The LUTRONIC GENIUS Radiofrequency System consists of the system control module and RF power supply in a main body on locking castor wheels, a handpiece equipped with disposable handpiece tips with microneedle array, footswitch, handpiece hanger and holder, and an LCD touch screen control panel. The sterilized handpiece tips include the tip body containing the microneedle array and a protective cap. The treatment parameters are entered via a touchscreen console that also displays system output information during treatment. The microneedles come in light contact with the epidermis of the patient and minimally penetrate the epidermis during the treatment. Needle depth, Power level and Duration (Power x Duration = RF Energy), are userselectable via the GUI console. The RF Power output is controlled to insure for a given Duration that a determinate RF Energy is delivered to the 7x7 bipolar microneedle array of the handpiece tips. The handpiece is held at right angles to the target tissue. As the RF energy passes into the skin via the needles, it generates an electro-thermal reaction capable of coagulating the tissue surrounding the uninsulated portion of the needles.

AI/ML Overview

The provided text describes the LUTRONIC GENIUS Radiofrequency System, a medical device, and its comparison to a predicate device for FDA 510(k) clearance. The focus of the study to prove the device meets acceptance criteria is primarily on demonstrating substantial equivalence to the predicate device, the INFINI Radiofrequency System (K121481), rather than a study against a pre-defined set of clinical performance metrics. Therefore, the information provided does not fully align with the typical structure of an AI/ML-based medical device performance study, especially concerning elements like multi-reader multi-case studies, ground truth establishment for a test set, and detailed acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity).

However, I can extract the relevant information from the document to describe the acceptance criteria and the study that proves the LUTRONIC GENIUS Radiofrequency System's equivalence to its predicate, as this is the primary method of acceptance described in the 510(k) summary.

Acceptance Criteria and Study for LUTRONIC GENIUS Radiofrequency System

The LUTRONIC GENIUS Radiofrequency System sought 510(k) clearance by demonstrating "substantial equivalence" to a legally marketed predicate device, the INFINI Radiofrequency System (K121481). The acceptance criteria were centered around demonstrating that the modified device's technological characteristics and performance are sufficiently similar to the predicate device such that it raises no new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate)	Reported Device Performance (LUTRONIC GENIUS Radiofrequency System vs. INFINI Radiofrequency System)
Intended Use & Indications for Use: Identical or very similar to predicate, raising no new safety/effectiveness questions.	Identical Intended Use: Dermatologic and general surgical procedures for electrocoagulation and hemostasis. (Note: The LUTRONIC GENIUS removed "percutaneous treatment of facial wrinkles" from its indications, which was present in the predicate. This simplifies the claim, not adds complexity).
Technological Characteristics: Similar fundamental scientific technology, design, and principles of operation. Minor differences should not raise new safety/effectiveness questions.	Similar Technology: Both are Bipolar RF (Radiofrequency) systems delivering energy via microneedles. Key parameters: - Frequency: GENIUS: 460 KHz; INFINI: 1 MHz (Change, but deemed minor). - Max Output Power: Both 50W. - Operation Mode: Both Microneedle Fractional RF. - Treatment Duration (Time): Both 10 - 1000 msec. - Tip (Microneedle array, depth adjustment): Both 49 tip, 7x7 microneedles; 10x10 mm; depth 0.5 - 3.5 mm. - Needle Diameter: Both 200 micrometers. Other differences in dimensions, electrical requirements, GUI, packaging, shelf life, and needle coating were evaluated.
Performance Data: No significant differences in biological effects or safety outcomes.	Ex Vivo Animal Study Findings: Porcine tissue model. No statistically significant differences in the coagulation profiles (height, width, volume of thermal coagulative zones) between the two systems as per ANOVA and student t-tests. The LUTRONIC GENIUS fell within the 95% confidence interval of the INFINI for coagulation profile height, width, and volume at each setting. Additional Safety Data: Biocompatibility, Sterilization Validation, Electrical Safety & EMC, Software V&V, Cleaning & Disinfection Testing were all conducted and met relevant standards.

2. Sample Size Used for the Test Set and Data Provenance

Test Set (Ex Vivo Animal Study): The document states "an ex vivo animal study utilized a porcine tissue model." It does not specify the exact number of porcine tissue samples or animal subjects used.
Data Provenance: The ex vivo animal study was conducted to compare the LUTRONIC GENIUS with the INFINI Radiofrequency System. The data is prospective for this comparison study, specifically designed for this submission. The country of origin of the data is not explicitly stated, but the submitter is Lutronic Corporation, Republic of Korea, with a contact person in Massachusetts, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable in the context of this 510(k) submission as described. The "ground truth" for the performance comparison was the quantitative measurement of thermal coagulative zones in the ex vivo animal study, not expert consensus on medical images or patient outcomes. The evaluation involved scientific measurement and statistical analysis.

