(226 days)
No
The summary describes a standard radiofrequency device for electrocoagulation and hemostasis. There is no mention of AI, ML, image processing, or any data-driven algorithms for decision making or analysis. The performance studies focus on tissue effects at different power levels, not on the performance of any AI/ML component.
No.
The device is indicated for electrocoagulation and hemostasis in surgical procedures, which are not considered therapeutic but rather supportive functions during a surgical procedure.
No
The device is indicated for electrocoagulation and hemostasis, which are treatment procedures, not diagnostic ones. It delivers energy to alter tissue, rather than to detect or identify a medical condition.
No
The device description explicitly lists hardware components such as a handpiece, footswitch, and a neutral electrode pad, indicating it is not solely software.
Based on the provided information, the DefineRF device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "electrocoagulation and hemostasis" in dermatological and general surgical procedures. This involves directly treating tissue within the body.
- Device Description: The device is a "monopolar radiofrequency device" that delivers energy to a needle tip for tissue treatment.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health. The DefineRF does not perform any such analysis of specimens.
The DefineRF is a therapeutic device used for surgical procedures, not a diagnostic device used for analyzing samples.
N/A
Intended Use / Indications for Use
DefineRF is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
DefineRF is a monopolar radiofrequency device that delivers up to 50W to the chosen location of the single needle tip. The device is equipped with touchscreen user interface, a footswitch, a handpiece, a needle type RF electrode, and an FDA cleared single use neutral electrode pad (K092761). The needle tip is single use and provided sterile. The system is designed for use in a clinical environment for use on adults.
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
adults
Intended User / Care Setting
clinical environment
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 - NonClinical:
- ISO 10993-1: 2009, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process ●
- ISO 10993-5: 2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity ●
- ISO 10993-10: 2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization . Biocompatibility Tests were performed in accordance with FDA standards and all patient contacting materials were determined to be biocompatible.
Performance Testing:
Testing was performed on three different tissue types recommended by the FDA: ex vivo kidney, muscle, and skin. Treatment setting included the three power levels, low (1.2)), medium (6.8)), for skin and kidney specimens. For muscle specimen low (4.J), Medium (5.6), and maximum (8 J) power levels were tested. Treatments in all tissues were performed at the demis layer in all specimens. All treatments were performed at 37°C, the temperature close to physiological. Treatments produced clearly detectable Coagulation Micro Zones in all treated tissues at the target depths. The Test device were consistent in all test tissue. The study concluded that treatment by the device possessed a desirable clinical treatment effect.
Clinical Evidence – N/A. No clinical studies were conducted as part of this submission.
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.
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 14, 2024
Aesthetic Management Partners Shlomo Assa Consultant 9019 Macon Road Cordova, Tennessee 38016
Re: K232301
Trade/Device Name: Define RF Microneedling System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: February 2, 2024 Received: February 2, 2024
Dear Shlomo Assa:
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 (QS) 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 OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 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 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,
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.03.14 10:07:29 -04'00' Mark Trumbore, Ph.D. 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
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Indications for Use
510(k) Number (if known)
Device Name DefineRF
Indications for Use (Describe)
DefineRF is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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This 510(K) Summary of safety and effectiveness for the DefineRF is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant | Aesthetic Management Partners |
|---|---|
| Address | 9019 Macon Road |
| Cordova, TN 38016 | |
| Contact Person | Shlomo Assa |
| Consultant | |
| Acclaro Corporation | |
| Contact Information | (619) 988-4796 |
| sassa@acclaromd.com | |
| Preparation Date | Februar 2, 2024 |
| Device Trade Name | DefineRF |
| Classification Name | |
| Common Name | |
| Regulation Number | Electrosurgical cutting and coagulation |
| RF Electrosurgical Device | |
| 878.4400 | |
| Product Code | |
| Regulatory Class | GEI |
| II | |
| Legally Marketed Predicate | |
| Device | Agnes (K160469) |
| Gowoonsesang Cosmetics Co., Ltd |
Device Description:
DefineRF is a monopolar radiofrequency device that delivers up to 50W to the chosen location of the single needle tip. The device is equipped with touchscreen user interface, a footswitch, a handpiece, a needle type RF electrode, and an FDA cleared single use neutral electrode pad (K092761). The needle tip is single use and provided sterile. The system is designed for use in a clinical environment for use on adults.
