(243 days)
Not Found
No
The description focuses on user-selectable parameters and controlled RF energy delivery, with no mention of AI or ML for decision-making or analysis.
No.
The intended use states the device is for "electrocoagulation and hemostasis", which are surgical procedures, not therapeutic ones.
No
The LUTRONIC GENIUS Radiofrequency System is intended for therapeutic purposes (electrocoagulation and hemostasis in dermatologic and general surgical procedures), not for diagnosing conditions.
No
The device description clearly outlines multiple hardware components including a system control module, RF power supply, handpiece with disposable tips, footswitch, handpiece hanger, and an LCD touch screen control panel. This is not a software-only device.
Based on the provided information, the LUTRONIC GENIUS Radiofrequency System 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 diagnostic test performed on a sample taken from the body.
- Device Description: The device description details a system that delivers radiofrequency energy via microneedles to coagulate tissue. This is a physical treatment method, not a method for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue biopsies, etc.) to diagnose a condition or provide information about a patient's health status.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. The LUTRONIC GENIUS system's function is to treat tissue directly.
N/A
Intended Use / Indications for Use
The LUTRONIC GENIUS Radiofrequency System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Product codes
GEI
Device Description
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.
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)
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 Management Process," as recognized by FDA. The battery of testing included 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.
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, AAMI TIR30:2011/(R)2016, ASTM E1837-96 (2014), ISO/IEC 17025, 2017, and 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. No clinical data was provided in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 Aesthetics
Lutronic Center, 219, Sowon-ro
Deogyang-gu, Goyang-si, Gyeonggi-do, 410-220
Republic of Korea |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James J Childs, Ph.D.
Clinical Science Director
Lutronic Aesthetics, Inc.
19 Fortune Drive
Billerica, MA 01863
jchilds@lutronic.com
Tele: 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
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
4
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.
5
| Device | LUTRONIC GENIUS
Radiofrequency System | INFINI Radiofrequency System |
|---------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Lutronic Corporation | Lutronic Corporation |
| 510(k) # | K180945 | K121481 |
| Indication for
Use | Dermatologic and general
surgical procedures for
electrocoagulation and
hemostasis. | Dermatologic and general surgical
procedures for electrocoagulation
and hemostasis, and the
percutaneous treatment of facial
wrinkles |
| System Type | Bipolar RF (Radiofrequency) | Bipolar RF (Radiofrequency) |
| Frequency | 460 KHz | 1 MHz |
| Max Output
Power | 50W | 50W |
| Operation
Mode | Microneedle Fractional RF | Microneedle Fractional RF |
| Treatment
Duration
(Time) | 10 - 1000 msec | 10 - 1000 msec |
| Tip | 49 tip: 7x7 microneedles; 10x10 mm
Microneedle depth adjustment 0.5 -
3.5 mm | 49 tip: 7x7 microneedles; 10x10 mm
Microneedle depth adjustment 0.5 -
3.5 mm |
| Needle
Diameter | 200 micrometers | 200 micrometers |
| Weight | 27 kg | 28 kg |
| Dimension | 452 mm (W) x 582 mm (L) x 1540
mm (H) RF (Radiofrequency) | 362 mm (W) x 409 mm (L) x 1713
mm (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
6
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.
7
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.