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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "DefineRF Microneedling System." It primarily focuses on demonstrating substantial equivalence to a predicate device, Agnes (K160469), rather than presenting a detailed clinical study for acceptance criteria.

While it mentions performance testing and biocompatibility, it explicitly states: "Clinical Evidence – N/A. No clinical studies were conducted as part of this submission."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets them based on clinical evidence, because such a study was not conducted or submitted for this 510(k). The regulatory pathway chosen (510(k)) relies on demonstrating substantial equivalence to a legally marketed predicate device, often through non-clinical performance data and technical comparisons, rather than de novo clinical trials to prove efficacy and safety in the same way a PMA would.

However, I can extract the non-clinical performance testing details described in the document, which serve as evidence for substantial equivalence, and frame them in the context of what would typically be considered "acceptance criteria" for a non-clinical evaluation.

Here's a breakdown of the available information and why some requested points cannot be answered:

Acceptance Criteria and Reported Device Performance (Non-Clinical):

Acceptance Criteria (Implied Non-Clinical)	Reported Device Performance (Non-Clinical)
Electrical Safety & EMC Conformance: Adherence to relevant IEC 60601 standards for medical electrical equipment, including general safety (60601-1), radiofrequency surgical equipment (60601-2-2), and electromagnetic disturbances (60601-1-2).	Tests performed in accordance with IEC 60601-1: 2005, IEC 60601-2-2: 2017/AMD2:2020, and IEC 60601-1-2: 2014/AMD1:2020. (Implicitly passed, as clearance was granted).
Biocompatibility: Patient-contacting materials must be biocompatible according to ISO 10993 standards (e.g., cytotoxicity, irritation, sensitization).	Biocompatibility tests performed according to ISO 10993-1: 2009, ISO 10993-5: 2009, and ISO 10993-10: 2010. "all patient contacting materials were determined to be biocompatible."
Software Verification & Validation: Software must meet FDA's guidance for medical device software life cycle processes and risk management.	Software V&V testing conducted and documentation provided in accordance with IEC 62304:2006+A1:2015 and EN ISO 14971:2019+A11:2021. (Implicitly passed).
Sterility & Packaging: Sterilization process, biological indicator efficacy, residuals, and packaging integrity must meet ISO standards.	Tests performed in accordance with ISO 11135: 2014, ISO 11138-2: 2006, ISO 10993-7: 2008, ISO 11607-1: 2006, ISO 11607-2:2019, and ISO 11737-2:2019. (Implicitly passed).
Functional Performance (Thermal Effect/Coagulation): Device should produce desirable clinical treatment effect (coagulation micro zones) at target depths across different tissue types and power levels, comparable to expectations for electrocoagulation.	Testing on three ex vivo tissue types (kidney, muscle, skin) at 37°C. Treatment settings included low, medium, and maximum power levels. "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."
Equivalence to Predicate Device: Overall design, principle of operation, technical specifications, and indications for use must be substantially equivalent to the predicate.	The document extensively details comparisons, highlighting similarities in indications, operation, frequency, modality, and even slightly higher safety features (impedance monitoring, needle scanning). Despite some differences in power, needle length, and voltage, these were addressed by performance testing and deemed not to impact safety or efficacy, leading to a strong conclusion of substantial equivalence.

Information Not Available / Not Applicable (as per the document):