Indications for use:
DefineRF is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
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Device Comparison—Indications for Use:
| Subject Device (DefineRF) | Predicate Device (Agnes K160469) | Reference Device (Darwin K212607, RF Microneedle only) | Comparison |
|---|---|---|---|
| DefineRF is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. | Agnes is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. | Darwin RF Microneedle handpiece is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. | Same |
Device Comparison – Technical Specifications:
| Specification | Define RF (Subject Device) | Agnes (K192728) | Reference Device (Darwin K212607, RF microneedle only) | Comparison |
|---|---|---|---|---|
| Product Code | GEI | GEI, KCW | GEI | The Define RF does not include the KCW product code because the device is not intended for epilation |
| Operation | The device uses RF energy delivered through micro needle electrode to apply heat to target tissue for coagulating. | The device uses RF energy delivered through micro needle electrode to apply heat to target tissue for coagulating. | The device uses RF energy delivered through micro needle electrode to apply heat to target tissue for coagulating. | Same |
| # of needles | 1 | 1 | 10 and 25 | Same |
| Frequency | 1MHz | 1MHz | 2MHz | Same |
| Modality | Monopolar | Monopolar | Bipoloar | Same |
| Indications | DEFINE is indicated for use in dermatological and general surgical procedures for | AGNES is indicated for use in dermatological and general surgical procedures for | Use in dermatologic and general surgical procedures for electrocoagulation and | Same |
| electrocoagulation and | ||||
| hemostasis. | electrocoagulation and | |||
| hemostasis. | hemostasis | |||
| Materials | Stainless steel with polyester | |||
| based coating | Electrode: STS 304, Insulating | |||
| Coating: pxylylene dimer C | Tip: Polycarbonate Needles: | |||
| SU304 | Different. The Define Rf has | |||
| undergone biocompatibility | ||||
| testing to ensure safety of | ||||
| patient contacting | ||||
| materials | ||||
| Power | 50W | 46W at 200Ω | Up to 36W | Different. The maximum |
| power on the Define RF is | ||||
| slightly higher than the | ||||
| predicate device. However, | ||||
| performance testing shows | ||||
| their equivalence. | ||||
| Return | Disposable neutral electrode | |||
| pad | Disposable neutral electrode | |||
| pad | N/A | Same | ||
| RF Duration | 1-2000ms | 50-2000ms | Not publicly available | Different. The minimum |
| pulse duration on the | ||||
| Define is slightly lower than | ||||
| the predicate device. The | ||||
| difference is minimal and | ||||
| does not impact the safety | ||||
| or efficacy of the device. | ||||
| Needle | ||||
| Length | Needle Length: 3.5mm (2.5mm | |||
| active zone) | ||||
| Thickness: .37mm | Needle length : 0.8/1.25/1.5/ | |||
| 2.0 mm Thickness : 0.2mm | 0.5 – 3.5mm treatment depth | Different. The active zone | ||
| of the Define RF needle is | ||||
| slightly longer than the | ||||
| predicate's longest needle, | ||||
| but the same as the | ||||
| reference device. | ||||
| Single Use or | ||||
| Reusable | Single Use | Single use | Single Use | Same |
| Sterilization | EO gas | EO gas | EO Gas | Same |
| Max output | ||||
| voltage | 160 V | 104 V | Not publicly available | Different |
| Temperature | None | None | Not publicly available | Same |
| Sensors | DefineRF | |||
| Impedance | ||||
| Monitor | Yes, during pulsing, the system | |||
| continuously monitors | ||||
| impedance and adjusts output | ||||
| to deliver the selected power. | ||||
| As a safety feature, above 340Ω | ||||
| impedance, it faults and stops | ||||
| pulsing. | None | Not publicly available | Different. The Define RF | |
| has a more robust safety | ||||
| function than the | ||||
| predicate. | ||||
| Continuity | ||||
| Monitor | There is no requirement for a | |||
| grounding pad however the | ||||
| system will not operate without | ||||
| a grounding pad due to | ||||
| exceeding the maximum | ||||
| voltage. | Checking the connection | |||
| between the neutral | ||||
| electrode and the | ||||
| electrosurgical unit. | Not publicly available | Different systems, but | ||
| same level of safety | ||||
| function. | ||||
| Electrode | ||||
| Monitor | Needles are monitored via RFID | |||
| scanning | Provide a camera to monitor | |||
| the electrode coating | ||||
| condition and shape before | ||||
| using by the user. | Not publicly available | Different systems. The | ||
| Define RF system ensures | ||||
| that no needles are reused. | ||||
| Output | ||||
| power levels | (3 to 20W) in 1 Watt | |||
| increments | 25 levels (2 to 46W) | 10 levels (up to 36W) | While the max power | |
| outputs for the two devices | ||||
| are very similar, the Define | ||||
| RF has a functional output | ||||
| power level that is lower | ||||
| than the predicate. | ||||
| Functional testing (see | ||||
| details below) shows | ||||
| comparable performance | ||||
| between the two devices | ||||
