: | mJOULE RF System |
| Common Name: | Electrosurgical Cutting and Coagulation Device and Accessories |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and Accessories, 21 CFR 878.4400 |
| Classification Product Code: | GEI |
| Legally Marketed PredicateDevice: | K192545 Potenza |
| Description of the mJOULERF System: | The mJOULE RF System consists of console and radio frequency deliveryaccessories. The control console houses the power supply, cooling system and RFdelivery system. The treatment parameters are entered via a touchscreen on theconsole. The user activates RF emission by means of a footswitch. |
| Indications for Use: | The mJOULE RF system is intended for use in dermatologic and general surgicalprocedures for electrocoagulation and hemostasis. |
| TechnologicalCharacteristics: | The mJOULE System shares the same indications for use. Predicate Comparisonof this submission, shares similar design features (including frequency and deliverysystems, power supply, cooling and control system), functional features (includingpower output and needle array size), and is therefore substantially equivalent to theabove legally marketed predicate device. |
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Comparative representation of Potenza (K192545), which is the predicate for the subject device, mJOULE
RF System (K222958).
| Specification | Predicate Device | This Application |
|---|---|---|
| 510(k) Number | K192545 | K222958 |
| Product | Potenza | mJOULE RF System |
| Regulation | GEI, 21 CFR 878.4400 | GEI, 21 CFR 878.4400 |
| Device Class | ll | ll |
| Intended Use | The POTENZA is intended for usein dermatologic and generalsurgical procedures forelectrocoagulation andhemostasis. | mJOULE RF System is intendedfor use in in dermatologic andgeneral surgical procedures forelectrocoagulation andhemostasis. |
| Frequency | 1MHz, 2MHz | 1MHz |
| Needle Array Size | 7x7, 5x5, 4x4, 1 | 7x7, 6x6 |
| Needle Array Pitch | 1.4 mm, 2 mm | 1.4 mm, 1.7 mm |
| Needle ExposedLength | 0.4 mm | 0.4 mm |
| Needle Depth | 0.5 - 4.0 mm | 0.5 - 4.0 mm |
| Needle Polarity | Bipolar | Bipolar |
| Needle Diameter | 0.2 mm | 0.2 mm |
| Treatment Time | 10 – 500 ms | 10 – 600 ms |
| Power Max | 50 W | 50 W |
| Power per Needle | 1.02 W for 7x7 array | 1.02 W for 7x7 & 6x6 array |
| Sterilization | EO | EO |
| Power Source(Active Accessory) | 100 - 240 VAC, 50/60 Hz | 100 - 240 VAC, 50/60 Hz |
| Electrode - SingleUse (Yes/No) | Yes | Yes |
| Control System | Microprocessor | Microprocessor |
| Energy Monitor | Display Indicates EnergyDelivered to Tissue | Display Indicates EnergyDelivered to Tissue |
| Safety | NA | Safety Eyewear and RemoteInterlock Connector |
| Safety ComplianceStandards | IEC 60601-1, IEC 60601-1-2, IEC60101-2-2, IEC 60601-1-6 | IEC 60601-1, IEC 60601-1-2, IEC60601-2-2, IEC 60601-1-6 |
| Console Dimension | 20" x 14" x 12" | 12" x 15" x 43" |
| User Interface | Touch screen control | Touch screen control |
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Performance Testing – Bench:
The safety and efficacy of the mJoule RF System were established by a series of performance tests; lab performance tests, design validation and software verification and validation. Sciton conducted bench testing to ensure that the mJoule RF System operates safely and within predefined design specifications.
-
- Tested parameters include:
- · Frequency: Bipolar at 1MHz
- Power measurements
- · Energy per pin and total energy
- · Impedance measurement accuracy and range
- · Safety test of various warnings / failsafe mechanisms
- · Needle depth
- Motor speed level
- Biocompatibility testing The biocompatibility tests were performed according to ISO 10993 standards for acute systemic toxicity, cytotoxicity, irritation, sensitization, and pyrogenicity assessment of mJoule RF device as recommended in ISO 10993-1 and FDA's guidance document.
-
- Sterilization testing The sterilization of single use disposable tips was tested to ensure the sterility assurance level (SAL) of at least 10-6.
| 4. | Electrical safety and electromagnetic compatibility (EMC) Electrical safety, EMC, device related electrical safety for higher frequency and usability were conducted on the mJoule RFMN system according to the following consensus standards: IEC 60601-1 Medical Electrical equipment Part1: General requirements for basic safety and essential performance IEC 60601-1-2 EMC testing- General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and Tests IEC 60601-2-2 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
|---|---|
| 5. | Software verification and validation testing Software verification and validation testing was conducted in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for the subject device. |
| Performance Testing – Thermal Testing: | Thermal testing is conducted on ex vivo porcine tissue in accordance with FDA's Guidance for Industry and FDA Staff: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery, March 9, 2020 to quantitatively determine the depth, height and width of thermal coagulative zones. It is concluded from this study that coagulation zones are created below the surface of the tissue that are proportional to the amount of energy delivered to the tissue. The ex-vivo study results show that the RF microneedling tips are safe for use and effective in achieving the specified indications of dermatologic and general surgical procedures for electrocoagulation and hemostasis. |
| Safety and Effectiveness: | The mJOULE RF System is similar to predicate device with respect to principles of operation, technological characteristics, as well as performance characteristics. Results of design validation and verification activities, i.e., testing to designated |
Safet Effec Results of design validation and verification activities, i.e., testing to standards and performance testing of the device has demonstrated substantial equivalence of the subject device to the predicate device in terms of safety and effectiveness for requested intended use.
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Conclusion:
The mJOULE RF System shares similar indications for use, design features, and similar functional features as, and therefore is substantially equivalent to the currently marketed predicate device. Any minor differences in the technological characteristics do not raise new safety or effectiveness concerns.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.