(574 days)
Not Found
No
The summary describes a standard RF system with a console, touchscreen, and footswitch, and the performance testing focuses on electrical, thermal, and software validation without mentioning any AI/ML specific methodologies or data sets.
Yes
The device is intended for dermatologic and general surgical procedures for electrocoagulation and hemostasis, which are therapeutic applications.
No
The device description and intended use state that it is for electrocoagulation and hemostasis in dermatologic and general surgical procedures, which are treatment rather than diagnostic functions.
No
The device description explicitly states that the mJOULE RF System consists of a console and radio frequency delivery accessories, including a power supply, cooling system, and RF delivery system, which are hardware components. While software is mentioned in the performance studies, the device is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "dermatologic and general surgical procedures for electrocoagulation and hemostasis." This describes a therapeutic or surgical intervention performed directly on a patient's tissue, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a system that delivers radio frequency energy to tissue. This is consistent with a device used for surgical procedures, not for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to directly interact with tissue for therapeutic/surgical outcomes.
N/A
Intended Use / Indications for Use
The mJoule RF System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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.
- 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
- 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 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.
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.
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
§ 878.4400 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
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).
1
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
2
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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3
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 Predicate | |
| Device: | K192545 Potenza |
| Description of the mJOULE | |
| RF System: | 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. | |
| Indications for Use: | The mJOULE RF system is intended for use in dermatologic and general surgical |
| procedures for electrocoagulation and hemostasis. | |
| Technological | |
| Characteristics: | The mJOULE System shares the same indications for use. Predicate Comparison |
| of this submission, shares similar design features (including frequency and delivery | |
| systems, power supply, cooling and control system), functional features (including | |
| power output and needle array size), and is therefore substantially equivalent to the | |
| above legally marketed predicate device. |
4
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 use | |
| in dermatologic and general | ||
| surgical procedures for | ||
| electrocoagulation and | ||
| hemostasis. | mJOULE RF System is intended | |
| for use in in dermatologic and | ||
| general surgical procedures for | ||
| electrocoagulation and | ||
| hemostasis. | ||
| 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 Exposed | ||
| Length | 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 - Single | ||
| Use (Yes/No) | Yes | Yes |
| Control System | Microprocessor | Microprocessor |
| Energy Monitor | Display Indicates Energy | |
| Delivered to Tissue | Display Indicates Energy | |
| Delivered to Tissue | ||
| Safety | NA | Safety Eyewear and Remote |
| Interlock Connector | ||
| Safety Compliance | ||
| Standards | IEC 60601-1, IEC 60601-1-2, IEC | |
| 60101-2-2, IEC 60601-1-6 | IEC 60601-1, IEC 60601-1-2, IEC | |
| 60601-2-2, IEC 60601-1-6 | ||
| Console Dimension | 20" x 14" x 12" | 12" x 15" x 43" |
| User Interface | Touch screen control | Touch screen control |
5
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.
6
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.