| when tested to the 20W | ||||
| max output power. | ||||
| Dimensions | 368mm(W)x551mm(L)x607mm(H) | 290mm(W)x455mm(L)x271.7mm(H) | Unknown | Different |
| Weight | 11.3kg | 5.8kg | Not publicly available | Different |
| Power input | 100-250VAC, 50-60Hz | 100-250VAC, 50-60Hz | AC 220-240 V, 50 /60 Hz, 16A | Same |
| DefineRF | ||||
| Footswitch | ||||
| Specifications | Single pole, double throw | Single pole, single throw | Not publicly available | Different. The double throw function of the |
| Define predicate provides | ||||
| an additional layer of | ||||
| safety against misfiring | ||||
| from the footswitch. |
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510(K) Summary
Comparison
The DefineRF microneedling system is very similar to its design, principle of operation and technical specifications and has the same indications for use. Both devices are single-need, monopolar radiofrequency systems with similar maximum output power, frequency, and pulse duration. The DefineRF contains additional safety features that are not present in the Agnes, including impedance regulation and needle scanning to ensure needles are not reused.
The needle length of the DefineRF is slightly longer than that of the same as the reference device's needle length. The Define RF thermal testing was conducted to a depth of 3.5mm. Thermal effect was evaluated through histopathology testing and the results show similar performance for the two devices and do not raise any problems in the safety and effectiveness.
Electrical Safety and Electromagnetic Compatibility
The Electrical Safety and Electromagnetic compatibility tests were performed in accordance with the following standards.
- IEC 60601-1: 2005, Medical electrical equipment Part 1: General reguirements for basic safety and essential performance ●
- IEC 60601-2-2: 2017/AMD2:2020 Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of Radio frequency surgical equipment and Radio frequency.
- IEC 60601-1-2: 2014/AMD1:2020, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Performance Testing - NonClinical
- ISO 10993-1: 2009, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process ●
- ISO 10993-5: 2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity ●
- ISO 10993-10: 2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization . Biocompatibility Tests were performed in accordance with FDA standards and all patient contacting materials were determined to be biocompatible.
8
- IEC 62304:2006+A1:2015; Medical Device Software Life Cycle Processes . Software verification and validation testing was conducted, and documentation provided in accordance with FDA's Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices.
- EN ISO 14971:2019+A11:2021; Medical Devices Application of Risk Management To Medical Devices .
Sterility and Packaging
- · ISO 11135: 2014, Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 11138-2: 2006, Sterilization of health care products Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processes
- . ISO 10993-7: 2008, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- ISO 11607-1: 2006, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and . packaging systems
- . ISO 11607-2:2019, Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
- · ISO 11737-2:2019, Sterilization of medical devices Microbiological methods -Part 2: Tests of sterlity performed in the definition, validation and maintenance of sterilization process
Performance Testing
Testing was performed on three different tissue types recommended by the FDA: ex vivo kidney, muscle, and skin. Treatment setting included the three power levels, low (1.2)), medium (6.8)), for skin and kidney specimens. For muscle specimen low (4.J), Medium (5.6), and maximum (8 J) power levels were tested. Treatments in all tissues were performed at the demis layer in all specimens. All treatments were performed at 37°C, the temperature close to physiological. Treatments produced clearly detectable Coagulation Micro Zones in all treated tissues at the target depths. The Test device were consistent in all test tissue. The study concluded that treatment by the device possessed a desirable clinical treatment effect.
Clinical Evidence – N/A. No clinical studies were conducted as part of this submission.
Conclusion
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The DefineRF microneedling system is very similar the Agnes in its design, principle of operation and technical specifications and has the same indications for use. Both devices are single-ney systems with similar maximum output power, frequency, and pulse duration. The DefineRF contains additional safety features that are not present in the Agnes, including impedance regulation and needle scanning to ensure need. The similarities in design and functionality as well as the results of histopathology testing shows that the DefineRF is substantially equivalent to the Agnes. In additional safety features built into the DefineRF shows that the Define RF is as safe or safer than the predicate.
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510(K) Summary