4. Adjudication Method for the Test Set

This is not applicable. The ex vivo animal study data was quantitative (height, width, and volume of thermal coagulative zones) and analyzed statistically (ANOVA, student t-tests, 95% confidence intervals). There was no subjective assessment requiring adjudication.

5. 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

No Multi-Reader Multi-Case (MRMC) study was done. This device is a direct energy delivery system, not an AI-assisted diagnostic tool. Therefore, human reader improvement with AI assistance is not relevant to this submission.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a hardware medical device, not an algorithm/software-only device intended for standalone performance evaluation in diagnosis or prediction.
Software verification and validation testing were conducted, and the software was considered a "major" level of concern, indicating a thorough V&V process for the embedded software controlling the device.

7. The Type of Ground Truth Used

The "ground truth" for the performance comparison was quantitative measurements of physical effects (height, width, and volume of thermal coagulative zones) on porcine tissue, obtained through standardized H&E staining techniques. This is a scientific and objective measure rather than expert consensus, pathology, or outcomes data in the traditional sense for diagnostic devices.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware medical device with embedded software. It is not an AI/Machine Learning device that undergoes a "training" phase on a dataset in the conventional sense. The "training set" concept is relevant for AI models, not for traditional medical devices undergoing performance testing for substantial equivalence.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, there is no "training set" as this is not an AI/ML device in the context of data-driven model training.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font below.

December 10, 2018

Lutronic Corporation James Childs, Ph.D. Clinical Science Director, Lutron Globel 19 Fortune Drive Billerica, Massachusetts, 01863

Re: K180945

Trade/Device Name: LUTRONIC GENIUS Radiofrequency System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: November 9, 2018 Received: November 13, 2018

Dear Dr. Childs:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Long H. Lona H. Chen -S Date: 2018.12.10 15:54:22 for 05'00' Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180945

Device Name LUTRONIC GENIUS Radiofrequency system

Indications for Use (Describe)

The LUTRONIC GENIUS Radiofrequency 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 CER 801 Subpart D)
☐ Over-The-Counter Use (21 CER 801 Subpart C)

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510(k) Summary for the LUTRONIC GENIUS Radiofrequency System

This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

1. General Information

Submitter:	Lutronic AestheticsLutronic Center, 219, Sowon-roDeogyang-gu, Goyang-si, Gyeonggi-do, 410-220Republic of Korea
Contact Person:	James J Childs, Ph.D.Clinical Science DirectorLutronic Aesthetics, Inc.19 Fortune DriveBillerica, MA 01863jchilds@lutronic.comTele: 508-446-1126
Summary Preparation Date:	December 6, 2018

2. Names

Trade Name: LUTRONIC GENIUS Radiofrequency System Classification Name: Electrosurgical, cutting & coagulation device & accessories Product Code: GEI Panel: General and Plastic Surgery

3. Predicate Devices

The INFINI Radiofrequency System (K121481). This predicate device has not been subject to a design-related recall. No reference devices were used in this submission.

4. Device Description

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touch screen control panel. The sterilized handpiece tips include the tip body containing the microneedle array and a protective cap. The treatment parameters are entered via a touchscreen console that also displays system output information during treatment. The microneedles come in light contact with the epidermis of the patient and minimally penetrate the epidermis during the treatment. Needle depth, Power level and Duration (Power x Duration = RF Energy), are userselectable via the GUI console. The RF Power output is controlled to insure for a given Duration that a determinate RF Energy is delivered to the 7x7 bipolar microneedle array of the handpiece tips. The handpiece is held at right angles to the target tissue. As the RF energy passes into the skin via the needles, it generates an electro-thermal reaction capable of coagulating the tissue surrounding the uninsulated portion of the needles.

5. Indications for Use

The LUTRONIC GENIUS Radiofrequency System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

6. Device Modifications

The following changes to the Predicate device, INFINI Radiofrequency System, were applied in the LUTRONIC GENIUS Radiofrequency System:

Change in dimensions of device and accessories
Change in electrical requirements ●
Change in RF frequency from 1 MHz to 460 kHz ●
Change in GUI design
Change in disposable tip packaging ●
Change in shelf life of disposable tip ●
. Change in coating of disposable tip needle

7. Comparison of Technological Characteristics with the Predicate Device

The Subject device has the same intended use and indications for use and the same fundamental scientific technology as the Predicate device, the INFINI Radiofrequency System cleared in K121481. The Subject device design, technology, and the principles of operation are the same as the Predicate device. The LUTRONIC GENIUS Radiofrequency System and the Predicate device are bipolar radiofrequency systems, with delivery methods through microneedles inserted from the handpiece and the tip. The LUTRONIC GENIUS Radiofrequency System and the Predicate device are minimally invasive radiofrequency devices employing bipolar microneedle electrode system. The Subject device has the same power, same treatment duration, needle diameter, and needle depth as the original device. Therefore, the minor differences do not raise any new safety and effectiveness questions because the LUTRONIC GENIUS parameters are similar to those of the Predicate device.