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for the ex vivo tissue performance testing. The document mentions "three different tissue types" and "all specimens" but no specific case count.
- Data Provenance: Ex vivo tissue testing. Country of origin not specified, but typically conducted in a controlled lab environment. The document describes it as "ex vivo kidney, muscle, and skin". It is a non-clinical, prospective test for the device's performance within a controlled lab setting, not using human patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as there was "no clinical studies" and "no human-in-the-loop performance." The "ground truth" for the ex vivo performance testing was the observation of "clearly detectable Coagulation Micro Zones" via methods like histopathology, which would be evaluated by lab personnel or pathologists, but not "experts" in the context of clinical interpretation like radiologists for AI.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no human adjudicated clinical test set was used.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an electrosurgical tool, not an AI or imaging diagnostic device that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical electrosurgical system, not an algorithm. The "performance testing" described is the device's direct physical interaction with tissue.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the ex vivo performance testing, the "ground truth" was likely established through histopathology analysis of the treated tissue samples to confirm the presence and nature of "coagulation micro zones." This is a laboratory/pathological assessment, not expert consensus in a clinical context or outcomes data.
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established:
- Not applicable. (No training set).

Summary

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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 RoadCordova, TN 38016
Contact Person	Shlomo AssaConsultantAcclaro Corporation
Contact Information	(619) 988-4796sassa@acclaromd.com
Preparation Date	Februar 2, 2024
Device Trade Name	DefineRF
Classification NameCommon NameRegulation Number	Electrosurgical cutting and coagulationRF Electrosurgical Device878.4400
Product CodeRegulatory Class	GEIII
Legally Marketed PredicateDevice	Agnes (K160469)Gowoonsesang Cosmetics Co., Ltd

Device Description:

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 andhemostasis.	electrocoagulation andhemostasis.	hemostasis
Materials	Stainless steel with polyesterbased coating	Electrode: STS 304, InsulatingCoating: pxylylene dimer C	Tip: Polycarbonate Needles:SU304	Different. The Define Rf hasundergone biocompatibilitytesting to ensure safety ofpatient contactingmaterials
Power	50W	46W at 200Ω	Up to 36W	Different. The maximumpower on the Define RF isslightly higher than thepredicate device. However,performance testing showstheir equivalence.
Return	Disposable neutral electrodepad	Disposable neutral electrodepad	N/A	Same
RF Duration	1-2000ms	50-2000ms	Not publicly available	Different. The minimumpulse duration on theDefine is slightly lower thanthe predicate device. Thedifference is minimal anddoes not impact the safetyor efficacy of the device.
NeedleLength	Needle Length: 3.5mm (2.5mmactive 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 zoneof the Define RF needle isslightly longer than thepredicate's longest needle,but the same as thereference device.
Single Use orReusable	Single Use	Single use	Single Use	Same
Sterilization	EO gas	EO gas	EO Gas	Same
Max outputvoltage	160 V	104 V	Not publicly available	Different
Temperature	None	None	Not publicly available	Same
Sensors		DefineRF
ImpedanceMonitor	Yes, during pulsing, the systemcontinuously monitorsimpedance and adjusts outputto deliver the selected power.As a safety feature, above 340Ωimpedance, it faults and stopspulsing.	None	Not publicly available	Different. The Define RFhas a more robust safetyfunction than thepredicate.
ContinuityMonitor	There is no requirement for agrounding pad however thesystem will not operate withouta grounding pad due toexceeding the maximumvoltage.	Checking the connectionbetween the neutralelectrode and theelectrosurgical unit.	Not publicly available	Different systems, butsame level of safetyfunction.
ElectrodeMonitor	Needles are monitored via RFIDscanning	Provide a camera to monitorthe electrode coatingcondition and shape beforeusing by the user.	Not publicly available	Different systems. TheDefine RF system ensuresthat no needles are reused.
Outputpower levels	(3 to 20W) in 1 Wattincrements	25 levels (2 to 46W)	10 levels (up to 36W)	While the max poweroutputs for the two devicesare very similar, the DefineRF has a functional outputpower level that is lowerthan the predicate.Functional testing (seedetails below) showscomparable performancebetween the two deviceswhen tested to the 20Wmax 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
FootswitchSpecifications	Single pole, double throw	Single pole, single throw	Not publicly available	Different. The double throw function of theDefine predicate providesan additional layer ofsafety against misfiringfrom 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.

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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

Regulation Number and Section

§ 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.