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Device	LUTRONIC GENIUSRadiofrequency System	INFINI Radiofrequency System
Manufacturer	Lutronic Corporation	Lutronic Corporation
510(k) #	K180945	K121481
Indication forUse	Dermatologic and generalsurgical procedures forelectrocoagulation andhemostasis.	Dermatologic and general surgicalprocedures for electrocoagulationand hemostasis, and thepercutaneous treatment of facialwrinkles
System Type	Bipolar RF (Radiofrequency)	Bipolar RF (Radiofrequency)
Frequency	460 KHz	1 MHz
Max OutputPower	50W	50W
OperationMode	Microneedle Fractional RF	Microneedle Fractional RF
TreatmentDuration(Time)	10 - 1000 msec	10 - 1000 msec
Tip	49 tip: 7x7 microneedles; 10x10 mmMicroneedle depth adjustment 0.5 -3.5 mm	49 tip: 7x7 microneedles; 10x10 mmMicroneedle depth adjustment 0.5 -3.5 mm
NeedleDiameter	200 micrometers	200 micrometers
Weight	27 kg	28 kg
Dimension	452 mm (W) x 582 mm (L) x 1540mm (H) RF (Radiofrequency)	362 mm (W) x 409 mm (L) x 1713mm (H) RF (Radiofrequency)

8. SUBSTANTIAL EQUIVALENCE TABLE

Lutronic has removed from the Subject device the percutaneous treatment of facial wrinkles as an Indication for Use. The LUTRONIC GENIUS Radiofrequency System and the INFINI Radiofrequency System have the same Indication for Use.

9. Performance Data

The following performance data were provided in support of the substantial equivalence determination:

Biocompatibility testing

Biocompatibility evaluation for the GENIUS handpiece tip body and microneedles was conducted in accordance with the FDA Blue Book memorandum #G95-1 "Use of the International Standard ISO-10993, Biological Evaluation of Medical Devices", and ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk

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Management Process," as recognized by FDA. The battery of testing included the following tests:

Cytotoxicity: ISO 10993 5 (2009) ●
Intradermal Irritation and Skin Sensitization: ISO 10993 - 10 (2010)
Acute Systemic toxicity: ISO 10993 11 (2017) & ISO10993 12 (2012) ●

Sterilization Validation

Sterilization validation of the GENIUS handpiece tip with microneedle array has been conducted per the standard ISO 10993 - 7 (2008) for Ethylene Oxide (standard ISO 11135 (2014)).

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on LUTRONIC GENIUS Radiofrequency System consisting of the console, main body and GENIUS handpiece. The system complies with the IEC 60601-1 standards for safety and the IEC 60601-1-2 standard for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

Ex Vivo Animal Study

An ex vivo animal study utilized a porcine tissue model and standardized H&E staining techniques to quantitatively compare the height, width and volume of thermal coagulative zones created by the LUTRONIC GENIUS and INFINI Radiofrequency Systems operating over a range of treatment parameters. No statistically significant differences in the coagulation profiles between the two systems were observed either in the ANOVA analyses for each measure or student t-tests for each parameter tested. When validating the affect of the design changes between the original device and the modified device, the LUTRONIC GENIUS Radiofrequency System fell within the 95% confidence interval of the INFINI Radiofrequency System for coagulation profile height, width and volume at each setting.

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Cleaning and Disinfection Testing

A low-level disinfection protocol and a cleaning protocol were developed for the LUTRONIC GENIUS Radiofrequency System's handpiece, the GENIUS handpiece, to mitigate cross-contamination. The study to validate the protocols conformed to 21 CFR Part 820 GMP and was based on the following references:

AAMI TIR12:2010, Designing, Testing, and Labeling Reusable Medical . Devices for Reprocessing in Health Care Facilities: A Guide for Medical Device Manufacturers. 7 September 2010.
AAMI TIR30:2011/(R)2016, A Compendium of Processes, Materials, Test . Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices, 15 December 2016.
ASTM E1837-96 (2014). Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices (Simulated Use Test), December 1, 2014.
ISO/IEC 17025, 2017, General Requirements for the Competence of Testing ● and Calibration Laboratories.
Guidance for Industry and Food and Drug Administrator Staff, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Document issued March 17, 2015. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluations.

No clinical data was provided in this submission.

10. Conclusion

The intended use, dermatologic and general surgical procedures for electrocoagulation and hemostasis, of the LUTRONIC GENIUS Radiofrequency System is identical to the intended use of the Predicate device, the INFINI Radiofrequency System. The technological characteristics of the LUTRONIC GENIUS Radiofrequency System are similar to the technological characteristics of the Predicate device. The Animal study demonstrates that the Subject and Predicate devices' coagulative effect on tissue are statistically equivalent for the same treatment parameters. Any differences between the LUTRONIC GENIUS Radiofrequency System and the Predicate device have therefore no significant influence on safety and effectiveness of the LUTRONIC GENIUS Radiofrequency System. Therefore, the LUTRONIC GENIUS Radiofrequency System is substantially equivalent to the Predicate device.

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.